J. Stuart Showalter | Sallie Thieme Sanford LAW THE of Healthcare Administration T ENT H EDIT ION LAW THE of Healthcare Administration FM.indd 1 02/01/23 2:13 PM HAP/AUPHA Editorial Board for Graduate Studies Ning Lu, PhD, Chair Governors State University Julie Agris, PhD, FACHE SUNY at Stony Brook Robert I. Bonar, DHA George Washington University Kim C. Byas, Sr., PhD, FACHE Union Institute & University Lynn T. Downs, PhD, FACHE University of the Incarnate Word P. Shannon Elswick, FACHE University of Central Florida Cheryl J. Holden, DHS University of Arkansas – Fort Smith Diane M. Howard, PhD, FACHE Rush University Sandra S. Murdock, DrPH, FACHE Texas Woman’s University Kourtney Nieves, PhD, MSHS University of Central Florida Martha C. Riddell, DrPH University of Kentucky Gwyndolan L. Swain, DHA Belmont Abbey College Karen M. Volmar, JD, FACHE University of North Carolina at Chapel Hill Asa B. Wilson, PhD Southeast Missouri State University FM.indd 2 02/01/23 2:13 PM J. Stuart Showalter Sallie Thieme Sanford LAW THE of Healthcare Administration T ENT H EDIT ION Health Administration Press, Chicago, Illinois Association of University Programs in Health Administration, Washington, DC FM.indd 3 02/01/23 2:13 PM Your board, staff, or clients may also benefit from this book’s insight. For information on quantity discounts, contact the Health Administration Press Marketing Manager at (312) 424-9450. This publication is intended to provide accurate and authoritative information in regard to the subject matter covered. It is sold, or otherwise provided, with the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought. 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Riverside Plaza, Suite 1900 Suite 810 Chicago, IL 60606-6698 Washington, DC 20036 (312) 424-2800 (202) 763-7283 FM.indd 4 02/01/23 2:13 PM BRIEF CONTENTS Preface������������������������������������������������������������������������������������������������������xv Acknowledgments������������������������������������������������������������������������������������������� xxi Chapter 1. A Brief History of Law and Medicine�������������������������������� 1 Chapter 2. Access to Healthcare Insurance and Treatment���������������� 53 Chapter 3. The Organization and Management of a Corporate Healthcare Institution��������������������������������������������������� 111 Chapter 4. Human Resources Law������������������������������������������������� 151 Chapter 5. Contracts and Intentional Torts������������������������������������ 195 Chapter 6. Negligence�������������������������������������������������������������������� 227 Chapter 7. Liability of the Healthcare Institution��������������������������� 273 Chapter 8. Medical Staff Privileges and Peer Review����������������������� 309 Chapter 9. Fraud and Abuse Laws and Corporate Compliance������� 351 Chapter 10. Health Information Management���������������������������������� 403 Chapter 11. Emergency Care������������������������������������������������������������ 447 Chapter 12. Consent for Treatment�������������������������������������������������� 483 Chapter 13. Tax-Exempt Healthcare Organizations�������������������������� 537 Chapter 14. Competition and Antitrust Law������������������������������������� 571 Chapter 15. Issues of Reproduction and Birth���������������������������������� 609 List of Healthcare Law Abbreviations������������������������������������������������������ 659 Glossary������������������������������������������������������������������������������������������������� 663 Case Index��������������������������������������������������������������������������������������������� 671 Subject Index����������������������������������������������������������������������������������������� 682 About the Authors���������������������������������������������������������������������������������� 730 v FM.indd 5 02/01/23 2:13 PM FM.indd 6 02/01/23 2:13 PM DETAILED CONTENTS Preface.......................................................................................................xv Acknowledgments������������������������������������������������������������������������������������������� xxi Chapter 1. A Brief History of Law and Medicine�������������������������������� 1 Part 1: The History of Law����������������������������������������������� 1 The Historical Foundation of the US Legal System����������� 1 The Vast, Complex, and Dynamic Field of Healthcare Law������������������������������������������������������������������������������ 4 Major Sources of US Law and the Hierarchy of Authorities������������������������������������������������������������������� 5 Federal and State Court Systems������������������������������������� 14 Litigation Process������������������������������������������������������������ 20 A Turning Point in the Quest for Healthcare Justice������� 23 Discussion Questions for Part 1�������������������������������������� 27 Part 2: The History of Medicine������������������������������������� 30 The Pharaohs and Babylonians���������������������������������������� 31 Discussion Questions for Part 2�������������������������������������� 42 Chapter Summary����������������������������������������������������������� 43 Vocabulary���������������������������������������������������������������������� 43 Notes������������������������������������������������������������������������������ 44 Appendix 1.1: A Select Timeline of the History of Medicine�������������������������������������������������������������������� 48 Chapter 2. Access to Healthcare Insurance and Treatment���������������� 53 The US Healthcare System: Fragmented and Unequal��������������������������������������������������������������������� 53 A Century of Efforts to Achieve Broader Access to Care��������������������������������������������������������������������������� 58 Medicare and Medicaid: Healthcare’s Fraternal Twins at Middle Age������������������������������������������������������������� 62 The Affordable Care Act: Obamacare’s “Four M’s of Access”����������������������������������������������������������������������� 69 vii FM.indd 7 02/01/23 2:13 PM viii Det a iled C o n te n ts Legal Issues Related to Particular Populations and Facility Processes�������������������������������������������������������� 78 Final Thoughts: ACA Stability, Medicaid Universality, Medicare Commonality���������������������������������������������� 89 Chapter Summary����������������������������������������������������������� 90 Vocabulary���������������������������������������������������������������������� 90 Discussion Questions������������������������������������������������������ 90 Notes������������������������������������������������������������������������������ 99 Appendix 2.1: Medicare/Medicaid/CHIP Comparison�������������������������������������������������������������� 105 Appendix 2.2: History of Health Reform Efforts���������� 108 Chapter 3. The Organization and Management of a Corporate Healthcare Institution��������������������������������������������������� 111 Formation and Nature of a Corporation������������������������ 113 Responsibilities of Management������������������������������������ 127 Piercing the Corporate Veil������������������������������������������� 128 Multi-institutional Systems and Corporate Reorganization: The Independent Hospital and Independent Physician as Anachronisms������������������� 130 Alternative Corporate Strategies������������������������������������ 133 Collaborative Strategies with Physicians������������������������� 135 Chapter Summary��������������������������������������������������������� 138 Vocabulary�������������������������������������������������������������������� 139 Discussion Questions���������������������������������������������������� 139 Notes���������������������������������������������������������������������������� 146 Chapter 4. Human Resources Law������������������������������������������������� 151 Introduction����������������������������������������������������������������� 151 Who Is an Employee?���������������������������������������������������� 152 Types of Employment and Workforce Arrangements����� 154 Nondiscrimination Statutes������������������������������������������� 158 Labor Law�������������������������������������������������������������������� 168 Statutes Enforced by the US Department of Labor������� 174 State Employment Law������������������������������������������������� 176 Special Legal Challenges for HR Departments�������������� 177 Employee Relations Generally��������������������������������������� 180 Chapter Summary��������������������������������������������������������� 181 Vocabulary�������������������������������������������������������������������� 181 Discussion Questions���������������������������������������������������� 182 Notes���������������������������������������������������������������������������� 189 FM.indd 8 05/01/23 5:44 PM D etailed C ontents ix Appendix 4.1: Fair and Unfair Labor Practices�������������� 192 Appendix 4.2: Helpful Human Resources–Related Sites������������������������������������������������������������������������� 194 Chapter 5. Contracts and Intentional Torts������������������������������������ 195 Think Like a Lawyer����������������������������������������������������� 195 The Taxonomy of Law�������������������������������������������������� 196 Contracts and Intentional Torts as Bases of Liability�������������������������������������������������������������������� 196 Elements of a Contract������������������������������������������������� 197 The Provider–Patient Relationship�������������������������������� 200 Liability for Breach of Contract������������������������������������� 210 Liability for Breach of Warranty������������������������������������ 211 Intentional Torts����������������������������������������������������������� 212 Chapter Summary��������������������������������������������������������� 219 Vocabulary�������������������������������������������������������������������� 220 Discussion Questions���������������������������������������������������� 220 Notes���������������������������������������������������������������������������� 224 Chapter 6. Negligence�������������������������������������������������������������������� 227 Duty����������������������������������������������������������������������������� 227 Breach of Duty������������������������������������������������������������� 237 Causation, Injury, and Damages������������������������������������ 246 Defenses������������������������������������������������������������������������ 248 Liability for Acts of Others: Vicarious Liability�������������� 253 Countersuits by Physicians ������������������������������������������� 253 Reforming the Tort System������������������������������������������� 254 Chapter Summary��������������������������������������������������������� 257 Vocabulary�������������������������������������������������������������������� 257 Discussion Questions���������������������������������������������������� 258 Notes���������������������������������������������������������������������������� 264 Appendix 6.1: National Quality Forum’s Preventable Medical Errors���������������������������������������������������������� 270 Appendix 6.2: State Apology Laws�������������������������������� 272 Chapter 7. Liability of the Healthcare Institution��������������������������� 273 Background������������������������������������������������������������������ 273 Respondeat Superior Versus Independent Contractor Status����������������������������������������������������������������������� 275 Erosion of Physicians’ Independent Contractor Status����������������������������������������������������������������������� 277 FM.indd 9 02/01/23 2:13 PM x Det a iled C o n te n ts Erosion of Captain-of-the-Ship and BorrowedServant Doctrines����������������������������������������������������� 279 Doctrine of Corporate Liability������������������������������������� 281 Liability of Managed Care Organizations���������������������� 288 Chapter Summary��������������������������������������������������������� 293 Vocabulary�������������������������������������������������������������������� 293 Discussion Questions���������������������������������������������������� 294 Notes���������������������������������������������������������������������������� 303 Chapter 8. Medical Staff Privileges and Peer Review����������������������� 309 Overview���������������������������������������������������������������������� 309 The Medical Staff Organization������������������������������������� 310 Relationships Among Board, Management, and Medical Staff������������������������������������������������������ 311 Appointment of the Medical Staff��������������������������������� 312 Standards for Medical Staff Appointments��������������������� 313 Peer Review, Discipline, and the Health Care Quality Improvement Act����������������������������������������������������� 318 Lessons from Poliner and Kadlec����������������������������������� 328 Quality Issues and Accountable Care Organizations����������������������������������������������������������� 332 Chapter Summary��������������������������������������������������������� 339 Vocabulary�������������������������������������������������������������������� 340 Discussion Questions���������������������������������������������������� 340 Notes���������������������������������������������������������������������������� 345 Chapter 9. Fraud and Abuse Laws and Corporate Compliance������� 351 Introduction����������������������������������������������������������������� 351 The Enforcement Climate and Practical Challenges for Healthcare Providers������������������������������������������� 352 False Claims Act������������������������������������������������������������ 354 Anti-Kickback Statute���������������������������������������������������� 364 The Civil Monetary Penalties Law��������������������������������� 371 Stark (Physician Self-Referral) Law�������������������������������� 372 Foreign Corrupt Practices Act��������������������������������������� 379 Corporate Compliance Programs���������������������������������� 380 Chapter Summary��������������������������������������������������������� 383 Vocabulary�������������������������������������������������������������������� 383 Discussion Questions���������������������������������������������������� 383 Notes���������������������������������������������������������������������������� 390 FM.indd 10 02/01/23 2:13 PM D etailed C ontents xi Appendix 9.1: Summary of Major Fraud Statutes���������� 394 Appendix 9.2: OIG Advisory Opinion No. 22-01��������� 397 Chapter 10. Health Information Management���������������������������������� 403 Federal Law Sets the Floor for Privacy, Confidentiality, and Security Protections������������������������������������������� 403 HIPAA Privacy Rule for Covered Entities �������������������� 404 HIPAA (with HITECH) Security Rules and Breach Notification�������������������������������������������������������������� 410 State-Based Privacy Protections and Reporting Obligations��������������������������������������������������������������� 413 Emerging Federal and State Issues Relating to Telemedicine������������������������������������������������������������ 429 Chapter Summary��������������������������������������������������������� 431 Vocabulary�������������������������������������������������������������������� 432 Discussion Questions���������������������������������������������������� 432 Notes���������������������������������������������������������������������������� 440 Appendix 10.1: HIPAA Breach Notification������������������ 444 Chapter 11. Emergency Care������������������������������������������������������������ 447 A Federal Statutory Right to Emergency Treatment���������������������������������������������������������������� 447 The Need for Emergency Services��������������������������������� 449 Duty to Treat and Aid��������������������������������������������������� 450 EMTALA Enacted�������������������������������������������������������� 453 Post-Dobbs Legal Issues in Emergency Treatment���������� 467 Training of Hospital Staff���������������������������������������������� 468 Good Samaritan Statutes����������������������������������������������� 469 Chapter Summary��������������������������������������������������������� 471 Vocabulary�������������������������������������������������������������������� 471 Discussion Questions���������������������������������������������������� 471 Notes���������������������������������������������������������������������������� 475 Appendix 11.1: EMTALA Statutory Provisions������������� 479 Appendix 11.2: Coming to the Emergency Department�������������������������������������������������������������� 481 Chapter 12. Consent for Treatment�������������������������������������������������� 483 Types of Informed Consent and Recommended Procedures��������������������������������������������������������������� 484 The Healthcare Institution’s Role in Obtaining Informed Consent���������������������������������������������������� 488 FM.indd 11 02/01/23 2:13 PM xii Det a iled C o n te n ts How “Informed” Must Informed Consent Be?������������� 489 Surrogate Decision Makers for Patients Who Lack Decisional Capacity�������������������������������������������������� 493 Consent Issues for Minors��������������������������������������������� 494 Decision-Making Near the End of Life�������������������������� 503 End-of-Life Decision-Making for Patients Who Lack Decisional Capacity�������������������������������������������������� 507 Legislation and Protocols on End-of-Life Issues������������ 512 Chapter Summary��������������������������������������������������������� 519 Vocabulary�������������������������������������������������������������������� 519 Discussion Questions���������������������������������������������������� 520 Notes���������������������������������������������������������������������������� 528 Appendix 12.1: Comparison of POLST Form and Advance Directive����������������������������������������������������� 535 Chapter 13. Tax-Exempt Healthcare Organizations�������������������������� 537 Exemption Is the Exception������������������������������������������ 537 The History of Healthcare as a “Charitable” Endeavor������������������������������������������������������������������ 538 Federal Tax Exemption: The “Community Benefit” Standard ������������������������������������������������������������������ 541 State and Local Tax Exemption: Charitable Purpose, Exclusive Use, and Budgetary Pressures�������������������� 548 The Future of Healthcare Tax Exemption?�������������������� 554 Chapter Summary��������������������������������������������������������� 555 Vocabulary�������������������������������������������������������������������� 555 Discussion Questions���������������������������������������������������� 555 Notes���������������������������������������������������������������������������� 565 Appendix 13.1: Affordable Care Act Requirements for Exempt Hospitals������������������������������������������������ 568 Chapter 14. Competition and Antitrust Law������������������������������������� 571 Overview���������������������������������������������������������������������� 571 The Sherman Act���������������������������������������������������������� 572 The Clayton Act������������������������������������������������������������ 575 The Federal Trade Commission Act������������������������������ 580 Jurisdiction, Exemptions, and Immunity����������������������� 581 Sanctions and Enforcement of Antitrust Statutes����������� 585 Rule of Reason Analysis and Per Se Violations��������������� 586 Chapter Summary��������������������������������������������������������� 598 FM.indd 12 02/01/23 2:13 PM D etailed C ontents xiii Vocabulary�������������������������������������������������������������������� 598 Discussion Questions���������������������������������������������������� 599 Notes���������������������������������������������������������������������������� 604 Chapter 15. Issues of Reproduction and Birth���������������������������������� 609 Out with the Old ��������������������������������������������������������� 609 Federal Constitutional and Statutory Framework����������� 610 Abortion����������������������������������������������������������������������� 618 Other State-Law Reproduction Issues��������������������������� 631 Future Legal Issues Related to Reproduction and Birth������������������������������������������������������������������������� 642 Chapter Summary��������������������������������������������������������� 642 Vocabulary�������������������������������������������������������������������� 643 Discussion Questions���������������������������������������������������� 643 Notes���������������������������������������������������������������������������� 652 List of Healthcare Law Abbreviations������������������������������������������������������ 659 Glossary������������������������������������������������������������������������������������������������� 663 Case Index��������������������������������������������������������������������������������������������� 671 Subject Index����������������������������������������������������������������������������������������� 682 About the Authors���������������������������������������������������������������������������������� 730 FM.indd 13 02/01/23 2:13 PM FM.indd 14 02/01/23 2:13 PM PREFACE Overview This is the tenth edition of The Law of Healthcare Administration (LOHA), a work that was begun nearly 50 years ago by Professor Arthur F. Southwick of the University of Michigan. After Professor Southwick’s sudden death in 1997, the staff of Health Administration Press (HAP) needed someone to write the third edition. They eventually approached Stuart Showalter, who was then a vice president of the Catholic Health Association of the United States and an adjunct instructor in the master of health administration (MHA) program at the Washington University School of Medicine, St. Louis, Missouri. HAP had published Showalter’s study guide and set of case excerpts for the second edition of LOHA, and he had been using the book in his classes for several years. In the words of Robert Fromberg, then associate director and acquisitions editor at HAP, two assumptions argued against asking Showalter to take on the project: (1) that a textbook needed a full-time academic as its author, and (2) that an executive would not have the time to do a creditable job. “On the other hand, having an author who worked full time for a health system had a huge potential advantage—a practical bent,” Fromberg said. Subsequent history has proven the wisdom of HAP’s decision. Since 1999—from the third through the ninth edition—Showalter has offered a thorough and practical treatment of healthcare law in plain language for nonlawyer students of the field. We are excited to introduce Sallie Thieme Sanford, associate professor of law and adjunct associate professor of health systems and population health at the University of Washington in Seattle, as coauthor of this and future editions of LOHA. As a practicing attorney, Sanford represented the University of Washington’s medical centers and health sciences schools. Since entering academia nearly two decades ago, she has had the pleasure of teaching health law courses to MHA, executive MHA, and law students, as well as regularly presenting to student, professional, and academic audiences. xv FM.indd 15 02/01/23 2:13 PM xvi Prefa c e Drawing on their practice and teaching backgrounds, Showalter and Sanford aim to provide an accurate, accessible, and engaging textbook that helps students understand the law’s evolving, multifaceted role in the administration of healthcare entities. Like its predecessors, this edition provides a comprehensive overview of healthcare law, and its 15 chapters include substantial revisions and new material, including discussions of Dobbs v. Jackson Women’s Health (the US Supreme Court’s June 2022 decision that overturned the constitutional right to abortion), Biden-era Affordable Care Act (ACA) litigation and regulation, evolving antidiscrimination standards, the federal No Surprises Act, new fraud and abuse regulations, crisis standards of care, Good Samaritan overdose statutes, apology laws, and much more. This edition also features greater attention to issues of healthcare justice, raising questions about how the law might help or hinder efforts to create a better healthcare system for all. It employs inclusive language and highlights examples that involve nonhospital institutional providers (e.g., community health centers, nursing homes), and nonphysician individual providers (e.g., pharmacists, nurse practitioners). Each chapter incorporates thought-provoking discussion questions, captivating sidebars, practical advice, regulatory or case law excerpts, and “COVID Connections” that highlight the pandemic’s continuing influence on legal standards. Fundamentally, this textbook aims to help healthcare leaders succeed, whether they work at the smallest rural clinic or the largest multistate system. In any healthcare setting, they will need to navigate a complex, changing legal environment. While doing so, they will have opportunities to work with legal and policy tools to promote a more just, accessible, affordable, and quality care healthcare system. Inspired by their prior students, Showalter and Sanford offer this tenth edition to those aspiring to be the thoughtful, nimble, and transformative healthcare leaders of the future. Chapter Contents Chapter 1: A Brief History of Law and Medicine The chapter’s discussion of precedent, constitutional law, and federalism includes reference to the US Supreme Court’s 2022 Dobbs decision, which will have repercussions for law, medicine, and politics for years to come. Different types of legal authorities are highlighted in a new section that examines the law’s role in maintaining and then dismantling formal racial segregation in hospitals. Noting issues raised by COVID-19, there is an expanded discussion of public health law. In addition, the chapter provides more detail about the history of the nursing profession and the history of educational and practice opportunities for persons of color in health professions and administration. FM.indd 16 02/01/23 2:13 PM Prefac e xvii Chapter 2: Access to Healthcare Insurance and Treatment With the increasing solidity of the ACA and the growth of Medicare and Medicaid, federal law is now the driving force behind access to healthcare insurance. Thus, federal programs are increasingly influential in shaping payment and delivery systems. This chapter includes clear details about Medicare, Medicaid, the Children’s Health Insurance Program, accountable care organizations, and the ACA’s “four M’s of access.” The US Supreme Court’s 2021 individual mandate decision in California v. Texas is explained and excerpted. The chapter also includes a section on the evolving standards for the applicability of antidiscrimination laws to the provision of healthcare. Finally, appendices detail health reform efforts over the years and compare the primary federal healthcare insurance programs. Chapter 3: The Organization and Management of a Corporate Healthcare Institution New to this chapter are details about Federally Qualified Health Centers and their board structure requirements, as well as discussion of board members’ duty of obedience. It also features an expanded discussion of professional limited liability corporations and joint venture arrangements. The potential implications of the corporate practice of medicine doctrine and state open meetings laws are noted. Chapter 4: Human Resources Law Incorporated into an expanded antidiscrimination section is discussion of the US Supreme Court’s 2020 decision in Bostock v. Clayton County, which held that the statutory prohibition on sex discrimination includes discrimination based on sexual orientation or gender identity. Also included are the evolving legal standards around COVID-19 vaccine mandates for healthcare workers and increasingly prominent conscience protections. Finally, the chapter includes a list of key federal labor statutes and practical tips for conducting legally appropriate job interviews. Chapter 5: Contracts and Intentional Torts This chapter now includes information about “noncompete” provisions in physician contracts and updated examples of explicit warranties for treatment results. It also raises questions about termination of treatment and its possible connection to healthcare inequities. Also discussed are the types of damages generally available under different causes of action. Chapter 6: Negligence Medical malpractice cases arising during the COVID-19 pandemic are likely to be affected, implicitly or explicitly, by “crisis standards of care,” which are explained in this chapter. Also new to the chapter are discussions of state laws FM.indd 17 02/01/23 2:13 PM xviii Prefa c e regarding apologies for medical errors and an expanded section on settlement negotiations and mandatory arbitration clauses. Chapter 7: Liability of the Healthcare Institution This chapter includes more details about liability issues involving managed care organizations, as well as a revised explanation of the multifaceted impacts of the federal Employee Retirement Income Security Act of 1974. It also reviews the No Surprises Act, which went into effect in 2022, protecting patients from many out-of-network charges and creating potential conflicts between insurers and providers. Chapter 8: Medical Staff Privileges and Peer Review This chapter recognizes the increased focus on population health with an expanded discussion of ACOs and quality metrics. It also adds details about credentialling issues related to complementary and alternative medicine and integrative healthcare. Chapter 9: Fraud and Abuse Laws and Corporate Compliance The federal False Claims Act, Anti-Kickback Statute, and Stark law present huge liability risks and significantly affect provider contracting; they also are notoriously difficult to understand. Thus, with this edition, we moved the topic earlier in the book and simplified its organizational structure. We have included discussion of new safe harbors and exceptions that are aimed at supporting population health and value-based payment arrangements. The appendices contain an excerpt of a recent advisory opinion and a summary of the major federal fraud and abuse laws. Chapter 10: Health Information Management Reflecting the importance of federal law in this area, this chapter centers on the Health Insurance Portability and Accountability Act (HIPAA), with expanded details on breach notification, the 21st Century Cures Act, and telemedicine. State-law causes of action, and their intersection with HIPAA, are highlighted by inclusion of a case in which a pharmacy and pharmacist were found liable for improper disclosure of protected healthcare information. Chapter 11: Emergency Care This chapter focuses on the Emergency Medical Treatment and Labor Act (EMTALA), with an expanded discussion of practical issues that arise when attempting to ensure compliance with its requirements. It also highlights some of the legal issues that emergency providers will face in providing medically appropriate treatment to pregnant patients in light of new state abortion restrictions enacted post-Dobbs. Newer emergency-related laws are FM.indd 18 02/01/23 2:13 PM Prefac e xix also discussed, including the federal No Surprises Act, as well as state Good Samaritan overdose laws and emergency preparedness requirements. Chapter 12: Consent for Treatment This chapter includes discussion of the emerging idea of shared decisionmaking and its linkages to patient knowledge, payment conditions, and malpractice protections. It also explains state law changes related to surrogate decision makers. It also broadens the discussion of circumstances in which minors have the authority to consent to their own treatment. Chapter 13: Tax-Exempt Healthcare Organizations The ACA’s enhancements to the 501(c)(3) standards for tax exemption drive much of the activity in this area. This chapter now includes an appendix that excerpts Internal Revenue Service compliance guidance with respect to these standards. It also features more details about tax implications of joint ventures between for-profit and not-for-profit healthcare entities and explains the uses of unrelated business income taxation and intermediate sanctions for excess benefit transactions. Chapter 14: Competition and Antitrust Law The healthcare sector has seen a spate of mergers, acquisitions, and alliances in recent years, drawing the attention of antitrust enforcers, whether federal, state, or private. This consolidation activity is reflected in the chapter’s updated analyses and case law. It notes that possibly anticompetitive activity might involve not only hospitals and physician groups but also insurers, pharmacies, and newer entrants into the healthcare arena. Chapter 15: Issues of Reproduction and Birth In June 2022, the US Supreme Court overruled nearly 50 years of precedent and held that there is no federal constitutional right to abortion. This chapter explains the ruling and includes excerpts from the majority, concurring, and dissenting opinions. It also flags potential challenges for institutional and individual providers as they navigate new laws that restrict abortion and create criminal, civil, or licensure risk. The chapter includes a new section on access to insurance coverage for birth control and abortion, features a recent state case grounded in theories of wrongful birth and wrongful life, and discusses newer state laws that provide a legal framework for compensated surrogacy. FM.indd 19 02/01/23 2:13 PM xx Prefa c e Instructor Resources This book’s Instructor Resources include a test bank; PowerPoint presentations; an updated instructor’s manual with chapter overviews, answers to end-of-chapter discussion questions, answers to end-ofcase discussion questions; and a transition guide to the new edition. For the most up-to-date information about this book and its Instructor Resources, visit ache.org/HAP and search for the book’s order code (2481I). This book’s Instructor Resources are available to instructors who adopt this book for use in their course. For access information, please email hapbooks@ache.org. FM.indd 20 02/01/23 2:13 PM ACKNOWLEDGMENTS It has been a privilege to work on this new edition, both humbling and enlightening to grapple with new material and how best to present it. Throughout, we were inspired by our current and former students and the key roles that they play in our complicated healthcare system. Our work was vastly improved by the help of many others. Carly E. Zipper provided outstanding research assistance and thoughtful, timely editorial comments. Mary Whisner and other University of Washington (UW) reference librarians skillfully tracked down sources, and UW editor Cindy Fester advised on matters of legal citation and style. We also benefited from advice given by exceptional lawyers and teachers, including Doug Ross, Jeff Sconyers, and Rosemary Daszkiewicz, who provided extensive, substantive comments on specific chapters, as well as Joseph Topinka, Shawn Mathis, and Frank Hackmann, each of whom has adopted prior editions of the book as the text for their classes. At HAP, La’Toya Carter, Kevin McLenithan, Nancy Vitucci, and others smoothly shepherded the textbook to completion. And lastly, Deborah A. Ring was our final editorial check on the entire manuscript. We are profoundly grateful to all these helping hands, and any errors or omissions that may have escaped notice are our responsibility. We are also indebted to our families. Chris Sanford provided Sallie with love, support, and encouragement, magnified by that from their boys, Nate and Henry. For his part, Stuart thanks his extended family (which now includes three grandchildren) for putting up with his isolationism while researching and writing eight previous versions of the text over the past quarter century. Both of us and, to be sure, our kin, look forward to the book’s appearance and a return to other endeavors—at least until it is time for the eleventh edition. xxi FM.indd 21 02/01/23 2:13 PM FM.indd 22 02/01/23 2:13 PM CHAPTER A BRIEF HISTORY OF LAW AND MEDICINE 1 A page of history is worth a volume of logic. —Justice Oliver Wendell Holmes Jr. (New York Trust Co. v. Eisner, 256 U.S. 345, 349 [1921]) L aw is ancient; medicine is a relative newborn. A bit of history will help put these two disciplines in perspective. What follows in this first chapter is historical synthesis, neither the product of primary research nor drawn from any one or even a few secondary sources. Instead, it is a collection of harmonious facts, opinions, and sentiments drawn from varied perspectives, reviews of the literature, and the authors’ personal experiences. It is intended to give the reader a feel for what some might call the “crossroads” of law and medicine and to set the stage for a thoughtful overview of the law as it relates to healthcare administration. PART 1: THE HISTORY OF LAW After reading part 1 of this chapter, you will • understand that US law comes from four basic sources; • know that healthcare administration is subject to a complex, dynamic mix of federal and state law; • appreciate the balance of power between the branches of government; • know the basics of the state and federal court structures; and • be familiar with basic aspects of legal procedure. The Historical Foundation of the US Legal System It is reasonable to assume that laws—rules for human interaction—have existed in some form since the first sentient beings roamed the Earth. The oldest known written laws were proclaimed nearly four millennia ago 1 CH01.indd 1 02/01/23 1:52 PM 2 T h e L aw o f H e a l th c a re A d mi n i stra ti o n EXHIBIT 1.1 Code of Hammurabi common law The body of law based on judicial precedents, as distinct from statutory law; its historical roots are found in the traditional laws of England that developed over many centuries and were carried over to the American colonies and thus the United States. CH01.indd 2 by King Hammurabi of Babylon. They were inscribed on an 8-foot-tall black stela (stone pillar), lost for centuries but rediscovered in 1901 (see exhibit 1.1). Dubbed the “Code of Hammurabi,” it is an example of lex talionis (law of retaliation), under which a person who injures another is to be given a specific punishment appropriate for the crime. For example, in Hammurabi’s realm, adultery and theft were punishable by death, and a surgeon who caused injury risked a hand amputation. This latter provision may have been the first version of malpractice law known to humankind. In addition to these harsh “eye for an eye, tooth for a tooth” standards, the code contained rules for everyday social and commercial affairs—sale and lease of property, maintenance of lands, commercial transactions (contracts, credit, debt, banking), marriage and divorce, estates and inheritance, and criminal procedure. As a result of Hammurabi’s reputation as a lawgiver, depictions of him can be found in several US government buildings, including the US Capitol and the US Supreme Court. In later centuries, other concepts helped law to evolve. Aristotle spoke of natural law—the idea that there exists a body of moral principles common to all persons and recognizable by reason alone—as distinct from positive law (formal legal enactments).1 In Leviathan, an important work of seventeenth-century political thought, Thomas Hobbes described law as a “social contract” between the individual and the state in which people agree to obey certain standards in return for peace and security. Without that implicit agreement and adherence to law, Hobbes famously wrote, people would be in a constant state of war and life would be “solitary, poor, nasty, brutish, and short.” These and other schools of thought—including utilitarianism, strict constructionism, and libertarianism—have influenced the US legal system over the centuries. One can, of course, study law by merely reading statutes and judicial decisions, but it helps to be aware of some of these philosophies because they lie at the root of American common law. Anglo-American law can be traced back more than a millennium, to the time when the Anglo-Saxon inhabitants of what was to become England tried to centralize their disparate kingships to ward off enemies 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine and maintain peace. In the process, they created a legal system that would eventually prevail throughout England—hence the term common law. That system included certain concepts that are familiar today: writs (court orders); the offices of sheriff, bailiff, and mayor; taxation; complex legal record keeping; the use of sworn testimony; and stare decisis (respect for legal precedent). In its broadest sense, law is a system of principles and rules devised by organized society or groups in society to set norms for human conduct, resolve disputes, and prevent anarchy. As retired US Supreme Court Justice Stephen Breyer explained, “Law . . . grows out of communities of people who have some problems they want to solve.”2 One valid critique of legal systems, including that of the United States, is that they often serve to maintain power structures and protect wealth at the expense of addressing problems in the broader community. This is one of the reasons for the push to include in lawmaking roles people with diverse backgrounds and experiences. Because law is concerned with human behavior, it is not an exact science. Indeed, “it depends” is a law instructor’s most frequent answer to students’ questions. This response is frustrating for both the students and the instructor, but it is honest. Law provides only general guidance; it is not an exact blueprint for living. It evolves over time, adapts to new circumstances, and can be highly fact dependent. As undesirable as hardening of the arteries, legal sclerosis would result in a debilitating lack of progress and innovation. Viewed in proper light, therefore, law is a landscape painting that captures the beliefs of a society at a certain moment in time. However, it is not static; it is a work in progress, a constantly changing piece of art—a hologram, perhaps—that moves with society. Most often, it moves at a glacial pace—slowly and quietly, the land shifting slightly beneath it. At other times, law moves seismically, as was the case in 2010 with the passage of a legislative temblor known as the Affordable Care Act (ACA), sometimes referred to as “Obamacare.”3 Despite outcries from some segments of the political spectrum, dozens of attempts to repeal it, and countless court battles, the US Supreme Court has upheld the constitutionality of the central aspects of the law. Indeed, the ACA has survived three near-death experiences at the Supreme Court, setting important constitutional precedents in the process. Most of the ACA’s key healthcare access reforms took effect in 2014, and the aftershocks of these and myriad other reforms will be felt for years. Until the dust settles completely, we will not know how much the act has altered the legal topography (see chapter 2 for more information about the ACA’s access provisions). Another earthquake shook the law and the country on June 24, 2022, when the US Supreme Court overruled Roe v. Wade, ending nearly 50 years of a constitutionally protected right to abortion. The decision, Dobbs v. Jackson Women’s Health Organization,4 allows states (and perhaps the federal CH01.indd 3 3 law A system of standards to govern the conduct of people in an organization, community, society, or nation. Affordable Care Act (ACA) The health reform law enacted by Congress in 2010; full name: Patient Protection and Affordable Care Act, Pub. L. No. 111-148. The ACA’s access provisions are discussed more fully in chapter 2. Other aspects of the ACA are incorporated into other chapters. 02/01/23 1:52 PM 4 T h e L aw o f H e a l th c a re A d mi n i stra ti o n government) to ban, criminalize, reaffirm, or expand abortion access. The aftershocks began that same day as “trigger laws” went into effect in several states prohibiting most abortions. A tsunami of legislation and litigation was expected to follow in short order. As of the summer of 2022, many questions remained unresolved: what exceptions are legally required or permitted; how providers might apply the exceptions given potential legal and licensure risks; what steps states can legally take to restrict medication abortions; whether a state can reach across its borders to criminally charge an abortion provider; what the restrictive laws mean for prenatal counseling, birth control access, and assisted reproduction procedures; and whether an individual can bring a cross-border civil lawsuit against those that facilitate abortion access. Healthcare providers, both institutional and individual, are likely to find themselves on unsteady ground as they navigate new state laws regardless of where in the country they practice. The Dobbs decision’s potential effects on access to reproductive healthcare are explored most fully in chapter 15. Other issues raised by the decision are discussed later in this chapter and in many others. The Vast, Complex, and Dynamic Field of Healthcare Law The US healthcare system is vast, complex, and dynamic, so it should come as no surprise to learn that the relevant body of law shares these characteristics. The law permeates today’s healthcare field because the US medical system is perhaps the most heavily regulated enterprise in the world. It is subject not only to the legal principles that affect all businesses (everything from antitrust to zoning) but also to myriad provisions that are peculiar to healthcare. Historically the field was dominated by state law, but federal law has become increasingly dominant, starting with the adoption of Medicare and Medicaid in 1965 and accelerating with the many provisions set forth in the ACA of 2010. Our goal is not to turn you into lawyers. (Though if you decide to go on to law school, we would not be disappointed.) Instead, whether you plan to be a healthcare administrator, regulator, or advocate, we aim to help you better appreciate the role of the law in shaping how medical care is delivered and paid for in the United States. In your future careers, we hope you will be able to identify legal issues when they arise, resolve them when possible, and recognize when you need to consult with a lawyer. With a solid overview of this fascinating area of law, you should be better prepared to manage healthcare entities effectively, thoughtfully, and nimbly. You should have a better understanding of the legal tools available to effectuate change. And you should be better equipped to comment thoughtfully on proposed healthcare laws or regulations. With those goals in mind, as you study the interrelated CH01.indd 4 02/01/23 1:52 PM 5 C h ap ter 1: A Br ief H istor y of L aw and Medic ine topics included in this textbook, consider how the law helps or hinders efforts to create a more equitable, accessible, affordable, and quality healthcare system. Major Sources of US Law and the Hierarchy of Authorities Law in Action: Tips for ­Working with Attorneys You are certain to interact with lawyers at different points in your career. Following are a few tips to keep in mind: • An organization’s lawyer represents the organization, not any individual who works for it. What an individual says to the attorney might need to be passed along to others in the organization. • Always be truthful. Do not hide facts from your attorney if you want good advice. (Garbage in, garbage out.) • The “attorney–client privilege” relates only to specific sorts of communications. A communication is not entitled to the privilege merely because someone stamps it so or copies a lawyer on the communication. • Seek advice early. Lawyers would rather help clients avoid problems than deal with a situation after mistakes are made. • The lawyer gives legal advice. The client uses that advice to make business decisions. • “It depends” is a common answer. It is the rare legal question that has a simple yes/no answer. Often the answer depends on the specific facts and other variables and will live somewhere in a gray area. The individual’s or organization’s risk tolerance will usually guide the ultimate decision. • Emails live forever. Before you send one, think how it would look as a headline in the local newspaper or as a trial exhibit. There are four major sources of law in the United States. In rough order of hierarchy, they are constitutions, statutes, regulations, and judicial decisions. This hierarchal order is rough because judicial decisions, at the bottom of the list, are interpretations of the meaning of constitutions, which are at the pinnacle. ­Similarly, statutes can change judge-made common law, and judicial decisions can void improperly enacted regulations. All four sources of law exist at both the federal and state levels. Federal law trumps conflicting state law. It is not always obvious, though, whether federal and state law are in direct conflict, or whether the laws of the different sovereigns can coexist, both to be followed by the regulated entity. You will learn about this sort of interpretive challenge, for example, when studying how the federal healthcare privacy and security statute (the Health Insurance Portability and Accountability Act of 1996) intersects with state law in this arena (see chapter 10). State laws often vary and even conflict with one another. This feature of our federalist system—some might even say one of its great virtues—­ provides a “laboratory of the states” in which to test different approaches. If there is no conflict with federal law, this variability from state to state does not pose a problem for the legal system, but it can present challenges for multistate healthcare operations. For example, one state might have a broad scope of practice for nurse practitioners, while its neighbor limits what nurse practitioners can do. Similarly, some states require government-granted “certificates of need” for CH01.indd 5 02/01/23 1:52 PM 6 T h e L aw o f H e a l th c a re A d mi n i stra ti o n expanded healthcare operations, while other states abandoned those requirements long ago. It will be your job as a healthcare executive to comply with the laws and regulations in your particular service area and to advocate for change when needed. This aspect of federalism will be severely tested by the patchwork of conflicting state (and perhaps federal) laws going into effect in the wake of the Dobbs decision. One state might vigorously protect the right to abortion and those who facilitate it, while a neighboring state might criminalize abortion in most circumstances and aggressively prosecute those who facilitate it. And all sorts of novel legal issues are raised by “bounty hunter” state statutes that purport to allow their state residents to bring a civil lawsuit against a person or entity elsewhere in the United States who aids or abets a resident of their state in obtaining an abortion. Experts predict that within a year of the Supreme Court’s Dobbs decision, about half the states will prohibit or severely restrict abortion. During that time, the federal government may attempt to limit the impact of some of those laws—for example, regarding medication access, information privacy, or travel protections—and it is conceivable that one political party or the other in Congress might be able to pass a statute setting a national standard either legalizing or prohibiting abortion. One thing is certain, however: our federalist system will be strained by new political and legal battles among the states as well as between the states and the federal government. Constitutions The US Constitution is aptly called the “supreme law of the land” because it sets standards against which all other laws are judged. In other words, whether good, bad, or ugly, a law must be constitutional. With respect to the federal government, this means both that Congress must have the constitutionally grounded power to enact the law (e.g., its taxing and spending authority) and that the law must not violate any other constitutional protections (e.g., the protection for freedom of speech). The US Constitution establishes the three branches of the US government: the executive branch, legislative branch, and judicial branch (see exhibit 1.2). It also grants specified powers to the federal government and guarantees essential individual rights. The Constitution is a grant of power from the states to the federal government (see Legal Brief). All powers not granted to the federal government in the Constitution are reserved by the individual states. This grant of power to the federal government is both express and implied. For example, the Constitution expressly authorizes the US Congress to levy and collect taxes and to regulate interstate commerce. Congress may also enact laws that are “necessary and proper” to carry out these express powers. Thus, the power to tax also includes the power to spend, such as expenditures in support of the Medicare program, and the CH01.indd 6 02/01/23 1:52 PM 7 C h ap ter 1: A Br ief H istor y of L aw and Medic ine 1. Impeach and convict; confirm or block permanent appointments 2. Appoint judges 3. Approve or veto legislation 4. Draft legislation; override vetoes 5. Interpret laws and regulations 6. Establish court system; amend laws to cure defects 7. Change regulations to cure defects EXHIBIT 1.2 Checks and Balances 1 1 2 3 7 Executive Legislative 4 Judicial 5 5 6 power to regulate interstate commerce encompasses the power to pass antidiscrimination legislation, such as the Civil Rights Act of 1964. The main body of the Constitution establishes, defines, and limits the power of the three branches of the federal government: 1. The legislature (Congress) has the power to enact statutes. 2. The executive branch has the power to enforce the laws. 3. The judiciary has the power to interpret the laws. Twenty-seven amendments follow the main body of the Constitution. The first ten are known as the Bill of Rights; they were ratified in 1791, just two years after the Constitution took effect (see Legal Brief). The rights specifically secured by the Bill of Rights include • freedom of religion, speech, and press; • the rights of assembly and petition; • the right to bear arms; • protection against unreasonable searches and seizures; CH01.indd 7 Legal Brief The United States is not a union; it is a federation (from the Latin word foedus, meaning “covenant”) of 50 self-governing states that have ceded some of their sovereignty to the central (federal) government to promote the welfare of all. 02/01/23 1:52 PM 8 T h e L aw o f H e a l th c a re A d mi n i stra ti o n due process of law The administration of justice according to established rules and principles meant to ensure that a person is not unfairly deprived of life, liberty, or property. • rights in criminal and civil cases (e.g., jury trial, self-incrimination); and • the right to substantive and procedural due process of law. The Ninth Amendment specifies that “[t]he enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.” Among the unenumerated rights identified and upheld by the US Supreme Court are the right to travel and the right of privacy. Of the 17 other amendments, two canceled each other: the Eighteenth Amendment, which established Prohibition, and the Twenty-First, which repealed the Eighteenth. Thus, as of this writing, only 15 substantive changes have been made to the basic structure of US government since 1791. Read literally, the Bill of Rights applies only to the federal government. However, the US Supreme Court has held that most of the rights set forth in those ten amendments also apply to the states under the Fourteenth Amendment. (This is an example of judicial interpretation, which is discussed in greater detail in the following section on statutes.) In addition to the US Constitution, each state has its own constitution. A state’s constitution is the supreme law of that state, but it is subordinate to the federal Constitution. State and federal constitutions are similar, although state constitutions are more detailed and sometimes more protective of individual rights. Native American tribes also have constitutions, which are the supreme law in those jurisdictions. A few states’ constitutions include privacy protections, either explicitly or as interpreted by their courts. Less than a week after the US Supreme Court’s 2022 decision that the US Constitution’s unenumerated right of privacy does not include a right to abortion, a Florida court cited privacy protections in the Florida constitution to temporarily block that state’s 15-week abortion ban, which sprang into effect when the Dobbs decision was handed down.5 This will be one of many decisions concerning state constitutional protections in this arena. Efforts to amend state constitutions to explicitly protect the right to choose or, conversely, efforts to explicitly protect the unborn from the moment of conception, can also be expected. The Fourteenth Amendment was adopted after the Civil War. It is an important (and much litigated) source of substantive and procedural rights. Its first section reads in part, “No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any ­person . . . the equal protection of the laws.” CH01.indd 8 Statutes At the federal level, Congress enacts statutes (written laws). After a bill has passed both the House of Representatives and the Senate, it becomes law if the president signs it. If the president vetoes the bill, Congress can override a veto with enough votes and the provision will become law despite the president’s veto. Federal laws 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine are codified in the United States Code (abbreviated U.S.C.). A major law may have provisions found in many different sections of the United States Code. The ACA is a good example: its provisions are codified in several sections of the United States Code, including those that deal with taxes, with Medicaid, and with employment. State legislatures enact statutes through similar processes and have similar codification systems (often readily available on state government websites). Local government authorities (including cities and counties) are also empowered to enact laws, which are sometimes known as ordinances. Enactments by federal, state, and local authorities all can apply simultaneously to a healthcare organization. For example, a not-for-profit hospital that wants to be exempt from taxes will strive to meet the exemption standards not only of the federal government, but also of the state government and perhaps a local taxing authority such as the city or county. The tax-exemption standards of these different jurisdictions are likely to be similar but not identical. To further complicate matters, although statutes (and their implementing regulations) should be drafted so that they are clear enough for people to understand what is required and what is not, absolute clarity is rarely possible. Statutes are somewhat general, and questions almost always arise about their meaning or their application to a particular case, particularly in a novel situation. For this reason, courts (in the person of judges) are often called upon to engage in judicial interpretation—that is, to explain the meaning of the statutory language. Rules of construction help judges interpret statutes. In some states, rules of construction are themselves the subject of a separate statute. Some of the more common rules of construction include the following: • Absent a contrary definition in the statute, words must be given their plain, ordinary, and literal meaning, even if the legislative intent might suggest a different interpretation. (This is the plain meaning rule.) • Despite the plain meaning rule, a statute should be internally consistent, so that the meaning of one provision is not divorced from the functioning of the rest of the law. • Interpretation of a provision’s meaning should be consistent with the stated intent of the legislature and should give effect to all the statute’s key provisions. • If a provision is unclear, the statute’s purpose, the result to be attained, its legislative history, and the consequences of one interpretation over another are among the analytical factors that might be considered. 9 judicial interpretation The way the judiciary explains or clarifies the meaning of a legal provision and applies it to a specific case. Judicial interpretation can involve the meaning of language in a constitution, statute, or regulation; it can also involve the meaning of contracts, prior court decisions, or other writings pertinent to the issue at hand. These “rules” are not inflexible, and judges often disagree about how to apply them, but the rules do help one to ascertain the meaning of statutory provisions and their application to individual cases. Consider these rules CH01.indd 9 02/01/23 1:52 PM 10 T h e L aw o f H e a l th c a re A d mi n i stra ti o n when you read the US Supreme Court’s discussion in King v. Burwell (see chapter 2) of what is meant by the ACA’s phrase “established by the State.” Judicial interpretation, whether it involves constitutions, statutes, regulations, or other language, is the pulse of the law, and numerous examples can be found throughout this text. Readers should be alert for them and try to discern the different philosophies of interpretation reflected in the majority, concurring, and dissenting opinions. Administrative Regulations administrative law The branch of law that concerns the creation and powers of administrative agencies, the rules and regulations those agencies make, and the relationships among the agencies and the public at large. The third major source of law is particularly important in the healthcare arena: administrative regulations. At the federal level, Congress typically delegates to one or more federal agencies the job of fleshing out the practical specifics of a statute that it enacts. State legislatures do the same. If, as we often hear, “the devil is in the details,” those details are found in agency-promulgated regulations and less formal pronouncements such as FAQs, guidance documents, and enforcement memoranda. These subregulatory materials do not quite have the force of law, but they provide key insights into how the agency views the legal requirements and its own responsibilities in enforcing them. Administrative agencies are not mentioned in the US Constitution, but they are extremely important actors that have considerable power in what is sometimes termed our evolving “administrative state.” Agencies have powers that are akin to the three branches of government. That is to say, they have quasi-legislative power when they write regulations; they have executive power when they conduct investigations and seek to enforce their rules; and they perform quasi-judicial functions when they adjudicate disputes over potential violations. On a day-to-day basis, healthcare personnel are typically far more concerned with the details of administrative regulations than they are with the legal principles found in constitutions, statutes, or judicial decisions. Administrative law is the type of public law that deals with the rules of government agencies, and it has greater scope and significance than some people realize. This fact was noted more than two centuries ago by the Irish and British statesman Edmund Burke (1729–1797), who, when writing about the government of England, stated, The laws reach but a very little way. Constitute government how you please, infinitely the greater part of it must depend upon the exercise of powers, which are left at large to the prudence and uprightness of ministers of state. [A]ll the use and potency of the laws depends upon them. Without them your commonwealth is no better than a scheme upon paper, and not a living, active, effective organization.6 Administrative agencies exist at all levels of government: local, state, and federal. Well-known federal agencies that affect healthcare include the National Labor Relations Board (NLRB), Centers for Medicare & Medicaid CH01.indd 10 02/01/23 1:52 PM 11 C h ap ter 1: A Br ief H istor y of L aw and Medic ine Services (CMS), Internal Revenue Service (IRS), US Department of Health and Human Services (HHS), Federal Trade Commission (FTC), and Food and Drug Administration (FDA). State-level administrative agencies include boards of professional licensure, Medicaid agencies, workers’ compensation commissions, zoning boards, and numerous other agencies whose rules affect healthcare organizations. Delegation of rulemaking authority puts this responsibility in the hands of experts, but the enabling legislation stipulates the standards to be followed by an administrative agency when it writes the regulations. At the federal level, the Administrative Procedure Act (5 U.S.C. §§ 551–559) specifies the processes that agencies must follow to enact regulations and the circumstances (e.g., public health emergencies) under which those rules can be waived or their timelines shortened. In general, to commence a rulemaking, a federal agency must publish in the Federal Register (in print and online) a notice of proposed rulemaking indicating what it intends to do and seeking public comment. Anyone may submit comments, and as a healthcare administrator, you Legal Brief might well be tapped to help draft comments that will be submitted on behalf of your organization or a professional Statutes are “no better than a scheme upon paper,” association. Public comments are also a to use a phrase from Edmund Burke (1729–1797), way for healthcare advocates to elevate a British statesman, economist, and philosopher. the voices of patients and others who may Their effectiveness depends on the expertise of the personnel within the administrative agencies. be affected by a proposed rulemaking. Agency personnel are charged with putting meat Absent an emergency, this process is rarely on the statutory bones by drafting regulations, quick, and when there are many competconsistent with the Administrative Procedure Act, ing views or changes in executive branch and publishing other interpretive and enforcement leadership, it can drag out for quite some guidelines. Courts often defer to administrative regtime. For example, it took 11 years for the ulations and interpretations, thus giving agencies significant power to interpret and enforce the laws. first regulations to be issued to implement The question of when judicial deference is the federal Emergency Medical Treatappropriate has both legal and political implicament and Labor Act (EMTALA) of 1986. tions, and at least two schools of thought have When it publishes the final rule, emerged. Chevron deference, a term coined after the agency will include a preamble setting a US Supreme Court case involving the Chevron out its rationale for the regulatory decioil company, holds that if a statute is ambiguous, the courts should defer to an agency’s interpretasions it made and how it accounted for tion so long as that interpretation is reasonable the comments it received. The final rule (Chevron U.S.A., Inc. v. Natural Resources Defense will be published in the Code of Federal Council, Inc., 467 U.S. 837 [1984]). Regulations (abbreviated C.F.R.). States On the other hand, Skidmore deference, have similar procedures for rulemaking by so called for a 1944 Supreme Court case and their agencies and similar regulatory com(continued) pilations. To survive a legal challenge, a CH01.indd 11 02/01/23 1:52 PM 12 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) revitalized in 2000, narrows the scope of Chevron deference. The Skidmore viewpoint holds that (1) an agency’s policy statements, manuals, enforcement guidelines, and other subregulatory interpretations do not warrant deference and are “entitled to respect” only to the extent that they are persuasive; and (2) an agency’s interpretation of its own regulation is warranted “only when the regulation’s language is ambiguous” (Christensen v. Harris County, 529 U.S. 576, 588 [2000], citing Skidmore v. Swift & Co., 323 U.S. 134 [1944]). Aside from the Chevron and Skidmore approaches, the makeup of the US Supreme Court in June 2022 suggested a reluctance to give any deference to administrative agencies unless their actions were clearly authorized by Congress. For example, in West Virginia v. Environmental Protection Agency (597 U.S. ___ [2022]), a 6–3 majority of justices refused to defer to the Environmental Protection Agency’s expertise in regulating carbon emissions from power plants, stating that, instead, there must be “clear congressional authorization” for the agency to regulate in the way intended. This ruling and the philosophy behind it reflect skepticism toward the power of administrative agencies and a conservative approach that favors reducing the power of the administrative state. holding The portion of a judicial decision that states how the law is being applied to the facts of the case. Many cases contain dicta (singular dictum, from Latin “to say”), which are side remarks that are not necessary for the decision and thus do not have precedential value. CH01.indd 12 regulation must be appropriately adopted, within the scope of the authorizing legislation, and constitutional. Judicial Decisions The final major source of law is judicial decisions, often derided as “judge-made law.” And while it may seem undemocratic that one or a few members of the judiciary (or administrative law judges) can “make law,” it is indisputable that to decide a case, it is often necessary to construe the meaning of constitutional, statutory, or regulatory language. For example, in 2020, the US Supreme Court had to decide whether the prohibition of “sex discrimination” in the Civil Rights Act of 1964 includes discrimination based on sexual orientation or transgender status. (Answer: it does. See chapter 4.). At other times, judges must explain the meaning of relevant precedents set in earlier opinions. In doing so, they engage in common-law decision-making. For example, a court might be presented with the question of whether a provision in a gestational surrogacy agreement is “contrary to public policy” (see ­chapter 15). The holding in the case might make new law, or it might confirm earlier related precedent. Common-law decision-making is particularly important in what is known as private law, the type of law that predominantly concerns legal issues between individuals or private entities, in contrast with public law, which focuses on legal issues between an individual or entity and a government. Contracts and torts (including medical malpractice) are key areas of private law for healthcare organizations, as discussed in chapters 5 and 6. The Power of Precedent The common law produced two ancient concepts that endure today: writ and stare decisis. A writ is a court order directing the recipient to appear before the court or to perform, or cease performing, a certain act. Although writs are significant in individual cases, we need not discuss them further here. 02/01/23 1:52 PM 13 C h ap ter 1: A Br ief H istor y of L aw and Medic ine On the other hand, stare decisis is a fundamental principle that is key Legal Brief to understanding how the common law works. Stare decisis is essentially the conUse of precedent distinguishes ­common-law juriscept of precedent. It requires that courts dictions from code-based civil law systems, which look to past disputes involving similar traditionally rely on comprehensive collections of facts and similar legal principles when rules. The civil law system is the basis for the law in considering how to rule in a pending case. Europe, Central and South America, Japan, Quebec, Unless there is good reason to abandon and (because of its French heritage) the state of Louisiana. precedent, courts should ground their conclusions in the reasoning expressed in their own prior decisions and those of appellate courts above them. Key goals of this practice are to engender stabil- writ A court order ity in the legal system and respect for the judicial process (see Legal Brief). commanding Consider, for example, the opening sentence of the controlling someone or an opinion in Planned Parenthood of Southeastern Pennsylvania v. Casey,7 in organization to which Justices Sandra Day O’Connor, Anthony Kennedy, and David Souter perform or cease summed up stare decisis in nine memorable words: “Liberty finds no refuge performing a particular act. in a jurisprudence of doubt.” The Casey case, decided in 1992, hinged on whether to uphold or stare decisis overturn Roe v. Wade, the 1973 decision that established a right to abortion Latin for “to stand grounded in the Constitution’s protection of “liberty interests.” The plural- by things decided,” stare decisis ity opinion (aspects of which were joined by other justices) focused in part refers to the idea on the extent to which stare decisis requires upholding a prior decision even that appellate if the current justices might have decided the precedential case differently. As courts should stick to their prior the court explained, [O]nly the most convincing justification under accepted standards of precedent could suffice to demonstrate that a later decision overruling the first was anything but a surrender to political pressure and an unjustified repudiation of the principle on which the Court staked its authority in the first instance. So, to overrule under fire in the absence of the most compelling reason to reexamine a watershed decision would subvert the Court’s legitimacy beyond any serious question.8 precedents absent some compelling reason to the contrary. It also incorporates the directive that lower courts are bound to respect the precedents of higher courts within their jurisdiction when ruling on cases with similar facts. By way of contrast, 30 years after Casey, a new set of justices applied a different philosophy about precedent and reached a stunningly different conclusion than the Casey court. Writing for the majority in Dobbs9 (discussed earlier in this chapter), Justice Samuel Alito stated, Justice O’Connor was the first woman appointed to “No Justice of this Court has ever argued the US Supreme Court and the only female justice at the time Casey was decided. that the Court should never overrule a constitutional decision, but overruling a CH01.indd 13 02/01/23 1:52 PM 14 T h e L aw o f H e a l th c a re A d mi n i stra ti o n precedent is a serious matter. It is not a step that should be taken lightly.” Alito went on to list “five factors [that] weigh strongly in favor of overruling Roe and Casey: the nature of their error, the quality of their reasoning, the ‘workability’ of the rules they imposed on the country, their disruptive effect on other areas of the law, and the absence of concrete reliance.” After analyzing each of these factors at length and finding that they are not compelling, he concluded, Stare decisis, the doctrine on which Casey’s controlling opinion was based, does not compel unending adherence to Roe’s abuse of judicial authority. Roe was egregiously wrong from the start. Its reasoning was exceptionally weak, and the decision has had damaging consequences. And far from bringing about a national settlement of the abortion issue, Roe and Casey have enflamed debate and deepened division. It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives. (See The Court Decides at the end of chapter 15 for a lengthy excerpt from the Dobbs opinions.) As mentioned earlier, appellate courts (not trial courts) establish binding precedent, which applies internally and downward, but not horizontally. An Ohio trial court, for example, is bound by the decisions of Ohio’s Supreme Court and the US Supreme Court but not by the decisions of other Ohio trial courts or out-of-state courts. Courts in one state may, but are not required to, examine judicial decisions of other states for guidance, especially if the issue is new to the state. For example, the California Supreme Court’s decision in Tarasoff v. Regents of the University of California (discussed in more detail in chapters 5 and 10) is binding precedent only in California, but numerous other state courts have found its reasoning to be persuasive and adopted it as their own. Similarly, a federal trial court is bound by the decisions of the US Supreme Court and the appellate court of its circuit but not by the decisions of other appellate or district courts. The doctrine of stare decisis should not be confused with a related concept: res judicata, which in Latin means “a thing or issue settled by judgment.” In practical terms, once a legal dispute has been resolved in court and all appeals have been exhausted, res judicata prohibits the same parties from later suing regarding the same matters. Federal and State Court Systems In a perfect world, we would not need courts and lawyers. This idea might have inspired William Shakespeare’s famous line in Henry VI, “The first thing we do, let’s kill all the lawyers.”10 At the time—the sixteenth CH01.indd 14 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 15 century—resentment against lawyers ran high in England. Shakespeare was perhaps engaging in a little lawyer bashing, and his intention may have been to express his indictment of a corrupt system. On the other hand, the remark may have been a compliment; the character who utters the famous words was an insurgent who would not want skillful lawyers around to uphold law and order. Or maybe the Bard was just trying to get a laugh out of the audience, something he often did. Regardless of one’s interpretation of the play, we do not live in Utopia, so we do need courts and lawyers. There are more than 50 different court systems in the United States. In addition to the state and federal courts, there are courts for the District of Columbia, the Virgin Islands, Guam, the Northern Mariana Islands, and Puerto Rico; there are also tribal courts with their independent spheres of authority. The large number of court systems makes the study of US law complicated, but the decentralized nature of federalism adds strength and vitality. As various courts (and legislatures) adopt different approaches to a novel issue, the states can become a testing ground on which a preferred solution eventually might become apparent. One relatively unique aspect of US federalism is the overlapping jurisdiction between the federal and the state courts. Our state courts are courts of general jurisdiction. That means they can rule on any legal issue except where a federal statute or the US Constitution grants exclusive jurisdiction to the federal courts. The federal courts are courts of limited jurisdiction, meaning that they can hear cases only as authorized by the US Constitution or federal statutes. Issues of purely state law do end up in the federal courts, though, particularly when the parties are from different states. As described later, this sort of diversity jurisdiction is one avenue for getting to federal court. The other avenue is federal question jurisdiction, in which the primary legal issue relates to a federal statute or the US Constitution. Federal Courts The federal court system is divided into three tiers: district courts, circuit courts, and the US Supreme Court (see exhibit 1.3). The judges on these courts are known as “Article III judges,” after the section of the Constitution related to the judiciary. They are nominated by the president, confirmed by the Senate, and have lifetime tenure. There are about 1,000 district court judges in 94 courts, each of which covers a particular geographic area. A district spans a portion of a state (or territory) or an entire state. Federal trials take place in district courts, either before a judge (referred to as a bench trial) or a jury. Cases involve both legal questions, which are for the judge to decide, and factual questions, which are decided by the “fact-finder”—the jury in a jury trial or the judge in a bench trial. CH01.indd 15 02/01/23 1:52 PM 16 T h e L aw o f H e a l th c a re A d mi n i stra ti o n EXHIBIT 1.3 Model of a Typical ThreeTier Court Structure Supreme Court Court of Appeals (Region 1) Trial Court Trial Court Trial Court Court of Appeals (Region 2) Trial Court Trial Court Trial Court Trial Court Court of Appeals (Region 3) Trial Court Trial Court Trial Court Trial Court Trial Court Trial Court Trial Court Trial Court As decreed by the relevant federal laws, the federal courts (beginning with the district courts) have exclusive jurisdiction over certain kinds of cases, including alleged violations of federal antitrust or securities laws, bankruptcy, and issues related to the Employee Retirement Income Security Act (ERISA). Federal and state courts have concurrent jurisdiction in cases arising under the US Constitution or any federal statute that does not confer exclusive jurisdiction to the federal court system. A federal district court may hear suits based on state law in which a citizen of one state sues a citizen of another state if the amount in dispute is more than $75,000.11 These suits are called diversity of citizenship cases. For example, although medical malpractice claims are almost always grounded in state law, if the injured patient and the allegedly negligent doctor reside in different states, the case may be brought in federal court. There is diversity of citizenship because the parties are from different states. There might be strategic reasons for filing a suit in federal court as opposed to state court. The federal district court hearing the case will apply the relevant state law on medical malpractice claims in deciding which party should prevail, and any appeal will go to the federal circuit court for that geographic area. Concurrent jurisdiction also means that state courts may decide issues involving federal law (unless, as discussed earlier, the case involves an area of exclusive federal jurisdiction). For example, if a missed diagnosis in the emergency department caused injury to a patient, the patient might sue the hospital for medical malpractice (“negligent failure to diagnose”) and for violating EMTALA (“failure to conduct an appropriate screening examination”). That case could be heard in state court or in federal court under federal question jurisdiction because EMTALA is a federal statute. In either situation, the trial court would need to determine both the facts and whether CH01.indd 16 02/01/23 1:52 PM 17 C h ap ter 1: A Br ief H istor y of L aw and Medic ine those facts constitute liability under the different legal standards expressed in the state’s medical malpractice law and in EMTALA. The hospital might be liable under either state law or federal law, both, or neither. Note that claims involving federal statutes and the US Constitution may also be tried in state court, depending on the situation. The losing party in federal district court has a right to appeal to a US court of appeals, where the case is heard by a panel of three judges. In rare situations involving cases of exceptional importance, all the judges on the circuit court might consider a case after the initial panel has issued its ruling. In this case, the judges are said to be sitting en banc. There are 13 appeals courts, 12 of which are geographically organized and hear cases from the district courts in their respective regions. The Court of Appeals for the Ninth Circuit covers the biggest geographic area and hears the most cases each year. The District of Columbia Circuit covers the smallest geographic area, but it is highly influential, partly because of the number and importance of the cases it hears involving federal regulations. The other federal appeals court is the US Court of Appeals for the Federal Circuit, which has subject-matter responsibilities rather than oversight of a given region. It hears appeals in specialized cases, such as those involving patent laws or specific statutes assigned to it by Congress (see exhibit 1.4).12 At the highest level of the federal court system, of course, sits the US Supreme Court, with its nine justices. Most litigants who lose at the court EXHIBIT 1.4 Map of US Courts of Appeals WA MT OR ME ND ID WY SD 8 NV CA NE UT 9 2 MN WI IL AZ 10 KS NM OK MO PA OH IN 6 WV KY MS TX NC TN AR AK AL SC GA CT 3 RI NJ DE MD DC Circuit Federal Circuit VA 4 1 LA 5 9 7 1 MA NY MI IA CO VT NH 3 VI 11 PR FL HI MP GU CH01.indd 17 02/01/23 1:52 PM 18 T h e L aw o f H e a l th c a re A d mi n i stra ti o n writ of certiorari An order from a higher court to a lower court, requesting that the record of a case be sent up for review. of appeals level do not have an absolute right to have their case heard by the US Supreme Court. Instead, they must petition for a writ of certiorari—an order to the lower court requiring that the case be sent to the high court for review—and they must persuade at least four of the nine justices that the issue merits the court’s attention. The Supreme Court “grants cert” (i.e., grants certiorari) in about 80 cases per year from the 7,000 to 8,000 petitions it receives each year. If the court “denies cert,” the lower court’s decision stands. The Supreme Court is most likely to accept an appeal when a significant interpretation of federal statutory or constitutional law is at stake or when there is a “circuit split” (meaning that at least two circuit courts have come to different legal conclusions on the same issue). As an example, consider the initial cases challenging the constitutionality of the ACA. Starting on the day that President Barack Obama signed the ACA into law in March 2010, challengers filed lawsuits in federal district courts across the country arguing that Congress did not have the constitutionally grounded authority to enact key provisions of the law, and therefore the entire law must go. Several circuit courts reached different conclusions about the constitutionality of the ACA, throwing into confusion the fate of the most consequential piece of healthcare legislation since the enactment of Medicare and Medicaid. The Supreme Court could have denied cert, but because of the importance of the issues and the split among the circuit courts, there was little doubt that it would take the case. The result was National Federation of Independent Businesses (NFIB) v. Sebelius,13 which spawned the longest Supreme Court oral argument in modern times. Argument took place for more than six hours over three days—typically, cases get just one hour for oral argument. This case also generated intense public interest and the most amicus (friend of the court) briefs ever. The Court’s decision narrowly upheld the constitutionality of most of the ACA, excising only the requirement that states expand their Medicaid programs. The NFIB decision was a landmark not only for the substance of healthcare law but also for issues of constitutional interpretation. It is now a staple of constitutional law textbooks, typically excerpted in more than one textbook section because the decision sets precedents relating to Congress’s constitutional authority to regulate interstate commerce, to levy taxes, and to attach conditions to spending bills (for a more thorough discussion of this case, see chapter 2). State Courts As in the federal judiciary, state court systems are typically divided into three levels: trial courts, appeals courts, and a high court (usually called the state supreme court). In a state court system, the lowest tier—the trial CH01.indd 18 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 19 courts—is often divided into courts of limited jurisdiction and courts of general jurisdiction. Typically, courts of limited jurisdiction hear only specific types of cases, such as criminal trials involving lesser crimes (e.g., misdemeanors, traffic violations) or civil cases involving disputes of a certain amount (e.g., in small claims court, lawyers are not allowed and complex legal procedures are relaxed). State courts of general jurisdiction hear more serious criminal cases involving felonies and civil cases involving larger sums of money. The next tier in most states is the intermediate appellate courts. They hear appeals from the trial courts. In exercising their jurisdiction, appellate courts are usually limited to examining the evidence from the trial court and to interpreting questions of law, not questions of fact. Appellate courts always have more than one judge and do not have juries. The highest tier in the state court system is the state supreme court. This court hears appeals from the intermediate appellate courts—or from trial courts if the state does not have intermediate courts. (Texas and Oklahoma are a little different: each has two separate high courts, one for civil cases and the other for criminal cases.) The high court is also charged with administrative duties, such as adopting rules of procedure and disciplining attorneys. Alternatives to the Court System The primary alternatives to the court system are mediation and arbitration. Both forms of alternative dispute resolution are typically faster and less expensive than using the court process and may provide more confidentiality. In mediation, a neutral third party aims to help both sides come to an agreement. In arbitration, the neutral third party renders an opinion, which might or might not be binding. For certain types of cases or amounts in dispute, a court alternative might be required, at least as a preliminary matter. Parties to a medical malpractice lawsuit, for example, might be required to try mediation to see whether a settlement can be reached before trial. One party or the other might be more likely to settle having heard the assessment of a neutral, knowledgeable third party (e.g., a retired judge who acts as a mediator). However, the mediator cannot force a settlement. It is increasingly common for contracts to require that disputes be handled through arbitration, which is usually but not always binding. Arbitration involves submission of a dispute for decision (binding or not) by a neutral third person or a panel of experts outside the judicial process; the decision is often binding. When mandatory arbitration is a bargained-for agreement between sophisticated parties, it can be a logical and time- and money-saving approach. Statutory law in most states favors voluntary binding arbitration and frequently provides that an agreement to arbitrate is CH01.indd 19 arbitration An extrajudicial process of dispute resolution by one or more persons with subjectmatter expertise chosen by mutual consent of the parties. 02/01/23 1:52 PM 20 T h e L aw o f H e a l th c a re A d mi n i stra ti o n enforceable by the courts.14 Particularly when one party is vulnerable or not in a position to bargain (a patient, say, or a nursing home transfer), mandatory arbitration clauses have been voided by courts as contrary to public policy, and they are an increasing focus of concern among legislators. Litigation Process Substantive law is the type of law that creates and defines rights and duties. Most of this book is devoted to substantive law as it relates to healthcare providers. Procedural law, as the term implies, specifies the processes for enforcing and protecting rights granted by substantive law. The branch of procedural law discussed in this section is law relating to trial of a case. Complaint, Answer, Reply To begin a civil lawsuit (an action), the plaintiff files a complaint against another party (the defendant). The complaint states the nature of the plaintiff’s injury and the amount of damages or other remedy sought from the defendant. (The complaint and other documents subsequently filed in court are pleadings.) A copy of the complaint, along with a summons, is then served on the defendant. The defendant must answer the complaint or take other action within a limited time (e.g., 30 days) or else the plaintiff will be granted judgment by default. In response to the summons, the defendant files an answer to the complaint, admitting to, denying, or pleading ignorance of each allegation. The plaintiff then typically files a reply. The defendant may also file a complaint against the plaintiff (a countersuit or counterclaim) or against a third-party defendant whom the original defendant believes is wholly or partially responsible for the plaintiff’s alleged injuries. Discovery Phase and Motions In rare cases, the court’s decision or a settlement agreement between the parties quickly follows the complaint and answer stages. Usually, however, several months (or even years) elapse between commencement of the action and settlement or trial. During this time, each party engages in discovery, an attempt to determine the facts and strength of the other party’s case. Note that discovery might require action by a nonparty. For example, a physical therapy clinic might be required to produce healthcare records of a patient who is suing the driver of the car that allegedly hit and injured the patient. During the discovery phase, parties may use any or all of the following techniques to uncover relevant facts and nonprivileged information (though CH01.indd 20 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 21 courts may impose limits on the number of each category of discovery that may be requested) and thereby assess the strength of the other party’s case: 1. Deposition. Sworn testimony given under oath before a court reporter and in the presence of attorneys for each side; transcripts of the testimony may be used as evidence in court in some circumstances. 2. Written interrogatories. Written questions, the answers to which are sworn to and may be used as evidence; interrogatories are somewhat less effective than oral depositions because there is little opportunity to ask follow-up questions. 3. Subpoena duces tecum. A request requiring documents, such as medical records, as evidence for the case; special rules govern the handing over of healthcare records because of the sensitivity of those documents. 4. Physical or mental examination of a party. Used when the physical or mental condition of a party to the lawsuit is in dispute and good cause for the examination is shown. 5. Examination of property. Rarely used in healthcare cases but could come up when the condition of premises or devices is at issue. 6. Request for admission of facts. A request that the opposing party admit certain facts; once a fact has been admitted, the parties save the time and expense of proving it in open court and thus may simplify the case. Before trial, it is common for one or both parties to submit pretrial motions to limit the scope of issues to be tried or to dismiss the case altogether. A common type of pretrial motion is a motion for summary ­judgment as to one or more of the claims in the case. This helps narrow the issues to be decided and might speed up appeal of key legal questions. The trial court judge will grant a motion for summary judgment if, on viewing the facts in the light most favorable to the nonmoving party, there are no genuine issues of material fact, and the moving party is entitled to judgment as a matter of law. Many appellate court decisions are based on appeals from grants of summary judgment. The 2012 NFIB decision about the constitutionality of the ACA, for example, was decided at the district court level on summary judgment because, at its core, the case was one of constitutional interpretation that did not require much, if any, factual inquiry. Settlement, Trial, Appeal Most civil actions are dismissed or settled before trial. Part of the point of discovery is that all the evidence should be available to the parties before trial. Surprise witnesses and out-of-the-blue evidence make for good television but CH01.indd 21 subpoena duces tecum A request by one of the parties to a suit, that asks a witness or the opposing party to bring to court or to a deposition any relevant documents under the other’s control. summary judgment An order by a court finding in favor of one party against the other without a trial. It can be issued if the judge finds that there is no “genuine issue of material fact” left to be determined and the moving party is “entitled to judgment as a matter of law” (Rule 56, Fed. R. Civ. Proc.). 02/01/23 1:52 PM 22 T h e L aw o f H e a l th c a re A d mi n i stra ti o n inefficient dispute resolution. With all the evidence at hand, and a sense of the finanCOVID Connection cial and other risks of proceeding to trial, In both law and medicine, the COVID-19 panparties commonly engage in settlement demic spurred increased use of remote access negotiations. If they reach an agreement, technology, notably, telemedicine visits and Zoom the case is dismissed by mutual consent or hearings. With courthouse access limited, judges with the court’s approval, if required (e.g., throughout the country heard motions, and even when a child’s interests are involved). entire trials, with participants (including jurors) A trial begins with the selection of logging in from their homes or offices. The jury is still out on the overall success of this experiment. a jury if either party has requested a jury Nonetheless, some aspects of litigation practice trial and it is an option for that type of seem well suited to the efficiencies of remote case. After jury selection, each attorney access. Zoom hearings related to scheduling and makes an opening statement that explains discovery questions, for example, might well conmatters to be proven during the trial. The tinue beyond the public health emergency. For a plaintiff’s attorney then calls witnesses and humorous look at technology challenges, search online for the video of a hearing in which a lawyer presents other evidence; the defense has stuck in a Zoom filter reassures the judge that an opportunity to cross-examine each wit“I am not a cat.” ness. Then the defendant’s attorney calls witnesses and presents its evidence, subject to cross-examination by the other side. Finally, there might be rebuttal witnesses and evidence. A party may ask the court for a directed verdict. They judge will grant such a motion if the jury, directed verdict An order from viewing the facts most favorably to the other party, could not reasonably the judge for the return a verdict in that other party’s favor. The motion can be made by the jury to issue a defendant after the plaintiff has presented all their evidence, or by either party particular verdict if no reasonable after both parties have made their respective cases; however, such motions person could reach are rarely granted. a decision to the Before the jury begins its deliberations, the judge gives the jurors contrary based instructions concerning applicable law. The jury retires to deliberate until it on the evidence presented. reaches a verdict (or declares that it is unable to do so, a rare circumstance known as a “hung jury”). Many times, after the jury has reached its decision, the losing party asks the court for a “judgment notwithstanding the verdict”—also known as judgment NOV, an abbreviation of the Latin term judgment NOV (non obstante non obstante veredicto—and a new trial. The motion is granted if the judge veredicto) decides that the verdict is clearly not supported by the evidence. Note that A judgment attorneys will often request a directed verdict or judgment NOV simply to “notwithstanding the verdict” preserve their right to appeal the case. Without bringing these motions, a entered by the party might be deemed to have forfeited the right to appeal. court when a jury’s The judge and the jury each play a key role in the trial. The judge verdict is clearly decides whether evidence is admissible and instructs the jury on the law unsupported by the evidence. before deliberation begins. The judge also has the power to take the case away from the jury by means of a directed verdict or a judgment NOV. The CH01.indd 22 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 23 jury decides the facts and determines whether the plaintiff has proven the allegations by the appropriate standard. In civil cases, that standard is usually a preponderance of the evidence, which means more likely than not. This is quite different from the “beyond a reasonable doubt” standard used in criminal cases. In rare cases, the outcome suggests that the jury finds the application of the legal standard unjust and decides the case accordingly. This phenomenon is known as jury nullification. The next stage in litigation is often an appeal. For a variety of reasons (e.g., satisfaction with the verdict, unwillingness to incur further expense), not all cases go to an appellate court. In the event that a case does move to a higher court, the party that brings the appeal (the losing party in the trial court) is usually called the appellant, and the other party is the appellee. Thus, when reading appellate court decisions, one must not assume that the first name in the case heading is the plaintiff’s, because many appellate courts reverse the order of the names when the case is appealed (see exhibit 1.5). An appellate court’s function is limited to a review of the law applied in the case; it accepts the facts as determined by the trier of fact. In its review, the appellate court may affirm the trial court’s decision, modify or reverse the decision, or reverse it and remand (send back) the case for a new trial. A Turning Point in the Quest for Healthcare Justice Students of healthcare administration should know something about the law’s role in maintaining and then in dismantling formal racial segregation in hospitals. This history informs current efforts to address healthcare disparities. It also highlights many of the types of law discussed in this chapter, as well as litigation processes. As you read the following section, consider what shades of difference may exist from time to time between moral standards, public policy, and legal requirements. Also note the judiciary’s role as an interpreter of the Constitution’s meaning, the uses of litigation compared with legislation, and the role of statutes in expressing societal norms. As discussed earlier, the Fourteenth Amendment to the US Constitution was one of three amendments adopted in the wake of the Civil War. It requires states to extend due process and equal protection of the law to all their citizens, thus mirroring the Fifth Amendment’s requirements of the federal government. (The other two Reconstruction Era amendments were the Thirteenth, which outlawed slavery, and the Fifteenth, which granted the right to vote to Black men.) The post–Civil War Reconstruction Era did not last long, as efforts to integrate newly freed people gave way to efforts to limit their rights through intimidation, violence, and law. “Jim Crow laws,” enacted throughout the South, legalized racial segregation, including in the CH01.indd 23 02/01/23 1:52 PM 24 T h e L aw o f H e a l th c a re A d mi n i stra ti o n EXHIBIT 1.5 Legal Citation System The legal system uses a unique citation method. The citation in the case Simkins v. Moses H. Cone Memorial Hospital (which is included at the end of this chapter) provides a good example. Its heading efficiently conveys a sizable amount of information, as follows: Names of the parties: Simkins v. Moses H. Cone Mem. Hosp. “Appellant” or “Petitioner” (the one who brought the case to the court) Citation: Volume number “Appellee” or “Respondent” (the one who is answering the petitioner’s arguments) 323 F.2d 959 (4th Cir. 1963) Name of “reporter” Page Court and date** number where case is found All US Supreme Court decisions are published, as are roughly a quarter of circuit court decisions and an even smaller percentage of district court decisions. Of course, many of these unpublished decisions are now available on the internet, even though they may be marked “not for publication.” State and federal court decisions are published in the National Reporter System (NRS) of West Publishing, a subsidiary of Thomson Reuters. The NRS is organized by level and location of the courts. Even though advance copies of decision are often issued, only the printed, bound volume of the NRS contains the official version of a court’s decision. The volume number is generally known before pagination; thus, a blank space will be given after the name of the report when citing to a case that has not yet been published in final form. For example, see the citation to West Virginia v. Environmental Protection Agency, 597 U.S. ___ (2022), discussed in a Legal Brief earlier in this chapter. provision of healthcare. Healthcare segregation in the North was less likely to be based on law, and more commonly grounded in hospital and medical association policy. And, of course, the racialized decisions of individuals—healthcare providers, administrators, and board members—permeated the system. In one of its more shameful decisions, the US Supreme Court in 1896 upheld Jim Crow laws as constitutional under the Fourteenth Amendment. This decision, Plessy v. Ferguson,15 involved a challenge to a state law that required racially segregated railroad cars. The court ruled that this “separate but equal” state law was not a violation of the Constitution’s equal protection clause, and it did not require any assessment of the actual similarity of CH01.indd 24 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 25 the racially separate but supposedly “equal” facilities. The court’s oftencriticized opinion reasoned that the Fourteenth Amendment “could not have been intended to abolish distinctions based upon color, or to enforce . . . a commingling of the two races.” A prominent federal healthcare law explicitly supported and codified the Jim Crow regime in hospitals. The 1946 Hill-Burton Act16 authorized vast federal funding in support of state plans to expand hospital capacity throughout the country. Hill-Burton nominally prohibited racial discrimination, but, in deference to Southern states (where most hospitals were either fully or partially segregated by race), it contained a sweeping exception for “cases where separate hospital facilities are provided for separate population groups.”17 The implementing regulations tracked this language and thus authorized funding for hospitals that excluded or segregated Black patients, staff, and providers if that was part of the state’s plan. Nearly a decade later, the US Supreme Court ruled unanimously in Brown v. Board of Education (1954) that “separate but equal” public schools are inherently unequal and violate the Fourteenth Amendment’s equal protection clause.18 The court then ordered public schools to desegregate “with all deliberate speed,” a directive that, in practice, led to decades of delays and opposition and attempts at legal “workarounds.” Although the Brown decision concerned only public schools, the rationale behind this new precedent should clearly have applied to all government programs. However, it was nearly another decade before separate but equal was addressed in the context of Hill-Burton. In 1963, the US Court of Appeals for the Fourth Circuit heard a case that has been called “the Brown v. Board of Education for hospitals.”19 Dentist George Simkins, the head of the local chapter of the National Association for the Advancement of Colored People, and several Black doctors and patients sued two private, not-for-profit hospitals in Greensboro, North Carolina, arguing that their segregationist practices violated the US Constitution. Both hospitals had received Hill-Burton funds pursuant to North Carolina’s plan for hospital expansion (as had the town’s other hospital, the smallest of the three, which served Black patients and had Black physicians on staff). The federal district court dismissed the case on summary judgment, holding that the US Constitution’s equal protection requirements did not apply to these private businesses. The plaintiffs appealed (see The Court Decides at the end of this chapter). The appeal was unusual in at least two respects. First, the appellate court decided on its own to hear the case en banc—that is, with all the court’s judges, not just the usual panel of three. Second, in an action that is rare and was perhaps unprecedented at the time, the US government intervened (joined the lawsuit) on the side of the plaintiffs to challenge the CH01.indd 25 02/01/23 1:52 PM 26 T h e L aw o f H e a l th c a re A d mi n i stra ti o n constitutionality of a law that had been passed by Congress. The Department of Justice did so during the thick of the 1960s Civil Rights Movement, a prominent aspect of which was the push for healthcare justice, including hospital desegregation. In a 3–2 decision, the Fourth Circuit held in late 1963 that the hospitals’ involvement with the Hill-Burton program provided the requisite “state action” to bring them within the Constitution’s equal protection requirements. As a result, they were required to desegregate. The court also ruled unconstitutional the Hill-Burton Act’s “separate but equal” provision. The hospitals (with the explicit support of the American Medical Association and the American Hospital Association) petitioned the US Supreme Court to take the case, seeking to reverse this decision. The Supreme Court, with unusual speed, denied cert; this meant that the Simkins v. Moses H. Cone Memorial Hospital 20 decision stood as binding precedent. At the same time, across the street from the Supreme Court, Congress was debating the Civil Rights Act, including a provision (Title VI) that would bar racial discrimination by any recipient of federal funds. Proponents of this provision highlighted the Simkins ruling, and the Civil Rights Act passed in 1964 with Title VI left intact. Future recipients of Hill-Burton funds could not racially discriminate; and Simkins-style lawsuits could be brought to force desegregation of private hospitals that had received this federal funding in the past. In 1965, advocates of healthcare justice gained a more powerful legal tool when Congress established the vast Medicare and Medicaid programs (see chapter 2). Medicare was set to go live on July 1, 1966, covering all citizens over age 65, and any hospital that wanted to participate and receive Medicare payments could not overtly discriminate based on race in its admitting, privileging, or employment practices. The Lyndon B. Johnson administration, pressed by civil rights advocates, decided that mere “intent” to comply would be insufficient, and it tasked the newly created Office of Equal Health Opportunity (OEHO, now the HHS Office for Civil Rights) with visiting hospitals and documenting actual desegregation. When the OEHO began its work, “[m]ore than four thousand hospitals were clearly out of compliance, many resistant to becoming compliant.”21 Although the OEHO faced obstructionist tactics from powerful hospital leaders and board members, these bureaucrats and the community members they worked with succeeded in ending overt racial segregation in hospitals throughout the country, and Medicare successfully launched. The Simkins decision is not widely known. On its face, the Civil Rights Act is not healthcare legislation. And Medicare is not, per se, a civil rights law. But taken together, they were crucial factors in the ongoing quest for healthcare justice. They highlight the power of legal tools to advance efforts CH01.indd 26 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 27 to achieve equitable access to high-quality, affordable healthcare. As Martin Luther King Jr. said in an often-quoted March 1966 speech, “Of all the forms of inequality, injustice in health care is the most shocking and inhumane.” Discussion Questions for Part 1 1. Identify a current problem that has healthcare implications. In your view, have constitutional, statutory, case law, or regulatory standards helped or hindered its appropriate resolution? Which branch of government is best suited to address it? Is it more a state or a federal issue? 2. Consider the term “Obamacare” as it is used in your community. Does it have positive or negative connotations? Is support for or opposition to the ACA a campaign issue in your community? 3. Have you ever been involved in litigation, arbitration, or mediation, either as a party, a witness, or a juror? What were your impressions of the legal system? Do you think the parties were adequately heard and that justice was done? 4. Go to Oyez.org and listen to a recent US Supreme Court oral argument in a case that interests you. Are you able to understand the legal issues? Is this what you expected from a Supreme Court hearing? 5. Have you ever reviewed a regulation or submitted comments about a proposed regulation? On what sort of regulations do you think a healthcare administrator might usefully offer an opinion? 6. Do you think it matters whether members of the judicial, executive, and legislative branches include people with diverse backgrounds? Why or why not? 7. What are the purposes of discovery? How might healthcare providers, whether institutional or individual, be involved in responding to a discovery request? CH01.indd 27 02/01/23 1:52 PM 28 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The Court Decides Simkins v. Moses H. Cone Memorial Hospital 323 F.2d 959 (4th Cir. 1963) (en banc) Sobeloff, Chief Judge The threshold question in this appeal is whether the activities of the two defendants, Moses H. Cone Memorial Hospital and Wesley Long Community Hospital, of Greensboro, North Carolina, which participated in the Hill-Burton program, are sufficiently imbued with “state action” to bring them within the Fifth and Fourteenth Amendment prohibitions against racial discrimination. Beyond this initial inquiry lies the question of the constitutionality of a portion of the Hill-Burton Act. . . . Because of the importance of these questions the court, on its own motion, has heard the appeal en banc. [This means that the appeal was considered by all the judges on the Fourth Circuit, not the usual three-judge panel.] The plaintiffs are Negro physicians, ­dentists and patients suing on behalf of themselves and other Negro citizens similarly situated. . . . The basis of their complaint is that the defendants have discriminated, and continue to discriminate, against them because of their race in violation of the Fifth and Fourteenth Amendments to the United States Constitution. The plaintiffs seek an injunction restraining the defendants from continuing to deny Negro physicians and dentists the use of staff facilities on the ground of race; an injunction restraining the defendants from continuing to deny and abridge admission of patients on the basis of race, . . . and a judgment declaring unconstitutional [the portions of the Hill-Burton Act and its implementing regulations] which authorize the construction of hospital facilities . . . on a ‘separate-but-equal’ basis. . . . CH01.indd 28 [Because the complaint challenges the constitutionality of a federal statute and affects the public interest, the United States moved to intervene (requested to participate) in the proceeding.] Its motion for intervention was granted and throughout the proceedings the [Federal] Government, unusually enough, has joined the plaintiffs. . . . .... Factual Background .... The claims of racial discrimination were, as the District Court found, “clearly established.” In fact the hospitals’ applications for federal grants for construction projects openly stated, as was permitted by [the HillBurton] statute, and regulation, . . . that ‘certain persons in the area will be denied admission to the proposed facilities as patients because of race, creed or color.’ These applications were approved by the North Carolina Medical Care Commission, a state agency, and the Surgeon General of the United States under his statutory authorization. .... When this action was commenced, the United States had appropriated $1,269,950.00 to the Cone Hospital and $1,948,800.00 to the Long Hospital. . . . These appropriations for the most part were after the Supreme Court’s landmark decisions in Brown v. Board of Education [the 1954 and 1955 US Supreme Court decision that overruled its prior precedent and unanimously held that the Fourteenth Amendment prohibits states from segregating students by race] . . . . .... 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine The point of present interest is not the equality or lack of equality in “separate-butequal,” but the degree of participation by the national and state governments. [Though, in a footnote, the court cited a 1962 report finding that in North Carolina the hospitals “available to nonwhites were both inferior to those available to whites and more limited.”] THE LEGAL ISSUE In our view the initial question is . . . whether the state or the federal government, or both, have become so involved in the conduct of these otherwise private bodies that their activities are also the activities of these governments and performed under their aegis without the private body necessarily becoming either their instrumentality or their agent in a strict sense. . . . [The court recognizes that purely private action would not violate the Constitution, but concludes that there is state action here, pointing to the “massive use of public funds and extensive state-federal sharing in the common plan” inherent in the Hill-Burton program’s functioning. The test for what constitutes “state action” is different now; this is discussed further in chapter 14.] .... Moreover, the [Federal] Government’s argument stresses the fact that the challenged discrimination has been affirmatively sanctioned by both the state and the federal government pursuant to federal law and regulation. . . . These federal provisions undertaking to authorize segregation by state-­connected institutions are unconstitutional. . . . Unconstitutional as well under the Due Process Clause of the Fifth Amendment and the Equal Protection Clause of the Fourteenth are the relevant regulations implementing this passage in the statute. [The court discusses the hospitals’ counterarguments and dismisses them.] Not only 29 does the Constitution stand in the way of the [defendant hospitals’] claimed immunity but there are powerful countervailing equities in favor of the plaintiffs. Racial discrimination by hospitals visits severe consequences upon Negro physicians and their patients. [In a footnote, the court supports this statement by noting that “[r]acial discrimination in medical facilities is at least partly responsible for the fact that in North Carolina the rate of Negro infant mortality is twice the rate for whites and maternal deaths are five times greater.” Furthermore “[e]xclusion of Negro physicians from practice in hospitals on account of their race denies them opportunities for professional improvement and has discouraged Negro physicians from practicing in the cities of the South.”] Giving recognition to its responsibilities for public health, the state elected not to build publicly owned hospitals, which concededly could not have avoided a legal requirement against discrimination. Instead it adopted and the defendants participated in a plan for meeting those responsibilities by permitting its share of Hill-Burton funds to go to existing private institutions. The appropriation of such funds to the Cone and Long Hospitals effectively limits Hill-Burton funds available in the future to create nonsegregated facilities in the Greensboro area. In these circumstances, the plaintiffs can have no effective remedy unless the constitutional discrimination complained of is forbidden. The order of the District Court is reversed. [Two judges joined the chief judge’s opinion, forming a narrow majority; two judges dissented, “[b]elieving the majority both unprecedented and unwarranted.”] Note: Internal citations have been omitted from this and all other The Court Decides excerpts. (continued) CH01.indd 29 02/01/23 1:52 PM 30 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) Discussion Questions 1. Why has this case been called “the Brown v. Board of Education decision for hospitals”? How is it similar to Brown? How is it different? 2. This was the first case in which the federal government intervened to argue that a federal statute was unconstitutional. Noting particularly the date of this case, consider what factors might have influenced the US Department of Justice to intervene in this case, advocating for the plaintiffs’ position. 3. The dissent noted that in August 1963, just a couple of months before this decision was handed down, “the Senate rejected a proposal that henceforth grants in aid to hospitals under the Hill-Burton Act be restricted to hospitals which are desegregated, and which practice no discrimination on account of race.” Does that surprise you? 4. The US Supreme Court “denied cert” in this case. What does that mean? What is the practical consequence of that action? ~ ~ PART 2: THE HISTORY OF MEDICINE After reading part 2 of this chapter, you will • have a greater appreciation for the evolution of medicine over the millennia; • understand that “modern medicine” is a recent phenomenon; and • recognize that the structure of today’s US health system is the result of compromises made over the course of decades. If it helps to know some history when studying the US legal system, the same can be said about healthcare. Without some background, we may be in danger of concluding that our health system is timeless and ineluctable. It is neither. It was not predestined, and surely no creator would have designed it thusly on a tabula rasa. Therefore, let us review some history of how our health system came to be the peculiar creature it is.22 Appendix 1.1 at the end of this chapter provides a detailed timeline of the history of medicine from the pharaohs to the present. If that history were displayed on a 24-hour clock with the pharaohs at 12:01 a.m. and the present CH01.indd 30 02/01/23 1:52 PM 31 C h ap ter 1: A Br ief H istor y of L aw and Medic ine being 11:59 p.m., we would see that “modern medicine” is only about an hour old. What came before the modern era? The Pharaohs and Babylonians For eons, medicine consisted primarily of mysticism and spiritual belief systems. Ancient cultures had some understanding of good dietary habits and the pharmacological effects of certain plants, such as tobacco and peyote, but they had little knowledge of natural disease processes. They usually relied on shamans to invoke what they believed to be the healing powers of the spirit world. It should be noted that shamanism and similar practices persist in many cultures today including those of some Native American tribes, the Hmong of Southeast Asia (see Shamanism: The Ancient Meets the Modern), certain African tribes, and practitioners of traditional Chinese medicine. The ancient Egyptians were relatively advanced in terms of their medical knowledge.23 They were familiar with anatomy (perhaps because of their embalming practices), they were aware of the connection between the pulse and the heart, they could diagnose and treat a few diseases, and they were adept at simple surgery and orthopedics. Magic and mysticism were prevalent nevertheless, and some of their medical practices were ineffective—even harmful.24 In any event, what useful knowledge they amassed was not communicated widely, perhaps because of their use of hieroglyphic writing, which was not deciphered in the Western world until the early 1800s. The ancient Babylonians introduced Shamanism: The Ancient Meets the the concepts of diagnosis and prognosis, Modern wrote prescriptions, used logic and obserA particularly striking example of the contrast vation to advance medical knowledge, and between scientific medicine and traditional beliefs even published a diagnostic handbook can be found in Anne Fadiman’s The Spirit Catches around 1050 BCE.25 Like their Egyptian You and You Fall Down: A Hmong Child, Her Americounterparts, however, Babylonian physican Doctors, and the Collision of Two Cultures cians did not spread their science widely, (Farrar, Straus and Giroux 1997). The book tells the story of a severely epileptic Hmong child in Califorand when patients were not cured by the nia whose parents’ beliefs in shamanistic animism basic medicine of the day, exorcism and severely challenged her physicians, caseworkers, similar techniques were the only remaining and local officials. The book is sympathetic to options. Hippocrates, Galen, and 2,000 Years of Medical Practice Being ignorant of the concepts and practices developed in Asia, the Middle East, CH01.indd 31 both sides of the cultural divide, but the child’s tragic end—she was in a persistent vegetative state for 26 years before dying at the age of 30 in 2012—highlights the problems caused by a lack of cultural competency. 02/01/23 1:52 PM 32 T h e L aw o f H e a l th c a re A d mi n i stra ti o n EXHIBIT 1.6 Humoralism and the Four Humors Humor Organ Personal Characteristic Disposition Blood Liver Sanguine Courage, amorousness Yellow bile Gallbladder Choleric Anger, bad temper Black bile Spleen Melancholic Depression, irritability, sleeplessness Phlegm Brain and lungs Phlegmatic Peacefulness and calm and elsewhere, Greek and Roman physicians such as Hippocrates (ca. 460–370 BCE) and Claudius Galenus (known as Galen, ca. 131–201 CE) practiced humoralism, the belief that the body consisted of four basic substances (called humors) that determined one’s state of health. According to this theory, an imbalance in the humors was said to be the cause of disease and disability. The four humors and their corresponding attributes are summarized in exhibit 1.6. This theory dominated Western medical practice for more than two millennia, during which time practices such as bloodletting, purging, administration of emetics, and application of poultices were common. These treatments were largely ineffective and often did more harm than good. For example, several twentieth-century scholars surmised that President George Washington, who died in December 1799 at age 84, succumbed to acute inflammatory edema of the larynx (which resulted in suffocation) secondary to a septic sore throat. His condition was probably aggravated by the removal of up to half his blood volume in the hours before his death.26 Medicine finally began to advance in the early nineteenth century, but physicians—given their ignorance of etiology, pathology, and similar disciplines—often had little to offer patients besides comfort, compassion, and concern, as illustrated in the famous Victorian-era painting The Doctor, shown in exhibit 1.7. In time, however, a few foundational developments started the process that gradually led to what we can call “modern medicine.” Anesthesia One of these developments occurred in 1846 when physician John C. Warren (1778–1856), and dentist William T. G. Morton (1819–1868) performed the first significant public demonstration of the use of anesthesia at Massachusetts General Hospital. Using diethyl ether, and with Morton as his anesthetist, Warren removed a tumor from a patient’s jaw. After the patient, Gilbert Abbott, awoke and reported that he had felt no pain, Warren proudly announced to the audience of physicians and medical students, “Gentlemen, this is no humbug.”27 The era of painless surgery and dentistry CH01.indd 32 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 33 EXHIBIT 1.7 The Doctor, Sir Luke Fildes (1891) Source: Used with the permission of the Tate Gallery, London. had officially begun in the Western world (see Anesthesia: A Brief History). Germ Theory and Vaccines Use of anesthesia was followed in the 1860s by Louis Pasteur’s (1822–1895) germ theory, the scientific principle that infectious diseases are caused by microorganisms. Pasteur disproved the myth of spontaneous generation (the idea that living organisms can grow from nonliving matter); developed vaccines for rabies, cholera, and anthrax; and created a process, now known as pasteurization, to slow the growth of microbes in food. An earlier pioneer, the Hungarian physician Ignaz Philipp Semmelweis (1818–1865), had shown that the incidence of puerperal (childbed) fever could be reduced drastically with antiseptic techniques and handwashing in obstetrical clinics, but he was roundly ridiculed until Pasteur provided scientific proof of this proposition.28 CH01.indd 33 Anesthesia: A Brief History Hanaoka Seishu (1760–1835), a Japanese surgeon, is said to have been the first person to perform surgery using general anesthesia when he treated a patient’s breast cancer in 1804 (Masuru Izuo, Medical History: Seishu Hanaoka and His Success in Breast Cancer Surgery Under General Anesthesia Two Hundred Years Ago, 11 Breast Cancer 319 [2004]). Because of the country’s isolation, however, this development was unknown outside of Japan for many years. The American surgeon C. W. Long (1815–1878) used ether as an anesthetic in 1842 but did not publish his results until 1849 (C. Singer & E. A. Underwood, A Short History of Medicine 343 [1962]). Morton and Warren were unaware of Long’s success when they performed their operation in 1846. The term anesthesia (or anaesthesia), from the Greek meaning “absence of sensation,” was coined by the American neurologist Oliver Wendell Holmes, father of the famed US Supreme Court Justice (Aidan O’Donnell, Anaesthesia: A Very Short Introduction [2012]). 02/01/23 1:52 PM 34 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Antisepsis In the 1860s, Joseph Lister (1827–1912) began to promote antiseptic surgery at the University of Glasgow, Scotland. Building The final third of the nineteenth century saw on Pasteur’s discoveries, and consistent rapid industrial development and increased ecowith Semmelweis’s beliefs, Lister treated nomic growth in the United States and elseinstruments with a carbolic acid solution where. This period is known as the “Second and required surgeons to wear clean gloves Industrial Revolution” and, in America, as the and wash their hands before and after “Gilded Age.” Advances in medicine and other operations. As a result of these new pracfields of applied science were comparable to those in heavy industries such as steel and tices, he saw a profound drop in the numrailroads. (See, e.g., Ryan Engelman, The Secber of wound infections. The results were ond Industrial Revolution, 1870–1914, http:// published in a widely respected British ushistoryscene.com/article/second-industrialmedical journal in 1867,29 and Lister was revolution [https://perma.cc/S6WU-UE5U] [last later elected to the Royal College of Suraccessed Dec. 7, 2018]). geons. Listerine mouthwash is named in his honor, as is the bacterial genus Listeria. Based on these and other developments of the day, we can say that the era of modern medicine began around the end of the US Civil War (see Late Nineteenth Century: The Gilded Age). Given the progress made to that date, nursing and medical care were of better quality during that conflict than one might think. In particular, antiseptic techniques and anesthesia were not uncommon. Still, healthcare at the time was rudimentary by today’s standards, and wartime casualties had a much greater chance of dying from infection and disease than from direct combat injuries.30 Late Nineteenth Century: The Gilded Age The Public Health System As medical science began to advance, so, too, did greater awareness of preventive measures that would improve the health of entire populations. In the 1850s—before the adoption of modern plumbing and public sanitation measures—the English physician John Snow (1813–1858) determined that a cholera epidemic in London had been caused by contaminated drinking water. His findings were disputed at the time, as most physicians held to the belief that the disease was caused by airborne “miasmas,” but Snow was later proven to be correct, and the offending bacterium was identified as Vibrio cholerae. Although cholera is still present in low- and lowermiddle-income countries, water purification systems prevent its recurrence in most of the world today, and Snow is now considered to be the “father of modern epidemiology.”31 The growing acceptance of epidemiology, germ theory, the value of vaccines, and other scientific advances in the mid- to late 1800s led to what CH01.indd 34 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 35 we now recognize as the field of “public health,” which has enabled the eradicaWhat Is Public Health? tion of smallpox and vast decreases in Public health is the science of protecting and the incidence of polio, diphtheria, measles, improving the health of people and their commuwhooping cough, and other diseases. Public nities. This work is achieved by promoting healthy health measures have also worked to address lifestyles; researching disease and injury prevennoncommunicable health conditions such tion; and detecting, preventing, and responding as obesity, diabetes, and tobacco- and mento infectious diseases. Overall, public health is tal health–related ailments. These efforts— concerned with protecting the health of entire populations. These populations can be as small as especially the elimination of childhood disa local neighborhood, or as big as an entire couneases—were the main reason why average try or region of the world (Public Health in Action, life expectancy at birth increased from about CDC Found., https://www.cdcfoundation.org/what40 years in 1850 to over 75 by 2000.32 public-health [https://perma.cc/HB9R-48VW]). In short, while the medical profession aims to cure, public health aims to prevent. As the American Public Health Association (APHA, founded 1872) states, “We champion prevention as both an effective and cost-efficient path to improved health and wellness.”33 Each public health measure is met with resistance from entrenched groups, of course. For example, fluoridation of drinking water continues to be controversial in some areas even though it is an inexpensive and highly effective means of preventing dental cavities. Likewise, the use of iodized salt is highly effective in reducing iodine-deficiency disorders such as alopecia and goiter, but these diseases persist in many parts of the world. Recently and most dramatically, COVID-19 vaccinations, mask mandates, and social-distancing requirements led to angry demonstrations, disinformation on social and mass media, and political obstruction. The US Surgeon General and other experts labeled this opposition a threat to the nation’s health,34 but it continued throughout the pandemic. Such phenomena illustrate the challenges that public health professionals face from conservative political elements, vested interests, and a skeptical public that feels empowered by social media to spread misinformation. Public health activities are carried out through many hundreds of federal, state, and local agencies as well as nongovernmental organizations. As stated by the National Academy of Sciences, In the United States, government responsibility to protect the public’s health is represented by public health agencies, state and local health departments, and by the federal Department of Health and Human Services. The public health system in the United States includes a wide array of other public agencies, such as environmental, occupational safety, mental health, developmental disability, and social service agencies at national, state, and local levels. It also includes national, CH01.indd 35 02/01/23 1:52 PM 36 T h e L aw o f H e a l th c a re A d mi n i stra ti o n state, and local private organizations and providers, such as health professional associations, citizen advocacy groups, the media, community health centers, and research foundations. Together, these participants in the system fulfill the mission of public health. The public health agencies, as the governmental representative of public health, focus this mission.35 A full review of the public health system is well beyond the scope of this text or any single course in healthcare administration. Accredited master of healthcare administration programs include courses that relate to public health (e.g., epidemiology, statistics). In addition, there are nearly 200 postgraduate degree (master of public health) programs that focus entirely on the subject. The topic is mentioned here simply to remind readers that promotion of health is not only the calling of physicians, nurses, midwives, and other care providers but also a social responsibility, a duty of individuals and organizations to act in the best interests of society as a whole. The Nursing Profession Coincident with scientific advances came improvements in the practice of nursing. The primary meaning of to nurse is “to feed at the breast” or “to suckle”36—thus, it is no coincidence that nursing was long considered solely “women’s work.” For centuries, much of nursing care was provided by religious women: Catholic nuns and women of other faiths. This gender bias was reinforced during wartime as men went off to do battle and women were left to care for the wounded. Even today, the nursing field is more than 90 percent female.37 The first inklings that nursing is a profession with standards of its own arose during the Crimean War in the early 1850s, when Florence Nightingale (1820–1910) led a group of women to serve as nurses for English troops and began to bring order to nursing services for the first time. In addition to dressing wounds and comforting casualties, she organized supplies, improved sanitation, attended to dietary needs, and addressed other aspects of patient care of the time. In 1860, with generous public donations, Nightingale established the first official nurses’ training program, and her legacy lives on at the Florence Nightingale School of Nursing and Midwifery, a subdivision of King’s College London.38 Because of her fame and her influential books Notes on Hospitals (1858) and Notes on Nursing (1859), Nightingale (known as “the lady with the lamp”) is generally regarded as the founder of modern nursing. The US Civil War brought similar pressures for nursing services in this country, and the first US nursing schools opened during that conflict. According to one source, by the end of the nineteenth century, “somewhere between 400 to 800 schools of nursing were in operation in the country.”39 As the need for nurses and nursing schools grew, nursing began to consider itself a profession, not a trade. It was inevitable that the field CH01.indd 36 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 37 would seek to generate some professional associations (see What Is a Profession?). What Is a Profession? Thus, the late 1890s saw the creation of The American Heritage Dictionary defines a profesthe American Society of Superintendents sion as “an occupation, such as law, medicine, or of Hospital Training Schools (now the engineering, that requires considerable training National League for Nursing) and the and specialized study.” It could be said, whimsiNurses Associated Alumnae of the United cally, that a field is not truly a profession until States (the forerunner of today’s American it has one or more membership associations to Nurses Association). represent it. These national organizations were soon followed by state societies and associations, annual conventions, elections of officers, publication of professional materials and educational standards, and similar activities typical of most professional groups today. The nursing groups even developed the modern title “registered nurse” and lobbied successfully for enactment of nurse licensure statutes similar to those being passed to license physicians and other practitioners. The nurses’ lobbying successes were a “significant legislative accomplishment at a time when women held little political power.”40 The demand for nurses increased dramatically, of course, during each of the two world wars in the twentieth century, and after World War II, a debate arose about the best method of nurse training. Hospital-based nurse training programs (diploma programs) emphasized the practicalities of bedside care, while college-level degree programs were focused on more advanced types of nursing. A third avenue, community college–based associate’s degree programs, tried to split the difference. These distinctions continue today. Emergence of Modern Hospitals and Medical Education The ancestors of today’s hospitals were the almshouses of the Middle Ages. Those pits of misery and horror were used primarily to sequester the poor, the insane, and other unfortunate souls from “respectable society.” After all, effective treatment as we know it today was impossible, and recovery was more a matter of fate than of human intervention. The picture began to change in the early nineteenth century, and after the US Civil War, the transformation in this country was stunning. Professor Paul Starr characterized it thusly in his Pulitzer Prize–winning book The Social Transformation of American Medicine: Few institutions have undergone as radical a metamorphosis as have hospitals in their modern history. In developing from places of dreaded impurity and exiled human wreckage into awesome citadels of science and bureaucratic order, they acquired a new moral identity, as well as new purposes and patients of higher status. The hospital is perhaps distinctive among social organizations in having first CH01.indd 37 02/01/23 1:52 PM 38 T h e L aw o f H e a l th c a re A d mi n i stra ti o n been built primarily for the poor and only later entered in significant numbers and an entirely different state of mind by the more respectable classes. As its functions were transformed, it emerged, in a sense, from the underlife of society to become a regular part of accepted experience, still an occasion for anxiety but not horror.41 One might dispute whether hospitals are, even today, citadels of “bureaucratic order,” but the overall thrust of Starr’s argument is correct: once a place to segregate the contagious and dying “dregs of society,” the hospital as an institution rapidly gained prestige and honor when the medical profession as a whole emerged from its “dark ages” and moved from the late nineteenth century into the twentieth. As Starr put it, “No longer [was a hospital] a well of sorrow and charity but a workplace for the production of health.”42 As hospitals evolved and the body of medical knowledge grew, the need for improvements in medical education became self-evident. For centuries, medical education had placed little or no emphasis on science and research, and prior to the twentieth century, the quality of education remained “highly variable and frequently inadequate.”43 It was presented in one of three ways: through apprenticeships with local practitioners, in proprietary schools owned by other physicians, or at the few universities that provided a combination of didactic and clinical training. The few university-affiliated schools that existed taught diverse types of medicine, such as scientific, osteopathic, homeopathic, chiropractic, eclectic, physiotherapy, botanical, and Thomsonianism (which used herbs and application of different forms of heat). Because of the heterogeneity of educational experiences and the lack of standards for physician licensure, physicians in post–Civil War America varied tremendously in their medical knowledge, therapeutic philosophies, and aptitudes for healing the sick.44 It should be noted, of course, that alternative treatment modalities such as physical therapy, herbal remedies, and chiropractic have many followers today and can provide therapeutic benefit. While all medical education at the time was disorganized, the situation for Black medical students was even more confused. The first Black physician in the United States, James McCune Smith (1813–1865), had to travel to Scotland to obtain his medical degree. No Black woman graduated from a medical school until Rebecca Lee Crumpler obtained her MD degree in 1864. Nineteen Black medical schools opened after the Civil War. One author, writing in the journal of the National Medical Association (an organization for Black physicians), described their situation as follows: Before the turn of the 20 century, medical education for African Americans was haphazard, inconsistent, and of uneven quality. Black medical schools were either CH01.indd 38 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 39 church-related missionary institutions or proprietary operations. . . . That some proprietary schools were pure commercial endeavors and little more than diploma mills further complicated and compromised the medical education of African Americans.45 As one might expect, given the racial attitudes that have persisted throughout our history, it was virtually impossible for persons of color to gain admission to most medical schools well into the twentieth century. In fact, “for more than 100 years, the AMA [American Medical Association] actively reinforced or passively accepted racial inequalities and the exclusion of African-American physicians.”46 The association has since formally apologized for its policies that excluded Black physicians from AMA membership and barred them from some state and local medical societies.47 Reform of the medical education system began with influential college presidents such as Charles Eliot (1834–1909) at Harvard University and Daniel Coit Gilman (1831–1908) at Johns Hopkins University. The number of commercial medical schools dropped, training requirements for physicians increased from a few months after high school to three or more years, and programs placed more emphasis on science and research. According to Starr, The new [medical education] system greatly increased the homogeneity and cohesiveness of the profession. The profession grew more uniform in its social composition. The high costs of medical education and more stringent requirements limited the entry of students from the lower and working classes. And deliberate policies of discrimination against Jews, women, and [B]lacks promoted still greater social homogeneity. The opening of medicine to immigrants and women, which the competitive system of medical education allowed in the 1890s, was now reversed.48 The Early Twentieth Century Physician education reform continued in 1904 when the AMA (established in 1847) created the Council on Medical Education and then supported the Carnegie Foundation’s Bulletin Number Four (also called the Flexner Report).49 This document, issued in 1910, proposed new standards for medical schools and helped increase physicians’ professional stature. In the wake of the Flexner Report, the number of medical schools was reduced and the quality of teaching improved. Only two of the Black schools survived, however: Howard University College of Medicine in Washington, DC, and Meharry Medical College in Nashville, Tennessee. Only two other historically Black medical schools have since been founded: Charles R. Drew University of Medicine and Science in Los Angeles (established in 1966) and Morehouse Medical College in Atlanta (established in 1975).50 CH01.indd 39 02/01/23 1:52 PM 40 T h e L aw o f H e a l th c a re A d mi n i stra ti o n In 1914, the AMA council set the first standards for hospital internship proIn conjunction with the National Conference of Catholic Bishops, the CHA has for many years pubgrams and identified the few hospitals that lished Ethical and Religious Directives for Catholic met them. Concurrent with these efforts, Health Care Services. This publication ­contains the Catholic Hospital Association (now guidance for Catholic healthcare institutions on the Catholic Health Association of the numerous issues including abortion, euthanasia, United States, or CHA) was established assisted suicide, sterilization, care of the poor, in 1915. The number of Catholic hospiand collaborative arrangements with non-Catholic organizations. In some situations, the Directives tals was growing, and the new association present challenges for mergers, joint ventures, said it wanted to respond to technological and similar corporate arrangements. They may advances while ensuring that its hospialso make compliance with state laws concerning tals’ Catholic mission, identity, and values availability of services difficult. “would not be derailed by this new movement [for healthcare standardization].”51 In 1920, CHA began publishing an official journal, Hospital Progress (now Health Progress), to further promote quality in inpatient healthcare. Around the same time, the newly established American College of Surgeons (ACS) developed a set of minimum standards for hospitals and began on-site inspections of facilities. It found that fewer than 15 percent of hospitals met the standards. In 1951, the ACS joined the AMA, the American Hospital Association (established in 1899), and other groups to form the Joint Commission on Accreditation of Hospitals. Now known as The Joint Commission, it publishes Standards for Hospital Accreditation, a document cited frequently to establish the standard of care in negligence cases (see the discussion of the Darling case in chapter 7). By the third decade of the twentieth century, hospitals were becoming high-quality organizations with state-of-the-art diagnostic and treatment methodologies. Use of X-rays (discovered in 1895) was common, as was administration of penicillin (discovered accidentally by Sir Alexander Fleming in 1928). Laboratory and other equipment became more sophisticated, not to mention more expensive. As hospitals became operationally more complex, they needed trained staff to handle personnel issues, billing, purchasing, medical records maintenance, fundraising, and similar corporate functions. Thus, a division of labor occurred: patient care was left to physicians, nurses, and other clinicians, whereas business activities were carried out by salaried administrative personnel. Some hospital administrators were physicians, but many were nurses (and, in Catholic hospitals, often nuns) by training. Their quaint titles (“superintendent” or “nurse matron”) reflected the old paradigm of hospital qua asylum. These titles eventually changed as hospital administration became a recognized profession. Like any good profession, it needed an CH01.indd 40 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 41 association, so the American College of Hospital Administrators (now the AmeriA Wry Definition can College of Healthcare Executives) was A colleague at Washington University School of established in 1933. At that time, there Medicine used to describe a hospital as “a collecwere more than 6,000 hospitals in the tion of individual fiefdoms connected by a common country—there had been fewer than 200 heating, ventilating, and air-conditioning system.” To what extent does the professor’s point about after the Civil War—and they needed proindividual fiefdoms remain valid now that most fessionals to run them. hospitals are no longer single buildings with a What developed was a “peculiar common HVAC system? bureaucracy” (Starr’s expression)52 with two lines of operational authority—one clinical and the other administrative. The former often considered hospitals merely to be “doctors’ workshops,” created for their benefit; the latter tended to see hospitals as dedicated to serving the broader needs of the community. Adding to the anomalous situation was the fact that most hospitals were ultimately governed by a board of trustees representing local religious, business, professional, philanthropic, or other community interests. The trustees were charged with making major policy and strategic decisions that management and (presumably) providers were expected to implement. This odd governance and operating structure led to hospitals being described as resting on a “three-legged stool” of physicians, administrators, and governing board members. Few self-respecting sociologists or management consultants would recommend such a confounding arrangement, but it is what it is: a product of historical coincidence and practical considerations (see A Wry Definition). Other Health-Related Professions As modern medicine advanced in the twentieth century, new types of professionals began providing services to complement the work of physicians and nurses. These included anesthesiology assistants, athletic trainers, audiologists, dietitians, dental hygienists, emergency medical technicians, medical assistants, nuclear medicine technicians, nurse practitioners, pharmacists, physical and occupational therapists, physician assistants, radiology technicians, respiratory therapists, speech-language pathologists, and others. It has been estimated that these allied health professionals (AHPs) now constitute nearly 60 percent of the healthcare workforce.53 Like physicians and nurses, AHPs are now subject to licensing and regulatory standards intended to protect the public and exclude unqualified persons. Of course, this legal regime can also inappropriately protect economic interests, as discussed in chapter 14 regarding legal prohibitions on anticompetitive behavior. These regulatory schemes vary from state to state, and CH01.indd 41 02/01/23 1:52 PM 42 T h e L aw o f H e a l th c a re A d mi n i stra ti o n payment for AHP services varies depending on the patient’s insurance coverage. Federal law does not license or regulate AHPs directly, but, of course, it now determines provider eligibility under Medicare and Medicaid, and federal policy positions can influence state licensing boards’ regulatory activities. World War II to the Present As shown in appendix 1.1, most miraculous advances in healthcare—the “wonders of modern medicine”—have appeared within the past 100 years. These include more effective treatments for cancer, coronary artery bypass surgery and cardiac pacemakers, vaccines for polio and influenza, organ transplantation, and gene therapy. When used in the modern hospital by well-trained physicians, nurses, and allied health professionals, these wondrous and relatively new practices constitute the best healthcare the world has ever known. These developments underscore the sagacity of Starr’s comment that few institutions have changed as much in their recent history as have hospitals. Barely 200 years ago, they were horrid cesspools of suffering, infected by ignorance and medieval—even ancient—belief systems. Even as recently as 100 years ago, they were generally to be avoided. Today, just four or five generations later, the prospect of a hospital stay may cause some anxiety but is far less likely to inspire dread. In fact, hospital care is much more likely to be a cause for hope, recovery, and celebration of life. As significant as these changes have been, however, consider what may happen in the next few decades. Universal insurance coverage (perhaps), improved disease prevention, better wellness programs, genetic and stem cell therapies, better information systems, high-tech tools, online doctor visits, a team approach to care, concierge medicine for all, greater use of complementary and alternative medicine, and competition among providers on the basis of value rather than cost—these developments and others not yet imagined will make the medicine of today seem as cumbersome to future generations as Civil War medicine appears to us. Discussion Questions for Part 2 1. In your opinion, what was the most important development in the history of medicine? Be prepared to defend your position. 2. Define when “modern medicine” began and explain why you chose that moment in history. 3. Do you believe that people of all races and genders now have equal access to medical school, residencies, and medical staff privileges? If not, what barriers do you perceive, and what, if anything, can the law do about that? CH01.indd 42 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 43 4. Before reading this chapter, had you heard of the Ethical and Religious Directives for Catholic Health Care Services? If so, what was the context? 5. Describe what you think the healthcare system of the future should look like. Would it require different educational pathways for healthcare providers? Is it shaped by new medical discoveries or technological advances? Chapter Summary Part 1 Part 1 of this chapter discussed the following topics: • • • • The history and sources of law The relationships among the three branches of government The basic structure of the federal and state court systems Some basics of legal procedure in civil cases (the procedures followed in criminal cases are somewhat different and beyond the scope of this text) • The quest for racial justice in healthcare Part 2 Part 2 of this chapter discussed the following topics: • The history of medicine • “Modern medicine” as a relatively new phenomenon • Major advances in medicine developed after the Civil War (e.g., anesthesia, vaccines) • The differences between hospitals as we know them today and those a century ago Vocabulary administrative law Affordable Care Act (ACA) arbitration common law directed verdict due process of law CH01.indd 43 02/01/23 1:52 PM 44 T h e L aw o f H e a l th c a re A d mi n i stra ti o n holding judgment NOV judicial interpretation law stare decisis subpoena duces tecum summary judgment writ writ of certiorari Notes 1. See, e.g., Michelle J. Benton, An Overview of Natural Law, The Moral Liberal (Jan. 29, 2012), http://www.themoralliberal. com/2012/01/29/an-overview-of-natural-law [https://perma. cc/5SP9-PCX5]. 2. Pete Williams, Justice Stephen Breyer to Retire from Supreme Court, Paving Way for Biden Appointment, NBC News (Jan. 26, 2022), https://www.nbcnews.com/politics/supreme-court/justice-stephenbreyer-retire-supreme-court-paving-way-biden-appointment-n1288042 [https://perma.cc/3TKX-2JPM]. 3. Pub. L. No. 111-148, 124 Stat. 119, codified as amended at various titles and sections of the United States Code. 4. Dobbs v. Jackson Women’s Health Organization, 597 U.S. ___ (2022). 5. Patricia Mazzei, Florida Judge Will Temporarily Block 15-Week Abortion Ban, N.Y. Times (June 30, 2022), https://www.nytimes. com/2022/06/30/us/florida-abortion-ban-blocked.html [https:// perma.cc/M3TV-6WSW]. 6. Quoted in Woodrow Wilson, Congressional Government: A Study in American Politics 1 (1885). 7. Planned Parenthood of S.E. Pennsylvania v. Casey, 505 U.S. 833 (1992). 8. Id. at 867. 9. Supra note 4. 10. William Shakespeare, Henry VI (act 4, scene 2). 11. 28 U.S.C. § 1332—Diversity of citizenship; amount in controversy; costs. 12. See generally, United States Courts, About Federal Courts, http:// www.uscourts.gov/about-federal-courts [https://perma.cc/UE46LDXC] (last visited Dec. 10, 2018). CH01.indd 44 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 45 13. National Federation of Independent Businesses v. Sebelius, 567 U.S. 519 (2012). 14. See, e.g., Ohio Rev. Code Ann. § 2711.03, http://codes.ohio.gov/ orc/2711.03 [https://perma.cc/4FLK-8ENL]. 15. Plessy v. Ferguson, 163 U.S. 537, 544 (1886). 16. Hospital Survey and Construction Act, 42 U.S.C.. § 291— Congressional declaration of purpose. 17. 42 U.S.C.A. §291(e)—Projects for construction or modernization. 18. Brown v. Bd. of Educ., 347 U.S. 483, 495 (1954) (declaring segregated public schools unconstitutional), supplemented, 349 U.S. 294 (1955). 19. P. Preston Reynolds, Professional and Hospital Discrimination and the US Court of Appeals Fourth Circuit 1956–1967, 94 Am. J. Pub. Health 710, 712 (2004), https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC1448322/pdf/0940710.pdf [https://perma.cc/AN5K-R3V5]. 20. Simkins v. Moses H. Cone Memorial Hospital, 323 F.2d 959 (4th Cir. 1963) (en banc). 21. David Barton Smith, The Power to Heal: Civil Rights, Medicare, and the Struggle to Transform America’s Health Care System 112 (Vanderbilt Univ. Press 2016). See also the documentary film The Power to Heal: Medicare and the Civil Rights Revolution (Bullfrog Films 2019). 22. Part 2 is synthetic historiography culled from many sources. Primary among them are Charles Singer & E. Ashworth Underwood, A Short History of Medicine (Oxford Univ. Press 1962); Paul Starr, The Social Transformation of American Medicine (Basic Books 1982); and American College of Healthcare Executives, Coming of Age: The 75-Year History of the American College of Healthcare Executives (Health Admin. Press 2008). 23. See generally, John F. Nunn, Ancient Egyptian Medicine (Red Rover Books 2002). 24. See, e.g., Michael D. Parkins, Pharmacological Practices of Ancient Egypt, in Proceedings of the 10th Annual History of Medicine Days (W. A. Whitelaw ed., 2001). 25. See, e.g., Health and Fitness History, Ancient Babylonian Medicine, HealthAndFitnessHistory.com, https://healthandfitnesshistory.com/ ancient-medicine/babylonian-medicine/ [https://perma.cc/5X8N88CE] (last visited July 17, 2019). 26. See Fielding O. Lewis, Washington’s Last Illness, 4 Annals Med. Hist. 245–48 (1932); Creighton Barker, A Case Report, 9 Yale J. Biology & Med. 185–87 (1936); S. L. Shapiro, Clinic-of-the-Month: General CH01.indd 45 02/01/23 1:52 PM 46 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. CH01.indd 46 Washington’s Last Illness, 54 Eye Ear Nose & Throat Monthly 164– 66 (1975). Cristin O’Keefe Aptowicz, The Dawn of Modern Anesthesia, The Atlantic (Sept. 4, 2014), http://www.theatlantic.com/health/ archive/2014/09/dr-mutters-marvels/378688/ [https://perma.cc/ FF2B-SVSJ]. See Semmelweis Society International, Dr. Semmelweis’s Biography, at https://semmelweis.org/?s=biography [https://perma.cc/NYR5YHWU] (last visited Oct. 10, 2019); O. Hanninen, M. Farago, & E. Monos, Ignaz Philipp Semmelweis, the Prophet of Bacteriology, 4 Infection Control 367 (1983). Joseph Lister, On the Antiseptic Principle in the Practice of Surgery, 90 Brit. Med. J. (1867). For Lister’s life generally, see Encyclopedia of World Biography, Joseph Lister Biography, https://www. notablebiographies.com/Ki-Lo/Lister-Joseph.html [https://perma. cc/X954-9NB9] (last visited Dec. 20, 2012). Michael R. Gilchrist, Disease & Infection in the American Civil War, 60 Am. Biology Tchr. 258 (1998), www.jstor.org/pss/4450468 [https://perma.cc/H8CY-X4YP]. See, e.g., David Vachon, Doctor John Snow Blames Water Pollution for Cholera Epidemic, UCLA Department of Epidemiology (2005), http://www.ph.ucla.edu/epi/snow/fatherofepidemiology.html [https://perma.cc/7EHX-S3A2]. See, e.g., Life Expectancy Graphs, Mapping Hist., https:// mappinghistory.uoregon.edu/english/US/US39-01.html [https:// perma.cc/X8VG-6KEM] (last visited Sept. 12, 2021). Our Work, Am. Pub. Health Ass’n, https://www.apha.org/AboutAPHA/Our-Work [https://perma.cc/E47N-ZC8G] (last visited Sept. 7, 2021). Jacqueline Yao, Misinformation Harming US Health, Surgeon General Says, Pub. Health. Newswire (July 19, 2021 5:01 PM), http:// publichealthnewswire.org/?p=surgeon-general-advisory [https:// perma.cc/VXK7-ET25] (last visited Sept. 7, 2021). Institute of Medicine, The Future of Public Health (National Academies Press 1998), https://doi.org/10.17226/1091. See, e.g., Am. Heritage Dictionary of the English Language (5th ed., 2011). See, e.g., Richard A. Smiley, et al., The 2020 National Nursing Workforce Survey, 12(1) J. Nursing Reg. Supplement S1, S12 Table 3, https://doi.org/10.1016/S2155-8256(21)00027-2. 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 47 38. See King’s College London, Florence Nightingale Faculty of Nursing and Midwifery, https://www.kcl.ac.uk/nmpc [https://perma. cc/94SK-SPF5] (last visited July 14, 2016). 39. Jean C. Whelan, American Nursing: An Introduction to the Past, Univ. Penn. Sch. Nursing (2017), https://www.nursing.upenn.edu/nhhc/ american-nursing-an-introduction-to-the-past/ [https://perma.cc/ EMV3-6T65] (last visited July 17, 2019). 40. Id. 41. Paul Starr, The Social Transformation of American Medicine 145 (1982). 42. Id. at 123. 43. Andrew H. Beck, The Flexner Report and the Standardization of American Medical Education, 291 J. Am. Med. Ass’n. 2139 (2004), http://jama.jamanetwork.com/article.aspx?articleid=198677 [https:// perma.cc/3ZC3-TNQB]. 44. Id. 45. Earl H. Harley, The Forgotten History of Defunct Black Medical Schools in the 19th and 20th Centuries and the Impact of the Flexner Report, 98 J. Nat. Med. Ass’n. 1425 (2006), https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC2569729/pdf/jnma00196-0027.pdf [https:// perma.cc/44FW-3V4M]. 46. The History of African Americans and Organized Medicine, AMA History, https://www.ama-assn.org/about/ama-history/historyafrican-americans-and-organized-medicine [https://perma.cc/UD5LQ3ZZ] (last visited Jan. 26, 2022). 47. Id. 48. Starr, supra note 41, at 123–24. 49. See Thomas P. Duffy, The Flexner Report—100 Years Later, 84 Yale J. Biol. Med. 269 (2011), https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3178858/ [https://perma.cc/59FZ-KGJ5]. 50. Harley, supra note 45, at 1428. 51. Our History, Cath. Health Ass’n U.S., https://www.chausa.org/ about/about/our-history [https://perma.cc/5HEU-BDB5] (last visited July 14, 2016). 52. Starr, supra note 41 at 177. 53. David H. Demo, et al., A Call for Action: Advocating for Increased Funding for the Allied Health Professions, 44(1) J. Allied Health 57 (2015), https://static1.squarespace.com/ static/57a64a023e00beb95af13929/t/58000c2e8419c2e26 86c7365/1476398127700/A-Call-for-Action-Advocating-forIncreased-Funding.pdf [https://perma.cc/S6C9-ZY3S]. CH01.indd 47 02/01/23 1:52 PM 48 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Appendix 1.1: A Select Timeline of the History of Medicine Date Key Events Third millennium BCE Imhotep describes the diagnosis and treatment of 200 diseases (ca. 2600 BCE). He and others use trepanation surgery for unknown purposes. Spirits and supernatural forces are thought to be the cause of disease. Second millennium BCE Code of Hammurabi is inscribed (ca. 1790 BCE). Fifth century BCE Hippocrates, the “father of Western medicine,” uses observation of the body as a basis for medical knowledge. He recommends changes in diet, rudimentary drugs, and keeping the body “in balance” (humoralism) rather than prayer and sacrifice to divinities. Fourth century BCE Aristotle codifies known science. First known anatomy book appears (ca. 300 BCE), but religion still dominates medicine. Hippocratic Oath appears. Second century BCE Galen becomes physician to Roman emperor Marcus Aurelius and builds on Hippocrates’s theories of the humors but supports observation and reasoning in medical science. Fifth to tenth century Western Europe experiences decreasing population and trade; a flood of migrants and invaders; and a paucity of literary, cultural, and scientific output. Culture continues to flourish in the Byzantine (Eastern Roman) Empire. Eighth century Baghdad becomes “a veritable seedbed of medical learning, crossfertilized by Persian-Mesopotamian, Byzantine-Greek, and Indian traditions” (NLM and NIH 2006). The recent introduction of paper enables knowledge to be more easily recorded and published. Tenth century Rhazes—considered the greatest physician and practitioner of Islamic medicine during the Middle Ages—revolutionizes Islamic medicine by using careful clinical observation and notation, writes scientific treatise on infectious disease, identifies smallpox, and publishes The Comprehensive Book on Medicine (the Hawi). Eleventh century Persian polymath Avicenna (Ibn Sina) builds on Rhazes’s work and publishes The Canon of Medicine, an encyclopedic book dealing with pharmacology, the nature of contagious diseases, experimental and evidence-based medicine, and many other topics. It is consulted for centuries thereafter in some parts of the world. Thirteenth century Roger Bacon invents spectacles (1249). Fourteenth century Bubonic plague, believed by many to be a punishment from God, kills millions in Europe. Fifteenth century Leonardo da Vinci and others study anatomy by dissecting corpses, much to the displeasure of the Catholic Church. Printing press is invented (1454), enabling knowledge to be recorded and transmitted more freely. CH01.indd 48 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine 49 Date Key Events Sixteenth century New drugs such as quinine and laudanum (an opiate) are discovered. Royal College of Physicians is formed in London (1518). Paracelsus (1493–1541) rejects ancient texts, emphasizes natural sciences, and founds the fields of toxicology and psychology. Zacharias Janssen invents the microscope (1590). Seventeenth century William Harvey publishes An Anatomical Study of the Motion of the Heart and of the Blood in Animals (1628). The book forms the basis for future research on blood vessels, arteries, and the heart. Sir Christopher Wren experiments with canine blood transfusions (1656). Anton van Leeuwenhoek improves the microscope, discovers blood cells, and later observes bacteria (1670). Eighteenth century Based on the work of Edward Jenner and others, smallpox inoculations gain acceptance in England and America. (They had long been practiced in Africa, India, and China, but this was not well known in the West.) James Lind discovers that citrus fruit prevents scurvy. First successful appendectomy is performed. Early nineteenth century Royal College of Surgeons is formed (1800). Rene Laennec invents the stethoscope. First successful human blood transfusion is performed. Ether and nitrous oxide are used as general anesthetics. Benjamin Rush (1746–1813)—signatory of the Declaration of Independence, founder of Dickinson College, professor of medicine at the University of Pennsylvania, and proponent of bloodletting and similar therapies—is considered the “father of American psychiatry.” Syringe is invented. Mid- to late nineteenth century The Home for the Colored Aged (later the Colored Home and Hospital and now part of NYC Health + Hospitals) opens in New York City in 1839 to serve former enslaved persons. American Medical Association is founded (1847). Louis Pasteur identifies germs as cause of disease; antiseptic techniques begin. Florence Nightingale lays the foundations for professional nursing and modernization of hospitals. Joseph Lister develops antiseptic surgical techniques. Vaccines developed for cholera, anthrax, rabies, tetanus, diphtheria, typhoid fever, and bubonic plague. New England Female Medical College (NEFMC)is founded, becoming the first US medical school for women (1848). It merged with Boston University School of Medicine in 1873. Rebecca Lee Crumpler (1831–1895) becomes the first Black woman to earn an MD degree, graduating from NEFMC in 1864. (continued) CH01.indd 49 02/01/23 1:52 PM 50 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Date Key Events Sir William Osler (1849–1919), the “father of modern medicine” and cofounder of Johns Hopkins Hospital, establishes the first medical residency program to involve medical students in bedside clinical training (“grand rounds”). Howard University, traditionally an all-Black institution, is established (1867). American Public Health Association is formed (1872). Clara Barton promotes public support for a national society to work with the International Red Cross. The American Red Cross is founded (1881). X-rays are discovered, rather accidentally, by Wilhelm Roentgen (1895). National Medical Association, a pioneering organization of Black physicians, is formed (1895). Association of Hospital Superintendents, forerunner of the American Hospital Association, is founded (1899). Early twentieth century CH01.indd 50 Karl Landsteiner introduces blood classification system (types A, B, AB, and O). Charles R. Drew (1904–1950), prominent Black surgeon and researcher, develops improved techniques for blood storage and helps develop largescale blood banks. William Montague Cobb (1904–1990), Black physician and the first Black PhD in anthropology, studies and teaches the idea of race as having a negative impact on communities of color. X-ray technology becomes available. US Pure Food and Drug Act is enacted (1906). Tuberculosis skin test is introduced (1907). The Flexner Report on medical education is published (1910). Solomon Carter Fuller (1872–1953), Black psychiatrist and neurologist and professor at Boston University, makes major contributions to research on Alzheimer’s disease. American College of Surgeons, first of the American medical specialty colleges, is founded (1913). Catholic Hospital Association (now Catholic Health Association of the United States) is founded (1915). Paul Dudley White develops the electrocardiogram. Polio epidemics break out in New York and Boston (1916) and continue elsewhere for years. Influenza pandemic kills 15 million worldwide (1918–1919). Edward Mellanby discovers vitamin D connection with rickets (1921). Sheppard-Towner Act establishes child and maternal health centers; insulin is first used to treat diabetes (1922). Vaccines are developed for whooping cough, tuberculosis, and yellow fever. Medical Group Management Association is founded (1926). 02/01/23 1:52 PM C h ap ter 1: A Br ief H istor y of L aw and Medic ine Date 51 Key Events American Health Information Management Association is founded (1928). Penicillin is discovered (1928). American College of Hospital Administrators (now American College of Healthcare Executives) is founded (1933). Vitamins A, B1, B2, and B3 are identified. First blood bank opens in Chicago (1937). National Cancer Institute is founded (1937). Mid-twentieth century Ultrasound is developed (1942). Chemotherapy is developed for cancer treatment (1942). Healthcare Financial Management Association is founded (1946). Association of University Programs in Health Administration is founded (1948). Sydenham Hospital, in the Harlem neighborhood of New York City, becomes the nation’s first hospital to have a fully desegrated staff at all levels (including trustees and physicians), and hires Jean Murray Smith as the first Black hospital administrator at a nonsegregated facility. Influenza vaccines and streptomycin are developed. First cardiac pacemaker is invented (1950). Joint Commission on Accreditation of Hospitals (now The Joint Commission) is established (1951). Polio vaccine is used widely (1950s). James Watson and Francis Crick describe the structure of the DNA molecule (1953). First kidney transplant is performed (1954). Vaccines for measles, mumps, rubella, chicken pox, pneumonia, and meningitis are developed. Health Information and Management Systems Society (founded as Hospital Management Systems Society) is established (1961). Nursing home administrators form an association (now American College of Health Care Administrators) (1962). Medicare and Medicaid are enacted (1965). Federation of American Hospitals (for-profit hospitals) is established (1966). American Organization of Nurse Executives is founded (1967). First heart transplant and coronary bypass operations are performed (1967). Health Maintenance Organization Act is passed (1973). Black physician Patricia E. Bath (1942–2019), the first woman ophthalmologist appointed to the faculty of University of California, Los Angeles medical school; she goes on to invent a new device for laser cataract surgery (1986). American Association for Physician Leadership is founded (1975); it was previously called American Academy of Medical Directors and American College of Physician Executives. (continued) CH01.indd 51 02/01/23 1:52 PM 52 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Date Key Events Late twentieth century World Health Organization declares smallpox eradicated (1980). HIV, the virus that causes AIDS, is identified (1983). Artificial kidney dialysis machine is invented (1985). Consolidated Omnibus Budget Reconciliation Act is passed to allow for the continuation of group health coverage after a job loss (1985). Emergency Medical Treatment and Active Labor Act is passed to prohibit patient dumping (1986). Hepatitis A vaccine is developed (1992). Dolly the sheep is the first cloned mammal (1996). Health Insurance Portability and Accountability Act is passed to provide insurance portability and new privacy standards (1996). State Children’s Health Insurance Program and Medicare+Choice (later Medicare Advantage) are established (1997). Balanced Budget Act is enacted to cut Medicare spending and provide beneficiaries with additional choices through private health plans (1997). Early twenty-first century Healthcare costs continue to rise in the United States; total healthcare spending makes up more than 17.3 percent of the gross domestic product ($2.7 trillion). The Human Genome Project is completed (2003), and the entire sequence of nearly 40,000 human genes is documented. Medicare Part D (drug benefit) begins (2006). Affordable Care Act (ACA) is signed into law (2010) and upheld by the US Supreme Court (2012), but Medicaid expansion is optional. Thirty-nine states and District of Columbia expand Medicaid per ACA (by early 2022). Sources See generally, US National Library of Medicine, History of Medicine at https://www.nlm.nih.gov/hmd/ index.html [https://perma.cc/5KLZ-2QVU] (last visited July 9, 2019). Drew Altman & William Frist, Medicare and Medicaid at 50 Years, 314 J. Amer. Med. Ass’n. 384 (2015). American College of Healthcare Executives, Coming of Age: The 75-Year History of the American College of Healthcare Executives (Health Administration Press 2008). History of Medicine Timeline, DatesAndEvents.org, http://www.datesandevents.org/eventstimelines/10history-of-medicine-timeline.htm [https://perma.cc/9HQJ-HRQ4] (last visited July 9, 2019). The 1619 Project, chs. 12, 15 (Nikole Hannah-Jones, ed., 2021). CH01.indd 52 02/01/23 1:52 PM CHAPTER ACCESS TO HEALTHCARE INSURANCE AND TREATMENT 2 After reading this chapter you will • appreciate the long history of the federal government’s efforts to provide near-universal access to affordable, high-quality healthcare within a fragmented system; • understand the basics of Medicare financing, coverage, and payment, as well as the program’s influence on the healthcare system as a whole; • understand the role of Medicaid in providing healthcare access for the categorically eligible and the expansion population using matching federal funds to support state-run programs; • be able to describe four key Affordable Care Act reforms related to access and three US Supreme Court decisions about those reforms; and • know some of the key legal issues related to healthcare access and health facility operations. The US Healthcare System: Fragmented and Unequal We sometimes hear people claim that the United States has “the best healthcare system in the world.” There are at least two objections to this assertion, however. First, it is somewhat anomalous to call our fragmented approach to healthcare a “system.” Consider that the federal government alone has numerous major programs that provide direct care or help finance healthcare services for citizens and some legal residents: • Medicare, the insurance program for people aged 65 or older and younger people with qualifying disabilities or kidney failure • Medicaid, the federally subsidized, state-run insurance program that is available in most of the country to any American citizen or “lawfully 53 CH02.indd 53 02/01/23 1:54 PM 54 T h e L aw o f H e a l th c a re A d mi n i stra ti o n federal poverty level (FPL) A benchmark annual income amount, set by the federal government, that theoretically represents the minimum amount that a family or individual could survive on. The FPL is used to determine eligibility for government benefits including, but not limited to, subsidized healthcare. • • • • • present” noncitizen whose income is less than 138 percent of the federal poverty level (FPL)—or, in states that have not expanded their Medicaid programs pursuant to the Affordable Care Act (ACA), to certain categories of low-income people, including those over age 65, children, the disabled, and those who are pregnant Health insurance marketplaces (also called exchanges), portals established under the ACA for people to compare and purchase individual health insurance plans with federal subsidies for most purchasers The Children’s Health Insurance Program (CHIP), which provides low-cost health coverage to children in families that earn too much money to qualify for Medicaid but not enough to buy insurance The US Department of Defense’s TRICARE program, the healthcare program for uniformed service members, retirees, and their families The health program of the Veterans Administration, a healthcare system providing care to more than 9 million veterans of the US military The Indian Health Service (IHS), which is responsible for providing health services to American Indians and Alaska Natives Because of overlapping eligibility, is impossible to cite a precise number of people covered by these federal programs, but it is safe to say that the number exceeds one-third of all Americans (see appendix 2.1). And this does not account for the services of the US Department of Health and Human Services (HHS) that benefit the entire population through public health initiatives. As explained briefly in part 2 of chapter 1, HHS’s mission is to protect and improve the health of the general population. That mandate is so broad that, in typical bureaucratic fashion, responsibilities have been meted out to many different agencies, including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Indian Health Service (IHS), and National Institutes of Health (NIH). Elsewhere, both within HHS and in other federal departments, other federal offices also work in the public health arena. They address such topics as climate change, health equity, toxic substances, occupational safety, minority health, infectious disease, HIV/AIDS policy, and the health of children and families. At the state and local levels, myriad other entities deliver direct care or public health services in one way or another: state and local departments of health, public safety, or environmental protection; state and local government hospitals and clinics; private hospitals and clinics; long-term care facilities; pharmacies; and hospices. One must also note the contributions of many nongovernmental human service groups: education and youth development programs; housing, recreation, and arts groups; and other organizations.1 CH02.indd 54 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 55 Atop this patchwork of government care and prevention services sits a jumble of other payment mechanisms that we label “health insurance,” for lack of a better term. These include private insurance plans (usually employer based), self-pay, and true charity care. In sum, to call this a “system” is a misnomer. As the late Princeton University economist Uwe Reinhardt once wrote, “At international conferences on health policy, the US system of financing health care is routinely viewed as the bogeyman—as an example of how not to structure a nation’s health system.”2 A second objection to the claim that the United States has the “best healthcare system in the world” is that the United States does not guarantee its citizens access to care, and as a result of this and other factors, our overall health status does not compare well with other industrialized nations. A 2013 Institute of Medicine report concluded that compared with people in other wealthy, industrialized countries, Americans live shorter lives and have poorer health.3 In 2021, a Commonwealth Fund report reviewed five factors—access to care, care processes, administrative efficiency, equity, and healthcare outcomes—and concluded that, overall, the United States ranks last among the 11 countries studied. Following are some of the report’s most salient findings: • The United States ranks last among the 11 countries on access to care, a measure of affordability and timeliness. • The United States continues to outspend other nations on healthcare, devoting nearly twice as much of its gross domestic product—nearly 17 percent—as the average country in the Organisation for Economic Co-operation and Development (OECD). • US out-of-pocket health spending per person is the second highest in the OECD, which makes it difficult for many Americans to obtain needed care. OECD • The United States ranks poorly on administrative efficiency because of high “The Organisation for Economic Co-operation and documentation and other bureaucratic tasks Development (OECD) is an international organisathat patients and clinicians face, restrictions tion [of 37 countries] that works to build better polon insurance coverage, and the amount of icies for better lives. Our goal is to shape policies nonemergency care rendered in emergency that foster prosperity, equality, opportunity and well-being for all. We draw on 60 years of expedepartments. rience and insights to better prepare the world • The United States ranks last on healthcare of tomorrow” (OECD Secretary-General’s Report to outcomes (maternal and infant mortality, Ministers 2021 [OECD Publishing 2021], https:// overall preventable mortality, etc.) and doi.org/10.1787/8cd95b77-en [https://perma. equity (how income disparities affect access cc/8DVS-7HWF]). and efficiency). CH02.indd 55 02/01/23 1:54 PM 56 T h e L aw o f H e a l th c a re A d mi n i stra ti o n • The United States compares favorably only on care process, which includes measures of preventive care, safety, coordination of care, and patient preferences; in that category, the United States ranks second. It cannot be disputed that for those who are covered by some form of payment system or who can afford to pay out of pocket, the highest-quality healthcare on the planet is available in the United States. For a variety of reasons, however, many people cannot access the care they need, so the claim that the United States has the best healthcare system in the world is somewhat dubious. It is clear that we could do better. In the words of the Commonwealth Fund’s 2021 report, As the COVID-19 pandemic has amply shown, no nation has the perfect health system. Health care is a work in progress; the science continues to advance, creating new opportunities and challenges. But by learning from what’s worked and what hasn’t elsewhere in the world, all countries have the opportunity to try out new policies and practices that may move them closer to the ideal of a health system that achieves optimal health for all its people at a price the nation can afford.4 Moral and Legal Issues These thoughts raise a fundamental question: do we have a right to healthcare? There are both moral and legal aspects to the answer. The moral aspect concerns distributive justice: how goods, benefits, and burdens should be fairly allocated in a society. Reinhardt phrased the question this way after President Bill Clinton’s health reform initiative failed in 1997: As a matter of national policy, and to the extent that a nation’s health system can make it possible, should the child of a poor American family have the same chance of avoiding preventable illness or of being cured from a given illness as does the child of a rich American family?5 To many observers, the answer is a clear, resounding “yes.” But moral questions are so complex and fraught with emotion that politicians and policymakers are chary of confronting them explicitly. To quote Reinhardt again, And so, permanently reluctant ever to debate openly the distributive social ethic that should guide our health system, with many Americans thoroughly confused on the issue, we shall muddle through health reform, as we always have in the past, and as we always shall for decades to come. Our doctors, nurses, and research scientists will work hard to bring about many wondrous cures on the clinical facet of our health system, while the financial facet will forever remain a fount of rancor, confusion, litigation, and political posturing.6 CH02.indd 56 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 57 On the legal side of the issue, the answers are less emotional but still somewhat complicated. Clearly, there is no constitutional right to healthcare.7 Given the level of medical knowledge in the eighteenth century (see chapter 1, part 2), it is no wonder that the Founders did not consider it one of our “unalienable rights.” Although the Constitution provides that Congress has the power to “lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common Defence and general Welfare of the United States,”8 the “general welfare” does not necessarily include the provision of healthcare in the context of constitutional law. Constitutional principles aside, a number of statutes and common law principles provide for certain legal rights in healthcare, but these provisions fall short of universal coverage, and their application depends on the circumstances. Consider the following examples: • Medicare coverage is available to Americans over age 65 or with qualifying disabilities. • In most of the country, Medicaid coverage is available to any American citizen or “lawfully present” noncitizen whose income is less than 138 percent of the FPL. In states that have not expanded their programs pursuant to the ACA option, Medicaid is available to certain categories of low-income people, including those over age 65, children, the disabled, and those who are pregnant. • All Americans are entitled to buy individual comprehensive insurance, without preexisting condition consideration, on the Marketplaces, with premium and out-of-pocket subsidies for most. • In emergencies, individuals who go to or are taken to a hospital have a statutory right to be seen and to have their emergency conditions stabilized. • People with health insurance have a contractual right to their covered benefits. • People with limited English proficiency have a statutory right to effective communication with their care providers. • The doctor–patient relationship implies a contractual right to treatment without abandonment. • There are common law and statutory rights to informed consent and patient self-determination. As this discussion makes clear, the United States does not guarantee universal access to healthcare either constitutionally or by statute, and it does not confront candidly the underlying social justice issues. The reforms contained in the ACA are the closest we have come to doing so, but given the CH02.indd 57 02/01/23 1:54 PM 58 T h e L aw o f H e a l th c a re A d mi n i stra ti o n contentious history of this issue and the contentiousness of today’s political climate, we are unlikely to see universal coverage anytime soon. More detail about the ACA can be found later in this chapter, but first let us review the history of government involvement in healthcare over the past century or so (appendix 2.2 summarizes much of this history in a table format). A Century of Efforts to Achieve Broader Access to Care police power The right of a government to protect its population from threats to the public health and safety. The term police power predates the organization of organized police forces, which did not exist until the postcolonial period. Federal, state, and local public health laws are examples of the exercise of police power. CH02.indd 58 Until the dawn of the twentieth century, law had little effect on the evolution of healthcare in this country. While European countries were adopting broad plans of social insurance—for sickness, old age, industrial accidents, and the like—the US government did little to ensure the “general welfare” of the citizenry. Instead, responsibility for social programs and health policy resided almost entirely with the states. Examples of the federal government’s deference to the states can be seen in Congress’s faltering attempts to deal with two health-related issues many years ago. The Vaccine Act of 1813 provided “genuine vaccine matter” for the prevention of smallpox and furnished it, postage-free, to any US citizen who applied for it. But the law was repealed in 1822 after contaminated vaccines caused an outbreak of the disease and panic in North Carolina. Burned by the Vaccine Act experience, Congress refrained from enacting any significant health policy statute for nearly a century, when it passed the Sheppard-Towner Act in 1921 as a response to the lack of adequate medical care for women and children. This law, too, was short-lived; when it came up for renewal a few years later, it faced constitutional challenges and opposition from the American Medical Association (AMA), which saw it as a “socialist threat” to physician autonomy. Sheppard-Towner was allowed to expire in 1929.9 Deference to states was seen in the judiciary when the question of a vaccine mandate reached the US Supreme Court in the landmark 1905 case of Jacobson v. Massachusetts.10 At issue in Jacobson was a state law that allowed cities to require vaccination against smallpox. The plaintiff, Mr. Jacobson, had been convicted of refusing to comply with a vaccination ordinance enacted in Cambridge, Massachusetts. The Supreme Court held that the law was a legitimate exercise of the state’s police power to protect public health, and thus the city ordinance was valid. Although the law was upheld, Jacobson did not set a national vaccine standard. State-by-state or city-by-city requirements were the norm, as they were during the 1918 flu pandemic and the COVID-19 pandemic a century later. Physician licensure became a serious health policy issue after the Civil War, and it, too, was handled on a state-by-state basis. Licensure laws had 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 59 long been disfavored as elitist and monopolistic, but the need to protect the public For a delightful, if somewhat disturbing, review of ridiculous, even fraudulent, treatments offered by from charlatans and poorly trained practisome of history’s worst mountebanks, see Lydia tioners was strong. West Virginia passed K ang & Nate Pedersen, Quackery: A Brief History of the one of the earliest physician licensing laws Worst Ways to Cure Everything (2017). in the early 1880s, and it was immediately challenged by Frank Dent, a practitioner of “eclectic medicine,” a discipline that made use of botanical and other folk remedies. Dent argued that the law unconstitutionally deprived him of the right to practice his trade, and his case—Dent v. West Virginia (1889)—was the first significant healthcare issue decided by the US Supreme Court. In a unanimous decision, Justice Stephen J. Field displayed little sympathy for “Doctor” Dent’s argument and upheld the West Virginia statute “for the protection of society”: No one has a right to practice medicine without having the necessary qualifications of learning and skill; and the statute only requires that whoever assumes, by offering to the community his services as a physician, that he possesses such learning and skill, shall present evidence of it by a certificate or license from a body designated by the state as competent to judge of his qualifications.11 By the turn of the twentieth century, as the quality of care had improved and the public’s expectations had grown, health and healthcare became a matter of greater national concern. For example, when the book The Jungle by Upton Sinclair (1878–1968) appeared in 1906 and exposed horrendous working conditions in the slaughterhouses of Chicago, Congress stepped in to pass the Federal Meat Inspection Act of 1906 and the Pure Food and Drug Act of the same year. These statutes led eventually to the creation of the FDA. Despite Congress’s action in 1906, other arguably health-related topics such as workers’ compensation were left to the states’ discretion, and the idea of insurance coverage for medical care was a fantasy. Theodore Roosevelt to the Great Society President Theodore Roosevelt (1858–1919) and other Progressives supported the concept of health insurance for all Americans during Roosevelt’s 1912 campaign for the presidency, but the idea died with his defeat by William Howard Taft (1857–1930). The onset of World War I, the Red Scare following the 1917 Russian Revolution, and opposition from employers and physicians prevented further consideration of the idea for decades. By the time Franklin D. Roosevelt (FDR) (1882–1945) was elected president in 1932, a few states had passed old-age pension laws, and 34 foreign CH02.indd 59 02/01/23 1:54 PM 60 T h e L aw o f H e a l th c a re A d mi n i stra ti o n countries were operating some form of social insurance program for their citizens.12 Born out of necessity in the Great Depression, the Blue Cross concept was created in 1929 by a FDR made Social Security a hallmark of pioneering businessman, Justin Ford Kimball. He his New Deal, proposing it to Congress offered a way for 1,300 schoolteachers in Dallas, in June 1934, but the idea of the federal Texas, to finance 21 days of hospital care by makgovernment even studying the concept of ing small monthly payments ($6 per person) to national health insurance was considered Baylor University Hospital. too politically controversial and was left Around the same time, the Blue Shield concept was emerging out of the lumber and mining out of the bill. Reform of our fragmented camps of the Pacific Northwest. Serious injuries health system has remained a volatile issue and chronic illness were common among workers ever since.13 in these hazardous jobs. Employers that wanted The Great Depression era saw the to provide medical care for their workers made birth of managed care in the form of “conarrangements with physicians who were paid a tract doctor” programs such as the one that monthly fee for their services. These pioneer programs provided the basis served workers on the Los Angeles Aquefor what would become the “modern” Blue Shield duct project—a consortium now known as plans. (See, e.g., Blue Cross and Blue Shield: A HisKaiser Permanente14—and the Blue Cross torical Compilation [Consumer Rep. 2013], https:// and Blue Shield plans. As we will see, “The advocacy.consumerreports.org/wp-content/ Blues” were destined to play a major role in uploads/2013/03/yourhealthdollar.org_blueMedicare and Medicaid years later. cross-history-compilation.pdf [https://perma. cc/9TJG-6RCC].) During World War II, when wage and price controls were in effect, employers added health coverage as a benefit in lieu of salary increases, and in 1954, the Internal Revenue Code was amended to exclude those benefits from employees’ taxable income. For this managed care Insurance basic reason, employment-based health insurance covers most Americans programs that under age 65 today. In the words of Professor Paul Starr, this has led us to “a attempt to reduce policy trap—a costly, extraordinarily complicated system which nonetheless the cost of care through economic [protects] enough of the public to make the system resistant to change.”15 incentives, This “trap” has bedeviled every attempt to reform the system for threereview of the quarters of a century. medical necessity, In 1948, President Harry S. Truman (1884–1972) campaigned for beneficiary cost sharing, controls reelection on a platform that included a plan for national health insurance, on admissions but he never submitted a specific proposal to Congress. Even some m ­ embers and lengths of of Truman’s own party were not in favor of national health ­ i nsurance. stay, etc. They “Southern Democrats in key leadership positions blocked [Truman’s] include health maintenance ­initiatives, partly in fear that federal involvement in health care might lead to organizations federal action against segregation at a time when hospitals were still separat(HMOs), ing patients by race.”16 (See the discussions of Medicare’s role in desegregatpreferred provider organizations ing hospitals and Simkins v. Moses H. Cone Memorial Hospital in chapter 1, (PPOs), and pointpart 1.) of-service (POS) plans. CH02.indd 60 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 61 At Truman’s urging, Congress did pass one piece of health-related legislation: the Hill-Burton Act.17 Although Hill-Burton enabled racial segregation to continue for a time, it did require hospitals that received federal money to provide a reasonable amount of free or reduced-cost services to people who were unable to pay. The act was arguably the first federal law to address the problem of the healthcare uninsured, and it would be the last until the Great Society years. As healthcare made significant advances in the 1930s, 1940s, and 1950s, the federal government became somewhat more supportive of medicine in other ways. The medical programs of the military services were strengthened. Agencies such as the NIH and the National Science Foundation were created or expanded. Furthermore, HHS became more involved in medical research and providing care to certain populations, such as those who were incarcerated, afflicted with leprosy, or addicted to narcotics. Outside of government, private groups spurred public support for scientific research on specific diseases. Polio, the most frightening disease of the time, was targeted for a cure by the National Foundation for Infantile Paralysis and its “March of Dimes” campaign. When the Salk vaccine, named after its principal developer, Dr. Jonas Salk (1914–1995), was declared effective and made available in 1955, parents were so excited that “pandemonium swept the country.”18 With a variety of private insurance options in place, the nation recovering from the effects of World War II, and medical research proving effective against polio and other diseases, a generation passed before we reached the next milestone in health policy: the landmark legislation of President Lyndon B. Johnson (1908–1973). The Great Society: Medicare and Medicaid After assuming office upon the death of President John F. Kennedy in 1963, President Johnson was elected to a full term in 1964. With an overwhelming majority in Congress, Democrats dove right in to consider Johnson’s “Great Society” agenda, which included civil rights, consumer protection, the environment, and healthcare, the last being one of Johnson’s first and highest priorities. As a wily political professional, Johnson was aware of the stiff opposition he would face as his proposals went forward. Some level of cooperation from doctors, hospitals, and the insurance industry was therefore essential. The AMA and the American Hospital Association (AHA) had vigorously objected to proposed bills. Among national healthcare organizations, only the National Medical Association (representing Black physicians) testified in support. Rather than advocate a comprehensive system of national health insurance (an idea that was not politically viable), President Johnson came up with CH02.indd 61 02/01/23 1:54 PM 62 T h e L aw o f H e a l th c a re A d mi n i stra ti o n an ingenious proposal that one observer described as a “three-layered cake.” It had something that all sides could like: 1. The Democrats’ plan for hospital insurance for those over age 65 (now called Medicare Part A). 2. A Republican-backed plan for government-subsidized insurance to cover physicians’ services for those eligible for Part A (Medicare Part B). 3. Assistance to the states for healthcare for some categories of poor people, including poor seniors (Medicaid). In addition, the proposal allowed healthcare providers (e.g., hospitals, physicians, long-term care facilities) to nominate private companies to act as go-betweens in dealing with the Social Security Administration, the agency tasked with administering the new programs. These Medicare Administrative Contractors (MACs)—originally known as Part A Fiscal Intermediaries and Part B Carriers—would receive the federal money and pay the providers’ claims. They would also render consulting, auditing, and similar services. Although the AMA and AHA continued to object to the bill, the overall arrangement seemed to assuage concerns enough to ensure passage of the bill, and it would ultimately prove financially rewarding for the MACs, which, of course, provide their services for a fee. In the following sections, we describe Medicare and Medicaid in more detail. Medicare and Medicaid: Healthcare’s Fraternal Twins at Middle Age Medicare and Medicaid (Titles XVIII and XVIX of the Social Security Act, respectively) were signed into law on July 30, 1965, and—with surprising rapidity, it seems to us now—the federal government began to implement Medicare the following year. These extremely influential federal healthcare programs are like fraternal twins.19 Although they were created in the same context and born at the same time, they look and function differently. They have improved the lives of many millions of people and made ours a better society, while serving distinct (though overlapping) populations. Like many fraternal twins, in their middle age, they resemble each other more and more. Medicaid is adopting some of the characteristics of its historically more favored sibling. Although the two programs retain their separate identities, both face questions about how they will evolve in the future in the face of competing political visions, budgetary pressures, CH02.indd 62 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 63 changing demographics, and healthcare advances. And both are flexing their financial muscles to help enable health system reforms.20 Medicare Of the twins, Medicare has always been the more stable and popular. It provides health insurance coverage for those over age 65 and those with qualifying disabilities. Over the years, Medicare has enjoyed relatively consistent administration by the federal government while containing significant private elements consistent with federal regulations. Medicare Eligibility and Benefits: Parts A, B, C, and D As it was first enacted, Medicare covered citizens and qualifying noncitizens who were over age 65. In 1972, the program was expanded to cover those with certain serious disabilities or end-stage renal disease (ESRD) regardless of age.21 (Coverage for disabilities is subject to a two-year waiting period; ESRD eligibility begins immediately upon diagnosis.) Medicare benefits are set forth in four parts, lettered A through D. Part A (hospital insurance) covers inpatient hospital and skilled nursing facility stays as well as hospice services. It has potentially high out-of-pocket costs for lengthy stays. Part B covers physician services (whether inpatient or outpatient) and durable medical equipment. The beneficiary is responsible for 20 percent of the allowed charges, which can be expensive. Parts A and B were established by the 1965 legislation and are now known as “traditional Medicare.” Part C allows Medicare benefits to be delivered through private managed care plans. This option is known as Medicare Advantage (MA), and it is a popular choice among beneficiaries, about 40 percent of whom are now enrolled in MA plans. Premiums and out-of-pocket costs vary depending on the MA plan. Part D was added in 2003 by the Medicare Modernization Act, which was passed by a Republican Congress and signed into law by President George W. Bush. It provides outpatient prescription drug coverage through private plans with extensive federal subsidies and can be purchased separately or as part of an MA plan. Although the ACA reduced some costs to beneficiaries (particularly for preventive care and pharmaceuticals), traditional Medicare still has potentially high out-of-pocket costs and coverage gaps. Thus, most beneficiaries have some sort of additional coverage, through an MA plan, Medicaid (if they are low-income), a retiree plan, or a private “Medigap plan.” Medicare Financing: Taxes, General Revenues, Beneficiary Payments Each of Medicare’s four parts is financed differently. Part A is funded by a federal payroll tax, designated for the Hospital Insurance Trust Fund. Part B CH02.indd 63 02/01/23 1:54 PM 64 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The Pig in a Python The baby boom generation—people born between 1946 and 1964—created a huge bulge in the otherwise level US population immediately after World War II. Demographers often describe this bulge as moving through the population like “a pig in a python,” and it raises serious concerns about the financial stability of Social Security because current members of the workforce pay taxes that provide benefits to older generations. When Social Security began in 1935, the life expectancy at birth was about 60 years. Because eligibility was pegged at age 65, the average person born that year would not live long enough to collect benefits. There were, however, 7.8 million Americans aged 65 or older at the time, so there were many people who could receive Social Security at the outset. (See, e.g., Social Security History, Soc. Sec. Admin., http://www.ssa.gov/history/ lifeexpect.html [https://perma.cc/R9MN-RQNB] [last visited May 9, 2022].) When Medicare was enacted 30 years later, life expectancy had increased to roughly 70 years, and many more people were eligible for benefits.22 But because baby boomers were approaching their twenties and would soon begin to pay into the system, their parents’ benefits were adequately funded. Now, however, baby boomers are retiring in large numbers. This raises a question about whether the relatively smaller number of workers will be able to provide the older generations with the benefits they have come to expect. is funded by general federal revenues (75 percent) and by premiums paid by beneficiaries (25 percent). These premiums are generally deducted from Social Security payments; in 2022, the premium was $170.10 per month (although those with high incomes are charged more). Part C (Medicare Advantage) plans are funded by federal payments on a per member, per month (PMPM) basis and by purchaser premiums (which in some cases are low or $0). The PMPM federal payment may vary depending on the enrollee’s health status. The overall cost of Part C payments is a perennial issue for the federal budget. Part D premiums are funded mainly out of general federal revenues, though purchasers also pay monthly premiums. A contentious issue is whether Part D should be changed to allow the Centers for Medicare & Medicaid Services (CMS), the federal agency that administers the programs, to bargain over drug prices. Federal legislation adopted in the summer of 2022 will allow the agency to begin doing so in subsequent years. As the US population ages, and the Medicare population increases commensurately, funding Medicare will increasingly be a challenge. This is particularly true for Part A, with its funding statutorily linked to payroll taxes on working Americans (see The Pig in a Python). Medicare Payments: PPS, ACOs, and More At its inception, Medicare paid hospitals and physicians their usual rates for the services they provided. Obviously, under such a system, the more services you provide, the lengthier the hospital stay, the more you get paid. This arrangement was advantageous for both hospital and physician providers, and Medicare spending rose at an annual rate more than twice that of inflation during the 1970s and early 1980s.23 Concerned about these sharply rising costs, Congress in 1983 replaced Medicare Part A’s cost-based reimbursement system with a prospective CH02.indd 64 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent payment system (PPS) based on diagnosis-related groups (DRGs). Under the DRG system—which was also widely adopted by commercial insurers— hospitals are paid a fixed amount based on the patient’s primary diagnosis. The DRG amount is meant to reflect the average cost to the hospital of treating the typical patient with that diagnosis, knowing that some patients might require more intensive hospital services and others fewer. There are a variety of “modifiers” to the DRG payments, however, including modifiers for extreme patient outliers and for hospitals that train residents or serve a disproportionate share of uninsured patients. “Critical access hospitals” (which are typically small and rural organizations) are still paid primarily on a cost-reimbursement basis. In 1992, Medicare significantly changed the way it paid for physician services under Part B. Rather than paying the “usual and customary” rates (which were inherently inflationary), the government adopted a standardized payment schedule—a resource-based relative value scale—that basically assigns a relative weight to any service a physician might provide. The resulting relative value unit (RVU) is then multiplied by a set dollar amount (modified each year) to arrive at the actual payment. The RVU system has been widely adopted by other insurers despite criticism that it rewards medical procedures more than the personal provider– patient relationship. As one multispecialty clinic executive lamented years ago to one of the authors, “We certainly hope our patients get better, but in fact we get paid for doing stuff to them, and the more stuff we do the better we get paid.” He gave this example: under the fee schedule, physicians get paid very little to counsel patients with diabetes about how to control their blood sugar levels, but a lot to amputate the foot of a diabetic whose levels were poorly controlled. The ACA’s payment models are intended to address these kinds of perverse financial incentives. The ACA promotes a variety of arrangements aimed at “paying for value rather than volume” and generally bending the cost curve while improving quality. The readmission program, for example, financially penalizes hospitals that have high readmission rates for patients with specified diagnoses. Another program promotes patient-centered medical homes, a way of delivering primary care in a more coordinated way. One of the best-known ACA cost-cutting provisions is the Shared Savings Program, which encourages the creation of provider networks called accountable care organizations (ACOs). In fact, in many healthcare executives’ minds, this is such a prominent part of the ACA that they often slip up and call the law the “Accountable Care Act.” Under this optional program, if an ACO improves the quality of care that it provides to its Medicare beneficiaries while simultaneously reducing Medicare’s costs as to those beneficiaries, it shares in the savings that result. In 2022, 483 ACOs participated in this Medicare program.24 CH02.indd 65 65 accountable care organization (ACO) A group of doctors, hospitals, and other healthcare providers who come together voluntarily to give coordinated, high-quality, costeffective care to the traditional Medicare patients they serve. If an ACO meets specified quality metrics and reduces overall costs attributable to those patients, it is entitled to a share of the Medicare savings. 02/01/23 1:54 PM 66 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The form of an ACO is quite flexible, and CMS offers several models to appeal to organizations of differing sophistication and risk tolerance. At its core, the standard ACO has at least 5,000 traditional Medicare beneficiaries (not in Part C) to whom it provides primary care.25 It then needs a plan, acceptable to CMS, to improve on its own regulatorily specified quality metrics. If, during the term of the agreement with CMS (typically three years), the ACO improves its quality metrics and, at the same time, reduces Medicare’s costs for the beneficiaries in its ACO, then the organization shares in those savings.26 Note that the beneficiaries may seek care outside the ACO, and the ACO need not include a hospital. Although the promise of financial rewards is one inducement, most early ACO advocates argued that the program’s real virtue was in supporting system-wide transformation. The train was coming, they argued, and organizations ought to get on board or risk being run over. Conditions of Participation and Conditions for Coverage A set of regulations (42 C.F.R. pts. 482–498) with which healthcare organizations must comply to qualify for Medicare and Medicaid payments. These health and safety standards are the foundation for improving quality and protecting the health and safety of beneficiaries. CH02.indd 66 Medicare Innovation: System-wide Influence It is sometimes said that “when Medicare sneezes, the whole healthcare system catches a cold.” This is so because since its inception, the program has driven change throughout the country. Its Conditions of Participation and Conditions for Coverage have shaped providers’ policies; its payment systems—including its value-based models—have been widely emulated; and its reimbursements form a significant part of most hospitals’ and individual providers’ revenues. Medicare’s influence will long endure. The number of Medicare beneficiaries will grow as our population ages, and the program’s share of the federal budget is likely to increase regardless of whether advocates are successful in their attempts to lower the eligibility age, allow people to buy into the program, or expand it to the entire population (an idea referred to as “Medicare for all”). If those reforms are adopted, the fiscal implications will be even more significant. Medicaid Medicaid has long been the scrappier and—because its original design drew on “welfare medicine” programs—the less politically popular of the twins. Medicaid’s design is a classic example of our federal system at work: it allows the states considerable discretion to determine eligibility criteria and covered services while providing federal matching funds for implementation. During its nearly six decades, the program has grown (in both its services and the size of its eligible population) and now covers more people than does Medicare. With the expansion encouraged by the ACA, Medicaid is becoming the default coverage for low-wage families and a major piece of the coverage continuum. In the words of US Supreme Court Chief Justice John Roberts, it is 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent becoming “an element of a comprehensive national plan to provide universal health insurance coverage.”27 67 Dual Eligibles People who are covered by both Medicare and Medicaid are known as “dual eligibles.” They tend Medicaid Eligibility: Categorical and to have significant healthcare needs and often live Expansion Populations in nursing homes or have in-home support. Note For a variety of political reasons, not all that whereas Medicaid covers general nursing states participated in Medicaid during its home care, Medicare does not. early years, and the program was not available throughout the country until 1982, when the final holdout, Arizona, joined. Furthermore, from its inception, Medicaid has differed from state to state. While the program has always had key mandatory elements in terms of populations to be covered and services to be offered, it has also allowed states a great deal of flexibility regarding optional populations, services, and financing structures. Originally, Medicaid covered only certain categories of low-income people, and it still operates that way in many states. Income levels for these “categorically eligible” beneficiaries vary depending on the basis for coverage. The covered categories are sometimes described in the academic literature as the deserving poor, and, as Medicaid was originally enacted, they included low-income people over age 65, some disabled people, and some families with children on welfare. In the 1980s, Congress expanded Medicaid to require coverage of more pregnant women and children. Other changes expanded coverage for services for people with disabilities, especially in the areas of home- and community-based care. In the late 1990s with the enactment of CHIP, more children in low-wage households received health insurance, as did some lowincome parents of young children. CHIP functions somewhat differently than Medicaid (and requires periodic congressional reauthorization), but many states operate it basically as an extension of that larger program. Until 2014, low-income adults under age 65 who were not pregnant, not disabled, and not the parent of a young child generally remained ineligible for Medicaid coverage no matter how low their incomes. That has changed in most of the country because of a significant ACA reform. As originally written, the ACA required states to expand their Medicaid populations to cover all otherwise uninsured citizens and some legal residents with incomes below 138 percent of the FPL. In its 2012 decision in National Federation of Independent Business (NFIB) v. Sebelius,28 however, the Supreme Court held that this provision exceeded Congress’s constitutional powers because it unduly coerced the states into action. As a result, the court effectively made coverage of the “expansion population” an option for the states rather than a mandate. CH02.indd 67 02/01/23 1:54 PM 68 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (The Medicaid expansion and its intersection with other key ACA accessrelated reforms are described in more detail later in this chapter.) Medicaid Financing: Federal and State Contributions As noted earlier, Medicaid is a classic—some would say the classic—example of cooperative federalism at work. Each state runs its own program, pursuant to federal standards and with matching federal funds. The federal medical assistance percentage (FMAP) for coverage of the categorically eligible varies between 50 and 83 percent, depending on the average per capita income of a state’s residents.29 So, the lowest possible FMAP is 50 percent, with the state and federal government paying equal amounts. The highest possible FMAP is 83 percent, with the federal government covering the bulk of the costs and the state paying the remaining 17 percent of the costs. The FMAP has its roots in early twentieth-century programs, the Hill-Burton Act being a prominent example. For the ACA expansion population, however, the FMAP is higher. Originally set at 100 percent federal contribution, it was statutorily ratcheted down over the first few years of the program to a fixed 90 percent match. So, all states that have adopted the Medicaid expansion pay only 10 percent of the costs for that population’s coverage, with the federal government picking up the rest. This, of course, has been a significant inducement for states to expand their Medicaid programs. Medicaid Payments: The Trend Toward Managed Care One original purpose of Medicaid was to transition low-income people from charity care wards into the mainstream of American medicine. Thus, Medicaid payments originally tracked the fee-for-service model that was common at the time, but over the past several decades, many Medicaid beneficiaries have been transitioned to private managed care plans, particularly children and adults without disabilities. These private managed care plans contract with the states in which they operate. State-set payment rates and plan contracting must be approved by CMS. In general, Medicaid reimbursement rates (whether through a managed care or fee-for-service plan) are lower than commercial insurance rates and lower than Medicare. In lean financial times, state legislators face pressure to cut rates and eliminate optional Medicaid services (e.g., adult dental) to balance their state budgets. Medicaid Innovation: Section 1115 Waivers Innovation within Medicaid programs is promoted by statutorily authorized waivers. Under either a narrow section 1915 “program waiver”30 or a broader section 1115 “demonstration project”31 (these numbers refer to sections of CH02.indd 68 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 69 the Social Security Act), CMS can excuse a state from complying with some Medicaid requirements if the state’s proposal meets Medicaid’s objectives. Several of the section 1115 waivers that were active in 2022, for example, focused on improving behavioral healthcare delivery and payment.32 These waivers recognize the importance of mental health and addiction treatment, as well as the challenges of accessing these services, particularly in coordination with other types of healthcare. In prior years, a different type of Medicaid demonstration project had gained traction. With the Donald Trump ­administration’s strong encouragement, many states applied for and received section 1115 waivers that allowed them to condition Medicaid coverage for many beneficiaries on ongoing documentation of work or “community engagement activities.” These conditions were challenged in court as violating Medicaid’s statutory requirements. Before those cases, and related regulatory changes, were fully resolved, however, the Joe Biden administration revoked the waivers.33 Although not as effective an innovator as its more favored twin, Medicaid is a major player in the healthcare system. It covers more than a quarter of the population, pays for about half of all US births and more than a third of children’s healthcare, and is a principal payer for long-term care and mental health services. The Affordable Care Act: Obamacare’s “Four M’s of Access” In 2010, more than four decades after the enactment of Medicare and Medicaid, Congress passed, and President Barack Obama signed into law, the Patient Protection and Affordable Care Act. Often termed “Obamacare,” this historic statute was intended to broaden access, improve quality, and lower costs through a variety of intertwined mechanisms. (Aspects of the law that relate to tax, organizational structures, fraud law, and more are discussed throughout subsequent chapters.) At the heart of the ACA, though, is near-universal access to comprehensive health insurance. The ACA advances this goal through its “four M’s of access”—the mandate for individuals, the mandate for employers, the marketplaces for private coverage, and Medicaid expansion. These access provisions were intended to go into effect in 2014, but there were some implementation delays for each of them. Mandate for Individuals The ACA’s individual mandate requires most citizens to maintain qualified health insurance unless exempted (for financial or other reasons) or else pay a tax penalty, referred to as a shared responsibility payment. The tax penalty CH02.indd 69 02/01/23 1:54 PM 70 T h e L aw o f H e a l th c a re A d mi n i stra ti o n for an individual was originally the greater of $695 or 2.5 percent of income. The individual mandate has been the most unpopular aspect of the law.34 The day the ACA was signed into law, the mandate was challenged on the grounds that it is beyond Congress’s power to enact. (The blockbuster US Supreme Court decision in that case, NFIB v. Sebelius, is discussed later in this chapter.) This coverage requirement was considered a key element of the ACA’s interlinked insurance reforms. The ACA prohibits insurers from considering a person’s health in deciding whether to offer them a plan, its coverage terms, or its price.35 (Limited statutory exemptions to these preexisting condition protections apply to certain religious ministries and to short-term, limited-duration plans, which are tightly regulated and prohibited in some states.) In addition to protections for preexisting conditions, the plans must meet Essential Health Benefits (EHBs) standards of comprehensiveness, pay for ­ preventive services without cost sharing, The ACA requires the following EHBs to be limit out-of-pocket costs, and impose no included in all plans sold on the ACA-established annual or lifetime maximums. Plans sold on marketplaces: the ACA-created marketplaces (described • Ambulatory patient services (outpatient care in more detail later) must cover ten essenyou get without being admitted to a hospital) • Emergency services tial health benefits (EHBs) (see sidebar). • Hospitalization (e.g., surgery, overnight stays) These provisions caused insurers to • Pregnancy, maternity, and newborn care worry that people would wait until they • Mental health and substance use disorder were sick, injured, or pregnant to sign up services, including behavioral health treatment for coverage unless required to do so by (e.g., counseling and psychotherapy) law to maintain coverage—hence the indi• Prescription drugs • Rehabilitative and habilitative services and vidual mandate. devices (e.g., services and devices to help In December 2017, after failing people with injuries, disabilities, or chronic numerous times to repeal the ACA, Conconditions gain or recover mental and physical gress reduced the tax penalty to $0, thus skills) rendering it essentially toothless.36 That • Laboratory services action set up another serious constitu• Preventive and wellness services and chronic disease management tional challenge to the law, but again the • Pediatric services, including oral and vision Supreme Court decided in the ACA’s favor care (however, adult dental and vision coverage in 2021 (see The Court Decides: Califorare not essential health benefits) nia v. Texas at the end of this chapter). Source: What Marketplace Health Insurance Plans Cover, HealthCare.gov, http://www. healthcare.gov/coverage/what-marketplaceplans-cover/ (last visited September 19, 2022). CH02.indd 70 Mandate for Employers The employer mandate requires most large employers to either pay a tax penalty or to provide adequate, affordable health 02/01/23 1:54 PM 71 C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent insurance to their employees who work 30 hours or more a week.37 The ACA The Law in Action does not require employers to offer spousal coverage and, when that coverage is The US Supreme Court’s 2022 decision in Dobbs offered, does not require subsidization, or v. Jackson Women’s Health Organization and otherwise set affordability standards. Large resulting changes in state law are likely to affect employers, though, are required to cover insurance coverage for birth control and abortion. children of employees and to do so up to The Hyde Amendment has long prohibited federal age 26, though, again, without subsidizafunding for abortion in most circumstances. (See tion or affordability standards.38 Coverage chapter 15 for more details on Dobbs.) for dependents up to age 26 is among the ACA’s most popular provisions.39 Employer coverage must include preventive care without cost sharing (meaning the patient gets the service without having to pay a deductible, copay, or coinsurance). This preventive services coverage requirement has been further defined to include services such as cancer screenings, routine vaccinations, and, controversially for some employers, coverage of FDAapproved contraceptives. Three cases challenging the contraceptive coverage requirement on religious grounds have reached the US Supreme Court. These cases, which are discussed in more detail in chapter 15, exempted from this requirement religiously affiliated institutions (e.g., Catholic universities and hospitals) and closely held private companies whose owners have religiously grounded objections to some or all forms of birth control (e.g., Hobby Lobby). Marketplace for Private Insurance The ACA creates marketplaces (also known as exchanges) where people who lack health insurance (through, say, an employer or Medicaid) can buy private plans for themselves or their families and receive premium subsidies and costsharing reductions (CSRs) if they are eligible based on their income. Under the law, sliding-scale premium subsidies are available to those with incomes between 100 and 400 percent of the FPL. In the continental United States in 2022, that translated to $13,590 to $54,360 for an individual and $26,500 to $106,000 for a family of four. A COVID-19 relief package temporarily extended the subsidies above 400 percent of the FPL and increased their amount. In addition, sliding-scale CSRs are available for marketplace plans to people with incomes between 100 and 250 percent of the FPL. These CSRs are available only for silver-level plans, not for the bronze-, gold-, or platinum-level plans. Thus, low-income marketplace purchasers who select bronze-level plans because of the low premiums (many are available for $0 per month) might find themselves unable to afford the out-of-pocket costs, which in 2022 could be as high as $8,700 a year for an individual. Had they CH02.indd 71 02/01/23 1:54 PM 72 T h e L aw o f H e a l th c a re A d mi n i stra ti o n purchased silver-level plans (which would have some monthly premium costs even after the premium subsidies), the out-of-pocket maximum would be substantially less. This situation is known as the “bronze trap”; in addition to disadvantaging some patients, it can be a concern for providers trying to collect copays from bronze-level plan holders. Note that in Medicaid expansion states, those making less than the relevant percentage of the FPL would be covered by Medicaid, as intended by the ACA (see the next section for a discussion). Thus, in nonexpansion states, we see an anomalous situation in which an uninsured person making 101 percent of the FPL would be entitled to buy and use a marketplace plan while paying very little out-of-pocket, but an uninsured person making 99 percent of the FPL or less would not be eligible for any premium subsidy or any CSR. The least expensive plan might well exceed the purchaser’s entire annual income, particularly if the purchaser is older, as the ACA allows older people to be charged up to three times more than younger people. Most marketplace purchasers receive premium subsidies. These subsidies are technically advanceable, refundable tax credits that generally go directly to the insurance company chosen by the purchaser. Hence, the Internal Revenue Service (IRS) is the federal agency that administers them. Some states set up their own marketplaces, as anticipated by the ACA. Most, however, declined to do so and thus left the federal government as the fallback to run these state-based marketplaces through the federal HealthCare.gov portal. This website and the state-run portals also serve the important function of directing eligible people to state Medicaid programs. In addition to running the federal website, CMS also oversees the marketplace plans’ compliance with ACA requirements. The “M” in CMS is already a placeholder for two words, but given the center’s workload, it really ought to be three and formally renamed the Centers for Medicare, Medicaid & Marketplace Services. Medicaid Expansion Medicaid expansion broadens that federal–state program from one that covers categories of low-income citizens to one that covers all otherwise uninsured citizens with incomes below 138 percent of the FPL. The expansion population thus comprises low-income adults who do not have access to employerprovided coverage and those who are not categorically eligible (because they are not pregnant, disabled, or over age 65). One of the populations that benefited from this expansion is higher education students, who also gained comprehensive coverage (though sometimes at significant expense) under the ACA’s other access provisions.40 As written, this expansion was to be a CH02.indd 72 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 73 Law in Action The Kaiser Family Foundation maintains an interactive map showing the status of state decisions on Medicaid expansion pursuant to the ACA. Status of State Action on the Medicaid Expansion Decision WA MT OR ME ND MN ID SD NY WY MI NV UT CA PA IA NE IL CO KS AZ OK NM MO AK WV VA NC TN AR SC AL MA RI CT OH IN KY MS TX VT NH WI GA NJ DE MD DC LA FL HI Adopted and implemented Adopted but Not Implemented Not Adopted Status of State Medicaid Expansion Decisions: Interactive Map, Kaiser Fam. Found. (Apr. 19, 2022), https://perma.cc/4UQ4-57VK. mandatory part of the Medicaid program. Pursuant to the ACA framework, the federal government picks up at least 90 percent of the cost for the expansion population, a match rate that is significantly higher than the federal contribution for those who are categorically eligible. Several states challenged the Medicaid expansion as unconstitutionally coercive, and in its 2012 NFIB v. Sebelius decision,41 the Supreme Court agreed. As a result, expansion became optional. Roughly half the states expanded their programs in 2014, the earliest opportunity to do so. As of mid-2022, 12 states had not expanded, including populous Texas and Florida (see Law in Action). The ACA’s “four Ms of access” have worked to dramatically reduce uninsurance rates for all racial/ethnic groups in the United States (see Law in Action). Those still uninsured today include low-income adults in nonexpansion states; self-employed workers who make too much to qualify for marketplace subsidies; younger adults who doubt the value of health insurance; and undocumented individuals. The ACA succeeded at increasing the percentage of people who have comprehensive insurance and moving the country closer to universal coverage despite significant challenges. The law’s first decade saw dozens of unsuccessful congressional efforts to “repeal and CH02.indd 73 02/01/23 1:54 PM 74 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Law in Action: Reduction in Uninsurance Rates by Race 32.6% 30.5% 32.0% 30.2% 19.9% 25.6% 24.8% 22.0% 21.8% 14.9% 19.1% 19.0% 13.9% 10.7% 11.5% 18.9% 17.9% 18.5% 16.7% 16.3% 13.1% 12.5% 11.2% 9.3% 7.5% 10.8% 9.8% 6.8% 7.1% 2010 2011 2012 2013 2014 2015 2016 2017 2018 21.7% 20.0% AIAN Hispanic NHOPI 12.7% 11.4% 7.8% 7.2% Black White Asian 2019 Health Coverage by Race and Ethnicity, 2010–2019, Kaiser Fam. Found. (July 16, 2021), http://www.kff.org/racial-equity-and-health-policy/issue-brief/healthcoverage-by-race-and-ethnicity/ [https://perma.cc/9XB9-QF5U]. replace” the law. Many states actively impeded its implementation. And the Trump administration aggressively pursued executive actions designed to undermine it.42 Furthermore, as discussed in the next section, the ACA has faced three US Supreme Court challenges, any one of which could have effectively killed the law. COVID Connection In 2020 and 2021, the uninsured rate in the United States remained stable despite the global COVID19 pandemic. In the face of significant job losses and wage reductions, which disproportionally affected people of color, most Americans under age 65 continued to have employer-sponsored coverage, private insurance, or Medicaid plans, thanks in no small part to federal rules and funding. For employer-sponsored plans, the federal government extended the time frame for former employees to continue (or “COBRA”) their benefits and provided financial assistance for them to do so. The American Rescue Plan Act expanded the ACA’s marketplace premium subsidies, contributing to record-high enrollment in those plans. And regarding Medicaid, the federal government required that states refrain from disenrolling Medicaid beneficiaries during the public health emergency. CH02.indd 74 The Supreme Court’s Trilogy of ACA Access Cases Litigation immediately threatened the ACA’s existence. Just minutes after President Obama signed the act into law on March 23, 2010, Florida and 12 other states filed suit to challenge it. They were later joined by 13 additional states, several individual plaintiffs, and the National Federation of Independent Business (NFIB) in a case that made its way to the US Supreme Court as NFIB v. Sebelius.43 NFIB focused on two main questions. The first was whether the individual mandate—the requirement to buy health insurance unless exempted or else make a shared responsibility payment—exceeds Congress’s constitutional authority. In a rather remarkable bit of judicial diplomacy 02/01/23 1:54 PM 75 C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent and legal craftsmanship, Chief Justice Roberts cobbled together a 5–4 majority, Law in Action which held that the individual mandate is not a valid exercise of Congress’s power That a concept can be classified as one thing for a to regulate commerce, but it is a valid certain purpose and as something else for another exercise of Congress’s taxing power. This boggles the minds of some people and provided issue turned on whether the individual talking points for politicians and commentators mandate and shared responsibility paywho opposed the ACA. However, Chief Justice ment amount to a “tax.” As a foundaRoberts’s distinction is not logically inconsistent. tional matter, this question is important A concept can be judged by different standards depending on context and function. because under the Anti-Injunction Act A simple example may help clarify. In botany, (AIA), taxes can be challenged only after a tomato is classified as a fruit—the fleshy, seedthey have been paid. If the payment were bearing part of a flowering plant. To a cook, howconsidered a tax for purposes of the AIA, ever, a tomato is a vegetable because it has less the case would have to be dismissed as sugar than most fruits and is served as part of a untimely because no tax would be owed salad or entree rather than at dessert. As British journalist Miles Kington once wrote, “Knowledge until April 15, 2015. is knowing that a tomato is a fruit; wisdom is not The chief justice and his colleagues putting it in a fruit salad.” To hold that it is a fruit in found it significant that Congress used the one context (botany) and not in another (cooking) word “penalty” to describe this payment is eminently defensible. but called other payments in the ACA This distinction was precisely the finding “taxes.” All nine justices agreed that the that the US Supreme Court made more than a century ago. In the late 1800s, US tariff laws shared responsibility payment is not a tax imposed a tax on imported vegetables but not in the context of the AIA, and thus the case on fruits, so classification of the tomato was was not dismissed on that basis. Howa matter of some legal and financial imporever, the AIA’s language does not detertance. In Nix v. Hedden (149 U.S. 304 [1893]), mine whether the penalty is a tax within the Supreme Court decided that, regardless of the meaning of Congress’s constitutional what botanists say, the tomato is a vegetable for purposes of customs regulations because authority to “lay and collect taxes”44 (see of how the tomato is used and the popular Law in Action). The constitutional quesperception that it is more vegetable-like than tion turned on a more functional analysis, fruit-like. and the shared responsibility payment Like a tomato, the shared responsibility functioned as a tax. Thus, the majority payment is one thing by one set of standards held, the shared responsibility payment but something else by another. It is a tax for purposes of constitutional analysis, but it does is not a command to enter the insurance not qualify as a tax under the narrower definimarket (a command that would be beyond tion of the AIA. Congress’s power to issue), but it is a constitutionally permissible penalty for people who are required to maintain insurance and decline to do so. The second major question in NFIB was whether the federal government can force states to expand their Medicaid programs, which it attempted to do by threatening to cut their existing Medicaid funding (a threat that has CH02.indd 75 02/01/23 1:54 PM 76 T h e L aw o f H e a l th c a re A d mi n i stra ti o n death spiral A situation in a health insurance market in which premiums grow, healthy enrollees drop coverage (a phenomenon known as adverse selection), the risk pool becomes riskier, and premiums grow even faster for the remaining insured population, resulting in the market’s eventual collapse if left unchecked. CH02.indd 76 always been part of the Medicaid legislation as applied to mandatory populations and services). On this point, the Supreme Court ruled that Medicaid expansion as written in the ACA is unconstitutionally coercive. As a remedy, the court made the expansion optional for states. Relying on this decision, governments in as many as two dozen states, most of them led by Republicans, initially refused to expand their Medicaid programs on the grounds that the cost to the states would be a significant burden and that it was wrong to expand health insurance via government programs. Proponents countered that the federal share of the increased cost would be at least 90 percent, and eventually a few recalcitrant states reversed their positions after electing new governors or passing initiative ballot measures. As of mid-2022, 39 states (including the District of Columbia) had expanded their Medicaid programs, while 12 had not.45 The practical effect of NFIB v. Sebelius on access to health insurance was that the ACA’s four M’s of access survived, although the Medicaid expansion was modified to make it an option rather than a mandate. The second case in the Supreme Court’s trilogy of ACA decisions was King v. Burwell,46 decided in 2015. As described earlier, the ACA requires the creation of health insurance marketplaces (called exchanges in the statute) in each state; the federal government establishes an exchange for any state that does not create one of its own. The law then provides for tax credits (subsidies) for certain low-income taxpayers who are enrolled in an insurance plan through “an Exchange established by the State.” An IRS regulation interpreted that language to mean any exchange, whether created by the state or the federal government. The plaintiffs in King v. Burwell were four residents of Virginia in their sixties who would be exempt from the individual mandate requirement because the cost of an unsubsidized plan would make it statutorily unaffordable to them. (Recall that the ACA allows older marketplace purchasers to be charged up to three times more for the same plan than younger purchasers; smokers may also be charged twice as much, and some of these plaintiffs were smokers.) Given that Virginia had opted to use the federal exchange, the plaintiffs argued that no marketplace “established by the State” was available to them, so they could not receive the tax subsidies and thus would not need to be insured. According to the IRS’s interpretation, however, they would receive the subsidies and thus would be required to purchase insurance. In a 6–3 decision, Chief Justice Roberts noted that without subsidies, the statute would not work as Congress intended. Instead, low-income people in states relying on the federal exchange would not be able to afford coverage, and those states’ insurance markets would be pushed into a socalled death spiral. The court’s majority was not about to let the ACA fail 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 77 because of a few examples of what Roberts called “inartful drafting.” Roberts opined that in the context of the whole statute, the federal exchanges are not meaningfully different from those created by the state. This reading of “established by the State” is in line with Congress’s intent to cover as many people as possible (see The Court Decides: King v. Burwell at the end of this chapter). The late Justice Antonin Scalia, joined by Justices Clarence Thomas and Samuel Alito, dissented vociferously. Justice Scalia argued that the plain language of the statute clearly limits the tax subsidies to state-created exchanges. To hold otherwise is “quite absurd,” Scalia wrote, adding, in his typically colorful language, Words no longer have meaning if an Exchange that is not established by a State is “established by the State.” . . . Under all the usual rules of interpretation, in short, the Government should lose this case. But normal rules of interpretation seem always to yield to the overriding principle of the present Court: The Affordable Care Act must be saved. . . . I wholeheartedly agree with the Court that sound interpretation requires paying attention to the whole law, not homing in on isolated words or even isolated sections. Context always matters. Let us not forget, however, why context matters: It is a tool for understanding the terms of the law, not an excuse for rewriting them. . . . Ordinary connotation does not always prevail, but the more unnatural the proposed interpretation of a law, the more compelling the contextual evidence must be to show that it is correct. Today’s interpretation is not merely unnatural; it is unheard of. Who would ever have dreamt that “Exchange established by the State” means “Exchange established by the State or the Federal Government”?47 The third case in the Supreme Court’s ACA trilogy was decided six years after King v. Burwell. The election of 2016 brought Donald Trump to the White House, and during his time in office, congressional Republicans introduced scores of bills to replace the ACA entirely. When those “repeal and replace” attempts failed, they next attempted to undermine the law by adding a provision to the 2017 tax reform law (the Tax Cuts and Job Reforms Act) that would reduce the shared responsibility payment to $0. Many people (including the president) interpreted that provision to mean that the individual mandate was dead. Texas and more than a dozen other states, as well as two individuals, filed suit to confirm that understanding. Among other things, the plaintiffs in California v. Texas48 claimed that the individual mandate requirement provision was invalid without the monetary penalty, and that the penalty was so intertwined with the rest of the law that the entire ACA was unconstitutional. California, 15 other states, CH02.indd 77 02/01/23 1:54 PM 78 T h e L aw o f H e a l th c a re A d mi n i stra ti o n standing The principle that to be able to bring suit, a plaintiff must show that the defendant has caused or is likely to cause the plaintiff some direct or substantial injury if an alleged wrong is not addressed; sometimes referred to as standing to sue. and the District of Columbia intervened to defend the law’s constitutionality, something the Trump administration had refused to do. The plaintiffs’ arguments prevailed in the trial court and at the Fifth Circuit Court of Appeals, but in a 7–2 decision issued in June of 2021, the Supreme Court reversed the lower courts’ decisions and held that the plaintiffs had no standing to challenge the law because they could not show that they had been or were likely to be injured in any way. After all, the court seemed to be saying, what harm could be done by a “mandate” with no penalty? (See The Court Decides: California v. Texas at the end of this chapter.) By deciding the case on the standing question, the court did not address the merits of the plaintiffs’ argument. Thusly has the ACA as a whole survived three Supreme Court challenges, any one of which could have upended the law. It remains the most recent national effort at health reform, and the most significant since the enactment of Medicare and Medicaid. Legal Issues Related to Particular Populations and Facility Processes Being insurable does not necessarily equate to having healthcare insurance. And having healthcare insurance is not the same thing as having access to high-quality healthcare. A variety of access barriers remain, some more or less amenable to legal intervention. Although the United States does not have a constitutional right to healthcare, there are access-related legal standards that apply to particular populations and facility processes. Antidiscrimination Laws: Evolving Federal and State Standards As discussed in chapter 1, Medicare played a crucial role in the effort to desegregate hospitals. Along with the Civil Rights Act of 1964, Medicare’s Conditions of Participation make clear that hospitals cannot overtly discriminate based on race, religion, sex, or national origin in their patient admission policies, staff employment criteria, or provider privileging standards. As to people seeking treatment in emergency departments, the federal Emergency Medical Treatment and Labor Act (EMTALA) allows screening and treatment differences based only on medically indicated criteria (see chapter 11). In addition, numerous other federal, state, and local laws prohibit discrimination by healthcare entities. Many are described in some detail in chapter 4, with particular attention to their roles in human resources matters. One antidiscrimination issue of note regards language interpretation. The Civil Rights Act of 1964 prohibits discrimination based on national origin, and this includes discrimination against those who have limited English CH02.indd 78 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 79 proficiency (LEP). The HHS Office of Civil Rights has issued guidance that requires recipients of federal financial assistance from HHS to take reasonable steps to provide meaningful access for LEP individuals.49 The agency explains that the obligation to provide meaningful access is fact dependent and starts with an assessment of four factors: (1) the number or proportion of LEP persons eligible to be served or likely to be encountered by the recipient; (2) the frequency with which LEP individuals come into contact with the recipient; (3) the nature and importance of the services provided to the individuals; and (4) the resources available to the recipient and the costs of interpretation/translation services. There is no one-size-fits-all solution for Title VI compliance with respect to LEP persons, and what constitutes “reasonable steps” for large providers may not be reasonable where small providers are concerned. Basically, then, all healthcare providers that participate in Medicare and Medicaid must take steps to overcome language barriers and provide language assistance to their LEP patients and families. This includes translation of important written documents such as consent forms and provision of live, simultaneous interpretation of spoken communications. If requested, the organization is required to provide competent interpretation at no charge to the LEP individual, and the patient cannot be required to use family members or friends as interpreters. Smaller entities, such as physician offices, physical therapy clinics, and hospice providers have more flexibility in how they meet the needs of LEP people, but they are not exempt from the Civil Rights Act obligations (see also Law in Action in chapter 12 regarding interpreters). The ACA includes a specific antidiscrimination provision (section 1557) that applies certain long-standing federal requirements to a wide swath of healthcare programs and activities. Section 1557 specifies that an individual shall not—on the basis of race, color, national origin, age, disability, or sex—“be excluded from participation in, be denied the benefits of, or be subject to discrimination under, any health program or activity, any part of which is receiving Federal financial assistance, including credits, subsidies, or contracts of insurance.”50 The Obama, Trump, and Biden administrations have each interpreted the scope of Section 1557 differently, and their varying regulatory approaches have faced court challenges. Areas of ongoing contention include antidiscrimination standards for transgendered patients and permissible exemptions for religiously affiliated healthcare entities. These issues will continue to evolve over time. A Constitutional Right to Treatment While Incarcerated The Eighth Amendment to the US Constitution prohibits cruel and unusual punishment. It has been interpreted as requiring governments to provide convicted prisoners with adequate medical treatment.51 The due process CH02.indd 79 02/01/23 1:54 PM 80 T h e L aw o f H e a l th c a re A d mi n i stra ti o n clauses of the Fifth and Fourteenth Amendments require that persons who have not been convicted but who have been detained or are under arrest be given essential food, shelter, clothing, and medical care.52 Countless constitutional claims have been brought alleging that prison conditions during the COVID-19 pandemic constituted cruel and unusual punishment, both in state and federal courts, with mixed success.53 Some laws clearly state that the government must pay for care given to those it imprisons54 or detains.55 The duty to pay might be limited to cases in which the government’s institutional facilities are inadequate56 or in which the patient or their family is unable to pay.57 However, most states’ laws simply uphold a right to receive treatment and are silent on the question of the government’s financial obligations.58 Although the police generally have a duty to seek medical care for injured persons, especially those whose injuries are the result of police actions during apprehension, the government may not be obligated to pay the care provider if the patient has not been arrested. This precedent may be the reason some law enforcement agencies do not officially arrest injured suspects until after emergency treatment has been completed. For example, in City of Revere v. Massachusetts General Hospital,59 Patrick M. Kivlin attempted to flee the scene of a crime and was shot by a police officer. The police summoned an ambulance, and the ambulance took Kivlin to Massachusetts General Hospital, where he remained for nine days. Although he was in police custody and a warrant had been issued, he was not officially arrested until the date of his discharge from the hospital. A month later, he was again hospitalized, but the City of Revere refused to pay for either hospitalization. The Massachusetts Supreme Judicial Court held that state contract law provided no basis for ordering the city to pay, but it found that the Eighth Amendment’s prohibition against cruel and unusual punishment required it to do so. After granting certiorari, the US Supreme Court overruled the state court’s finding on the Eighth Amendment issue, stating that the amendment did not apply because there had not yet been a formal finding of guilt at the time Kivlin needed medical care.60 Although the Supreme Court noted that due process requires persons in Kivlin’s situation be given care, local government had no duty to pay for that care in the absence of state legislation. Mental Illness and Incapacity: Standards for Involuntary Detention and Treatment The legal rights of patients with mental illness and those lacking capacity are determined by constitutional law and state statutes. Both sources of law are evolving, so hospital management needs competent, current advice concerning emergency treatment, temporary detention, and formal admission of these individuals. Hospitals must give emergency care to all persons, but CH02.indd 80 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 81 in some cases, an appropriate transfer may be justified if the hospital is not staffed or equipped for psychiatric patients. Nevertheless, all hospitals must be prepared to interact with such patients in the best possible way to ensure the safety of all involved. Involuntary Detention or Commitment Because institutionalization is a significant deprivation of personal liberty, state statutes governing civil commitment by reason of mental illness must ensure that the patient is granted both substantive and procedural due process of law.61 A person may not be committed involuntarily unless mental illness presents a danger to the patient or to third parties.62 Danger to self can be found if patients cannot provide the basic necessities of life or if they exhibit indications that they may harm themselves. Unless persons are adjudged dangerous to themselves or others, indefinite confinement without treatment violates their right to due process, and the officials responsible for such confinement can be personally liable under civil rights laws. When patients present a danger to themselves, the state has a legitimate interest—under its parens patriae powers—to provide needed care.63 parens patriae If someone with a mental illness presents a danger to others, a psychiatric The doctrine that the government evaluation and possible civil commitment are justified by the state’s inher- is the ultimate ent power to regulate matters of health, safety, and welfare. In evaluating guardian of all whether patients meet these criteria, psychiatrists and other professionals people who must predict behavior, a challenging task from a medical standpoint (see have a legal disability, such as Legal Brief). Many states require evidence of a timely overt act or threat of minors and the violence to show that the patient presents a danger. mentally ill. The balance between the legitimate rights of patients and the recognized interests of society depends on the answers to difficult questions of social policy and medicolegal judgment. Setting this balance involves three main Legal Brief risks: (1) some patients might be detained unnecessarily; (2) some who are not dangerous might be released but not receive The American Psychiatric Association (APA) . . . needed outpatient care; and (3) patients informs us that “[t]he unreliability of psychiatric predictions of long-term future dangerousness is who are thought to pose no risk might by now an established fact within the profession.” be released and proceed to harm othThe APA’s best estimate is that two out of three 64 ers. Both law and medicine have defined [such predictions] are wrong. The Court does not dangerousness poorly, thus increasing the dispute this proposition, and indeed it could not potential for error in setting the balance. do so; the evidence is overwhelming. Moreover, in many commitment hearings —Barefoot v. Estelle, 463 U.S. 880, 920 (1983) the matter is left for the jury to decide (Blackmun, J. dissenting) on the basis of testimony from expert witnesses. Misdiagnosis alone does not CH02.indd 81 02/01/23 1:54 PM 82 T h e L aw o f H e a l th c a re A d mi n i stra ti o n constitute negligence or malpractice; causation must also be proven. Proof may be difficult to furnish because dangerousness is difficult to predict. State statutes typically allow for involuntary detention of psychiatric patients for a limited period, ranging from 48 to 72 hours. The Florida Mental Health Act (also called the Baker Act) is typical of the process.65 Under the Florida law, involuntary psychiatric examination can be accomplished if there is reason to believe that a person has a mental illness, does not agree to a voluntary examination, and may present a danger to self or others if not cared for. The process can be initiated by court order, by a law enforcement officer, or by a physician or mental health professional. The person is taken into custody and delivered to a “receiving facility” (a facility designated by the state for such purposes) and must be examined within 72 hours. If the patient is first seen in a hospital emergency department, as is often the case, the 72-hour period begins at that time. The patient may not be held involuntarily for longer than 72 hours, at which time the facility must (1) release the patient entirely or to law enforcement if charged with a crime, (2) admit the patient for voluntary treatment, or (3) petition a court for involuntary civil commitment. Because civil commitment takes away a person’s freedom, the patient in a civil commitment proceeding receives full due process rights: a court hearing, representation by legal counsel, and full consideration of the evidence regarding the patient’s competence and mental illness. These kinds of protections reflect a nationwide emphasis on the rights of mental health patients that began in the last few decades of the twentieth century. A 1975 Florida case, O’Connor v. Donaldson,66 illustrates the plight of some who were confined against their will before legal protections were enacted. Kenneth Donaldson had been confined against his will in a state mental hospital for 15 years. He was not thought to be dangerous to himself or others and was receiving no treatment. According to Justice Potter Stewart, his confinement amounted to nothing more than “a simple regime of enforced custodial care, not a program designed to alleviate or cure his supposed illness.” Based on these findings and without dissent, the Supreme Court held: A finding of “mental illness” alone cannot justify a State’s locking a person up against his will and keeping him indefinitely in simple custodial confinement. Assuming that that term can be given a reasonably precise content and that the “mentally ill” can be identified with reasonable accuracy, there is still no constitutional basis for confining such persons involuntarily if they are dangerous to no one and can live safely in freedom. . . . In short, a State cannot constitutionally confine . . . a nondangerous individual who is capable of surviving safely in freedom by himself or with the help of willing and responsible family members or friends. Since the jury found, upon CH02.indd 82 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 83 ample evidence, that O’Connor [the hospital superintendent], as an agent of the State, knowingly did so confine Donaldson, it properly concluded that O’Connor violated Donaldson’s constitutional right to freedom.67 This landmark decision and others like it gave impetus to the patients’ rights movement and led to the due process protections in most states’ laws. Standard of Care and Administration of Medication Once committed, psychiatric patients retain substantive constitutional rights to adequate food, shelter, clothing, medical care, safe physical conditions, reasonable freedom from physical restraints, and rehabilitation or training appropriate to their diagnoses. Hospital officials who fail to observe these rights can be held personally liable.68 One federal court defined minimally adequate medical care as follows: In order to render effective care and treatment, a hospital for the mentally ill must not only hire qualified individuals but must ensure the continuation of their training and education during their employment. . . . [T]he court finds that there are four standards generally advanced by mental health professionals as essential for minimally adequate treatment: a humane and therapeutic environment; qualified staff in sufficient numbers; an individualized treatment plan for each patient; and planned therapeutic programs and activities. It is against these standards that the conditions at [a psychiatric facility] must be measured in order to determine whether [those operating the facility] have failed to provide treatment for those mentally ill individuals involuntarily confined for such purpose in violation of the Fourteenth Amendment [of the US Constitution].69 In several contexts, courts have developed the principle that mentally ill persons should not be presumed incompetent to make treatment decisions. The decision to commit someone involuntarily is not the same as a finding of incompetence. Thus, a competent patient has the right to consent (or refuse to consent) absent compelling safety justifications. For example, competent psychiatric patients who are not a danger to themselves or others may not be given antipsychotic medications (which may have serious side effects) against their will and may not be forced to become subjects of medical research. The foundation for this rule has been described as part of a “right of privacy” or, more simply, as a principle of common law.70 The right to give informed consent (see chapter 12) can be overcome, and medications, restraints, and other measures can be forcibly administered only when there are compelling reasons for doing so. In all jurisdictions, unless an immediate danger or threat of harm exists, the patient is entitled to (1) a professional determination that medication or restraint is necessary; CH02.indd 83 02/01/23 1:54 PM 84 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (2) evaluation of alternatives; and (3) regular review of the recommended course of treatment. A formal hearing is not required, but a judicial determination of incompetence and the appointment of a guardian might be required. Patient Registration: Hospital Processes for Nonemergency Treatment Although an individual usually has no basis for claiming a legal right to be treated for a nonemergency condition at a particular hospital, many factors affect whether the patient will be admitted. Rather than focus on whether a patient has such a right, the hospital should be attentive to its mission and purpose in the community. If it adheres to its mission, the narrow legal question of a patient’s right to admission usually becomes a nonissue. Hospitals must be prepared to register any patient who meets the facility’s admission criteria and for whom a provider with admitting privileges has written an order for treatment. Patients may be registered as either inpatient or outpatient. Outpatient status comprises various subcategories, such as observation, ambulatory surgery, emergency, clinic, rehabilitation, laboratory, and nonpatient (i.e., the patient is not present, but the patient’s specimens are in the laboratory for analysis). The registration process varies by category, and detailed policies and procedures must be in place to handle every eventuality. For example, once an order has been written to admit an individual as an inpatient, the hospital typically collects the following information: • Demographics, such as patient name, address, telephone number, marital status, personal representative (if other than a spouse), gender, race, and Social Security number • Religious affiliation if the patient cares to disclose it • Emergency contacts • Identity and demographics of the financially responsible party (e.g., patient, parent, guardian) • Insurance coverage • Patient’s language preferences and English proficiency • Special needs (e.g., assistance for deaf or blind persons) • Generalized acknowledgment of privacy practices and any special requests regarding release of patient information • Generalized consent for routine care and diagnostic procedures (which must be signed and placed in the medical record and does not substitute for a detailed informed consent for significant medical procedures) Registration personnel must review the collected information for any “red flags” of medical identity theft, the phenomenon of registering with CH02.indd 84 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 85 another individual’s insurance information, name, Social Security number, or other identifier (see chapter 10). The Federal Trade Commission (which enforces the so-called red flag rules) has identified warning signs such as suspicious documents, inconsistent identifying information, discrepancies between mailing addresses, a reluctance to provide needed information, an inability to provide one’s phone number or address, and other questionable activities.71 During registration, the hospital gives the patient and family a wide range of information out of both general courtesy and legal need. This information includes the following: • Notice of privacy practices • Written notice of rights under the Patient Self-Determination Act (e.g., decision-making rights, advance directives, healthcare power of attorney) • General hospital information (maps, telephone numbers, parking restrictions, visiting hours, cafeteria location, gift shop hours) • Instructions for storing personal belongings and valuables The preceding lists are not exhaustive, and the requirements vary from state to state; thus, each hospital’s legal counsel and other experts should advise on the full range of issues to be addressed at registration. The main point is that these matters must be covered by detailed hospital policies and procedures, and registration staff must be trained appropriately. It should also be noted that a patient’s occupation of a hospital bed overnight does not always confer inpatient status for Medicare’s purposes. One becomes a Medicare inpatient only when formally admitted as such. Inpatient status must meet certain regulatory guidelines to be eligible for Medicare inpatient coverage and the attendant reimbursement. Some outpatients—such as those occupying a bed for observation purposes or ambulatory surgery—may appear indistinguishable from those who are technically inpatients. Utilization Review: Practical Implications for Admission and Discharge Thus far, this chapter has discussed the health reform laws and the traditional principles concerning hospital admission and discharge. Both topics pose questions about the use—actually, the potential for overuse—of healthcare services: questions relating to cost, quality, and value; questions relating to what is medically necessary; questions about who should pay and how much. This section—indeed, an entire chapter—cannot do justice to the myriad issues involved; issues of public policy and ethics are beyond the scope of this book. The ensuing paragraphs briefly discuss a few of the legal implications of utilization review (UR) not covered elsewhere in the book. CH02.indd 85 02/01/23 1:54 PM 86 T h e L aw o f H e a l th c a re A d mi n i stra ti o n third-party payer A managed care organization, government program, employee benefit plan, private insurance plan, or similar entity that is responsible for paying for health services. Most hospitals have a type of internal UR process known as case (or care) management. Case management departments provide ongoing concurrent reviews of patient care to determine whether treatments are medically necessary and, if not, to assist in placing patients in more appropriate (usually less costly) care settings. The departments are closely aligned with or part of the quality improvement function, and they typically track average length of stay and similar indicators. Internal case management serves an advisory purpose and does not have the authority to order a patient’s discharge or transfer; for this reason, it does not present a significant legal risk. As discussed in chapter 7, legal risks can arise when the financial pressures of third-party payers conflict with the perceived best interests of the patient. The UR decisions of third-party payers are made in several ways: • Prospectively (whether to authorize payment for treatment before the treatment has begun) • Concurrently (whether to permit treatment to continue beyond a certain point) • Retrospectively (whether to deny payment for treatment that has been completed) Legal Brief In insurance parlance, loss ratio (LR) essentially means the cost of claims per premium dollar: LR = Losses + loss-related expense Earned premiums In health insurance, the medical loss ratio (MLR) represents the percentage of premium dollars paid for medical care and related quality improvement efforts. If an insurer pays out less, it has a lower MLR, which in turn means higher retained earnings (profits) for the insurer. The average MLR for private insurance plans is typically 80 to 85 percent, and the ACA sets that range as a minimum depending on market size. If an insurer’s MLR falls below the applicable level, it must provide a premium rebate to its insureds. A government program’s MLR is much higher (usually 95 percent or higher) because government programs are not motivated to earn a profit. CH02.indd 86 UR decisions are almost always based on physicians’ recommendations and sound professional judgment related to the patient’s medical needs. However, to keep their costs (medical loss ratio) as low as possible, third-party payers (managed care plans) sometimes approve payment for only a certain number of days in the hospital (see Legal Brief). In such cases, hospitals have an incentive to see patients discharged as soon as possible, perhaps even before optimum outcomes have been achieved. A physician who believes that a patient is not ready for discharge should carefully document the reasons for not signing a discharge order. A physician who bows to pressure and orders a discharge that is contrary to professional standards and sound judgment might invoke significant liability consequences (see the discussion of the Wickline case in 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 87 chapter 7). The physician and hospital usually can appeal the coverage decision, but a physician who believes treatment is necessary and desired by the patient must strive to ensure that the treatment is provided. Conversely, if the physician sees no need for continued hospitalization and recommends discharge or transfer to an available and less expensive facility, patients often bear the cost of care if they choose to stay in the hospital. Attending physicians and case management staff must carefully explain coverage limitations and transfer options to patients and their family members, and together they must decide on the future course and site of care. Hospitals and physicians should be patients’ advocates if insurance coverage is threatened. The Joint Commission alludes to this responsibility in its hospital accreditation standards. In the leadership chapter of the standards, a section on ethical issues in operations states the following: The hospital is professionally and ethically responsible for providing care, treatment, and services within its capability and law and regulation. At times, such care, treatment, and services are denied because of payment limitations. In these situations, the decision to continue providing care, treatment, and services or to discharge the patient is based solely on the patient’s identified needs.72 Patients whose medical conditions justify a discharge or transfer have no common law or constitutional right to remain in the hospital. A patient who remains is a trespasser, and the hospital may ask a court to issue an injunction to remove the person from the premises.73 The courts have reasoned that hospitals have a duty to reserve their beds and facilities for patients who genuinely need them and should not permit a patient to remain when adequate care can be provided elsewhere. On the other hand, the hospital and physician may not abandon or discharge a patient who needs further care without making appropriate arrangements for that care. Thus, someone who needs continuing care—in a nursing home, for example—presents a dilemma for all the parties involved if no appropriate facility is available, especially if the patient is unable to pay the ongoing hospital charges. Monmouth Medical Center v. State illustrates the conflict between economic and human values in these circumstances.74 At issue were New Jersey’s administrative regulations prohibiting Medicaid reimbursement for indigent patients who no longer need hospitalization and are awaiting transfer to a nursing home. Because there was a shortage of nursing home beds, the state regulations required the hospital to absorb the cost; the hospital was unwilling to do so, and it filed suit. The New Jersey Supreme Court pointed out that the purpose of the Medicaid program is to provide financial assistance for “medically necessary” CH02.indd 87 02/01/23 1:54 PM 88 T h e L aw o f H e a l th c a re A d mi n i stra ti o n services, and the regulations require states to furnish services “sufficient in amount, duration, and scope to reasonably achieve [their] purpose.” The court held that the state regulations conflicted with the federal rules; as long as the hospital exercised good faith and reasonable diligence in attempting to place patients in nursing homes, it was legally entitled to reimbursement from Medicaid. In essence, the court said that fairness required society—not the hospital—to absorb the costs even if the patient no longer needed the services of an acute care facility. Putting the issue in sharper focus, a later case—Monmouth Medical Center v. Harris75—upheld the government’s right to deny Medicare reimbursement to a hospital for a patient who no longer required hospital or skilled nursing care. The patient needed custodial care, but beds in a nursing home that provided such care were not available. The court said the unavailability of beds was irrelevant because Medicare does not reimburse for custodial care. Federal law requires organizations that contract with Medicare to conduct utilization and quality control reviews to evaluate the services they provide to Medicare beneficiaries.76 Through retrospective reviews of data, peer review organizations (PROs; also known as quality improvement organizations) are responsible for determining whether • hospital services are reasonable and medically necessary, • the quality of those services meets professional standards, and • the services could be provided more economically elsewhere. Each PRO is expected to conduct reviews of admission patterns and identify groups of patients whose diagnoses or contemplated treatments indicate that they could be safely cared for somewhere other than in an acute care hospital. Each PRO is empowered to set objectives for reducing inappropriate admissions in its geographic region and to identify unacceptable admission patterns in use by particular institutions and medical practitioners. To measure the quality of care furnished to Medicare patients, the review organization has the following responsibilities: • To ensure that patients with certain diagnoses receive adequate medical services, especially when appropriate facilities are available but are underused • To review hospital readmissions caused by previous substandard care • To identify instances of unnecessary surgery • To reduce the number of preventable deaths To achieve these objectives, PROs develop treatment protocols for particular diagnoses and set specific statistical goals. In addition to performing CH02.indd 88 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 89 these functions on behalf of the federal government, PROs have the power to deny reimbursement to a Medicare provider for unnecessary or inappropriate care.77 In certain circumstances, the review organization may also recommend penalties—ranging from monetary fines to exclusion from the Medicare program—for providers that render unnecessary or inappropriate care. The ACA contains many provisions related to quality improvement, such as technical assistance and research, support for patient-centered medical homes, better treatment of chronic disease, and regionalized emergency care systems and trauma centers. Further examples include provisions for demonstration programs on quality and patient safety training, improvements to women’s health, a patient navigator program, and studies and reports on new tort claims or causes of action generated by quality initiatives. It remains to be seen how the reforms will affect quality programs generally and PROs specifically. In any event, these provisions will affect access to healthcare in the United States. (Peer review and quality issues are discussed more fully in chapter 8.) Final Thoughts: ACA Stability, Medicaid Universality, Medicare Commonality No existential legal or congressional threats to the ACA existed as of mid2022. The law, with its key access provisions, seems to be resting on generally stable ground. The protections for preexisting conditions continue to have widespread public support, and the zeroing out of the individual mandate’s tax penalty seems to have had little practical effect. Enrollment in ACA marketplace plans is at an all-time high, certainly boosted by pandemic-related job losses and premium subsidies. States continue to gradually adopt the Medicaid expansion, sometimes through ballot initiative rather than legislative action. While the end of the public health emergency (with its coverage maintenance requirement) will likely see a reduction in Medicaid enrollment, the trend is clear. Historically a stigmatized program for categories of low-income people, Medicaid is becoming, as Justice Roberts predicted, “an element of a comprehensive national plan to provide universal health insurance coverage.”78 In this trend toward universality, with its financial and programmatic challenges, it will be important to pay close attention to Medicaid’s crucial role in supporting the most medically fragile Americans. And Medicare, Medicaid’s fraternal twin, continues to drive systemwide change, especially with regard to value-based payment models. With Medicare’s popularity, we can expect continued advocacy to make it a more common option, whether by dropping the eligibility age, allowing younger people to buy into the program, or making it the default for all. But each of CH02.indd 89 02/01/23 1:54 PM 90 T h e L aw o f H e a l th c a re A d mi n i stra ti o n the many options to expand Medicare presents daunting issues, both political and financial. These issues and the debates that no doubt will ensue are emblematic of our country’s long and ongoing struggle to expand access to healthcare, improve its quality, and reduce its cost. Chapter Summary This chapter discussed the following topics: • The history of federal efforts to achieve near-universal health insurance coverage • Medicare financing, coverage, and payment • Medicaid categorical and expansion coverage • The ACA’s “four M’s of access” • Legal challenges to the ACA • Antidiscrimination laws related to healthcare access • Legal standards related to healthcare for prisoners and the mentally ill • Processes for nonemergency admission and discharge Vocabulary accountable care organization (ACO) Conditions of Participation and Conditions for Coverage death spiral federal poverty level (FPL) managed care parens patriae police power standing third-party payers Discussion Questions 1. Does everyone in the United States have equal access to high-quality healthcare? Why or why not? 2. Describe four key ACA reforms related to access and identify three US Supreme Court cases that center on those reforms. CH02.indd 90 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 91 3. Have you ever obtained marketplace private insurance or a Medicaid plan for yourself or another person? What did you think of the process and the resulting coverage? 4. The ACA allows a marketplace plan to charge older people three times as much as younger people, and smokers twice as much as nonsmokers. Thus, if a nonsmoking 21-year-old who earned too much to get a premium subsidy could buy a particular plan for $300 a month, that same unsubsidized plan would cost a 64-year-old $900 a month and, if that 64-year-old were a smoker, $1,350 a month. Is that fair? Is it wise? Why or why not? 5. What is the status of Medicaid expansion throughout the country? What do you think of the arguments advanced in favor of and against state decisions about whether to adopt the expansion? Is Medicaid expansion a current issue in your community? 6. How do you think health reform efforts are likely to proceed in the next decade given competing political visions, federal and state budgetary pressures, healthcare advances, and changing demographics? 7. What are the general legal standards and processes for involuntary admission of persons who are mentally ill? Are there challenges in your area regarding access to mental health treatment, whether inpatient or outpatient? 8. There has been a lot of attention to the need to “bend the cost curve.” How does this attention manifest—with respect to both general system-level value-based payment reforms and specific utilization review decisions about individual patients? What do you think are the best ways to support appropriate patient-centered medical decisionmaking while reducing unnecessary healthcare spending? CH02.indd 91 02/01/23 1:54 PM 92 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The Court Decides King v. Burwell 576 U.S. 473 (2015) Roberts, Chief Justice The Patient Protection and Affordable Care Act adopts a series of interlocking reforms designed to expand coverage in the individual health insurance market. First, the Act bars insurers from taking a person’s health into account when deciding whether to sell health insurance or how much to charge. Second, the Act generally requires each person to maintain insurance coverage or make a payment to the Internal Revenue Service. And third, the Act gives tax credits to certain people to make insurance more affordable. In addition to those reforms, the Act requires the creation of an “Exchange” in each State—basically, a marketplace that allows people to compare and purchase insurance plans. The Act gives each State the opportunity to establish its own Exchange, but provides that the Federal Government will establish the Exchange if the State does not. This case is about whether the Act’s interlocking reforms apply equally in each State no matter who establishes the State’s Exchange. Specifically, the question presented is whether the Act’s tax credits are available in States that have a Federal Exchange. I.A [Here the chief justice summarizes what he calls a “long history of failed health insurance reform,” including two related concepts that several states adopted in the 1990s: a “guaranteed issue” requirement and a “community rating” requirement. Together, these reforms meant that anyone who wanted health insurance in those states could buy it, and insurers could not deny coverage CH02.indd 92 or charge a higher premium because of preexisting conditions. Then the opinion ­continues.]. . . . The guaranteed issue and community rating requirements achieved [the goal of making insurance available to all], but they had an unintended consequence: They encouraged people to wait until they got sick to buy insurance. Why buy insurance coverage when you are healthy, if you can buy the same coverage for the same price when you become ill? This consequence—known as “adverse selection”—led to a second: Insurers were forced to increase premiums to account for the fact that, more and more, it was the sick rather than the healthy who were buying insurance. And that consequence fed back into the first: As the cost of insurance rose, even more people waited until they became ill to buy it. This led to an economic “death spiral.” As premiums rose higher and higher, and the number of people buying insurance sank lower and lower, insurers began to leave the market entirely. As a result, the number of people without insurance increased dramatically. In 1996, Massachusetts adopted the guaranteed issue and community rating requirements and experienced similar results. But in 2006, Massachusetts added two more reforms: The Commonwealth required individuals to buy insurance or pay a penalty, and it gave tax credits to certain individuals to ensure that they could afford the insurance they were required to buy. The combination of these three reforms—insurance market regulations, a coverage mandate, and tax 02/01/23 1:54 PM 93 C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent credits—reduced the uninsured rate in Massachusetts to 2.6 percent, by far the lowest in the Nation. [Massachusetts’s reforms— sometimes referred to as “Romneycare,” a reference to then governor Mitt Romney— were a model for drafters of the ACA.] B [The opinion next describes the ACA’s reform provisions: (1) adoption of the guaranteed issue and community rating requirements; (2) a requirement for individuals to have insurance or make a tax payment to the IRS—the “individual mandate” upheld in NFIB v. Sebelius, and (3) the giving of tax credits to low-income persons to help make insurance more affordable.]. . . . These three reforms are closely intertwined. . . . Congress found that the guaranteed issue and community rating requirements would not work without the coverage requirement. And the coverage requirement would not work without the tax credits. The reason is that, without the tax credits, the cost of buying insurance would exceed eight percent of income for a large number of individuals, which would exempt them from the coverage requirement. [The ACA exempts from the individual mandate individuals who would have to spend more than 8 percent of their income on health insurance.] C In addition to those three reforms, the Act requires the creation of an “Exchange” in each State where people can shop for insurance, usually online. An Exchange may be created in one of two ways. First, the Act provides that “[e]ach State shall . . . establish an American Health Benefit Exchange . . . for the State.” Second, if a State nonetheless chooses not to establish its own Exchange, the Act provides that the Secretary of Health and Human Services “shall . . . establish and operate such Exchange within the State.” The issue in this case is whether the Act’s tax credits are available in States that have a Federal Exchange rather than a State Exchange. The Act initially provides that tax credits “shall be allowed” for any “applicable taxpayer.” 26 U.S.C. § 36B. The Act then provides that the amount of the tax credit depends in part on whether the taxpayer has enrolled in an insurance plan through “an Exchange established by the State” [under § 18031 of the ACA]. [To implement these provisions, the IRS promulgated a rule that made tax credits available to applicable taxpayers who enrolled in an insurance plan through an exchange regardless of whether the exchange was established by the state or by HHS. The petitioners in this case were four residents of Virginia who do not want to buy health insurance. They argue that Virginia’s exchange does not qualify as “an Exchange established by the State” because it was established by HHS, that they therefore should not receive tax credits, and that they are exempt from the individual mandate because without the credits the cost would be more than 8 percent of their income.]. . . . II *** Petitioners argue that a Federal Exchange is not “an Exchange established by the State under [42 U.S.C. §18031],” and that the IRS [regulation making tax credits available to federal exchange enrollees] therefore contradicts Section 36B. The Government responds that the IRS Rule [referred to earlier] is lawful because the phrase “an Exchange established by the State under [42 U.S.C. §18031]” should be read to include Federal Exchanges. . . . It is . . . our task to determine the correct reading of Section 36B . . . [and in doing (continued) CH02.indd 93 02/01/23 1:54 PM 94 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) so] we must read the words “in their context and with a view to their place in the overall statutory scheme.” Our duty, after all, is “to construe statutes, not isolated provisions” [quoting an earlier Supreme Court case]. A We begin with the text of Section 36B. . . . Section 36B allows an individual to receive tax credits only if the individual enrolls in an insurance plan through “an Exchange established by the State under [42 U.S.C. §18031].” [A]ll parties agree that a Federal Exchange qualifies as “an Exchange” for purposes of Section 36B. Section 18031 provides that “[e]ach State shall . . . establish an American Health Benefit Exchange . . . for the State.” . . . [But] if the State chooses not to do so, Section 18041 provides that the Secretary “shall . . . establish and operate such Exchange within the State.” By using the phrase “such Exchange,” Section 18041 instructs the Secretary to establish and operate the same Exchange that the State was directed to establish under Section 18031. . . . In other words, State Exchanges and Federal Exchanges are equivalent—they must meet the same requirements, perform the same functions, and serve the same purposes. Although State and Federal Exchanges are established by different sovereigns, Sections 18031 and 18041 do not suggest that they differ in any meaningful way. A Federal Exchange therefore counts as “an Exchange” under Section 36B. *** The Act defines the term “Exchange” to mean “an American Health Benefit Exchange CH02.indd 94 established under section 18031.” If we import that definition into Section 18041, the Act tells the Secretary to “establish and operate such ‘American Health Benefit Exchange established under section 18031.’” That ­suggests that Section 18041 authorizes the Secretary to establish an Exchange under Section 18031, not (or not only) under Section 18041. Otherwise, the Federal Exchange, by definition, would not be an “Exchange” at all. This interpretation of “under [42 U. S. C. §18031]” fits best with the statutory context. All of the requirements that an Exchange must meet are in Section 18031, so it is sensible to regard all Exchanges as established under that provision. In addition, . . . the Act repeatedly uses the phrase “established under [42 U.S.C. §18031]” in situations where it would make no sense to distinguish between State and Federal Exchanges. A Federal Exchange may therefore be considered one established “under [42 U. S. C. §18031].” . . . The Affordable Care Act contains more than a few examples of inartful drafting. . . . [W]e “must do our best, bearing in mind the fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme” [citing a 2014 case]. After reading Section 36B along with other related provisions in the Act, we cannot conclude that the phrase “an Exchange established by the State under [Section 18031]” is unambiguous. B Given that the text is ambiguous, we must turn to the broader structure of the Act to determine the meaning of Section 36B. “A provision that may seem ambiguous in isolation is often clarified by the remainder of the 02/01/23 1:54 PM 95 C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent statutory scheme . . . because only one of the permissible meanings produces a substantive effect that is compatible with the rest of the law.” Here, the statutory scheme compels us to reject petitioners’ interpretation because it would destabilize the individual insurance market in any State with a Federal Exchange, and likely create the very “death spirals” that Congress designed the Act to avoid. . . . The guaranteed issue and community rating requirements ensure that anyone can buy insurance; the coverage requirement creates an incentive for people to do so before they get sick; and the tax credits—it is hoped— make insurance more affordable. Together, those reforms “minimize . . . adverse selection and broaden the health insurance risk pool to include healthy individuals, which will lower health insurance premiums.” 42 U.S.C. § 18091(2)0). Under petitioners’ [interpretation], however, the Act would operate quite differently in a State with a Federal Exchange. As they see it, one of the Act’s three major reforms—the tax credits—would not apply. And a second major reform—the coverage requirement—would not apply in a meaningful way. . . . The combination of no tax credits and an ineffective coverage requirement could well push a State’s individual insurance market into a death spiral. . . . It is implausible that Congress meant the Act to operate in this manner. . . . Congress made the guaranteed issue and community rating requirements applicable in every State in the Nation. But those requirements only work when combined with the coverage requirement and the tax credits. So it stands to reason that Congress meant for those provisions to apply in every State as well. . . . *** Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter. Section 36B can fairly be read consistent with what we see as Congress’s plan, and that is the reading we adopt. The judgment of the United States Court of Appeals for the Fourth Circuit is Affirmed. Discussion Questions 1. As discussed in chapter 1, when interpreting a statute, judges typically analyze not only the text of the law itself but also its history and purpose, other judicial decisions, and the consequences of one outcome versus another. Compare the majority opinion in King v. Burwell with Justice Scalia’s dissent as summarized in the text. In your opinion, which rationale addresses those factors more satisfactorily? 2. Can you explain the logic behind the majority opinion? Do you find it persuasive? 3. What are the “death spirals” to which the chief justice refers? ~ CH02.indd 95 ~ 02/01/23 1:54 PM 96 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The Court Decides California v. Texas 593 U.S. ___ (2021) Justice Breyer delivered the opinion of the Court. As originally enacted in 2010, the Patient Protection and Affordable Care Act required most Americans to obtain minimum essential health insurance coverage. The Act also imposed a monetary penalty, scaled according to income, upon individuals who failed to do so. In 2017, Congress effectively nullified the penalty by setting its amount at $0. Texas and 17 other States brought this lawsuit against the United States and federal officials. They were later joined by two individuals. . . . The plaintiffs claim that without the penalty the Act’s minimum essential coverage requirement is unconstitutional. Specifically, they say neither the Commerce Clause nor the Tax Clause (nor any other enumerated power) grants Congress the power to enact it. They also argue that the minimum essential coverage requirement is not severable from the rest of the Act. Hence, they believe the Act as a whole is invalid. We do not reach these questions of the Act’s validity, however, for Texas and the other plaintiffs in this suit lack the standing necessary to raise them. .... The Constitution gives federal courts the power to adjudicate only genuine “Cases” and “Controversies.” That power includes the requirement that litigants have standing. A plaintiff has standing only if he can “allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief.” Neither the individual nor the state plaintiffs have shown that the injury they will suffer or have suffered is “fairly traceable” to the CH02.indd 96 “allegedly unlawful conduct” of which they complain. We begin with the two individual plaintiffs. They claim a particularized individual harm in the form of payments they have made and will make each month to carry the minimum essential coverage that [the ACA] requires. The individual plaintiffs point to the statutory language, which, they say, commands them to buy health insurance. But even if we assume that this pocketbook injury satisfies the injury element of . . . standing, the plaintiffs nevertheless fail to satisfy the traceability requirement. Their problem lies in the fact that the statutory provision, while it tells them to obtain that coverage, has no means of enforcement. With the penalty zeroed out, the IRS can no longer seek a penalty from those who fail to comply. Because of this, there is no possible Government action that is causally connected to the plaintiffs’ [alleged] injury—the costs of purchasing health insurance. .... Next, we turn to the state plaintiffs. We conclude that Texas and the other state plaintiffs have similarly failed to show that they have alleged an “injury fairly traceable to the defendant’s allegedly unlawful conduct” [emphasis in the original]. They claim two kinds of pocketbook injuries. First, they allege an indirect injury in the form of the increased use of (and therefore cost to) state-operated medical insurance programs. Second, they claim a direct injury resulting from a variety of increased administrative and related expenses required, they say, by the minimum essential coverage provision, along 02/01/23 1:54 PM 97 C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent with other provisions of the Act that, they add, are inextricably “‘interwoven’” with it. First, the state plaintiffs claim that the minimum essential coverage provision has led state residents subject to it to enroll in state-operated or state-sponsored insurance programs such as Medicaid and health insurance programs for state employees. The state plaintiffs say they must pay a share of the costs of serving those new enrollees. As with the individual plaintiffs, the States also have failed to show how this injury is directly traceable to any actual or possible unlawful Government conduct. . . . That alone is enough to show that they, like the individual plaintiffs, lack . . . standing. But. . . . we need only examine the initial factual premise of their claim to uncover another fatal weakness: The state plaintiffs have failed to show that the challenged minimum essential coverage provision, without any prospect of penalty, will harm them by leading more individuals to enroll in these programs. unconstitutional the Act’s minimum essential coverage provision. Therefore, we reverse the Fifth Circuit’s judgment in respect to standing, vacate the judgment, and remand the case with instructions to dismiss. .... Unsurprisingly, the States have not demonstrated that an unenforceable mandate will cause their residents to enroll in valuable benefits programs that they would otherwise forgo. It would require far stronger evidence than the States have offered here to support their counterintuitive theory of standing, which rests on a “highly attenuated chain of possibilities.” Justice Thomas, concurring. There is much to commend JUSTICE ALITO’s account of “our epic Affordable Care Act trilogy.” [Referring to Alito’s dissenting opinion, shown next.] This Court has gone to great lengths to rescue the Act from its own text. So have the Act’s defenders, who argued in first instance that the individual coverage mandate is the Act’s linchpin, yet now, in an about-face, contend that it is just a throwaway sentence. But, whatever the Act’s dubious history in this Court, we must assess the current suit on its own terms. And, here, there is a fundamental problem with the arguments advanced by the plaintiffs in attacking the Act—they have not identified any unlawful action that has injured them. Today’s result is thus not the consequence of the Court once again rescuing the Act, but rather of us adjudicating the particular claims the plaintiffs chose to bring. [Justice Thomas proceeds to explain why he concurs in the result. “The plaintiffs failed to demonstrate that the harm they suffered is traceable to unlawful conduct.” And he adds, “Although this Court has erred twice before in cases involving the Affordable Care Act, it does not err today.”] .... For these reasons, we conclude that the plaintiffs in this suit failed to show a concrete, particularized injury fairly traceable to the defendants’ conduct in enforcing the specific statutory provision they attack as unconstitutional. They have failed to show that they have standing to attack as Justice Alito, with whom Justice Gorsuch joins, dissenting. [Justice Alito sets the stage for his rather petulant dissent with the following introductory paragraphs.] Today’s decision is the third installment in our epic Affordable Care Act trilogy, and it follows the same pattern as installments one and two. In all three (continued) CH02.indd 97 02/01/23 1:54 PM 98 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) episodes, with the Affordable Care Act facing a serious threat, the Court has pulled off an improbable rescue. [Here he reviews the histories of NFIB v. Sebelius and King v. Burwell.] . . . Now, in the trilogy’s third episode, the Court is presented with the daunting problem of a “tax” that does not tax. Can the taxing power, which saved the day in the first episode, sustain such a curious creature? In 2017, Congress reduced the “tax” imposed on Americans who failed to abide by the individual mandate to $0. With that move, the slender reed that supported the decision in NFIB was seemingly cut down, but once again the Court has found a way to protect the ACA. Instead of defending the constitutionality of the individual mandate, the Court simply ducks the issue and holds that none of the Act’s challengers, including the 18 States that think the Act saddles them with huge financial costs, is entitled to sue. Can this be correct? The ACA imposes many burdensome obligations on States in their capacity as employers, and the 18 States in question collectively have more than a million employees. Even $1 in harm is enough to support standing. Yet no State has standing? In this suit, as I will explain, Texas and the other state plaintiffs have standing, and now that the “tax” imposed by the individual mandate is set at $0, the mandate cannot be sustained under the taxing power. As a result, it is clearly unconstitutional, and to the extent that the provisions of the ACA that burden the States are inextricably linked to the individual mandate, they too are unenforceable. [The promised explanation occupies 28 pages of dense legal reasoning that has not been well received by legal scholars. The dissent concludes with the following.] . . . . No one can fail to be impressed by the lengths to which this Court has been willing to go to defend the ACA against all threats. A penalty is a tax. The United States is a State. And 18 States who bear costly burdens under the ACA cannot even get a foot in the door to raise a constitutional challenge. So a tax that does not tax is allowed to stand and support one of the biggest Government programs in our Nation’s history. Fans of judicial inventiveness will applaud once again. But I must respectfully dissent. Discussion Questions 1. What do you know of the judicial philosophies of the seven Justices who voted to reverse the court of appeals? 2. Compare the majority opinion and Justice Thomas’s concurring opinion with the opinion of the two dissenters. Which of the viewpoints do you find more persuasive? 3. What would the effect have been on the healthcare sector of our economy if the plaintiffs’ arguments had prevailed in the Supreme Court? ~ CH02.indd 98 ~ 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 99 Notes 1. See generally, Institute of Medicine, Appendix A: Summary of the Public Health System in the United States, in The Future of Public Health 168–202 (1988), https://www.ncbi.nlm.nih.gov/books/ NBK218212/ (last visited May 9, 2022). 2. Uwe E. Reinhardt, Priced Out: The Economic and Ethical Costs of American Health Care xxviii (2019) (emphasis in original). 3. Nat’l Rsch. Council & Inst. of Med., U.S. Health in International Perspective: Shorter Lives, Poorer Health (Steven H. Woolf & Laudan Aron eds., 2013). 4. Schneider et al., Mirror, Mirror 2021: Reflecting Poorly: Health Care in the U.S. Compared to Other High-Income Countries (Commonwealth Fund 2021), https://doi.org/10.26099/01dv-h208 [https://perma. cc/E9H2-ZABH]. 5. Quoted in Reinhardt, Priced Out, supra note 2, at xxiv. 6. Id. at xxvi–xxvii. 7. The narrow exception to this rule is the constitutional right to adequate medical care for people who are imprisoned or detained. Deliberate indifference to a prisoner’s medical needs is considered cruel and unusual punishment. U.S. Const. amends. VII, XIV. 8. U.S. Const. art. I, § 8, cl. 1. 9. See, e.g., Protecting Mothers and Infants, U.S. Capitol Visitor Center, https://www.visitthecapitol.gov/exhibitions/april-2010september-2011/protecting-mothers-and-infants [https://perma. cc/5WK7-TPEF]; Edward R. Schlesinger, The Sheppard-Towner Era: A Prototype Case Study in Federal–State Relationships, 57 Am. J. Pub. H. 1034 (June, 1967), https://doi.org/10.2105/AJPH.57.6.1034. 10. Jacobson v. Massachusetts, 197 U.S. 11 (1905). 11. Dent v. West Virginia, 129 U.S. 114, 123 (1889). 12. See, e.g., Historical Background and Development of Social Security, Soc. Sec. Admin., https://www.ssa.gov/history/briefhistory3.html [https://perma.cc/A7AB-GGJF]. 13. See generally, National Health Insurance—A Brief History of Reform Efforts in the U.S., Kaiser Fam. Found. (Feb. 28, 2009), https://www.kff.org/health-reform/issue-brief/national-healthinsurance-a-brief-history-of/ [https://perma.cc/ST4Y-75YH] [hereinafter Kaiser Fam. Found. Rep.]. CH02.indd 99 02/01/23 1:54 PM 100 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 14. See, e.g., Our History, Kaiser Permanente, https://share. kaiserpermanente.org/about-us/history/ [https://perma.cc/ MJ7J-HTBD]. 15. Paul Starr, Remedy and Reaction: The Peculiar American Struggle Over Health Care Reform 41 (rev. ed. 2013). 16. See Kaiser Fam. Found. Rep., supra note 13, at 3. 17. Hospital Survey and Construction Act, 42 U.S.C. § 291. 18. Paul Starr, The Social Transformation of American Medicine 347 (1st ed., 1982) [hereinafter STAM]. Today, except for a few cases in a handful of low-income countries, polio has been virtually eradicated from the earth. 19. Abbe R. Gluck, Symposium Issue Introduction: The Law of Medicare and Medicaid at Fifty, 15 Yale J. Health Pol’y, L., & Ethics 1 (2015) https://openyls.law.yale.edu/bitstream/handle/20.500.13051/5912/ AbbeGluck.pdf?sequence=2&isAllowed=y [https://perma.cc/ A5DN-JU4H]. 20. Sallie Thieme Sanford, Health Care’s Fraternal Twins at 50: The Birth and Development of Medicare and Medicaid, Jurist (Nov. 1, 2015), https://www.jurist.org/commentary/2015/11/sallie-thieme-sanfordhealthcare/ [https://perma.cc/9DHQ-FGUT]. 21. Historical Background and Development of Social Security, Soc. Sec. Admin., https://www.ssa.gov/history/briefhistory3.html [https:// perma.cc/LP9F-VADK] (last visited May 9, 2022). 22. See, e.g., Health, United States, 2019 Table 004 (Nat’l Center for Health Stat., 2021), https://www.cdc.gov/nchs/hus/contents2019. htm [https://perma.cc/BR5H-CD32]. 23. For a history of total healthcare spending in the United States dating back to 1960, see National Health Expenditure Data: Historical, Ctrs. Medicare & Medicaid Serv. (Dec. 11, 2018), https://www.cms.gov/ Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ NationalHealthExpendData/NationalHealthAccountsHistorical [https://perma.cc/L5DB-KKSY]. 24. See generally Accountable Care Organizations (ACOs): General Information, Ctrs. Medicare & Medicaid Serv. (Dec. 15, 2021), https://innovation.cms.gov/innovation-models/aco [https://perma. cc/53TW-QPJM]. See also Medicare Shared Savings Program Continues to Grow and Deliver High-Quality, Person-Centered Care Through Accountable Care Organizations, Ctrs. Medicare & Medicaid Serv. (Jan. 26, 2022), https://www.cms.gov/newsroom/press-releases/ medicare-shared-savings-program-continues-grow-and-deliverhigh-quality-person-centered-care-through [https://perma.cc/ KH3P-VNNR]. CH02.indd 100 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 101 25. See Accountable Care Organizations (ACOs): General Information, Ctrs. Medicare & Medicaid Serv. (Feb. 10, 2022), https:// innovation.cms.gov/initiatives/aco/ [https://perma.cc/QP9S-PJJ5]. 26. Affordable Care Act, Pub. L. No. 111-148, codified at § 3022, 42 U.S.C. § 1395 et seq. (2012). 27. National Federation of Independent Business (NFIB) v. Sebelius, 567 U.S. 519, 583 (2012). 28. 567 U.S. 1 (2012). 29. See 86 Fed. Reg. 67479 (Nov. 26, 2021). 30. 42 U.S.C. § 1396n. 31. 42 U.S.C. § 1315. 32. CMS maintains a list of waivers (including those which are pending and open for comment). State Waivers List, Ctrs. Medicare & Medicaid Servs., https://www.medicaid.gov/medicaid/section-1115demo/demonstration-and-waiver-list/index.html [https://perma. cc/8W9Q-K9ZY] (last visited Apr. 25, 2022). 33. Madeline Guth, Elizabeth Hinton, MaryBeth Musumeci & Robin Rudowitz, The Landscape of Medicaid Demonstration Waivers Ahead of the 2020 Election, Kaiser Fam. Found. (Oct. 30, 2020), https://www. kff.org/medicaid/issue-brief/the-landscape-of-medicaid-demonstrationwaivers-ahead-of-the-2020-election/#:~:text=Section%201115%20 waivers%20offer%20states,waivers%20to%20respond%20to%20 emergencies [https://perma.cc/CH3J-H6VW]. 34. The Kaiser Family Foundation has conducted regular polling about the ACA overall and its component parts since shortly after it was signed into law. Kaiser Health Tracking Poll: The Public’s Views on the ACA, Kaiser Fam. Found. (Mar. 22, 2022) https://www.kff. org/interactive/kaiser-health-tracking-poll-the-publics-views-on-theaca/#?response=Favorable--Unfavorable [https://perma.cc/3MZDFAC6] [hereinafter Kaiser Health Tracking Poll]. 35. Sallie Thieme Sanford, The Struggle to Bury Pre-Existing Condition Consideration, 7 St. Louis J. Health L. & Pol’y 405, 410–412 (2014). 36. Affordable Care Act, Pub. L. No. 111-148, § 1501, 26 U.S.C. § 5000A (2012), amended by Act to Provide for Reconciliation Pursuant to Titles II and V of the Concurrent Resolution on the Budget for Fiscal Year 2018, Pub. L. No. 115-97 § 11081, 131 Stat. 2054, 2092 (2017) (originally introduced as the Tax Cuts and Jobs Act of 2017). 37. 26 U.S.C. § 4980H (2012). 38. 42 U.S.C. § 300gg-14, Extension of dependent coverage; 45 CFR. § 147.120 (pertaining to eligibility of children until at least age 26). 39. Kaiser Health Tracking Poll, supra note 34. CH02.indd 101 02/01/23 1:54 PM 102 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 40. Sallie Thieme Sanford, Health Reform and Higher Ed: Campuses as Harbingers of Medicaid Universality and Medicare Commonality, 47 J. L. Med. & Ethics 79–90 (Winter 2019). 41. Supra note 30. 42. Sallie Thieme Sanford, Nobody Knew How Complicated: Constraining the President’s Power to (Re)Shape Health Reform, 45 Am. J. L. & Med. 106–129 (2019). 43. NFIB v. Sebelius, 567 U.S. 1 (2012). 44. US Const. art. I, § 8. 45. The 12 states that have refused to expand their Medicaid programs are Ala., Fla., Ga., Kan., Miss., N.C., S.C., S.D., Tenn., Tex., Wis., and Wyo. See Status of State Medicaid Expansion Decisions, Kaiser Fam. Found., https://www.kff.org/medicaid/issue-brief/status-ofstate-medicaid-expansion-decisions-interactive-map/ [https://perma. cc/4UQ4-57VK] (last visited May 9, 2022). 46. King v. Burwell, 576 U.S. 473 (2015). 47. Id. at 500–501 (Scalia, J. dissenting) (emphasis in original). 48. California v. Texas, 141 S.Ct. 2104, 2112 (2021). 49. See Guidance to Federal Financial Assistance Recipients Regarding Title VI and the Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons—Summary, HHS Office for Civil Rights, HHS.gov (Jul. 26, 2013), https://www.hhs.gov/ civil-rights/for-providers/laws-regulations-guidance/guidance-federalfinancial-assistance-title-vi/index.html [https://perma.cc/5MYPMPTS] (last visited May 9, 2022). 50. 42 U.S.C. § 18116(a). 51. Estelle v. Gamble, 429 U.S. 97, reh’g denied, 429 U.S. 1066 (1977) (Eighth Amendment is violated by “deliberate indifference to serious medical needs”). See also Bivens v. Six Unknown Federal Narcotics Agents, 403 U.S. 388 (1971) (persons subjected to constitutional violations by federal officials have a right to recover damages against the official in their individual capacity). 52. Youngberg v. Romero, 457 U.S. 307 (1982) (an involuntarily committed mental patient was entitled to medical care). 53. See, e.g., Hampton v. California, No. 21-CV-03058-LB, 2022 WL 838122 (N.D. Cal. Mar. 20, 2022) (federal court denying motion to dismiss cruel and unusual punishment claim where plaintiff’s husband died of COVID-19 in San Quentin) and In re Von Staich, 56 Cal. App. 5th 53, 270 Cal. Rptr. 3d 128, review granted and cause transferred sub nom. Staich on H.C., 477 P.3d 537 (Cal. 2020) (state appellate court finding cruel and unusual punishment for 64-year-old CH02.indd 102 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 54. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64. 65. 66. 67. CH02.indd 103 103 who contracted COVID-19 in San Quentin; subsequently remanded for evidentiary hearing by the state supreme court). See, e.g., Conn. Gen. Stat. § 18-7 (Supp. 1985); see also Hillcrest Medical Center v. State of Okla., ex rel. Dep’t of Corrections, 675 P.2d 432 (Okla. 1983) (the county was liable for the medical expenses of a convicted murderer injured in an automobile accident while in the county’s custody). Idaho Code § 20-209 (1979); but see Sisters of Third Order of St. Francis v. County of Tazewell, 461 N.E.2d 1064 (Ill. App. Ct. 1984) (the county was not liable for care furnished to an arrestee in the custody of municipal police). Alaska Stat. § 33.30.050 (1982). Md. Ann. Code art. 27, § 698 (Supp. 1985). Florida has a statute that establishes a hierarchy of responsibility for medical expenses provided to “any person ill, wounded, or otherwise injured during or at the time of arrest.” The first tier of responsibility includes (1) insurance, (2) the patient, and (3) a financial settlement relating to the cause of the injury or illness; only when those sources are not available may the provider seek reimbursement from governmental authority. On the basis of the “during or at the time of arrest” language, some law enforcement officials attempt to avoid governmental responsibility by not formally arresting the suspect until after treatment is rendered. Fla. Stat. § 901.35. See William Contente, Note and Comment, City of Revere v. Massachusetts General Hospital: Government Responsibility for an Arrestee’s Medical Care, 9 Am. J. L. & Med., 359, 369–70 (1983). Massachusetts Gen. Hosp. v. City of Revere, 484 N.E.2d 185 (Mass. 1982) rev’d on other grounds, City of Revere v. Massachusetts Gen. Hosp., 463 U.S. 239 (1983). City of Revere v. Massachusetts Gen. Hosp., 463 U.S. 239 (1983). Lewis v. Donahue, 437 F. Supp. 112 (W.D. Okla. 1977) (a patient released from state hospital and transferred to outpatient status may not be recommitted without due process protections). See also In re Anderson, 140 Cal. Rptr. 546 (Cal. Dist. Ct. App. 1977). People in Interest of Paiz, 603 P.2d 976 (Colo. App. 1979). Addington v. Texas, 441 U.S. 418 (1979). See Tobias v. Manhattan Eye & Ear Hosp., 283 N.Y.S.2d 398 (N.Y. App. Div. 1967), aff’d, 244 N.E.2d 59 (N.Y. 1968). Fla. Stat. §§ 394.451–394.4789. O’Connor v. Donaldson, 422 U.S. 563 (1975). Id., at 575–576. 02/01/23 1:54 PM 104 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 68. See, e.g., Wyatt v. Stickney, 344 F. Supp. 387 (M.D. Ala. 1972), Wyatt v. Stickney, 344 F. Supp. 373 (M.D. Ala. 1972), aff’d in part, remanded in part, 503 F.2d 1305 (5th Cir. 1974) (people involuntarily committed have a constitutional right to treatment that will afford them a realistic opportunity to return to society), and Youngberg v. Romero, 457 U.S. 307 (an intellectually disabled person was not provided treatment appropriate for his diagnosis). 69. Rone v. Fireman, 473 F. Supp. 92, 104, 119–120 (N.D. Ohio 1979); see also Ohlinger v. Watson, 652 F.2d 775 (9th Cir. 1980). 70. Rennie v. Klein, 653 F.2d 836 (3d Cir. 1981), vacated, 458 U.S. 1119, on remand, 720 F.2d 266 (1983); Davis v. Hubbard, 506 F. Supp. 915 (N.D. Ohio 1980); Rogers v. Okin, 634 F.2d 650 (1st Cir. 1980), vacated, 457 U.S. 291; Goedecke v. State, 198 Colo. 407, 603 P.2d 123 (1979) (common law recognizes a mental patient’s right to refuse medication). 71. 16 C.F.R. § 681. 72. Comprehensive Accreditation Manual for Hospitals (CAMH), The Joint Comm’n, Rationale for LD.02.05, at L-29 (Joint Comm’n Res. 2021) (emphasis added). 73. Jersey City Medical Center v. Halstead, 404 A.2d 44 (N.J. Super. Ct. Ch. Div. 1979); Lucy Webb Hayes Nat’l School v. Geoghegan, 281 F. Supp. 116 (D.D.C. 1967). 74. Monmouth Medical Center v. State, 403 A.2d 487 (N. J. 1979), cert. denied, 444 U.S. 942 (1979). 75. Monmouth Medical Center v. Harris, 646 F.2d 74 (3d Cir. 1981). 76. 42 U.S.C. §§ 1320c–1320c-13. (1983 and Supp. 1987). 77. 42 U.S.C. § 1320c-3. 78. NFIB, 567 U.S. at 583. CH02.indd 104 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent 105 Appendix 2.1: Medicare/Medicaid/CHIP Comparison Note: The federal government also insures additional populations through the Indian Health Service (2.5 million), Veterans Health Administration (9+ million), Military Health System (TRICARE) (9.6 million), and Federal Employees Health Benefits (FEHB) Program (8+ million). Some people may be covered under more than one program. Those covered by both Medicare and Medicaid are known as “dual eligibles.” Medicare Medicaid CHIP Coverage in 2020 61.2 million 70.5 million 6.7 million Program Type Federal program with no sunset date Federal–state partnership. States administer their programs pursuant to federal rules and with federal financial support. All states participate. They must cover certain categories of people and services, but optional categories may also be covered. For this reason, Medicaid programs vary from state to state. The federal government may also grant a state’s request to waive certain program requirements (section 1115 waiver). Federal–state partnership providing health insurance for certain groups, mostly children. Periodic reauthorization of federal funding required (last extended in 2018 for six years). In some states, CHIP is an extension of Medicaid, but in others, it is run as a separate program. Funding Sources Payroll taxes and general federal revenues. Potentially high out-ofpocket (OOP) costs to beneficiaries, particularly those with only traditional Medicare (Parts A and B). Parts C and D are obtained through private insurers with federal financial support. Because of cost, most beneficiaries have some other source of coverage in addition to traditional Medicare. Federal medical assistance percentage (FMAP) allocated to states based on the state’s per capita income. Federal government pays onehalf to two-thirds of the costs for the categorically eligible and 90% of the costs for those newly eligible due to ACA Medicaid expansion. States pay the difference, with limited allowed OOP contribution from beneficiaries. Enhanced FMAP of 15% above a state’s Medicaid FMAP. States pay the difference with some premiums and other OOP costs allowed to be charged to beneficiaries. (continued) CH02.indd 105 02/01/23 1:54 PM 106 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Medicare Medicaid CHIP Eligibility Citizens and permanent residents who: • are over 65 and paid (or whose spouse paid) Social Security taxes for ten years (plus buy-in option for those without work history); or • have a qualifying disability (after 24-month waiting period); or • have ESRD or ALS (no waiting period) Note: low-income Medicare beneficiaries might also be eligible for Medicaid; these are known as “dual eligibles.” Low-income citizens and legal residents who are either: Categorically eligible* • Over 65 • Children • Living with qualifying disabilities • Pregnant • Extremely poor parents of minors * These eligibility levels vary by state (see graphic). In the expansion population: • Income below 138% of FPL • Living in a state that expanded its Medicaid program pursuant to the ACA As of mid-2022, 38 states (including DC) had adopted the expansion; 12 had not. Primarily low-income children whose families make too much to qualify for Medicaid. Some states also cover pregnancy under this program. Income eligibility levels vary by state, up to a possible maximum of 400% of FPL. Covered Services Part A: Hospital, skilled nursing facility, hospice, home health care Medicaid rules include both mandatory and optional covered services. Services also differ based on a beneficiary’s eligibility category and the special needs of certain populations. Notably, Medicaid covers general nursing home stays, while Medicare does not. Many dual eligibles are in nursing homes. Mandatory covered services for those under age 21 include dental and vision. Although prescription medications are in the optional category, all states include prescription medication coverage. Federal rules for state programs include both mandatory and optional covered services. Part B: Physician, outpatient, durable medical equipment Part C: Alternative coverage of Parts A + B or Parts A + B + D through private Medicare Advantage plans Part D: Prescription medications (through private insurers with significant federal subsidies) CH02.indd 106 02/01/23 1:54 PM C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent Medicare Costs to enrollees Medicaid 107 CHIP Part A: No premium for most enrollees, but there is a deductible and copay that can make long hospital stays very expensive States have the option to charge premiums and establish other OOP requirements for some Medicaid beneficiaries, notably those with incomes above 150% of FPL. Part B: Monthly premium, Certain groups (including a deductible, and 20% children) and conditions copay on all charges (e.g., pregnancy) are exempt from most OOP Part C: Premium costs, and there is a and other OOP costs cap on OOP costs for all determined by private beneficiaries. insurer States can charge a premium and require cost sharing, including enrollment fees, premiums, deductibles, coinsurance, and copayments. There are federal limits on the amount of cost sharing and a prohibition on cost sharing for certain populations and certain services. Part D: after deductible, plan pays 75% and patient pays 25%. OOP costs can be high, particularly for those in traditional Medicare, so many beneficiaries enroll in Medicare Advantage plans that provide drug coverage. About one in five also have Medicaid coverage, and many others enroll in “Medigap” plans (private plans designed to cover the gaps in traditional Medicare). Expansion States 266% 216% 203% Non-Expansion States 199% 138% 138% 41% 0% Children CH02.indd 107 Pregnant Women Parents Other Adults 02/01/23 1:54 PM 108 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Appendix 2.2: History of Health Reform Efforts The tortuous history of healthcare reform in the United States spans more than a century and a half and at least a dozen presidential administrations. Year Event 1854 A bill that would have established asylums for the “indigent insane” as well as for the blind and deaf passes both houses of Congress but is vetoed by President Franklin Pierce. Pierce argues that the federal government should not commit itself to social welfare, which he argued was the responsibility of the states. 1865 After the Civil War, the federal government establishes the first system of national medical care in the South. Through an agency known as the Freedmen’s Bureau, the government constructs 40 hospitals, employs more than 120 physicians, and treats more than a million sick and dying former slaves. The hospitals last only from 1865 to 1870 because continuation of the bureau is opposed by President Andrew Johnson, a southerner. 1912 Former President Theodore Roosevelt champions national health insurance in his unsuccessful third-party bid for election as the “Bull Moose” candidate. 1935 President Franklin D. Roosevelt (FDR) favors creating national health insurance amid the Great Depression but decides to push for Social Security first. 1942 FDR establishes wage and price controls during World War II. Businesses cannot attract workers with higher pay, so they compete by adding benefits, including health insurance. Employer-paid health insurance grows into a workplace perk and becomes the usual source of coverage for most Americans. 1945 President Harry S. Truman calls on Congress to create a national insurance program. The American Medical Association denounces the idea as “socialized medicine,” and it goes nowhere. 1960 Candidate John F. Kennedy makes healthcare a major campaign issue. Later, as president, he cannot get a plan for the elderly through Congress. 1965 President Lyndon B. Johnson’s legendary arm-twisting and a Congress dominated by his fellow Democrats leads to creation of two landmark government health programs: Medicare for the elderly and Medicaid for the poor. 1974 President Richard Nixon proposes an employer mandate to offer private health insurance and reforms to Medicaid. The Watergate scandal intervenes, causing Nixon’s resignation. 1976 President Jimmy Carter promotes a mandatory national health plan, but an economic recession helps push it aside. 1986 President Ronald Reagan signs the Consolidated Omnibus Budget Reconciliation Act (COBRA), a requirement that employers let former workers stay on the company health plan for 18 months after leaving a job, with the workers bearing the cost. CH02.indd 108 02/01/23 1:54 PM 109 C h a p te r 2 : A c c ess to H ealthc are Insuranc e and Treatm ent Year Event 1988 Congress expands Medicare by adding a prescription drug benefit and “catastrophic care” coverage. Barraged by protests from older Americans upset about paying a tax to finance the additional coverage, Congress repeals the catastrophic care law the next year. 1993 President Bill Clinton puts First Lady Hillary Rodham Clinton in charge of developing what becomes a 1,300-page plan for universal coverage. “Hillarycare” would require businesses to cover their workers and require everyone to have health insurance. The plan meets Republican opposition, divides Democrats, and comes under a firestorm of lobbying from businesses and the healthcare field. It dies in the Senate. 1997 Clinton signs bipartisan legislation—the Children’s Health Insurance Program (CHIP)—creating a state-federal program to provide coverage for millions of children in families of modest means whose incomes are too high to qualify for Medicaid. 2003 In a major expansion of the program for older people, President George W. Bush persuades Congress to add prescription drug coverage to Medicare. 2009 President Barack Obama and the Democratic-controlled Congress spend an intense year ironing out legislation to require most companies to cover their workers, mandate that everyone have coverage or pay a penalty to the IRS, require insurance companies to accept all comers regardless of preexisting conditions, assist people who cannot afford insurance, create state and federal health benefit exchanges, and encourage states to expand Medicaid coverage. This effort becomes the ACA, which passes in 2010 with no Republicans voting in favor. 2012 In National Federation of Independent Business v. Sebelius, the US Supreme Court upholds the “individual mandate” portion of the ACA (the penalty for individuals who do not have insurance) but strikes down the provision requiring states to expand Medicaid. 2015 In King v. Burwell, the court holds that the ACA’s tax credits are available to applicable taxpayers in states that have a federal exchange rather than a state exchange. 2017 President Donald J. Trump takes office and vows to “repeal and replace” the ACA. Despite scores of attempts to do so legislatively, Congress fails to repeal the law. It does, however, reduce to $0 the penalty for failure to obtain insurance. Texas and numerous other plaintiffs argue that this invalidates the entire ACA. 2021 In California v. Texas, the US Supreme Court rules that the plaintiffs had no standing to challenge the ACA on the basis of the $0 penalty, thus leaving the ACA intact even though the individual mandate is unenforceable. CH02.indd 109 02/01/23 1:54 PM CH02.indd 110 02/01/23 1:54 PM CHAPTER THE ORGANIZATION AND MANAGEMENT OF A CORPORATE HEALTHCARE INSTITUTION 3 After reading this chapter, you will • understand that a corporation is a “person” for many legal purposes, but not an “individual” or a “citizen”; therefore, laws that apply to persons also apply to corporations, but laws that specify individuals or citizens do not; • appreciate that incorporation has many advantages, the most significant of which is limiting the liability of the individuals who own the corporation; • know that the powers of a corporation are limited to those specified in state law and the corporate charter; • understand the governing board’s fiduciary duties of care, loyalty, and obedience to the mission of their organization; • be able to explain why the governing board must be actively involved in overseeing the affairs of the company without meddling in management’s control of day-to-day operations; • realize that many factors have led to the development of multi-institutional healthcare systems rather than stand-alone entities; and • see that the Affordable Care Act provided the impetus for another round of corporate reorganization, especially in the area of hospital–physician relations. M ost institutional healthcare providers are corporations; thus, this chapter focuses on the fundamental nature of the corporate form of organization. However, healthcare is also provided by sole proprietorships, partnerships, and other types of business entities. In a sole proprietorship, an individual (e.g., a family physician in solo practice) assumes all organizational roles: employer, employee, and owner. The proprietor usually retains any profits or suffers any losses and bears the 111 CH03.indd 111 02/01/23 1:56 PM 112 T h e L aw o f H e a l th c a re A d mi n i stra ti o n fiduciary Relating to the duty of acting in good faith for the benefit of another person or entity. CH03.indd 112 full risks of the enterprise. A partnership exists if someone joins the proprietor and shares in the rewards and risks. Partnerships are governed by state law and by an agreement between the parties.1 The parties have great latitude to develop an agreement that suits their needs. The simplest kind of partnership is a general partnership. In this arrangement, the partners usually receive equal shares of profits or losses, are entitled to equal voting rights, and are liable for the debts and torts of the venture. On the death or departure of a partner, the partnership is automatically dissolved, but the business operation does not necessarily end. General partners ordinarily control the business by consensus; however, as the volume of business and number of partners increase, this arrangement may become cumbersome and the liability risks too great. Providers who are in a legal partnership with other providers are liable for the torts of their partners (if they acted in the scope of the partnership) because every partner is legally an agent of the other partners. This is one reason for the growth in professional limited liability companies as an alternative organizational model. These alternative organizational models go by different names, including limited partnership, limited liability company, professional limited liability company (PLLC), and professional corporation. They may be used by licensed individuals such as physicians, psychologists, midwives, and others to protect their personal assets from lawsuits brought against their practices. PLLCs and similar state-authorized entities hold a lot of appeal for healthcare professionals desiring to work as a group. The requirements for creating these entities vary from state to state, and the implications for taxation and tort liability may differ from one type to another. The details are too many to describe here; it is sufficient to say that competent legal and accounting advice should be sought before creating any business entity. A joint venture is a special form of relationship created by contract for a specific purpose and for a limited duration. A joint venture is thus one way of integrating two or more business organizations. In joint ventures, the parties have fiduciary responsibilities to each other, and, depending on the contractual terms, each usually has a right to participate in management. Profits and losses are shared according to the agreement, and each participant may be liable to third parties. Although somewhat similar, a joint venture differs from a general partnership in that its participants are not agents of each other. Because of their flexibility, joint ventures have become popular in the healthcare sector and have been used, for example, to effect hospital–­physician integration (discussed later in this chapter). The rest of this ­chapter focuses primarily on corporations, the predominant form of healthcare organization. 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 113 Formation and Nature of a Corporation A corporation is “an artificial being, invisible, intangible, and existing only in contemplation of law. Being the mere creature of the law, it possesses only those properties which the charter confers on it, either expressly or as incidental to its very existence.”2 The modern corporation came to prominence in the late nineteenth century with the passage of state statutes regarding business incorporation. These laws allow any group of persons (or, in some states, a single individual) to incorporate an enterprise for any lawful purpose, as long as it meets statutory requirements. General business corporation acts provide for the formation and operation of a wide range of commercial activities, such as manufacturing, wholesaling, and retailing. Most states have a separate corporate statute for ­not-for-profit organizations. The type of statute under which the organization is formed will shape its permissible endeavors, for a corporation has only the powers granted to it by its charter, as specified in its articles of incorporation and authorized by the relevant state corporations law. corporation An organization formed with governmental approval to act as an artificial person to carry on business (or other activities), able to sue or be sued, and (unless it is a not-for-profit corporation) able to issue shares of stock to raise capital. The Corporation Is a “Person” Because corporations are legal entities distinct from the individuals who create or manage them, they fall within the definition of “person” for most constitutional and statutory purposes. For example, the Fifth and Fourteenth Amendments to the US Constitution provide that no person shall be deprived of “life, liberty, or property without the due process of law.” Similarly, the Fourteenth Amendment provides that no state “shall deny to any person . . . the equal protection of the laws.” Corporations are protected by these fundamental doctrines (see Legal Brief). Personhood also enables a corporation to acquire, own, and dispose of property (including stock in other corporations) and to sue and be sued. In short, a corporation is an Legal Brief independent entity with rights and responsibilities of its own. On the other hand, a corporation Corporations’ constitutional rights were confirmed in the 2010 Citizens United case, in which the US is not a citizen. It cannot vote in an elecSupreme Court held that corporate funding of tion, and it is not protected by the Fourpolitical broadcasts during election campaigns is a teenth Amendment’s provision that “no form of free speech protected by the First Amendstate shall make or enforce any law which ment. “Political speech does not lose First Amendshall abridge the privileges or immuniment protection ‘simply because its source is a ties of citizens of the United States.” corporation’” (Citizens United v. Federal Election Commission, 558 U.S. 310 [2010]). Neither is a corporation protected by the Fifth Amendment’s prohibition against CH03.indd 113 02/01/23 1:56 PM 114 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Legal Brief The prohibition on the corporate practice of medicine (CPM) was announced decades ago as a means of discouraging commercialization and exploitation of the medical profession and emphasizing that the physician’s individual loyalties belong solely to the patient. In some states, it was the creature of common law; in others, the doctrine was enshrined in statutes. The CPM doctrine has been eroded over time. Most scholars believe that absent a specific statute, courts would be unlikely to apply it to a hospital, at least a not-for-profit one, whose physician contracts disclaim control over medical decision-making. In the few states where CPM statutory prohibitions remain, creative contractual arrangements are often available to bypass their effect. For example, California—which continues the CPM prohibition more stringently than most states do—allows exceptions for professional medical corporations and foundations, teaching hospitals, some community clinics, substance abuse programs, and some not-for-profit organizations. For example, in California Medical Association v. Regents of University of California (79 Cal. App. 4th 542 [2000]), an appellate court wrote, “Concerns about for-profit corporations have nothing to do with non-profit teaching hospitals.” Before an entity decides to hire physicians, it needs to clarify the status of the CPM doctrine in the states at issue. • • • • • CH03.indd 114 self-incrimination because that right applies only to real people (individuals). Similarly, a corporation is not a person for the purpose of professional licensure statutes because it cannot meet the educational requirements or standards of personal character required for that type of licensure. Of course, the entity itself might be licensed to operate a clinic, pharmacy, hospital, or other type of regulated healthcare business. Whether the entity can hire physicians is a function, among other concerns, of the strength of the corporate practice of medicine doctrine in its state (see Legal Brief ). Forming a Corporation A corporation is formed by filing articles of incorporation with the secretary of state or other designated official of the state in which incorporation is sought. On approval, a corporate charter is issued. Although requirements regarding the specific content of the articles differ from state to state, the articles typically must include the following: • Name of the corporation • Address of the corporation’s office • Name of the registered agent authorized to accept delivery of writs, summonses, or other legal papers Names and addresses of the incorporators Duration of corporate existence (which is usually unlimited) Purpose of the corporation Names of the initial members of the governing board (also known as board of directors and board of trustees) Number and classification of shares of stock (in a for-profit corporation) or the designation of members, if any (in a not-for-profit organization) 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution The incorporators are those who prepare, sign, and file the articles of incorporation. Some states require a minimum number of incorporators, while others permit an individual to act as the incorporator. Advantages of the Corporate Form of Organization There are five principal advantages to incorporation: 1. Limited liability. Normally, the owners of a corporation are not personally liable for the corporation’s contracts or torts. A shareholder of a for-profit corporation is not personally liable, with a few exceptions, for corporate debts beyond the extent of the shareholder’s investment in the corporation’s stock. Similarly, employees generally are not personally liable for corporate obligations if they act in the scope of delegated authority; rather, the corporation would be liable for employees’ actions within the scope of their employment. 2. Perpetual existence. Unlike a sole proprietorship or partnership, a corporation’s continued legal existence and operational capabilities in most instances are not affected by the death or disability of an owner. 3. Free transfer of ownership interests (at least if the corporation is forprofit). Shareholders in the organization can sell their interests to fellow shareholders or the general public (unless special provisions are made and noted on the stock certificates). Free transferability increases the liquidity and value of corporate investments. State statutes usually provide that membership interests in not-for-profit corporations may not be transferred. 4. Taxation separate from individual income taxes. The corporate tax rate is generally lower than the personal income tax rate, and the persons who own the corporation are taxed only on the distributions of income (dividends) they receive, not on their proportionate shares of the entire corporate profit. 5. Ability to raise capital. Access to equity capital, as distinct from borrowing and creating debt, is a major consideration when undertaking new or expanded ventures. 115 physician For purposes of federal healthcare programs, a physician is a doctor of medicine (MD), doctor of osteopathy (DO), doctor of dental surgery (DDS), doctor of dental medicine (DMD), doctor of podiatric medicine (DPM), doctor of optometry (OD), or chiropractor (DC) (see 42 U.S.C. § 1395x[r]). corporate charter The fundamental document (usually articles of incorporation) of a corporation’s legal authority. Powers of a Corporation A corporation may act only within its corporate authority, and its powers are limited to those consistent with its charter (articles of incorporation) and the statute under which it was formed. There are two kinds of powers: express and implied. Express powers are those specifically designated by charter or statute. The relevant statute under CH03.indd 115 02/01/23 1:56 PM 116 T h e L aw o f H e a l th c a re A d mi n i stra ti o n ultra vires A departure from express or implied corporate power, from the Latin phrase meaning “beyond the powers.” which the corporation is formed enumerates express powers, such as the power to buy, lease, or otherwise acquire and hold property and the power to make contracts to effectuate corporate purposes. Implied powers are those reasonably necessary to carry out the express powers and achieve the corporation’s purposes and objectives. Any departure from express or implied corporate power is said to be ultra vires. For example, the case of Charlotte Hungerford Hospital v. Mulvey, although it does not involve a typical corporate charter, illustrates the importance of knowing the limits of corporate power. (To read this case, see The Court Decides at the end of this chapter.) Therefore, in planning for the future and in making commitments, the governing body of the corporation must keep a close eye on the corporation’s legal authority, and legal advice regarding this issue is of utmost importance. For example, if a not-for-profit corporation donates or transfers assets to another institution for a purpose not included in its own charter, the donation or transfer is ultra vires. As such, it could be challenged in a suit for an injunction and would likely be held void. Some hospital transactions that may raise questions about corporate power include the following: • • • • • • Lending credit or guaranteeing the debts of another corporation Issuing loans to its corporate trustees, officers, or members Forming a partnership with another corporation or an individual Consolidating or merging with another corporation Leasing publicly owned facilities to a private corporation Engaging in independent private business enterprises (if a public hospital) without statutory authority to do so These transactions are not necessarily ultra vires, but the authority to engage in them must be verified with legal counsel. (Corporate consolidations and mergers are discussed later in this chapter.) Not-for-Profit Corporation not-for-profit (or nonprofit) A type of organization in which legal and ethical restrictions prohibit the distribution of profits to owners or shareholders. CH03.indd 116 A general for-profit business corporation is owned by shareholders, who are entitled to and expect to receive dividends from the earnings of the corporation and to share in assets should the corporation be dissolved. By contrast, no part of the net earnings of a not-for-profit corporation may be distributed for the private gain of its members, directors or trustees, officers, or other private individuals. However, a not-for-profit corporation can earn income in excess of its expenses (see Legal Brief) without sacrificing its not-for-profit status, as long as it uses that net income for institutional 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 117 purposes. As the saying goes, “no margin, no mission.” Moreover, it can, without Legal Brief question, pay its employees. If the compensation paid is reasonable, salaries are The terms not-for-profit and nonprofit are synnot “private gain” that would jeopardize onymous. The former expression is preferred, how3 the corporation’s not-for-profit status. ever, because it emphasizes that the purpose of (This topic is addressed in more depth the corporation is not to make a profit even though in chapter 13 with respect to tax-exempt it may (and usually does) do so. Clearly, no corpoorganizations.) ration can long survive with a negative bottom line. Although charitable status is contingent on not-for-profit status, a notfor-profit corporation need not have a charitable purpose. Many social clubs and similar organizations that provide services exclusively to members are organized and operated as legitimate not-for-profit corporations without charitable or benevolent purposes. Such corporations do not qualify for the tax-exempt status that charitable corporations enjoy (see chapter 13). Not-for-profit status is a prerequisite for tax exemption not only under federal law but also under the state statutes providing for taxes on sales, income, and real or personal property.4 Not-for-profit corporations do not have shareholders, but they may or may not have “corporate members” (depending on the provisions of the law under which they are incorporated). These members are roughly equivalent to a business corporation’s shareholders, but they are not entitled to receive dividends. Like shareholders, however, they hold certain reserved powers, such as the authority to • elect directors to the governing body; • approve merger or dissolution of the corporation; • amend the articles of incorporation and bylaws, including the corporate purpose; • set the corporate philosophy and mission; and • adopt annual budgets, unless the board of directors is given this power. In most states, members must meet at least annually to conduct business. In a corporation without members, the board of directors is the sole governing authority, and it has the statutory power to exercise the reserved powers. In any event, the reserved powers are set forth in the not-for-profit corporation law and the articles of incorporation. On the dissolution or merger of a not-for-profit corporation, the assets of the corporation must be distributed in accordance with state law and the provisions of the articles of incorporation. CH03.indd 117 02/01/23 1:56 PM 118 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Management of a Corporation Corporate bylaws contain rules for the internal management and governance of corporations. Unless state statutes or a corporation’s articles of incorporation provide otherwise, the power to adopt and amend a corporation’s bylaws lies with its members or shareholders. In short, the governing body of a corporation cannot adopt or amend corporate bylaws unless state statutes or the corporation’s charter have specifically granted it this power. The bylaws define the rights and duties of the corporate members or shareholders, the powers and responsibilities of the governing body, and the rights and duties of the major corporate officers. Corporate bylaws are an internal document; hence, they need not be filed in any public office or otherwise made available for public inspection (unless state law so requires). As noted earlier, certain extraordinary matters normally require the vote of members or shareholders. As discussed in the following section, other major powers reside with the governing board. Otherwise, the day-to-day management of the corporation is the responsibility of its CEO and other management staff. Responsibilities of the Governing Board The governing body of a healthcare institution has four major functions: 1. 2. 3. 4. Develop policy and strategic plans Appoint senior administration and medical staff members Delineate clinical privileges Oversee the professional performance of lay administrators and the medical staff To fulfill these functions properly, the board must ensure the proper organization of its own committee structure. For example, the board must ensure that the executive committee is properly executing corporate policy in the interval between board meetings, and this committee must not assume the decision-making power legally reserved for the whole board or for corporate members or shareholders. Moreover, the executive committee is usually not permitted to delegate its responsibilities to any single member of the committee. In addition to the executive committee, other standing committees often include committees on finance, medical staff relations, corporate compliance, buildings and grounds, personnel, public relations, and education. Committees that focus on diversity, equity, and inclusion (DEI) are gaining in popularity, as are other committees composed of members of the local community to advise on DEI and similar issues. In addition to providing important input to the board about community needs, these committees can be a source of future board members. CH03.indd 118 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 119 Having set policy for the institution, the board must ensure that the medical staff and management execute it effectively. The board should not become involved in the details of day-to-day operations—these responsibilities should be delegated to hospital administration and the medical staff—but it must have mechanisms in place to review performance and hold accountable the corporation’s agents (employees or others authorized to act on the organization’s behalf). Supervising agents is essential because the actions of agents can expose the corporation to liability. When authority for implementing policy is delegated, it can be revoked if performance is unsatisfactory. The board must monitor delegated powers; it cannot abdicate its oversight responsibilities. Board Composition and Meetings The board’s size is determined by the articles of incorporation or bylaws.5 Some states require a minimum number of directors—usually three—while others allow as few as one board director. In a not-for-profit corporation of the membership type, the corporate members elect the governing board. In a not-for-profit corporation without corporate members, the board may select new directors; boards that do so are referred to as self-perpetuating. In some situations, such as in a state or county hospital, a public official or body may appoint the directors; directors of public hospital districts are typically elected. Terms of office and qualifications of these directors are determined by charter or bylaw provisions drafted in accordance with statutory requirements. For example, local statutes may require that directors be of majority age and that a certain number be residents of the state of incorporation.6 In at least one type of healthcare corporation the composition of the board is also subject to federal regulations. Federally Qualified Health Centers (FQHCs) are community-based outpatient clinics that receive federal grants to provide care to people in underserved areas or who are economically or medically vulnerable. Some FQHCs function as general community health centers, open to all but typically caring for many uninsured and underinsured people with fees based on ability to pay. Others are designed to focus on particular populations, such as migrant workers, the unhoused, or Native Americans. An FQHC’s board must be structured in a certain way to qualify for receipt of federal grant money. Among the requirements is that most of the board members be patients of the FQHC (see exhibit 3.1). Most healthcare organizations’ governing boards include representatives from the local community, including business leaders, government officials, clinicians, and other influential persons with track records of success in their respective fields and a willingness to work as a team to enhance the mission of the organization. Directors usually cannot be paid or compensated for their services unless local law and the corporate charter permit it. CH03.indd 119 02/01/23 1:56 PM 120 T h e L aw o f H e a l th c a re A d mi n i stra ti o n EXHIBIT 3.1 Requirements for Governing Boards of Federally Qualified Health Centers 42 C.F.R. § 51c.304 Governing board. A governing board for the [FQHC] shall be established by an applicant as follows: (a) Size. The board shall consist of at least 9 but not more than 25 members, except that this requirement may be waived by the Secretary for good cause shown. (b) Composition. (1) A majority of the board members shall be individuals who are or will be served by the center and who, as a group, represent the individuals being or to be served in terms of demographic factors, such as race, ethnicity, sex. (2) No more than one-half of the remaining members of the board may be individuals who derive more than 10 percent of their annual income from the health care industry. (3) The remaining members of the board shall be representative of the community in which the center’s catchment area is located and shall be selected for their expertise in community affairs, local government, finance and banking, legal affairs, trade unions, and other commercial and industrial concerns, or social service agencies within the community. (4) No member of the board shall be an employee of the center, or spouse or child, parent, brother or sister by blood or marriage of such an employee. The project director may be a non-voting, ex-officio member of the board. This rule is particularly relevant to not-for-profit corporations because of the fundamental doctrine that members and directors of not-for-profits must not derive personal financial gain from the corporation. (This prohibition does not exclude the salary paid to a director who is also a corporate employee, if that is permitted.) State law, along with the corporate charter, governs for-cause removal of directors as well as procedures for special elections to fill board vacancies. Legal counsel should be sought in such situations. In managing the affairs of the corporation, the board must act in properly constituted, formal meetings. Independent action by one, or even by a majority of directors, does not bind the corporation. Except for regular meetings provided for in the articles of incorporation or corporate bylaws, proper notice (usually in writing) of a meeting must be given to each director. Unless such notice is given, the meeting is invalid. There is one exception: if all directors attend a meeting that was called without proper notice, they have, in effect, waived the notice requirement. Even so, decisions made at a casual, unannounced gathering of the board may lack legal effect. If the statutes and bylaws permit, meetings can be held by teleconference; otherwise, CH03.indd 120 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 121 directors must attend in person.7 Likewise, if the statutes and bylaws permit, some types of board action can be taken without a meeting if all board members consent to the proposed action in writing. A written record (minutes) should be made of the actions taken at each board meeting. Directors who object to a proposed action should make certain that their dissents are noted in the record. The frequency of meetings depends on provisions in the charter or bylaws and on particular circumstances. Unless the local statutes, charter, or bylaws provide otherwise, the location of the board meeting may be at the discretion of the board. Meetings may even occur outside the state of incorporation, as long as the place is a reasonably convenient destination. The charter or bylaws fix the number of directors necessary for a quorum. In the absence of a provision, the rule is that a quorum is a simple majority of the board and that a majority vote is sufficient to bind the corporation. Directors may not vote by proxy in the absence of a specific statutory or bylaw provision because each director has a fiduciary duty to attend meetings personally and exercise independent judgment. The foregoing general principles of corporate law are reflected in the hospital accreditation standards published by The Joint Commission. Many public hospitals (e.g., those owned by counties, cities, tax districts) are also governed by the provisions of state open-meetings statutes as to the frequency, location, and public notice of meetings and the public’s right to attend. State Open Meeting and Public Records Laws Every state has statutes that determine when government agencies must allow the public to attend meetings and to make minutes and other records available for public inspection.8 These statutes are often referred to as sunshine laws, a term implying that the public is entitled to have light shed on the conduct of governmental affairs. They are also, more prosaically, called open meeting laws or public records laws. Therefore, government hospitals and hospital authorities are covered not only by federal statutes and regulations but also by laws at the state, county, and municipal levels, some of which do not apply to other healthcare organizations. CH03.indd 121 COVID Connection The American Hospital Association (AHA) noted that many hospital CEOs saw reduced “energy levels” from their corporate directors during the pandemic. Board members had been “under significant pressure in their own business and professional leadership roles, with the personal and family impact of the pandemic layered on too.” There was also less engagement due to use of virtual meetings, cancellation of board retreats and social gatherings, and a desire not to distract management from pandemic priorities. (See Kimberly A. Russel, Health Care Governance in Changing Times, AHA Trustee Services, https://trustees. aha.org/health-care-governance-changing-times [https://perma.cc/2H66-L5GV] [last visited May 16, 2022].) 02/01/23 1:56 PM 122 T h e L aw o f H e a l th c a re A d mi n i stra ti o n For example, a county hospital authority in Georgia was subject to that state’s similar legislation, and the Supreme Court of Georgia held that a newspaper had the right to access the names, job titles, and salaries of all hospital employees who earned more than $28,000.9 In Florida, an appellate court held in Gadd v. News-Press Publishing Company, Inc. that a newspaper was entitled to view a public hospital’s medical staff files and its utilization review documents.10 Although another Florida statute exempts peer review records and proceedings from use in an action against a provider of health services,11 the state’s Public Records Act does not do so specifically. The Gadd court held that the apparent inconsistency between the two statutory schemes was a matter for the legislature to resolve, but as of mid-2022, the issue remains unresolved. These cases are examples of the typical judicial approach, which is to interpret the sunshine laws liberally in accordance with legislative intent. Most of the sunshine statutes contain exceptions to the right of public access. Some of the exceptions are cast in general language, but some are more specific—as is the exception in Florida related to autopsy photos (see the discussion in chapter 10 about autopsy photos of NASCAR driver Dale Earnhardt). A court may create an exception when it is presented with a persuasive reason for limiting the applicability of the legislation. Typically, the statutes exclude meetings and records related to pending litigation, negotiations with labor unions, acquisition of capital (e.g., the purchase of real estate), and personnel matters. Questions about public records laws involve balancing competing interests. The outcome of each case depends on the language of the relevant statute, judicial understanding of legislative intent, the purposes or motives of those seeking access, and the countervailing interests of the defendant or third parties. The Governing Board’s Duties Directors of any corporation have fiduciary duties to the corporation, to its members (if any), and to its intended beneficiaries. These can be summarized as the duties of care, loyalty, and obedience to the mission. In the case of a hospital corporation, these duties obligate the board to • • • • • • CH03.indd 122 protect hospital property, avoid self-dealing and conflicts of interest, establish and oversee the hospital’s strategic goals, select the CEO and a qualified medical staff, monitor the quality of care, and approve the operating budget. 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 123 Duty of Care Board members are expected to act with due care in all they do for the corporation. This standard may be codified by statute, as it is in Michigan, where the law states, A director or officer shall discharge his or her duties as a director or officer including his or her duties as a member of a committee in the following manner: (a) In good faith. (b) With the care an ordinarily prudent person in a like position would exercise under similar circumstances. (c) In a manner he or she reasonably believes is in the best interests of the corporation.12 Whether or not the duty is enshrined in statute, due care requires honesty and good faith, and it requires board members’ active involvement. They must take an active role in directing the company. Merely preserving corporate property as caretakers is not enough; they must use that property to achieve corporate objectives. They must attend meetings and participate actively in decisionmaking by learning about the issues, asking appropriate questions, and demonstrating complete rectitude in their decisions. The duty also includes exercising reasonable care in selecting and appointing the CEO and other corporate agents, such as outside legal counsel.13 They must use care in supervising the agents they appoint and in holding them accountable, and they have a duty to remove an incompetent CEO or other agent. It is also important to clearly communicate to agents the limits of their authority; Members of the governing boards of charitable this may protect the corporation from liabilcorporations are sometimes called trustees. This ity if the agent exceeds those limits. terminology is a historical artifact. They are not “trustees” in the technical sense. A true trustee Directors also have a duty to use holds legal title to property and manages that care in appointing individuals to the mediproperty for the benefit of others. In a corporation, cal staff and to restrict clinical privileges however, the title to property is vested in the coror terminate an appointment when they poration itself. Furthermore, under trust law, the know or should have known of incomduty of a trustee is generally higher than the duty petence on the part of a medical staff of a corporate director. For example, the trustee of a trust may be liable for poor business judgments member (see chapters 7 and 8). Thus, the in the management of the property held for the corporation may be held liable for failure beneficiaries’ benefit. A corporate director is gento monitor the quality of patient care. erally held liable only for actual negligence, willful In reaching a decision on these or disregard of duty, or wrongful acts. Throughout the other matters, directors may rely on written, following discussion, we use the term director to documented reports and recommendations encompass board members of charitable corporations generally. from responsible professional sources such as medical staff committees, accountants, CH03.indd 123 02/01/23 1:56 PM 124 T h e L aw o f H e a l th c a re A d mi n i stra ti o n and legal counsel. They need not personally verify all items in these reports if no activity arouses suspicion or question,14 but they face potential liability if they fail to obtain professional advice when a problem becomes apparent—for example, if they fail to obtain competent legal counsel when the hospital has a recognizable legal issue. In general, directors are not personally liable for honest errors in business judgment. This standard is consistent with that applicable to the directors of for-profit corporations and means that board members must exercise the judgment that reasonably prudent directors or trustees would be expected to exercise under similar circumstances. An example of dishonest business judgment that could render a director personally liable is permitting institutional funds to remain in a bank that they knew or ought to have known was in financial straits.15 A famous case involving Sibley Memorial Hospital in Washington, DC, illustrates the kinds of responsibilities that board directors carry and the difficulties that can arise when directors do not adhere to them (see The Court Decides: Stern v. Lucy Webb Hayes National Training School for Deaconesses and Missionaries at the end of this chapter). As you read this case, remember that its facts occurred in 1966, and the sanctions that the court meted out are mild compared with what would be ordered if board members today abdicated their duties in the way that Sibley Memorial’s directors did. Duty of Loyalty This duty requires board members to put the interests of the corporation before self-interest. Thus, no director is permitted to gain personally, accept bribes, or compete with the corporation.16 Conflicts of Interest The duty of loyalty raises the question In their daily lives, corporate board members of whether a director can personally contract wear many hats. But in any interaction involving with the corporation. Can directors, for the interests of that corporation, they all wear instance, sell supplies or services to the hosonly one, and it bears the corporation’s logo. A pital? The answer is yes, if certain high stanhospital board member might, for example, own a dards are met. A director may usually conlocal construction company, invest in real estate, and volunteer for the mayor’s reelection camtract with the corporation if the contract is paign. This level of community involvement and fair, if full disclosure of all personal interest is knowledge might be part of the reason they were made, and if utmost good faith is exercised. selected. But membership on the board must not A director should not vote on or participate be used to benefit the individual’s construction in the board’s decision to approve or veto company, personal investments, or political cansuch a transaction. Competitive bids should didate. If any of those interests are implicated in a proposed board action, the director must disclose be solicited to establish the fairness of the the conflict of interest and withdraw from particicontract. The burden of proving the fairness pation on the issue. of a contract and disclosing self-interest is always on the individual director, and courts CH03.indd 124 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 125 will closely scrutinize the transaction if the matter is challenged. A contract with a director that does not meet these standards is not void, but it is voidable.17 There may be specific state statutes pertaining to directors’ contracts with the corporation they serve.18 In a government hospital, state law may prohibit all transactions between a director and the corporation, even if full disclosure is made and the contract is fair. Whenever directors wish to contract with the corporation they serve, they and the board should seek careful legal advice based on local law. Every hospital should have and follow conflict-of-interest policies. Each director must be required to file a written declaration of possible conflicts of interest and disclose gifts, gratuities, and lavish entertainment offered by companies that do business with the hospital. Duty of Obedience As noted earlier, every corporation has a mission—a corporate purpose— spelled out in its articles of incorporation. It is the responsibility of the board to ensure that the organization remains loyal to that mission. Actions that are inconsistent with the mission and purpose of the corporation are considered ultra vires and are void or voidable. Adherence to the mission is especially significant in the case of charitable, not-for-profit corporations, because their assets are considered to be held “in trust” for the benefit of the public, and that trust can be enforced by the state’s attorney general. Such was the case some 45 years ago when the board of directors of Queen of Angels Hospital in Los Angeles attempted to lease the facility to a for-profit management company and use the proceeds of the lease to operate free medical clinics for the poor. Learning of this transaction, the California attorney general brought suit contending that the corporation’s assets were held “primarily for the purpose of operating a hospital, and the use of those assets exclusively for outpatient clinics would constitute an abandonment of [the] charitable purpose.” A threejudge panel of the California Court of Appeals agreed. Relying heavily on the language of the entity’s articles of incorporation, the court held that although operating clinics for the poor is undoubtedly an admirable undertaking, “whatever else Queen of Angels Hospital Corporation may do under its articles of incorporation, it was intended to and did operate a hospital and cannot, consistent with the trust imposed upon it, abandon the operation of the hospital business in favor of clinics.”19 Following a revision of the articles of incorporation, the building (which has been featured in a number of movies) was sold. A similar case arose in New York City some 20 years later, when the board of the Manhattan Eye, Ear and Throat Hospital decided to “monetize the assets”—that is, sell the hospital—and use the proceeds to establish diagnostic and treatment centers in underserved areas. The New York attorney general challenged that decision, and the court agreed, blocking the deal and stating: CH03.indd 125 02/01/23 1:56 PM 126 T h e L aw o f H e a l th c a re A d mi n i stra ti o n [T]he Board of Directors is charged with the duty to ensure that the mission of the charitable corporation is carried out. This duty has been referred to as the “duty of obedience.” It requires the director of a not-for-profit corporation to “be faithful to the purposes and goals of the corporation,” since “[u]nlike business corporations, whose ultimate objective is to make money, nonprofit corporations are defined by their specific objectives: perpetuation of particular activities are central to the raison d’etre of the organization.” . . . [T]he duty of obedience, perforce, must inform the question of whether a proposed transaction to sell all or substantially all of a charity’s assets promotes the purposes of the charitable corporation when analyzed under [New York Not-For-Profit Law].20 In summary, these and other cases establish that in addition to being careful in their decision-making (the duty of care) and loyal to the organization (the duty of loyalty), board members have a duty of obedience: the duty to remain faithful to the purposes for which the organization was established. This is done by scrupulous attention to the articles of incorporation or other organizing documents. Protection Against Liability In general, hospital directors are not at serious personal risk as long as they comply with these three duties. In practice, that means they should regularly attend board meetings, review necessary materials, vote personally, disclose conflicts of interest, recuse themselves when appropriate, and exercise utmost good faith and honesty in overseeing the corporation’s affairs. The best means of establishing good faith and honesty is a written record of all the board’s deliberations, including the votes of individual directors on transactions that involve personal interests. Any director who dissents from majority actions of the board should make sure that their dissent is part of the written record. In addition to making a good faith effort to fulfill their fiduciary duties, individual directors and corporate officers have two means of protecting themselves. These are (1) purchasing liability insurance and (2) making sure that the corporation has appropriate indemnification provisions to protect them in the event they suffer personal loss as a result of exercising their (good faith) board responsibilities. Many not-for-profit corporations favor indemnification plans or a combination of insurance and indemnity. Insurance for directors and officers, called D&O coverage, may exclude coverage for gross negligence, intentional acts, and criminal activity. Indemnification is corporate reimbursement of a trustee’s personal expenses in the event the trustee faces a civil suit or criminal prosecution for alleged violation of fiduciary responsibilities. The trustee may be reimbursed for attorneys’ fees and possibly for amounts paid as a result of a judgment against the individual. The hospital may, in turn, purchase insurance covering the costs of indemnification. Careful legal advice is necessary CH03.indd 126 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution to ensure that directors understand the circumstances under which insurance and indemnification can and cannot be provided. Drafting the corporate charter or bylaw provisions covering these issues with utmost care is imperative. Responsibilities of Management 127 Legal Brief The word management comes from the Latin phrase manu agere, meaning “to lead by the hand,” as in training horses, for example. We prefer to think of enlightened leaders as people who set goals and empower others to reach those goals, not as taskmasters who pull employees along by the bridle. Regardless of the metaphor, the fact remains that the job of management (or leadership, if you prefer) is to enable people to get things done. Administration is also derived from Latin, a compound of ad (to) and ministratio (serve). The term is also the source of the verb to minister. The line separating the board’s authority from that of management is hard to define precisely. In general terms, it is the board’s responsibility to set the overall direction of the organization and monitor its accomplishment while leaving the dayto-day details to management personnel. In other words, as we have heard it said, the board should “keep its nose in but its hands off.” Management, then, consists of the CEO and other members of the workforce who carry out the specific tasks that achieve the overall purposes of the organization as set by the board (see Legal Brief). It is concerned with leadership: setting goals (strategies), creating an action plan to achieve those goals (tactics), measuring outcomes, and reassessing the strategy and tactics on the basis of those outcomes—all while keeping the board informed of salient issues. In a healthcare organization, management functions begin with senior administrative positions, including those of CEO, vice presidents, and department directors (or similar titles). Their responsibilities include the following: • Supporting the governing board in its strategic planning and policymaking activities • Carrying out (implementing, administering, executing) the board’s policies and strategic goals • Communicating board policies and the strategic plan to employees and the medical staff • Overseeing day-to-day operations, including personnel functions and personnel records • Measuring the quality of patient care • Managing operating funds • Selecting qualified junior executives • Conducting necessary business transactions CH03.indd 127 02/01/23 1:56 PM 128 T h e L aw o f H e a l th c a re A d mi n i stra ti o n employment law The collection of laws and rules that regulate the employer– employee relationship. Management must report regularly to the governing board on the general status of these activities while maintaining a distinction between the board’s governance role and management’s day-to-day operations. Because corporations can act only through people, members of management find that they spend large portions of their time dealing with personnel issues: recruitment, performance reviews, dispute resolution, discipline, terminations, and myriad related subjects. All of these situations implicate employment law, which covers such things as wages and overtime, nondiscrimination, sexual harassment, disabilities, relationships with unions, workplace safety, and many others.21 Chapter 4 covers employment law in some detail. Piercing the Corporate Veil A corporation is a legal entity that has rights and responsibilities separate from those of its owners. It is a convenient legal fiction, and because it can limit legal and financial liability, it has been an invaluable vehicle for encouraging investment in for-profit and not-for-profit activities. On the other hand, if a corporation is used to “defeat public convenience, justify wrong, protect fraud, or defend crime,” the law will disregard the corporate fiction and place liability on the owners of the corporation.22 This action is known as piercing the corporate veil. Most litigated cases in which the corporate veil has been pierced have involved closely held corporations or parent–subsidiary relationships. For a court to pierce the corporate veil, the party challenging the corporation normally must prove three elements: 1. The corporation’s owners dominated it completely. 2. The owners used their control of the corporation to commit fraud or perpetrate a wrong, violate a statutory or other duty, or commit a dishonest or unjust act. 3. Corporate control was the proximate cause of the injury that is the subject of the suit.23 Although precedent for piercing the corporate veil is more than a century old, courts are reluctant to look beyond the corporate form.24 Accordingly, as a general rule, all three of these elements must be proven to the satisfaction of the “trier of fact” (the judge or the jury). Complete domination of the corporation means domination of finances, business practices, and corporate policies to such an extent that the entity has no mind or will of its own. Mere directorship of the corporation by a sole shareholder entitled to corporate profits is not enough to justify piercing the CH03.indd 128 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 129 veil. Courts look, on a case-by-case basis, for unity of interest and ownership sufficient to destroy the separate identities of the owner or owners and the corporation. Evidence of this unity is found in such factors as the following: 1. Mingling of corporate assets with the owner’s personal funds 2. Neglect of business formalities, such as failure to file separate tax returns, hold regular board meetings, and keep adequate corporate minutes 3. Having a mere “paper corporation” with nonfunctioning officers and directors listed in the articles of incorporation 4. Insufficient investment of capital in the corporation25 The decision whether to disregard the corporate fiction, however, does not rest on a single factor. Courts most often look for several factors suggesting that the corporation and owner should be treated as one and the same.26 United States v. Healthwin-Midtown Convalescent Hospital is a good example.27 Defendant Israel Zide owned half the stock of Healthwin, a convalescent center that provided skilled nursing care in return for payments from Medicare. Zide also had a 50 percent interest in a partnership that held title to the real estate occupied by Healthwin and the furnishings of the nursing home. Concluding that the nursing home had been overpaid, the government brought suit against Healthwin and against Zide for the amount of the alleged overpayment. Zide defended the claim against him on the basis that the debt was solely the corporation’s and that he was entitled to limited liability. In rejecting Zide’s defense, the court noted these factors: • He alone controlled the corporation’s affairs. • He was a member of the board, the president of the corporation, and the administrator of the nursing facility. • He alone signed corporate checks without concurrence of another corporate officer. • The governing board did not meet regularly. • Zide failed to maintain an arm’s-length relationship with the corporation by permitting Healthwin’s funds to be “inextricably intertwined” with his personal accounts and other business transactions. • The corporation was seriously undercapitalized, having liabilities consistently in excess of $150,000 and an initial capitalization of only $10,000. • He diverted corporate funds to the detriment of creditors. CH03.indd 129 02/01/23 1:56 PM 130 T h e L aw o f H e a l th c a re A d mi n i stra ti o n In the court’s opinion, these facts demonstrated that Zide used the corporation to accommodate his personal business dealings. The court held that to allow him to escape liability in these circumstances would be unfair to his creditors (including Medicare). Accordingly, Zide was found personally liable for the amount due the federal government because the corporation was a mere alter ego of its principal shareholder. In addition to the factors showing a unity of interest and ownership strong enough to outweigh the separate identity of the corporation, for the corporate veil to be pierced, limited liability must result in an inequity. An inequitable result is often found when a statutory duty has been violated or fraud or other wrongful action has been perpetrated (see The Court Decides: Woodyard, Insurance Commissioner v. Arkansas Diversified Insurance Co. at the end of this chapter for another case that illustrates judicial application of the doctrine of piercing the corporate veil). Multi-institutional Systems and Corporate Reorganization: The Independent Hospital and Independent Physician as Anachronisms For many years the hospital was a single legal entity, and its purpose was merely to provide doctors with a building, equipment, and supplies so they could treat their patients. Today, however, these former “doctors’ workshops” operate as multifaceted organizations with teams of people who work toward a new vision: promoting health rather than merely treating illness. Achieving this organizational vision (see Legal Brief) required restructuring stand-alone hospitals into multi-institutional systems that would permit them, for example, to add new service lines, partner with physicians or other organizations, increase market share, and improve the bottom line. Physicians, particularly recent graduates, are increasingly likely to join large organizations. They might be employees of a healthcare system or join a multispecialty PLLC; fewer and fewer are hanging out their own Legal Brief shingle or partnering in small offices. A multiorganizational system can The vision statement of the AHA reads, “The AHA diversify operations and engage in a wide vision is of a society of healthy communities, range of activities that a single institution where all individuals reach their highest potential cannot. Subsidiary entities can provide for health” (American Hospital Association, AHA Guide special services or perform functions not to the Health Care Field at B2 [Health Forum Publishrelated to healthcare without being haming 2009]). This type of broad aspirational vision is typical of that espoused by many large healthcare pered by hospital-focused regulations, organizations today. restrictive corporation laws, and thirdparty reimbursement regulations. CH03.indd 130 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 131 Multi-institutional system and corporate reorganization are generic terms, and no single definition, model, or form exists that describes either concept. The AHA defines multihospital systems as “two or more acute care hospitals that are owned, leased, sponsored, or contract-managed by a central organization,” and it distinguishes them from networks, which are “group[s] of hospitals, physicians, other providers, insurers and/or community agencies that work together to coordinate and deliver a broad spectrum of services to their community.”28 This distinction reminds us that healthcare systems now include skilled nursing facilities, extended care facilities, ambulatory care centers, outpatient surgical centers, hospital-owned physician practices, home health agencies, pharmacies, managed care plans, and various other healthrelated organizations (see exhibit 3.2 for an example of a multi-institutional healthcare system). Systems may comprise both not-for-profit and for-profit (proprietary) entities. For example, a not-for-profit system corporation may own not-forprofit and for-profit subsidiaries. A system may also be owned and managed by a state or local government. Whether consisting of multiple corporate entities or a single corporation with multiple divisions, all multi-institutional systems have a corporate office responsible for activities that are best performed centrally, thus providing efficiency and economies of scale. Some functions commonly managed at the corporate level include the following: • • • • • • • • • Finance and billing Legal and risk management Quality assurance Compliance Legislative advocacy Human resources and benefits administration Health information management Strategic planning In-service education In addition to these functions, the US Supreme Court’s 2022 decision overturning Roe v. Wade will require multi-institutional systems to develop abortion-related policies in compliance with the law of each state in which they operate. These policies will need to address such topics as which abortion-related services are permitted, if any; the use of telemedicine technology for abortion consults; the permissibility of interorganizational referrals (especially referrals across state lines); and possible access to abortion medications. Other issues include when, if at all, the system will assist in defense of providers charged with abortion law violations; whether coverage for abortion services (including travel and lodging expenses when necessary) CH03.indd 131 02/01/23 1:56 PM CH03.indd 132 Practice C Practice D Practice A Practice B ACO (physician practices) Home Health Agency Land Development, Inc. Hospice A Hospice B Nursing home A Nursing home B Long-Term Care, Inc. Note: ACO = accountable care organization; PAC = political action committee. Retail pharmacy Medical home Health education Children’s Hospital XYZ PAC = Not-for-profit company For-profit = company Noncontrol = relationship No shape = Unincorporated Hospice Care, Inc. Child protection team Mobile care team Ambulatory surgery center Cancer Institute Other nonhospital services Health screenings Hospital B Fundraising XYZ Health Foundation, Inc. Freestanding ED Hospital A XYZ Regional Health System, Inc. Physician referral service Wellness programs Community Services, Inc. EXHIBIT 3.2 XYZ Regional Health System Organization Chart 132 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 133 is to be included in employee benefit plans; and myriad other questions too numerous to mention and as yet unimagined. Developing these system-wide policies will require a multidisciplinary approach at all levels of the organization to understand the risks and conduct necessary employee education in every facility and every state in which the system provides health services. Alternative Corporate Strategies Sale of Assets For a variety of reasons, corporations sometimes sell all or a substantial portion of their assets to another corporation. This transaction is relatively straightforward, except that local law must be followed carefully when the seller is a charitable corporation. Normally, the stockholders or members and the governing boards of both the buyer and the seller must approve the terms of the sale. If the seller is a charitable corporation, state laws may require that a designated state officer approve the final arrangement because the state has the ultimate responsibility to enforce the terms of charitable trusts. This might also require establishment of a well-funded foundation to benefit the community once served by the charitable corporation. After the sale is completed, the selling corporation may dissolve or continue to operate on a restricted scale. Merger and Consolidation Corporations also sometimes wish to join forces with others. They can integrate in several different ways, including merger, consolidation, and joint venture. In a merger or acquisition, two or more corporations are joined, whereby one or more of the organizations transfers assets to another (the survivor) and then is dissolved. A consolidation, in contrast, is a transaction in which two or more organizations combine to form a new corporation, thereby dissolving the predecessor companies. The terms are often used interchangeably in casual conversation, but keeping this distinction in mind is advisable: in a merger or acquisition, one company survives after taking over one or more other corporations; in a consolidation, two companies blend into a completely new entity. Before completing any type of corporate integration, each party must carefully scrutinize state corporation law; certificate-of-need requirements that exist in many states; tax implications, if one entity is tax-exempt; and other regulatory requirements. Normally, the governing boards and the shareholders or corporate members of the respective corporations must CH03.indd 133 merger (or acquisition) The joining of two or more corporations, whereby one or more of the organizations transfers assets to another (the survivor) and then is dissolved. consolidation A transaction in which two or more organizations combine to form a new corporation, thereby dissolving the predecessor companies; sometimes used as a general term inclusive of merger and acquisition. 02/01/23 1:56 PM 134 T h e L aw o f H e a l th c a re A d mi n i stra ti o n approve the plan. The terms of any bond documents may require approval of the bondholders. When the interested parties approve the plan, articles of merger or consolidation are prepared and filed with the state officer responsible for enforcing the relevant corporate law, who then issues a certificate authorizing the transaction. Once the certificate is issued, the new corporation owns all the property of the former entities, has all their rights and privileges, and is liable for all their debts.29 If the merger or consolidation significantly affects competition in the relevant market, it may invite charges of antitrust law violation. Depending on the size of the deal, federal or state antitrust authorities might need to be notified in advance. (The antitrust aspects of asset acquisitions, consolidations, joint ventures, and mergers are thoroughly discussed in chapter 14.) The twenty-first century has seen significant consolidation in all areas of the healthcare system. The jury is still out on whether this has benefited patients in general, or only certain sectors. Advocates of consolidation point to possible efficiencies and stronger risk management and quality assurance programs when managerial functions are combined. They also argue that larger entities can offer a wider range of services, and that small, stand-alone entities are at particular risk of failure. On the other hand, critics point to evidence that prices go up when healthcare organizations gain bargaining power because of their size, and not necessarily because of any increase in quality. Consolidation also might mean fewer options (e.g., in the pharmacy arena), as local needs are subsumed into more national trends. And the vast reach of religiously affiliated healthcare networks raises particular concern about access to types of medical treatment disfavored or prohibited by church teaching. These treatments might include, for example, sterilization, abortion, aid in dying, and genderaffirming healthcare. Joint Venture In contrast with a merger or consolidation, a joint venture is a mutual endeavor by two or more organizations for a specific purpose or for a limited duration. This term is loosely applied to a variety of relationships (e.g., between a hospital and a physician practice) for purposes such as: joint venture A mutual endeavor by two or more organizations for a specific purpose or for a limited duration. CH03.indd 134 • • • • diversifying both parties’ activities, providing new or additional services to the community, seeking capital from interested investors, or maximizing revenues. Although the joint venture participants are not agents of each other, other rules of a general partnership normally apply. That is to say, the 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 135 property is jointly owned and the parties owe fiduciary duties to each other. Each has a right to participate in management. They share profits and losses according to their agreement. Each can be held liable to third parties for the negligence and financial obligations of the venture. As discussed in the following sections, outright employment of physicians is on the rise, but historically, joint ventures have been the most common form of hospital–physician collaboration. In cases in which one party to a joint venture is tax-exempt and the other is not, particular rules must be followed to ensure that charitable resources are not diverted to the benefit of the for-profit entity. As explained in more detail in chapter 13, there are both organizational and operational aspects to these rules to ensure that the exempt entity maintains control. Collaborative Strategies with Physicians Medicare as a Driver At its inception, Medicare basically paid hospitals and physicians their usual rates for the services they provided. Obviously, under such a system, the more services you provide, the more you get paid. This arrangement was an advantage for both hospital and physician providers, and Medicare spending rose at an annual rate more than twice that Legal Brief of inflation during the 1970s and early 1980s.30 As described in chapter 2, conMedicare beneficiaries are citizens and legal residents who are over age 65 or have qualifying discerned about these sharply rising costs, abilities. Because Medicare has potentially high Congress in 1983 replaced Medicare out-of-pocket costs, most beneficiaries have supPart A’s cost-based reimbursement sysplemental coverage in the form of Medicaid (if they tem with a prospective payment system are low income), a Medicare Advantage Plan (Part (PPS) based on diagnosis-related groups C), a separate Medigap policy, or retiree coverage. (the DRG system). Analogously, in 1992, Medicare is an extremely popular program with four substantive parts: Medicare significantly changed the way it paid for physician services under Part B, • Medicare Part A covers hospitalization, hospice adopting the resource-based relative value care, skilled nursing, and home health care. • Medicare Part B covers physician visits, scale, also known as RVU-based payment. outpatient care, medical supplies, and other (See Legal Brief for a review of the four necessary services. “parts” of Medicare, which are discussed • Medicare Part C (also known as Medicare in more detail in chapter 2.) Advantage) covers the services in Parts A, B, Both the DRG and RVU sysand (usually) D through private insurers. tems have been criticized for introduc• Medicare Part D covers outpatient prescription drugs. ing their own perverse financial incentives and for failing to adequately “bend CH03.indd 135 02/01/23 1:56 PM 136 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Legal Brief A 1997 federal statute’s “sustainable growth rate” trigger for Part B reimbursement led to what came to be known as the “Doc Fix.” This ­happened when, not long after the statute’s enactment, Medicare Part B costs reached the statutorily unsustainable rate and mandatory cuts were scheduled to go into effect. The American Medical Association and other physician groups lobbied and fundraised around the issue, coining the term in the process. Congress repeatedly postponed the cuts, never allowing them to go into effect, and the issue recurred with some regularity, sometimes more than once a year. “Fix” is a contranym—a word that is its own opposite. In this context, it is not clear whether the word referred to the problem (the “fix” that doctors were in) or the solution (the “fix” that the lobbyists proposed). It seemed to mean both. In 2015, Congress finally enacted a permanent fix by repealing the 1997 sustainable growth rate provision, so doctors are no longer in this particular “fix.” the cost curve.” Nonetheless, both of these prospective payment systems have their appeal, and both have been widely adopted by other insurers. Over the years, Congress and the Center for Medicare & Medicaid Services (CMS) have attempted a variety of payment mechanisms to rein in costs (at least costs to the federal government) without sacrificing access or quality. One you might have heard of was known as the “Doc Fix,” under which Part B reimbursements would automatically be cut if the rate of growth in those costs reached specified levels and Congress did not take other ameliorative action. Congress kicked this can down the road many times, and at one point a 30 percent across-the-board cut in Part B reimbursements was set, theoretically, to go into effect. The “Doc Fix” was repealed in 2015 in the hope that new shared savings models targeting physicians might hold Medicare costs to a sustainable level (see Legal Brief). The First Wave of Hospital–Physician Integration Recognizing the difficult situation they faced, and considering the increasingly competitive and cost-conscious environment of the late 1980s, many healthcare institutions attempted to develop business arrangements with groups of physicians to share risk and reap economic rewards. Most commonly, hospitals integrated with members of their own medical staffs, but sometimes hospitals acquired the practices of previously unrelated physicians—either by contracted services or through direct employment. ­ Typically, the goals of these collaborative efforts were to: • • • • • • • CH03.indd 136 reduce costs, provide a full range of services along the continuum of care, provide practice management and administrative support, negotiate contracts with payer organizations, generate economies of scale, provide access to capital, improve quality, 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 137 • conduct utilization reviews, and • provide staffing for particular hospital departments (e.g., radiology, anesthesiology, emergency). The arrangements took different names, such as management services organization, physician–hospital organization, integrated delivery system, and health maintenance organization. They were sometimes organized as joint ventures but were more commonly set up as corporations. Regardless of their organizational form, many well-intentioned ­hospital–physician collaborations met with limited success, if not outright failure. Hospital executives discovered that managing a physician practice is different from running a hospital, that salaried physicians sometimes do not work as many hours as their contracts require, and that they may actually increase the hospital’s costs. Physicians, on the other hand, discovered that hospitals are large bureaucracies that can stifle their independence and limit their autonomy. For various reasons, each side was often skeptical of the other; thus, many of the arrangements fell apart. To be successful, collaboration between physicians and hospitals requires more than a written contract and a lofty mission statement. It requires true congruence of interests. Both groups must have common values, shared governance and management, and common data systems. Full openness and complete trust must exist. Physicians and hospitals learned this lesson the hard way in the 1990s, and interest in hospital–physician collaboration waned for a time. The Second Wave of Hospital–Physician Integration As the twenty-first century approached, a second wave of interest in ­hospital– physician cooperation began. One reason for this was the Bill Clinton administration’s health reform initiative, which, despite its failure as public policy, spawned a boom in hospital mergers and physician practice acquisitions. In addition, declining incomes and the increased cost and stress of running a private practice prompted many older physicians to retire or switch to concierge medicine. During the Great Recession of 2008–2010, younger physicians became more open to hospital employment than those of the baby boom generation had been.31 As older physicians retired and the prospect of medical staff shortages appeared, hospitals made physician recruitment and retention a higher priority. Then came what has been perhaps the most significant factor in hospital–physician integration: passage of the Affordable Care Act (ACA) in 2010. The law promotes a variety of arrangements aimed at “paying for value rather than volume” and generally bending the cost curve while improving quality. The readmission program, for example, financially penalizes hospitals CH03.indd 137 concierge medicine A relationship between a patient and a primary care physician in which the patient pays an annual fee in return for direct, personalized care; also known as boutique medicine. 02/01/23 1:56 PM 138 T h e L aw o f H e a l th c a re A d mi n i stra ti o n that have too high a readmission rate for patients with specified diagnoses. Another program promotes “patient-centered medical homes,” a way of delivering primary care. And the ACA’s Shared Savings Program, which encourages creation of accountable care organizations (ACOs), was also an impetus for integration of physician practices within hospitals’ auspices. (Chapter 2 contains a further discussion of ACOs.) As ACOs took hold and the ACA became fully operative, hospitals and health systems continued to consolidate and seek new modes of care delivery. Prior to the COVID-19 pandemic, 67 percent of the nearly 6,100 US hospitals were affiliated with systems, and they represented 75 percent of all US hospital beds.32 Consolidation is likely to continue and to include not just acute care hospitals and medical clinics but also long-term care facilities, rehabilitation and behavioral health facilities, ambulatory surgery centers, and so on. Furthermore, the pandemic accelerated the trend toward increased use of telemedicine and other outpatient options—and this trend is also likely to continue.33 Healthcare executives must work closely with their attorneys and other consultants to analyze carefully both the business arguments and the legal reasons for undertaking a merger, acquisition, or other collaborative venture before embarking on it. Depending on the arrangement implemented, there may well be fraud and abuse, tax, and antitrust implications. (See chapters 9, 13, and 14, respectively.) Chapter Summary This chapter discussed the following topics: • • • • • • • CH03.indd 138 Principles of corporation law The corporation as a “person” State law regarding corporate powers Duties of the governing board and management of a corporation The distinctions between “for-profit” and “not-for-profit” corporations Trends toward mergers, acquisitions, and hospital–physician integration Medicare as a driver of collaborative strategies 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 139 Vocabulary concierge medicine consolidation corporate charter corporation employment law fiduciary joint venture merger (or acquisition) not-for-profit (or nonprofit) physician ultra vires Discussion Questions 1. Describe the advantages of incorporation as opposed to organization as a partnership. Where would you look to find the powers of a particular corporation? 2. How are most physician groups in your area organized? Are they in small groups or large, partnerships or PLLCs, independent or networked? 3. What about the hospitals in your state? How many are for-profit and not-for-profit? Do government hospitals or public hospital districts or religious hospitals have a big presence? 4. What might be a hypothetical example of a breach of the duty of care by a board member? Of a breach of the duty of loyalty? Of a breach of the duty of obedience? Feel free to be outrageous in your examples, but do link them to the particular duties described in this chapter. 5. Explain the concept of “accountable care” in such a way that someone who is not in the healthcare industry would understand. Is it different from managed care? If so, how? CH03.indd 139 02/01/23 1:56 PM 140 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The Court Decides Charlotte Hungerford Hospital v. Mulvey 26 Conn. Supp. 394, 225 A.2d 495 (1966) MacDonald, J. [In court opinions, a jurist’s position is often given by the addition of “J” or “CJ” behind the name. The initials stand for Judge or Justice, or Chief Judge or Chief Justice, depending on the title of the position in the particular jurisdiction. This decision was written by Justice MacDonald.] The plaintiff in this action for a declaratory judgment is a nonstock corporation which for many years has owned and operated a voluntary general hospital in a complex of buildings located on a 120-acre tract of wooded land about one mile from the center of the city of Torrington. The land was acquired under a deed of trust providing that the premises thus conveyed “are to be held and used by said grantee for the purpose of maintaining and carrying on a general hospital and, if a majority of corporators so elect, a training school for nurses in connection therewith may be established, and for no other purpose whatsoever.” The deed of trust in question, executed in 1917, specifically provided that “if the land herein granted shall cease to be used for the [stated] purposes, title . . . shall thereupon pass to and vest in said town of Torrington . . . to be used forever as a public park.” [A state statute later chartered the hospital subject to the “terms, conditions, restrictions and provisions” of the deed of trust.] Plaintiff [now wants to erect] a medical office building on the hospital grounds [because it] would be of great convenience and advantage both to the individual doctors and to the hospital. . . . . . . [However,] various questions have arisen with respect to the right, power and authority of plaintiff, under the terms of said CH03.indd 140 deed of trust and special act, to proceed with such a project. . . . The specific questions which the court is requested to answer . . . are (a) whether plaintiff is authorized . . . to construct and operate, as an integral part of its general hospital complex, a medical office building for members of its medical staff; (b) whether such a medical office building may, under the terms of the aforesaid deed of trust, be located on a portion of the land held by plaintiff thereunder; (c) whether . . . the plaintiff is authorized and empowered to lease . . . a portion of the land included in the aforesaid deed of trust [to a subsidiary corporation that will operate the medical office building]; [and] (d) whether, in addition to offices and office suites for members of plaintiff ’s medical staff, said building may contain facilities related to or supporting such offices and suites, such as medical laboratories, pharmacies and dispensaries. The court, after hearing the evidence and the arguments of counsel with full participation by counsel representing the only interested parties, namely, the attorney general of the state of Connecticut, as representative of the public interest in the protection of trusts for charitable uses and purposes . . . and the city of Torrington, contingent beneficiary, has no hesitation in answering all four of the questions posed in the affirmative. It is clear . . . that the proposed project would materially aid the plaintiff in more efficiently carrying out the stated purposes of the trust deed under which it was founded. . . . It is equally clear from the extremely impressive testimony of [the president of the AHA and another witness] that the modern trend is 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution almost universally toward the practice of having nonprofit hospitals provide physicians’ private offices for rental to staff members, either in the hospital buildings themselves or on the hospital grounds. . . . The language of the deed of trust is to be construed in light of the settlor’s purpose. And reasonable deviations and expanded interpretations must be made from time to 141 time in order to keep pace with changes in recognized concepts of the proper sphere of general hospital operations. . . . Such deviations are recognized by our Connecticut courts even though the elements for applying cy pres principles are not present. A decree may enter advising plaintiff of its rights, powers and authority herein by answering the four questions propounded in the affirmative. Discussion Questions 1. 2. 3. 4. Why is the state attorney general an “interested party” to these proceedings? What is a settlor? What are cy pres principles? How does this case enhance your understanding of the limits of corporate power? ~ ~ The Court Decides Stern v. Lucy Webb Hayes National Training School for Deaconesses and Missionaries 381 F. Supp. 1003 (D.D.C. 1974) Gesell, J. [This is a class-action suit in which patients of Sibley Memorial Hospital, known officially by the name shown above, challenged various aspects of the hospital’s management and governance. The defendants were certain members of the hospital’s board of trustees and the hospital itself. For a summary of the differences between trustees of a trust and directors of a corporation, see the discussion in this chapter.] The two principal contentions in the complaint are that the defendant trustees conspired to enrich themselves and certain financial institutions with which they were affiliated by favoring those institutions in financial dealings with the Hospital, and that they breached their fiduciary duties of care and loyalty in the management of Sibley’s funds. . . . [The court explains that the hospital was begun by the Methodist Church-affiliated Lucy Webb Hayes School in 1895 and eventually became the school’s main activity.] In 1960 . . . the Sibley Board of Trustees revised the corporate by-laws. . . . Under the (continued) CH03.indd 141 02/01/23 1:56 PM 142 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) new by-laws, the Board was to consist of from 25 to 35 trustees, who were to meet at least twice each year. Between such meetings, an Executive Committee was to represent the Board [and in effect had full power to run the hospital]. . . . In fact, management of the Hospital from the early 1950s until 1968 was handled almost exclusively by two trustee officers: Dr. Orem, the Hospital Administrator, and Mr. Ernst, the Treasurer. Unlike most of their fellow trustees, to whom membership on the Sibley Board was a charitable service incidental to their principal vocations, Orem and Ernst were continuously involved on almost a daily basis in the affairs of Sibley. They dominated the Board and its Executive Committee, which routinely accepted their recommendations and ratified their actions. Even more significantly, neither the Finance Committee nor the Investment Committee ever met or conducted business from the date of their creation until 1971, three years after the death of Dr. Orem. As a result, budgetary and investment decisions during this period, like most other management decisions affecting the Hospital’s finances, were handled by Orem and Ernst, receiving only cursory supervision from the Executive Committee and the full Board. [It was only after the deaths of Dr. Orem and Mr. Ernst (in 1968 and 1972, respectively) that other trustees began to assert themselves and exercise supervision over the financial affairs of the hospital. At that point, it became known that over the years “unnecessarily large amounts of (Sibley’s) money” had been deposited in accounts bearing little or no interest at banks in which trustees had a financial interest. At the same time, the hospital bought certificates of deposit that paid lower-than-market rates and took out loans with interest rates higher than the interest rates being paid on funds deposited. Because there was no evidence that the trustees, other than Dr. Orem and Mr. Ernst, had ever actually agreed to engage in or profit CH03.indd 142 from these activities, the court found insufficient evidence to prove a conspiracy among them. The court then proceeds to discuss the allegations of breach of fiduciary duty.] III. Breach of Duty. Plaintiffs’ second contention is that, even if the facts do not establish a conspiracy, they do reveal serious breaches of duty on the part of the defendant trustees and the knowing acceptance of benefits from those breaches by the defendant banks and savings and loan associations. A. The Trustees. Basically, the trustees are charged with ­mismanagement, nonmanagement and selfdealing. The applicable law is unsettled. . . . [H]owever, the modern trend is to apply corporate rather than trust principles in determining the liability of the directors of charitable corporations, because their functions are virtually indistinguishable from those of their “pure” corporate counterparts. 1. Mismanagement. . . . Since the board members of most large charitable corporations fall within the corporate rather than the trust model, being charged with the operation of ongoing businesses, it has been said that they should only be held to the less stringent corporate standard of care. More specifically, directors of charitable corporations are required to exercise ordinary and reasonable care in the performance of their duties, exhibiting honesty and good faith. 2. Nonmanagement. . . . A corporate director . . . may delegate his investment responsibility to fellow directors, corporate officers, or even outsiders, but he must continue to exercise general supervision over the activities of his delegates. Once again, the rule for charitable corporations is . . . the traditional corporate rule: directors 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution should at least be permitted to delegate investment decisions to a committee of board members, so long as all directors assume the responsibility for supervising such committees by periodically scrutinizing their work. Total abdication of the supervisory role, however, is improper even under traditional corporate principles. A director who fails to acquire the information necessary to supervise investment policy or consistently fails even to attend the meetings at which such policies are considered has violated his fiduciary duty to the corporation. While a director is, of course, permitted to rely upon the expertise of those to whom he has delegated investment responsibility, such reliance is a tool for interpreting the delegate’s reports, not an excuse for dispensing with or ignoring such reports. . . . 3. Self-dealing. Under District of Columbia Law, neither trustees nor corporate directors are absolutely barred from placing funds under their control into a bank having an interlocking directorship with their own institution. In both cases, however, such transactions will be subjected to the closest scrutiny to determine whether or not the duty of loyalty has been violated. . . . Trustees may be found guilty of a breach of trust even for mere negligence in the maintenance of accounts in banks with which they are associated while corporate directors are generally only required to show “entire fairness” to the corporation and “full disclosure” of the potential conflict of interest to the Board. Most courts apply the less stringent corporate rule to charitable corporations in this area as well. It is, however, occasionally added that a director should not only disclose his interlocking responsibilities but also refrain from voting on or otherwise influencing a corporate decision to transact business with a company in which he has a significant interest or control. 143 [The court goes on to point out that the hospital board had recently adopted the AHA’s policy guidelines that essentially imposed the standards described earlier: (1) a duality or conflict of interest should be disclosed to other members of the board, (2) board members should not vote on such matters, and (3) the disclosure and abstention from voting should be recorded in the minutes.] . . . [T]he Court holds that a director . . . of a charitable hospital . . . is in default of his fiduciary duty to manage the fiscal and investment affairs of the hospital if it has been shown by a preponderance of the ­evidence that (1) . . . he has failed to use due diligence in supervising the actions of those officers, employees or outside experts to whom the responsibility for making day-to-day financial or investment decisions has been delegated; or (2) he knowingly permitted the hospital to enter into a business transaction with himself or with any [business entity] in which he then had a substantial interest or held a position as trustee, director, general manager or principal officer [without disclosing that fact]; or (3) except [with disclosure], he actively participated in or voted in favor of a decision . . . to transact business with himself or with any [business entity] in which he then had a substantial interest or held a position as trustee, director, general manager or principal officer; or (4) he otherwise failed to perform his duties honestly, in good faith, and with a reasonable amount of diligence and care. Applying these standards to the facts in the record, the Court finds that each of the defendant trustees has breached his fiduciary duty to supervise the management of Sibley’s ­investments. . . . [In conclusion, the court noted that the plaintiffs pushed for strict sanctions against the various defendants: the removal of (continued) CH03.indd 143 02/01/23 1:56 PM 144 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) certain board members, the cessation of all business transactions with their related firms, an accounting of all hospital funds, and awards of money damages against the individual defendants. However, the court declined to adopt these rather severe measures. The court points out the factors that it considered significant: (1) the defendant trustees are a small minority of the board, whereas all board members were in some way guilty of nonmanagement; (2) the defective practices have been corrected, and those who were most responsible for them have either died or been dismissed; (3) the defendants did not profit personally from the transactions; (4) the defendants will soon leave the board because of age, illness, or the completion of a normal term; and (5) this case is essentially the first in the District of Columbia to discuss these issues comprehensively, and thus no clear legal standards previously existed. For these reasons, the court declines to remove the defendants from the board, to assess money damages, or to take other more severe actions. Instead, it requires new policies and procedures to make certain that all present and future trustees are aware of the requirements of the law and that they fully disclose all hospital transactions with any financial institutions in which they have an interest or position.] Discussion Questions 1. If this case were decided today, would the outcome be different? If so, how? 2. As the CEO or board member of a not-for-profit hospital corporation, what measures would you put in place to prevent a repeat of the activities that led to the lawsuit involved here? 3. How would you summarize the duties of board members based on the holding in this case? ~ ~ The Court Decides Woodyard, Insurance Commissioner v. Arkansas Diversified Insurance Co. 268 Ark. 94, 594 S.W.2d 13 (1980) Hickman, J. The appellant is Arkansas Insurance Commissioner W. H. L. Woodyard, III. The appellee is Arkansas Diversified Insurance Company (ADIC). ADIC sought a certificate of authority from Woodyard to sell group life insurance to Blue CH03.indd 144 Cross and Blue Shield . . . subscriber groups. Woodyard denied the application. On appeal, his decision was reversed by the Pulaski County Circuit Court as being arbitrary and not supported by substantial evidence. We 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution find on appeal [that] the circuit court was wrong and [we] reverse the judgment. We affirm the commissioner. The only evidence before the commissioner was presented by ADIC. The appellee candidly admitted it was a wholly owned subsidiary of a corporation named Arkansas Diversified Services, Inc. (ADS) which is a wholly owned subsidiary of Blue Cross and Blue Shield, Inc. . . . ADIC candidly admitted it was created solely to serve Blue Cross customers. It would provide services that could not otherwise be provided by law. . . . ADS wanted its own life [insurance] company to better compete in the market place. Blue Cross owns all the stock of ADS, which in turn owns all the stock of ADIC. The president of Blue Cross is the president of both ADS and ADIC. Other Blue Cross officials hold positions in ADS and ADIC. The companies use the same location and similar stationery. ADIC will use Blue Cross employees to sell insurance. Underwriting for ADIC will be done by a division of ADS. There was no real controversy over the commissioner’s findings of fact. He concluded that: (2) That [Arkansas law] would apparently authorize a hospital and medical service corporation [of which Blue Cross is one] to invest in a wholly owned subsidiary insurance corporation with the Commissioner’s consent. (3) That Blue Cross is limited by [law] to transact business as a non-profit hospital and medical service corporation. (4) That ADIC is not a separate corporate entity from Blue Cross since Blue Cross through ADS owns all the capital stock of ADIC. ADIC has common Officers and Directors with Blue Cross, Blue Cross pays the salary for the Officers and employees of ADIC, ADIC will sell its products only to Blue Cross subscriber groups and the record indicates that ADIC is to be treated as a division 145 of Blue Cross. The evidence indicates that ADIC’s management will not act independently but will conduct the affairs of ADIC in a manner calculated primarily to further the interest of Blue Cross. . . . The commissioner found that since Blue Cross could not sell life insurance itself, it should not be able to do so through corporate subsidiaries. We find that decision neither arbitrary nor unsupported by substantial evidence. We agree with the commissioner’s finding that [Arkansas law] limits the power of medical corporations to providing medical service. If it did not, they could not only sell life insurance, but automobiles or anything else. Clearly, an insurance company organized under a charter or statute empowering it to sell one kind of insurance lacks authority to sell another. The appellees argue that even if the commissioner was right in ruling Blue Cross could not market its own life insurance policies, Blue Cross could . . . invest in a wholly owned subsidiary which would [have that power]. The statutes, however, provide that such an investment can be made only with the commissioner’s consent. . . . Blue Cross is a tax exempt, non-profit corporation enjoying a financial advantage over conventional insurers. Allowing it to sell, through subsidiaries, its own life insurance policies, could be unfair to competitors. While the commissioner did allow Blue Cross to invest in ADS, we can see why he disapproved of ADIC. ADS, unlike ADIC, could sell only policies written by insurance companies which lacked the competitive advantages of Blue Cross. The appellee argues the commissioner arbitrarily pierced the corporate veil of these subsidiaries. . . . [C]ourts will ignore the corporate form of a subsidiary where fairness demands it. Usually, this will be where it is necessary to prevent wrongdoing and where (continued) CH03.indd 145 02/01/23 1:56 PM 146 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) the subsidiary is a mere tool of the parent. We believe both criteria were met here. . . . Blue Cross, through its president and other officials, candidly admitted why they wanted ADIC to sell insurance. Blue Cross can, through its total control of both subsidiaries by stock, officers and directors, direct all efforts and endeavors of ADIC, and collect all profits. We cannot say the commissioner was wrong in piercing the corporate veil or in denying the application. The facts are clearly there to support his findings. This order is not contrary to law. Reversed. Discussion Questions 1. How does a Blue Cross health plan fall under the definition of a “hospital and medical service corporation”? 2. What is the function of that type of corporation in the healthcare system? (Other states assign different names to those corporations.) 3. What factual differences in this general situation might have led to a different outcome in the case, applying the same legal standard? ~ ~ Notes 1. Since 1914, the National Conference of Commissioners on Uniform State Laws has promoted a Uniform Partnership Act (UPA) for adoption by the states and territories. Louisiana is the only state that has not adopted some version of the UPA. See 6 U.L.A. 1 (Supp. 1986) (table of jurisdictions). 2. Trustees of Dartmouth College v. Woodward, 17 U.S. (4 Wheat) 518, 636 (1819). 3. For example, the Michigan statute specifically states that a not-forprofit corporation “may pay compensation in a reasonable amount to shareholders, members, directors, or officers for services rendered to the corporation.” Mich. Comp. Laws Ann. § 450.2301(3)(a). 4. See I.R.C. § 501 and the discussion of tax issues generally in chapter 13. 5. See, e.g., Ohio Rev. Code Ann. § 1702.27 (A)(1). The Ohio nonprofit corporation statute states, “The number of directors as fixed by the articles or the regulations shall not be less than three or, if not so fixed, the number shall be three.” See also Mich. Comp. Laws Ann. § 450.2505(1), which states that “the board shall consist of 3 or more CH03.indd 146 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 6. 7. 8. 9. 10. 11. 12. 13. 14. CH03.indd 147 147 directors. The bylaws shall fix the number of directors or establish the manner for fixing the number, unless the articles of incorporation fix the number.” For example, a California statute prohibits anyone who owns stock or has any property interest in a private hospital or is a director or officer of a private hospital from serving as a director or officer of a public hospital serving the same area. Cal. Health & Safety Code § 32110 (West 1973 and Supp. 1986). Accordingly, in Franzblau v. Monardo, 108 Cal. App. 3d 522, 166 Cal. Rptr. 610 (1980), the president of a not-for-profit private hospital was prohibited from serving as a director of the public hospital district. See, e.g., Mich. Comp. Laws Ann. § 450.2521(3). Reporters Committee for Freedom of the Press, Open Government Guide, http://www.rcfp.org/ogg [https://perma.cc/4RRG-VBBA] (last visited August 19, 2016). Richmond County Hosp. Auth. v. Southeastern Newspapers Corp., 311 S.E.2d 806 (Ga. 1984); see also Moberly v. Herboldsheimer, 345 A.2d 855 (Md. App. 1975) (a newspaper may compel a municipal hospital to disclose an administrator’s salary and fees paid to legal counsel). 412 So. 2d 894 (Fla. App. 1982). Fla. Stat. § 766.101(5) (2014). Mich. Comp. Laws Ann. § 450.2541. See Reserve Life Ins. Co. v. Salter, 152 F. Supp. 868 (S.D. Miss. 1957). State statutes may specify the items on which directors or trustees may rely in discharging their duties. For example, the Michigan statute (supra note 7) does so by saying that a director or officer is entitled to rely on information, opinions, reports, or statements, including financial statements and other financial data, if prepared or presented by any of the following: (a) One or more directors, officers, or employees of the corporation, or of a domestic or foreign corporation or a business organization under joint control or common control, whom the director or officer reasonably believes to be reliable and competent in the matters presented. (b) Legal counsel, public accountants, engineers, or other persons as to matters the director or officer reasonably believes are within the person’s professional or expert competence. (c) A committee of the board of which he or she is not a member if the director or officer reasonably believes that the committee merits confidence. 02/01/23 1:56 PM 148 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 15. See Epworth Orphanage v. Long, 207 S.C 384, 36 S.E.2d 37 (1945). 16. With respect to the duty of loyalty, see Patient Care Services, S.C. v. Segal, 32 Ill. App. 3d 1021, 337 N.E.2d 471 (1975). A corporate officer and director who actively engaged in a rival and competing business to the detriment of a corporation must answer to the corporation for injury sustained. The defendant physician was an officer and director of the professional service corporation bringing the charge. He had established another professional service corporation to perform identical medical planning services for a hospital client, thereby attempting to seize an opportunity due the plaintiff corporation. 17. In Gilbert v. McLeod Infirmary (219 S.C. 174, 64 S.E.2d 524 [1951]), the sale of hospital property to a corporation controlled by Mr. Aiken, a hospital trustee, was voided even though there was no actual fraud and in spite of the fact that Aiken had refrained from discussing the matter and had not voted on the transaction. However, the attorney for Aiken, who was also a trustee of the board, had favorably discussed the sale and voted in favor of the proposal. Moreover, Aiken had failed to carry his burden of proof to show fair and adequate consideration for the sale of the property. 18. See, e.g., Wyo. Stat. Ann. § 17-6-104 (1977), and Md. HealthGeneral Code Ann. § 19-220 (1982). 19. Queen of Angels Hospital v. Younger, 66 Cal. App. 3d 359, 136 Cal. Rptr. 36 (1977). 20. In the Matter of Manhattan Eye, Ear Throat Hospital, 186 Misc. 2d 126 (N.Y. Sup. Ct. 1999). 21. See generally, 30 C.J.S., Employer-Employee Relationships. Two relevant texts from Health Administration Press are Carla Jackie Sampson & Bruce Fried, Human Resources in Healthcare: Managing for Success (5th ed. 2021), and Rita Numerof & Michael Abrams, Employee Retention: Solving the Healthcare Crisis (2003). 22. W. Fletcher, Cyclopedia of the Law of Private Corporations § 41 (perm. ed. 1983). 23. See, e.g., Lowendahl v. Baltimore & Ohio R.R., 247 A.D. 144, 287 N.Y.S. 62, aff’d, 272 N.Y. 360, 6 N.E.2d 56 (1936). 24. J. J. McCaskill Co. v. United States, 216 U.S. 504, 515 (1910). 25. “In a sense, faithfulness to these [corporate] formalities is the price paid for the corporate fiction, a relatively small price to pay for limited liability.” Labadie Coal Co. v. Black, 672 F.2d 92, 97 (D.C. Cir. 1982). 26. See Jabczenski v. Southern Pac. Memorial Hosp., 119 Ariz. 15, 579 P.2d 53 (1978) (mere existence of interlocking directorates between CH03.indd 148 02/01/23 1:56 PM Ch ap t er 3 : T h e O rg a n i z a ti o n a n d M a n a gem ent of a C or p orate H ealthc are Institution 27. 28. 29. 30. 31. 32. 33. CH03.indd 149 149 a not-for-profit and a for-profit corporation was insufficient to justify disregarding the corporate identities). United States v. Healthwin-Midtown Convalescent Hospital, 511 F. Supp. 416 (1981), aff’d, 685 F.2d 448 (1982). American Hospital Association, AHA Guide to the Health Care Field at B2 (Health Forum Publishing 2009). See generally, Harry G. Henn & John R. Alexander, Laws of Corporations and other Business Enterprises § 346 (West 1983). For a history of total healthcare spending in the United States dating back to 1960, see National Health Expenditure Data: Historical, Ctrs. Medicare & Medicaid Serv. (modified Dec. 1, 2021), https://www. cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trendsand-Reports/NationalHealthExpendData [https://perma.cc/ YQ3H-JU6N]. See, e.g., Debra Beaulieu-Volk, MGMA Physician Placement Report: 65 Percent of Established Physicians Placed in Hospital-Owned Practices (June 4, 2010 03:07 AM), https://www.fiercehealthcare.com/ practices/mgma-physician-placement-report-65-percent-establishedphysicians-placed-hospital-owned [https://perma.cc/XML9-UMXW]. Fast Facts: U.S. Health Systems 2021 Infographic, Am. Hosp. Assn., https://www.aha.org/infographics/2021-01-15-fast-facts-us-healthsystems-infographic [https://perma.cc/4CY6-BJ6W] (last visited May 16, 2022). See, e.g., Traci Prevost et al., The Potential for Rapid Consolidation of Health Systems, Deloit Insights (Dec. 10, 2020), https://www2. deloitte.com/us/en/insights/industry/health-care/hospital-mergersacquisition-trends.html [https://perma.cc/DA6Y-QF97] (last visited May 16, 2022). 02/01/23 1:56 PM CH03.indd 150 02/01/23 1:56 PM CHAPTER HUMAN RESOURCES LAW 4 After reading this chapter, you will • understand how employment and labor law affect healthcare organizations; • identify the major antidiscrimination in employment statutes and case law principles; • appreciate some of the legal issues involved in vaccine mandates for healthcare workers; • recognize the most significant areas of contention; and • know when to consult employment law experts. Introduction As noted in chapter 3, most healthcare organizations are corporations, and corporations are “artificial persons.” As such, corporations per se can do nothing; they function only through real human beings. Given the laborintensive nature of healthcare, the variety of human personalities, and the infinite number of ways in which people work and interact, it is no wonder that managers spend large portions of their workdays dealing with human resources (HR) issues such as recruitment, goal setting, training and development, performance appraisal, discipline, dispute resolution, or termination. These issues and the laws that concern them are so pervasive that HR degree programs are available from many universities, and employment law is typically a full course in those curricula. In healthcare programs—master of health administration (MHA) or master of public health (MPH) programs, for example—the subject is taught either as a stand-alone course or under the general healthcare law rubric. In any event, employment law must be covered in some significant way for these university programs to gain certification from their accrediting bodies.1 This chapter cannot provide the depth of knowledge available in a semester-long course or, obviously, an HR degree program. It will, however, highlight the major topics and give the reader an appreciation for when to seek the advice of HR professionals and attorneys who specialize in the subject matter. 151 CH04.indd 151 02/01/23 1:57 PM 152 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Who Is an Employee? workforce The labor pool working or available to work in a nation, industry, company, etc. The primary purpose of the HR function is to manage the flow of personnel into, within, and out of the workforce. The first issue, then, is to identify who qualifies as an employee. Not all the individuals who work for the organization are employees—for example, some are volunteers, and others are independent contractors. Management must ensure that all members of the workforce are classified correctly. Why Is This Important? employee An individual who, in return for remuneration, performs services for another individual or for a company under circumstances in which that other party can control what work will be done and how it will be done. CH04.indd 152 Some companies believe that classifying workers as independent contractors will save them money and promote workforce flexibility. The point of view is shortsighted, and frequently it exposes a company to significant financial risk. Correct worker classification is important because, among other things, it determines whether the individual is entitled to benefits such as insurance, pension, paid leave, and (in the case of hourly workers) overtime pay. It also determines whether the employer must withhold income taxes, pay unemployment taxes, and pay Federal Insurance Contributions Act (FICA) (Social Security and Medicare) taxes. Businesses normally do not have to withhold or pay taxes on payments made to independent contractors; those individuals do not receive employment benefits, and they are subject to self-employment tax on their earnings. Misclassifying as an independent contractor someone who is properly an employee could make the company liable for back taxes and for penalties under federal and state wage and hours laws. The state and federal agents who investigate these kinds of cases often uncover many violations over a period of years, and the financial impact can be heavy. Finally, proper classification may have implications for tort liability because an employee is an agent of the employer, and—as will be seen in later chapters—an agent’s negligence, if committed within the scope of employment, will typically be justification for holding the employer liable. Although the employer’s classification decision would not determine the outcome of a tort case, it could be used as evidence if agency were an issue. For all these reasons, worker classification is critically important. Understanding that fact, the HR department must then properly apply the criteria for making the determination. Distinction Between Employees and Contractors As described by the Internal Revenue Service (IRS), an employee is “anyone who performs services for you . . . if you can control what will be done and how it will be done. This is so even when you give the employee freedom of action. What matters is that you have the right to control the details of how the services are performed.”2 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw Independent contractors, on the other hand, are workers such as accountants, attorneys, physicians with admitting privileges, and building contractors, who are in their own trade or profession but offer their services to others. The general rule is that an individual is an independent contractor if the one who pays for the work has the right to control or direct only the end result of the work and not the details of how it will be done. While it is relatively simple to state, this common-law “control of details” standard for determining who is an employee can be difficult to apply. As the US Supreme Court has stated, “Few problems in the law have given greater variety of application and conflict in results than the cases arising in the borderland between what is clearly an employer–employee relationship and what is clearly one of independent [contractor].”3 The IRS lists 20 factors as an aid to determining whether an individual is an employee or an independent contractor.4 These include such items as who gives instructions and training to the worker, whether the functions are part of the company’s regular activities, whether the worker must perform the work personally, who sets the hours and work schedule, and who provides the tools and materials used. Businesses must weigh all these factors when determining whether a worker is an employee or an independent contractor. The key is to look at the entire relationship, consider the degree or extent of the right to direct and control, and document each of the factors used in coming up with the determination. To complicate matters, some workers have more than one employer at a time. In healthcare, this situation can arise when temporary employees— such as traveling nurses—are supplied by outside agencies. In a Missouri case, for example, a federal appeals court held that nurses from a staffing agency who were assigned to work at a prison could bring sexual harassment charges against both the temp agency and the state department of corrections. In its opinion, the court underscored the difficulty inherent in these decisions: 153 independent contractor A person who agrees with another to perform work according to their own processes and methods and is not subject to the other’s control except for the delivery of outcomes specified in the contract. Determining whether a party is an employee or an independent contractor . . . requires a fact-intensive consideration of “‘all aspects of the working relationship’ between the parties” [quoting a separate case]. Moreover, while the right to control the manner and means by which tasks are accomplished is a primary consideration, no single factor is decisive. . . . [N]othing in the law precludes the possibility that a person may have two or more employers for the same work. In the present case, the undisputed fact that plaintiffs were employed by [the agency] for the work they were doing at [the prison] was a factor to be considered by the district court in assessing plaintiffs’ employment status vis-a-vis DOC [the department of corrections], but it was not the decisive factor.5 CH04.indd 153 02/01/23 1:57 PM 154 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Types of Employment and Workforce Arrangements Private healthcare organizations’ employees may have written employment contracts, or they may be employed at will. Government employees are a distinct category protected by the due process of law principles. Whether the employer is a public or private entity, the workforce member may or may not be represented by a union. The following sections outline the terms of the different types of employment and their legal relationships. Contracts of Employment employment at will An arrangement in which an employer can fire an employee at any time for any reason (or no reason), except an illegal reason, without incurring legal liability. Conversely, an employee in this situation is free to leave the job at any time for any reason (or no reason) without incurring legal liability. Professionals and top-level management employees sometimes have written contracts with their employers. These agreements typically describe the rights and responsibilities of both parties, the individual’s salary and benefits, the duration of employment, the grounds for possible termination, and so on. They may also include confidentiality and nondisclosure provisions, noncompete clauses (discussed more thoroughly in chapter 5), agreement on severance (called golden parachute) payments in the event of unanticipated termination, and other requirements. Employment contracts are the exception rather than the rule in healthcare and most nonunion businesses. Employment at Will Most people are hired into their jobs without signing employment contracts. This arrangement is called employment at will—a common-law rule that the relationship is for an indefinite period and can be terminated by either the employer or the employee at any time for any reason (see Legal Brief). Because of the harshness of this concept, it is relatively common for terminated employees to claim that their employer waived employmentat-will status through failure to follow the terms of the employee handbook or Legal Brief company policies or by deviating from past practice. In other words, the former employee claims that there is an implicit Employment at will is the “black letter” rule of law understanding that the employer would in every state save one: Montana has abrogated the employment-at-will doctrine by statute. Monact in good faith and that failure to do so tana law states that employees may be terminated creates an exception to the employmentonly for “good cause,” which is defined as “reaat-will concept. sonable job-related grounds for dismissal based For example, after Charles Touson a failure to satisfactorily perform job duties, saint was let go from his job at Blue disruption of the employer’s operation, or other Cross and Blue Shield of Michigan in the legitimate business reason” (Mont. Code Ann. § 39-2-903(5); see also Mont. Code Ann. § 39-2-904). mid-1970s, he filed suit claiming wrongful termination and breach of an implied CH04.indd 154 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 155 contract. He testified that he had inquired about job security when he was hired and Law in Action was told that he would be with the company “as long as I did my job.” To reinforce It can be difficult to decide whether to defend this oral assurance, Toussaint was given the against a case claiming waiver of employmentBlue Cross personnel policy manual, which at-will or to settle out of court. Litigation is stated that it was company policy to release ­expensive, time-consuming, and disruptive of employees “for just cause only.” operations; the outcome is always uncertain; and The Michigan Supreme Court held a bad result may set an unfortunate precedent. that given facts such as these, “a fair conSettlements can often be reached more quickly and at less than the cost of defense, and the struction is that the employer has given up terms can be kept confidential. On the other hand, 6 his right to discharge at will.” It added a favorable result at trial can send a strong mesthat if Blue Cross had desired, it could sage to other employees that employment-at-will have required prospective employees to is alive and well in the company. These decisions acknowledge that they served at the will should be made with the advice of experienced or the pleasure of the company and thus employment lawyers. could have avoided the misunderstandings that generated the lawsuit. Because it did not have such an acknowledgment, the employee handbook created a binding contract. (More about contracts in general is revealed in chapter 5.) Because of cases such as this, in which a terminated employee claims the company waived the employment-at-will status, many companies now do as the Michigan court hinted and require employees to acknowledge in writing that personnel policies do not constitute a contract, that the policies can be amended at any time, and that the employees can be terminated at will (see Law in Action). Government Employees A third category of employment seen in the healthcare field relates to government employees, whose jobs are protected by two important constitutional principles: due process and equal protection. Under the Fifth and Fourteenth Amendments to the US Constitution, government cannot take actions that deprive a person of “life, liberty or property without due process of law” or deny them “the equal protection of the laws.” Activities undertaken on behalf of government are called state action, and the persons or organizations undertaking them are called state actors. State actors include government agencies, government-owned corporations, and individuals employed by the state. Others who have only an indirect relationship with the state but whose actions have some degree of state authority may also be state actors. Clearly, a state-, county-, or city-owned hospital is a state actor, as are its employees and agents. A private corporation that operates a state-owned facility under contract may also be engaged in state action. CH04.indd 155 equal protection The requirement that persons who are in similar situations be treated equally, without irrelevant distinctions, by government. state action Conduct undertaken on behalf of a government body. 02/01/23 1:57 PM 156 T h e L aw o f H e a l th c a re A d mi n i stra ti o n In sum, constitutional protections apply to employees of governmental orgaLegal Brief nizations such as hospitals or clinics run by the Department of Veterans Affairs, In Baldetta v. Harborview Medical Center, the Indian Health Service, or armed forces, concept of state action was implicated when the or by a state, city, county, or tax district plaintiff sued a county hospital where he had (see Legal Brief). Employees of those been employed as a nursing aide.7 He alleged that organizations have a property interest in his forearm tattoo of the words “HIV-Positive” their jobs, and thus they cannot be termiwas protected speech under the First Amendment and that the hospital acted unlawfully when it nated without being given due process: terminated him for refusing to cover it. The court fair notice and an opportunity to defend found in the hospital’s favor because the hospithemselves. tal’s interests in facilitating its patients’ recovery The constitutional principles of outweighed Baldetta’s interest in displaying the due process and equal protection do not tattoo, but the constitutional argument had to be apply to private employment because addressed because Harborview is a governmentowned facility. no state action is implicated. Nevertheless, providing basic fairness is good HR practice and has become the hallmark of all enlightened HR systems. A California case characterized this standard as requiring “good cause” for termination, for example: We give operative meaning to the term “good cause” in the context of implied employment contracts by defining it . . . as fair and honest reasons, regulated by good faith on the part of the employer, that are not trivial, arbitrary or capricious, unrelated to business needs or goals, or pretextual. A reasoned conclusion, in short, supported by substantial evidence gathered through an adequate investigation that includes notice of the claimed misconduct and a chance for the employee to respond. . . . [T]he common law requirement of a fair procedure does not compel formal proceedings with all the embellishments of a court trial, nor adherence to a single mode of process. It may be satisfied by any one of a variety of procedures which afford a fair opportunity for an applicant to present his position.8 Thus, good faith and fair dealing—like most common-law doctrines—are malleable concepts that can vary with the circumstances of each individual case. Furthermore, interpretation of the principle may vary from state to state. It is important to seek experienced counsel when there are questions about the proper classification of workers. Other Worker Categories Two other categories of workers—statutory employees and statutory nonemployees—are possible under IRS regulations. CH04.indd 156 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 157 Statutory employees are individuals who would be considered independent contractors under common-law rules but are employees for purposes of withholding FICA taxes. Examples include certain drivers who deliver food and pick up and deliver laundry, full-time life insurance sales agents, persons who work at home on materials or goods supplied by the employer, and fulltime traveling salespersons. However, other conditions apply as well. Statutory nonemployees include direct sellers, licensed real estate agents, and certain companion sitters (i.e., persons who furnish personal attendance, companionship, or household care services to children or to individuals who are elderly or disabled). These “nonemployees” are treated as self-employed for federal tax purposes. Statutory employees and statutory nonemployees are rarely seen working for a healthcare organization, but they are mentioned here for the sake of thoroughness.9 Other Members of the Workforce Everyone working or available to work in an organization is considered a member of the workforce, including numerous individuals who are not technically employees. For example, volunteers are members of the workforce but, as the terms implies, they are not employees and do not receive wages and benefits. They are, nevertheless, subject to many HR policies and other rules of the organization. Independent contractors (discussed a few pages earlier) are likewise not on the hospital payroll but are members of the workforce to the extent that they are performing their contracted responsibilities. These include, for example, locum tenens (temporary) physicians and nurses or temporary IT personnel. These individuals, although not hospital employees, are nevertheless expected to comply with generally applicable policies such as those ­relating to smoking, safety, or respect for patient privacy. Independent contractors typically sign a written agreement specifying that because they are not employees, the hiring company is not responsible for providing them with benefits such as tax withholding, workers compensation, or health insurance. The Joint Employer Concept Complicating matters even further, it is sometimes possible for an individual to have more than one employment relationship at the same time for the same job. This can be the case when a hospital contracts with an agency to provide the kinds of temporary services needed to make up for staff shortages. In the view of the US Equal Employment Opportunity Commission (EEOC), the National Labor Relations Board (NLRB), and some state courts, these individuals may be employees of both the hospital and the staffing agency, thus both organizations would be liable for the individuals’ torts, and both may be responsible for ensuring compliance with wage and hour CH04.indd 157 02/01/23 1:57 PM 158 T h e L aw o f H e a l th c a re A d mi n i stra ti o n laws, the Family and Medical Leave Act (FMLA), hiring and termination procedures, labor laws, and other requirements.10 A finding of joint employer status will be made if the putative joint employers exercise “direct and immediate” control over the essential terms of employment. This conclusion turns, obviously, on the facts of each specific case. Healthcare leaders, especially HR executives, must therefore take heed when using staffing agencies. They should ensure that both the hospital and the agency are compliant with all applicable laws and regulations and that “travelers” are accorded the same protections as full-time employees. Nondiscrimination Statutes The law is never static; it evolves as society changes. Thus, “due process” and “implied contract” now stand as exceptions to the rather harsh employmentat-will doctrine. Additional limitations on an employer’s freedom to terminate workers arbitrarily are also in place. Those limitations take the form of antidiscrimination statutes, as the following pages demonstrate. Civil Rights Acts of 1866 and 1964 Law in Action In addition to Title VII’s ban on discrimination by employers, Title VI of the 1964 Civil Rights Act prohibits discrimination on the grounds of race, color, or national origin “by any program or activity receiving federal financial assistance” (42 U.S.C. § 2000d). When the Medicare and Medicaid programs were enacted the following year, Title VI made it illegal for hospitals to receive federal funding while continuing to discriminate on the basis of race in their staffing, privileging, or patient populations. For a fascinating description of how the struggle to eliminate segregated hospitals became a major victory in the movement to end segregation nationwide, see David B. Smith, The Power to Heal: Civil Rights, Medicare, and the Struggle to Transform America’s Health Care System (2016) and the documentary based on it, The Power to Heal: Medicare and the Civil Rights Revolution (Bullfrog Films 2019). See also The Court Decides: Simkins v. Moses H. Cone Memorial Hospital in chapter 1. CH04.indd 158 The Civil Rights Act of 1866 was the first federal legislation in this field. Intended to implement the Thirteenth Amendment’s prohibition of slavery, the law is used today mainly to address racial discrimination in housing. The most sweeping of all antidiscrimination statutes is the Civil Rights Act of 1964.11 Title VII of this federal law makes it unlawful for an employer to discriminate against an employee or applicant “because of such individual’s race, color, religion, sex, or national origin.” It provides equal access to training and prohibits sexual harassment, discrimination based on pregnancy, and retaliation against employees who oppose discrimination. These and other federal civil rights laws discussed in the following sections are enforced by the EEOC.12 Employees may also bring lawsuits alleging violation of these laws (and state antidiscrimination 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 159 laws). Note that, as a general matter, these laws apply most clearly to acts of individualized discrimination; they are less suited to address instances of systemic discrimination. Age Discrimination The Age Discrimination in Employment Act of 1967 (ADEA) forbids discrimination (treating someone less favorably) because of age if the individual is age 40 or older.13 The law applies to any employer with 20 or more employees, and although it does not protect workers under the age of 40, some states have laws that protect younger workers. The ADEA prohibits discrimination because of age in any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, benefits, and any other term or condition of employment. An employment policy or practice that applies to everyone, regardless of age, can still be illegal if it has a disparate and negative impact on persons age 40 or older and is not based on “reasonable factors other than age” (abbreviated RFOA).14 According to EEOC regulations, A reasonable factor other than age is a non-age factor that is objectively reasonable when viewed from the position of a prudent employer mindful of its responsibilities under the ADEA under similar circumstances. Whether a differentiation is based on reasonable factors other than age must be decided on the basis of all the particular facts and circumstances surrounding each individual situation. To establish the RFOA defense, an employer must show that the employment practice was both reasonably designed to further or achieve a legitimate business purpose and [was] administered in a way that reasonably achieves that purpose.15 Disability Discrimination The Americans with Disabilities Act (ADA) of 1990 prohibits private employers, state and local governments, employment agencies, and labor unions from discriminating against qualified individuals with disabilities in hiring, firing, advancement, compensation, training, and other aspects of their employment.16 The law covers employers with 15 or more employees, including state and local governments. (A separate statute—the Rehabilitation Act of 1973—provides the same protections for federal employees, programs receiving federal money, and federal contractors.) Healthcare is one of the largest segments of the American economy, and it has a high incidence of occupational injury and illness resulting from its significant workplace hazards. Healthcare jobs often involve potential exposure to airborne and blood-borne infectious diseases, sharps injuries, and other dangers. Many healthcare jobs can also be physically demanding CH04.indd 159 02/01/23 1:57 PM 160 T h e L aw o f H e a l th c a re A d mi n i stra ti o n and mentally stressful, and healthcare workers with illness or injury—whether occupational or nonoccupational—face unique challenges because of the societal misperception that they should be free from physical or mental impairment.17 For example, Gillen v. Fallon Ambulance Service, Inc., stands for the proposition that “the ADA prohibits employment decisions based on stereotypes about a disability, but it does not prohibit decisionmaking based on the actual attributes of a disability.”18 In that case, Kelly Gillen, an applicant for a position as an emergency medical technician (EMT), was born without a left hand, and she appealed a summary judgment upholding an ambulance company’s refusal to hire her. Gillen had completed a preparatory course and passed the Massachusetts EMT certification examination—an examination composed of both written and practical portions. Nevertheless, the company decided not to employ her because the physician who conducted her preemployment physical concluded that she could not perform certain essential functions of the job: lifting gurneys, grasping and stabilizing patients, and so on. The trial court judge granted the company’s motion for summary judgment, thus dismissing the case without a full hearing. After lengthy analysis of the law, the court of appeals remanded the case for further proceedings to determine whether the ambulance company “acted on an illegal stereotype as opposed to an adequate assessment of the appellant’s capabilities.” Whether Gillen’s impairment was in fact disabling, whether she was qualified for the position at the time that she applied, and whether the ambulance service discriminated against her on the basis of an illegal stereotype—according to the court, all these questions were “genuine issues of material fact” that justified a trial on the merits and an opportunity for Gillen to prove her abilities. For purposes of the ADA, a person with a disability is someone who (a) has a physical or mental impairment that substantially limits one or more major life activities; (b) has a record of such an impairment; or (c) is regarded as having such an impairment. One case discussed the third aspect of this definition in particular, saying, Congress was concerned about eliminating society’s myths, fears, stereotypes, and prejudices with respect to the disabled, [and] the EEOC’s Regulations and Interpretive Guidance make clear that even an innocent misperception based on nothing more than a simple mistake of fact as to the severity, or even the very existence, of an individual’s impairment can be sufficient to satisfy the statutory definition of a perceived disability.19 Employers are required to make a “reasonable accommodation” for a qualified applicant or employee with a disability unless an undue hardship on CH04.indd 160 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 161 the employer’s business would result.20 Reasonable accommodations include such things as making facilities accessible to the individual, modifying their work schedule, acquiring modified equipment or devices, and providing qualified interpreters. For example, the ability to do heavy lifting is sometimes an issue for nurses. If lifting is an essential element of the job and the inability to perform that task results from a disability, reasonable accommodation—such as assigning “light duty”—would be required. In a case in Ohio, a nurse who was being treated for osteoarthritis in both knees and had also suffered a fractured femur was returning to work after a six-month leave of absence. Upon her return, she was unable to perform normal bedside nursing, but the hospital attempted to make an accommodation for her disability by considering her for positions that were not physically strenuous. She declined one such accommodation because the salary was too low, and she was not chosen for the other positions for a variety of legitimate reasons. The nurse eventually accepted a temporary assignment in the admissions department, but she filed suit alleging violations of the ADA in not hiring her for the other positions. The trial court found in favor of the hospital, and the nurse appealed. The US Court of Appeals for the Sixth Circuit affirmed the judgment of the district court, and its decision summarized well the applicable law of accommodation: [T]o satisfy its duty under the ADA, an employer is only required to transfer an employee to a position comparable to the employee’s prior position. . . . The ADA does not require an employer to offer an employee a promotion as a reasonable accommodation, and “an employee cannot make his employer provide a specific accommodation if another reasonable accommodation is instead provided.” In fact, where a comparable position is not vacant, an employer’s obligation to reassign an employee may include an assignment to a position with a lower grade of pay if the employee meets the job’s qualifications. Finally, the regulations indicate that, although an employee is not required to accept an offered accommodation, if an individual rejects a reasonable accommodation, the individual will no longer be considered a qualified individual with a disability.21 Application and Interview Questions The ADA also provides that employers may not ask job applicants about the existence or nature of a disability, but applicants may be asked about their ability to perform specific job functions. A job offer may be conditioned on the results of a medical examination if the examination is required for all entering employees in similar jobs, is job related, and is consistent with the employer’s business needs. CH04.indd 161 02/01/23 1:57 PM 162 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Legality of Marijuana Use of medical marijuana (cannabis) in one form or another is now legal in nearly every state and the District of Columbia (DC), and marijuana’s recreational (nonmedical) use is legal in DC and at least 13 states. In addition, some local ordinances have decriminalized minor cannabis offenses notwithstanding contrary state law. Despite its growing social and legal acceptability, marijuana—along with LSD, heroin, opium, oxycodone, and other far more dangerous substances—remains a Schedule I drug under the federal Controlled Substances Act (21 U.S.C. §§ 801 et seq.). To be sure, employers can create rules prohibiting marijuana use while an employee is working. But restricting an employee’s marijuana use outside of work presents serious issues for HR policy and clinical practice, and the implications must be given careful consideration. Tests for illegal drugs are not subject to the ADA’s restrictions on medical examinations. Employees and applicants engaging in the illegal use of drugs are not covered by the ADA when an employer acts on the basis of such use. Employers may hold illegal drug users and alcoholics to the same performance standards as other employees (see Legality of Marijuana). Equal Pay and Compensation An employee’s right to be free from discrimination in compensation is protected by several federal laws, including the Equal Pay Act of 1963,22 part of the Fair Labor Standards Act (FLSA),23 and the Lilly Ledbetter Fair Pay Act of 2009.24 Taken together with the Civil Rights Act of 1964, these laws prohibit sex-based wage discrimination between men and women in the same establishment who perform jobs that require substantially equal skill, effort, and responsibility under similar working conditions. Pay differentials are permitted, however, when they are based on seniority, merit, quantity or quality of production, or factors other than sex. The differentials are “affirmative defenses,” and it is the employer’s burden to prove that they apply. When a prohibited pay differential is found, no employee’s pay may be reduced; instead, the pay of the lower-paid employee (or employees) must be increased. National Origin National origin discrimination is addressed in the Immigration Reform and Control Act of 1986.25 Under the law, it is an unfair employment practice to discriminate against a US citizen or documented resident with respect to hiring or recruitment because of the person’s national origin or citizenship status. This includes treating someone unfavorably because they are from a particular country or part of the world, because of ethnicity or accent, or because they appear to be of a certain ethnic background, even if they are not. National origin discrimination can also involve treating people unfavorably because they are married to or associated with a person of a certain national origin. Discrimination can occur even when the victim and the person who inflicted the discrimination are of the same national origin. CH04.indd 162 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 163 Race or Color The 1964 Civil Rights Act also prohibits Legal Brief racial discrimination—treating someone unfavorably because they are of a certain Although the Civil Rights Act prohibits racial race or because of personal characteristics discrimination in hiring, the US Supreme Court associated with race such as hair texture, has held that it does not always prohibit private skin color, or certain facial features. Color employers from instituting racial affirmative action discrimination involves treating someone programs. The court has specified, however, that unfavorably because of skin color or comsuch plans must be temporary and intended “to eliminate conspicuous racial imbalance in tradiplexion. Race and color discrimination tionally segregated job categories” (United Steelalso can involve treating someone unfaworkers of America, AFL-CIO-CLC v. Weber, 443 vorably because the person is married to U.S. 193, 209 [1979]). If a healthcare organization or associated with a person of a certain wishes to diversify its workforce through a volunrace or color. tary affirmative action program, it is important to The law forbids such discriminaconsult with a skilled lawyer to avoid unintentionally running afoul of antidiscrimination laws and tion when it comes to any aspect of being subject to allegations of “reverse discriminaemployment, including hiring, firing, tion” by members of a majority group. pay, job assignments, promotions, layoffs, training, fringe benefits, and any other term or condition of employment. It also prohibits harassment of someone because of race or color. Harassment can include, for example, racial slurs, offensive or derogatory remarks about a person’s race or color, or the display of racially offensive symbols. Although the law does not prohibit simple teasing, offhand comments, or isolated incidents that are not serious, harassment is illegal when it is so frequent or severe that it creates a hostile or offensive work environment or when it results in an adverse employment decision (e.g., the victim being fired or demoted). Even when conduct does not rise to the level of illegality, it may be viewed differently in a civil case and could result in severe tort liability for the employer. Religion Title VII of the Civil Rights Act also protects people from discrimination based on religion. The term religion “includes all aspects of religious observance and practice, as well as belief, unless an employer demonstrates that it is unable to reasonably accommodate [a person’s] religious observance or practice without undue hardship on the conduct of the employer’s business.”26 The law protects not only people who belong to traditional organized religions, such as Buddhism, Christianity, Hinduism, Islam, and Judaism, but also others who have sincerely held religious, ethical, or moral beliefs. Religious discrimination can also involve treating someone differently because that person is married to or associated with an individual of a particular religion. CH04.indd 163 02/01/23 1:57 PM 164 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The United States has a long history of protecting individuals’ and entities’ Law in Action religious beliefs and moral scruples, and numerous federal “freedom of conscience” In 2019, the US Department of Health and Human laws apply to the healthcare field. These Services issued revised regulations meant to include, for example, conscience protec“ensure vigorous enforcement of Federal contions related to persons who refuse to science and antidiscrimination laws applicable to participate in abortion, sterilization, or the Department, its programs, and recipients of certain end-of-life services. Although it is HHS funds.” These provisions (45 C.F.R. pt. 88) commendable to respect others’ religious reinforce an individual or corporate healthcare provider’s right to refuse to participate in services and moral convictions, doing so can pre­ that are contrary to their own religious and ethisent stunningly complex issues when those cal views. Some groups praised the regulations, beliefs conflict with a patient’s need for but numerous commentators warned that they services. Some of these issues are discussed amount to a broad license to discriminate under in later chapters, but they are worth menthe guise of religious freedom against women; tioning here because of the dilemmas they lesbian, gay, bisexual, transgender, and queer (LGBTQ) patients; and other vulnerable populapresent to management personnel (see tions. Legal challenges to these and similar conLaw in Action). science protections, and calls to statutorily revise The subject teems with HR-related them, are sure to continue, raising difficult issues issues. Can employees whose beliefs confor healthcare providers. flict with those of the institution where they practice be terminated or disciplined for refusal to cooperate in services they deem ethically objectionable? Conversely, can the organization prevent them from providing services that it opposes but that the patient needs and requests? Furthermore, when labor unions are involved, are these issues subject to collective bargaining as a “term or condition of employment”? These “conscience protections” will be a source of ongoing friction for some time to come, especially given the multiplicity of laws and waves of litigation that are expected in the wake of the US Supreme Court’s abrogation of abortion rights in its 2022 decision in Dobbs v. Jackson Women’s Health Organization (see chapter 15). Sex and Sexual Harassment It is unlawful to discriminate against or harass someone because of their sex. Harassment can include unwelcome sexual advances, requests for sexual favors, and other verbal or physical harassment of a sexual nature. Prohibited harassment can also include offensive remarks about a person’s sex or about the opposite sex in general, or the creation of a hostile work environment even without economic loss to the employee.27 Both the victim and the harasser can be a person of any gender, and the victim and harasser can be the same sex. The harasser can be the victim’s CH04.indd 164 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 165 supervisor, a supervisor in another area, a coworker, or someone who is not an employee of the employer, such as a client or customer. The harasser is often someone in a position of power or authority over the individual, and thus these cases are particularly problematic from an HR perspective due to the potential for retaliation and quid pro quo issues. As with racial harassment, the law does not prohibit simple teasing or other isolated incidents that are not serious, but harassment is illegal when it is so frequent or severe that it creates a hostile or offensive work environment. Such an environment occurs, for example, when there are frequent or pervasive unwanted sexual comments, advances, requests, or other similar conduct. It can also occur when there is other verbal or physical conduct that is sexual in nature. This conduct might include displays of inappropriate or offensive materials; sexual jokes; interference with someone’s ability to move freely; and persistent, unwanted interactions, such as inappropriate touching (groping) or continually asking for dates. Sexual harassment also occurs when a quid pro quo is involved—that is, when some type of employment benefit is made contingent on sexual favors or some negative consequences result from refusal of sexual advances. Even a single incident of quid pro quo sexual harassment is illegal and can be grounds for a lawsuit. The well-known public allegations of sexual harassment against corporate executives, actors, politicians, judicial nominees, and others in recent years make sexual harassment an especially serious concern for all management personnel. Along with other forms of harassment, discrimination against employees based on their gender identity, transgender status, or sexual orientation has gained greater visibility in recent years. In 2020, the US Supreme Court held that the prohibition on employment discrimination based on sex (Title VII of the Civil Rights Act) includes discrimination based on sexual orientation or transgender status. In the unambiguous words of Justice Neil ­Gorsuch, “An employer who fires an individual merely for being gay or transgender [violates] the law.”28 Pregnancy Discrimination on the basis of pregnancy is prohibited by a 1978 amendment to Title VII that expanded the definition of “sex” to include “pregnancy, childbirth, and related medical conditions.”29 Thus, for the purposes of employment, pregnant employees must be treated in the same manner as nonpregnant employees with similar limitations on their ability to work. Unless there is undue hardship to the employer’s business, reasonable accommodations—such as light duty, alternative assignments, disability leave, or family leave after the child is born—must be made for pregnancy if the CH04.indd 165 02/01/23 1:57 PM 166 T h e L aw o f H e a l th c a re A d mi n i stra ti o n same would be offered to employees who are not pregnant. What amounts to a reasonable accommodation or an undue hardship to the business is, of course, open to interpretation. Genetic Information The Genetic Information Nondiscrimination Act of 2008 prohibits health plans and health insurers from denying coverage to healthy individuals or charging them higher premiums based solely on a genetic predisposition to developing a disease in the future. It also bars employers from using individuals’ genetic information when making employment-related decisions.30 Retaliation and Whistleblower Protections According to the EEOC, retaliation is the most frequently alleged basis of discrimination in the federal sector and the most common discrimination finding in federal cases.31 A variety of equal employment opportunity laws prohibit punishing job applicants or employees for asserting their rights to be free from employment discrimination. Asserting these rights is called protected activity, and it can take many forms. For example, it is unlawful to retaliate against applicants or employees for any of the following: • Filing an EEO case or acting as a witness • Communicating with a supervisor or manager about employment discrimination • Answering questions during an investigation of alleged harassment • Refusing to follow orders that would result in discrimination • Resisting sexual advances or intervening to protect others • Requesting accommodation of a disability or for a religious practice • Asking managers or coworkers about salary information to uncover potentially discriminatory wages Participating in a complaint process is protected from retaliation under all circumstances. Other acts to oppose discrimination are protected so long as the employee was acting on a reasonable belief that something in the workplace could have violated equal employment laws. Outside the EEOC arena, numerous federal and state statutes protect “whistleblowers”—individuals who disclose information that they reasonably believe shows evidence of a violation of law, abuse of authority, a specific danger to public health and safety, and so on. For example, federal law contains employment protections for people who file claims under the False Claims Act (see chapter 9). CH04.indd 166 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 167 Leaves of Absence Numerous statutes require employers to provide employees with a leave of absence and guaranteed reinstatement to the same or a similar position at the end of the leave, and failure to provide leave as required can be considered a form of discrimination. Among these statutes are the FMLA, the Pregnancy Discrimination Act (PDA) (discussed earlier), and the Uniformed Services Employment and Reemployment Rights Act (USERRA). Family and Medical Leave Act The FMLA requires most employers with 50 or more employees to allow up to 12 weeks of leave (26 weeks for military caregivers) in case of the following: • The employee’s own serious illness or that of their spouse, child, parent, or sibling • Baby bonding (includes bonding with a newborn, newly adopted child, or newly placed foster child) • Military exigency (employee’s family member needs assistance while on active duty or as a result of being called to active duty) • Caregiving for a family service member wounded in the line of duty The FMLA does not require employers to pay employees while on leave, but employees may use accrued paid time off, and, under certain circumstances, employers may require employees to use paid time off. Employers must continue to provide group health insurance while an employee is on FMLA leave. In addition, although FMLA leave for an employee’s own illness is limited to 12 weeks, an employer may be legally required to provide additional leave as a reasonable accommodation under the ADA.32 Uniformed Services Employment and Reemployment Rights Act USERRA protects employees who take leave for military service. USERRA applies to all employers and employees, regardless of number of employees or length of service. It prohibits discrimination against employees based on military service and retaliation for exercising USERRA rights and requires employers to permit employees to take leave for military service for up to a total of five years. As with FMLA, USERRA leave is unpaid, although the employee may use accrued vacation and, if permitted by the employer, paid sick leave. Employers are required to continue group health benefits for employees on USERRA leave. An employee returning from USERRA leave must be reemployed promptly, which under normal circumstances means within two weeks of notification by the employee. (There are limited exceptions to this CH04.indd 167 02/01/23 1:57 PM 168 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Legal Brief Whether an employee’s position is exempt or nonexempt under wage and hour laws determines whether they must be paid overtime. The definition revolves around the individual’s level of responsibility: executive, professional, and management personnel are generally exempt, whereas hourly workers are not. The latter must be paid at least the minimum wage and extra for every hour of overtime; the former receive their salary no matter how long they toil at their jobs. requirement.) USERRA also prohibits employers from terminating a returning employee without cause for a period following reemployment depending on the length of the leave. For employers who pay severance based on the number of years an employee has been with the company, USERRA requires that the time an employee is on military leave must be included in this calculation.33 Other Nondiscrimination Laws Because they are so numerous, space does not permit even a summary treatment of all the other federal, state, and local laws that apply to discrimination in the workplace, but they include the FMLA, the Occupational Safety and Health Act (OSHA), the Civil Service Reform Act of 1978 (CSRA), sections of the Rehabilitation Act, the Social Security Act (SSA), and the Fair Labor Standards Act (FLSA). These laws are enforced by agencies other than the EEOC, and many of them have state or local law equivalents that must also be considered and that might go beyond what federal law requires. For example, the FLSA—which regulates minimum wages, overtime pay, and child labor—operates in conjunction with state laws and is a major focus of HR administration. Wage and hour laws govern the hourly wage rates that an employer pays its “nonexempt” employees (essentially, those who are not in salaried positions) and the hours for which they must be compensated (see Legal Brief). The best known are minimum wage and overtime laws, but there are also laws relating to child labor; meals and breaks; vacation, sick, holiday, and military leave; time off for jury duty; and laws relating to severance. Labor Law In one sense, all laws that affect the employer–employee relationship are “labor laws,” but the term is generally used to mean laws relating to workers’ rights to form unions and engage in collective bargaining. Labor law is governed almost entirely by federal statutes, mainly the National Labor Relations Act (NLRA), which was enacted in 1935 as part of the New Deal legislation under President Franklin D. Roosevelt. Other laws have supplemented the NLRA, as will be summarized, but first a brief history. CH04.indd 168 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 169 Labor Relations During the Industrial Revolution As the manufacturing and transportation industries grew in the United States during the late nineteenth and early twentieth centuries, turmoil began to brew in the relations between labor and management. Workers pressed for better and safer working conditions, and management usually pushed back; strikes, violent clashes, prosecutions, and litigation often ensued. For example, in 1894 a massive strike against railroads—the Pullman strike—involved up to 80,000 workers and led to the violent deaths of as many as 30 strikers. The work stoppage was broken only when the federal government became involved and the army and courts intervened. Even peaceable efforts by workers to improve wages and working conditions were often deemed to be illegal under the law of that time. Thus, labor unions were essentially powerless to confront management on issues relating to the terms and conditions of employment. Many companies even required new hires to sign, as a condition of employment, an agreement not to join a union or take part in union activities. These “yellow-dog contracts” were outlawed by the Norris-LaGuardia Act of 1932, one of the first major labor laws passed by the US Congress.34 Major Labor Relations Laws The National Labor Relations Act of 1935, also known as the Wagner Act after its sponsor, New York senator Robert Wagner, was meant to protect the rights of employees and correct the inequality of bargaining power that previously existed between management and labor. The law guarantees the right of most private sector employees to organize into unions, engage in collective bargaining, and go on strike if necessary (but see Exceptions to the National Labor Relations Act). The law also created the NLRB, which supervises union elections and sets rules for conduct by both unions and management. The NLRA was amended in 1947 by the Labor Management Relations Act (LMRA), popularly known as the Taft-Hartley Act after its sponsors, Senator Robert A. Taft and Representative Fred A. Hartley Jr. Together, the NLRA and the LMRA set forth a set of unfair labor practices for both employers and unions.35 For example, it is an unfair labor Exceptions to the National Labor practice for an employer to do any of the Relations Act following: • Interfere with employees’ rights to unionize, bargain collectively, and engage in other concerted activity • Dominate or interfere with the administration of a labor organization CH04.indd 169 The NLRA does not apply to agricultural employees; domestic employees; supervisors; federal, state, and local government employees; independent contractors; and employees in the railroad and airline industries. These workers are covered by separate statutes. 02/01/23 1:57 PM 170 T h e L aw o f H e a l th c a re A d mi n i stra ti o n secondary boycott An attempt by a union to pressure a neutral company to refuse to do business with the employer with which the union has a dispute. union shop A place of work in which employees are required to belong to a union and new hires can be required to join the union within a certain period. featherbedding Deliberately inefficient work practices that require the employment of excessive numbers of workers. CH04.indd 170 • Encourage or discourage union membership by discrimination in hiring, tenure of employment, or terms and conditions of employment • Discriminate against an employee for union activity • Refuse to bargain collectively with union representatives In addition, it is an unfair labor practice for a union to do any of the following: • Coerce employees when they exercise their right to bargain collectively, choose a representative, or vote against unionization • Cause an employer to discriminate against any employee • Refuse to participate in collective bargaining • Engage in certain secondary boycotts • Require union members in a union shop to pay excessive initiation fees or dues • Engage in featherbedding The labor laws apply to virtually all private employers, including hospitals, whether they are unionized or not. For example, a 2005 case involving a hospital exemplified the prohibition against secondary boycotts. The Sheet Metals Workers International Association local union had a dispute with a construction company that was working on a project at Brandon Regional Medical Center in Florida. To protest the construction firm’s use of nonunion labor, the union staged a mock funeral procession in front of the hospital. The protest involved one union member dressed as the grim reaper and others carrying a coffin back and forth on a sidewalk near the hospital’s main entrance while loudspeakers broadcast somber funeral music. This was disturbing to patients, visitors, and staff, and the hospital sought relief by filing an unfair labor practice complaint. The trial court granted an injunction against the strike, and the union appealed. The US Court of Appeals for the Eleventh Circuit affirmed the injunction and, in so doing, explained that a violation of the secondary boycott prohibition “consists of two elements: (1) a union engages in conduct that threatens, coerces, or restrains an employer or other person engaged in commerce; and (2) an object of the union’s conduct is to force or require an employer or person not to handle the products of, or to do business with, another person.”36 The union conceded that it was trying to pressure the hospital to stop doing business with the construction company, but it argued that its members’ First Amendment right to free speech should prevail. The court disagreed, saying that the union’s activities were more than just expressions of opinion such as can be done by “peaceful handbilling.” Instead, the funeral procession amounted to coercion through secondary picketing, which is not protected by the First Amendment and can 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 171 be enjoined.37 (See appendix 4.1 for a further list of fair and unfair labor practices.) Union Organizing Unionization of a workplace begins with an organizing campaign by employees who want a union to represent them. They ask other employees holding similar jobs to sign “authorization cards”—forms that designate the union to be their representative to bargain with their employer. These activities can be disruptive to normal operations, and employers typically attempt to discourage unionization. Doing so is fraught with danger, however, because numerous types of unfair labor practices can arise as a result (see appendix 4.1). For example, the right to free speech generally extends to employees in the workplace—thus, the NLRA protects employees’ right to wear union insignia and campaign buttons, unless doing so creates a safety hazard or there is a real threat of violence between union supporters and others. The law provides an exception, however, for employees who work with the public and are required to wear a uniform. For example, a hospital that requires employees to wear a uniform and bans pins, buttons, and other insignia except for professional association pins and hospital service awards could lawfully forbid a carpenter from wearing a button promoting union membership. The US Court of Appeals for the Fifth Circuit held that “the interest of the Hospital in promoting the efficiency of the public service it performs by means of its uniform non-adornment policy outweighs the interest of [employees] in wearing a ‘Union Yes’ button on their uniforms while on duty at the Hospital.” There was no evidence that the hospital’s policy was adopted out of “anti-union animus” or that it was enforced unfairly.38 If at least 30 percent of employees in a bargaining unit sign on, the union can request the employer to recognize it voluntarily. Voluntary recognition is rarely granted, however, and in that case, the union may petition the NLRB to supervise an election. If the union prevails, the employer must thereafter recognize the union as the employees’ representative and negotiate a collective bargaining agreement (CBA). A bargaining unit is a group of nonmanagement employees who have similar jobs and a clear set of common interests and who are represented by a single labor union in their dealings with management. In acute care hospitals, there are, by regulation, eight recognized groups of employees that can constitute bargaining units:39 1. 2. 3. 4. CH04.indd 171 Registered nurses Physicians Professionals (except for registered nurses and physicians) Technical employees collective bargaining agreement (CBA) An agreement (also known as a collective labor agreement) negotiated between management and a union acting on behalf of a group of employees. The CBA regulates the terms and conditions of employment and the respective duties of the employer and employees. 02/01/23 1:57 PM 172 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 5. 6. 7. 8. supervisor Any individual having authority, in the interest of the employer, to hire, transfer, suspend, lay off, recall, promote, discharge, assign, reward, or discipline other employees, or responsibly to direct them, or to adjust their grievances, or effectively to recommend such action, if in connection with the foregoing the exercise of such authority is not of a merely routine or clerical nature, but requires the use of independent judgment (29 U.S.C. § 152(11)). Skilled maintenance employees Business office clerical employees Guards Other nonprofessional employees not covered by categories 4 through 7 The NLRB will determine which employees belong to a bargaining unit and are eligible to vote in the representation election. As defined by the NLRA, supervisors are not considered “employees” because they are part of management and their interests differ from those of rank-and-file workers. Supervisors are therefore excluded from a bargaining unit and are not entitled to union representation. The question of who is a supervisor often arises in healthcare organizations when a union attempts to organize nurses. For example, in a 2006 ruling, the NLRB addressed the question of whether charge nurses—those who oversee patient care units in addition to performing regular nursing duties—were part of management or the rankand-file labor force.40 Twelve nurses at an acute care hospital served permanently as charge nurses on every shift they worked, while others took turns rotating into the charge nurse position and performed nonsupervisory duties most of the time. The union wanted to include all nurses in the bargaining unit of registered nurses. The hospital sought to exclude the permanent and rotating charge nurses, arguing that they use independent judgment in assigning and directing other employees and thus fit the meaning of “supervisor” under the NLRA. In a lengthy opinion, the labor board found that the permanent charge nurses were supervisors because they regularly assigned other personnel to particular patients and used their own judgment in doing so. The rotating charge nurses, however, did not exercise supervisory authority for a substantial part of their work time, and thus they were included in the bargaining unit. Collective Bargaining Once a union has been recognized as representing a certain bargaining unit, the union and management begin the process of negotiating a CBA on important work-related issues. Refusal to do so is an unfair labor practice. Certain topics that materially or significantly affect the terms or conditions of employment are mandatory subjects of bargaining. These include the following: • Drug testing • Dues checkoff (the employer’s practice of deducting union dues from paychecks and forwarding them to the union) CH04.indd 172 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw • • • • • • • 173 Work rules Bans on moonlighting Transfers to positions outside of the bargaining unit Contracting out work done by employees in the bargaining unit Bonuses Medical insurance Clauses that forbid strikes and lockouts Other issues that affect the work environment are permissible subjects of bargaining. Some of the issues that are often addressed in CBAs include the following: • • • • • • • • • • • • Description of the bargaining unit Management rights Workday and workweek Overtime Classification of jobs for wage purposes Compensation, bonuses, health, and other benefits Paid time off (e.g., who is eligible, scheduling time off, who must be notified, which paid holidays are provided) Sick leave (e.g., number of days available, waiting period, doctors’ notes, discipline for misusing sick leave) Severance pay The discipline process (i.e., the steps—such as reprimands, conferences, and written warnings—that will be provided before an employee is discharged) Grievance procedures Workplace safety Strikes Under the NLRA, employees have a right to engage in “concerted activities” for their mutual aid and protection.41 Thus, they may join together to organize, protest, and otherwise assert their interests in a lawful manner. Such activities include going on strike if a new contract cannot be negotiated, if the employer has committed unfair labor practices, or if working conditions are unreasonably dangerous. A striking union’s gamble is that the employer will need to maintain continuous operations and therefore will grant significant concessions before the employees lose too much income by stopping work. CH04.indd 173 02/01/23 1:57 PM 174 T h e L aw o f H e a l th c a re A d mi n i stra ti o n A strike is one thing in a major sector such as transportation or automobile manufacturing; it is quite another in a service sector such as healthcare, where the lives and well-being of patients can be affected. Thus, a separate section of the NLRA prohibits a labor organization from engaging in a strike, picketing, or other concerted refusal to work at any healthcare institution without first giving at least ten days’ notice in writing to the institution and the Federal Mediation and Conciliation Service.42 This “cooling off” period gives the employer extra time to address the underlying complaint or arrange for a continuation of services in the event a strike cannot be avoided. A Word of Caution Labor disputes can be emotional, even violent, and they interfere with the nation’s economic well-being. Because it is in the national interest to maintain full production, labor laws attempt to define and protect the rights of both employees and employers, to encourage collective bargaining, and to eliminate certain practices that are harmful to the general welfare. The laws are extremely complex, and their application is fraught with legal peril, so it is imperative that healthcare executives—especially those in HR departments—rely on legal counsel and other advisors who specialize in labor law. These legal standards are not topics for amateurs and poseurs (see appendix 4.2). Statutes Enforced by the US Department of Labor There are many other federal statutes that affect the workplace, and each state has additional employment-related laws and regulations. It is not possible in this chapter to list them all and discuss them in detail, but exhibit 4.1 summarizes some of the major statutes that fall under the jurisdiction of the US Department of Labor and that affect the healthcare sector. They are organized by the type of labor standard involved. The laws and regulations featured in exhibit 4.1 have provisions relating to the rights of employees, and they detail employers’ responsibilities concerning record keeping, reporting, and notices and posters. The Department of Labor can impose civil money penalties and institute criminal prosecution for violations, and aggrieved persons can seek remedies through private litigation. HR directors and other members of management need to be aware of these requirements and seek competent legal counsel when dealing with related issues. CH04.indd 174 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 175 EXHIBIT 4.1 Key Federal Labor Statutes Wages and Hours Worked Title Citation Function Fair Labor Standards Act (FLSA) 29 U.S.C. §§ 201 et seq.; 29 C.F.R. pts. 510 to 794 Establishes standards for minimum wages, overtime pay, record keeping, and child labor Title III, Consumer Credit Protection Act (CCPA) 15 U.S.C. § 1671; 29 C.F.R. pt. 870 Protects employees from discharge by their employers because their wages have been garnished for any one debt; limits the amount of an individual’s earnings that may be garnished for certain types of debts Safety and Health Standards Title Citation Function Occupational Safety and Health Act of 1970 (OSH Act) 29 U.S.C. §§ 651 et seq. and 29 C.F.R. pts. 1900 to 2400 Sets standards to ensure that employers are providing safe and healthful workplaces; creates the Occupational Safety and Health Administration (OSHA) Health Benefits, Retirement Standards, Workers’ Compensation Title Citation Function Employee Retirement Income Security Act (ERISA) 29 U.S.C. §§ 1001 et seq. and 29 C.F.R. pt.2509 et seq. Sets minimum standards for most private sector employee benefit plans (e.g., medical/dental/vision, retirement, life and long-term care insurance, relocation); generally does not cover plans maintained by churches or government entities Family and Medical Leave Act of 1993 (FMLA) 29 U.S.C. §§ 2601 et seq. and 29 C.F.R. pt. 825 Provides a means for employees to balance their work and family responsibilities by taking unpaid, job-protected leave for certain reasons such as the birth of a child, care of a seriously ill close family member, or an emergency arising out of a family member’s active duty in the military (continued) CH04.indd 175 02/01/23 1:57 PM 176 T h e L aw o f H e a l th c a re A d mi n i stra ti o n EXHIBIT 4.1 Key Federal Labor Statutes (continued) Health Benefits, Retirement Standards, Workers' Compensation Title Citation Function Immigration and Nationality Act of 1952 (INA) 8 U.S.C. §§ 11511382; 20 C.F.R. pt. 656 Addresses employment eligibility, employment verification, and nondiscrimination: employers may hire only persons who can legally work in the United States, and they must verify the identity and employment eligibility of anyone to be hired, which includes completing the Employment Eligibility Verification Form (I-9) 20 C.F.R. pt. 655 Contains provisions to permit certain foreign workers (e.g., engineers, teachers, computer programmers, medical doctors, physical therapists) to be employed under special visa classifications Note: Many states also have statutes regulating these areas of law; in general, states may enact laws that are more protective of employees. State Employment Law In addition to the federal statutes described earlier, there are literally hundreds of state laws affecting the employment relationship. There are state minimum wage laws, for example. There are state laws relating to child labor. There are state laws on paid rest periods, meal periods, payday requirements, vacations, alcohol and drugs, background checks, privacy, military and personal leave, unemployment compensation, and myriad other details. Some states have employment laws specific to the healthcare setting. The California Health and Safety Code, for example, prohibits a healthcare facility from discriminating or retaliating in any way against an “employee, member of the medical staff, or any other healthcare worker” who complains to an accrediting agency, to the medical staff, or to a government entity or who participates in an investigation related to the quality of care at the facility.43 These are just a few examples of how state law can affect human resource management. Because each state’s set of employment laws is unique, generalizing is impossible, but many resources are available. The US Department of Labor maintains a website on state labor laws.44 The National Conference of State Legislatures (ncsl.org) is a resource for state laws on employmentrelated topics. An online search can locate professional associations, national CH04.indd 176 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 177 law firms, and other sources for comparative information. Each state’s labor department will have relevant information as well. But what is most crucial is to engage the advice of legal counsel and HR professionals who are familiar with the legal standards of the state in which the healthcare organization is operating. Special Legal Challenges for HR Departments Every field has its own set of HR challenges, and the healthcare sector operates under unique pressures. Following are a few of the challenges facing HR departments in the health sector today. • Vaccine mandates for healthcare employees. During the COVID-19 pandemic, vaccination or regular testing of employees at healthcare facilities that receive Medicare or Medicaid funding was required. This included hospitals, dialysis clinics, outpatient surgical facilities, and home health care agencies. (Nursing homes were already covered by a previous order.) The authority for this mandate stemmed from the power of the Centers for Medicare & Medicaid Services (CMS) to impose Conditions of Participation on Medicare and Medicaid providers. The US Supreme Court upheld the regulation on January 13, 2022.45 • Other federal mandates. A second vaccine-or-test requirement applied to all federal employees, and a third required federal contractors with 100 or more full-time employees to ensure that their workers are vaccinated or tested. The former order was issued pursuant to the government’s role as an employer. Authority for the latter, an emergency temporary standard, was based on OSHA’s rulemaking powers. On January 13, 2022, the Supreme Court ruled that OSHA went beyond its statutory authority in enacting such a broad requirement.46 • State mandates and prohibitions of mandates. As is typical in our federal system of government, state and local governments varied widely in their vaccination requirements, with some being more stringent and some prohibiting employers from requiring vaccination or testing of their workforce. On their own, many healthcare organizations mandated COVID-19 vaccination as a condition of employment, and many employees were terminated for failure to comply. But those mandates drew fire from, among others, the governors of Arkansas, Arizona, Georgia, Florida, Indiana, Montana, South Carolina, Tennessee, and Texas. Especially in those states, a healthcare organization’s policy to require vaccinations may lead to legal challenges irrespective of the federal standards. CH04.indd 177 06/01/23 3:22 PM 178 T h e L aw o f H e a l th c a re A d mi n i stra ti o n • Vaccine mandate lawsuits. Vaccine mandate lawsuits filed during the pandemic raised myriad legal issues. The lawsuits challenging government-imposed vaccination requirements raised various statutory and constitutional issues, including the need for religious exemptions. In addition, the suits filed against private employers cited labor relations law (where unions were involved) as well as local, state, and/ or federal statutes, including the Civil Rights Act and the ADA. Given the managerial challenges of implementing vaccination and/or testing requirements and the potential for liability if the workforce is not COVID-free, sound legal advice is essential. • Privacy violations. Protection of patient information is required by the Health Insurance Portability and Accountability Act (HIPAA), and employees can be terminated for breaches of confidentiality (see chapter 10). Privacy violations can also extend to an employer’s use of subcontractors or vendors who do not use HIPAA-compliant methods for protecting personal information. • Use of social media. Employees’ use of social media (e.g., Facebook, Twitter, Instagram, TikTok) can create a variety of legal issues, and the extent to which employers may access those accounts to monitor employees’ nonworkplace behavior is an open question. • Staff shortages. As baby boomers age and the need for healthcare grows, the sector is running out of nurses.47 • High turnover. With so many vacancies, it is easy for employees to leave for other positions if they are unhappy in their current post. • Employee burnout. Staffing shortages have negative cascading effects on the remaining staff, and stress and burnout can occur. • Need for additional training. Technological advancements (especially in the form of high-tech digital systems and healthcare devices) require staff members to learn new skills, which places greater demands on HR professionals to ensure that proper training is given and documented. • Complexity of the regulatory system. Healthcare may be the world’s most highly regulated sector because it is subject not only to laws that apply to every business, but also to the peculiar and detailed requirements of the Medicare and Medicaid systems, state and federal insurance regulations, multiple fraud laws, and other similarly unique legal provisions. This presents significant challenges for compliance, audit, and HR departments to maintain discipline and to take corrective action when necessary. • Unionization. Nurses and other groups of healthcare employees tend to have strong unions, which presents challenges for managers, payroll CH04.indd 178 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 179 personnel, and HR professionals (see Union Organizing earlier in this chapter). • Workplace safety. The intersection of nondiscrimination principles with safety issues presents challenges. For example, a pregnant employee may require accommodation to protect the unborn child from dangerous substances, and employees may claim a religious objection to vaccinations. • Background checks. As a result of the special relationship between the healthcare organization and its patients, extra caution is required in doing background checks for sex offenders, other types of abusers, those with a history of violence, and so on. State laws may vary on the types of checks that can be run on applicants or current employees. Law in Action Vaccine mandates raise a question that is deeply rooted in our history: the line between the powers of states and those of the federal government. States have the general “police power” to regulate for the health and safety of their residents. The federal government’s powers, on the other hand, are limited by the US Constitution. The Joe Biden administration’s COVID-19 vaccine mandate for healthcare workers was issued by CMS, an executive agency that has been delegated certain powers that the Constitution assigns to Congress. Because the healthcare entities covered by the rule receive Medicare and Medicaid funding, CMS issued the rule as an exercise of Congress’s authority to tax and spend. Would the federal government’s power to regulate interstate commerce support a general requirement for citizens to be vaccinated, be tested regularly for COVID-19, or wear masks? We might never know for sure, but that seems like a stretch. Mandates also raise the question of how to weigh individual liberties against the needs of public health. The venerable US Supreme Court case Jacobson v. Massachusetts (197 U.S. 11 [1905]) upheld the power of state government entities to require vaccinations for the common good. The majority opinion in Jacobson stated that a “community has the right to protect itself against an epidemic of disease which threatens the safety of its members.” Of course, this case was decided more than a century ago; whether today’s courts will follow that precedent in pandemic-related cases remains to be seen. It must also be noted that the EEOC’s definition of “religion” is broad and protects beliefs, practices, and observances with which the employer may be unfamiliar. These are some of the most divisive cases from an HR standpoint. Employers must have a legally justifiable policy for determining when to grant a religious or medical exemption and what accommodations are reasonable. The advice of experienced legal counsel is required. EEOC guidance concerning COVID-19 is collected at Coronavirus and COVID-19, U.S. EEOC, https:// www.eeoc.gov/coronavirus [https://perma.cc/QKX4-Y35G]. See also Fact Sheet: COVID-19 Vaccination Mandates: Recent Court Cases, Network Pub. Health L., https://www.networkforphl.org/resources/covid19-vaccination-mandates-recent-cases/ [https://perma.cc/N7T7-BLV6] (both sites last visited May 19, 2022). CH04.indd 179 02/01/23 1:57 PM 180 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Employee Relations Generally The employment relationship begins with the interview, and numerous legal standards apply when interviewing and selecting candidates. A responsible HR department will keep managers apprised of the applicable laws and regulations and train those who make hiring decisions in how to avoid legal pitfalls. Some of the greatest hiring failures occur when interviewers make inquiries that are illegal or irrelevant to the job in question. Interviewing is an art, and it should be guided by qualified HR professionals who help the interviewer focus on the candidate’s ability to perform essential job functions. A job interview should be a preplanned, structured process that is the same for all candidates but is specific to the job in question. Exhibit 4.2 lists some EXHIBIT 4.2 Generic Interview Tips You May Not . . . • Ask the candidate’s age. You may only inquire whether they can prove they are the applicable minimum age for employment. • Ask whether they are disabled or, if a disability is obvious, how long they have been disabled. You may, however, ask questions about their ability to perform specific job-related functions. For example, if the job requires travel, you may ask an individual using a wheelchair how they would get around to job sites. • Ask about past substance abuse. However, you may ask whether the candidate currently uses illegal drugs, and you may require they take a drug test. • Ask whether the person has ever been arrested. You may, however, ask about past convictions. • Ask whether (or imply that) the person is an illegal alien. You may, however, ask whether they can provide proof of the legal right to work in the United States if they were to be hired (see Immigration and Nationality Act in exhibit 4.1). • Ask about social clubs, union membership, fraternal organizations, and so on. However, you may ask about membership in relevant professional associations. • Ask about marital and family status, whether they have or plan to have children, or similar issues. You may, however, ask whether any job requirements that extend beyond “normal working hours” (travel or overtime, for example) would pose a problem. • Ask any questions regarding race, religion, national origin, personal appearance, gender, sexual orientation, financial status, or home ownership. You may, however, ask whether working on Saturdays or Sundays would pose a problem. Note: If a candidate volunteers information that touches on any prohibited topic of discussion, do not pursue the comment or make note of it. CH04.indd 180 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 181 helpful tips for interviewing in an unbiased, legally appropriate manner, and, as always, the advice of qualified HR and legal professionals is essential. Once a candidate has been chosen, HR will ensure that they complete all necessary onboarding steps and that statistical reporting and affirmative action monitoring requirements are met. These include collection of personal or demographic information, completion of tax forms (e.g., W-4), verification of eligibility for employment (I-9), identification of veteran status, arranging for preemployment medical or drug testing, and similar details. For the organization’s total workforce, HR professionals ensure ongoing compliance with federal and state employment laws (e.g., wages, family leave, disability); assist in performance evaluations; advise on disciplinary issues, including possible termination; help provide professional training and staff development; and update employee relations policies on a regular basis. There are legal land mines at every turn, and an enlightened employee relations team consisting of specially trained HR professionals is the first line of defense against expensive and disruptive litigation. Chapter Summary This chapter discussed the following topics: • • • • • Employment law Who is an employee or other member of the workforce Nondiscrimination statutes Labor relations law and union activities Special human resources issues in healthcare, including vaccine mandates • General employee relations issues, including do’s/don’ts for interviewing Vocabulary collective bargaining agreement (CBA) due process employee employment at will equal protection featherbedding independent contractor secondary boycott CH04.indd 181 02/01/23 1:57 PM 182 T h e L aw o f H e a l th c a re A d mi n i stra ti o n state action union shop supervisor workforce Discussion Questions 1. Why would an employer prefer to classify a worker as an independent contractor rather than as an employee? 2. From the individual worker’s standpoint, what are the pros and cons of being an employee versus an independent contractor? 3. Under the wage and hours laws, what is the difference between being an exempt employee and a nonexempt employee? 4. What is the legal status of vaccine mandates for healthcare workers in your state? If healthcare workers are required to be vaccinated (as a matter of organizational policy or state law) against the flu, COVID-19, or other diseases, what types of accommodations, if any, are available for those with medical or religious bases for refusing vaccination? CH04.indd 182 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 183 The Court Decides Prescott v. Rady Children’s Hospital-San Diego 265 F.Supp.3d 1090 (S.D. Cal. 2017) [Katharine Prescott filed suit against Rady Children’s Hospital-San Diego (RCHSD) on behalf of herself and her deceased minor son, Kyler. She alleged that RCHSD advertised that it was expert in treating transgender and gender-nonconforming children and adolescents and that it was “competent, careful, and experienced in the care and treatment of patients, particularly transgender patients and those with gender dysphoria.” The opinion defined gender dysphoria “as a marked difference between a person’s gender identity and their assumed gender at birth, which persists for at least six months and manifests itself in at least two other symptoms (e.g., ‘a desire to prevent the development of the anticipated secondary sex characteristics,’ ‘a strong desire to be of the other gender,’ and ‘a strong desire to be treated as the other gender’).” In her lawsuit, Prescott alleged violations of several statutes, including Title IX of the Education Amendments of 1973, a section of the Affordable Care Act that bars discrimination on any ground that is prohibited by the Civil Rights Act, and certain other federal statutes. She also alleged violations of California’s unfair competition and false advertising laws.] I. BACKGROUND Kyler was assumed to be female at birth. However, at the age of ten Kyler began exhibiting signs that he was a boy. At the age of twelve, due to increasing gender dysphoria, Kyler began engaging in self-harming behaviors. When Kyler was thirteen, he told Ms. Prescott that he was a boy. As Kyler entered puberty, his gender dysphoria significantly worsened and he continued to engage in severe self-harming behaviors. [Over the next few years, he saw a therapist and an endocrinologist and received some treatment, but “he still experienced depression and gender dysphoria” and continued to have suicidal thoughts. Eventually, he was admitted to RCHSD’s Child and Adolescent Psychiatry Services (CAPS) unit on a psychiatric hold because he was a danger to himself.] The RCHSD and CAPS staff was informed by Ms. Prescott of Kyler’s male identity and “his need to be referred to exclusively with male gender pronouns.” Kyler’s medical records reflected his legal name and gender change. His male gender identity was also denoted on his RCHSD medical wrist bracelet. Upon intake, the RCHSD staff assured Ms. Prescott “that Kyler’s sex and gender identity would be respected and affirmed” and that “all staff would refer to Kyler with male gender pronouns and would otherwise treat him as a boy.” Despite knowing that Kyler was a “transgender boy in acute psychological distress,” “nursing and other RCHSD staff repeatedly addressed and referred to Kyler as a girl, using feminine pronouns.” Kyler complained to his mother during his stay that the staff referred to him with feminine pronouns, which caused him extreme distress. Kyler also reported that while the other children who were patients initially referred to him with male pronouns, after the RCHSD staff’s repeated use of female pronouns, (continued) CH04.indd 183 02/01/23 1:57 PM 184 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) the children also began calling him “she.” After Kyler was discharged, he also told Ms. Prescott that one RCHSD employee told him, “Honey, I would call you ‘he,’ but you’re such a pretty girl.” Every time Ms. Prescott observed staff calling Kyler “she,” she reiterated that “it was essential to exclusively refer to Kyler with male gender pronouns, and that misgendering caused him serious harm.” . . . Despite concerns over Kyler’s continuing depression and suicidal thoughts, Kyler’s medical providers concluded that he should be discharged early from the hold at RCHSD because of the staff’s conduct. On April 7, 2015, Kyler was discharged from RCHSD’s facility. After being discharged, Kyler continued to feel anxious and depressed as a result of RCHSD staff’s treatment during his stay. On May 18, 2015, Kyler died by suicide. III. DISCUSSION . . . At the outset it is worth noting that in evaluating Title IX [Education Act] claims, federal courts regularly look to [Civil Rights Act] Title VII cases for guidance. [For example, in one case] the Ninth Circuit . . . reasoned that “‘sex’ under Title VII encompasses both sex— that is, the biological difference between men and women—and gender.” It explained that while earlier cases distinguished between “sex” and “gender,” the Supreme Court [has] abandoned this distinction and held that Title VII bars discrimination based on both an individual’s sex and failure to conform to socially-constructed gender expectations. [Specifically,] the Ninth Circuit reaffirmed that “it is unlawful to discriminate against a transgender (or any other) person because he or she does not behave in accordance with an employer’s expectations for men or women.” Other Circuits have similarly interpreted the sex discrimination provisions under Title IX and Title VII to protect transgender individuals from discrimination. . . . Because Title VII, and by extension Title IX, recognize that discrimination on the basis of transgender identity is discrimination on the basis of sex, the Court interprets the ACA to afford the same protections. [The court denied the hospital’s motion to dismiss Prescott’s claim for damages under the Affordable Care Act’s antidiscrimination provisions. It also denied motions to dismiss her allegations of unfair competition and unfair advertising in violation of California law. The question of damages was reserved for further proceedings.] Discussion Questions 1. Can you explain why this is a civil rights issue? Why do you suppose Prescott did not assert a wrongful death claim? 2. What were the responsibilities of the CAPS unit personnel in implementing the psychiatric “hold,” and why were they not carried out? 3. What is the difference between “sex” and “gender”? 4. Can you explain the terms transgender, gender-nonconforming, and cisgender? How do they differ, if at all, from sexual orientation? 5. How can HR policies and practices be used to deal with these kinds of situations? ~ CH04.indd 184 ~ 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 185 The Court Decides Humphrey v. Memorial Hospitals Association 239 F.3d 1128 (9th Cir. 2001) Reinhardt, Circuit Judge Carolyn Humphrey brought suit against her former employer, Memorial Hospitals Association (MHA), under the Americans with Disabilities Act (ADA) and its California counterpart, the Fair Employment and Housing Act (FEHA) for failure to reasonably accommodate her disability and wrongful termination. We reverse the district court’s grant of summary judgment in favor of MHA. I. BACKGROUND [Humphrey worked for MHA as a medical transcriptionist from 1986 until her termination in 1995. Her performance was consistently rated as excellent, exceeding the hospital’s standards for speed, accuracy, and productivity. However, in 1989, she began to experience problems getting to work on time, or at all, because of certain obsessive rituals related to grooming and dressing that sometimes took three hours or more. Some days when she realized she was going to be late, she would panic and become embarrassed, making it even harder to leave her house. As a result of her difficulties with tardiness and absenteeism, MHA disciplined Humphrey with progressive warnings and counseling, sent her to their employee assistance program, and paid for psychological evaluations. The opinion of the psychiatric professionals was that obsessive-compulsive disorder (OCD) was the likely cause of her attendance problems. Humphrey was offered an accommodation in the form of a flexible start time arrangement in which she could begin work any time within a 24-hour period on days on which she was scheduled to work. She accepted this offer but continued to miss work, at which point she requested to be allowed to work at home—an arrangement that MHA had previously granted to certain medical transcriptionists. This request was “summarily denied” because of the hospital’s policy that employees who are involved in disciplinary actions are not eligible to work from home. After a few more absences, Humphrey was terminated as a result of her “history of tardiness and absenteeism.” The trial court granted MHA’s motion for summary judgment on the theory that the hospital had satisfied its duty to make reasonable accommodation for her disability.] II. DISCUSSION Humphrey contends that MHA violated the ADA and the FEHA by failing to reasonably accommodate her disability and by terminating her because of that disability. The ADA provides that “no covered entity shall discriminate against a qualified individual with a disability because of the disability. . . .” Title I of the ADA insures [sic] full opportunities for people with disabilities in the workplace by requiring reasonable accommodation of employees’ disabilities by their employers. Under the ADA, the term “discriminate” is defined as including “not making reasonable accommodations to the known physical or mental limitations of an otherwise qualified (continued) CH04.indd 185 02/01/23 1:57 PM 186 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) individual with a disability who is an applicant or employee, unless such covered entity can demonstrate that the accommodation would impose an undue hardship on the operation of the business of such covered entity.” To prevail on a claim of unlawful discharge under the ADA, the plaintiff must establish that he is a qualified individual with a disability and that the employer terminated him because of his disability. The ADA defines a “qualified individual with a disability” as “an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the employment position that such individual holds or desires.” A “disability” is “a physical or mental impairment that substantially limits one or more of the major life activities of such individual.” The facts are undisputed with regard to Humphrey’s ability to care for herself. The testimony of Humphrey and . . . her mental health provider, reflects that it took Humphrey significantly more time than the average person to accomplish the basic tasks of washing and dressing. According to Humphrey, the process of washing and brushing her hair alone could take several hours, and she at times would prepare for work from eight o’clock in the morning until five or six o’clock in the evening. [O]n one OCD screening test, she was rated as taking three times as long as most people to shower, wash her hands, dress, and handle or cook food. MHA argues that even if Humphrey’s ritualistic behaviors caused her to take more time to complete basic activities than the average person, she is not disabled under the ADA because her OCD did not prevent her from accomplishing those activities. As the Supreme Court has noted, however, “the [ADA] addresses substantial limitations on major life activities, not utter inabilities.” . . . An impairment “substantially limits” one’s ability to carry out a major life activity if, because of the impairment, the CH04.indd 186 individual is “significantly restricted as to the condition, manner, or duration under which an individual can perform a major life activity as compared to the condition, manner, or duration under which the average person in the general population can perform that same major life activity.” [Quoting the ADA regulations.] An individual who has a physical or mental impairment that causes him to take inordinately more time than others to complete a major life activity is substantially limited as to that activity under the ADA. There is no dispute on the record before us that Humphrey falls within that category. Accordingly, in determining whether Humphrey is disabled for purposes of the ADA, the question is not whether she is substantially limited in her ability to care for herself, but whether she had OCD, and, if so, whether her OCD was the cause of her limitation. . . . Humphrey is a “qualified individual” under the ADA so long as she is able to perform the essential functions of her job “with or without reasonable accommodation.” Either of two potential reasonable accommodations might have made it possible for Humphrey to perform the essential functions of her job: granting her a leave of absence or allowing her to become a “home-based transcriptionist.” . . . [T]he ADA does not require an employee to show that a leave of absence is certain or even likely to be successful to prove that it is a reasonable accommodation. [In an earlier case] we noted that “as long as a reasonable accommodation available to the employer could have plausibly enabled a handicapped employee to adequately perform his job, an employer is liable for failing to attempt that accommodation.” . . . [Furthermore,] MHA denied Humphrey’s application for a work-at-home position because of her disciplinary record, which consisted of Level I and Level III warnings for tardiness and absenteeism prior to her diagnosis of OCD. It would be inconsistent 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw with the purposes of the ADA to permit an employer to deny an otherwise reasonable accommodation because of past disciplinary action taken due to the disability sought to be accommodated. Thus, Humphrey’s disciplinary record does not constitute an appropriate basis for denying her a work-at-home accommodation. . . . A reasonable jury could conclude that if Humphrey was relieved of the stress of having to leave the house, she could perform her transcriptionist duties and thus was “qualified” under the ADA. Accordingly, we hold that MHA is not entitled to summary judgment on the issue of whether Humphrey is a “qualified individual with a disability” for purposes of the ADA. 187 [In the remainder of the opinion, the court held that MHA “had an affirmative duty under the ADA to explore further methods of accommodation before terminating Humphrey.” Moreover, “once an employer becomes aware of the need for accommodation, that employer has a mandatory obligation under the ADA to engage in an interactive process with the employee to identify and implement appropriate reasonable accommodations.” According to the court, this is a continuing duty that is not exhausted by one effort. Thus, “MHA was under a continuing duty to offer a reasonable accommodation,” and it violated the ADA’s reasonable accommodation requirement by failing to do so.] Discussion Questions 1. Was the “work from home” option a realistic solution to Humphrey’s attendance problem? 2. How much tardiness and absenteeism should an employer permit before taking disciplinary action if a disability is not known to be the cause? 3. What would you have done had you been in Humphrey’s supervisor’s position? ~ ~ The Court Decides National Labor Relations Board v. Lakepointe Senior Care & Rehab Center, LLC 680 Fed. Appx. 400 (6th Cir. 2017) Kethledge, Circuit Judge Lakepointe Senior Care & Rehab, LLC, operates a long-term care facility in Michigan. It employs licensed practical nurses and registered nurses, which together are called “charge nurses.” The National Labor Relations Board permitted the charge nurses to bargain with Lakepointe through a union, SEIU Healthcare Michigan (the Union), because the Board determined that they were “employees” rather than “supervisors” under the National Labor Relations Act. . . . (continued) CH04.indd 187 02/01/23 1:57 PM 188 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) The National Labor Relations Act gives employees, but not supervisors, the right to bargain collectively with their employers. The Board’s regional directors determine who counts as an “employee” under the Act. . . . After the Board identifies a group of employees who are entitled to union representation, it allows them to vote on whether the union will represent their interests. If a majority of the employees vote to join the union, but their employer refuses to bargain with it, the Board may find that the employer has committed an “unfair labor practice” in violation of the Act and order the employer to bargain. In 2005, the Union asked the Board to recognize Lakepointe’s charge nurses as employees under the Act, so that the Union could represent them. In the representation proceeding that followed, the Board found that Lakepointe’s charge nurses were supervisors rather than employees. It therefore denied the Union’s request. About ten years later, the Union filed another petition with the Board, again seeking to bargain on behalf of Lakepointe’s charge nurses. Lakepointe moved to dismiss, arguing that the Board’s earlier determination that the nurses were supervisors barred the Union’s second petition to represent them. The Board’s regional director denied Lakepointe’s motion and held a representation hearing, during which Lakepointe offered evidence that its charge nurses supervised its certified nursing assistants. The regional director determined that Lakepointe’s charge nurses were employees and thus were entitled to union representation. A majority of the nurses thereafter voted to join the Union, but Lakepointe refused to bargain with the Union on their behalf. The Union filed a complaint with the Board, which determined that Lake-pointe’s refusal was an unfair labor practice. Hence the Board ordered Lakepointe to bargain. The Board now petitions for enforcement of that order. . . . Lakepointe argues that the charge nurses were supervisors and thus not CH04.indd 188 entitled to unionize under the Act. . . . In representation proceedings, the employer bears the burden of showing, by a preponderance of the evidence, that the putative employees are actually supervisors. To be a supervisor, one must perform or “recommend” action on at least one of twelve functions, which include imposing “discipline” on other employees. A person who recommends discipline . . . will be a supervisor only if her recommendations are “effective,” which means that managers give weight to them. Supervisors must also use “independent judgment” when deciding whether to exercise their authority. Here, the Board argues that Lakepointe’s charge nurses were employees because, the Board says, the nurses did not effectively recommended [sic] discipline, among other things. Lakepointe presented evidence, however, that its nurses used disciplinary forms to “write up” certified nursing assistants (the “aides”) for misconduct—and that those forms invariably led to discipline. The question here largely turns on whether the charge nurses imposed or recommended discipline when they wrote up the aides for misconduct with these forms. The Board contends that Lakepointe’s charge nurses used the disciplinary forms merely to report the aides’ work performance, not to recommend discipline. Where a person acts “as a conduit for information and exercises no judgment in passing the knowledge along to management,” he does not independently recommend discipline. But the evidence shows that Lakepointe’s charge nurses were more than mere conduits. The nurses testified that, when they learned that an aide had violated work rules, they had a choice: they could counsel the aide, do nothing, or write up the aide with the disciplinary form. If the charge nurse chose to fill out the form, she would write down what the aide did wrong, explain what the aide should have done, and sign above a line marked 02/01/23 1:57 PM 189 C hap ter 4 : H um an Resourc es L aw “supervisor.” Absent the write-up, the aide would not be disciplined; and the charge nurses did not “consult with a superior” or get approval before filling out the disciplinary form. That the nurses had this choice, therefore, shows that they used independent judgment when deciding whether to write up aides. . . . In summary, Lakepointe’s charge nurses chose whether to write up aides for misconduct. And when the nurses did write them up, the nurses described the rule violation . . . and submitted the form so that the managers would discipline the aide. The nurses therefore independently recommended discipline . . . [and] the record makes plain that Lakepointe’s supervisors gave substantial if not decisive weight to the charge nurses’ recommendations. [T]he record shows that the disciplinary forms always led to discipline and that the managers regularly relied on the charge nurses’ recommendations without questioning their version of events. The regional director overlooked this evidence when she found that the charge nurses lacked the authority to effectively recommend discipline. . . . [The regional director’s] decision therefore was not based on substantial evidence. The Board’s application for enforcement of its February 11, 2016 order finding that Lakepointe had committed an unfair labor practice is therefore denied. Discussion Questions 1. What does “LLC” stand for in the rehab center’s name? 2. Why does an employer care whether “supervisors” are included in a bargaining unit with other employees? ~ ~ Notes 1. For example, healthcare administration curricula are accredited by the Association of University Programs in Health Administration, http://www.aupha.org [https://perma.cc/8AG8-95UQ], and the Commission on Accreditation of Healthcare Management Education, http://www.cahme.org [https://perma.cc/SH3U-XX6J]. The Society for Human Resource Management provides recommended minimum standards for HR degree programs, http://www.shrm.org [https:// perma.cc/Q455-TWDR]. 2. See I.R.S. Pub. 15-A: Employer’s Supplemental Tax Guide, I. R. S. 5, (last visited Nov. 13, 2018), https://www.irs.gov/pub/irs-pdf/p15a. pdf [https://perma.cc/J43Y-XRQM] (emphasis added). 3. NLRB v. Hearst Publications, 322 U.S. 111, 121 (1944). CH04.indd 189 02/01/23 1:57 PM 190 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 4. Rev. Rul. 87-41. See also Joint Committee on Taxation, Present Law and Background Relating to Worker Classification for Federal Tax Purposes (JCX-26-07) (May 7, 2007), https://www.irs.gov/pub/irsutl/x-26-07.pdf [https://perma.cc/ESF9-SZ2X]. 5. Hunt v. State of Missouri, Dept. of Corrections, 297 F.3d 735, 741– 42 (8th Cir. 2002). 6. Toussaint v. Blue Cross & Blue Shield of Michigan, 292 N.W.2d 880, 408 Mich. 579 (1980). 7. Baldetta v. Harborview Medical Center, 116 F.3d 482 (1997). 8. Cotran v. Rollins Hudig Hall Int’l., Inc., 69 Cal. Rptr. 2d 900, 948 P.2d 412, 422 (1998) (internal quotations and citations omitted). 9. I.R.S. Pub. 15-A, supra note 2, at 6. 10. See Hy-Brand Industrial Contractors, Ltd., et al., 365 NLRB 156 (Dec. 14, 2017); Browning-Ferris Industries of Cal., Inc. v. Nat’l Labor Relations Bd., 362 NLRB No. 186 (Aug. 27, 2015), review granted, 911 F.3d 1195 (Dec. 28, 2018). 11. 42 U.S.C. §§ 2000e to 2000e-17. 12. See, e.g., EEOC, Laws & Guidance (last visited May 19, 2022), https://www.eeoc.gov/laws/index.cfm [https://perma.cc/ VK4L-MF5M]. 13. 29 U.S.C. §§ 621–634. The regulations are found at 29 C.F.R. pt. 1625. 14. Smith v. City of Jackson, 544 U.S. 228, 233 (2005). 15. 29 C.F.R. § 1625.7. 16. 42 U.S.C. §§ 12101–12213. 17. See Questions and Answers about Healthcare Workers and the Americans with Disabilities Act, EEOC (updated May 9, 2019), https://www. eeoc.gov/facts/health_care_workers.html#_ednref2 [https://perma. cc/Q9HS-MMYN]. 18. 283 F.3d 11, 28 (1st Cir. 2002). 19. Deane v. Pocono Medical Center, 142 F.3d 138, 144 (1998). 20. 29 C.F.R. § 1630.9. 21. Hedrick v. Western Reserve Care System, 355 F.3d 444, 457 (6th Cir. 2004). 22. 29 U.S.C. § 206(d). 23. 29 U.S.C. § 203. 24. 42 U.S.C. § 2000e-(5)(e)(3). 25. 8 U.S.C. § 1324b. 26. 42 U.S.C. § 2000e(j). Regulations can be found at 29 C.F.R. pt. 1605. CH04.indd 190 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 191 27. Meritor Sav. Bank, FSB v. Vinson, 477 U.S. 57 (1986). 28. Bostock v. Clayton County, Ga., 140 S. Ct. 1731, 1754 (2020). 29. 42 U.S.C. § 2000e(k). The Pregnancy Discrimination Act is enforced by the EEOC. 30. Pub. L. No. 110-233, May 21, 2008. The law is codified in various sections of U.S.C. Titles 29 and 42, primarily 42 U.S.C. § 2000ff-1. The regulations are at 29 C.F.R. pt. 1635. 31. See Facts About Retaliation, EEOC, https://www.eeoc.gov/laws/ types/retaliation.cfm [https://perma.cc/NS2G-X9B5] (last visited May 19, 2022). 32. The FMLA is codified at 29 U.S.C. § 2601 et seq. with related regulations beginning at 29 C.F.R. § 825.100. The FMLA is enforced by the US Department of Labor. 33. USERRA is codified at 38 U.S.C. § 4308 et seq. and is enforced by the Department of Labor. 34. 29 U.S.C. §§ 101–115. 35. The federal laws governing labor–management relations are found in Title 29, U.S.C. Ch. §§ 141–187. 36. Kentov ex rel. NLRB v. Sheet Metal Workers’ Int’l Ass’n Local 15, AFL-CIO, 418 F.3d 1259, 1263 (11th Cir. 2005). 37. Kentov v. Sheet Metal Workers’ Int’l. Local 15, 418 F.3d 1259 (11th Cir. 2005). 38. Communications Workers of Am. v. Ector County Hosp. Dist., 467 F.3d 427, 433 (5th Cir. 2006). 39. 29 C.F.R. § 103.30. 40. Oakwood Healthcare, Inc., 348 N.L.R.B. 37 (2006). See also Golden Crest Healthcare Center, 348 N.L.R.B. 39 (2006). 41. 29 U.S.C. § 157. 42. 29 U.S.C. § 158(g). 43. Cal. H&S Code § 1278.5. 44. State Labor Laws, U.S. Dep’t of Labor, https://www.dol.gov/ agencies/whd/state [https://perma.cc/N4C5-9684]. 45. Biden v. Missouri, 142 S.Ct. 647 (2022). 46. N.F.I.B. v. Dept. of Labor, 142 S.Ct. 661 (2022) (per curium). 47. See, e.g., Fact Sheet: Nursing Shortage, Am. Ass’n Coll. Nursing (updated Sept. 2020), https://www.aacnnursing.org/NewsInformation/Fact-Sheets/Nursing-Shortage [https://perma.cc/ MXN2-LACQ]. CH04.indd 191 02/01/23 1:57 PM 192 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Appendix 4.1: Fair and Unfair Labor Practices Under Sections 7 and 8(a)(1) of the NLRA, an employer may not interfere with employees’ right to decide whether to unionize and join together to advance their interests. Following are examples of actions by employers that would constitute unfair labor practices, followed by practices that would not be considered such. Note that in all matters concerning labor–management relations, it is imperative to seek competent legal advice. Prohibited Practices • Threatening, interrogating, or spying on pro-union employees. • Promising benefits if employees agree not to unionize. • Threatening adverse consequences (e.g., closure of the workplace, loss of benefits, more onerous working conditions) if employees engage in union activity or select a union to represent them. • During a union organizing campaign, withholding planned changes in wages or benefits that would have been made had the union not been on the scene. • Coercively questioning employees about their own or coworkers’ union activities or sympathies. • Prohibiting employees from talking about the union during working time, if you permit them to talk about other non-work-related subjects. • Banning union-related activities in areas such as lunchrooms or cafeterias if you allow other uses there that are not work related (e.g., book sales, charity drives). • Prohibiting use of work email for union purposes if use for other personal purposes is allowed. • Polling employees to determine the extent of their support for a union, unless you comply with certain safeguards. • Spying or even creating the impression that you are spying on employees’ union activities by doing something out of the ordinary to observe the activity. (Observing openly engaged-in union activity in workplace areas frequented by supervisors is not “spying.”) • Photographing or videotaping employees engaged in peaceful union or other protected activities. • Soliciting individual employees to appear in a campaign video. • Enforcing work rules that tend to inhibit employees from exercising their rights. • Denying off-duty employees access to outside nonworking areas of your property, unless legitimate business reasons justify it. • Prohibiting employees from wearing union buttons, T-shirts, and other union insignia unless special circumstances warrant. • Conveying the message that selecting a union would be futile. • Interviewing employees to prepare your defense in an unfair labor practice case, unless you provide certain assurances (see Permitted Practices). • Initiating, soliciting employees to sign, or lending more than minimal support to a uniondisaffection petition or a petition to decertify a union. • Discharging, suspending, laying off, demoting, or taking any other adverse action against employees because of their protected, concerted activities. CH04.indd 192 02/01/23 1:57 PM C hap ter 4 : H um an Resourc es L aw 193 Permitted Practices • Pointing out that supervisors and the company are opposed to unionization (if no threat is implied). • Telling employees that they do not have to sign union cards and that the law says they have the absolute right to refrain from joining a union. • Informing them that they do not have to speak to union organizers or to admit organizers into their homes. • Reminding workers of the benefits that they enjoy. You may also compare those benefits with benefits in unionized companies. • Pointing out that with a union, they may have to bring their problems to a shop steward (a union representative) instead of dealing with their supervisor. • Listing the disadvantages of belonging to a union (e.g., dues, initiation fees, potential fines and assessments). • Stating that, if employees engage in an economic strike, they may be permanently replaced and will be reinstated only if an opening occurs. • Telling them that they may be required to picket other employers, even when they are not on strike. • Reminding workers that a union can always promise advantages but can, in fact, guarantee nothing. • Publicizing the arrest records of union officials. • Laying out why you recommend a vote against the union and suggest that employees encourage others to do the same. • Informing them that merely signing a union authorization card or application for membership does not mean they must vote for the union in an election. • Refuting any untrue or misleading statements made by an organizer, a handbill, or any union propaganda. Possibly Permissible Practices (If Done Properly) • Implementing planned wage and benefit changes during an organizing campaign if the employees are clearly informed that the changes will occur regardless of whether they select the union and that your sole purpose in postponing the change is to avoid any appearance of trying to influence the outcome of the election. • Interviewing an employee in preparing to defend a lawsuit. You must communicate to the employee the purpose of the questioning, ensure that reprisals will not occur, and obtain voluntary participation. Questioning must occur in a context free from employer hostility to union organization and must not itself be coercive. Questioning must not go beyond what is needed to achieve its legitimate purpose—that is, you may not pry into other union matters, elicit information concerning the employee’s subjective state of mind, or otherwise interfere with employee rights under the NLRA. Source National Labor Relations Board, https://www.nlrb.gov/rights-we-protect/whatslaw/employers/interfering-employee-rights-section-7-8a1 [https://perma. cc/6X77-6U8Y]. CH04.indd 193 02/01/23 1:57 PM 194 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Appendix 4.2: Helpful Human Resources–Related Sites • • • • • • • • • • • • • • • • American Society for Healthcare Human Resources Administration (ASHHRA): http://www. ashhra.org/ [https://perma.cc/UVF3-R9UH] Americans with Disabilities Act (ADA): http://www.ada.gov [https://perma.cc/V5ZB-MS3F] US Department of Labor (DOL): http://www.dol.gov [https://perma.cc/9XGE-EJK3] Employment Law Guide, US Department of Labor: http://www.dol.gov/compliance/guide/ index.htm [https://perma.cc/NS3X-D497] Employment Law Information Network: http://www.elinfonet.com/ [https://perma.cc/ GP5K-KCXB] Equal Employment Opportunity Commission (EEOC): http://www.eeoc.gov [https://perma. cc/6U9X-DLN9] Federal courts: http://www.uscourts.gov/courtlinks/ [https://perma.cc/DZ5D-SUMZ] FindLaw: http://employment.findlaw.com/ [https://perma.cc/AXT3-EH4P] Guide to Disability Rights Laws, US Department of Justice: http://www.ada.gov/cguide. htm#anchor62335 [https://perma.cc/VM69-4GCP] Internal Revenue Service (IRS): http://www.irs.gov [https://perma.cc/5BDJ-VQQT] Legal Information Institute (LII): http://www.law.cornell.edu/states/ [https://perma. cc/59SZ-X4UL] National Labor Relations Board (NLRB): https://www.nlrb.gov [https://perma.cc/LZV7-CWTR] Occupational Safety and Health Administration (OSHA): http://www.osha.gov/ [https:// perma.cc/E965-5G7W] Social Security Administration (SSA): http://www.ssa.gov/employer/ssnv.htm [https:// perma.cc/7ENB-CN2K] US Citizenship and Immigration Services (USCIS): http://uscis.gov/graphics/index.htm [https://perma.cc/PQ4Y-DJ6F] Workforce (multimedia publication for HR professionals): http://www.workforce.com [https://perma.cc/ARA6-H5FK] CH04.indd 194 02/01/23 1:57 PM CHAPTER CONTRACTS AND INTENTIONAL TORTS 5 After reading this chapter, you will • know the essential elements of a valid, enforceable contract; • understand why contract law is relevant to provider–patient relationships; • recognize possible legal concerns with noncompete clauses in physician contracts; • appreciate how the contract principle of breach of warranty can apply to the healthcare setting; and • grasp the basics of intentional torts and how they might apply to healthcare professionals. Think Like a Lawyer In the 1973 movie The Paper Chase, the Shakespearean actor John Houseman won an Academy Award for portraying Charles W. Kingsfield, a stern, intimidating contract law professor. A highlight of the film is Kingsfield’s description of the Socratic method—a type of philosophical inquiry commonly used in law schools. To a room filled with first-year students, he explains that this technique comprises a series of questions followed by the students’ answers, and that it is intended to stimulate critical thinking rather than simply convey information. The Socratic method is, essentially, teaching by asking. Kingsfield struts slowly across the dais; glares at the timorous tyros before him; and announces that in his classroom there are no absolute answers, only an endless string of questions. The students are his patients on an operating table, and he is a neurosurgeon whose questions are instruments that probe their brains. He stops. He stares. After a dramatic pause, and with a stentorian voice worthy of King Lear, he concludes, “You teach yourselves the law, but I train your mind. You come in here with a skull full of mush, and you leave thinking like a lawyer!” Yes, contracts class can teach you how to think like a lawyer—or at least it can teach you enough to know when to call a lawyer for solid advice. 195 CH05.indd 195 02/01/23 1:58 PM 196 T h e L aw o f H e a l th c a re A d mi n i stra ti o n EXHIBIT 5.1 The Taxonomy of Law Law Criminal Misdemeanor Civil Felony Express Contracts Implied Intentional Torts Negligent Strict Liability The Taxonomy of Law In chapter 1, you learned that law can be thought of as either public or private, but law can be categorized in other ways as well. For example, there is criminal law and civil law, and civil law has subdivisions of its own (see exhibit 5.1). This chapter discusses the subdivision of civil law that deals with contracts: agreements between two or more parties. liability Legal responsibility for one’s acts or omissions. cause of action The basis of a lawsuit; sufficient legal grounds and alleged facts that, if proven, would constitute all the requirements for the plaintiff to prevail. damages Money required to be paid as compensation for an injury or wrong. CH05.indd 196 Contracts and Intentional Torts as Bases of Liability When people think of liability in healthcare, they usually think of medical malpractice, which is a form of negligence. Negligence is the most common type of malpractice, but liability can also be based on a breach of contract or the commission of intentional torts. In fact, many malpractice suits allege more than one cause of action. The reasons for multiple allegations vary, but they often include the fact that damage awards differ depending on the type of claim. The choice of which cause(s) of action to allege is a strategic decision made by plaintiffs’ lawyers based on such variables as the facts of the case and the types of damage awards possible if the plaintiff wins. For example, verdicts in contract law cases are typically limited to the harm caused to the contracting party’s economic interests, and the remedy might involve only cancellation of the contract or a requirement that it be performed as agreed. Sometimes, however, a contract will specify in advance the damages to be paid if there is a breach; this is known as a liquidated 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts damages provision. Including a liquidated damages provision can be a time and money saver in the event of a breach; as with all contract terms, however, it can be tricky to negotiate. By way of contrast, the general theory in tort law is that the successful plaintiff should be “made whole” by compensating for all consequences of the injury. Unless limited by state law (e.g., by a “tort reform” measure that limits damages), the verdict could include payment for such items as lost wages, pain and suffering, the cost of additional medical or supportive care, and the cost of property retrofitting. In the case of intentional torts (discussed later in this chapter), punitive damages are sometimes awarded if state law allows. In chapter 8, you will read about a case (Poliner v. Texas Health System) in which a jury awarded a physician $110 million in punitive damages in addition to $90 million compensation for defamation (damage to his reputation).1 (The court did substantially reduce this outrageously high award, and it was entirely thrown out on appeal because the hospital had substantially complied with federal law in its privileging action against the physician.) The existence of a legal duty is essential to any liability case, and the concept of duty tends to change as our society and values change. The legal duty may be imposed by constitution, legislation, common law (including negligent or intentional torts), or contract (e.g., with a health insurer or between a provider group and a healthcare system). In healthcare, special legal duties arise from the contractual aspects of the provider–patient relationship.2 Except for a brief foray into the inclusion of noncompete clauses in physician contracts, this chapter does not address the law of contracts as it relates to operational issues such as employment, materials management, facilities maintenance, and procurement. Although many of the basic principles discussed here apply to those areas, too, a full discussion of the breadth of contracts law is beyond the scope of this text; indeed, the subject of contracts occupies an entire semester-long course in the typical law school curriculum. As with the human resources chapter, we will only hit the highlights here. 197 punitive damages Damages awarded as punishment for especially egregious conduct; punitive damages are allowed for some, but not all, causes of action and are intended to serve as a deterrent to bad behavior. Elements of a Contract In simple terms, four conditions must exist for a contract to be valid: 1. Both parties must be legally competent to enter into the contract. Contracts entered into by mentally incompetent persons are not valid, and neither are most contracts entered into by minors. (See chapter 12 for a discussion of the situations in which minors are allowed to consent to their own medical care.) CH05.indd 197 02/01/23 1:58 PM 198 T h e L aw o f H e a l th c a re A d mi n i stra ti o n consideration Payment, essentially; something of value (not necessarily money) that is given (or promised) in return for what is received (or promised). exculpatory Absolving or clearing of blame; from the Latin words ex (from) and culpa (guilt). 2. There must be a meeting of the minds. One party must make an offer— to buy or sell, for example—and the other party must accept that offer. The terms of the offer and acceptance must be identical. 3. Consideration must be given. Consideration is the price paid for the agreed-upon terms, but it need not be in the form of money. It may also be a promise (a) to do something you otherwise would not be required to do, or (b) to refrain from doing something you otherwise would be able to do. This contractual element is one reason for the nominal $1 payment provisions in some contracts. 4. The purpose of the contract must not be illegal or contrary to public policy. The classic example of this condition is a contract for an assassination; a court will not enforce such a contract, or award damages for its breach, and a person who attempts either remedy would find themselves in a lot of trouble. A less obvious, and more controversial, example in the healthcare context is the New Jersey Supreme Court’s decision in the case of In re Baby M to void a surrogacy contract as contrary to public policy, reasoning that it is akin to baby selling. (See chapter 15 for a discussion of this 1988 case and subsequently enacted state laws allowing compensated surrogacy.) Likewise, many exculpatory contracts—those in which one party agrees in advance to excuse the other from liability for negligence—are invalid because they are contrary to public policy. Contracts may be express (written, spoken) or implied. Many of our day-to-day human interchanges are implied contracts. For example, consider a patron ordering lunch in a restaurant. Implicit in the situation is this offer: “If you serve me what I order, I will pay the bill.” By taking the order and serving the food, the restaurant has accepted the patron’s offer and a contract exists. The offer and acceptance are rarely expressed as such in words, but the contract is valid nonetheless. Similarly, the provider–patient relationship generally includes an offer (“If you treat me, my insurance or I will pay you.”) and an acceptance (“We’ve scheduled your appointment for next Tuesday.”). Statutory law requires some contracts to be in writing; for example, federal fraud and abuse laws, discussed in chapter 9, require that certain types of agreements between physicians and healthcare systems be memorialized in writing (among other requirements). Noncompetes in Physician Contracts Although this chapter does not address the myriad contractual issues that are common to any business setting, one aspect of physician contracting is worth a brief discussion here. That is the inclusion of noncompetition covenants, called noncompetes, in physician employment or independent contractor CH05.indd 198 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 199 agreements. In this context, a noncompete would prohibit a physician from practicing medicine within a given geographic area for a set amount of time after leaving the contracted practice setting. The practice restriction might, for example, last for two years, and include the immediate town but not the next one over. The validity of these contractual provisions highlights the interplay of private negotiations, judicial interpretation, third-party interests, and legislative action. Broadly speaking, healthcare systems might want to include noncompetes in their contracts with physicians and physicians do not want them included. The systems are concerned with protecting their investment in the physician practice and their patient referrals; the physicians are concerned with their ability to practice at other nearby settings in the future. Both might be concerned with patient access to quality care or call coverage. This is a type of contract provision in which a liquidated damages clause can be beneficial. Noncompetes have been governed by state law, which is highly variable on the topic. Courts and lawmakers see noncompetes as a restraint on trade, and some states have statutes barring nearly all noncompetes (California is a prominent example). However, reasonable noncompetes are still enforceable in most jurisdictions as to most professions. Noncompetes restraining physicians and other healthcare professionals are scrutinized slightly differently than other noncompetes. Courts and lawmakers see physician noncompetes as a risk to the public interest because they may limit patient access to medicine and disrupt continuity of care. As a result of this concern, some states restrict physician noncompetes by statute. In Texas, for example, physician noncompetes must meet specific, heightened requirements to be enforceable.3 Those requirements include providing the physician with access to certain patient lists and medical records and allowing physicians to buy out their noncompetes for a reasonable price. Absent statutory or regulatory specifics, what a court considers reasonable will be somewhat dependent on the facts. The courts will often consider the potential harm to patients when determining whether a noncompete should be allowed, revised, or voided as contrary to public policy. A 2005 case about the validity of a noncompete, for example, involved a perinatologist who treated patients with high-risk pregnancies. Dr. Bayliss wanted out of his noncompete, which stated that he would not practice perinatology in a five-county area for two years after leaving the practice. The court held that the scope of the noncompete was unreasonable because one of the restricted counties was “underserved in the area of maternal fetal medicine” (Dr. Bayliss, if he practiced in that county, would have been its sole perinatologist).4 In addition to state law restrictions, the federal government is poised to create some type of national restriction on noncompetes, particularly as CH05.indd 199 02/01/23 1:58 PM 200 T h e L aw o f H e a l th c a re A d mi n i stra ti o n they apply to low-wage workers. President Joe Biden signed an executive order in July 2021 directing agency action on this topic. The order states, “To address agreements that may unduly limit workers’ ability to change jobs, the Chair of the FTC is encouraged to consider working with the rest of the Commission to exercise the FTC’s statutory rulemaking authority under the Federal Trade Commission Act to curtail the unfair use of non-compete clauses and other clauses or agreements that may unfairly limit worker mobility.”5 The Provider–Patient Relationship Good Samaritan laws Statutes that aim to encourage healthcare providers—and often anyone—to voluntarily provide help at the scene of an emergency by providing immunity for negligence in the provision of that help. CH05.indd 200 In general, the American legal system does not require people to help strangers unless they are bound by a contractual, statutory, or employment obligation. Thus, like other passersby, healthcare professionals generally have no legal obligation to stop and voluntarily render aid at the scene of an accident. If they do stop to help, and do not take payment for doing so, Good Samaritan laws provide protection for negligent (but not grossly negligent) assistance. With rare and difficult-to-enforce exceptions, these laws do not require anyone to act. (See chapter 11 for more detail about Good Samaritan laws, including more recently enacted ones that aim to reduce the number of fatal drug overdoses by providing legal protections to bystanders who seek medical help for a person who is overdosing.) Whether there are moral duties to help are a different question (see Legal Decision Point). It is against the law’s general “no-duty” backdrop that the healthcare provider–patient relationship came to be conceptualized, somewhat oddly, as a contractual relationship. Where there is a provider–patient relationship, the provider has a duty to follow the standard of care in treating the patient. Where there is no provider–patient relationship, there is no such duty. The contractual nature of this relationship is exemplified when a provider agrees to provide treatment in exchange for payment. Such a contractual agreement can be implied when a provider undertakes to provide treatment (absent a Good Samaritan situation as described earlier). This contractual framing, while helpful and pervasive, is incomplete. Today a treatment obligation might be externally imposed, by, for example, an agreement with an insurer to care for those with that coverage. And a ­provider–patient and hospital–patient relationship can be required by statute, as, for example, when an individual seeks care at an emergency department. (See chapter 11 for a discussion of the screening and treatment obligations that the federal Emergency Treatment and Labor Act requires of hospitals and physicians, including on-call physicians.) Furthermore, healthcare providers are bound by federal and state antidiscrimination laws. While they may 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 201 not unlawfully discriminate against patients, individual providers are free to limit the scope of their practices in terms of numbers of patients, types of insurance, and medical specialty. Creation of the Relationship The contract necessary to form a provider–patient relationship can be express (e.g., when you fill out financial responsibility forms at the provider’s office), implied (e.g., when you make a follow-up appointment and are seen by the provider), or even inferred from the circumstances. Consider this situation: a patient is unconscious or otherwise unable to consent to treatment, but an emergency exists and the treatment team proceeds with appropriate interventions. The law will presume (infer) that a contract exists. Although this presumption is a legal fiction, among other things, it prevents unjust enrichment by requiring payment for services that presumably would have been agreed to. Whether express, implied, or inferred, the provider–patient contract is bilateral—that is, it imposes duties on both parties. This is true although most of the payment is likely to come from an insurer or, in the case of a low-income uninsured person, be lower than the usual rate. Although clear enough in the abstract, these “black-letter” principles are often difficult to apply in practice. For Legal Decision Point example, providers commonly and informally consult one another regarding their An affidavit is a written document in which the patients’ diagnosis and treatment, and affiant—the one who signs the document—swears the consulted provider may not see the under penalty of perjury that the facts asserted in patient or know the patient’s name. Do the statement are true. Affidavits generally cannot these informal hallway consults create a substitute for in-court testimony because they are not subject to cross-examination. However, affiprovider–patient relationship? Generally, davits are sometimes used to support arguments the answer is no. on collateral matters, especially if the opposing For example, in Oliver v. Brock,6 attorney does not object. In Oliver v. Brock, affiDr. Whitfield was treating Anita Oliver in davits were used to support Dr. Brock’s position rural Demopolis, Alabama, for injuries susthat he did not have a doctor–patient relationship tained in an automobile accident. During with Oliver, and by the plaintiffs to support their own position. a telephone conversation with a colleague Who do you suppose wrote the affidavits in named Dr. Brock about another patient, this case? Are any of their assertions not, strictly Dr. Whitfield casually mentioned Oliver’s speaking, facts? If you were opposing counsel, treatment and asked for Dr. Brock’s opinwould you object to the use of such affidavits? If you ion. According to Dr. Whitfield’s affidavit were the judge, what weight would you give them? (see Legal Decision Point), Dr. Brock If you could cross-examine Dr. Whitfield (the treating physician who consulted with Dr. Brock), what told him that the treatment seemed to questions would you ask him about his assertions? be correct under the circumstances. The conversation was apparently informal and CH05.indd 201 02/01/23 1:58 PM 202 T h e L aw o f H e a l th c a re A d mi n i stra ti o n gratuitous, and one can almost imagine Dr. Whitfield saying, “Oh, by the way, what do you think about this other situation I have?” Dr. Brock practiced in Tuscaloosa, which is about 60 miles from Demopolis. In his affidavit, he introduced himself as “one of the Defendants in the above styled cause,” and asserted that he never saw the patient, talked to her or her family, or even learned her name. He admitted that he occasionally talked to Dr. Whitfield by phone (apparently to discuss patients), but he continually emphasized that he did not know Oliver and that she had never been his patient. His affidavit concluded, “I have never been employed or requested to care for or treat Anita Oliver and I have not been employed or requested to advise anyone with regard to her medical problems.” As result of Dr. Whitfield’s course of treatment, which presumably had been at least casually supported by Dr. Brock, Oliver ended up suffering further injury. In her own affidavit as plaintiff, the patient’s mother, Cathy Oliver, stated, “I became concerned regarding the care and treatment rendered or done by Dr. Whitfield and . . . Dr. Whitfield told me that he would call Dr. Brock in Tuscaloosa to get some advise [sic] on how to treat my daughter’s injuries.” She said that Dr. Whitfield later told her that Dr. Brock told him that the treatment was correct and should be continued. Her affidavit concludes, “I sincerely believe that Dr. Brock took part in the treatment of my daughter and that he is at fault for the serious injuries suffered by my daughter as a result of this treatment.” After reviewing the evidence, such as it was, the Supreme Court of Alabama in 1976 unanimously decided that there was no provider–patient relationship between Dr. Brock and Anita Oliver, so the physician could not be held liable for the injuries the patient sustained because of the treatment. One of the justices summarized this position clearly in a concurring opinion: The mere discussion between professional people of hypothetical situations cannot be viewed as a basis for liability. To hold otherwise would tend to adversely affect the quality of the services they offer to members of the public. Physicians, lawyers, dentists, engineers, and other professionals, by comparing problemsolving approaches with other members of their disciplines, have the opportunity to learn from one another. Possessing this freedom, they are better positioned to bring theory into practice for the benefit of those whom they serve. Our decision in this case preserves these essential learning situations for all professional people.7 The general rule is stated in the 2022 edition of the legal encyclopedia American Jurisprudence as follows: In the absence of statute providing otherwise, a physician or surgeon is under no legal obligation to render professional services to everyone who applies to him or CH05.indd 202 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 203 her, not even in the case of an emergency. . . . If a physician or surgeon accepts employment, however, he or she is bound by law to exercise a high standard of skill and care, to continue the treatment until the relation of physician and patient is legally terminated, and not to abandon the case.8 On the other hand, a provider need not come into direct contact with a patient for a provider–patient relationship to exist. Pathologists, for example, have a relationship with patients even though they probably never see the people whose specimens they examine, the patients do not know who the pathologists are, and they are perhaps not even conscious of the fact that pathologists are involved in their treatment.9 Another issue involves the duty of a provider who provides services to someone who is not a party to the contract, and where the patient has agreed to that arrangement. For example, a nurse practitioner conducts a focused preemployment examination, or examines a plaintiff for a personal injuries case. In these situations, the general rule is that because the typical treatment relationship does not exist, the nurse practitioner owes no duty to the individual being examined—only to the party who contracted for the examination. This general rule seems to be changing, however; some courts have found at least a limited duty toward the individual, even in the absence of a contractual relationship. In James v. United States, the plaintiff applied for a position at a shipyard and, as a condition of employment, was required to take a physical examination. A chest X-ray revealed an abnormality, but through a clerical error, the physician never saw the X-ray or the radiologist’s report. Almost two years later, the plaintiff was diagnosed with an inoperable cancer. The defense argued that the absence of a physician–patient relationship precluded any duty of care. The court in 1980 awarded damages anyway because “[h]aving made a chest X-ray an essential part of the preemployment examination to determine an applicant’s physical fitness, . . . defendant failed to use due care when . . . the report on the X-ray was not brought to the attention of the examining physician.”10 Scope of the Duty Arising from the Relationship The provider–patient relationship involves a bilateral undertaking: the provider agrees to treat the patient in accordance with their scope of practice and following the appropriate standards of care, and the patient agrees to pay—or have insurance pay—for the services rendered. This understanding continues until the natural termination of the relationship. (The standards of practice and termination of the relationship are discussed later in this chapter.) On the other hand, the patient does not contractually promise to follow the provider’s orders, so failure to do so may excuse the provider from liability CH05.indd 203 02/01/23 1:58 PM 204 T h e L aw o f H e a l th c a re A d mi n i stra ti o n for untoward results. Similarly, the provider does not contractually promise to cure the patient, only to use their best efforts to do so. In some circumstances, however, a provider’s express or implied promise may be viewed as a guarantee, in which case if a cure is not effected, the provider could be held liable for breach of warranty. (This topic is discussed further later in this chapter.) Now that managed care organizations, such as health maintenance organizations (HMOs) and preferred provider organization (PPOs), and governmental payers dominate the health insurance market, the relationship is no longer simply between a patient and a provider; it includes the payer’s contractual obligations and limitations as well. Nevertheless, the relationship is viewed as founded in contract principles. Providers may limit the scope of their practice to a designated geographic area, a certain medical specialty, or even to specific services (see Legal Brief). In McNamara v. Emmons, a woman sustained a bad cut and was treated by an associate of her physician.11 The next morning the patient left for a vacation in a town miles away. While there, she felt she needed further treatment and asked the physician to come to the town. He refused but gave her instructions and named a local physician whom she might call. The court held that in these circumstances, the defendant physician was justified in limiting his practice to his own area. These issues are discussed elsewhere in the text (see, e.g., Law in Action Legal Brief relating to religion in chapter 4), but they are noted here because there are contracA dilemma arises when a patient requests legititual implications, especially for employed mate medical services that run counter to the providers. provider’s or the organization’s religious or moral convictions. For example, a patient might request a vasectomy, morning-after pills, a first-trimester abortion, or aid in dying consistent with state statutes. All these legal services might run afoul of, for example, the ethical directives guiding Catholic healthcare organizations. Likewise, a nurse who does not want to participate in sterilizations or abortions will likely be allowed to opt out based on federal or state conscience protections. A physician who wants to lawfully prescribe life-ending medications to a terminally ill patient might be precluded from doing so based on the healthcare system’s policies. If a pharmacist refuses to fill a prescription for morning-after pills, the pharmacy might be required to find another nearby pharmacist to do so (Stormans, Inc. v. Wiesman, 794 F.3d 1064 [9th Cir. 2015], cert. denied, 579 U.S. 942 [2016]). CH05.indd 204 Duties to Persons Other than the Patient Although a provider’s duty to a particular patient arises only when a contract has been formed, the scope of that duty can extend beyond the patient to others who are not contractual parties. In many states, a contractual provider–patient relationship not only allows the provider to warn certain persons that a patient has an infectious disease without violating the patient’s privacy rights, it obliges the provider to do so. For example, state law may require the healthcare provider to notify the local or state health department if a patient is diagnosed with HIV or AIDS. Health department 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 205 staff will then undertake partner notification to locate those who might have been COVID Connection exposed and provide them testing, counselContact tracing is a powerful public health tool ing, and referrals for other services. to reduce the spread of infectious disease and In the famous case Tarasoff v. ensure that those infected receive appropriate Regents of the University of California treatment and support. At the start of the pan(also discussed in chapter 10), the Calidemic, many local and state health departments fornia Supreme Court ruled that when ramped up their contract-tracing staffs. The rapid a therapist determines, or should have spread of COVID-19, however, and the lack of testing resources quickly overwhelmed the capacity determined, that a patient presents a serifor widespread contact tracing. ous danger of violence to a reasonably identifiable person, the therapist has a duty to use reasonable care to protect the threatened person.12 This “duty to warn” overrides the obligation to protect patient confidentiality. In Tarasoff, the patient had told his psychotherapist that he intended to kill his roommate’s sister (readily identifiable as Tatiana Tarasoff), and he later made good on his threat. On these facts, the court determined that the victim’s parents had a valid cause of action for failure to warn, and the case could go to trial as to whether the psychotherapist’s actions (in notifying campus police and others) satisfied that duty. Whether the injury to the third party is foreseeable is an important consideration in such cases. In Brady v. Hopper, a suit by persons injured in the assassination attempt on President Ronald Reagan in 1981, the court held that John Hinckley Jr.’s psychiatrist owed no duty to the plaintiffs because there was no evidence that Hinckley had made specific threats suggesting his intentions.13 Similarly, in Freese v. Lemmon, a pedestrian was injured by an automobile when its driver suffered a seizure.14 Both the driver and his physician were sued by the injured person—the physician on the theory that he was negligent in diagnosing an earlier seizure and in advising the driver that he could operate an automobile. The trial court dismissed the case against the physician, but the Supreme Court of Iowa reversed that outcome on the theory that an unreasonable risk of harm to a third party or a class of persons (i.e., other drivers) was foreseeable. The case was remanded for a trial on the merits of the evidence. Termination of the Relationship and Abandonment Like all contracts, the one between the provider and the patient is terminated at certain points: • • • • CH05.indd 205 When When When When the the the the patient is cured or dies provider and the patient mutually consent to termination patient dismisses the provider provider terminates the relationship 02/01/23 1:58 PM 206 T h e L aw o f H e a l th c a re A d mi n i stra ti o n A provider might unilaterally terminate the relationship because it is ceasing that line of service (e.g., closing a clinic), because it will no longer be accepting a certain type of insurance, or because a patient has proved too challenging. For a provider to terminate the relationship before the patient is cured might be considered abandonment. Whether abandonment is a breach of contract, an intentional tort, or negligence has been a matter of some dispute, and there might be valid claims for all three, especially when the physician thought the patient had been cured and thus effectuated a premature discharge from the hospital.15 To avoid a successful allegation of abandonment, the provider needs to give reasonable notice and opportunity to find substitute care. As highlighted in the cases discussed in this section, just what is “reasonable” notice and opportunity will vary depending on the nature of the patient’s condition and perhaps the local healthcare resources. Abandonment may be express or implied. Express abandonment occurs when a provider notifies a patient that the treatment relationship will be ending (for any number of reasons) but fails to give the patient reasonable notice and time to secure the services of another provider. In Norton v. Hamilton, the plaintiff reported that she had begun labor several weeks before her baby was due.16 According to the plaintiff’s allegations, the physician examined her and concluded that she was not in labor. When the pains continued, the plaintiff’s husband called the physician twice to say that his wife was still in pain. At that point, the physician said he was withdrawing from the case. While the husband was looking for a substitute physician, the plaintiff delivered her child alone and suffered unnecessary pain and distress. The court held that the physician’s acts would be abandonment, if proven. (The decision only concerned the legal principle that would apply; it was not a final judgment based on evidentiary findings.) Sometimes abandonment is inferred from the circumstances, as in the 1963 Kentucky case Johnson v. Vaughn.17 The facts involved a 46-year-old man who had suffered a gunshot wound to the neck in the early hours of a Saturday morning. When the patient arrived at the hospital, a nurse phoned Dr. Vaughn, who arrived a short time later. He admitted the patient, treated him somewhat (although the opinion is not clear on the extent of that treatment), and then went home, leaving word that he was to be called if the patient’s condition grew worse. The record contains evidence that the doctor was under the influence of alcohol at the time: [Four] witnesses . . . described Dr. Vaughn’s condition and actions as that he was “red-eyed,” “stumbled,” “wobbled,” “staggered,” “talked rough” and was “thick tongued.” The [patient’s] son smelled the odor of alcohol on the doctor’s breath and expressed the view “he had been drinking.” CH05.indd 206 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 207 Because the patient seemed dangerously injured, his son had a nurse call another doctor, Dr. Kissinger, who arrived at 4:00 a.m. and “gave such attention as appeared to be most urgent” but felt he could not proceed further without a release from Dr. Vaughn. He called Dr. Vaughn, advising him that the patient was dying and needed immediate attention. On hearing this news, Dr. Vaughn became “irate and vulgar,” called Dr. Kissinger “a louse” for trying to steal his patient, and hung up. A call from the patient’s son produced more verbal abuse. Finally, Dr. Vaughn said he would release the patient if he was paid $50 by 9:00 the next morning. Meanwhile, 30 or 40 minutes had passed before Dr. Kissinger could operate, and the patient later died. The court held that these facts were sufficient to state a claim of abandonment against Dr. Vaughn. The opinion states, in part, It is a rule of general acceptance that a physician is under the duty to give his patient all necessary and continued attention as long as the case requires it, and that he should not leave his patient at a critical stage without giving reasonable notice or making suitable arrangements for the attendance of another physician, unless the relationship is terminated by dismissal or assent. Failure to observe that professional obligation is a culpable dereliction.18 As this quote from the Johnson case implies, providers can raise a variety of defenses to claims of abandonment. If the patient dismisses the provider or agrees to the latter’s departure, or if the provider gives notice of withdrawal early enough for the patient to find another provider of equal ability, the claim will fail. Providers have the right to limit their practice to a certain specialty or geographic area. A provider who is too ill to treat a patient or to find a substitute also has a valid defense to an abandonment claim. If a provider obtains a substitute provider, this constitutes a valid defense so long as the substitute is qualified and the patient has enough time to find another if the substitute is unacceptable. Two California cases exemplify purposeful termination of the p ­ rovider– patient relationship when a patient is uncooperative. In Payton v. Weaver, the patient was Brenda Payton, an indigent 35-year-old woman with end-stage renal disease and a history of significant mental health challenges, obesity, and drug and alcohol abuse.19 After treating her for more than three years— during which time Payton was often uncooperative—her physician, Dr. Weaver, informed her that he could no longer see her because her intensely antisocial behavior and refusal to follow instructions made it extremely difficult to provide her with the medical care that she so desperately needed. He did, however, continue to treat her on an emergency basis while she tried to find an alternative provider. CH05.indd 207 02/01/23 1:58 PM 208 T h e L aw o f H e a l th c a re A d mi n i stra ti o n When no alternative was found, Dr. Weaver agreed that he would continue to see her if she met certain conditions of cooperation: that she refrain from use of alcohol and drugs, maintain prescribed dietary habits, and “in all respects cooperate with those providing her care.” After nearly a year, during which time Payton did not live up to her part of the bargain, Dr. Weaver again notified her that he was withdrawing, and Payton filed suit to compel him to treat her. After an extensive hearing, the trial court found that Payton had violated the previous conditions and adversely affected other dialysis patients. The court of appeals began its opinion by noting, “Occasionally a case will challenge the ability of the law, and society, to cope effectively and sensitively with fundamental problems of human existence. This is such a case.” The court went on to note the basis for the termination: The trial court . . . found that Brenda had violated each and every condition which she had accepted as part of the stipulated order providing for continued treatment, and that finding is basically undisputed. There was evidence that Brenda continued . . . to buy barbiturates from pushers on the street at least twice a week; that she failed to restrict her diet, gaining as much as 15 kilograms between dialysis treatments; that she continued to be late and/or miss appointments; that due primarily to missed appointments she had 30 emergencies requiring hospitalization in the 11 months preceding trial; that she would appear for treatment in an intoxicated condition; that she discontin- Legal Decision Point ued her program of counseling after a brief period; and . . . she displayed in general “gross non-cooperation with her treating phy- End-stage renal disease (ESRD) is chronic kidney failure that has progressed to the point of requiring kidney dialysis or transplant. (Payton’s body had rejected a kidney transplant at one point in her medical odyssey.) An ESRD patient needs to undergo dialysis every three or four days but can live a somewhat normal existence between treatments, subject to contributing conditions such as high blood pressure or diabetes. The Payton court stated that “there was no emergency” in Payton’s case. Do you agree? Was she a patient with a chronic disease, or was she a patient who was bound to have serial emergencies? Instead of attending regular dialysis appointments, she had gone to the emergency department every week or so in extremis and in need of dialysis. If you were a hospital executive, how would you advise the emergency department to manage a patient such as Payton? CH05.indd 208 sician [and hospital providers].” The trial court found that her behavior in these respects was “knowing and intentional.” The court also found that there was no emergency requiring treatment under a California statute,20 that Dr. Weaver’s notice to Payton was sufficient to end the relationship, and that the doctor was not responsible for the fact that no other dialysis unit would accept her (see Legal Decision Point). Reflecting on the difficulties in addressing systemic healthcare inequities in the context of individualistic legal obligations, the court opined that there might exist a collective responsibility on the part of providers of scarce healthcare resources to share over time in the care 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 209 of difficult patients. As to the immediate issue, the appellate court sustained the trial court decision that Dr. Weaver was not obliged to continue treating Payton, and she died pending appeal to the state Supreme Court.21 In another case, the court decided that a medical group and hospital must provide nonemergency care to a husband and wife. In Leach v. Drummond Medical Group, Inc., the plaintiffs, who were regular patients of the group practice, had written to a state agency commenting adversely on the performance of the group’s physicians.22 The practice told the couple that because they had complained to the medical board, “a proper physician– patient relationship” could not be maintained and they would receive only 30 days of care, after which they would be treated only for emergencies. The couple sued to compel continued treatment of their many health problems. (The practice was the only medical group available within 100 miles.) The trial court denied relief, but the appellate court reversed the decision and allowed the suit to continue. The court decided that although one physician may not be required to treat a patient they do not like, the group as a whole could be ordered to do so.23 Because the patients had not publicly criticized the doctor but only discreetly contacted the appropriate state agency, the court held that denying services to them was not justified. Some cases have extended the provider’s duty to the patient even after the provider–patient relationship has ended. In Tresemer v. Barke, the physician had implanted an intrauterine device (IUD) in the plaintiff in 1972.24 The physician had seen the patient only on that one occasion. The plaintiff later Law in Action suffered injury from the device (a Dalkon Shield, which was later found to have caused severe injury to a large percentage The foregoing discussions of Johnson v. Vaughn of patients) and filed suit against the phyand Payton v. Weaver purposely omit the fact that each of the patients was a person of color. Celie sician. She alleged that he had known the Johnson was described by the Kentucky judge as risks of using the IUD but failed to warn a “46-year-old colored man,” and the California her. The court held that the defendant had court described Brenda Payton as a “35-year-old a duty to warn the plaintiff, noting that a black woman.” Considering that the cases are physician is in the best position to alert roughly 60 and 40 years old, respectively, one a patient and that death or great bodily might wonder to what extent overt racial animus or implicit bias affected the course of either harm might be prevented as a result.25 Linkage with Healthcare Inequities Decisions to terminate a patient relationship risk exacerbating healthcare inequities precisely because they can be connected to provider perceptions of uncooperativeness, with all the possible biases that could involve, as well as access-related systemic CH05.indd 209 patient’s treatment and their options for legal redress. Payton’s complaint did allege racial bias, and although she was unsuccessful in proving that claim as to her immediate dialysis treatment, the opinion’s language suggests that the court believed that racism and poverty throughout Payton’s life had contributed significantly to her poor health and limited options. 02/01/23 1:58 PM 210 T h e L aw o f H e a l th c a re A d mi n i stra ti o n issues. Even today, patients of color too often receive inferior treatment because of systemic healthcare inequities, including unconscious bias. Recent studies show that even after controlling for socioeconomic and insurance status, Americans of color, on average, “live sicker and die quicker” than do white Americans. By one estimate, “more than 84,000 black and brown lives are needlessly lost each year” because of health disparities.26 After decades of study, many policy makers and healthcare providers are now focusing on how healthcare systems (as well as public health entities) can address implicit biases, barriers to access, and other determinants of health. Improving population health outcomes, and promoting health justice, will not be easy, but it is something that healthcare executives, providers, policy makers, and society as a whole must seriously grapple with. Liability for Breach of Contract In the typical provider–patient contract, the provider agrees (or implies agreement) to perform a service. Failure to perform the service with reasonable skill and care may give the patient a basis for filing a claim, not only for negligence but also for breach of contract. The previous paragraphs illustrate breach-of-contract cases based on abandonment; Alexandridis v. Jewett offers an example of a different kind of contractual breach.27 In Alexandridis, two obstetricians agreed that one of them would personally deliver the patient’s second baby. When the time came, however, the patient’s labor progressed rapidly and the obstetrician whose night it was to take call could not arrive at the hospital in time. The baby was delivered by a first-year resident, who performed an episiotomy during the process and damaged the patient’s anal sphincter as a result. Because the partners had contractually agreed to deliver the patient’s baby and were more skilled than the resident who delivered the baby, the court found that the partners would be liable for breach of contract if their greater skill would have protected the patient from injury. A provider who uses a procedure that is different from the agreed-upon procedure may also be liable for breach of contract. In Stewart v. Rudner, the physician promised to arrange for an obstetrician to deliver a child by cesarean section.28 The patient, a 37-year-old woman who had suffered two stillbirths, was extremely eager to have a “sound, healthy baby.” While the patient was in labor, the physician told another obstetrician to “take care of this case” but did not tell him about the promise to perform a cesarean section. At the end of a lengthy labor, the baby was stillborn. The appellate court upheld a jury verdict for the patient on the grounds that the physician breached his promise that a cesarean operation would be used to deliver the baby. CH05.indd 210 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 211 Liability for Breach of Warranty Providers are susceptible to liability not only if they promise (but fail) to perform a certain service but also—especially—if they promise that their treatment will yield a specific result but it does not. In recent years, a few health systems have begun offering warranties for certain procedures, such as hip and knee replacements. These warranties are meant to appeal to insurers by protecting them (and the patients) from incurring additional costs for treatment of avoidable complications. These types of warranties should be drafted carefully to clarify which exigencies are covered and which are not. The following cases involve warranties made by individual providers. Note that most state laws now require the promised result to be specified in writing for a patient to bring an action for breach of warranty. The point of this requirement is to get around the challenge of figuring out, particularly in retrospect, what was stated as an expected result versus a guaranteed result. A provider who guarantees a result gives the patient a contractual basis for a lawsuit if the treatment is not successful, even if it was performed skillfully. In Sullivan v. O’Conner, a professional entertainer thought her nose was too long.29 She contracted with a physician to have cosmetic surgery. The physician promised that the surgery would “enhance her beauty and improve her appearance.” The surgery was unsuccessful, however, and after two more operations, the patient’s nose looked worse than before. Providers do not guarantee results simply by agreeing to perform a surgery or start a course of treatment, and drawing the line between an opinion and a guarantee is often difficult. The jury decided in this case, however, that there was a guarantee, and the appellate court affirmed the jury’s verdict for the plaintiff (see Legal Brief). Guilmet v. Campbell is a well-known case in health law circles. The plaintiff had a bleeding ulcer and talked with a surgeon Legal Brief about a possible operation. He testified that the surgeon said, Once you have an operation it takes care of all your troubles. You can eat as you want to, you can drink as you want to, you can go as you please. Dr. Arena and I are specialists; there is nothing to it at all—it’s a very simple operation. You’ll be out of work three to four weeks at the most. There is no danger at all Sullivan v. O’Conner is a good example of the roles that juries and appellate courts play in our legal system. The jury decides what the facts are, and the appellate court must accept those facts as true unless they are indisputably wrong. In some respects, this rule is analogous to the instant-replay rule in professional sports. Unless the review shows that the official’s decision was clearly wrong, the call “on the field” stands. in this operation. After the operation you can CH05.indd 211 02/01/23 1:58 PM 212 T h e L aw o f H e a l th c a re A d mi n i stra ti o n throw away your pill box. In twenty years if Law in Action you figure out what you spent for Maalox pills and doctor calls, you could buy an awful lot. Weigh [that cost] against an operation.30 The Supreme Court’s 2022 abortion decision in Dobbs v. Jackson Women’s Health Organization (see chapter 15) creates potential liability issues (both civil and criminal) for institutional and organizational healthcare providers (as well as others who might be considered to have aided or abetted an illegal abortion). State law will dictate the scope of abortion-related services allowed within a state, and will likely raise issues about interstate provision of reproductive healthcare services. Thus, all contracts that involve the provision of patient care should be reviewed to ensure that those involved in pregnancy-related treatment and counseling are cognizant of the relevant state laws and aware of any gray legal areas encompassed by the scope of services. tort A civil offense not founded on contract; a failure to conduct oneself in a manner considered proper under the given circumstances. intentional tort A category of torts that describes a civil wrong resulting from an intentional act on the part of the tortfeasor, regardless of whether the tortfeasor intended to cause harm. tortfeasor A wrongdoer; a person who commits a tort. CH05.indd 212 With this assurance, the plaintiff underwent the operation, during which his esophagus ruptured. As a result, his weight dropped from 170 to 88 pounds, and he developed hepatitis and numerous other complications. He sued the physician on both a negligence (medical malpractice) theory and a warranty (guarantee) theory. The jury decided that the physician was not negligent but had breached the promise to cure. The Michigan Supreme Court affirmed the decision. In response to Guilmet, and presumably after some heavy lobbying by the medical profession, the state legislature later passed a statute requiring that any alleged promise or guarantee of a cure will be void unless it is given in writing and signed by the physician alleged to have made it.31 Intentional Torts Another basis for professional liability is intentional tort. A tort (Latin for “wrong”) is a civil wrong, not based on contract, that results in injury to another person or another person’s property or reputation.32 Torts are usually divided into three categories, each of which involves a different type of proof (see exhibit 5.1): • Intentional tort, as the name implies, is a wrongful, volitional action on the part of the tortfeasor that causes injury. • Negligence is unintentional failure to do what a reasonably careful person would do under the circumstances. • Strict liability is incurred when a person commits a wrongful act that poses high risk of harm to others but did not do so intentionally or out of negligence. As noted earlier, most malpractice cases are based on negligence. Strict liability is uncommon in healthcare, but it surfaces in relation to defective drugs and medical devices. 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 213 In healthcare, lawsuits based on intentional tort are less common than negligence cases, but they do arise, sometimes in combination with negligence allegations. There may also be multiple consequences for a healthcare provider who commits an intentional tort. Medical malpractice insurance coverage might not apply to damages stemming from an intentional tort. Additionally, because intent is usually an essential element in proving both an intentional tort and a crime, many intentional torts, such as assault and battery, entail both criminal and civil liability. This point is significant because commission of a criminal act could result in suspension or revocation of one’s license to practice. negligence Failure to comply with established standards for the protection of others; departure from the conduct expected of a reasonably prudent person acting under the same or similar circumstances. Assault and Battery strict liability Automatic responsibility (without having to prove negligence) for damages as a result of possession or use of inherently dangerous equipment (e.g., explosives), wild or poisonous animals, or assault weapons. Product liability is a type of strict liability, and it could apply to defective drugs or medical devices that cause harm even when they are used as intended. “Assault and battery” actually refers to two intentional torts. An assault is conduct that places a person in apprehension of being touched in a way that is insulting, provoking, or physically harmful. Battery is the actual touching (see Legal Brief). Both assault and battery are acts done without legal authority or permission. A move to kiss someone without consent is an assault, and the act of kissing without consent is both assault and battery. If the person were asleep when kissed, the perpetrator would not be committing assault because the other person was not apprehensive. They would, however, be committing battery. (Obviously, kissing someone with consent is neither assault nor battery nor a cause of apprehension.) The question of consent to medical or surgical treatment is complex; chapter 12 features a detailed discussion of the topic. For present purposes, assault and battery cases can be grouped into three categories: 1. Those in which no consent for the touching was obtained. 2. Those in which the provider exceeded the scope of the consent given. 3. Those in which the consent was “uninformed.” First are the intentional acts committed by a healthcare provider with no patient consent whatsoever. In Burton v. Leftwich, for example, a physician who was having trouble removing sutures from the toe of a four-year-old child (whose parents were apparently not much help) smacked the tot’s thigh several times with his open hand, leaving bruises that were visible for three weeks.33 An appellate court upheld a jury verdict for the plaintiffs on the grounds that the physician had committed battery. CH05.indd 213 Legal Brief We accept the incidental touching that accompanies everyday life, but there are certain boundaries. For example, jostling others on a crowded subway train is not battery, but groping them is. Battery is sometimes characterized by the aphorism “Your right to swing your arm ends where my nose begins.” (And note: the swing that misses would be an assault if you saw it coming.) 02/01/23 1:58 PM 214 T h e L aw o f H e a l th c a re A d mi n i stra ti o n informed consent An agreement to permit a medical procedure after disclosure of all relevant facts needed to make an intelligent decision. CH05.indd 214 Compare that case with Mattocks v. Bell, in which a 23-month-old girl—whom a medical student was treating for a lacerated tongue—clamped her teeth on the student’s finger and would not let go.34 After a failed attempt to free his finger by forcing a tongue depressor into the child’s mouth, the student slapped her on the cheek. The parents lost the battery suit. The force the student used was judged to be reasonable under the circumstances. In the often-cited case Schloendorff v. Society of New York Hospital (discussed in more detail in chapter 12), a doctor was found liable for battery after he operated on a patient who had consented only to an examination under anesthesia but not to an operation.35 In another case, a patient signed a consent form to have his kidney stones removed by a certain urologist. After the surgery, the patient discovered that the operation had been performed not by the urologist he requested but by two other members of the urologist’s medical group. He sued all three physicians for malpractice and failure to obtain informed consent. After the jury found for the defendants, the Supreme Court of New Jersey reversed the decision. It held that the plaintiff had claims for battery and malpractice and that even if no physical injury occurred, the defendants could be liable for mental anguish and perhaps even punitive damages.36 The court stated, “Even more private than the decision who may touch one’s body is the decision who may cut it open and invade it with hands and instruments. Absent an emergency, patients have the right to determine not only whether surgery is to be performed on them, but also who shall perform it.”37 The second and third categories of assault and battery cases will be discussed in more detail in chapter 12. For now, it is sufficient to note that a case fitting either the second or third category can support a negligence theory in addition to the intentional tort of assault and battery. Negligence is the more common allegation, but liability on assault and battery is also possible. Mohr v. Williams is illustrative of this point.38 The plaintiff consented to an operation on her right ear. After she was anesthetized, the surgeon discovered that her left ear needed surgery more than the right one, so he operated on the left ear instead. On the grounds, among others, that the surgeon’s conduct amounted to assault and battery, the appellate court upheld a trial court’s decision to let the case proceed. Although the surgeon in Mohr should have consulted the patient before operating on the other ear and probably should have discussed that possibility before beginning the surgery, a surgeon may be justified in operating beyond the scope of the original consent when an emergency makes obtaining the patient’s further consent impossible or dangerous. In Barnett v. Bachrach, a surgeon operating on a patient for an ectopic pregnancy (a pregnancy outside the uterus) discovered that the pregnancy was normal but that the patient had acute appendicitis.39 He removed the appendix and later sued the patient for not paying the medical bill. The patient defended the collection suit by alleging that the appendix was removed without her consent. 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 215 In holding for the surgeon, the court noted that if he had not taken out the appendix, both the patient and the fetus might have been endangered. These cases of extending the scope of surgery can be extremely complicated, and the outcome can depend on small factual differences. Generalizing about the proper course of action to take is difficult. For this reason, most hospital risk management departments have detailed surgical consent forms that anticipate all possible intraoperative complications and document the patient’s permission for the medical team to make prudential judgments should those complications arise during the surgery. Defamation Defamation is wrongful injury to another person’s reputation. Written defamation is libel, and oral defamation is slander.40 To be actionable, the defamatory statement must be “published”—that is, the defendant must have made the statement to a third party, not just to the plaintiff. In Shoemaker v. Friedberg,41 a physician wrote a letter to a patient, stating that she had a venereal disease. The patient showed the letter to two or three other women and later, in the presence of a friend, discussed the diagnosis with the physician. In suing him, she alleged a breach of confidentiality, but the court held that no recovery should be allowed because the patient had herself made the diagnosis public. (This result is an example of what could be called the “it’s your own darn fault” rule.) There are several available defenses in defamation suits: defamation The act of making untrue statements about another that damage that person’s reputation. • The truth of a statement is an absolute defense. Even a true statement, however, can lead to liability for invasion of privacy or breach of confidentiality. (See further discussion of this point later in this chapter and in the discussion of the Health Insurance Portability and Accountability Act in chapter 10.) • Statements made in good faith for a required or encouraged safety purpose are usually entitled to a qualified privilege. An example is a false but good faith report of a sexually transmitted disease diagnosis to a state health department, as required by law. Similarly, good faith statements made in the course of credentialling responses might be protected by statute, and by a release signed by the physician seeking privileges. • Some statements, such as those made during a judicial proceeding or by one provider to another in discussing a patient’s treatment, are privileged and provide a defense. In Thornburg v. Long, for example, a specialist advised a patient’s family physician on the basis of an erroneous lab report that the patient had syphilis.42 When the patient sued the specialist for libel, the court held that the statement was privileged because the specialist had a duty to communicate the information to the other physician and had done so with reasonable skill, even though it turned out that the information was incorrect. CH05.indd 215 02/01/23 1:58 PM 216 T h e L aw o f H e a l th c a re A d mi n i stra ti o n False Imprisonment False imprisonment arises from unlawful restriction of a person’s freedom. In the healthcare context, this could arise when a mentally ill person is detained without following appropriate processes. In Stowers v. Wolodzko, for example, a psychiatrist was held liable for his treatment of a patient who had been forcibly committed against her will.43 Although this type of commitment was allowed under state law at the time, for many days the psychiatrist held the woman incommunicado and prevented her from calling an attorney or a relative. These actions amounted to false imprisonment because the patient’s freedom was unlawfully restrained. (The unusual facts of this case are laid out in The Court Decides at the end of this chapter.) Invasion of Privacy and Breach of Confidentiality Although truth is a defense in defamation cases, there are two other bases for possible liability: (1) invasion of privacy and (2) wrongful disclosure of confidential information. Invasion of privacy occurs when a patient is subjected to unwanted publicity. For example, in Vassiliades v. Garfinckel’s, Brooks Bros., the defendants (a physician and the famous department store) used “before” and “after” photographs of the plaintiff’s cosmetic surgery without her permission. This action was sufficient to support a verdict for invasion of privacy and breach of fiduciary duty.44 Similarly, a Michigan physician was held liable for invasion of privacy when he allowed a lay friend to observe the delivery of a baby in his patient’s home. Clearly, a patient’s expectation of privacy should be respected. In many situations, state or federal law requires disclosure of confidential information. For example, confidential information from a patient’s medical record may be disclosed for purposes of quality assurance and peer review activities and for reporting to state authorities in cases of suspected child abuse. Other reporting requirements include those relating to communicable disease, injury, or death resulting from the use of a medical device; environmental illness and injury; injuries resulting from suspected criminal activities (e.g., knife or gunshot wounds); and conditions affecting one’s ability to drive safely or operate heavy machinery. Disclosures made in conformity with the law are not wrongful, and no liability will attach. Similarly, no liability for disclosing patient information exists when the patient (or the patient’s authorized representative) has given permission. Healthcare facilities must be aware of the federal and state requirements regarding confidentiality of healthcare information and must have appropriately protective policies and procedures in place. (These requirements are discussed in more detail in chapter 10.) Misrepresentation Misrepresentation is another intentional tort for which providers can be held liable. Misrepresentation is either intentional (fraudulent or deceitful) or CH05.indd 216 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts negligent. Either way, the person claiming injury must show that a fact was falsely represented and that decisions based on the misrepresentation caused harm. Misrepresentation cases involving providers are of two types: (1) misrepresentation to persuade a patient to submit to treatment, and (2) misrepresentation of a prior treatment or its results. Providers who misrepresent the nature or results of treatment they have given are liable for fraud even if the treatment was done carefully. In Johnson v. McMurray,45 Dr. McMurray performed surgery on Lavoid Johnson and left a surgical sponge inside his body. Johnson specifically asked that Dr. McMurray not participate in the follow-up surgery needed to remove the sponge, and he sought out Dr. Griffith to operate. Unknown to Johnson, Dr. Griffith intended to have Dr. McMurray assist in the surgery anyway, which he did. More complications arose, and the patient eventually lost his leg. The court decided that the two doctors had fraudulently concealed a significant fact and a jury could award damages. Misrepresentation sometimes allows a patient to bring suit after the statute of limitation expires. In Hundley v. Martinez, the patient suffered vision problems for a number of months after cataract surgery. On numerous occasions, he returned to his ophthalmologist for follow-up visits and was repeatedly assured that his “eye was all right, getting along fine.”46 Eventually, the patient (an attorney) became virtually blind in the affected eye. More than two years later, he consulted another ophthalmologist about cataract formation in the other eye. Only then did he learn that the first eye had been permanently damaged by the earlier surgery. The court held that the twoyear limitation period should be disregarded (tolled) if the jury found that the physician had obstructed the plaintiff’s case by fraud or in other ways. Accordingly, a new trial was ordered. 217 statute of limitation A law setting the maximum period one can wait before filing a lawsuit, depending on the type of case or claim. Outrage The tort of outrage—sometimes called “intentional infliction of emotional distress”—arises from extreme and offensive conduct by the defendant. Rockhill v. Pollard is a graphic example of a case involving outrage.47 The plaintiff, her mother-in-law, and her ten-month-old daughter were injured in an automobile accident on a wintry evening in Oregon shortly before Christmas; the accident knocked the baby unconscious. A passing motorist picked them up and arranged for a physician to meet them at the doctor’s office. Here is a portion of the court’s opinion describing the encounter with the defendant, Dr. Pollard: Both plaintiff and [her mother-in-law] Christine Rockhill testified that defendant was rude to them from the moment they met him; plaintiff testified: “And the first thing he looked at us, and he had a real mean look on his face, and this is what he said. He said, ‘My God, women, what are you doing out on a CH05.indd 217 02/01/23 1:58 PM 218 T h e L aw o f H e a l th c a re A d mi n i stra ti o n night like this?’ . . . and my mother-in-law tried to explain to him why we were on the road, and her and I both pleaded to him.” Without making any examination, defendant told them there was nothing wrong with any of them. [The baby] was still unconscious at this time. According to plaintiff: “She was very lifeless. I was saying her name, and she wouldn’t respond at all. Her eyelids were a light blue. She was clammy, very cold. “In fact, I thought she was dead at the time.”48 After repeated requests to do so, the doctor finally gave the baby a cursory examination and said there was nothing wrong with her. The baby had vomited, and both the adults had blood and vomit on them. The opinion states that the doctor told the mother-in-law, “Get in there and clean yourself up. You are a mess.” The opinion continues, quoting from the transcript: “The doctor was out of the room, and I told her [Christine Rockhill, the mother-in law], I says, ‘We have got to get help for this baby,’ and she said, ‘Well, what are we going to do?’ “And the doctor came back in the room, and she asked the doctor, she says, ‘What are we going to do?’ And he just shrugged his shoulders and said he didn’t know, . . . ” When Christine Rockhill suggested that her brother would pick them up at defendant’s office, defendant said, “My God, woman, I can’t stay here until somebody comes and gets you.” Although the temperature was below freezing and [the baby’s] clothing and blanket were wet with vomit, he told them to wait outside by a nearby street light while someone came . . . to get them. prima facie Containing enough evidence to win unless the defendant presents contradictory evidence. After a 20-minute wait in the cold, the group was taken to a hospital. By the time they arrived, the baby was apparently semiconscious and suffering from shock. The women were given emergency treatment and released. The baby had surgery to repair a depressed skull fracture and was released after a week in the hospital. The trial court had dismissed the lawsuit, thinking that the plaintiff had not presented a prima facie case (enough evidence to win unless the defendant presents contradictory evidence). The Supreme Court of Oregon disagreed, stating, “We think the issue should have been submitted to the jury.”49 It is not hard to see why a jury could find that the defendant’s conduct was “outrageous” and thus an intentional tort. Violation of Civil Rights For well over 50 years now, courts have recognized causes of action for violations of patients’ civil rights. Violation of federal civil rights statutes—such CH05.indd 218 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts as committing discrimination on the basis of race, sex, religion, nationality, and other protected categories—is an obvious example.50 Less apparent discrimination is shown in Widgeon v. Eastern Shore Hospital Center.51 In this unusual case, the plaintiff was involuntarily committed to a Maryland hospital after an ex parte hearing (one in which only one party is present), in which the plaintiff’s wife testified that he had exhibited abnormal and violent behavior. Two physicians examined the plaintiff on his arrival at the hospital, and although he showed no outward signs of mental illness, the doctors ordered that he be held at the hospital. The plaintiff maintained that his wife had lied about his behavior because she wanted to be free to join her male friend in Florida. As soon as she met up with her “friend,” the hospital released the plaintiff. He promptly sued his wife, the physicians, and the hospital for violation of federal and state civil rights statutes, negligence, false imprisonment, false arrest, defamation, intentional infliction of emotional distress, and conspiracy to commit these wrongs. The court held that the complaint stated a valid cause of action under federal law and the Maryland Declaration of Rights: “That no man ought to be taken or imprisoned or disseized of his freehold, liberties or privileges, or outlawed, or exiled, or, in any manner, destroyed, or deprived of his life, liberty or property, but by the judgment of his peers, or by the Law of the land.”52 This case illustrates how civil rights may be defined differently at the state level as compared to the federal level. 219 ex parte hearing A hearing in which only one party is present. Chapter Summary This chapter discussed the following topics: • The essential elements of a valid contract (competent parties, a “meeting of the minds,” consideration, a purpose that is legal and not contrary to public policy) • How contract law impacts analysis of the provider–patient relationship • How the evolving law around noncompete clauses highlights the roles of case law and legislation • Consideration of the effect of racial animus and implicit bias in the provider–patient relationship • Standards for terminating a patient–provider relationship without it being considered abandonment • Liability for breach of warranty • The types of intentional torts and how they might arise in the healthcare setting CH05.indd 219 02/01/23 1:58 PM 220 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Vocabulary cause of action consideration damages defamation exculpatory ex parte hearing fiduciary Good Samaritan laws informed consent intentional tort liability negligence prima facie punitive damages statute of limitation strict liability tort tortfeasor Discussion Questions 1. A large urban hospital is having serious financial difficulties, and its board of directors has decided to close its dialysis clinic, which has been losing several million dollars a year. There are 51 patients of the clinic who have not been able to find alternative care, although there are several other dialysis centers in the area. You have been assigned to the team managing the closure. What questions do you have? What will you do? What legal risks might there be? 2. Explain why a case alleging a breach of contract, such as Guilmet v. Campbell, might be easier to prove than a standard case alleging negligence (harm resulting from the failure to follow the standard of care). 3. What are some policy arguments in favor of noncompetes, generally and as to physician contracts? What are some policy arguments against them? 4. Identify three types of intentional torts. For each type, make up a healthcare-related situation for which the plaintiff would have a prima facia case. CH05.indd 220 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 221 The Court Decides Stowers v. Wolodzko 386 Mich. 119, 191 N.W.2d 355 (1971) Swainson, J. This case presents complicated issues concerning the liability of a doctor for actions taken subsequent to a person’s confinement in a private mental hospital pursuant to a valid court order. . . . Plaintiff, a housewife, resided in Livonia, Michigan, with her husband and children. She and her husband had been experiencing a great deal of marital difficulties and she testified that she had informed her husband . . . that she intended to file for a divorce. On December 6, 1963, defendant appeared at plaintiff’s home and introduced himself as “Dr. Wolodzko.” Dr. Wolodzko had never met either plaintiff or her husband before he came to the house. He stated that he had been called by the husband, who had asked him to examine plaintiff. Plaintiff testified that defendant told her that he was there to ask about her husband’s back. She testified that she told him to ask her husband, and that she had no further conversation with him or her husband. She testified that he never told her that he was a psychiatrist. Dr. Wolodzko stated in his deposition . . . that he told plaintiff he was there to examine her. However, upon being questioned upon this point, he stated that he could “not specifically” recollect having told plaintiff that he was there to examine her. He stated in his deposition that he was sure that the fact he was a psychiatrist would have come out, but that he couldn’t remember if he had told plaintiff that he was a psychiatrist. Plaintiff subsequently spoke to Dr. Wolodzko at the suggestion of a Livonia policewoman, following a domestic quarrel with her husband. He did inform her at that time that he was a psychiatrist. On December 30, 1963, defendant Wolodzko and Dr. Anthony Smyk, apparently at the request of plaintiff’s husband and without the authorization, knowledge, or consent of plaintiff, signed a sworn statement certifying that they had examined plaintiff and found her to be mentally ill. Such certificate was filed with the Wayne County Probate Court on January 3, 1964, and on the same date an order was entered by the probate court for the temporary hospitalization of plaintiff until a sanity hearing could be held. The Judge ordered plaintiff committed to Ardmore Acres, a privately operated institution, pursuant to the provisions of [Michigan law]. Plaintiff was transported to Ardmore Acres on January 4, 1964. . . . The parties are in substantial agreement as to what occurred at Ardmore Acres. Defendant requested permission to treat the plaintiff on several different occasions, and she refused. For six days, she was placed in the “security room,” which was a bare room except for the bed. The windows of the room were covered with wire mesh. During five of the six days, plaintiff refused to eat, and at all times refused medication. Defendant telephoned orders to the hospital and prescribed certain medication. He visited her often ­during her stay. (continued) CH05.indd 221 02/01/23 1:58 PM 222 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) When plaintiff arrived at the hospital she was refused permission to receive or place telephone calls, or to receive or write letters. Dr. Wolodzko conceded at the trial that plaintiff wished to contact her brother in Texas by telephone and that he forbade her to do so. After nine days, she was allowed to call her family, but no one else. Plaintiff testified on direct examination that once during her hospitalization she asked one of her children to call her relatives in Texas and that defendant took her to her room and told her, “Mrs. Stowers, don’t try that again. If you do, you will never see your children again.” It is undisputed that plaintiff repeatedly requested permission to call an attorney and that Dr. Wolodzko refused such permission. At one point when plaintiff refused medication, on the written orders of defendant, she was held by three nurses and an attendant and was forcibly injected with the medication. Hospital personnel testified at the trial that the orders concerning medication and deprivation of communication were pursuant to defendant’s instructions. Plaintiff, by chance, found an unlocked telephone near the end of her hospitalization and made a call to her relatives in Texas. She was released by court order on January 27, 1964. Plaintiff filed suit alleging false imprisonment, assault and battery, and malpractice, against defendant Wolodzko, Anthony Smyk and Ardmore Acres. Defendants Ardmore Acres and Smyk were dismissed prior to trial. At the close of plaintiff’s proofs, defendant moved for a directed verdict. The court granted the motion as to the count of malpractice only, but allowed the counts of assault and battery and false imprisonment to go to the jury. At the Conclusion of the trial, the jury returned a verdict for plaintiff in the sum of $40,000. . . . Defendant has raised five issues on appeal. . . . CH05.indd 222 The second issue involves whether or not there was evidence from which a jury could find false imprisonment. “False imprisonment is the unlawful restraint of an individual’s personal liberty or freedom of locomotion.” It is clear that plaintiff was restrained against her will. Defendant, however, contends that because the detention was pursuant to court order (and hence not unlawful), there can be no liability for false imprisonment. However, defendant was not found liable for admitting or keeping plaintiff in Ardmore Acres. His liability stems from the fact that after plaintiff was taken to Ardmore Acres, defendant held her incommunicado and prevented her from attempting to obtain her release, pursuant to law. Holding a person incommunicado is clearly a restraint of one’s freedom, sufficient to allow a jury to find false imprisonment. Defendant contends that it was proper for him to restrict plaintiff’s communication with the outside world. Defendant’s witness, Dr. Sidney Bolter, testified that orders restricting communications and visitors are customary in cases of this type. Hence, defendant contends these orders were lawful and could not constitute the basis for an action of false imprisonment. However, the testimony of Dr. Bolter is not conclusive on this point. . . . Psychiatrists have a great deal of power over their patients. In the case of a person confined to an institution, this power is virtually unlimited. All professions (including the legal profession) contain unscrupulous individuals who use their position to injure others. The law must provide protection against the torts committed by these individuals. In the case of mental patients, in order to have this protection, they must be able to communicate with the outside world. In our country, even a person who has committed the most abominable crime has the right to consult with an attorney. Our Court and the courts of our sister States have recognized that interference with 02/01/23 1:58 PM 223 C hap ter 5: C ontrac ts and Intentional Tor ts attempts of persons incarcerated to obtain their freedom may constitute false imprisonment. Further, we have jealously protected the individual’s rights by providing that a circuit Judge “who willfully or corruptly refuses or neglects to consider an application, action, or motion for, habeas corpus is guilty of malfeasance in office.” . . . [P]laintiff was . . . attempting to communicate with a lawyer or relative in order to obtain her release. Defendant prevented her from doing so. We . . . hold that the actions on the part of defendant constitute false imprisonment. . . . A person temporarily committed to an institution pursuant to statute certainly must have the right to make telephone calls to an attorney or relatives. We realize that it may be necessary to restrict visits to a patient confined to a mental institution. However, the same does not apply to the right of a patient to call an attorney or relative for aid in obtaining his release. This does not mean that an individual has an unlimited right to make numerous telephone calls, once he is confined pursuant to statute. Rather, it does mean that such an individual does have a right to communicate with an attorney and/ or a relative in attempt to obtain his release. Dr. Bolter was unable to give any valid reason why a person should not be allowed to consult with an attorney. We do not believe there is such a reason. While problems may be caused in a few cases because of this requirement, the facts in the instant case provide cogent reasons as to why such a rule is necessary. Mrs. Stowers was able to obtain her release after she made the telephone call to her relatives and they, in turn, obtained an attorney for her. Prior to this, because of the order of no communications, she was virtually held a prisoner with no chance of redress. We, therefore, agree with the Court of Appeals that there was sufficient evidence from which a jury could find that Dr. Wolodzko had committed false imprisonment. The Court of Appeals is affirmed. Discussion Questions 1. What other information would you like to have to fully consider this case? 2. Note that this case was decided in 1971 on facts that occurred in the early 1960s. The case may remind readers of the classic movie One Flew Over the Cuckoo’s Nest. At the time, laws addressing involuntary psychiatric commitment were uncommon or nonexistent in some jurisdictions. Research your state’s standards for involuntary commitment and determine how these cases would be handled today. 3. According to the opinion, Stowers was committed on the strength of the statement of two physicians that she was “mentally ill.” What additional evidence would be sufficient today to have someone committed involuntarily? What would the evidence have to prove? Why? 4. What are the procedural steps to follow under the commitment laws of your state? ~ CH05.indd 223 ~ 02/01/23 1:58 PM 224 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Notes 1. Some physicians and hospitals may believe they have full professional liability coverage under their malpractice insurance policies, but those policies typically cover only negligent acts. For example, in Security Ins. Group v. Wilkinson, 297 So. 2d 113 (Fla. App. 1974), the court held that a hospital’s professional liability policy did not cover a breach of contract to treat the plaintiff’s wife. 2. Courts can and often do find legal duties where none existed previously. See discussion of Tarasoff v. Regents of the Univ. of Cal. in chapter 10. 3. Tex. Bus. & Com. Code Ann. §§ 15.50(b), 15.50(c). 4. WellSpan Health v. Bayliss, 2005 PA Super 76, 869 A.2d 990 (2005). 5. Exec. Order No. 14,036—Promoting Competition in the American Economy, 86 FR 36,987, 36,992 (§ 5(g) Further Agency Responsibilities) (July 9, 2021), https://www.govinfo.gov/content/ pkg/FR-2021-07-14/pdf/2021-15069.pdf [https://perma. cc/4XGT-8SCH]. 6. Oliver v. Brock, 342 So. 2d 1 (Ala. 1976). 7. 342 So. 2d at 5. 8. 61 Am. Jur. 2d, Physicians, Surgeons, Etc. § 121 (2022). 9. Angela R. Holder, Medical Malpractice Law 6 (2d ed. 1978). 10. James v. United States, 483 F. Supp. 581, 585 (1980). 11. McNamara v. Emmons, 36 Cal. App. 2d 199, 97 P.2d 503 (1939). 12. Tarasoff v. Regents of the University of California, 17 Cal. 3d 425, 551 P.2d 334 (Cal. 1976). See also Davis v. Lhim, 124 Mich. App. 291, 335 N.W.2d 481 (1983) (a psychiatrist was held liable for discharging a patient who subsequently killed his mother and for failing to warn the patient’s mother). But see Soto v. Frankford Hosp., 478 F. Supp. 1134 (E.D. Pa. 1979). 13. Brady v. Hopper, 751 F.2d 329 (10th Cir. 1984). 14. Freese v. Lemmon, 210 N.W.2d 576 (Iowa 1973). See also Kaiser v. Suburban Transp. Sys., 65 Wash. 2d 461, 398 P.2d 14 (1965), amended by 65 Wash. 2d 461, 401 P.2d 350 (1965) (passengers on a patient bus were allowed to recover damages from the defendant physician); Duvall v. Goldin, 139 Mich. App. 342, 362 N.W.2d 275 (1984) (physician owed a duty to third persons injured in an auto accident after the physician failed to warn his patient not to operate a motor vehicle). 15. David W. Louisell & Harold Williams, Medical Malpractice § 8.08 at 219 (1973). CH05.indd 224 02/01/23 1:58 PM C hap ter 5: C ontrac ts and Intentional Tor ts 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. CH05.indd 225 225 Norton v. Hamilton, 92 Ga. App. 727, 89 S.E.2d 809 (1955). Johnson v. Vaughn, 370 S.W.2d 591 (Ky. 1963). 370 S.W.2d at 596. Payton v. Weaver, 131 Cal. App. 3d 38, 182 Cal. Rptr. 225 (1982). Cal. Health & Safety Code § 1317 (West 1979). See Sallie T. Sanford, What Scribner Wrought: How the Invention of Modern Dialysis Shaped Health Law and Policy, 13 Rich. J. L. & Pub. Int. 337 (2010). A 2009 case involving Grady Memorial Hospital in Atlanta raises a larger issue in the context of undocumented immigrants with ESRD who are not eligible for Medicare or Medicaid and whose clinic at Grady had closed. See Kevin Sack, Hospital Falters as Refuge for Illegal Immigrants, N.Y. Times (Nov. 21, 2009), https://www. nytimes.com/2009/11/21/health/policy/21grady.html [https:// perma.cc/5VEN-XPEN]. Leach v. Drummond Medical Group, Inc., 144 Cal. App. 3d 362, 192 Cal. Rptr. 650 (1983). Cal. Civ. Code § 51. Tresemer v. Barke, 86 Cal. App. 3d 656, 150 Cal. Rptr. 384 (1978). 86 Cal. App. 3d at 672, 150 Cal. Rptr. At 394. Dayna B. Matthew, Just Medicine: A Cure for Racial Inequality in American Health Care (2005). Alexandridis v. Jewett, 388 F.2d 829 (1st Cir. 1968). Stewart v. Rudner, 349 Mich. 459, 84 N.W.2d 816 (1957). Sullivan v. O’Conner, 363 Mass. 579, 296 N.E.2d 183 (1973). Guilmet v. Campbell, 385 Mich. 57, 68, 188 N.W.2d 601, 606 (1971). Mich. Comp. Laws Ann. § 566.132(1)(g) (2009). For the subject of torts generally, see Restatement (second) of Torts. For intentional torts specifically, see Restatement §§ 13–62. Burton v. Leftwich, 123 So. 2d 766 (La. Ct. App. 1960). Mattocks v. Bell, 194 A.2d 307 (D.C. Ct. App. 1963). Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914). Perna v. Pirozzi, 92 N.J. 446, 438, 457, A.2d 431, 461 (1983). Against the urologist, the plaintiff had a cause of action for breach of contract, breach of fiduciary duty, and malpractice. 92 N.J. at 461, 457 A.2d at 439. Mohr v. Williams, 95 Minn. 261, 104 N.W. 12 (1905). Barnett v. Bachrach, 34 A.2d 626 (D.C. Mun. Ct. App. 1943). See generally, 53 C.J.S., Libel & Slander §§ 1–9. 02/01/23 1:58 PM 226 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 41. Shoemaker v. Friedberg, 80 Cal. App. 2d 911, 916, 183 P.2d 318, 322 (1947). 42. Thornburg v. Long, 178 N.C. 589, 101 S.E. 99 (1919). 43. Stowers v. Wolodzko, 386 Mich. 119, 191 N.W.2d 355 (1971). The court also held the psychiatrist liable for assault and battery for giving the patient involuntary medication beyond what was permitted by the statute. 44. Vassiliades v. Garfinckel’s, Brooks Bros., 492 A.2d 580 (D.C. App. 1985). The department store was not liable because it had obtained assurances from the physician that the plaintiff had given her consent. 45. Johnson v. McMurray, 461 So. 2d 775 (Ala. 1984). 46. Hundley v. Martinez, 151 W. Va. 977, 158 S.E.2d 159 (1967). 47. Rockhill v. Pollard, 259 Or. 54, 485 P.2d 28 (1971). 48. 259 Or. at 56–57, 485 P.2d at 29–30. 49. 259 Or. at 55, 485 P.2d at 29. 50. See, e.g., Washington v. Blampin, 226 Cal. App. 2d 604, 38 Cal. Rptr. 235 (1964). 51. Widgeon v. Eastern Shore Hospital Center, 479 A.2d 921 (Md. 1984). 52. Md. Declaration of Rights, Art. 24. CH05.indd 226 02/01/23 1:58 PM CHAPTER NEGLIGENCE 6 After reading this chapter, you will • understand that four essential elements must be proven for a plaintiff to prevail in a negligence case; • know that the standard of care (the duty) in a medical malpractice case is typically established by expert testimony; • grasp that the plaintiff’s injuries must be caused by the defendant’s breach of the duty; • appreciate the goals of medical error disclosure and apology laws; and • see why, under the concept of vicarious liability, one can be liable for the actions of someone else. A s mentioned in chapter 5, a tort is a Even a dog distinguishes between being civil wrong not based on contract. stumbled over and being kicked. The most common type of tort case —Oliver Wendell Holmes Jr., involves negligence, the unintentional failThe Common Law 7 (1881) ure to live up to accepted standards of behavior. Four elements are essential to a case alleging a negligent tort: (1) the duty of care, (2) breach of that duty, (3) injury, and (4) causation. Medical malpractice is a type of negligence. Duty Duty refers to a legal obligation that the defendant (the alleged tortfeasor) owes to the plaintiff. Although in some cases there are very precise standards by which to determine duty, most commonly it is expressed as a general obligation to act with due care—in other words, to conduct oneself as a reasonably prudent person would in similar circumstances. A breach of duty imposes liability if it results in injury to property or another person. The most common negligent tort is a motor vehicle accident. The duty—the standard of care—in such cases may be relatively easy to prove by standard of care The caution and prudence that a reasonable person would exercise under the circumstances or that are required by appropriate authority for such situations. 227 CH06.indd 227 02/01/23 2:00 PM 228 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n relying on such measures as traffic laws (e.g., speed limits, traffic lights), the driving conditions at the time, and common sense about what an average, reasonable driver would have done under the circumstances. Although the reasonably prudent person standard suffices in many tort cases, the most common negligent tort in healthcare—medical malpractice— usually cannot be judged on the basis of such simple criteria. Most jurors are not competent to judge whether a healthcare provider has acted reasonably. The courts have adapted the reasonably prudent person standard for medical malpractice cases so that a physician is measured against other physicians, nurses against other nurses, pharmacists against other pharmacists, and so on. They are not measured against the “average person,” per se. One venerable case stated the rule as follows: “A qualified medical or dental practitioner should be subject to liability, in an action for negligence, if [the practitioner] fails to exercise that degree of care and skill which is expected of the average practitioner in the class to which he belongs, acting in the same or similar circumstances.”1 Courts generally agree with this concept, but, like all legal standards, it is subject to interpretation when applied to specific facts. Interpretation is usually required when determining four aspects of duty in malpractice cases: 1. What would a “reasonable” healthcare provider do under these circumstances? 2. If the standard is not a national one, where should it be found? 3. What school of medicine (“school rule”) would other providers follow in this case? 4. Are the profession’s standards adequate? These questions are considered in the following paragraphs. Expert witnesses, whose role will be discussed in more detail later in the chapter, are used to help the jury answer these questions. Expert witnesses also opine about whether the defendant has met the duty that has thus been ­established—that is, whether the provider has met the standard of care or has breached it. The Reasonable Provider In general terms, healthcare providers are required to provide only “reasonable and ordinary” treatment. Their actions are not typically judged against those of their most knowledgeable and highly skilled colleagues but against the knowledge and skill of an average provider in the same line of practice. For example, if several methods of treatment for a patient’s condition are available, a provider’s treatment would not be considered malpractice simply because other providers might have opted for one of the alternative CH06.indd 228 02/01/23 2:00 PM C hap ter 6 : N egligenc e 229 treatment methods. Thus, the courts usually hold that the provider is not liable if the chosen treatment would be recognized by a “respectable minority” of the medical profession, even if most providers would have adopted another treatment plan.2 In one case, a surgeon damaged the patient’s laryngeal nerves while performing a thyroidectomy.3 In her subsequent lawsuit, the patient did not claim that the physician was reckless; rather, she claimed that the medical community recognized two possible surgical procedures for her condition and that the defendant should have chosen the other one. The Delaware Supreme Court rejected this argument because the evidence showed that the two methods were equally acceptable, the risk of nerve damage was roughly the same for the two procedures, and the choice of method was a matter of the physician’s professional judgment. A more difficult problem arises when the provider treats the patient by a method that even a respectable minority would deem unacceptable because it verges on experimentation. When standard methods have failed, however, providers might reasonably turn to innovative techniques if the condition is sufficiently serious. In one case, a surgeon performed an unorthodox operation on a patient’s ankle after trying standard techniques and other physicians had advised amputation.4 The court held that the operation was justified as a last resort. By way of contrast, a provider who performs an experimental procedure before attempting standard methods risks being found to have acted negligently. In one instance, a physician treating a baby for a curvature of the spine used a surgical procedure he had developed but no one else had used. The baby died after suffering a severe hemorrhage. In the lawsuit that followed, the court found both the doctor and the hospital liable for not disclosing to the baby’s parents that the procedure was unorthodox.5 The Neighborhood: Local, State, or (Usually) National The second aspect of duty compares the treatment in question with that used by providers “in the same neighborhood.” Originally, the neighborhood was considered to be the town or small region where the provider practiced and similar areas elsewhere in the state or the nation. This principle is called the locality rule because it measures the standard of care in a given instance solely by the practices of other providers in the same or a similar locality. The traditional locality rule was based on the theory that doctors in remote areas should not be held to the same standards of medical expertise as those in urban areas because of the difficulties of communication and travel and because they had limited opportunities to keep abreast of medical advances. It also relied on the fact that in such areas, providers were often forced to practice in inadequate hospital facilities.6 In most states, the CH06.indd 229 02/01/23 2:00 PM 230 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n COVID Connection It has long been recognized that during public health crises and other major emergencies, it is not always possible to give every patient the optimal care they would otherwise receive. This was especially so during the COVID-19 pandemic, when crushing loads of complicated, infectious patients caused shortages of stuff, space, and staff. In the face of those shortages, medical practice changed in myriad ways. Single-use masks were reused and ventilators were reconfigured for dual-patient use. Patients were housed in repurposed rooms, and nurses took on higher patient loads. Elective procedures were canceled, and routine screenings were postponed. Even patients in the intensive care unit were left alone for long stretches. In response to these challenges, individual hospitals, geographic regions, and even whole states explicitly invoked crisis standards of care (CSC), which are guidelines to be followed when overwhelming demand means that services must be rationed. Invoking CSC may add a level of liability protection for healthcare workers and facilities when it is impossible to provide a normal level of care. Under common law, of course, the standard is “due care under the circumstances,” whether CSC have been adopted or not. Although CSC predated the COVID-19 pandemic, the extraordinary length of the crisis and the severity of COVID patients’ conditions will severely test the standards’ “reasonableness.” It remains to be seen how courts and juries will interpret CSC, in what situations the standards actually provide protection from liability, and how they will affect care during future crises. crisis standards of care (CSC) The optimal level of care that can be delivered during a catastrophic event or public health emergency that requires substantial changes to normal healthcare operations. CH06.indd 230 traditional locality rule has given way to a broader standard because the original reasons for the rule have all but disappeared.7 As one court stated, Locality rules have always had the practical difficulties of: (1) a scarcity of professional people in a locality or community qualified [or willing] to testify; and (2) treating as acceptable a negligent standard of care created by a small and closed community of physicians in a narrow geographical region. Distinctions in the degree of care and skill to be exercised by physicians in the treatment of patients based upon geography can no longer be justified in light of the presently existing state of transportation, communications, and medical education and training which results in a standardization of care within the medical profession. There is no tenable policy reason why a physician should not be required to keep abreast of the advancements in [their] profession.8 For these reasons, the court in that case held that “the language ‘same neighborhood’ . . . refer[s] to the national medical neighborhood or national medical community, of reasonably competent physicians acting in the same or similar circumstances.”9 This newer, broader standard is all the more reasonable given national accreditation standards for medical education, national certification for medical board specialties, and advances in communications technology, including the internet. Today, a majority of jurisdictions employ the national standard in malpractice cases. Even where the law ostensibly follows a state standard, expert witnesses will typically testify that they know what the state standard is and that it is the same as the national standard. For providers who practice under conditions that are less than ideal, the burden of meeting a national standard is alleviated somewhat by permitting “justifiable circumstances” as a defense.10 For example, a nurse practitioner would not be responsible for providing a higher level of care if the necessary 02/01/23 2:00 PM C hap ter 6 : N egligenc e 231 facilities or resources for that care are not available. The test is what is reasonable under the circumstances. All surrounding circumstances are to be considered in determining whether there was a breach of the standard of care. The School Rule The third consideration is whether the care is comparable to that of providers “in the same general line of practice.” This principle, sometimes called the school rule, is a throwback to the days when the schools of treatment were school rule strictly divided. For example, traditional Western medicine as practiced by The principle that healthcare MDs—the allopathic school—treats disease by using agents, such as antibiot- practitioners are ics, that oppose the patient’s symptoms. The homeopathic school posits that judged by the to cure a patient’s symptoms, the doctor should give medicine that would standards of their cause in healthy people the same set of symptoms that the patient exhibits. own branch of medicine. Practitioners of osteopathic medicine and chiropractic medicine, at least in the “pure” form of their art, emphasize manipulative techniques to correct bodily anomalies thought to cause disease and inhibit recovery. Although still recognized, the distinctions among these schools have blurred, leaving what is sometimes called the “regular practice of medicine.” For example, for many years, osteopathy was not considered regular medicine in some states, and osteopaths were not allowed to prescribe drugs or perform surgery; they were judged only by the standards prevailing in their own discipline.11 Today, however, all states allow osteopaths to perform surgery and prescribe drugs, and they are regarded as part of the regular practice of medicine. The school rule remains important, however, because a few branches of medicine still exist and the trend is toward specialization. Moreover, nonphysician providers such as pharmacists, occupational and physical therapists, and others are judged by standards that correspond to their “school” of practice. Alternative forms of treatment such as acupuncture, herbal medicine, faith healing, naturopathy, massage, music therapy, and aromatherapy claim numerous adherents (see Legal Brief). These techniques are known to improve psychological and physical well-being in some circumstances, and their practitioners, who usually do not have medical degrees, generally apply them without promising or implying that they are practicing medicine. They are not, therefore, judged by the standards of medical practice unless they stray from their area of expertise. If they do, they may be judged against the standards taught in traditional medical Legal Brief schools and may be accused of practicing medicine without a license. In applying the school rule, courts The school rule becomes significant in cases involving complementary and alternative medicine. (See must decide whether the school is legitifurther discussion of this topic in chapter 8.) mate. Legitimacy generally depends on whether rules and principles of practice CH06.indd 231 02/01/23 2:00 PM 232 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n have been set up to guide the school’s members in treating patients. When the standard of care is in question, the existence of licensing requirements will usually suffice as recognition of a separate school.12 In one early case, the court did not recognize a spiritualist’s practice as following a school of treatment because the practitioner’s only principle was to diagnose and treat disease by means of a trance. Because there was no legitimate school, the practitioner was held to the standards of mainstream medical practice.13 In the case of a Christian Science practitioner, however, the court held the defendant to the standard of care, skill, and knowledge of ordinary Christian Science healers because he belonged to a recognized school.14 The school rule standards also hold nonphysician practitioners responsible for knowing which diagnoses are in their area of practice and which cases should be referred to a licensed physician for standard treatment. For example, in Mostrom v. Pettibon, a chiropractor was held liable for not identifying medical problems for which chiropractic treatment was not appropriate.15 Even allopathic physicians can be held responsible for failing to refer a case to a specialist if the problem is beyond their training and experience. For example, a general practitioner was held liable for negligence when a patient died of a hemorrhage after coughing up blood for two days. The court found that the physician should have grasped the seriousness of the patient’s condition and called in a thoracic surgeon, who might have saved the patient’s life.16 Assuming that a general practitioner remains in their area of expertise and does not fail to refer a patient to a specialist when required, most courts apply the standards of other general practitioners and not those of specialists.17 Physicians who present themselves as specialists, however, are held to a higher standard of care than that to which general practitioners are held.18 Practitioners who are licensed, trained, or credentialed only in certain fields of medicine are held to higher standards of care if they go beyond their ken. This situation has arisen not only with licensed practitioners such as chiropractors and podiatrists but also with nurses, medical students, and other clinical personnel. In Thompson v. Brent, a medical assistant working in an orthopedist’s office was held to the standard of care required of physicians when using a Stryker saw to remove a cast.19 The Standard of Care in a Post–Roe v. Wade World The US Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, which removed federal constitutional protections for abortion, raises myriad standard-of-care questions for providers. (See chapter 15 for a full discussion of Dobbs.) What is the permissible scope of abortion services CH06.indd 232 02/01/23 2:00 PM C hap ter 6 : N egligenc e 233 based on a particular state’s law? How could an organization’s policies be structured to comply and also support appropriate patient care? Under what circumstances could or must a licensed healthcare provider counsel a patient about abortion services if inducing the abortion would be prohibited in that jurisdiction? Does it matter whether pregnancy is a complicating factor for the patient’s primary diagnosis (e.g., cancer, infectious disease, or mental illness)? Does failure to provide abortion counseling or certain prenatal testing procedures amount to professional negligence? If state law ostensibly prohibits counseling, would the First Amendment’s right to freedom of speech serve as a defense to civil or criminal liability? If a medication has abortifacient effects, will it be available for other indications? Further, what are the implications of Dobbs for providers who are licensed in multiple states? May a state in which abortion is illegal revoke a provider’s license if the provider induces an abortion in a state where the procedure is legal? May a licensing board or hospital medical staff discipline a provider in such a case? Is there possible civil or criminal liability for assisting or enabling a someone to obtain an abortion in another state? Is it permissible to provide telemedicine across state lines when the two states’ abortion laws differ? Similarly, may medication to induce abortion be prescribed or provided across state lines? Does it matter whether the pregnant patient’s health or life is in jeopardy? Will those who provide emergency abortion treatment consistent with national standards of care risk license revocation, civil penalties, or jail time? In short, the legal landscape around medical care for pregnancy-related emergencies in abortion-restrictive states creates risks both for patients and providers. Finally, what might be the effect of abortion laws on the standard of care for infertility clinics? In vitro fertilization (IVF) typically results in the formation of multiple embryos, not all of which are implanted in a woman’s uterus to begin a pregnancy. In states where “personhood” is considered to begin at the moment of fertilization, does the destruction of embryos that were not implanted fall within the definition of “abortion”? If so, what is the potential civil and criminal liability for infertility clinic personnel? If preimplantation embryos are stored in a freezer, what is their status? Can those embryos be shipped to another state to be discarded? Does the liability of IVF specialists depend on the tenacity of local prosecutors? These and many other questions will need to be litigated repeatedly in the coming years, and the number of different answers is likely to grow exponentially. Lawyers, consultants, and judges are assured of full employment because of the Dobbs decision. While this plays out, providers will face standard-of-care and professional ethics conundrums, and patients will suffer. CH06.indd 233 02/01/23 2:00 PM 234 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n The Substandard Profession: Helling and Mammograms A final aspect of duty concerns the profession itself. Physicians are usually judged by what other physicians would do under the circumstances; however, on rare occasions, courts have found the profession’s own standards inadequate. In so doing, they have found negligence “as a matter of law” from the facts of the case. This sort of decision is relatively uncontroversial in nonmedical contexts. In the context of for-profit businesses, few would dispute the 1932 observation by the aptly named Judge Learned Hand that “a whole calling may have unduly lagged in the adoption of new and available devices.”20 That case involved commercial boats that would not have sunk had they carried readily available radios capable of receiving storm forecasts. As applied to healthcare professionals, though, there is significant pushback against the idea that their own standards could be legally inadequate. In Favalora v. Aetna Casualty & Surety Co., a 71-year-old patient fell while being x-rayed. She suffered numerous injuries, including a fractured femur.21 The patient’s subsequent prolonged hospitalization brought on a pulmonary embolism and a kidney infection. In bringing suit, the patient claimed that the fall would not have occurred if her radiologist had examined her medical records, which documented her history of sudden fainting spells. It was not the practice of radiologists to review a patient’s medical history; their role was merely to take and interpret “pictures.” When the judge explained the legal standard to the jury in this way, it returned a verdict for the defendant. The appellate court reversed the decision, however, believing that the accepted practices of the radiology profession were inadequate. In reaching this decision, the court looked to the custom of teaching hospitals, which did require radiologists to examine patients’ histories. Favalora received little attention, perhaps because the case was decided in Louisiana, a state not often considered a legal bellwether. However, 12 years later, in 1974, a landmark case from Washington State caused a furor in medicolegal circles. Barbara Helling, the plaintiff, had been treated by two ophthalmologists from 1959 until 1968 for difficulties with her contact lenses. After Helling was diagnosed with glaucoma in 1968, she sued her former ophthalmologists and alleged that her vision was permanently damaged because they did not conduct some simple tests nine years earlier. Although she argued that her eye problems should have prompted them to test her for glaucoma, the issue on appeal was different: whether she should have been tested for glaucoma as a routine matter. According to expert witnesses for the defense, the standard of practice at the time did not require routine testing for glaucoma in patients younger than age 40, and thus both the trial and appellate courts found for the CH06.indd 234 02/01/23 2:00 PM C hap ter 6 : N egligenc e ophthalmologists, because Helling was under 40 at the time they treated her. The Supreme Court of Washington disagreed, however; it held that reasonable prudence may require a standard of care higher than that actually practiced by the profession, and it reversed the trial court’s decision and remanded the case for a new trial on the issue of damages (see The Court Decides: Helling v. Carey at the end of this chapter). Reaction to Helling This decision sent shock waves through the physician community, and many assailed Helling as judicial impertinence toward the medical profession. In response, the Washington State legislature passed a statute that purported to overturn the Helling rule: 235 positive predictive value The probability that subjects with a positive screening test truly have the condition tested for. In any civil action for damages based on professional negligence against a hospital . . . or against a member of the healing arts . . . the plaintiff in order to prevail shall be required to prove by a preponderance of the evidence that the defendant or defendants failed to exercise that degree of skill, care, and learning possessed at that time by other persons in the same profession, and that as a proximate result of such failure the plaintiff suffered damages.22 Despite the statute, a later case, Gates v. Jensen, held that Helling’s rule was still in effect.23 The Gates court noted that the original bill had used the word “practiced” rather than “possessed,” as in the version that passed the legislature (quoted earlier). According to the court, the change in the bill prior to enactment showed that the standard was not limited to what members of the profession actually did but could be extended to what they ought to have done. The reaction to the Helling decision might have been different—and the case might have been decided differently—had more critical analysis been undertaken at trial. Tonometry, the test that Helling argued should have been used, measures intraocular pressure and produces a relatively high number of false positives. In other words, its positive predictive value is low, perhaps as CH06.indd 235 Legal Brief Consider this example of positive predictive value. Say the prevalence of a hypothetical disease is 1 percent. In a population of 25,000, there should be 250 actual cases. If the diagnostic test is 95 percent accurate, it will accurately diagnose about 237 of those cases (95 percent × 250), but it will falsely diagnose as positive 1,238 others (5 percent × the remaining 24,750), who we postulate do not have the disease. Thus, there will be a total of 1,475 positive test results, but only about 16 percent of them will be true positives (237 ÷ 1,475). Each positive test result will require further diagnostic procedures, which undoubtedly will contribute to higher costs and a heightened level of patient anxiety. Negative test results are similarly unrealistic and may lead to a false sense of security in the 13 persons who have the disease but tested negative. 02/01/23 2:00 PM 236 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n low as 5 percent, according to a 1989 report by the US Preventive Services Task Force (PSTF), an independent advisory panel charged with conducting impartial assessments of scientific evidence (see Legal Brief).24 Given the inaccuracy of tonometry tests, the relatively low incidence of the disease in younger persons, and some disagreement about the effectiveness of existing treatment options, there is a question as to whether universal glaucoma screening makes good sense as public policy, irrespective of Helling’s outcome. Similar issues of false-positive and false-negative results attend other diagnostic tests, such as prostate-specific antigen screening for prostate cancer. Science Versus Politics The Washington legislature’s involvement in the issue is an example of political interference in what should be a scientific issue. Another example occurred in late 2009, when the PSTF recommended changes to the standards for mammography screening. After reviewing the efficacy of five types of breast cancer screening, the group recommended against routine screening mammography for women younger than age 50. Rather, the PSTF stated, “The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and [should] take into account patient context, including the patient’s values regarding specific benefits and harms.”25 The mammogram issue was virtually the opposite of the question about glaucoma testing in the Helling case 25 years earlier. Whereas in Helling, the professional practice (standard of care) not to screen routinely was considered too loose a standard, a practice of regular mammography screening was considered too strict. Ocular tonometry is a relatively risk-free procedure, but certain harms can attend frequent mammograms. According to the PSTF, these include: psychological harms, unnecessary imaging tests and biopsies in women without cancer, and inconvenience due to false-positive screening results. Furthermore, one must also consider the harms associated with treatment of cancer that would not become clinically apparent during a woman’s lifetime (overdiagnosis), as well as the harms of unnecessary earlier treatment of breast cancer that would have become clinically apparent but would not have shortened a woman’s life. Radiation exposure (from radiologic tests), although a minor concern, is also a consideration.26 The timing of the mammogram recommendations was unfortunate. They were issued during the debate over President Barack Obama’s health reform initiative, which coalesced to become the Affordable Care Act. The CH06.indd 236 02/01/23 2:00 PM C hap ter 6 : N egligenc e thoughtful and nuanced approach taken by the group of scientists was lost on politicians, much of the media, and virtually all of the public. The report became a political football and an occasion for demagoguery, partisan posturing, and political interference in medical practice (see Mammograms in the Affordable Care Act Debate). Nevertheless, opinions such as that of the PSTF provide evidence to consider when determining the standard of care in malpractice cases. Breach of Duty Once the duty (the standard of care) has been established, the plaintiff must show that the defendant breached that duty by presenting evidence of the facts of the case and testimony from expert witnesses regarding whether the standard was met. Typically, these are the same witnesses who helped establish the duty in the first place. Expert Witnesses 237 Mammograms in the Affordable Care Act Debate In 2009, then Senate majority leader Harry Reid called the PSTF’s recommendations “outrageous” and added, “Women should be able to go get a mammogram and not have to wait until they are 50 years old,” which of course is not what the recommendations said. In an editorial in the Washington Post, the American Cancer Society’s chief medical officer called the recommendations “a step backward in the fight against breast cancer.” A New York radiologist surmised that the guidelines were “the first death panel” and must have been ordered by someone in the White House (see R. Langreth & R. Ruiz, Mammogram Debate Shows Why Reform Will Fail, Forbes [Nov. 19, 2009], https://www.forbes.com/2009/11/19/ mammogram-guidelines-cancer-business-healthcare-obamacare/?sh=22605e02699b [https:// perma.cc/ZH7P-QHUY]). An editorial in the New York Times noted the controversy, saying, “Opponents of the health care reform bills moving through Congress have seized on the new recommendations as evidence that the government is seeking to put bureaucrats between you and your doctor or that it would ration care by denying coverage for some mammograms that are now covered.” The opinion concluded that the issue should be a matter for medical professionals and patients to decide, and that it “should not be injected into the partisan debate over health care reform” (Editorial, The Controversy Over Mammograms [Nov. 19, 2009], https://www.nytimes. com/2009/11/20/opinion/20fri1.html [https:// perma.cc/4X6X-56G6]). Unlike lay witnesses, experts are not limited to testifying about facts. They may express opinions about the nature and cause of a patient’s illness or injury, whether the defendant treated it properly, and the likely future effects on the patient. Expert witnesses must have two qualifications. First, they must be familiar with the practice of medicine in the area in question, which now is likely the whole nation.27 Finding physicians in a particular town to testify against their colleagues and friends can be a daunting task; among trial lawyers, this situation is sometimes referred to as the “conspiracy of silence” (see Legal Brief). If a national standard applies, any otherwise qualified expert in the country is acceptable. A national standard of care therefore eases the plaintiff’s burden of finding a willing expert, and this is another reason the locality rule was relaxed. CH06.indd 237 02/01/23 2:00 PM 238 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n Second, expert witnesses must be professionally qualified. The basic Legal Brief requirement is knowledge of the standard practice involved in treating the In an Ohio case, the court noted that “[l]ocating an patient’s condition. They need not pracexpert to testify for the plaintiff in a malpractice tice the same specialty or even follow the action is known to be a very difficult task, mainly same school of medicine (though most because in most cases, one doctor is reluctant attorneys prefer that both be true), but and unwilling to testify against another doctor. they must be familiar with the type of Although doctors may complain privately to each other about the incompetence of other doctors, treatment involved in the patient’s case. they are extremely reluctant to air the matter pubFor example, specialists may testify about licly” (Faulkner v. Pezeshki, 44 Ohio App.2d 186, the standards for general practitioners if 193–94, 337 N.E.2d 158, 164 [1975]). they are knowledgeable about them even though they themselves do not practice as general practitioners.28 The plaintiff must “lay a foundation” for expert testimony—that is, persuade the judge that the witness has the appropriate training and experience to qualify as an expert. If the judge decides that the witness meets the qualifications, the testimony is allowed, and the jury decides what weight to give it. For example, in Gilmore v. O’Sullivan, an obstetrician/gynecologist’s negligence was alleged in the prenatal care and delivery of the plaintiffs’ son. The court refused to permit the plaintiffs’ expert to testify because he was not board certified in obstetrics/gynecology, there was no evidence of the number or types of maternity cases he had handled, he had not delivered a baby in more than 20 years, he had not performed surgery in 14 years, and he had pursued no research in or study of obstetrics/gynecology in recent years.29 In a case in Hawaii, a physician who often employed alternative medicine in his general practice was deemed unqualified to testify as an expert witness on the cause of his patient’s symptoms following breast implantation by a general surgeon. The court noted, Dr. Arrington does not possess any education, training, or experience with silicone. He is a general practitioner with an orientation toward holistic medicine and alternative therapies, such as nutritional, vitamin, and herbal remedies. He is not a pathologist, general surgeon, plastic surgeon, or an immunologist. Prior to moving to Hawai’i, Dr. Arrington practiced with chiropractic, naturopathic, and holistic medicine specialists. Nothing in Dr. Arrington’s background or experience suggested that he would be competent to testify regarding the effects of silicone on the human body.30 Medical Error Disclosure and Apology Laws When medical errors occur, patients and their family members want to know about them and want those responsible to express genuine remorse. And CH06.indd 238 02/01/23 2:00 PM C hap ter 6 : N egligenc e most providers want to disclose and apologize for errors and to express sympathy for a bad outcome, regardless of whether it stemmed from negligence. Ethical principles support this kind of transparency, but a medical “culture of silence” works against it. In addition to the challenge of knowing how to conduct such a difficult communication, providers cite concerns that their statements could be used against them in a subsequent medical malpractice trial.31 To allay these fears, as of 2020, 39 states and the District of Columbia had adopted apology laws.32 These laws differ in their particulars, but they generally provide that a healthcare provider’s prompt apology, expression of sympathy, offer of compensation, or similar statement is inadmissible in a subsequent malpractice trial. In the nine states with full apology laws, statements of fault are explicitly protected. In states with partial apology laws, it can be unclear what beyond an expression of sympathy is protected. Without statutory protection, such out-of-court statements might be used as evidence in court under the typical “admission against interest” exception to the hearsay rule. A recent Arizona case illustrates how these protections can function. During a vaginal delivery, one of Sean and Jodie Coleman’s twins suffered brain damage. In deposition statements, the Colemans testified that their obstetrician, Dr. Amon, told them that he was sorry, that he felt he had let them down by not making sure the on-call obstetrician followed the preexisting plan for a cesarean section, and that a surgical delivery might have avoided the brain damage. (Dr. Amon recalled these conversations differently.) Citing Arizona’s “I’m Sorry Statute,” the trial court prevented the parents from introducing these statements into evidence during trial as an admission against interest. The appeals court upheld that decision and the constitutionality of the law, noting that although the law “excludes potentially relevant evidence for certain purposes, it furthers the legislature’s policy goal of encouraging healthcare providers to speak with patients freely and with compassion about adverse or unforeseen medical outcomes without fear their words might later be used against them in litigation.”33 (Appendix 6.2 includes the text of Arizona’s law and a “partial apology” law from the state of Michigan.) It must be noted that the underlying facts that prompt an apology are not shielded by an apology law; the usual means of proving one’s case in court still apply. Furthermore, of course, a non-apology such as “I’m sorry you feel that way” or an apology without an attempt at remediation might ring hollow and, in fact, could spur aggressive litigation. Key purposes of apology laws are to reduce the number of medical malpractice cases, lower overall payouts, and, ultimately, decrease the instances of medical error. In theory, transparency about the facts should reduce the need to file suit to learn the truth of what happened, prompt an effort at appropriate compensation, and lead to improvement in the quality of care in the future. Evidence about whether apology laws achieve these ends CH06.indd 239 239 hearsay Information not personally known by a witness that is offered to prove the truth of the matter asserted. Hearsay is generally inadmissible because its truth cannot be verified through crossexamination of that witness. An admission against interest is one of the many exceptions to the hearsay rule because it is considered inherently reliable. 02/01/23 2:00 PM 240 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n remains preliminary and equivocal, though research suggests that full apology laws are more likely to achieve their purposes than partial ones.34 Furthermore, the evidence to date does not fully consider the increasing use of communication and resolution programs (CRPs). In CRPs, health systems and liability insurers encourage disclosure of unanticipated outcomes and proactively seek resolution, including apology, explanation, and compensation. The most comprehensive of these programs incorporate communication training and systemic response to prevent recurrence. While CRPs are still in their infancy and depend on strong institutional leadership, initial reports show promising outcomes.35 Other Evidence of the Standard In some instances, a plaintiff is permitted to introduce medical treatises as evidence to prove the standard of care. Because medical publications are hearsay—out-of-court statements offered to prove the truth of the matter asserted—most states limit their use to impeaching (i.e., challenging) the credibility of an expert witness or reinforcing the opinion given in an expert’s testimony.36 A few states, however, permit medical treatises to be used as direct evidence to prove the standard of care. In a Wisconsin case, the court took “judicial notice” of the standard of care set forth in a loose-leaf reference service, Lewis’ Practice of Surgery, to determine whether an orthopedic surgeon was negligent in performing surgery for a ruptured disk.37 In states that use the Wisconsin approach, the author must be proved to be a recognized expert or the publication to be a reliable authority. Written rules or procedures of the hospital, regulations of government agencies, standards of private accrediting agencies, and similar published material may be admissible to show the requisite standard of care. The landmark decision of Darling v. Charleston Community Memorial Hospital held, among other things, that the standards of The Joint Commission on Accreditation of Hospitals (now The Joint Commission) and provisions of the hospital’s medical staff bylaws were admissible as evidence that the hospital was negligent in failing to review the physician’s hospital practice.38 Darling is also a case, like Helling, in which the court found inadequate the practice of an entire calling, namely: hospital administration (see chapter 7 for more details about Darling). Similarly, a statute or other law may be used to establish the standard of care. Negligence that is established by showing a violation of law is negligence per se. This doctrine requires that several elements be proven, including that: 1. violation of the statute occurred and an injury resulted, 2. the injured person was one whom the statute was meant to protect, and 3. the harm was the type that the statute was enacted to prevent.39 CH06.indd 240 02/01/23 2:00 PM C hap ter 6 : N egligenc e In Landeros v. Flood, the defendant physician examined an 11-monthold child. She was suffering from a fracture of the right tibia and fibula, an injury that appeared to have been caused by a twisting force. Her mother gave no explanation for the injury, but in fact, she and her common-law husband had abused the child repeatedly. The physician failed to diagnose battered child syndrome, and he did not take X-rays that would have revealed a skull fracture and other injuries. The child was returned home, where she was again severely injured. Because the matter was not reported to the authorities as required by law, the court allowed the child’s guardian ad litem (from the Latin word litem, meaning “lawsuit”) to bring suit on the child’s behalf against the doctor and the hospital. “Plaintiff is entitled to prove by expert testimony that defendants should reasonably have foreseen that her caretakers were likely to resume their physical abuse and inflict further injuries on her if she were returned directly to their custody.”40 Similar laws require that abuse of other vulnerable persons also be reported. 241 guardian ad litem A person appointed by a court to represent the interests of a minor or an incompetent person, typically during a court proceeding. Inexcusable Outcomes (“Adverse” or “Never” Events) In some cases—for example, when the outcome is so egregious that it is indefensible—no expert testimony is required to establish professional negligence.41 (Although the error is obvious, expert testimony would usually still be required to establish damages.) One example of a “never event” is surgery conducted on the wrong body part. One such error resulted in the Legal Brief removal of a patient’s healthy left kidney when the plan was to remove the other The Joint Commission’s National Patient Safety one due to cancer.42 This error left the Goals state, “Wrong-site surgery should never patient facing a lifetime of dialysis and the happen, yet it is an ongoing problem in healthcare hospital facing huge fines and tort liability. that compromises patient safety.” It recommends Another example is shown by marking the procedure site as one way to protect Hammer v. Rosen,43 in which three lay patients from this error “when there is more than witnesses testified that the defendant had one possible location for a procedure. Examples include different limbs, fingers and toes, lesions, beaten an incompetent psychiatric patient. level of the spine, and organs.” Some observers The defendant physician claimed that suggest that marking the wrong site is prudent without expert testimony, the plaintiff as well. (See National Practice Safety Goals Effeccould not prove that the beatings devitive January 2021, The Joint Comm’n, https://www. ated from standard treatments, but the jointcommission.org/-/media/tjc/documents/ court held otherwise, because “the very standards/national-patient-safety-goals/2021/ npsg_chapter_obs_jan2021.pdf [https://perma. nature of the acts complained of bespeaks cc/F2XT-4X4J].) improper treatment and malpractice.” (Why experts were not asked to testify is CH06.indd 241 02/01/23 2:00 PM 242 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n not clear from the opinion, but the plaintiff’s attorneys may have thought it unnecessary. As things turned out, they were right.) In 1999, the Institute of Medicine issued the report To Err Is Human, which estimated that as many as 98,000 people die in US hospitals each year as a result of serious medical errors. This number may significantly understate the problem, however; another estimate is that more than four times that many people die each year from hospital errors.44 There are at least two dozen types of untoward medical occurrences that can result in injury or death and are usually preventable. Some would not require expert testimony to establish negligence. The National Quality Forum categorizes them as seen in appendix 6.1. Res Ipsa Loquitur res ipsa loquitur A rule of law that even when there is no specific evidence of negligence, one is presumed to have been negligent if one had exclusive control of the cause of the accident or injury that could not have happened without negligence. Perhaps the most complex exception to the need for expert testimony is the doctrine of res ipsa loquitur (Latin for “the thing speaks for itself”). Res ipsa, as it is commonly known, dates back to Byrne v. Boadle, an English case decided more than a century and a half ago.45 Plaintiff Byrne was walking down the street when he was hit by a barrel of flour that had rolled out of the upper level of a warehouse owned by defendant Boadle. The precise negligent act or omission was never determined, but the court found Boadle responsible because barrels of flour do not fall out of buildings unless someone has been negligent. The fact that this one did so “spoke for itself.” Three conditions must be present for res ipsa to apply: 1. The accident or injury must be of a type that normally would not occur without someone’s negligence. 2. The defendant must have had sole control of the apparent cause of the accident or injury. 3. The plaintiff could not have contributed to the accident or injury. The judge determines whether the doctrine applies in a particular case. Once a judge decides that res ipsa applies, an inference of negligence has been created, meaning that the case must go to the jury, which can then decide for the plaintiff or the defendant. Though res ipsa is not commonly used in cases that get as far as a trial, it can be helpful in medical malpractice cases because it is sometimes impossible for patients to know the precise cause of their adverse outcome, particularly if they were anesthetized during the treatment. A plaintiff who is permitted to invoke res ipsa can prevail even without proving that the defendant committed specific negligent acts. (Plaintiffs’ attorneys would prefer, however, to point to specific negligent acts in making their case rather than to rely on res ipsa, because proving specific negligence has a more dramatic effect on the jury.) CH06.indd 242 02/01/23 2:00 PM C hap ter 6 : N egligenc e 243 Requirement 1 The primary difficulty for malpractice plaintiffs in res ipsa cases is the first requirement: the accident or injury must be of a type that normally would not occur without someone’s negligence. The general test is whether, on the basis of common knowledge and ordinary experience, someone could infer that the defendant was negligent. In one example, a patient underwent surgery for removal of part of his colon.46 The incision was closed with sutures, but eight days later, it opened and a second operation was required to close it. The court held that res ipsa did not apply because a layperson would not know whether the incision failed to close because of the physician’s negligence or for some other reason. Thus, the doctrine cannot be based simply on bad treatment outcomes. In contrast, laypersons clearly understand that leaving foreign objects in a patient after surgery is negligence, and res ipsa is frequently used in such cases. In fact, this is often the example given when teaching law students about the doctrine. In Jefferson v. United States, the plaintiff was a soldier who had undergone a gallbladder operation.47 Eight months later, after he had been suffering spells of nausea and vomiting, another operation disclosed that a towel had eroded his small intestine. It was 30 inches long and 18 inches wide and marked “Medical Department US Army.” In this case, the thing almost literally “spoke” for itself! Requirement 2 In addition to showing that the accident or injury would not normally occur without someone’s negligence, the plaintiff must show that the defendant had sole control of the apparent cause of the accident or injury. This requirement can be a problem for malpractice plaintiffs. In cases involving surgery, there is often more than one defendant, and traditionally res ipsa cannot be applied in an action involving multiple defendants if any one of them alone might have caused the plaintiff’s injury.48 A major departure from the rule, however, was the California case of Ybarra v. Spangard.49 After an appendectomy, the plaintiff felt sharp pains in his right shoulder and later suffered paralysis and atrophy of the shoulder muscles. The subsequent suit went to a California appellate court, which allowed the use of res ipsa against all the defendants who had any control over the patient while he was anesthetized. They included the surgeon, the consulting physician, the anesthesiologist, the owner of the hospital, and several hospital employees. The court held, [W]here a plaintiff receives unusual injuries while unconscious and in the course of medical treatment, all those defendants who had any control over his body or the instrumentalities which might have caused the injuries may properly be called upon to meet the inference of negligence by giving an explanation of their conduct.50 CH06.indd 243 02/01/23 2:00 PM 244 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n Ybarra is by no means the majority view: it has been questioned by numerous authorities, and its applicability is extremely fact dependent. It is mentioned here, however, for the sake of thoroughness. gross negligence A lack of even slight diligence or care; the omission of even such diligence as careless and inattentive people would exercise in avoiding danger to their own person or property. Requirement 3 The third requirement for the use of res ipsa is showing that the plaintiff could not have contributed to the accident or injury. In many cases, this requirement is not difficult: a patient under anesthesia, for example, clearly has no responsibility for events that transpired during the surgery. However, if the injury could have been caused at least in part by the plaintiff’s negligence, res ipsa loquitur will not apply. In Rice v. California Lutheran Hospital, a hospital employee left a cup, saucer, tea bag, and hot water on a table beside a patient who was recovering from surgery and under the influence of painkilling drugs.51 Scalding water spilled on the patient, who claimed that res ipsa should apply because the injury occurred while she was under sedation and did not understand what was going on. The court held that the doctrine did not fit this case because witnesses testified that the plaintiff confessed to spilling the water on herself and that she was awake and alert at the time. As all these cases show, the applicability of res ipsa loquitur depends on the facts of each individual case. Where it applies, settlement is likely or, if a settlement agreement proves elusive, perhaps a trial, arbitration, or mediation on damages alone would be possible. Good Samaritan Statutes Good Samaritan statutes, discussed more completely in chapter 11, typically provide a defense for healthcare providers who voluntarily render aid at the scene of an accident even if they do so negligently (see Legal Brief). Sometimes these statutes cover laypeople as well. These statutes, which most states Legal Brief have in some form, commonly provide that healthcare providers who voluntarily provide emergency care will be held liable One might question the need for Good Samaritan only if they act in a grossly negligent manstatutes. Given that negligence is judged according to the standard of “due care under the circumner.52 There is also a federal rule to this stances,” it can be argued that nothing short of effect that applies in the air, on airplanes. gross negligence could lead to liability for renderMost of these statutes do not ing care in a true emergency. require anyone to assist in emergenIn fact, research fails to reveal any cases in cies, but they do protect those who do which Good Samaritan statutes have been applied volunteer their aid. They do not apply, to traditional emergency situations, such as when a nurse happens on the scene of an automobile however, when the assistance is provided accident and renders first aid. as part of a person’s job or when the aid is paid for. However, a couple of states (and CH06.indd 244 02/01/23 2:00 PM C hap ter 6 : N egligenc e 245 the nation of France) have created a duty to assist, with immunity from civil suit for persons who comply with the law.53 (These laws would be difficult to enforce but set forth a societal expectation.) References to a Good Samaritan statute may thus indicate either immunity or a duty to assist, or both. Strict Liability By definition, strict liability does not fit into a discussion of negligence; rather, strict liability imposes liability without any showing of negligence. A brief discussion is nevertheless relevant here because the concept is closely tied to the doctrine of res ipsa loquitur and the standard of reasonable prudence discussed earlier. A showing of fault was not required to impose liability until the midnineteenth century, when society decided that some wrongdoing must be shown before persons could be held responsible for injuries caused by their actions. Thus, negligence must be proven in most tort cases. Strict liability is imposed, however, on those whose activities—such as using dynamite or keeping dangerous animals—entail a high degree of risk to others. The rationale behind strict liability in these situations is to place the burden of inevitable losses on those best able to bear them, even if they dealt with the danger as carefully as possible. Developments in product liability law have imposed strict liability on the manufacturers and vendors of various products. The doctrine imposes liability on those responsible for defective goods that pose an unreasonable risk of injury and do in fact result in injury, regardless of how much care was taken to prevent the dangerous defect.54 Accidents caused by defective automobile parts are good examples, and product recalls are a direct result of developments in the law of product liability. In the healthcare context, the theory can be applied to defective medical devices. Strict liability does not apply to services, only to products. For example, Legal Brief courts have generally held that when giving blood, hospitals are providing a serOne of the authors of this book once had a case vice—not a product—and therefore strict involving a defective ventilator that malfunctioned, liability does not apply if the blood carcausing the death of the patient. The physician 55 ries defects (e.g., an infectious disease). tactfully explained to the patient’s family that the Most states have “blood shield laws” device was not known to be faulty and that the to this effect. One unresolved issue is manufacturer had been notified of the incident. whether products liability theories apply The family did not file suit against the physician or the hospital; rather, they claimed against the (or ought to apply) to human tissue, manufacturer under products liability law. sperm, and other bodily substances that are donated or sold. CH06.indd 245 02/01/23 2:00 PM 246 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n Causation, Injury, and Damages Causation proximate cause The legal cause of the damages to the plaintiff; the cause that immediately precedes and produces the effect (as contrasted with a remote or an intermediate cause); the act or omission from which an injury results as a natural, direct, uninterrupted consequence and without which the injury would not have occurred. CH06.indd 246 For a plaintiff to prevail, proving that a provider failed to meet the standard of care and that the patient was injured is not enough. The plaintiff must show that negligence was the proximate cause of the injury and damages. An injury is the proximate result of a negligent act if: • it would not have occurred but for the defendant’s act, or • it was a foreseeable result of the negligent conduct. The purpose of a malpractice trial is not to “convict” the defendant but to decide whether the plaintiff’s loss is more likely than not the result of substandard conduct on the part of the defendant. Therefore, the plaintiff’s burden of proof is lower than that of the government in a criminal prosecution, where proof beyond a reasonable doubt is required. The plaintiff in a civil trial need only prove that there is a strong likelihood (a “preponderance of the evidence”) that negligence caused the result, and the negligence need not be the sole cause of, but only a significant factor in, the injury. If a physician has failed to meet the standard of care, it may be difficult to determine whether the patient’s injuries were caused by that lapse. This element is especially difficult to determine in healthcare cases because the patient presumably already had some illness or impairment. Physicians can be absolved from liability, despite their negligence, if there is inadequate proof of causation. For example, in Henderson v. Mason, the defendant physician negligently failed to discover a small piece of steel embedded in the patient’s eye. The steel was eventually discovered and removed by another physician.56 The court denied recovery because testimony showed that the patient would have suffered infection and loss of vision even if the defendant’s diagnosis had been correct—in other words, the defendant’s negligence was not a “but for” cause of the patient’s injury, so proximate cause was not proved. A court may determine that only some of a patient’s injuries resulted from negligence. In one case, a woman and her obstetrician lived near each other. In the sixth month of pregnancy, she experienced labor pains, and her husband summoned the doctor. The doctor did not arrive for several hours, however, and the patient miscarried. In the suit charging him with negligence, the court decided that the obstetrician’s failure to treat the patient did not cause the miscarriage because his presence in the house would not have prevented it. He was nevertheless held liable for the patient’s pain and suffering, which he might have eased or prevented had he arrived sooner.57 02/01/23 2:00 PM C hap ter 6 : N egligenc e 247 Injury and Damages The question of damages is closely related to the element of causation. In addition to proving that the injury was caused by negligence, the plaintiff must prove what those injuries are worth. Punitive damages are seldom awarded in negligence cases; the most common damages are called actual or compensatory damages, which are intended to “make the plaintiff whole.” They compensate the plaintiff for out-of-pocket loss (e.g., the cost of medical and rehabilitation treatments, lost earnings) and for noneconomic loss (e.g., pain and suffering). While economic losses can be fairly accurately demonstrated, it can be difficult to attach dollar values to pain and suffering. ­Nevertheless, juries do assign dollar values to noneconomic injuries, sometimes in large amounts. For this reason, people who argue for reform in the tort system often suggest limitations on recovery for pain and suffering; several states have statutes that limit noneconomic damages, and these statutes have sometimes been upheld as constitutional.58 (Reform of the tort system is discussed at the end of this chapter.) Loss of a Chance Sometimes the nature of a disease means that a patient has virtually no chance of long-term survival, but an early diagnosis may prolong the patient’s life or permit a slim chance of survival. Should a practitioner who fails to make that early diagnosis be liable for damages even though the chances are great that earlier diagnosis would not have prevented the patient’s death? The courts have been divided on this question. Some jurisdictions have held that the defendant should not be liable if the patient more likely than not would have died anyway.59 Other courts have concluded that if the defendant increased the risk of death by lessening the chance of survival, such conduct was enough to permit the jury to decide the proximate cause issue, at least when the chance of survival was significant.60 In one case, the Supreme Court of Washington summarized this point as follows: “[I]t is not for the wrongdoer, who put the possibility of recovery beyond realization, to say afterward that the result was inevitable.”61 In that Washington case, the defendants allegedly failed to diagnose the patient’s lung cancer in its early stage, and the patient eventually died.62 The defendants offered evidence that, given that type of lung cancer, death within several years was virtually certain regardless of how early the cancer was diagnosed. The defendants moved for summary judgment. Because the plaintiff could not produce expert testimony that the delayed diagnosis more likely than not caused her husband’s death, the trial court dismissed the suit. For purposes of appeal, both parties stipulated that if the cancer had been diagnosed when the defendants first examined the patient, his chances of surviving five years (a common metric for successful cancer treatment) would CH06.indd 247 02/01/23 2:00 PM 248 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n have been 39 percent, but at the time the cancer was actually diagnosed, his chances were 25 percent. Thus, the delayed diagnosis may have reduced the chance of a five-year survival by 14 percent. The appellate court held that the reduced probability was sufficient evidence of causation to allow the issue to go to the jury, who would then decide whether the negligence was a substantial factor in producing the injury. “To decide otherwise would be a blanket release from liability for doctors and hospitals any time there was less than a 50 percent chance of survival, regardless of how flagrant the negligence.”63 The court also noted, however, that if the jury found the defendants liable, they would not necessarily be liable for all damages caused by the patient’s death, only for those resulting from the early death. Defenses Malpractice defendants may have legal defenses that can clear or reduce their liability even if a plaintiff can prove all the elements of the case. For example, a statute of limitation can prevent a case from going to trial. Other defenses, such as comparative negligence, require a decision by the trier of fact (the jury or the judge in nonjury trials). Defenses especially relevant in malpractice actions are discussed in the following sections. Other legal defenses, such as res judicata (discussed in chapter 1), can also be used but have no greater significance in malpractice cases than in any other civil litigation. Contributory and Comparative Negligence contributory negligence and comparative negligence Common-law doctrines relating to allocation of responsibility when the plaintiff was partially at fault. CH06.indd 248 Even if a physician has been negligent, contributory negligence is a complete defense in many states. Under this theory, if the patient failed to act as a reasonably prudent person would have done, and if the patient’s negligence contributed in any way to the injury, they cannot recover damages for the physician’s negligence. In one old case, a physician who was grossly intoxicated treated a patient negligently.64 The court refused to hold the doctor liable on the grounds that the patient was negligent in accepting treatment from a physician who was obviously drunk. There are cases, however, in which the patient’s contributory negligence merely aggravated an injury caused by the physician’s negligence. If the injury would have occurred despite due care by the patient, the patient will be allowed at least a partial recovery. In Schultz v. Tasche, an 18-year-old Wisconsin woman was treated negligently for a fracture of the femur. As a result, the ends of the broken bone were not put in apposition but were negligently allowed to override and unite, thus causing a shortening, lameness, weakness, and pain in the leg.65 The appellate court decided that the patient 02/01/23 2:00 PM C hap ter 6 : N egligenc e 249 could recover for the doctor’s negligence despite her own negligence in leaving the hospital early, driving 15 miles to her home, and failing to return for additional treatment. The plaintiff’s negligence, the court decided, merely aggravated the existing injury, and its only relevance was to reduce the damages awarded. Although nominally a contributory negligence case, Schultz—decided a century ago—illustrates the comparative negligence approach adopted by nearly all states because of the harsh “all-or-nothing” requirement of traditional contributory negligence. Several theories of comparative negligence exist, but all attempt to compensate the injured party in some way despite the injured party’s own negligence. A later Wisconsin case illustrates one variation.66 A hospital patient slipped while taking a shower and was injured. The jury decided that the hospital was 20 percent negligent—possibly for failing to install safety devices in the shower—but the patient was found 80 percent negligent and was awarded only $4,500. Exculpatory Contracts and Mandatory Arbitration Historically, defendant physicians could raise exculpatory contracts as a defense. An exculpatory contract is one in which a party forfeits in advance the right to sue; in other words, it allows one party to release the other party from liability for its future negligence. Absent separate consideration and the releasor’s clear understanding of the effect of the agreement, exculpatory contracts are invalid in most contexts, including in healthcare (see chapter 5 for a discussion of consideration). The landmark case is Tunkle v. Regents of the University of California, in which, nearly 60 years ago, the Supreme Court of California held that a contract between a hospital and a patient that attempted to release the hospital from malpractice liability in advance was contrary to public policy.67 The key provision of the contract read as follows: Release: The hospital is a nonprofit, charitable institution. In consideration of the hospital and allied services to be rendered and the rates charged therefor, the patient or his legal representative agrees to and hereby releases The Regents of the University of California, and the hospital from any and all liability for the negligent or wrongful acts or omissions of its employees, if the hospital has used due care in selecting its employees.68 The court held that this provision was not part of a fair bargain. It essentially says, “If you want to get treated, you must sign on the dotted line.” In a footnote, the opinion points out that when the plaintiff signed the release, he “was in great pain, under sedation, and probably unable to read.”69 This fact was not the underlying rationale for the decision, however. CH06.indd 249 public policy The general, well-settled, and usually unwritten sense of public opinion relating to the duties of citizens to one another; the common sense and common conscience of the citizenry as a whole that is applied to matters of public health, safety, and welfare. 02/01/23 2:00 PM 250 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n There is a controversial trend toward including mandatory arbitration clauses in patient agreements such as health insurance and nursing home contracts. They are ubiquitous in many commercial settings and may lead to quicker dispute resolution and lower payouts, but patient advocates argue against them in the healthcare arena. They assert that the same kinds of public policy objections applicable to exculpatory contracts are relevant to arbitration provisions as well: they disadvantage vulnerable people; they result from an inequality in bargaining power; and many patients are unaware of what they are signing. In addition, opponents claim that mandatory arbitration lacks the transparency of the judicial system and denies injured parties their right to a jury trial. State law on the subject varies widely.70 Release In contrast with an exculpatory contract such as the “release” at issue in Tunkle, a negotiated settlement agreement signed by a patient following treatment may operate to bar a later suit for injuries arising from the same negligent act. The situation is more complicated when a person wrongfully injures a patient and a provider’s treatment aggravates the injury later. If the patient settles with the original tortfeasor and releases that person, does the release also cover the provider? It depends. In Whitt v. Hutchison, the plaintiff—who was injured at a ski resort— claimed that his injuries were aggravated by the negligence of the physicians who treated him. Three and a half years after the original injury, the plaintiff had settled with the ski resort and signed a form releasing the resort from any and all liability . . . and any and all other loss and damage of every kind and nature sustained by or hereafter resulting to the undersigned . . . from an accident which occurred on or about the first day of March, 1969, at Clear Fork Ski Resort . . . and from all liability, claims, demands, controversies, damages, actions, and causes of action whatsoever, either in law or equity, which the undersigned, individually or in any other capacity . . . may have by reason of or in any wise incident [to] or resulting from the accident hereinbefore mentioned.71 The court held that this language was broad enough to include the subsequent malpractice claims and dismissed the suit against the physicians and the hospital. It reasoned that the injury created the need for the medical treatment, and therefore the malpractice was a proximate result of the ski resort’s negligence. The physicians and the hospital were not excluded from the terms of the release, so the release was considered to extinguish all claims for all parties jointly liable for the injury. The court stated, “Such a release is presumed in law to be a release for the benefit of all the wrongdoers who might also be liable.”72 CH06.indd 250 02/01/23 2:00 PM C hap ter 6 : N egligenc e 251 The outcome in other states may vary, and even in this case, the harsh result might have been avoided by more precise crafting of the release document to clarify the parties’ intentions. Nevertheless, the case is an example of a release being used successfully as a defense to a negligence claim against someone who was not a party to the contract. Assumption of Risk In many jurisdictions, people who perceive a risk and still voluntarily expose themselves to that risk are precluded from recovering damages if injury results. In medical malpractice cases, the risk often involves a new method of treatment, and an important issue is whether the possible effects of such treatment were made known to the patient. (This issue is closely related to informed consent, discussed in chapter 12.) In Karp v. Cooley, for example, the surgeon was not held liable for the patient’s death after a heart transplant because he had fully informed the patient of the risks and had obtained consent to perform the operation.73 Assumption of risk does not include the risk of a physician’s negligence. In the Karp case, if death had been caused by an error unrelated to the novelty of the surgery (e.g., a mishap in administering anesthesia), the defendants could have been held liable. Workers’ Compensation Laws Workers’ compensation statutes may provide a defense to employed physicians who are sued by fellow employees treated in the course of their employment (discussed more thoroughly in chapter 5). In many states, workers’ compensation laws are the exclusive remedy for employees, and a malpractice suit against the physician will not be permitted. Some courts, however, have allowed such suits. assumption of risk An affirmative defense that a defendant can raise in a negligence action; the doctrine under which individuals are barred from recovering damages for injuries sustained after voluntarily exposing themselves to known dangers. Governmental Immunity Governmental immunity is based on the historical concept of sovereign immunity, a principle derived from early English law that holds that the s­ overeign— in the United States, a locality, state, or the federal government—cannot commit a legal wrong and is immune from suit or prosecution. Sovereign immunity has been waived (abandoned) by most legislatures today (including the federal government) to allow tort claims against the government. Waivers of sovereign immunity come with certain limitations and procedural requirements. Many states, for example, require that a claim be filed with the relevant governmental risk management office 60 days before filing suit in court. The Federal Tort Claims Act74 has special procedures that apply to tort claims against the federal government. And, under the Feres doctrine, active-duty members of the military have historically been limited in their CH06.indd 251 sovereign immunity A venerable legal doctrine exempting the sovereign (monarch or government entity) from liability for wrongs. 02/01/23 2:00 PM 252 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n ability to bring medical malpractice claims against military providers.75 That changed somewhat in 2020 with the enactment of the National Defense Authorization Act (NDAA).76 The NDAA creates an exception to the Feres doctrine allowing service members to recover for medical malpractice by a US Department of Defense healthcare provider working in a covered military medical treatment facility. Correlatively, federal and state statutes may grant immunity to individual government employees in certain situations. Thus, it is sometimes a defense to litigation that the individual is immune from liability; in return, the government entity assumes the responsibility. Statutes of Limitation Statutes of limitation specify a period during which lawsuits must be filed. The time allowed for malpractice actions—often, two years—is generally shorter than for other actions, although the statutory provisions vary greatly from state to state. Statutes of limitation generally specify that the period begins when the cause of action “accrues.” A cause of action in an assault and battery case, for example, accrues the moment the defendant threatens or touches the plaintiff. In many malpractice cases, however, the beginning of the statutory period is difficult to determine, particularly if the adverse result appears months or years after the negligent treatment. There are three specific times at which the allowable timeframe for a lawsuit might begin, depending on the state’s law and the particular circumstances: 1. When the alleged negligent treatment is rendered77 2. When the patient discovers or should have discovered the alleged malpractice (the “discovery rule”)78 3. When the treatment ends or, in a few states, when the physician–patient relationship ends79 Particular circumstances create other possibilities. For example, if a physician fraudulently conceals malpractice, the limitation period begins only at discovery of the negligence.80 Likewise, the period is often delayed (“tolled,” to use the common legal terminology) in the case of patients who are minors. In one old case, for example, a physician’s negligent use of forceps during a birth caused an almost complete loss of sight in the child’s right eye.81 Suit was allowed 22 years later because it was brought after the injured person reached the age of majority, which was then 21. Moreover, some courts have decided that, despite the discovery rule, an action for wrongful death accrues at the date of the death.82 The limitation periods CH06.indd 252 02/01/23 2:00 PM C hap ter 6 : N egligenc e 253 vary by state, especially with regard to age-related legal disability and medical malpractice cases, and they are seldom as long today as in the old case mentioned earlier. Liability for Acts of Others: Vicarious Liability Even if they have not been personally negligent, healthcare providers can be held liable for the negligence of others. This principle, known as vicarious liability, arises under the common-law doctrine of respondeat superior (“let the superior respond”), the responsibility of the superior for the acts of their subordinates. Thus, hospitals, physicians, and other providers are responsible for the negligent acts of their nurses, paramedics, X-ray technicians, and other persons in their employ or under their supervision.83 (See chapter 7 for an additional discussion of this concept.) Countersuits by Physicians vicarious liability Attachment of responsibility to a person whose agent caused the plaintiff’s injuries. respondeat superior A doctrine in the common law of agency that provides that a principal— the employer (superior)—is responsible for the actions of their agent done in the course of employment. Being the defendant in a lawsuit can be an expensive and angst-ridden experience, especially for physicians. Even if insurance covers attorneys’ fees, expenses, and damage awards, the providers might lose work time, experience increased anxiety, see their reputations suffer, and, perhaps, see their malpractice insurance premiums rise. Providers who prevail in a lawsuit often ask afterward, “Can I now sue the plaintiff or the plaintiff ’s lawyer to get back at them for this outrage?” In most cases the answer is, “Yes, you can, but you will lose.” Even if the original suit was frivolous, a provider will have difficulty recovering damages in most states. The remote possibility of revenge is usually not worth the additional cost (see Legal Brief). The legal theories on which physicians have based countersuits in malpracLegal Brief tice cases include defamation, negligence, abuse of process, and malicious prosThe revenge-seeking defendant would be well ecution. Claims of defamation are rarely advised to heed Justice Learned Hand’s remark: successful because statements made in “After some dozen years of experience I must say the course of legal proceedings are “privithat as a litigant I should dread a lawsuit beyond leged” (protected against being used as almost anything else short of sickness and death” (quoted in Richard A. Posner, Law and Literature 135 evidence in court).84 Furthermore, courts [1998]). have held that an attorney owes no duty to an adverse party in litigation, so a CH06.indd 253 02/01/23 2:00 PM 254 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n negligence theory will not help a physician’s countersuit.85 Abuse of process is difficult to prove because, in itself, filing suit is not sufficient to sustain the cause of action. Providers have, however, sometimes successfully sued for malicious prosecution, an intentional tort. Although it sounds as if it would only refer to malicious criminal prosecutions, malicious prosecution is available for both civil and criminal defendants. In such cases, they generally must show that: • the malpractice suit was decided in the provider’s favor, • there was no probable cause to believe that the provider was liable, and • the plaintiff or their attorney acted with malice in bringing the suit. Although these cases are difficult for a provider to win, ill will or the lack of any reasonable possibility of success may support an allegation of malice. Most states require that actual damages be shown, and in some states, special damages—such as damages that arise from an arrest of the person or seizure of property—must be proven.86 Damages common to anyone involved in litigation—such as attorneys’ fees, injury to reputation, and mental distress—are not sufficient to uphold such an allegation. In short, it is seldom a good idea to pursue a countersuit after the successful defense of a malpractice claim. Reforming the Tort System Periodically, the healthcare system encounters a “malpractice crisis,” during which the cost of professional liability insurance rises steeply. These crises have multiple causes, but they are usually triggered by economic factors. Drops in the stock market cause insurance companies to lose investment income, which prompts them to raise their premiums, which causes providers to call for reform of the medical liability system. Press reports of high damage awards also prompt calls for change. State legislatures have responded enacting reforms such as the following, either to the tort system as a whole, or specifically as to medical malpractice standards: • Limiting awards for “pain and suffering” • Shortening the statute of limitation • Eliminating “joint and several” liability so that any one of multiple defendants is liable only for their percentage fault • Requiring pretrial screening of claims • Requiring arbitration or mediation in lieu of civil litigation • Limiting attorneys’ contingency fees CH06.indd 254 02/01/23 2:00 PM C hap ter 6 : N egligenc e 255 • Allowing the defendant to deduct from the jury’s award any payments made to the plaintiff by other sources (e.g., health insurance) • Creating joint underwriting associations to spread malpractice risks among various insurance carriers • Establishing “secondary” insurance plans to cover judgments beyond the limit of the primary insurance • Improving peer review measures to identify incompetent providers • Allowing insurers to pay out the award over time rather than in a lump sum (i.e., structured settlements, which are discussed later in this chapter) These attempts at tort reform have been only moderately successful in reducing malpractice cases, overall payments, or medical malpractice insurance premiums. Providers and others continue to blame malpractice suits for rising healthcare costs, doctors continue to practice defensive medicine, and the courts have struck down some of the reforms. For example, in 2010, the Supreme Court of Georgia ruled that the state legislature had no constitutional authority to limit pain and suffering awards.87 In addition, some of the reforms disproportionally affect people with certain types of injuries. For example, when negligent medical care causes disfigurement, infertility, or pain but does not affect earning potential, the economic damages might be minimal while the pain and suffering are real. Settlements Rather than defend a tort case, if an individual or insurance company wants to resolve a case without trial, there are numerous options for designing a settlement agreement. Structured settlements are financial arrangements that compensate the plaintiff through periodic payments rather than the traditional form of a lump sum. The total amount paid thus depends on how long the patient lives. These settlements are typically handled through income annuity contracts (or structured annuities) managed by insurance companies. A structured settlement incorporated into a trial judgment by agreement of the parties and with the approval of the court is similar. When it comes to settling a case, there is sometimes a difference of opinion between an individual provider, on one hand, and an institutional provider (e.g., a hospital) and its insurer, on the other. The insurance coverage documents will typically specify which party has the ultimate power to agree to a settlement, though the actual decision process might be more flexible. Risk tolerance and publicity concerns often come into play, in addition to financial or reputational factors. For example, a physician employed by a hospital might want to avoid being reported to the National Practitioner Data Bank and thus be more CH06.indd 255 02/01/23 2:00 PM 256 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n inclined to risk a trial, whereas the hospital employer might want to settle to avoid Law in Action negative publicity. On the other hand, a physician who is individually insured is The National Practitioner Data Bank (NPDB) is a weblikely to be most concerned about a verbased repository that includes information about dict exceeding their coverage limits and providers’ malpractice settlements and judgments thus be more inclined to settle, a consider(above a specified threshold), as well as adverse ation that is less likely to affect a hospital licensing and privileging actions. Established by defendant. Congress in 1986, it is intended to prevent practiThe dramatic rise in the percenttioners, primarily physicians, from moving state to state without disclosure or discovery of information age of employed physicians impacts this that might indicate performance concerns. dynamic. One reason for the trend toward Federal regulations require specified entiemployment is to get the medical malties to report to and/or query the NPDB, including practice protection of the employer hosprior to granting privileges. NPDB reports are pital or health system. That protection confidential, and not available to the public. (See comes with less official power to shape the chapter 8 for more details about the origins and function of the NPDB.) course of a medical malpractice defense, though, of course, that will depend on the circumstances. Complicating this dynamic is the fact that an institutional provider, particularly a big system, will generally be a less sympathetic defendant than an individual provider. And the institutional provider will have deeper pockets and higher medical malpractice coverage limits. Both factors could push medical malpractice payouts higher overall. EXHIBIT 6.1 Example of a Structured Settlement $ 1 million Age 0 Trust fund balance CH06.indd 256 72 Annual cost 02/01/23 2:00 PM C hap ter 6 : N egligenc e 257 One of the authors’ personal experience with a structured settlement includes a negligence case at a US Navy hospital in the 1970s. A baby suffered severe brain damage because of a lack of oxygen during delivery, but with proper care, she was expected to have a normal life expectancy. The parents and the government settled the case by creating a “reversionary trust” to care for the child as long as she lived. Calculations showed that a principal amount of $1 million, plus reinvested earnings, would be sufficient over time to cover the expected cost of custodial care for 72 years, the life expectancy of a newborn in the mid-1970s. To prevent the parents from receiving a windfall, the language of the trust document provided that the funds would revert to the government if the child died before age 72. (See exhibit 6.1 for a graph depicting this type of structured settlement.) More than 40 years after the settlement was approved, the father of the child reported that her neurological condition remained unchanged and that she was in a facility that provided around-the-clock care. The trust was functioning as planned, and its principal and accumulated interest seemed to be sufficient. Chapter Summary This chapter discussed the following topics: • • • • • • • The four basic elements of a tort case The standard of care Breach of duty Injury and causation Vicarious liability Provider countersuits Tort reform Vocabulary arbitration assumption of risk contributory and comparative negligence crisis standards of care (CSC) gross negligence guardian ad litem hearsay CH06.indd 257 02/01/23 2:00 PM 258 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n positive predictive value proximate cause public policy res ipsa loquitur respondeat superior school rule sovereign immunity standard of care vicarious liability Discussion Questions 1. What are the four elements of proof necessary for a plaintiff to succeed in a negligence case? Make up a situation in which one of the four is missing but the others are present. 2. How can the standard of care be proven in a medical malpractice case? Devise a situation in which it would be difficult to establish the standard of care, and then one in which doing so would be easy. 3. Have crisis standards of care been invoked in your area as a defense of a pandemic-era medical malpractice case? What do you think of how the CSCs were used in that case and its resolution? 4. What are some examples of tort reform in the medical malpractice context? How would you evaluate whether they are a good idea or not? In other words, what would be the measure of their success? 5. Do you think healthcare providers should apologize for their mistakes? Why or why not? If providers do intend to apologize for their mistakes, what sorts of institutional or other supports might make doing so less fraught and more fruitful for all involved? CH06.indd 258 02/01/23 2:00 PM C hap ter 6 : N egligenc e 259 The Court Decides Helling v. Carey 83 Wash. 2d 514, 519 P.2d 981 (1974) Hunter, J. We find this to be a unique case. The testimony of the medical experts is undisputed concerning the standards of the profession for the specialty of ophthalmology. . . . The issue is whether the defendants’ compliance with the standard of the profession of ophthalmology, which does not require the giving of a routine pressure test to persons under 40 years of age, should insulate them from liability under the facts of this case. . . . [The court points to evidence that the incidence of glaucoma in persons under the age of 40 was about 1 in 25,000.] However, that one person, the plaintiff in this instance, is entitled to the same protection, as afforded persons over 40, essential for timely detection of the evidence of glaucoma where it can be arrested to avoid the grave and devastating result of this disease. The test is a simple pressure test, relatively inexpensive. There is no judgment factor involved, and there is no doubt that by giving the test the evidence of glaucoma can be detected. . . . Justice Holmes stated in Texas & Pac. Ry. v. Behymer: What usually is done may be evidence of what ought to be done, but what ought to be done is fixed by a standard of reasonable prudence, whether it usually is complied with or not. In [another case,] Justice [Learned] Hand stated: [I]n most cases reasonable prudence is in fact common prudence; but strictly it is never its measure; a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests, however persuasive be its usages. Courts must in the end say which is required; there are precautions so imperative that even their universal disregard will not excuse their omission. Under the facts of this case reasonable prudence required the timely giving of the pressure test to this plaintiff. The precaution of giving this test to detect the incidence of glaucoma to patients under 40 years of age is so imperative that irrespective of its disregard by the standards of the ophthalmology profession, it is the duty of the courts to say what is required to protect patients under 40 from the damaging results of glaucoma. We therefore hold, as a matter of law, that the reasonable standard that should have been followed under the undisputed facts of this case was the timely giving of this simple, harmless pressure test to this plaintiff and that, in failing to do so, the defendants were negligent, which proximately resulted in the blindness sustained by the plaintiff for which the defendants are liable. The judgment of the trial court and the decision of the Court of Appeals [are] reversed. . . . (continued) CH06.indd 259 02/01/23 2:00 PM 260 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n (continued from previous page) Discussion Questions 1. The Supreme Court of Washington is often viewed as nontraditional—liberal, activist, or bellwether, depending on one’s point of view. Do you agree with the court’s decision in this case to abandon a traditional, physician-determined standard of care? Why or why not? 2. Is this decision an example of “judge-made law”? Is it “judicial activism”? Is it to be admired or disdained? Fashion an argument supporting each point of view. 3. The legislation that attempted to overturn the Helling precedent has been on the books since 1974, but it has had little effect. Why do you suppose this is so, and why has the legislature not seen fit to reinforce it? 4. Consider the discussion in the text concerning whether Helling is good public policy. Explain how a test that is 95 percent accurate can result in positive test results that are truly positive only 16 percent of the time. ~ ~ The Court Decides Perin v. Hayne 210 N.W.2d 609 (Iowa 1973) McCormick, J. This is an appeal from a directed verdict for a doctor in a malpractice action. We affirm. The claim arose from an anterior approach cervical fusion performed on plaintiff Ilene Perin by defendant Robert A. Hayne. . . . The fusion was successful in eliminating pain, weakness and numbness in plaintiff’s back, neck, right arm and hand caused by two protruded cervical discs, but plaintiff alleged she suffered paralysis of a vocal chord [sic] because of injury to the right recurrent laryngeal nerve during surgery. . . . The injury reduced her voice to a hoarse whisper. She sought damages on four theories: specific negligence, res ipsa loquitur, breach of express warranty and battery or trespass. After both parties had rested, the trial court CH06.indd 260 sustained defendant’s motion for directed verdict, holding the evidence insufficient to support jury consideration of the case on any of the pleaded theories. Plaintiff assigns this ruling as error. We must review each of the pleaded bases for recovery in the light of applicable law and the evidence. I. Specific negligence. Plaintiff alleges there was sufficient evidence to support jury submission of her charge [that] defendant negligently cut or injured the recurrent laryngeal nerve. Plaintiff had protruded discs at the level of the fifth and sixth cervical interspaces. The purpose of surgery was to remove the protruded discs and fuse the vertebrae with bone dowels from her hip. 02/01/23 2:00 PM C hap ter 6 : N egligenc e 261 (continued from previous page) Removal of a disc ends the pinching of the nerve in the spinal column which causes the patient’s pain. The bone supplants the disc. The procedure involves an incision in the front of the neck at one side of the midline at a level slightly below the “Adam’s apple.” Four columns run through the neck. The vertebrae and spinal cord are in the axial or bone column at the rear. In order to get to the axial column the surgeon must retract the visceral column which lies in front of it. The visceral column, like the vascular columns on each side of it, is covered with a protective fibrous sheath, called fascia. It contains the esophagus and trachea. The recurrent laryngeal nerve, which supplies sensitivity to the muscles that move the vocal chord, is located between the esophagus and trachea. The surgeon does not enter the visceral column during the cervical fusion procedure. The same pliancy which enables the neck to be turned enables the visceral column to be retracted to one side to permit access to the axial column. The retraction is accomplished by using a gauze-padded retractor specifically designed for retraction of the visceral column during this surgery. The record shows the defendant used this procedure in the present case. Plaintiff was under general anesthetic. The anesthesia record is normal, and there is no evidence of any unusual occurrence during surgery. Defendant denied any possibility the laryngeal nerve was severed. He said it could not be severed unless the visceral fascia was entered, and it was not. He also believed it would be impossible to sever the nerve during such surgery without also severing the esophagus or trachea or both. [An expert witness for the plaintiff testified that it would be unusual to specifically encounter the laryngeal nerve during this surgery but that “the injury could occur despite the exercise of all proper skill and care.”] Defendant testified he did not know the cause of the injury but presumed it resulted from contusion of the nerve incident to retraction of the visceral column. He thought plaintiff’s laryngeal nerve may have been peculiarly susceptible to such injury. He insisted the surgery was done just as it always was and if he were doing it again he would do it the same way. He said one study has shown the surgery will result in paralysis of a vocal chord in two- or three-tenths of one percent of cases in which it is used. He also said there is no way to predict or prevent such instances. In considering the propriety of the verdict directed for defendant we give the evidence supporting plaintiff’s claim the most favorable construction it will reasonably bear. We recognize three possible means to establish specific negligence of a physician. One is through expert testimony, the second through evidence showing [that] the physician’s lack of care is so obvious as to be within comprehension of the layman, and the third (actually an extension of the second) evidence that the physician injured a part of the body not involved in the treatment. The first means is the rule and the others are exceptions to it. In this case plaintiff asserts [that] a jury question was generated by the first and third means. We do not agree. Plaintiff alleges the laryngeal nerve was negligently cut or injured. The record is devoid of any evidence the nerve was severed during surgery. . . . The doctors agree the technique employed by defendant was proper. The sole basis for suggesting the expert testimony would support a finding of specific negligence is that the nerve was injured during retraction. Where an injury may occur despite (continued) CH06.indd 261 02/01/23 2:00 PM 262 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n (continued from previous page) due care, a finding of negligence cannot be predicated solely on the fact it did occur. Plaintiff also maintains there is evidence of negligence from the fact this is a case of injury to a part of the body not involved in the treatment. However, that is not so. The surgical procedure did include retraction of the visceral column. It was very much in the surgical field. Trial court did not err in directing a verdict for defendant on the issue of specific negligence. II. Res ipsa loquitur. Plaintiff also alleges the applicability of the doctrine of res ipsa loquitur. Our most recent statement of the doctrine appears in [a 1973 case]: Under the doctrine of res ipsa loquitur, where (1) injury or damage is caused by an instrumentality under the exclusive control of defendant and (2) the occurrence is such as in the ordinary course of things would not happen if reasonable care had been used, the happening of the injury permits, but does not compel, an inference defendant was negligent. The contest in this case concerns presence of the second foundation fact [from the quoted paragraph]. Defendant argues the second foundation fact for res ipsa loquitur is absent because it does not lie in the common knowledge of laymen to say injury to the laryngeal nerve does not occur if due care is exercised in anterior approach cervical fusion surgery. We must initially decide what has previously been an open question in this jurisdiction: may the common experience to establish the second foundation fact for res ipsa loquitur be shown by expert testimony? [The court proceeds to review cases from Wisconsin, California, Oregon, and Washington, plus three legal treatises on the subject. It quotes with favor the following from the Restatement of Torts:] CH06.indd 262 In the usual case the basis of past experience from which this conclusion may be drawn is common to the community, and is a matter of general knowledge, which the court recognizes on much the same basis as when it takes judicial notice of facts which everyone knows. It may, however, be supplied by the evidence of the parties; and expert testimony that such an event usually does not occur without negligence may afford a sufficient basis for the inference. Thus we disagree with defendant’s contention [that] the second foundation fact must be based exclusively on the common knowledge of laymen. In this case, however, even considering the expert testimony, the record at best only supports an inference [that] plaintiff suffered an extremely rare injury in anterior approach cervical fusion surgery which may occur even when due care is exercised. Rarity of the occurrence is not a sufficient predicate for application of res ipsa loquitur. . . . There is no basis in the present case, in expert testimony or otherwise, for saying plaintiff’s injury is more likely the result of negligence than some cause for which the defendant is not responsible. We do not believe there was any basis in this case for submission of res ipsa loquitur. Trial court did not err in refusing to submit it. III. Express warranty. [The court dismisses this count, saying that the evidence supporting her argument that the physician guaranteed a good result was equivocal in nature: “There comes a point when a question of fact may be generated as to whether the doctor has warranted a cure or a specific result. However, in the present case the evidence does not rise to that level.”] IV. Battery or trespass. Plaintiff contends there was also sufficient evidence to submit the case to the jury on the theory of battery 02/01/23 2:00 PM C hap ter 6 : N egligenc e or trespass. In effect, she alleges she consented to fusion of two vertebrae (removal of only one protruded disc) thinking there would be a separate operation if additional vertebrae had to be fused. She asserts the fact four vertebrae were fused combined with defendant’s assurances and failure to warn her of specific hazards vitiated her consent and makes the paralyzed vocal chord the result of battery or trespass for which defendant is liable even without negligence. There was no evidence or contention by her in the trial court nor is there any assertion here that she would not have consented to the surgery had she known those things she says were withheld from her prior to surgery. Defendant testified plaintiff was fully advised as to the nature of her problem and the scope of corrective surgery. He acknowledges he did not advise her of the hazard of vocal chord paralysis. He believed the possibility of such occurrence was negligible and outweighed by the danger of undue apprehension if warning of the risk was given. [The court next begins a discussion of the distinction between consent and informed consent, quoting with approval from its own landmark case Cobbs v. Grant.] Where a doctor obtains consent of the patient to perform one type of treatment and subsequently performs a substantially different treatment for which consent was not obtained, there is a clear case of battery. However, when an undisclosed potential complication results, the occurrence of which was not an integral part of the treatment procedure but merely a known risk, the courts are divided on the issue of whether this should be deemed to be a battery or negligence. ... We agree with the majority trend. The battery theory should be reserved for those 263 circumstances when a doctor performs an operation to which the patient has not consented. When the patient gives permission to perform one type of treatment and the doctor performs another, the requisite element of deliberate intent to deviate from the consent given is present. However, when the patient consents to certain treatment and the doctor performs that treatment but an undisclosed inherent complication with a low probability occurs, no intentional deviation from the consent given appears; rather, the doctor in obtaining consent may have failed to meet his due care duty to disclose pertinent information. In that situation the action should be pleaded in negligence. From our approval of this analysis it should be clear we believe the battery or trespass theory pleaded by plaintiff in this case is limited in its applicability to surgery to which the patient has not consented. There must be a substantial difference between the surgery consented to and the surgery which is done. Plaintiff asserts she consented to only one fusion rather than two. Assuming this is true, the most that could be argued is [that] the second fusion was a battery or trespass. But she does not claim damages for a second fusion. She asks damages because of injury to the laryngeal nerve during surgery. The evidence is undisputed that whether one or two fusions were to be done the path to the axial column had to be cleared by retraction of the visceral column. Hence, any injury caused by such retraction occurred during a procedure to which consent had been given. Retraction of the visceral column during the surgery was not a battery or trespass. We have no occasion to reach the question whether failure to advise plaintiff of the risk of laryngeal nerve injury would in the circumstances of this case have generated a jury issue on negligence, but we do point (continued) CH06.indd 263 02/01/23 2:00 PM 264 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n (continued from previous page) out that recovery on such basis is precluded unless a plaintiff also establishes he would not have submitted to the procedure if he had been advised of the risk. . . . There is no evidence plaintiff would have withheld her consent in this case. ... Affirmed. Discussion Questions 1. Has due care been shown? Need it be? 2. What is the “second foundation fact,” and how does “common experience” matter in relation to it? 3. The opinion states, “There must be a substantial difference between the surgery consented to and the surgery which is done [for a battery case to be made].” What would amount to a “substantial difference” in your mind? What if throat cancer had been discovered and cleanly removed with no aftereffects? Would that procedure be a substantial difference justifying damages for battery even though no other injury (and, in fact, a benefit) had resulted? 4. Why did the court “have no occasion” to decide whether failure to advise the plaintiff of the risk of nerve injury raised a negligence issue? ~ ~ Notes 1. Pederson v. Dumouchel, 431 P.2d 973, 978 (Wash. 1967). 2. Baldor v. Rogers, 81 So. 2d 658 (Fla. 1954), reh’g denied, 81 So. 2d 661 (Fla. 1955); Angela R. Holder, Medical Malpractice Law 47 (2d ed. 1978). 3. DeFilippo v. Preston, 53 Del. 539, 173 A.2d 333 (1961). 4. Miller v. Toles, 183 Mich. 252, 150 N.W. 118 (1914). 5. Fiorentino v. Wenger, 272 N.Y.S.2d 557, 26 A.D.2d 693 (1966), rev’d on other grounds, 19 N.Y.2d 407, 227 N.E.2d 296 (1967). 6. Faulkner v. Pezeshki, 44 Ohio App. 2d 186, 337 N.E.2d 158 (1975). 7. Small v. Howard, 128 Mass. 131, 35 Am. R. 363 (1880) was overruled by Brune v. Belinkoff, 235 N.E.2d 793 (Mass. 1968). 8. Zills v. Brown, 382 So. 2d 528, 532 (Ala. 1980). 9. 382 So. 2d at 532. See also Morrison v. MacNamara, 407 A.2d 555 (D.C. 1979). 10. Drs. Lane, Bryant, Eubanks & Dulaney v. Otts, 412 So. 2d 254 (Ala. 1982). 11. Jon R. Waltz & Fred E. Inbau, Medical Jurisprudence 54 (1971). CH06.indd 264 02/01/23 2:00 PM C hap ter 6 : N egligenc e 265 12. See, e.g., Dolan v. Galluzzo, 77 Ill. 2d 279, 396 N.E.2d 13 (1979) (a podiatrist was held to standards of podiatrists; physician testimony excluded). 13. Nelson v. Harrington, 72 Wis. 591, 40 N.W. 228 (1888). See also Hansen v. Pock, 57 Mont. 51, 187 P. 282 (1920) (an herbologist was held to standards of surgical and medical practice in the absence of a school of practice). 14. Spead v. Tomlinson, 73 N.H. 46, 59 A. 376 (1904). 15. Mostrom v. Pettibon, 25 Wash. App. 158, 607 P.2d 864 (1980). See also Kelly v. Carroll, 36 Wash. 2d 482, 219 P.2d 79 (1950), cert. denied, 340 U.S. 892 (1950) (a naturopath was liable for a patient’s death from appendicitis; the naturopath must know when treatment is ineffective and when standard medical care is needed). 16. Pittman v. Gilmore, 556 F.2d 1259 (5th Cir. 1977). See also Lewis v. Soriano, 374 So. 2d 829 (Miss. 1979) (a general practitioner had a duty to refer a complicated fracture to an orthopedic specialist). 17. See, e.g., Sinz v. Owens, 33 Cal. 2d 749, 205 P.2d 3 (1949) (a physician who did not use skeletal traction in treating a double comminuted fracture of a patient’s leg would be held to the skill of a specialist only if he should have known that greater skill than a general practitioner’s was necessary); Reeg v. Shaughnessy, 570 F.2d 309 (10th Cir. 1978) (physicians are held to the degree of care commensurate with their training and experience). 18. See, e.g., Lewis v. Soriano, 374 So. 2d 829 (Miss. 1979). 19. Thompson v. Brent, 245 So. 2d 751 (La. App. 1971). 20. The TJ Hooper, 60 F.2d 737, 740 (2d Cir. 1932). 21. Favalora v. Aetna Casualty & Surety Co., 144 So. 2d 544 (La. App. 1962). 22. Wash. Rev. Code § 4.24.290 (1975, as amended) (emphasis added). 23. Gates v. Jensen, 92 Wash. 2d 246, 595 P.2d 919 (1979). 24. Guide to Clinical Preventive Services 124 (U.S. Prev. Serv. Task Force 1989). The report states, “There is insufficient evidence to recommend routine performance of tonometry by primary care physicians as an effective screening test for glaucoma. . . . The limited specificity of tonometry combined with the low prevalence of [glaucoma] results in a positive predictive value of only 5% in asymptomatic populations.” 25. Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement, 151 Ann. Int. Med. 716–26 (U.S. Prev. Serv. Task Force Nov. 2009), at http://www.annals.org/ content/151/10/716.full [https://perma.cc/73RC-7VRZ]. CH06.indd 265 02/01/23 2:00 PM 266 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n 26. Id. 27. If the state still follows the locality rule, the witness must practice in or be knowledgeable about local practices. See, e.g., Johnson v. Richardson, No. W2009-02626-C0A-R3-CV (Tenn. Ct. App., Aug. 12, 2010), http://www.tba2.org/tba_files/TCA/2010/ johnsont_081310.pdf [https://perma.cc/3HUE-VNSK]; Callahan v. William Beaumont Hosp., 400 Mich. 177, 254 N.W.2d 31 (1977). 28. See, e.g., Siirila v. Barrios, 398 Mich. 576, 248 N.W.2d 171 (1976). 29. Gilmore v. O’Sullivan, 106 Mich. App. 35, 307 N.W.2d 695 (1981). 30. Craft v. Peebles, 893 P.2d 138, 153 (Haw. 1995). 31. Anna C. Mastroianni, Michelle M. Mello, Shannon Sommer, Mary Hardy & Thomas H. Gallagher, The Flaws in State “Apology” and “Disclosure” Laws Dilute Their Impact on Malpractice Suits, 29 Health Aff. 1611 (2010). 32. Nina E. Ross & William J. Newman, The Role of Apology Laws in Medical Malpractice, 49 J. Am. Acad. Psychiatry & L. 1, (2021). 33. Coleman v. Amon, 252 Ariz. 107, 498 P.3d 638 (Ariz. Ct. App., 2021). 34. Mastroianni, et al., supra note 31. 35. Michelle M. Mello, Richard C. Boothman, Timothy McDonald, Jeffrey Driver, Alan Lembitz, Darren Bouwmeester, Benjamin Dunlap & Thomas Gallagher, Communication-and-Resolution Programs: The Challenges and Lessons Learned from Six Early Adopters, 33 Health Aff. 20 (2014). 36. R. P. Bergen, Law & Medicine: Medical Books as Evidence, 217 J. Am. Med. Ass’n 527 (1971). 37. Burnside v. Evangelical Deaconess Hosp., 46 Wis. 2d 519, 175 N.W. 2d 230 (1970). 38. Darling v. Charleston Community Memorial Hospital, 33 1ll. 2d 326, 211 N.E.2d 253, 14 A.L.R.3d 860 (1965), cert. denied, 383 U.S. 946 (1966). 39. See, e.g., Cal. Evid. Code § 669 (Supp. 1985). 40. Landeros v. Flood, 17 Cal.3d 399, 412, 551 P.2d 389 (1976). 41. See, e.g., Sinz v. Owens, 33 Cal. 2d 749, 205 P.2d 3 (1949). 42. Paul Sisson, Sharp Fined for Botched Kidney Removal, San Diego UnionTrib. (Oct. 24, 2013), https://www.sandiegouniontribune.com/ news/health/sdut-sharp-alvarado-kidney-fall-fine-2013oct24-story.html [https://perma.cc/3GXU-E78H] (last visited May 26, 2022). 43. Hammer v. Rosen, 7 N.Y.2d 376, 380, 165 N.E.2d 756, 757 (1960). 44. To Err Is Human: Building a Safer Health System, Inst. of Med. (National Academies Press 1999). Fifteen years after the CH06.indd 266 02/01/23 2:00 PM C hap ter 6 : N egligenc e 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. CH06.indd 267 267 original report, it was reported that despite some progress, patient safety remained a serious public health issue. See Free from Harm: Accelerating Patient Safety Improvement Fifteen Years After To Err Is Human (Inst. Healthcare Imp. 2015), http://www.ihi.org/ resources/Pages/Publications/Free-from-Harm-Accelerating-PatientSafety-Improvement.aspx [https://perma.cc/99QP-XKD3]. Byrne v. Boadle, 2 H. & C. 722, 159 Eng. Rep. 299 (1863). Jamison v. Debenham, 203 Cal. App. 2d 744, 21 Cal. Rptr. 848 (1962). Jefferson v. United States, 77 F. Supp. 706 (Md. 1948), aff’d, 178 F.2d 518 (4th Cir. 1949), aff’d, 340 U.S. 135 (1950). Waltz & Inbau, supra note 11, at 100. Ybarra v. Spangard, 25 Cal. 2d 486, 154 P.2d 687 (1944). Ybarra, 25 Cal. 2d at 494, 154 P.2d at 691. Ybarra has been followed in some California cases—see, e.g., Hale v. Venuto, 137 Cal. App. 3d 910, 187 Cal. Rptr. 357 (1982)—and has been cited with approval in some other jurisdictions. It has also been questioned and “distinguished” (considered inapplicable) in numerous decisions (see, e.g., Barret v. Emanuel Hosp., 64 Ore. App. 635, 669 P.2d 835 (1983). Rice v. California Lutheran Hospital, 158 P.2d 579 (Cal. App. 1945), rev’d on other grounds, 27 Cal. 296, 163 P.2d 860 (1945). See, e.g., Vt. Stat. Ann. tit. 12, § 519(b) (1973). Vt. Stat. Ann. tit. 12, § 519 (1973); Minn. Stat. Ann. § 604.05 (as amended 1984) (West Supp. 1985). See Restatement (Second) of Torts § 402A. See, e.g., Perlmutter v. Beth David Hosp., 308 N.Y. 100, 123 N.E.2d 792 (1954). Many states have dealt with this issue by legislation; see, e.g., Wis. Stat. § 146.31(2) (West Supp. 1986). Henderson v. Mason, 386 S.W.2d 879 (Tex. Civ. App. 1964). Mehigan v. Sheehan, 94 N.H. 274, 51 A.2d 632 (1947). See, e.g., Johnson v. St. Vincent Hospital, Inc., 273 Ind. 374, 404 N.E.2d 585 (1980). See, e.g., Cornfeldt v. Tongen, 295 N.W.2d 638 (Minn. 1980); Hanselmann v. McCardle, 275 S.C. 46, 267 S.E.2d 531 (1980); Hiser v. Randolph, 126 Ariz. 608, 617 P.2d 774 (Ariz. Ct. App. 1980); Cooper v. Sisters of Charity of Cincinnati, Inc., 272 N.E.2d 97 (Ohio 1971). See, e.g., Hamil v. Bashline, 481 Pa. 256, 392 A.2d 1280 (1978); McBride v. United States, 462 F.2d 72 (9th Cir. 1972). Herskovits v. Group Health Cooperative of Puget Sound, 99 Wash. 2d 609, 614, 664 P.2d 474, 476 (1983). 02/01/23 2:00 PM 268 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n 62. Id. See also Glicklich v. Spievack, 16 Mass. App. 488, 452 N.E.2d 287 (1983), appeal denied, 454 N.E.2d 1276 (Mass. 1983) (diagnosis of breast cancer delayed for nine months; jury verdict for plaintiff upheld). 63. Herskovits, supra note 62, 99 Wash. 2d at 614, 664 P.2d at 477. 64. Champs v. Stone, 74 Ohio App. 344, 58 N.E.2d 803 (1944). 65. Schultz v. Tasche, 166 Wis. 561, 165 N.W. 292 (1917). 66. Schuster v. St. Vincent Hosp., 45 Wis. 2d 135, 172 N.W.2d 421 (1969). 67. Tunkle v. Regents of the University of California, 60 Cal. 2d 92, 94, 32 Cal. Rptr. 33, 34, 383 P.2d 441, 442 (1963). 68. Id. 69. Tunkle, 383 P.2d at 449. 70. See generally, Sarah Sachs, The Jury Is Out: Mandating Pre-Treatment Arbitration Clauses in Patient Intake Contracts, 2018 J. Disp. Resol. (2018), https://scholarship.law.missouri.edu/jdr/vol2018/iss2/16 [https://perma.cc/BA2E-4UPY], and Kaitlin V. Treadway, PreDispute Binding Arbitration Agreements for Medical Malpractice Claims: A Right-Threatening Procedure, 7 Stetson J. Advoc. & L. (2020), https://www2.stetson.edu/advocacy-journal/pre-disputebinding-arbitration-agreements-for-medical-malpractice-claims-a-rightthreatening-procedure/ [https://perma.cc/R7TA-38LH]. 71. Whitt v. Hutchison, 43 Ohio St. 2d 53, 61, 330 N.E.2d 678, 684 (1975). 72. Id. 73. Karp v. Cooley, 349 F. Supp. 827 (S.D. Tex. 1972), aff’d, 493 F.2d 408, cert. denied, 419 U.S. 845. This case is discussed in greater detail in chapter 12. See also Holder, supra note 2, at 306–9. 74. 28 U.S.C. §§ 1346(b), 1402(b), 2401(b), and 2761-2680. 75. Feres v. United States, 340 U.S. 135 (1950). 76. 10 U.S.C. §2733a. 77. Alan Richards Moritz & R. Crawford Morris, Handbook of Legal Medicine 211 (Mosby 1970); Hill v. Hays, 193 Kan. 453, 395 P.2d 298 (1964). 78. See, e.g., Cates v. Bald Estate, 54 Mich. App 717, 221 N.W.2d 474 (1974). 79. Tort Law—Statute of Limitations in Medical Malpractice Actions, 1970 Wis. L. Rev. 915, 918 (1970); Alan J. Sobel, Torts—Medical Malpractice—Statute of Limitations—Foreign Objects—The Adoption of the Discovery Rule—Legislative or Judicial Prerogative—Melnyk v. Cleveland Clinic, 6 Akron L. Rev. 265, 267–68 (1973). CH06.indd 268 02/01/23 2:00 PM C hap ter 6 : N egligenc e 80. 81. 82. 83. 84. 85. 86. 87. CH06.indd 269 269 Bauer v. Bowen, 63 N.J. Super. 225, 164 A.2d 357 (1960). Chaffin v. Nicosia, 261 Ind. 698, 310 N.E.2d 867 (1974). Hubbard v. Libi, 229 N.W.2d 82 (N.D. 1975). See, e.g., Thompson v. Brent, 245 So. 2d 751 (La. App. 1971) (the physician was liable because a medical assistant in his employ was negligent in removing a cast with a Stryker saw). Huene v. Carnes, 121 Cal. App. 3d 432, 175 Cal. Rptr. 374 (1981). See, e.g., Friedman v. Dozorc, 412 Mich. 1, 312 N.W.2d 585 (1981), and Hill v. Willmott, 561 S.W.2d 331 (Ky. App. 1978). See, e.g., Dakters v. Shane, 64 Ohio App. 2d 196, 412 N.E.2d 399 (1978); Berlin v. Nathan, Ill. App. 3d 940, 381 N.E.2d 1367 (1978), cert. denied, 444 U.S. 828, reh’g denied, 444 U.S. 974 (1979). Atlanta Oculopic Surgery, P.C. v. Nestlehutt, 691 S.E.2d 218 (Ga. 2010). 02/01/23 2:00 PM 270 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n Appendix 6.1: National Quality Forum’s Preventable Medical Errors 1. Surgical or Invasive Procedure Events A. Surgery or other invasive procedure performed on the wrong site B. Surgery or other invasive procedure performed on the wrong patient C. Wrong surgical or other invasive procedure performed on a patient D. Unintended retention of a foreign object in a patient after surgery or other invasive procedure E. Intraoperative or immediately postoperative/post procedure death in [a healthy patient who undergoes anesthesia] 2. Product or Device Events A. Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting B. Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended C. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare setting 3. Patient Protection Events A. Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person B. Patient death or serious injury associated with patient elopement (disappearance) C. Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a healthcare setting 4. Care Management Events A. Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, wrong route of administration) B. Patient death or serious injury associated with unsafe administration of blood products C. Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare setting D. Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy E. Patient death or serious injury associated with a fall while being cared for in a healthcare setting F. Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a healthcare setting G. Artificial insemination with the wrong donor sperm or wrong egg H. Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen I. Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results CH06.indd 270 02/01/23 2:00 PM 271 C hap ter 6 : N egligenc e 5. Environmental Events A. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a healthcare setting B. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contain no gas, contain the wrong gas, or are contaminated by toxic substances C. Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a healthcare setting D. Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a healthcare setting 6. Radiologic Events: Death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area 7. Potential Criminal Events A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider B. Abduction of a patient/resident of any age C. Sexual abuse/assault on a patient or staff member within or on the grounds of a healthcare setting D. Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a healthcare setting Source: List of SREs [Serious Reportable Events], Nat’l Quality Forum, http://www.qualityforum.org/Topics/SREs/List_ of_SREs.aspx#srei [https://perma.cc/RX35-ZJFU]. CH06.indd 271 02/01/23 2:00 PM 272 T h e L aw o f H e a l th c a re Ad mi n i stra ti o n Appendix 6.2: State Apology Laws Ariz. Rev. Stat. § 12-2605 (full apology law) Any statement, affirmation, gesture or conduct expressing apology, responsibility, liability, sympathy, commiseration, condolence, compassion or a general sense of benevolence that was made by a health care provider or an employee of a health care provider to the patient, a relative of the patient, the patient’s survivors or a health care decision maker for the patient and that relates to the discomfort, pain, suffering, injury or death of the patient as the result of the unanticipated outcome of medical care is inadmissible as evidence of an admission of liability or as evidence of an admission against interest. Mich. Comp. Laws. § 600.2155 (partial apology law) (1) A statement, writing, or action that expresses sympathy, compassion, commiseration, or a general sense of benevolence relating to the pain, suffering, or death of an individual and that is made to that individual or to the individual’s family is inadmissible as evidence of an admission of liability in an action for medical malpractice. (2) This section does not apply to a statement of fault, negligence, or culpable conduct that is part of or made in addition to a statement, writing, or action described in subsection (1). (3) As used in this section, “family” means spouse, parent, grandparent, stepmother, stepfather, child, adopted child, grandchild, brother, sister, half brother, half sister, father-in-law, or mother-in-law. Source: Apology Inadmissibility Laws: Summary of State Legislation, Am. Med. Assoc. (2012), http://www.akleg.gov/ basis/get_documents.asp?session=28&docid=23660 [https://perma.cc/GY3T-3S6U]. CH06.indd 272 02/01/23 2:00 PM CHAPTER LIABILITY OF THE HEALTHCARE INSTITUTION 7 After reading this chapter, you will • appreciate that the earliest healthcare institutions were religious works of mercy that were usually immune from liability for negligence; • grasp that the concept of independent contractor is less viable today as a defense in medical malpractice cases that arise out of hospital-based treatment; • know that under respondeat superior, the corporation is responsible through the acts of an agent, whereas under the principle of corporate liability, it owes a duty directly to the plaintiff; and • recognize that managed care organizations’ efforts to reduce costs present challenging liability issues, including those related to preemption by the Employee Retirement Income Security Act. Background As mentioned in chapter 1, the history of healthcare institutions begins with the almshouses of the Middle Ages. From then until the mid-nineteenth century, those institutions had little to do with medical care and more to do with housing unfortunates and keeping them away from “respectable” society. They were religious charities, and, as the word almshouses implies, they were supported by donated money and services. A vestige of this history is church groups’ sponsorship of so many of today’s hospitals. Given their charitable nature, hospitals and many other organizations were held to be immune from tort liability lest their good deeds be diminished by jury awards. Some courts adopted this position because they considered the assets of a charitable corporation to be held in trust for its beneficiaries and feared that the implied trust would be violated by payment of money damages. Others held that the beneficiaries of a charity (including the general public) 273 CH07.indd 273 02/01/23 2:01 PM 274 T h e L aw o f H e a l th c a re A d mi n i stra ti o n charitable immunity The venerable principle (now discredited) that a charitable organization is not to be held liable for the tortious actions of its agents. implicitly waived their rights to sue when accepting the benefits of charitable services. Still others based the rule simply on concepts of public policy, specifying that tort liability should apply only to a profit-making enterprise.1 Whatever its rationale, support for the doctrine of charitable ­immunity waned as modern medicine evolved in the twentieth century (see chapter 1), and the concept had virtually disappeared by the 1970s. The public’s perception of hospitals as purely charitable organizations had changed.2 Health plans and government programs (rather than alms) paid for operational expenses; liability insurance was available to cover defense costs and jury awards; and healthcare more readily adopted the traits of market-driven industries. In addition, immunity hardly seemed fair to the injured patients and their families. The courts began to treat not-for-profit enterprises in the same manner as other companies insofar as third-party liability claims were concerned, and thus charitable immunity was overturned in a series of state-by-state judicial decisions once the rationale for immunity dissolved. (As discussed in chapter 6, however, government hospitals still enjoy immunity or partial immunity in some jurisdictions, justified as “sovereign immunity” rather than charitable immunity.) The demise of charitable immunity is exemplified by the decisions of two courts. As long ago as 1969—in the state that was the US birthplace of the doctrine—the Massachusetts Supreme Judicial Court decided to abandon it: In the past on many occasions we have declined to renounce the defence [sic] of charitable immunity. . . . We took this position because we were of [the] opinion that any renunciation preferably should be accomplished prospectively and that this should be best done by legislative action. Now it appears that only three or four States still adhere to the doctrine. It seems likely that no legislative action in this Commonwealth is probable in the near future. Accordingly, we take this occasion to give adequate warning that the next time we are squarely confronted by a legal question respecting the charitable immunity doctrine it is our intention to abolish it.3 Wisconsin had never adopted the principle in the first place, and in 2001 its high court declined to do so, calling this legal fiction “an antiquated doctrine that fails to reflect the emergence of hospitals as modern health care facilities.”4 With the end of charitable immunity, healthcare became one of the most dramatically changing areas of personal injury law. This chapter reviews evolving legal principles that have affected traditional hospital liability standards since the 1970s, including the following: • Independent contractor status • Captain-of-the-ship and borrowed-servant doctrines CH07.indd 274 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 275 • Apparent agency or agency by estoppel • Corporate liability This chapter begins with a refresher course on the traditional rules of respondeat superior, proceeds to address the principles identified in the previous list, and ends with a section on the liability of managed care and similar organizations. Respondeat Superior Versus Independent Contractor Status Respondeat Superior Defined As noted in chapter 6, respondeat superior (vicarious liability) is the principle that an employer is liable for a tort an employee commits within the scope of employment. The idea is based on the principle qui facit per alium, facit per se—“one who acts through another, acts for himself.” Even though the employer is not directly at fault, it controls the means and methods of the employee’s work and thus should answer for the employee’s negligence. Presumably, the imposition of liability encourages the employer to apply sound procedures for controlling employees’ job performance. Liability asserted based on respondeat superior depends on the answers to three questions: 1. Was a tort committed? 2. Was the person who committed the tort an agent or an employee of the defendant? 3. Was the tort committed within the scope of the agent’s or employee’s duties? The duty of a healthcare institution (see Legal Brief) is to have its employees use the same reasonable level of care that is practiced in similar organizations in similar circumstances.5 Patients are entitled to the care their medical conditions require.6 As discussed in chapter 6, to prove breach of this duty, the plaintiff must usually produce expert testimony about the applicable standard of care under the circumstances of the case.7 Not surprisingly, the plaintiff’s experts will CH07.indd 275 Legal Brief For the sake of simplicity and readability, throughout much of this book the term hospital is used as shorthand for a healthcare institution because the general principles that apply to hospitals also usually apply to other corporate healthcare providers. Any discussion that applies solely or primarily to an actual hospital should be apparent from the context. 02/01/23 2:01 PM 276 T h e L aw o f H e a l th c a re A d mi n i stra ti o n testify that other hospitals or other doctors would have treated the patient differently. The defense will call witnesses who will say, “Oh, no! What the doctor [or nurse, or hospital] did was perfectly reasonable.” The battle of the experts is on, and the jury will be asked to decide who is correct. Sometimes, expert testimony is not necessary—such as when the situation involves routine or nonprofessional care (e.g., helping a patient to the bathroom or out of a wheelchair),8 when a provider’s order is violated,9 or when common sense makes the breach of duty apparent.10 Common sense underlies the US Department of Health and Human Services’ list of adverse events discussed in chapter 6. (See The Court Decides: Norton v. Argonaut Insurance Co. at the end of this chapter for a case in which all parties—hospital, physician, and nurse—were held liable for a fatal medication error that common sense indicates could have been prevented if appropriate precautions had been in place.) Whether experts testify or not, the principle of vicarious liability is based on public policy considerations. The employer is often able to establish systems and quality measures to reduce risk, and it usually has insurance coverage or superior financial means to compensate for the damage caused by the employee’s tort. Besides, a corporation can act only through agents and employees. Not holding the organization liable for its employees’ actions would mean that the company would not be responsible for decisions made and acts committed in furtherance of institutional aims. The employer and the responsible employee(s) are often named as codefendants, but the employer is usually the main target because of its “deep pockets.” In a healthcare context, the employer, a faceless corporation, is often a less sympathetic defendant than an individual, admired healthcare provider. Chapter 6 includes a discussion of this phenomenon as well as potential conflicts between individual and institutional providers over whether to settle a case or instead proceed to trial. Independent Contractor Defined Because respondeat superior is based on employers’ right to control the means and methods of employees’ work, employers are not liable for the negligence of independent contractors. An independent contractor has sole control over the means and methods of the work to be accomplished, although the person who employs, hires, or appoints a contractor retains the general power of approval over the final work product. For example, if a homeowner hires an independent contractor to build a house, provides the plans, and retains the power to approve the result but does not control the day-to-day activities of the laborers, then the contractor is responsible for the laborers’ actions. In effect, the owner is saying, “Here’s what I want built. Go do it, and tell me when you’re done.” CH07.indd 276 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 277 In the context of hospital liability, a physician in private practice who is a member of the medical staff was traditionally considered an independent contractor, and the hospital could use the physician’s independent status to avoid liability for the doctor’s malpractice (see also The Joint Employer Concept in chapter 4). There are numerous old cases to this effect. For example, in Heins v. Synkonis, the hospital was not held liable for the negligence of a private physician because the hospital merely provided office space for the doctor’s outpatient clinic and no actual or apparent employment relationship existed between the hospital and the independent contractor doctor.11 Things are not so simple today, and many hospital-based outpatient practices are, or appear to be, functioning under the hospital’s auspices. The facts of each case will determine where liability lies. Erosion of Physicians’ Independent Contractor Status The Heins case was decided in 1975, and although old cases are not necessarily bad law, its rationale has eroded over the years, making the independent contractor defense less viable today, particularly when the malpractice occurs within hospital walls. Some of the factors prompting courts to see an employment-like relationship include the following: • Physicians are much more likely to be employees of a health system, hospital, or multispecialty clinic. • Patients use hospitals’ emergency services more frequently, and inpatients are more likely to arrive through the emergency department (ED). In these instances, the patients will not have selected the physicians who treat them, at least for the initial phases of their stay. Private physicians commonly tell patients to go to the ED if they have concerns outside normal office hours. “Meet me at the ED” has morphed into “the ER docs will take care of you.” • Medical practice has become increasingly institutionalized and specialized. • The number of contracts with hospital-based specialists has increased dramatically. Employment of Physicians Because of lifestyle preferences, economic forces, insurance contracting realities, the effects of reforms implemented under the Affordable Care Act (ACA), and fraud laws that provide “safe harbors” for many transactions (see chapter 9), physicians are increasingly becoming employees of hospitals, clinics, or health systems. Young physicians coming out of residency often CH07.indd 277 02/01/23 2:01 PM 278 T h e L aw o f H e a l th c a re A d mi n i stra ti o n prefer to focus their energies on patient care rather than the business aspects of private practice, for which they may not feel well suited. At the other end of the age spectrum, baby boomer physicians frequently choose to sell their practices and become employees for many of the same reasons. According to one report, With the steady decline since 2012 in the share of physicians working in private practices, there has been a concurrent increase in the share of physicians working directly for a hospital or for a practice at least partially owned by a hospital or health system. Almost 40% of patient care physicians worked either directly for a hospital or for a practice with at least partial hospital or health system ownership in 2020, up from 34.7% in 2018 and 29% in 2012.12 This trend is in sharp contrast to the long-standing image of the private practice physician working independently or with a couple of partners and whose professional judgment went unquestioned by nonphysicians. Such was the autonomy of the medical doctor that for decades “corporate practice of medicine” laws in many states forbade doctors from becoming employees. Those laws are somewhat anachronistic today, and various exceptions and “workarounds” have developed to lessen their effect. (This issue is also discussed in a Legal Brief in chapter 8.) Apparent Agency, Agency by Estoppel, Etc. apparent agency The power to act on behalf of a principal, even though the power has not been expressly granted. This power arises when it is reasonable for a third party to infer from the circumstances that the purported agent is acting on the principal’s behalf. CH07.indd 278 Concepts such as apparent agency—also referred to as agency by estoppel, ostensible agency, nondelegable duty, and inherent or integral duty—can also counter the independent contractor defense and protect the interests of the innocent third party. (There are fine distinctions among these concepts, and some courts may note the difference, but as a practical matter, they are virtually indistinguishable.13) In the hospital setting, many physicians and others who are not on the human resources payroll have contracts to provide patient services. This arrangement is especially true of anesthesiologists; radiologists; pathologists; and specialists in emergency medicine, nuclear medicine, and a few other clinical fields. They are not technically hospital employees, but to the average person, they appear to be. Under the circumstances, liability may attach, though no actual authority was given and the provider was technically an independent contractor. Two Delaware cases illustrate this concept. In Vanaman v. Milford Memorial Hospital, a private physician was on call to provide emergency services.14 The court held that it was for the jury to decide whether the allegedly negligent doctor treated the patient in a private capacity or while fulfilling the hospital function of providing emergency care. The court said that the 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 279 hospital could be liable for the doctor’s negligence if it held the physician out to be its employee and the patient justifiably relied on that representation. Schagrin v. Wilmington Medical Center15 is in the same vein. The court found that a medical partnership staffing an ED may be an agent of the hospital and not an independent contractor—depending on the degree of hospital control, the methods of paying the doctors, and the degree of patients’ reliance on the hospital compared with their reliance on the physicians. Similarly, in Jackson v. Power,16 the Supreme Court of Alaska held that a hospital’s duty to provide emergency care is “nondelegable” and cannot be avoided by claiming that its ED physicians are independent contractors. The court summarized its ruling as follows: We are persuaded that the circumstances under which emergency room care is provided in a modern hospital mandates the rule we adopt today. Not only is this rule consonant with the public perception of the hospital as a multifaceted health care facility responsible for the quality of medical care and treatment rendered, it also treats tort liability in the medical arena in a manner that is consistent with the commercialization of American medicine. Finally, we simply cannot fathom why liability should depend upon the technical employment status of the emergency room physician who treats the patient. It is the hospital’s duty to provide the physician, which it may do through any means at its disposal. The means employed, however, will not change the fact that the hospital will be responsible for the care rendered by physicians it has a duty to provide. The outcome depends on the facts of each specific case, but many courts seem increasingly inclined to find a hospital liable irrespective of a purported independent contractor status by applying such principles as apparent agency, agency by estoppel, and so on. This is particularly likely where patients do not choose their providers but rely on those provided by the hospital. We thus see the gradual demise of the hospiLegal Brief tal’s independent contractor defense. Erosion of Captain-of-the-Ship and Borrowed-Servant Doctrines For many years, two other doctrines helped hospitals escape liability for providers’ acts: the captain-of-the-ship and borrowed-­ servant concepts, most notably invoked CH07.indd 279 As discussed in chapter 6, the US Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, which removed federal constitutional protections for abortion, raises many unanswered questions. The principles of vicarious liability, apparent agency, and so on, that we discussed earlier will apply in abortion-related cases as in other tort-law situations. (See chapter 15 for a full discussion of the Dobbs decision.) 02/01/23 2:01 PM 280 T h e L aw o f H e a l th c a re A d mi n i stra ti o n when negligence occurs during surgery. The former presumed that a surgeon was the “captain” during surgery and, like the captain of a real ship, responsible for what occurred within the surgery suite. Thus, the hospital’s argument was that the surgeon, not the hospital, was liable for any negligence that occurred during surgery. This argument was bolstered by the borrowed-servant doctrine, the related principle that one who is normally an employee of one person or entity (e.g., an employee of a hospital) may be borrowed by another—a surgeon, for example—thereby becoming a servant of the surgeon and making the surgeon liable for the “borrowed” employee’s negligence. (Readers who have watched Downton Abbey will appreciate the idea of “borrowing servants.”) In any vicarious liability case, the basis for liability is one’s right of control over the negligent activities of another. As the number of persons on surgical teams has grown and as anesthesiologists, nurses, surgical assistants, and others have been increasingly recognized as performing independent functions pursuant to hospital policies and their own professions’ standards of care, the courts have realized that imposing liability on the chief surgeon alone for the negligent acts of all surgical team members is not sound legal doctrine. Whether the surgeon or the hospital was the sole controlling master or whether both had control to justify joint liability is for the jury to decide. Many cases involving a miscount of instruments or surgical sponges illustrate erosion of the captain-of-the-ship and borrowed-servant doctrines. For example, in Tonsic v. Wagner, the trial court applied the captain-of-theship doctrine to hold the surgeon liable when neither the scrub nurse, a circulating nurse, nor an intern counted the surgical instruments at the conclusion Law in Action of a colectomy.17 As a result, a clamp was not removed from the patient. The trial court did not permit the jury to consider During a deposition in a case involving a retained the vicarious liability of the hospital, which surgical sponge, an exchange between the chief employed the nurses. The Pennsylvania operating room nurse and the plaintiff’s lawyer went as follows: Supreme Court reversed the decision, noting that under the law of agency, a negAttorney. When the operation was over, did you ligent party may be the employee of two or anyone else count the sponges that had been masters simultaneously, even when the used? masters are not joint employers. In such Nurse. No, sir. situations both masters may be liable.18 Accordingly, the plaintiff was entitled to a Attorney. Why not? new trial in her suit against the hospital (see Nurse. Well, we didn’t count them before the surLaw in Action). gery, so it wouldn’t have done any good to count The trend has been observable for them afterward, would it? decades.19 When medical care is provided Understandably, the case was settled before trial. by highly specialized, sophisticated teams of professionals working in an institutional CH07.indd 280 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 281 setting, determining who is exercising what control over whom at any given time is difficult. In such cases, many consider it logical that the corporate institution must share in the liability or bear sole responsibility depending on the facts. Doctrine of Corporate Liability Under the doctrine of corporate liability, the hospital is negligent because it breached a duty it owed directly to the patient. This liability is not “vicarious”; rather, it attaches to the corporation because the hospital owes a legal duty directly to the patient, and this duty is not delegable to the medical staff or other personnel. A Connecticut court defined corporate liability in these words: “Corporate negligence is the failure of those entrusted with the task of providing accommodations and facilities necessary to carry out the charitable purposes of the corporation to follow . . . the established standard of conduct to which the corporation should conform.”20 As previously discussed, healthcare systems are more than “doctors’ workshops.” They arrange, furnish, and provide the community with an entire range of health-related services—preventive, curative, and palliative; outpatient and inpatient; acute and long term. As their vision has expanded, so have their duties. Before the mid-1960s, courts generally limited hospitals’ corporate duties to such issues as selection and retention of employees and maintenance of hospital equipment, buildings, and grounds; these duties remain areas of potential liability today. “Slip and fall” cases are in this category. Negligence regarding equipment is seen when there are unrepaired defects, when equipment is misused,21 or when it is used for an unintended purpose.22 The duty of reasonable care regarding the use of equipment and its selection for an intended purpose also includes a duty to inspect the equipment systematically and regularly before use.23 Rules and regulations of licensing authorities, accreditation standards, and instructional manuals supplied by manufacturers to maintain equipment can be admitted at trial as evidence of expected standards of care. Failure on the part of hospital and medical personnel to comply with such standards constitutes evidence of breach of duty. Under negligence theories, physicians and institutional providers have a duty to warn a patient of known risks when the patient is furnished with a medical device. Moreover, courts are now extending the duty to include informing patients of risks that become known after the device is furnished. Thus, if a heart pacemaker is implanted and later recalled because of a defect, the hospital and the physician have a duty to notify the patient if they know or should know of the recall. Regarding the availability of equipment and services, one is not required to possess the newest and most modern equipment available on the CH07.indd 281 02/01/23 2:01 PM 282 T h e L aw o f H e a l th c a re A d mi n i stra ti o n market, but there is a duty to have available the usual and customary equipment and staff for any service that the hospital renders. (The same applies to physicians’ offices, nursing homes, and other facilities.) For example, providers have been found liable for using unsterilized hypodermic needles.24 In Garcia v. Memorial Hospital, a hospital did not have a pediatric endotracheal tube that might have saved a child’s life.25 The hospital operated an ED and held itself out as providing a full range of emergency services, and the court held that availability of a pediatric endotracheal tube is usual and customary in EDs. In another example, a Pennsylvania hospital was found liable when its electrocardiogram machine in the ED broke down and no backup instrument was available.26 The emergency patient had to be taken to another location for the test, but he died there. Healthcare organizations also have a corporate responsibility to exercise reasonable care in selecting and retaining employees. In Wilson N. Jones Memorial Hospital v. Davis,27 the hospital had to pay the plaintiff both compensatory and punitive damages for failure to investigate the background and references of an applicant for the position of orderly. The hospital’s normal hiring procedure was to obtain four employment references and three personal references. Established policy was to verify at least one of the employment references and one of the personal references before hiring the applicant. In this case, a hospital executive employed the applicant as an orderly without checking any of the references. The justification, asserted after the fact, was that the hospital had a critical need for personnel. This is a good lesson in the danger of establishing a rule or policy you are not willing to follow or enforce. After the individual began work, an inquiry was sent to one of the references, who verified that the orderly had worked for him for approximately four months but did not answer any of the other questions on the reference form. The hospital failed to follow up. Furthermore, the employee had stated that he received his training as an orderly while in the US Navy, but again the hospital did not inquire, saying the armed services had not been cooperative with it in the past. However, the plaintiff requested information from the Navy and promptly learned that the orderly had been expelled from the Navy’s Medical Corps School after a single month’s training, that he had been diagnosed as having a serious drug problem, and that he had a criminal record. The orderly also had listed three personal references on his application and included a local telephone number for each. The hospital attempted to contact only one of these references, and that attempt was unsuccessful. Soon after he was hired, the orderly attempted to remove a Foley catheter from a patient’s bladder without first deflating the bulb; this action seriously injured the patient. The hospital was held liable for both compensatory and punitive damages. The hospital’s critical need for orderlies at the time CH07.indd 282 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 283 did not justify its failure to exercise reasonable care in the employee selection process. Moreover, the punitive damages awarded in the case were assigned as a result of “such an entire want of care as to indicate that the act . . . was the result of conscious indifference to the rights, welfare, and safety of the patients in the hospital.”28 Failure to Adopt or Follow Rules Hospital bylaws, rules and regulations, and the accreditation standards of The Joint Commission are admissible as evidence at trial.29 If violation of a hospital rule is the proximate cause of a plaintiff’s injury, liability can be premised on the fact that the rule is the expected standard of care. Violation of a rule or written standard does not automatically amount to negligence, but it is strong evidence. For example, in Pederson v. Dumouchel, a hospital was held liable when—in violation of hospital policy—it permitted nonemergency dental surgery to be performed under a general anesthetic without the supervision of a medical doctor.30 Typically, the existence of a rule and evidence of its breach are submitted to the jury as a question of fact. As would be expected, evidence that a rule has been violated is often persuasive to jurors. For example, a jury verdict for the plaintiff was affirmed in Burks v. Christ Hospital, citing a hospital policy requiring that bedside rails be raised if a patient is restless, obese, or under sedation, unless the attending physician issues an order to the contrary.31 The plaintiff sustained injuries when he fell from the bed, and the jury was entitled to consider the violation of this written standard as evidence of negligence. In another example, a Michigan case noted that an administrative regulation requiring hospitals to have written policies regarding medical consultations and to record consultations was intended to protect hospitalized patients.32 Accordingly, the plaintiff was entitled to have the jury instructed on the purpose of this rule. Another variation of corporate liability is a hospital’s failure to have and to implement adequate rules regarding communication of vital information on patient care to others who are or will be responsible for treating the patient. For example, in Keene v. Methodist Hospital,33 an injured patient was seen at about 2:00 a.m. on December 25 by an on-call physician in a hospital ED. The patient was sent home after X-rays were taken, and a few hours later, a radiologist examined the films and detected a possible skull fracture. The radiologist suggested further X-ray studies and dictated a tentative diagnosis and recommendations into a recorder, but he did not communicate further with the attending physician, the patient, the patient’s family, or hospital administration. Because of the Christmas holiday, the dictation was not transcribed for two days. During this period, the patient lost consciousness, was returned to the hospital for emergency surgery, and died because of a fractured skull and hemorrhage. CH07.indd 283 02/01/23 2:01 PM 284 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The court stated that the patient “would not have died from his head injuries if he had been treated for a skull fracture during the morning of December 25” and found both the ED physician and the radiologist liable. In addition, the hospital was held liable because “[i]t is the duty of the Hospital to adopt procedures which would ensure that the opinion of a radiologist showing the possibility of a severe injury would be immediately conveyed to the proper persons.”34 Thus, failure to have and to follow proper rules, regulations, or systems when indicated by recognized professional standards can result in liability—whether it is called corporate negligence or vicarious liability.35 Negligence in Selection and Retention of Medical Staff The law in most states now recognizes that a corporate healthcare institution owes a duty directly to its patients to exercise reasonable care in the selection and retention of medical staff. The corporation may be liable if it knows or should have known that an individual provider was not competent to perform the permitted clinical procedures. This doctrine emerged from the 1965 landmark case Darling v. Charleston Community Memorial Hospital,36 in which the Illinois Supreme Court held that a hospital could be liable under either (1) respondeat superior, if nurse employees failed to notify medical and hospital administrators when they knew that a patient was receiving inadequate medical care, or (2) corporate liability, if the hospital failed to review and monitor the quality of care generally rendered to patients by the private physician. The private physician in this case was a general practitioner who had been permitted by the hospital to practice orthopedic medicine and whose clinical competence had not been reviewed in his more than three decades of practice. Significantly, Darling also established that to prove the standard of care expected of a hospital, the jury may consider standards set forth in medical staff bylaws as well as those promulgated by The Joint Commission and state licensing authorities. Moreover, the case abolished the “locality rule” in Illinois. In short, the hospital could no longer fully defend itself by asserting that other hospitals in the area also did not enforce their medical staff bylaws or review the performance of their medical staff members. The Illinois court rejected the view that a hospital simply procures nurses and doctors who then act on their own responsibility. A hospital treats patients and acts through its nurses and doctors, even if the latter are not employees.37 Following the Darling decision, one commentator wrote, Even in the absence of an employer-employee . . . relationship . . . there now appears to be some chance . . . to impose liability on the hospital on the theory of independent negligence in failing to review, supervise, or consult about, the CH07.indd 284 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 285 treatment given by the physician directly in charge, if the situation indicates that the hospital had the opportunity for such review but failed to exercise it, or that its servants (usually nurses or residents) were negligent in failing to call the attention of the proper hospital authorities to the impropriety or inadequacy of the treatment being given.38 Case law has firmly established that hospital administration and medical staff have a joint role with respect to the clinical performance of individual practitioners. The governing body of a hospital has a responsibility to adopt corporate and medical staff bylaws providing for an organized medical staff accountable to the board for quality of care. The governing board grants medical staff appointments, delineates privileges on an individual basis, and reappoints clinicians on the basis of the recommendations of medical staff committees. In ruling on these recommendations, the board must be satisfied that the peer review process is working properly and avoid rubber-stamping recommendations submitted by the medical staff. The responsibility of the governing body is nondelegable; the board does, however, delegate to the medical staff the authority to implement the credentialing process and prepare recommendations for appointments and reappointments (more on this subject in chapter 8). Other leading cases have recognized the corporate duty of a hospital to exercise reasonable care in the selection and retention of the medical staff. A 1971 Georgia case, Joiner v. Mitchell County Hospital Authority, held that members of the medical staff who make physician appointment recommendations to the governing body of a hospital are agents of the hospital.39 In considering these recommendations, the governing body must act in good faith and with reasonable care.40 Nevada’s Supreme Court recognized a similar institutional duty in Moore v. Board of Trustees of Carson-Tahoe Hospital, a case concerning medical staff privileges.41 The court stated, The purpose of the community hospital is to provide patient care of the highest possible quality. To implement this duty of providing competent medical care to the patients, it is the responsibility of the institution to create a workable system whereby the medical staff of the hospital continually reviews and evaluates the quality of care being rendered within the institution. The staff must be organized with the proper structure to carry out the role delegated to it by the governing body. All powers of the medical staff flow from the board of trustees, and the staff must be held accountable for its control of quality. . . . The role of the hospital vis-a-vis the community is changing rapidly. The hospital’s role is no longer limited to the furnishing of physical facilities and equipment where a physician treats his private patients and practices his profession in his own individualized manner. . . . CH07.indd 285 02/01/23 2:01 PM 286 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Licensing [of physicians], per se, furnishes no continuing control with respect to a physician’s professional competence and therefore does not assure the public of quality patient care. The protection of the public must come from some other authority, and that in this case is the Hospital Board of Trustees. The Board, of course, may not act arbitrarily or unreasonably in such cases. The Board’s actions must be predicated upon a reasonable standard.42 In Gonzales v. Nork, the defendant performed an unsuccessful and allegedly unnecessary laminectomy and spinal fusion procedure on a 27-yearold man who had been injured in an automobile accident.43 Complications developed that substantially reduced his life expectancy, and at trial, he presented evidence showing that the surgeon had performed more than three dozen similar operations negligently or unnecessarily. The trial court issued a lengthy opinion recognizing that the hospital owed a duty of care to the patient with respect to the delineation of surgical privileges extended to private surgeons. The court stated forcefully that this duty included the obligation to protect the patient from acts of malpractice by an independently retained doctor if the hospital knew or should have known that such acts were likely to occur. Even though the hospital had no actual knowledge of Dr. Nork’s propensity to commit malpractice or perform unnecessary surgery, its failure to have a system for acquiring such knowledge justified the finding of negligence. Gonzales v. Nork was decided in the 1970s, and today’s risk management, quality assurance, and peer review functions are at least in part a response to it and similar cases. A landmark Wisconsin case in 1981 took a particularly enlightened view of the role of a hospital in its relations with the medical staff. In Johnson v. Misericordia Community Hospital (see The Court Decides at the end of this chapter), the plaintiff alleged that the hospital was negligent in granting orthopedic surgical privileges to a particular physician.44 The Wisconsin Supreme Court affirmed a jury verdict for the plaintiff on the following bases: 1. The hospital failed to inquire into the physician’s professional background and qualifications prior to granting a staff appointment. 2. The hospital failed to adhere to its own bylaw provisions and to Wisconsin statutes pertaining to medical credentialing. 3. The exercise of ordinary care would have disclosed the physician’s lack of qualifications. 4. Had the hospital exercised due diligence, it would not have appointed the physician to the medical staff. 5. By not exercising due diligence, the hospital exposed patients to a “foreseeable risk of unreasonable harm.” CH07.indd 286 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 287 Johnson stands for the now well-recognized proposition that, as the Wisconsin court plainly and simply phrased it, “A hospital has a duty to exercise due care in the selection of its medical staff.”45 Only licensed practitioners can actually treat patients, but the governing board and administration are responsible for ensuring that the organized medical staff periodically reviews the clinical behavior of staff providers. Rather than second-guess medical care, the governing board delegates the review and evaluation functions to the medical staff, which in turn is accountable to the board for its recommendations in a process known as credentialing (see a complete discussion in chapter 8). The medical staff is responsible for developing reasonable criteria and fundamentally fair procedures for evaluation, appointment, and delineation of privileges. The medical staff must gather information and data that support its recommendations and must forward the information to the governing body. The board, in turn, is responsible for approving the criteria and procedures for appointment, the delineation of privileges, and the renewal of appointments. It then acts on the medical staff’s recommendations after ensuring that all supporting information is complete. Hospitals must develop a credentialing process for other p ­ rofessionals— physician’s assistants, nurse practitioners, podiatrists, technicians, pharmacists, and other providers—who also work in their facilities. Institutions must evaluate the competencies of these individuals just as they do those of the medical staff. Moreover, procedures must be developed to review periodically the performance of each of these professionals. The scope of their clinical activities is a matter for the medical and nursing staffs to develop according to local licensure laws and professional custom and usage. The cases discussed in this section illustrate significant changes in the theories of hospital liability. The law of agency and respondeat superior no longer suffice to explain corporate duty; rather, in the hospital setting, the rules of respondeat superior and corporate or independent negligence have essentially become one. In any given case, the applicable legal theory—corporate negligence or respondeat superior—is becoming increasingly difficult to determine, but it probably does not matter much. Just as in Bing v. Thunig46—which in 1957 eliminated any distinction between the administrative and professional acts of nurses for the purposes of respondeat superior—the distinction between hospitals’ vicarious liability (respondeat superior) and direct liability (corporate negligence) has nearly disappeared for all practical purposes. In any event, hospital rules, standards of accreditation, and licensure regulations must be realistic, known to all affected persons, implementable, and consistently enforced. Furthermore, the rules must be regularly and systematically reviewed; if they are not realistic and workable, they should be eliminated. CH07.indd 287 02/01/23 2:01 PM 288 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Liability of Managed Care Organizations Managed care organization (MCO) is a general term used to describe any number of health insurance arrangements that integrate the payment for healthcare with its provision in an effort to improve quality and reduce costs. The cost-cutting mechanisms are our focus here. Among those mechanisms are contracts with physicians, hospitals, skilled nursing facilities, pharmacies, and other healthcare providers to offer services to their members at reduced payment rates. These providers make up the MCO’s “network,” and they offer a range of services that varies depending on the type of plan chosen. There are generally three types of plans: utilization review (UR) Systematic (usually retrospective) review of the efficiency and medical necessity of healthcare services based on established guidelines. utilization management (UM) Proactive techniques to improve the efficiency and to control the cost of health services by influencing providers’ medical decisionmaking. UM typically includes concurrent peer review processes. CH07.indd 288 1. Health maintenance organizations (HMOs) usually only pay for care in the network; the patient’s primary care doctor coordinates the care. 2. Preferred-provider organizations (PPOs) usually pay more if care is provided in the network, but they still pay part of the cost if the patient goes outside the network. 3. Point-of-service plans let the patient choose between an HMO or a PPO each time they need care, and the level of payment will vary accordingly.47 MCOs have mechanisms for reviewing the medical necessity of specific services, controlling inpatient admissions and lengths of stay, establishing cost-sharing incentives for outpatient surgery, contracting selectively with certain healthcare providers, and managing high-cost healthcare cases intensively. They proliferated in the 1980s, during the frenzy over efficiency and cost savings; as with the first wave of physician-hospital organizations (see chapter 3), whether they have had any significant effect on rising healthcare costs is debatable. In general, managed care plans tend to emphasize preventive and primary care and to limit access to more costly services. In many MCOs, select primary care physicians act as gatekeepers who must be consulted before the patient can see a specialist. Many patients also must obtain MCO authorization for hospitalization or for hospitalization to extend beyond a certain number of days. This process is often referred to as utilization review (UR) or utilization management (UM), and the requests for authorization are often handled by nurses specially trained to administer the program. Authorization can be refused for a number of reasons; for example, the proposed treatment may not be a covered benefit, the proposed treatment may not be medically necessary, or the request may not have been made in a timely or procedurally correct manner. 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 289 Quality Versus Cost Savings Any of these reasons to deny care can be legitimate, but when UR denials appear to result from financial pressures, aggrieved patients often allege that the health plan neglected quality in favor of economy. They assert that a particular authorization request was denied for nonclinical reasons, that they were refused necessary treatment, or that they were discharged from the hospital prematurely. The aphorism that patients were being sent home “sicker and quicker” arose out of this last assertion. Typical of the cases that first raised these issues were two from California in the late 1980s. In Wickline v. State,48 the plaintiff argued that the d ­ ecision to admit patients or extend their stay is a medical one that only a physician—and not a health plan—should make; she attempted to assert liability against the state’s Medi-Cal program after a UR decision led to her being discharged early, which resulted in complications that caused her to lose a leg. The trial court decided in the patient’s favor, but the appellate court reversed the decision, emphasizing the difference between prospective and retrospective UR: In . . . prospective utilization review, authority for the rendering of health care services must be obtained before medical care is rendered. Its purpose is to promote the well recognized public interest in controlling health care costs by reducing unnecessary services while still intending to assure [sic] that appropriate medical and hospital services are provided to the patient in need. However, such a cost containment strategy creates new and added pressures on the quality assurance portion of the utilization review mechanism. The stakes, the risks at issue, are much higher when a prospective cost containment review process is utilized than when a retrospective review process is used. A mistaken conclusion about medical necessity following retrospective review will result in the wrongful withholding of payment. An erroneous decision in a prospective review process, on the other hand, in practical consequences, results in the withholding of necessary care, potentially leading to a patient’s permanent disability or death.49 The court went on to hold that it was ultimately the physician’s responsibility, not MediCal’s, to decide when the patient should be discharged: Third party payors of health care services can be held legally accountable when medically inappropriate decisions result from defects in the design or implementation of cost containment mechanisms. . . . However, the physician who complies without protest with the limitations imposed by a third party payor, when his medical judgment dictates otherwise, cannot avoid his ultimate responsibility for his CH07.indd 289 02/01/23 2:01 PM 290 T h e L aw o f H e a l th c a re A d mi n i stra ti o n patient’s care. He cannot point to the health care payor as the liability scapegoat when the consequences of his own determinative medical decisions go sour.50 dictum Latin meaning “remark”—a comment in a legal opinion that is not binding because it is not required to reach the decision but that states a related legal principle; plural dicta. The court concluded that although the physician was “intimidated” by Medi-Cal’s UR decision, he was not “paralyzed” by it and should have made a greater effort to keep his patient in the hospital. There is irony in this outcome: the court agreed with the plaintiff’s argument that the decision to discharge is one for physicians to make, and she lost her appeal as a result. Four years later, the other California case—decided by different judges on the same appellate court—limited the applicability of Wickline’s broad language. In Wilson v. Blue Cross of Southern California,51 a physician had requested three to four weeks of additional care for a depressed psychiatric patient. Based on a prospective review, the insurance company declined to pay for any further care. Because nobody else could afford to pay, the patient was discharged. He committed suicide less than three weeks later. The Wilson court found that there was “substantial evidence that [the] decision not to approve further hospitalization was a substantial factor in bringing about the decedent’s demise,”52 and it remanded the case for further proceedings. In their decision, the justices characterized Wickline’s statement that “the decision to discharge is . . . the responsibility of the patient’s own treating doctor” as being dictum and overly broad. According to the Wilson court, “This broadly stated language was unnecessary to the [earlier] decision and in all contexts does not correctly state the law relative to causation issues in a tort case.”53 Over the next few years, cases in several other states addressed the issue of MCOs’ allegedly wrongful denial of treatment, and the results were mixed. The decisions often depended on interpretation of the Employee Retirement Income Security Act (ERISA) of 1974.54 ERISA Preemption Complicates Matters Congress passed ERISA in 1974, largely to protect employer-sponsored pension plans, but it also affects employer-sponsored health benefit plans. Then, as now, most people under age 65 get their health insurance through an employer-sponsored plan, either the coverage sponsored by their employer or that of their spouse or parent. And more than half of employer-sponsored plans are now self-insured plans, where the employer (typically a large company) bears the financial risk but contracts with an insurer to administer the claims. As described earlier, the rise of managed care dates to the 1980s, after ERISA’s enactment. ERISA does not require employers to offer a health insurance plan, but the ACA’s employer mandate now has that effect for large employers. Additionally, ERISA does not require employer-sponsored plans to cover particular CH07.indd 290 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 291 treatments. Prior to passage of the ACA, there was very little substantive regulation of the content of employer-sponsored health insurance. What ERISA does is establish a nationally uniform regulatory structure for employer-sponsored plans, and in doing so it preempts (supersedes) vast areas of state law. Because of its complicated and confusing preemption framework,55 ERISA has had a huge, and mostly unintended, effect on healthcare. Broadly speaking, that impact is seen in three areas: 1. ERISA complicates state efforts at overarching health reform. That is because ERISA prohibits states from directly requiring employer participation in comprehensive reform frameworks. 2. ERISA limits the reach of state efforts to regulate the details of health insurance coverage for its citizens. That is because ERISA shields selfinsured employer plans from state mandates related to health insurance (see Law in Action). 3. ERISA shields MCOs from the consequences of most of their negligent coverage decisions. That is because, as detailed later, it generally supplants potentially broad state tort damages with limited ERISA recovery options. Aetna Health, Inc. v. Davila, decided by the US Supreme Court in 2004, highlights some of the effects of ERISA preemption.56 The facts of the cases—plural, because two lawsuits were consolidated and decided as one—typify many patients’ situations. The first patient, Juan Davila, had been prescribed Vioxx for arthritis pain, but his MCO refused to pay for it and approved a less expensive drug instead. According to the decision, Davila “suffered a severe reaction that required extensive treatment and hospitalization.” The second patient, Ruby Calid, had undergone surgery, and her physician felt she needed an extended hospital stay. The MCO’s discharge nurse denied this request, after which the patient “experienced postsurgery complications forcing her to return to the hospital.” She argued in her lawsuit that “these complications would not have occurred had [the MCO] approved coverage for a longer hospital stay.”57 Both patients sued their health plans under a Texas law enacted in 2000 that allowed state tort damages for, among other things, an MCO’s negligent coverage decisions. The US Supreme Court found the Texas law to be preempted by ERISA. In his opinion for a unanimous court, Justice Clarence Thomas wrote that “a benefit determination is part and parcel of the ordinary fiduciary responsibilities connected to the administration of a plan. . . . The fact that a benefits determination is infused with medical judgments does not alter this result.”58 He drew no distinction between medical and nonmedical judgments by benefits plan administrators, and he summed CH07.indd 291 02/01/23 2:01 PM 292 T h e L aw o f H e a l th c a re A d mi n i stra ti o n up the Supreme Court’s decision as follows: “[R]espondents bring suit only to Law in Action rectify a wrongful denial of benefits promised under ERISA-regulated plans, and do The ongoing effort to protect patients from “surnot attempt to remedy any violation of a prise bills” illustrates another effect of ERISA legal duty independent of ERISA. We hold preemption. For years, commercially insured that respondents’ state causes of action fall patients sometimes got unexpected medical bills within the scope of [ERISA’s preemption (a practice known as “balance billing”) when they language] and are therefore completely received emergency care, nonemergency care from pre-empted . . . and removable to federal out-of-network providers at in-network facilities, and air ambulance services from out-of-network district court.”59 providers, among other situations. More than 30 ERISA is thus the exclusive remedy states had laws aimed at protecting patients from for beneficiaries of employer-sponsored balance billing, but because ERISA preemption plans when challenging their MCOs’ UR prevents states from regulating employers’ selfdecisions. Because ERISA allows only confunded plans, the state laws did not protect a huge tractual damages and equitable relief (e.g., percentage of patients. To end this practice, in late 2020, Congress an injunction or repayment), the kinds of passed and the president signed the No Surprises remedies that would otherwise be available Act (NSA), 42 U.S.C. §§ 300gg-131–135. Beginning in state court are precluded. These preJanuary 1, 2022, as to emergency, air ambulance, cluded remedies include awards for comand other specified services, it is illegal for providpensatory damages (e.g., money awards ers to “balance bill” patients for more than their for lost wages, pain and suffering, loss of in-network cost-sharing amount if they did not choose or know that the service would come from consortium). As Justice Thomas pointed an out-of-network provider. out, Davila and Calid did have remedies We can expect legal challenges and lobbying under ERISA: they could have paid for the efforts concerning the details of the law and its disputed treatment (the medicine and the regulations. This is particularly likely as to the extra hospital days) and sought reimburseprocess for determining how much the insurer is ment, or they could have sued preempto pay the provider in an NSA situation. States with precursor laws are likely to revise or retract them. tively to force the coverage. As a practical Business strategies based on balance billing will matter, though, those limited remedies are be reevaluated. And health policy analysists will hardly worth suing over and would not wonder whether the new law reduces premiums have “made the plaintiffs whole.” and overall healthcare costs, as some predict. The decision also creates a strange injustice: tort and bad-faith claims against non-ERISA health plans (i.e., individual insurance policies, government plans, church-sponsored plans that have elected not to be covered by ERISA) are not affected. Patients who suffer injury because of non-ERISA plans’ UR decisions are free to pursue ­traditional remedies in state court, whereas patients with identical injuries resulting from identical decisions made by ERISA plans have no viable claim. In a strongly worded concurring opinion that was joined by ­Justice Stephen Breyer, Justice Ruth Bader Ginsburg wrote, “I . . . join the Court’s opinion. But, with greater enthusiasm . . . I also join the rising CH07.indd 292 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 293 judicial chorus urging that Congress and [this] Court revisit what is an unjust and Legal Brief increasingly tangled ERISA regime.”60 She pointed out with favor the suggesI would like to compliment the House [ACA] bill tion of one court of appeals: “The vital for one particular achievement. The convoluted thing . . . is that either Congress or the language brilliantly upholds the tradition of the Court act quickly, because the current original ERISA legislation in defying rational and situation is plainly untenable.”61 These straightforward analysis. That we’re already tryexhortations were written in 2004, and ing to parse whether ERISA preemption is being relaxed is an indication that Congress isn’t sure the health reform debate of 2009–10 what to do. was a grand opportunity for Congress to address the “tangled ERISA regime,” — Peter D. Jacobson, JD, MPH, but unfortunately the injustice created University of Michigan by ERISA preemption was not addressed (personal communication with one of the (see Legal Brief). authors) It seems that ERISA preemption issues will remain a tangled web unless Congress decides to act. Because the issues pit patient rights against business interests, risk raising healthcare costs, and would require bipartisan consensus, there is considerable doubt whether that will occur anytime soon. Chapter Summary This chapter discussed the following topics: • • • • • • The history and demise of charitable immunity The independent contractor concept Agency concepts (apparent and “by estoppel”) Vicarious and corporate liability The rise of managed care The Employee Retirement Income Security Act (ERISA) and employer-sponsored health plans Vocabulary apparent agency charitable immunity dictum utilization management (UM) utilization review (UR) CH07.indd 293 02/01/23 2:01 PM 294 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Discussion Questions 1. Explain at least three reasons why hospitals today are more likely to be liable for negligence that occurs within their walls than hospitals would have been in the mid-twentieth century. From a policy perspective, do you agree with this trend? 2. How is corporate liability different from vicarious liability under respondeat superior? 3. What is the liability of an MCO when it makes decisions about insurance coverage for hospital stays for a patient covered by employersponsored insurance? Why might an accountable care organization’s liability for similar decisions be analyzed differently? 4. How has the federal No Surprises Act affected patients, providers, or insurers? What is the current status of litigation over its regulations? CH07.indd 294 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 295 The Court Decides Norton v. Argonaut Insurance Co. 144 So. 2d 249 (La. Ct. App. 1962) Landry, J. [The plaintiffs are the parents of an infant who died after a medication error in a hospital. She was given an injection of a heart drug that should have been administered orally. The trial court found in the plaintiffs’ favor, and the defendants appealed. Shortly after her birth, the Norton baby was diagnosed as having congenital heart disease and was placed on Lanoxin (a form of digitalis) to strengthen her heart and reduce her pulse rate. She was discharged from the hospital at two and a half months, and her mother administered the medication at home by using a medicine dropper. The child was readmitted about two weeks later—on December 29, 1959—by her pediatrician, Dr. Bombet.] On this occasion [Dr. Bombet] issued admission orders on the infant to be placed in the child’s hospital chart or record. Included in his admission orders were instructions regarding medication, diet, etc., and the notation that special medication was being administered by the mother. In this connection it appears that Mrs. Norton preferred to continue administration of the daily maintenance dose of the Lanoxin herself since she had been performing this function since the child’s initial admission to the hospital on December 15th. Dr. Bombet noted in the hospital admission orders of December 29, 1959, that special medication was being given by the mother to thusly advise the hospital staff and employees that some medication was being administered the child other than that which he placed on the order sheet and would, therefore, be administered by the hospital nursing staff. On January 2, 1960 (Saturday) Dr. Stotler examined the Norton baby at approximately noon while in the course of making his rounds in the hospital. As a result of this examination he concluded that the child needed an increase in the daily maintenance dose of Lanoxin and instructed Mrs. Norton, who was present in the room, to increase the daily dose of the Lanoxin for that day only to 3 c.cs. instead of the usual 2.5 c.cs. Following this instruction to Mrs. Norton, Dr. Stotler went to the nurse’s station in the hospital pediatric unit floor to check the hospital chart or record on the Norton infant and noted on the Doctor’s Order Sheet contained therein certain instructions among which only the following is pertinent to the issues involved herein: “Give 3.0 cc Lanoxin today for 1 dose only.” Dr. Stotler’s entry of the foregoing order for medication constitutes the basis of plaintiff’s claim against Aetna as the professional liability insurer of Dr. Stotler. It is frankly conceded by Aetna that unless Dr. Stotler indicated on the order sheet that he had instructed the patient’s mother to increase the daily maintenance dose of Lanoxin to 3.0 c.cs. and administer the medication, his entry of the aforesaid prescription on the order sheet would indicate that the nursing staff of the hospital was to give the medication prescribed. It is further conceded that under such circumstances the child was subjected to the possibility of being administered a second dose of Lanoxin. The possibility thus presented is exactly what occurred in the instant case. A member of the nursing (continued) CH07.indd 295 02/01/23 2:01 PM 296 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) staff noting Dr. Stotler’s orders, administered 3 c.cs. of Lanoxin in its injectible [sic] form instead of the elixir form which Dr. Stotler intended. . . . It is readily conceded by all concerned that the 3 c.cs. of Lanoxin administered the baby by hypodermic was a lethal overdose and was in fact the cause of the infant’s demise. . . . [The day in question was a Saturday, and the regular staff was not on duty. Florence Evans, a registered nurse whose regular duties were administrative in nature, was assisting in the pediatric unit that day. She had not engaged in the actual clinical practice of nursing for some time, and she did not know that Lanoxin was available in oral form; the last she knew, Lanoxin was given only by injection. Noting the doctor’s orders for “3 cc of Lanoxin,” and seeing no indication that it had been given, she decided to inject the medication herself, even though she sensed that this “appeared to be a rather large dose,” according to the court.] . . . She discussed the matter very briefly with the student nurse, Miss Meadows, and inquired of the Registered Nurse, Miss Sipes, whether or not the child had previously received Lanoxin. Mrs. Evans then examined the patient’s hospital chart and found nothing [to indicate that] the child had been receiving Lanoxin while in the hospital. . . . Considering administration of the drug only by hypodermic needle, Mrs. Evans, accompanied by the Student Nurse, Miss Meadows, went to the medicine room of the pediatric unit and obtained two ampules of Lanoxin each containing 2 c.cs. of the drug in its injectable [sic] form. While pondering the advisability of . . . administering what she considered to be a large dose, Mrs. Evans noted that Dr. Beskin, one of the consultants on the child’s case, had entered the pediatric ward so Mrs. Evans consulted him about the matter and was advised that if Dr. Stotler prescribed 3 c.cs. he meant 3 c.cs. Still not certain about the matter Mrs. Evans also CH07.indd 296 discussed the subject with Dr. Ruiz and was informed by him in effect that although the dose was the maximum dose that if the doctor had prescribed that amount she could give it. [Despite her misgivings, she did give the injection. The baby went into distress, and despite emergency efforts, she died a little more than an hour later.] . . . The rule applicable in the instant case is well stated in the following language [of an earlier Louisiana case]: (1) A physician, surgeon or dentist, according to the jurisprudence of this court and of the Louisiana Courts of Appeal, is not required to exercise the highest degree of skill and care possible. As a general rule it is his duty to exercise the degree of skill ordinarily employed, under similar circumstances, by the members of his profession in good standing in the same community or locality, and to use reasonable care and diligence, along with his best judgment, in the application of his skill to the case. . . . [I]t is manifest that Dr. Stotler was negligent in failing to denote the intended route of administration and failing to indicate that the medication prescribed had already been given or was to be given by the patient’s mother. It is conceded by counsel for Dr. Stotler that the doctor’s oversight in this regard exposed the child to the distinct possibility of being given a double oral dose of the medicine. Although it is by no means certain from the evidence that a second dose of oral Lanoxin would have proven fatal, Dr. Stotler’s own testimony dose [sic] make it clear that in all probability it would have produced nausea. In this regard his testimony is to the effect that even if the strength of two oral doses were sufficient to produce death in all probability death would not result for the reason that nausea produced by overdosing would have most probably induced the child to vomit the second dose thereby saving her life. The contention that 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution Dr. Stotler followed the practice and custom usually engaged in by similar practitioners in the community is clearly refuted and contradicted by the evidence of record herein. Of the four medical experts who testified herein only Dr. Stotler testified in effect that it was the customary and usual practice to write a prescription in the manner shown. The testimony of Drs. Beskin, Bombet and Ruiz falls far short of corroborating Dr. Stotler in this important aspect. The testimony of Dr. Stotler’s colleagues was clearly to the effect that the better practice is to specify the route of administration intended. . . . In view of the foregoing, we hold that the act acknowledged by Dr. Stotler does not relieve him from liability to plaintiffs herein on the ground that it accorded with that degree of skill and care employed, under similar circumstances, by other members of his profession in good standing in the community. We find and hold that the record before us fails to establish that physicians in good standing in the community follow the procedure adopted by defendant herein but rather the contrary is shown. Pretermitting the issue of charitable immunity (with which we are not herein concerned in view of the fact that the suit is against the insurer of the hospital in the instant case) it is the settled jurisprudence of this state that a hospital is responsible for the negligence of its employees including, inter alia, nurses and attendants under the doctrine of respondeat superior. [I]t is not disputed that Mrs. Evans was not only an employee of the hospital but that on the day in question she was in charge of the entire institution as the senior employee on duty at the time. Although there have been instances in our jurisprudence wherein the alleged negligence of nurses has been made the basis of an action for damages for personal injuries . . . we are not aware of any prior decision 297 which fixes the responsibility or duty of care owed by nurses to patients under their care or treatment. The general rule, however, seems to be to extend to nurses the same rules which govern the duty and liability of physicians in the performance of professional services. Thus . . . we find the rule stated as follows: The same rules that govern the duty and liability of physicians and surgeons in the performance of professional services are applicable to practitioners of the kindred branches of the healing profession, such as dentists, and, likewise, are applicable to practitioners such as drugless healers, oculists, and manipulators of X-ray machines and other machines or devices. The foregoing rule appears to be wellfounded and we see no valid reason why it should not be adopted as the law of this state. Tested in the light of [this rule] the negligence of Mrs. Evans is patent upon the face of the record. We readily agree with the statement of Dr. Ruiz that a nurse who is unfamiliar with the fact that the drug in question is prepared in oral form for administration to infants by mouth is not properly and adequately trained for duty in a pediatric ward. As laudable as her intentions are conceded to have been on the occasion in question, her unfamiliarity with the drug was a contributing factor in the child’s death. In this regard we are of the opinion that she was negligent in attempting to administer a drug with which she was not familiar. While we concede that a nurse does not have the same degree of knowledge regarding drugs as is possessed by members of the medical profession, nevertheless, common sense dictates that no nurse should attempt to administer a drug under the circumstances shown in [this] case. Not only was Mrs. Evans unfamiliar with the medicine in question but she also violated what has been shown to be the rule generally practiced (continued) CH07.indd 297 02/01/23 2:01 PM 298 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) by the members of the nursing profession in the community and which rule, we might add, strikes us as being most reasonable and prudent, namely, the practice of calling the prescribing physician when in doubt about an order for medication. . . For obvious reasons we believe it the duty of a nurse when in doubt about an order for medication to make absolutely certain what the doctor intended both as to dosage and route. . . The evidence . . . leaves not the slightest doubt that when Dr. Stotler entered the order for the medication on the chart, it was the duty of the hospital nursing staff to administer it. Dr. Stotler frankly concedes this important fact and for that reason acknowledged that he should have indicated on the chart that the medication had been given or was to be given by the mother, otherwise some nurse on the pediatric unit would give it as was required of the hospital staff. Not only was there a duty on the part of Dr. Stotler to make this clear so as to prevent duplication of the medication but also he was under the obligation of specifying or in some manner indicating the route considering the drug is prepared in two forms in which dosage is measured in cubic centimeters. In dealing with modern drugs, especially of the type with which we are herein concerned, it is the duty of the prescribing physician who knows that the prescribed medication will be administered by a nurse or third party, to make certain as to the lines of communication between himself and the party whom he knows will ultimately execute his orders. Any failure in such communication which may prove fatal or injurious to the patient must be charged to the prescribing physician who has full knowledge of the drug and its effects upon the human system. The duty of communication between physician and nurse is more important when we consider that the nurse who administers the medication is not held to the same degree of knowledge with respect thereto as the prescribing physician. It, therefore, becomes the duty of the physician to make his intentions clear and unmistakable. If, as the record shows, Dr. Stotler had ordered elixir Lanoxin, or specified the route to be oral, it would have clearly informed all nurses of his intention to administer the medication by mouth. Instead, however, he wrote his order in an uncertain, confusing manner considering that the drug in question comes in oral and injectible form and that in both forms dosage is prescribed in terms of cubic centimeters. It is settled jurisprudence of this state that where the negligence of two persons combines to produce injury to a third, the parties at fault are [jointly] liable to the injured plaintiff. [Thus, the court affirmed the jury’s verdict and held everybody liable.] Discussion Questions 1. How many mistakes can you count in this set of facts? At how many points could the chain of errors have been interrupted? 2. If you were the hospital administrator, the chief of the medical staff, or the chief of nursing, what action would you take to prevent recurrence of this tragedy? 3. This child’s death occurred more than 50 years ago, yet a 2007 report by the Institute of Medicine (Preventing Medication Errors) states that at least 1.5 million people are injured each year because of medication errors. According to the report, on average, at least one medication error is made per hospital per patient per day. What safeguards are in place in hospitals today to prevent these kinds of mistakes? ~ CH07.indd 298 ~ 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 299 The Court Decides Johnson v. Misericordia Community Hospital 99 Wis. 2d 708, 301 N.W.2d 156 (1981) Coffey, J. [This case involves negligent surgery performed on Mr. Johnson by Dr. Salinsky at Misericordia Community Hospital in July 1975. Because of undisputed negligence by the doctor, the patient (plaintiff ) has “a permanent paralytic condition of his right thigh muscles with resultant atrophy and weakness and loss of function.” The doctor settled before trial, but the hospital disputed allegations that it was negligent. A verdict in favor of the plaintiff was affirmed by the court of appeals. Misericordia Community Hospital had previously been a religiously affiliated hospital, but it was sold to a private group of physicians who first operated it as a nursing home but subsequently reinstituted acute care services there. At the time of the incidents in this case, the hospital was not accredited by The Joint Commission.] On March 5, 1973 . . . Dr. Salinsky applied for orthopedic privileges on the medical staff. In his application, Salinsky stated that he was on the active medical staff of [other hospitals and that] his privileges at other hospitals had never “been suspended, diminished, revoked, or not renewed.” In another part of the application form, he failed to answer any of the questions pertaining to his malpractice insurance, i.e., carrier, policy number, amount of coverage, expiration date, [and] agent, and represented that he had requested privileges only for those surgical procedures in which he was qualified by certification. In addition to requiring the above information, the application provided that significant misstatements or omissions would be a cause for denial of appointment. Also, in the application, Salinsky authorized Misericordia to contact his malpractice carriers, past and present, and all the hospitals that he had previously been associated with, for the purpose of obtaining any information bearing on his professional competence, as well as his moral and ethical qualifications for staff membership. [The application also contained language releasing the hospital from any liability as a result of doing a background check on the applicant.] Mrs. Jane Bekos, Misericordia’s medical staff coordinator (appointed April of 1973) testifying from the hospital records, noted that Salinsky’s appointment to the medical staff was recommended by the then hospital administrator, David A. Scott, Sr., on June 22, 1973. Salinsky’s appointment and requested orthopedic privileges, according to the hospital records, were not marked approved until August 8, 1973. This approval of his appointment was endorsed by Salinsky himself. Such approval would, according to accepted medical administrative procedure, not be signed by the applicant but by the chief of the respective medical section. Additionally, the record establishes that Salinsky was elevated to the position of Chief of Staff shortly after he joined the medical staff. However, the court record and the hospital records are devoid of any information concerning the procedure utilized by the Misericordia authorities in approving either Salinsky’s appointment to the staff with orthopedic privileges or his elevation to the position of Chief of Staff. (continued) CH07.indd 299 02/01/23 2:01 PM 300 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) Mrs. Bekos testified that although her hospital administrative duties entailed obtaining all the information available regarding an applicant from the hospitals and doctors referred to in the application for medical staff privileges, she failed to contact any of the references in Salinsky’s case. In her testimony she attempted to justify her failure to investigate Salinsky’s application because she believed he had been a member of the medical staff prior to her employment in April of 1973, even though his application was not marked approved until some four months later on August 8, 1973. Further, Mrs. Bekos stated that an examination of the Misericordia records reflected that at no time was an investigation made by anyone of any of the statements recited in his application. At trial, the representatives of two ­Milwaukee hospitals . . . gave testimony concerning the accepted procedure for evaluating applicants for medical staff privileges. Briefly, they stated that the hospital’s governing body, i.e., the board of directors or board of trustees, has the ultimate responsibility in granting or denying staff privileges. However, the governing board delegates the responsibility of evaluating the professional qualifications of an applicant for clinical privileges to the medical staff. The credentials committee (or committee of the whole) conducts an investigation of the applying physician’s or surgeon’s education, training, health, ethics and experience through contacts with his peers in the specialty in which he is seeking privileges, as well as the references listed in his application to determine the veracity of his statements and to solicit comments dealing with the applicant’s credentials. Once [this has been done, a recommendation is relayed] to the governing body, which . . . has the final appointing authority. The record demonstrates that had [such an investigation been conducted, Misericordia] would have found, contrary to [Dr. Salinsky’s] representations, that he had in CH07.indd 300 fact experienced denial and restriction of his privileges, as well as never having been granted privileges at the very same hospitals he listed in his application. This information was readily available to Misericordia, and a review of Salinsky’s associations with various Milwaukee orthopedic surgeons and hospital personnel would have revealed that they considered Salinsky’s competence as an orthopedic surgeon suspect, and viewed it with a great deal of concern. [The court summarizes some of Dr. Salinsky’s professional history. At one hospital, his request for expanded orthopedic privileges was denied after being on the staff for a year and a half. At another, his privileges were temporarily suspended and subsequently limited after a report of “continued flagrant bad practices.” At a third, his initial application for privileges was flatly denied. The court adds, “The testimony at trial established many other discrepancies in Salinsky’s Misericordia application,” and it points out that experts in the field testified that, in their opinion, a prudent hospital would not have granted Salinsky’s application under these circumstances.] The jury found that the hospital was negligent in granting orthopedic surgical privileges to Dr. Salinsky and thus apportioned eighty percent of the causal negligence to Misericordia. Damages were awarded in the sum of $315,000 for past and future personal injuries and $90,000 for past and future impairment of earning capacity. . . . Issues 1. Does a hospital owe a duty to its patients to use due care in the selection of its medical staff and the granting of specialized surgical (orthopedic) privileges? 2. What is the standard of care that a hospital must exercise in the discharge of this duty to its patients[,] and did Misericordia fail to exercise that standard of care in this case? 02/01/23 2:01 PM 301 C h a p t er 7 : L iab ility of the H ealthc are Institution Duty At the outset, it must be noted that Dr. Salinsky was an independent contractor, not an employee of Misericordia, and that the plaintiff is not claiming that Misericordia is vicariously liable for the negligence of Dr. Salinsky under the theory of respondeat superior. Rather, Johnson’s claim is premised on the alleged duty of care owed by the hospital directly to its patients. . . . “The concept of duty in Wisconsin, as it relates to negligence cases, is irrevocably interwoven with foreseeability. Foreseeability is a fundamental element of negligence.” In [a prior case,] this court set the standard for determining when a duty arises: A defendant’s duty is established when it can be said that it was foreseeable that his act or omission to act may cause harm to someone. A party is negligent when he commits an act when some harm to someone is foreseeable. Once negligence is established, the defendant is liable for unforeseeable consequences as well as foreseeable ones. In addition, he is liable to unforeseeable plaintiffs. Further, we defined the term “duty” as it relates to the law of negligence: The duty of any person is the obligation of due care to refrain from any act which will cause foreseeable harm to others even though the nature of that harm and the identity of the harmed person or harmed interest is unknown at the time of the act. Thus, the issue of whether Misericordia should be held to a duty of due care in the granting of medical staff privileges depends upon whether it is foreseeable that a hospital’s failure to properly investigate and verify the accuracy of an applicant’s statements dealing with his training, experience and qualifications as well as to weigh and pass judgment on the applicant would present an unreasonable risk of harm to its patients. The failure of a hospital to scrutinize the credentials of its medical staff applicants could foreseeably result in the appointment of unqualified physicians and surgeons to its staff. Thus, the granting of staff privileges to these doctors would undoubtedly create an unreasonable risk of harm or injury to their patients. Therefore, the failure to investigate a medical staff applicant’s qualifications for the privileges requested gives rise to a foreseeable risk of unreasonable harm and we hold that a hospital has a duty to exercise due care in the selection of its medical staff. Our holding herein is in accord with the public’s perception of the modern day medical scientific research center with its computed axial tomography (CAT-scan), radio nucleide imaging thermography, microsurgery, etc., formerly known as a general hospital. The public is indeed entitled to expect quality care and treatment while [they are patients] in our highly technical and medically computed hospital complexes. The concept that a hospital does not undertake to treat patients, does not undertake to act through its doctors and nurses, but only procures them to act solely upon their own responsibility, no longer reflects the fact. . . . [T]he person who avails himself of our modern “hospital facilities” . . . expects that the hospital staff will do all it reasonably can to cure him and does not anticipate that its nurses, doctors and other employees will be acting solely on their own responsibility. Further, our holding is supported by the decisions of a number of courts from other jurisdictions. These cases hold that a hospital has a direct and independent responsibility to its patients, over and above that of the physicians and surgeons practicing therein, to take reasonable steps to (1) insure that its medical staff is qualified for the privileges granted and/or (2) to evaluate the care provided. (continued) CH07.indd 301 02/01/23 2:01 PM 302 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) [The court here embarks on a lengthy discussion of similar cases from various other states. It points out the leading case of Darling v. Charleston Community Memorial Hospital, in which the Supreme Court of Illinois found a direct duty flowing from hospital to patient regarding the qualifications of members of the medical staff. The Johnson court favorably quotes from the Darling opinion, including the following passage: “The Standards for Hospital Accreditation, the state licensing regulations and the defendant’s bylaws demonstrate that the medical profession and other responsible authorities regard it as both desirable and feasible that a hospital assume certain responsibilities for the care of the patient.”] There was credible evidence to the effect that a hospital, exercising ordinary care, [would have known of the deficiencies in Dr. Salinsky’s qualifications and] would not have appointed Salinsky to its medical staff. . . . This court has held “. . . a jury’s finding of negligence . . . will not be set aside when there is any credible evidence that under any reasonable view supports the verdict. . . . Thus, the jury’s finding of negligence on the part of Misericordia must be upheld [because] the testimony of [the expert witnesses] constituted credible evidence which reasonably supports this finding. In summary, we hold that a hospital owes a duty to its patients to exercise reasonable care in the selection of its medical staff and in granting specialized privileges. The final appointing authority resides in the hospital’s governing body, although it must rely on the medical staff and in particular the credentials committee (or committee of the whole) to investigate and evaluate an applicant’s qualifications for the requested privileges. However, this delegation of the responsibility to investigate and evaluate the professional competence of applicants for clinical privileges does not relieve the governing body of CH07.indd 302 its duty to appoint only qualified physicians and surgeons to its medical staff and periodically monitor and review their competency. The credentials committee (or committee of the whole) must investigate the qualifications of applicants. [Paragraph break added.] The facts of this case demonstrate that a hospital should, at a minimum, require completion of the application and verify the accuracy of the applicant’s statements, especially in regard to his medical education, training and experience. Additionally, it should: (1) solicit information from the applicant’s peers, including those not referenced in his application, who are knowledgeable about his education, training, experience, health, competence and ethical character; (2) determine if the applicant is currently licensed to practice in this state and if his licensure or registration has been or is currently being challenged; and (3) inquire whether the applicant has been involved in any adverse malpractice action and whether he has experienced a loss of medical organization membership or medical privileges or membership at any other hospital. The investigating committee must also evaluate the information gained through its inquiries and make a reasonable judgment as to the approval or denial of each application for staff privileges. The hospital will be charged with gaining and evaluating the knowledge that would have been acquired had it exercised ordinary care in investigating its medical staff applicants and the hospital’s failure to exercise that degree of care, skill and judgment that is exercised by the average hospital in approving an applicant’s request for privileges is negligence. This is not to say that hospitals are insurers of the competence of their medical staff, for a hospital will not be negligent if it exercises the noted standard of care in selecting its staff. The decision of the Court of Appeals is affirmed. 02/01/23 2:01 PM 303 C h a p t er 7 : L iab ility of the H ealthc are Institution Discussion Questions 1. In the opening paragraph of his classic 1881 treatise The Common Law, Oliver Wendell Holmes Jr. wrote, “The life of the law has not been logic: it has been experience. The felt necessities of the time, the prevalent moral and political theories, institutions of public policy, avowed or unconscious, even the prejudices which judges share with their fellow-men, have had a good deal more to do than the syllogism in determining the rules by which men should be governed.” How is this case an example of the truth of this passage? 2. Do you agree with the court’s rationale? What would have been the implications of the opposite result? 3. Does this decision mean that a hospital will be liable for every incident of malpractice committed by nonemployee members of its medical staff? Why or why not? Describe a situation in which a hospital would be unlikely to be found liable for a physician’s negligence that occurred within the hospital. ~ ~ Notes 1. The origin of immunity in the United States is generally attributed to McDonald v. Massachusetts Gen. Hosp., 120 Mass. 432, 21 A.529 (1876). This decision was a determining factor in the famous case of Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914), which is generally cited today for its dictum on negligence versus battery (see chapter 12). 2. For a landmark case abolishing charitable immunity, see President & Directors of Georgetown College v. Hughes, 130 F.2d 810 (D.C. Cir. 1942). 3. Colby v. Carney Hospital, 356 Mass. 527, 528, 254 N.E. 2d 407, 408 (1969) (internal citations omitted). 4. Lewis v. Physicians Ins. Co. of Wisconsin, 627 N.W.2d 484, 492 (Wis. 2001). 5. Foley v. Bishop Clarkson Memorial Hosp., 185 Neb. 89, 173 N.W.2d 881 (1970); Kastler v. Iowa Methodist Hosp., 193 N.W.2d 98 (Iowa 1917); McGillivray v. Rapides Iberia Management Enterprises, 493 So. 2d 819 (La. Ct. App. 1986). In addition, Lamont v. Brookwood Health Services, Inc., 446 So. 2d 1018 (Ala. 1983), held that the standard of care for hospitals was determined by the national hospital community. 6. Foley, 185 Neb. at 95, 173 N.W.2d at 885. CH07.indd 303 02/01/23 2:01 PM 304 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 7. See, e.g., Reifschneider v. Nebraska Methodist Hosp., 222 Neb. 782, 387 N.W.2d 486 (1986) (when a semiconscious patient was placed on a cart in the hospital emergency department without use of restraints, expert testimony was required to establish expected standard of care); Rosemont, Inc. v. Marshall, 481 So. 2d 1126 (Ala. 1985) (standard of care with respect to observation and supervision of patient’s ambulatory status requires expert testimony). 8. See, e.g., Keeton v. Maury County Hosp., 713 S.W.2d 314 (Tenn. App. 1986) (the hospital staff knew or could foresee that the patient would be in danger if moving about unassisted; expert testimony was not necessary to establish breach of duty). 9. Reifschneider, 222 Neb. 782, 387 N.W.2d 486 (violation of a physician’s order that patient be attended at all times presented a prima facie case of negligence). 10. Hastings v. Baton Rouge Gen. Hosp., 498 So. 2d 713 (La. 1986) (violation of hospital bylaws constitutes breach of duty and eliminates the need for expert testimony); Therrel v. Fonde, 495 So. 2d 1046 (Ala. 1986) (when facts establish a significant delay in treatment, expert testimony is not necessary to support a jury verdict that the defendant failed to provide adequate security). 11. Heins v. Synkonis, 58 Mich. App. 119, 227 N.W.2d 247 (1975). 12. AMA Analysis Shows Most Physicians Work Outside of Private Practice, Am. Med. Assoc. (May 5, 2021), https://www.ama-assn.org/presscenter/press-releases/ama-analysis-shows-most-physicians-workoutside-private-practice [https://perma.cc/RL6M-SR9F]. 13. See, e.g., Sanchez v. Medicorp Health Sys., 270 Va. 299, 303 (2005); Baptist Memorial Hosp. System v. Sampson, 969 S.W.2d 945 (Tex. 1998). In Baptist Memorial, the Texas Supreme Court wrote, “Many courts use the terms ostensible agency, apparent agency, apparent authority, and agency by estoppel interchangeably. As a practical matter, there is no distinction among them.” 14. Vanaman v. Milford Memorial Hospital, 272 A.2d 718 (Del. 1970). 15. Schagrin v. Wilmington Medical Center, 304 A.2d 61 (Del. Super. Ct. 1973). See also, e.g., Mehlman v. Powell, 281 Md. 269, 378 A.2d 1121 (1977); Paintsville Hosp. Co. v. Rose, 683 S.W.2d 255 (Ky. 1985); Jackson v. Power, 743 P.2d 1376 (1987). 16. Jackson v. Power, 743 P.2d 1376, 1385 (Alaska 1987). 17. Tonsic v. Wagner, 458 Pa. 246, 329 A.2d 497 (1974). 18. See Restatement (Second) of Agency § 226 (1958). 19. The trend was anticipated and forecast by Arthur Southwick (the original author of this textbook) as early as 1960, when he wrote, CH07.indd 304 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. CH07.indd 305 305 “The third trend in the law of hospital liability is the most significant. It is the increasing tendency . . . to impose vicarious liability on facts where none would have been imposed heretofore. By some leading decisions it no longer follows that a professional person using his own skill, judgment and discretion in regard to the means and methods of his work is an independent contractor. . . . Gradually, the test of hospital liability for another’s act is becoming simply a question of whether or not the actor causing injury was a part of the medical care organization.” Arthur F. Southwick, Vicarious Liability of Hospitals, 44 Marq. L. Rev. 151, 182 (1960). Bader v. United Orthodox Synagogue, 148 Conn. 449, 453, 172 A.2d 192, 194 (1961). Shepherd v. McGinnis, 257 Iowa 35, 131 N.W.2d 475 (1964); Ardoin v. Hartford Accident & Indem. Co., 350 So. 2d 205 (La. App. 1977). Phillips v. Powell, 210 Cal. 39, 290 P.2d 441 (1930); Milner v. Huntsville Memorial Hosp., 398 S.W.2d 647 (Tex. App. 1966). South Highlands Infirmary v. Camp, 279 Ala. 1, 180 So. 2d 904 (1965); Nelson v. Swedish Hosp., 241 Minn. 551, 64 N.W.2d 38 (1954). Peck v. Charles B. Towns. Hosp., 275 A.D. 302, 89 N.Y.S.2d 190 (1949). Garcia v. Memorial Hospital, 557 S.W.2d 859 (Tex. 1977). Hamil v. Bashline, 224 Pa. Super. 407, 307 A.2d 57 (1973). Wilson N. Jones Memorial Hospital v. Davis, 553 S.W.2d 180 (Tex. App. 1977). See also Hipp v. Hospital Auth., 104 Ga. App. 174, 121 S.E.2d 273 (1961); Garlington v. Kingsley, 277 So. 2d 183 (La. App. 173), rev’d on other grounds, 289 So. 2d 88 (La. 1974). Wilson N. Jones Memorial Hospital v. Davis, 553 S.W.2d at 181. Darling v. Charleston Community Memorial Hosp., 33 Ill. 2d 326, 211 N.E.2d 253 (1965), cert. denied, 383 U.S. 946 (1966). There are many other cases in accord, some of which are cited later. Pederson v. Dumouchel, 72 Wash. 2d 73, 431 P.2d 973 (1967). Burks v. Christ Hospital, 19 Ohio St. 2d 128, 249 N.E.2d 829 (1969). Kakligian v. Henry Ford Hosp., 48 Mich. App. 325, 210 N.W.2d 463 (1973). Keene v. Methodist Hospital, 324 F. Supp. 233 (N.D. Ind. 1971). Keene, 324 F. Supp. at 234–35. Hospitals owe a duty to exercise such reasonable care as the patient’s known condition requires and to guard against conditions that should have been discovered by the exercise of reasonable care (Foley v. 02/01/23 2:01 PM 306 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. CH07.indd 306 Bishop Clarkson Memorial Hosp., 185 Neb. 89, 173 N.W.2d 881 [1970]). Moreover, hospitals are held to standards and practices prevailing generally, not only in the local community but also in similar or like communities in similar circumstances (Dickinson v. Mailliard, 175 N.W.2d 588 [Iowa 1970]). Darling v. Charleston Community Memorial Hospital, 33 Ill. 2d 326, 211 N.E.2d 253, cert. denied, 383 U.S. 946 (1966). In support of its position, the court cited Bing v. Thunig, 2 N.Y.2d 656, 143 N.E.2d 3, 163 N.Y.S.2d 3 (1957). Andrea G. Nadel, Hospital’s Liability for Negligence in Failing to Review or Supervise Treatment Given by Doctor, or to Require Consultation, 12 A.L.R.4th 57 § 2[a], superceding W. E. Shipley. Hospital’s Liability for Negligence in Failing to Review or Supervise Treatment Given by Doctor, or to Require Consultation, 14 A.L.R.3d 873, 879 (1967). Joiner v. Mitchell County Hospital Authority, 125 Ga. App. 1, 186 S.E.2d 307, aff’d, 229 Ga. 140, 189 S.E.2d 412 (1972). The New York courts have also recognized that hospitals have a duty to patients to select and retain staff physicians with care. See Fiorentino v. Wenger, 19 N.Y.2d 407, 227 N.E.2d 296, 299, 280 N.Y.S.2d 373, 378 (1967), in which the court stated, “More particularly, in the context of the present case, a hospital will not be liable for an act of malpractice performed by an independently retained healer, unless it has reason to know that the act of malpractice would take place.” Moore v. Board of Trustees of Carson-Tahoe Hospital, 88 Nev. 207, 495 P.2d 605, cert. denied, 409 U.S. 879 (1972). Id., 495 P.2d at 608. See also Pedroza v. Bryant, 101 Wash. 2d 226, 677 P.2d 166 (1984) (hospitals owe independent duty to patients to use reasonable care in selection and retention of medical staff; duty does not extend to the patient of a physician who allegedly committed malpractice in private office practice). Gonzales v. Nork, Civ. No. 228566 (Super. Ct. Sacramento County, Cal. Nov. 27, 1973), rev’d for failure to grant jury trial, 60 Cal. App. 3d 728, 131 Cal. Rptr. 717 (1976), rev’d and remanded, 20 Cal. 3d 500, 573 P.2d 458, 143 Cal. Rptr. 240 (1978). Johnson v. Misericordia Community Hospital, 99 Wis. 2d 708, 301 N.W.2d 156 (1981). The opinion of the intermediate court of appeals is reported at 97 Wis. 2d 521, 294 N.W.2d 501 (1980). Johnson, 99 Wis. 2d at 723, 301 N.W.2d at 164. Bing v. Thunig, 2 N.Y.2d 656, 143 N.E.2d 3, 163 N.Y.S.2d 3 (1957). 02/01/23 2:01 PM C h a p t er 7 : L iab ility of the H ealthc are Institution 307 47. See, e.g., Medline Plus, Nat’l Libr. Med., https://medlineplus.gov/ managedcare.html [https://perma.cc/9CTP-PJHZ] (last visited June 10, 2022). 48. Wickline v. State, 192 Cal. App. 3d 1630, 239 Cal. Rptr. 810 (Ct. App. 1986). 49. Wickline, 192 Cal. App. 3d at 1633–35, 239 Cal. Rptr. at 811–12. 50. Wickline, 192 Cal. App. 3d at 1645, 239 Cal. Rptr. at 819. 51. Wilson v. Blue Cross of Southern California, 222 Cal.App.3d 660, 271 Cal. Rptr. 876 (Ct. App. 1990). 52. Wilson, 222 Cal.App.3d at 672, 271 Cal. Rptr. at 883. 53. Both quotes Wilson, 222 Cal.App.3d at 667, 271 Cal. Rptr. at 880. 54. U.S.C. § 1001 et seq. 55. 29 U.S.C. § 1144(a). 56. Aetna Health, Inc. v. Davila, 542 U.S. 200 (2004). 57. Davila, 542 U.S. at 205. 58. Davila, 542 U.S. at 219. 59. Davila, 542 U.S. at 214 (internal quotation marks omitted). 60. Davila, 542 U.S.at 222 (Ginsburg, J. dissenting) (internal quotation marks omitted). 61. Davila, 542 U.S. at 223 (Ginsburg, J. dissenting). CH07.indd 307 02/01/23 2:01 PM CH07.indd 308 02/01/23 2:01 PM CHAPTER MEDICAL STAFF PRIVILEGES AND PEER REVIEW 8 After reading this chapter, you will • know that the hospital board is ultimately responsible for the overall quality of care rendered in the facility; • understand that medical staff membership is not limited to those with a doctor of medicine (MD) degree; • recognize the role that physicians play in accountable care organizations and similar entities outside Medicare; • be aware that the courts usually support a hospital’s decision on medical staff privileges if a fundamentally fair process was followed; • appreciate the liability issues inherent in the peer review process under the Health Care Quality Improvement Act; and • understand the emerging role of complementary and alternative medicine practitioners. Overview This chapter concentrates on the relationship between the general acute care hospital and its organized medical staff, especially as it relates to ­medical staff privileges. The chapter also explores differences in the hospital–­physician relationship when physicians are employees rather than independent contractors. With some minor variations, the principles discussed here apply both to hospitals and to other healthcare institutions that grant licensed professionals the privilege to use their facilities when caring for patients. Therefore, unless otherwise indicated by the context, in this chapter, the word hospital usually includes other kinds of healthcare provider organizations. In addition, note that the term physician includes not only those with an MD degree, but also certain other licensed practitioners as defined by the Medicare statute. 309 CH08.indd 309 02/01/23 2:02 PM 310 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The Medical Staff Organization A structured medical staff is an essential part of a hospital. It is a miniature version of a corporation, complete with bylaws and rules that regulate the functions delegated to it by the governing board; some medical staffs are, in fact, incorporated, although this is not common. The functions of the medical staff organization include the following: • Serving as liaison between the board and the medical staff • Implementing the clinical aspects of corporate policies • Investigating applicants’ backgrounds and recommending applicants for medical staff membership • Supervising the quality of medical care provided throughout the facility by means of a peer review process • Providing continuing medical education The medical staff organization is founded on a set of bylaws approved by the hospital’s governing board. These bylaws define the structure of the medical staff, its areas of delegated authority, the functions of its committees, processes for peer review actions, and the lines of communication between the staff and the governing board. If a multihospital system has separate medical staffs for each facility, the system’s governing board must have a mechanism for communicating with each facility’s medical staff, and each medical staff must have a means of interacting with the corporate office. Healthcare systems commonly employ a physician liaison—referred to as the chief medical officer, corporate director of medical affairs, or similar title—to help form a meaningful relationship between staff physicians and hospital and system administrators. Because peer review and selection of medical staff members are responsibilities of the hospital’s governing board, physician representation on the board is advisable. Although conflicts between clinical and operational interests can occur, the arguments favoring integration of physicians into hospital governance far outweigh those favoring a board of trustees made up entirely of lay members. The passage of the Affordable Care Act (ACA) in 2010 raised salient questions about the relationship between the hospital corporation and its medical staff members. For example, consider the following: • As hospital–physician integration becomes more prevalent, prompted by arrangements such as accountable care organizations (ACOs), how will the management and control of operational functions and quality review be allocated? CH08.indd 310 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 311 • As physicians increasingly choose to work within large entities, will patient care improve and become more equitable? • How can hospital management support physicians in their individual practices, or require them to take Medicaid patients, in the absence of an ACO or other integrative arrangements? • How will the quality of care be assessed and controlled? • As hospital–physician relationships change, will there be joint liability for decisions about the selection of the medical staff? • If the hospital corporation creates an ACO and the ACO improves its quality metrics and reduces the costs to Medicare, how will the resulting shared savings be divided among participating physicians and facilities? Answers to these and similar questions will continue to evolve as public policy decisions on healthcare reform are made. Relationships Among Board, Management, and Medical Staff For many years, hospitals have been described as resting on a “three-legged stool” comprising the governing board, medical staff, and executive management. For a hospital to run smoothly and serve its community well, the three legs of that stool must be stable. The Joint Commission put it this way: How well leaders work together and manage conflict affects a hospital’s performance. In fulfilling its role, the governing body involves senior managers and leaders of the organized medical staff in governance and management functions. Good relationships thrive when leaders work together to develop the mission, vision, and goals of the hospital; encourage honest and open communication; and address conflicts of interest.1 A breakdown in this tripartite relationship can have serious consequences, as exemplified by a Minnesota case in which a medical staff filed suit against its own hospital. Tension and conflict had begun after a city-owned hospital was acquired by an out-of-state health system in 2009. The hospital board attempted to deal with the situation by unilaterally rescinding and replacing the medical staff organization’s bylaws, but disgruntled members of the medical staff filed suit. The hospital asked that the case be dismissed on the grounds that the medical staff lacked standing to sue. At the heart of the case was the question of who has ultimate control of a hospital: the governing board or the medical staff. The lower CH08.indd 311 02/01/23 2:02 PM 312 T h e L aw o f H e a l th c a re A d mi n i stra ti o n courts granted summary judgment in the hospital’s favor, and the medical staff The Joint Commission on Discord appealed. In December 2014, the MinneA hospital with an organized medical staff and sota Supreme Court ruled that the medical governing body that cannot agree on amendments staff could in fact sue the hospital, and it to critical documents has evidenced a breakdown remanded the case for further proceedings in the required collaborative relationship. on the merits of the claims.2 —The Joint Commission, Comprehensive Thus, after more than two years of ­Accreditation Manual, procedural wrangling and nearly six years Rationale for MS.01.01.03 (2021) of discontent, the ultimate issue remained unsettled, the drama and dysfunction continued, and the case shifted back to the trial court. The hospital again moved for summary judgment, that motion was again granted, and the medical staff again appealed. In July 2016, the Minnesota Court of Appeals affirmed the trial court’s decision.3 The case has not reappeared in the legal literature and perhaps has been resolved, but one suspects that the friction between the physicians and the governing board continued for some time. It serves as a reminder of the serious problems that can arise when there are disputes between the medical staff and hospital leadership. Given the ACA’s emphasis on hospital–physician integration and quality measurement, maintaining a well-balanced “three-legged stool” is more important than ever (see The Joint Commission on Discord). privileging The process whereby the specific scope and content of patient care (clinical) services are authorized for a healthcare practitioner by a healthcare organization on the basis of evaluation of the individual’s credentials and performance (The Joint Commission, Hospital Accreditation Standards, Glossary at GL-9, GL-32). CH08.indd 312 Appointment of the Medical Staff Duty of Reasonable Care As discussed in chapter 7, the hospital governing board has ultimate responsibility for the quality of patient care, and members of the governing board have a duty to exercise reasonable care in (1) reviewing the credentials of medical staff applicants and (2) privileging them to work in the facility. If the physicians are employees, respondeat superior applies and the hospital may be held liable for negligence in granting medical staff privileges. A hospital may also be held liable for negligence in granting privileges to independent contractors because the hospital’s duty to select medical staff physicians carefully and to monitor the quality of care is separate from its responsibility as an employer.4 This concept is referred to variously as corporate liability, institutional liability, or direct liability. The governing board may not abdicate its responsibility for quality. The board’s duty cannot be delegated to the medical staff organization, the local medical society, or any other group or individual. Although lay members of the governing board might not be qualified to judge physicians’ professional 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew competencies, they must ensure that a reliable review process is in place so that physicians’ peers may do so. The board thus authorizes the medical staff to investigate applicants’ backgrounds and quality concerns involving active physician members. The board usually approves the medical staff’s recommendations, but the staff’s role is advisory only; the board has ultimate decision-making responsibility (see Legal Brief).5 Standards for Medical Staff Appointments Legal Brief A physician friend and I (Stuart Showalter) were talking about appointments to the medical staff. He made a comment that led me to ask, “Who makes the decisions about medical staff privileges in your hospital?” His reply was, “The medical staff credentials committee, of course.” I had to disabuse him of this notion. Although the medical staff’s recommendations are usually adopted, the board has ultimate responsibility to decide. Board members must therefore ensure that the medical staff committee is following the credentialing process properly and must be prepared to ask appropriate questions and exercise independent judgment. Nearly a century ago, the US Supreme Court held that a licensed physician does not have a constitutional right to a medical staff appointment.6 However, as discussed in chapter 4, government hospitals are engaged in “state action” when they make decisions about medical staff privileges. Therefore, they must extend the constitutional rights of due process and equal protection to applicants for medical staff appointments and to current staff members who are subject to disciplinary action.7 Private hospitals, on the other hand, are not instrumentalities of the state for constitutional purposes.8 They do not become “state actors” merely because they are highly regulated and receive payments from government programs such Medicare and Medicaid,9 and they are not performing a public function when appointing physicians to their medical staffs.10 Having said that, any difference between public and private hospitals’ duties in matters of medical staff privileges disappeared decades ago because of accreditation standards and statutory law.11 Thus, healthcare organizations—whether public or private—must ensure that their medical staff ­policies are fundamentally fair. Privileging decisions must be based solely on the individual’s skills and the community’s needs and must be devoid of illegal discrimination or other inappropriate factors to infect the process. Fortunately, overt racial discrimination—such as was involved in the Simkins case discussed in chapter 1—is rare today, but more subtle forms of bias can occur based on gender, race, religion, sexual orientation, or other criteria. Allegations of anticompetitive motives are also a staple of court cases challenging denials of medical staff privileges, as will be seen in the Patrick case later in this chapter. CH08.indd 313 313 credentialing A process for establishing the qualifications and competence of medical staff applicants through review of their training, licensure, and practice history. 02/01/23 2:02 PM 314 T h e L aw o f H e a l th c a re A d mi n i stra ti o n In a legal challenge to a decision about medical staff privileges, the focus is often on whether fair and appropriate processes were followed rather than on the substance of the decision. Several statutes and principles shape this duty, including: • constitutional provisions, when applicable (as explained earlier), • state and federal nondiscrimination statutes, • the public policy of fundamental fairness as expressed in judicial decisions, • state and federal antitrust statutes prohibiting unlawful restraints of trade, and • tort law precedents prohibiting malicious interference with a physician’s right to practice. Discrimination Against Non-MD Providers In addition to constitutional issues and nondiscrimination statutes regarding race, sex, and so on, hospitals are prohibited by common law from arbitrarily excluding whole classes of non-MD practitioners. A seminal case on this point was decided six decades ago in New Jersey. In Greisman v. Newcomb Hospital,12 the plaintiff was a doctor of osteopathy (DO) who had been granted an unrestricted license to practice medicine and surgery in the state of New Jersey. He was the only osteopath in an area of about 100,000 people, and Newcomb Hospital—a private not-for-profit corporation—was the only hospital. Newcomb Hospital refused to permit Dr. Greisman to apply for admission to its medical staff. Its decision rested on a provision in the hospital’s bylaws stating that applicants must be graduates of a medical school approved by the American Medical Association (AMA) and must be members of the county medical society. The county had not acted on Dr. Greisman’s application to the county medical society, and he was not a graduate of an approved school because the AMA did not approve schools of osteopathy at the time. By the time the case came to the New Jersey Supreme Court, the American Hospital Association and The Joint Commission had changed their policies and begun to approve of hospitals having DOs on their staffs. Following their lead, the AMA adopted a policy statement allowing DOs “where it was determined locally that they practice on the same scientific principles as those adhered to by the American Medical Association.”13 The state medical society in New Jersey had also dropped its opposition. Thus, the Supreme Court of New Jersey—without the benefit of a constitutional or statutory foundation and without relying on tort or antitrust principles—simply held CH08.indd 314 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 315 that the hospital could not arbitrarily refuse to consider Dr. Greisman’s application. The decision was based on what the court felt was a fundamental public policy: A hospital has a duty to serve the public’s best interests, especially when it is the only hospital in town. In addition to common-law principles, statutes may prohibit a hospital from summarily dismissing an application solely because the applicant is an osteopath, a podiatrist, or a non-MD practitioner. For example, the relevant Ohio statute reads as follows: The governing body of any hospital, in considering and acting upon applications for staff membership or professional privileges within the scope of the applicants’ respective licensures, shall not discriminate against a qualified person solely on the basis of whether that person is certified to practice medicine, osteopathic medicine, or podiatry, or licensed to practice dentistry or psychology. Staff membership or professional privileges shall be considered and acted on in accordance with standards and procedures established [by the governing body].14 The California statute includes an affirmative obligation to allow podiatrists access to hospital facilities: The rules of a health facility shall include provisions for use of the facility by, and staff privileges for, duly licensed podiatrists within the scope of their respective licensure, subject to rules and regulations governing such use or privileges established by the health facility. Such rules and regulations shall not discriminate on the basis of whether the staff member holds a[n] MD, DO, or DPM degree.15 A similar California provision requiring medical staffs to be open to clinical psychologists includes language that summarizes the general principle at work: “Competence shall be determined by health facility rules and medical staff bylaws that are necessary and are applied in good faith, equally and in a nondiscriminatory manner, to all practitioners, regardless of whether they hold an MD, DO, DDS, DPM, or doctoral degree in psychology.”16 Rather than listing specific degrees, The Joint Commission simply states that “licensed independent practitioners are credentialed and privileged by the organized medical staff.” It defines a licensed independent practitioner as “any individual permitted by law and by the organization to provide care, treatment, and services, without direction or supervision.”17 In short, applicants for hospital privileges must be evaluated fairly based on their professional qualifications and competence. Exclusion of entire classes of non-MD practitioners is not permitted. CH08.indd 315 02/01/23 2:02 PM 316 T h e L aw o f H e a l th c a re A d mi n i stra ti o n General Standards and Judicial Review If we assume that the hospital does not discriminate against entire classes of persons, how may it define its qualifications for medical staff privileges? This question was the focus of Sosa v. Board of Managers of Val Verde Memorial Hospital.18 Over a number of years, Dr. Sosa had attempted and failed to gain appointment to the medical staff of Val Verde Memorial Hospital. His application had been denied after the medical staff credentials committee found his “character, qualifications, and standing in the community” inadequate. Although the hospital’s written criteria were vague, the committee listed nine specific reasons—each supported by evidence—for denying him privileges (see Law in Action). The hospital board concurred with the committee’s recommendations, and the US Court of Appeals deemed the hospital’s standards sufficiently clear, stating, [S]taff appointments may be . . . refused if the refusal is based upon any reasonable basis such as the professional and ethical qualifications of the physicians or the common good of the public and the Hospital. Admittedly, standards such as “character, qualifications, and standing” are Law in Action very general, but this court recognizes that in the area of personal fitness for medical staff privileges precise standards are difficult if not In Dr. Sosa’s case, the evidence showed that the doctor had: • abandoned obstetric patients in active labor because they could not pay his bill; • lacked knowledge of basic surgery techniques, operating procedures, and instrument use; • demonstrated an unstable physical demeanor and a markedly nervous manner, both of which were likely to jeopardize surgical patients; • suffered from an unstable and dangerous mental condition, which manifested in anger and fits of rage; • received unsatisfactory reports from references in his application; • followed an itinerant medical practice pattern since completing his education; • pleaded guilty to two felony charges; • had his license to practice suspended in two states; and • violated five of the ten principles of medical ethics. impossible to articulate. The subjectives of selection simply cannot be minutely codified. The governing board of a hospital must therefore be given great latitude in prescribing the necessary qualifications for potential applicants. So long as the hearing process gives notice of the particular charges of incompetency and ethical fallibilities, we need not exact a precis of the standard in codified form. On the other hand, it is clear that in exercising its broad discretion the board [may] refuse staff applicants only for those matters which are reasonably related to the operation of the hospital. Arbitrariness and false standards are to be eschewed. Moreover, procedural due process must be afforded the applicant so that he may explain or show to be untrue those matters which might lead the board to reject his application.19 CH08.indd 316 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 317 The court concluded with this excellent summary of the principles of judicial review in this area: It is the [hospital] Board, not the court, which is charged with the responsibility of providing a competent staff of doctors. The Board has chosen to rely on the advice of its Medical Staff, and the court cannot surrogate for the Staff in executing this responsibility. Human lives are at stake, and the governing board must be given discretion in its selection so that it can have confidence in the competence and moral commitment of its staff. The evaluation of professional proficiency of doctors is best left to the specialized expertise of their peers, subject only to limited judicial surveillance. The court is charged with the narrow responsibility of [ensuring] that the qualifications imposed by the Board are reasonably related to the operation of the hospital and fairly administered. In short, so long as staff selections are administered with fairness, geared by a rationale compatible with hospital responsibility, and unencumbered with irrelevant considerations, a court should not interfere. Courts must not attempt to take on the escutcheon of Caduceus.20 This case demonstrates that due process and fundamental fairness cannot be defined precisely; they are general principles that allow for interpretation based on the time, place, and circumstances of each case. An applicant must be given notice of the charges under consideration and an opportunity to rebut them at a hearing on the matter, but otherwise the standards are, by necessity, indefinite. They will be shaped by the staff bylaws, and those bylaws should, of course, be consistent with applicable laws and accreditation standards. Consistent with these standards, the courts have upheld adverse actions against physicians for the following reasons: • Lack of surgical judgment, lack of a surgical assistant, and assisting another who had no surgical privileges (all backed by supporting evidence)21 • Failure to carry prescribed malpractice insurance coverage22 • Failure to comply with rules regarding the maintenance and completion of medical records23 • Failure to supply references with the application24 • Violation of a rule requiring a full staff member to be in attendance when an associate medical staff member performs major surgery25 • Refusal to abide by reasonable medical staff bylaws26 • Refusal to serve on a rotating basis in the emergency department27 • Failure to consult with other physicians before performing surgery or delivering medical treatment, as defined by medical staff protocols28 CH08.indd 317 02/01/23 2:02 PM 318 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The circumstances of each case are different, but this list demonstrates that the courts give healthcare institutions considerable leeway to make decisions based on the needs of patients and the quality of care. Peer Review, Discipline, and the Health Care Quality Improvement Act The governing board is responsible for monitoring the professional qualifications of the medical staff, but most board directors are not qualified to judge the professional competence of clinicians. For this reason, under the board’s supervision, the medical staff organization must continually assess the quality of care provided in the facility. (This topic is closely related to the utilization review and case management function discussed in chapter 2.) Quality assessment has increased in importance with advances in the ability to collect data on process and outcome metrics related to patient care. Another driver is the increased role that quality data play in insurance reimbursement arrangements, from shared savings programs to hospital readmission penalties. The following discussion begins with a summary of the common law governing peer review and discipline, proceeds to a lengthy discussion of peer review under the federal Health Care Quality Improvement Act (HCQIA) of 1986 and concludes with a few words about the confidentiality of peer review records and about national fraud data banks. The Common Law As noted earlier, the courts generally defer to a hospital’s decisions about medical staff discipline if fair processes were followed and there is sufficient evidence of poor quality or intolerable behavior. Moore v. Board of Trustees of Carson-Tahoe Hospital is a classic example of the hospital’s duties under the common law—to wit, to exercise reasonable care in selecting and retaining medical staff and to extend due process to the physician when disciplinary action is undertaken.29 Moore involved the termination of a medical staff appointment at a Nevada public hospital. Dr. Moore had been licensed to practice in Nevada and was certified by his professional board in obstetrics and gynecology. The specific acts that led to Dr. Moore’s termination were not expressly prohibited in the medical staff bylaws or Carson-Tahoe Hospital’s rules and regulations, but the hospital’s governing body terminated his privileges on the ground of “unprofessional conduct.” The facts showed that he did not exercise proper sterile technique in administering a spinal anesthetic to an obstetrics patient. Specifically, he had not worn sterile gloves while preparing the medication, performing the skin preparation, and handling the spinal CH08.indd 318 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 319 needle. Two days later, the chief of the medical staff, with concurrence of another Legal Decision Point physician, canceled Dr. Moore’s scheduled surgery for that day, attesting that he was Why do you suppose Dr. Moore was “in no condi“in no condition physically or mentally tion” to perform the intended surgery? Should the to perform surgery” (see Legal Decision trial record and appellate decision have described Point). his condition specifically? Why do you suppose Dr. Moore sued to regain his hosthey did not? pital privileges. He did not allege any deficiency in the procedural aspects of the case because at the hearing he was permitted to have counsel, call witnesses of his own, and cross-examine adverse witnesses. But he claimed that “unprofessional conduct” was too vague a standard on which to revoke his privileges and that he was, therefore, denied substantive due process of law. The Nevada Supreme Court disagreed, citing this language from a Florida Legal Brief case: “Detailed description of prohibited conduct is concededly impossible, perhaps even undesirable in view of rapidly “Substantive due process” is a principle of constishifting standards of medical excellence tutional law stating that the Fifth and ­Fourteenth Amendments to the US Constitution protect cerand fact that a human life may be and tain fundamental, unenumerated rights from govquite often is involved in the ultimate ernment interference. These rights, also known decision of the board.”30 The court held as “liberty interests,” are often described as that the language “unprofessional conapplying to intimate and family decisions. Over duct” was objective enough to justify the many decades, the US Supreme Court has brought board’s decision to terminate the doctor’s within this privacy-grounded right a variety of practices including interracial marriage, contraprivileges. ceptive use, homeschooling, consensual adult In rendering its opinion, the sexual activity, and same-sex marriage. The right Nevada Supreme Court made these obserto abortion was grounded in substantive due vations about the status of the hospital as process until June 2022, when the Supreme Court an institution—prophetic words that ring overruled precedent to that effect and allowed even truer more than four decades later: states to prohibit or criminalize it. Although the Today, in response to demands of the public, the hospital is becoming a community health center. The purpose of the community hospital is to provide patient care of the highest possible quality. To implement this duty of providing competent medical care to the patients, it is the responsibility of the institu- decision, Dobbs v. Jackson Women’s Health Organization, explicitly concerned only the right to obtain an abortion, the dissenting justices and many commentators fear that the case may lead to the weakening or repudiation of other substantive due process rights as well, as called for by Justice Clarence Thomas in his concurrence, which no other justice joined. (See the discussion of Dobbs in chapter 15.) tion to create a workable system whereby the CH08.indd 319 02/01/23 2:02 PM 320 T h e L aw o f H e a l th c a re A d mi n i stra ti o n medical staff of the hospital continually reviews and evaluates the quality of care being rendered within the institution. The staff must be organized with a proper structure to carry out the role delegated to it by the governing body. All powers of the medical staff flow from the board of trustees, and the staff must be held accountable for its control of quality. The concept of corporate responsibility for the quality of medical care was forcibly advanced in Darling v. Charleston Community Memorial Hospital, wherein the Illinois Supreme Court held that hospitals and their governing bodies may be held liable for injuries resulting from imprudent or careless supervision of members of their medical staffs. The role of the hospital vis-a-vis the community is changing rapidly. The hospital’s role is no longer limited to the furnishing of physical facilities and equipment where a physician treats his private patients and practices his profession in his own individualized manner. The right to enjoy medical staff privileges in a community hospital is not an absolute right, but rather is subject to the reasonable rules and regulations of the hospital. Licensing, per se, furnishes no continuing control with respect to a physician’s The Triple Aim professional competence and therefore does not assure the public of quality patient care. According to the Institute for Healthcare Improvement (IHI), a focus on three critical objectives simultaneously can lead us to better models for providing healthcare. The IHI calls this approach the “Triple Aim,” and it is intended to • improve the health of the defined population; • enhance the patient care experience (including quality, access, reliability); and • reduce, or at least control, the cost of care. In 2007, the IHI launched initiatives to translate the Triple Aim concept into specific actions for change. The result was a model and a set of specific objectives to fulfill the Triple Aim in practice. This system includes the following components: • A focus on individuals and families • Redesign of primary care services and structures • Population health management • A cost-control platform • System integration and execution See Triple Aim for Populations, Inst. for Healthcare Improvement, http://www.ihi.org/ Topics/TripleAim [https://perma.cc/ W52D-RE4X] (last visited June 18, 2022). CH08.indd 320 The protection of the public must come from some other authority, and that in this case is the Hospital Board of Trustees. The Board, of course, may not act arbitrarily or unreasonably in such cases. The Board’s actions must also be predicated upon a reasonable standard.31 Moore stands as an excellent example of how (1) the medical staff properly exercises its responsibility for quality-ofcare issues; (2) a governing board should act on the medical staff’s recommended corrective action before injury to a patient occurs; and (3) courts usually defer to a hospital’s decisions if they are based on reasonable criteria related to the quality of care. Moore and cases like it give healthcare organizations the incentive, authority, and responsibility to focus on quality and to pursue the “triple aim” of better health, better care, and reduced cost (see The Triple Aim). 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 321 The Joint Commission’s accreditation standards for medical staff privileges are based on the following areas of general competency: • • • • • • Patient care Medical or clinical knowledge Practice-based learning and improvement Interpersonal and communication skills Professionalism Systems-based practice32 The standards also include the concepts of focused professional practice evaluation (used when specific questions about competency arise) and ongoing professional practice evaluation.33 Together, these processes are intended to identify performance issues that affect the quality of care and to resolve them as early as possible, with intervention by the organized medical staff if necessary. Peer Review Under the Health Care Quality Improvement Act Peer review is meant to be a discreet evaluation of physicians’ performance to see whether accepted standards of care were met and to suggest quality improvements if they were not. The HCQIA provides a framework for accomplishing peer review and for protecting persons involved in the process.34 The courts’ deference to hospitals’ decisions about staff privileges waned somewhat in the 1970s, for two major reasons. The first was the large increase in medical malpractice lawsuits in the 1970s. As the number of suits increased, so did the perception of medical incompetence and fear that discredited physicians could move across state lines and begin practice again without anyone knowing about their substandard performance. This apprehension prompted the creation of the HCQIA’s National Practitioner Data Bank (NPDB). The second reason for increased scrutiny of hospitals’ privileging decisions involved claims of malicious interference with the right to practice and antitrust suits for restraint of trade. The 1988 US Supreme Court case Patrick v. Burget is a prime example.35 The Patrick Case Dr. Timothy Patrick was a general and vascular surgeon in Astoria, Oregon, a coastal town of 10,000 people located far from a major population center. After practicing with the Astoria Clinic for a year, Dr. Patrick started a competing practice and, along with his former colleagues, maintained his CH08.indd 321 02/01/23 2:02 PM 322 T h e L aw o f H e a l th c a re A d mi n i stra ti o n surgical privileges at Astoria’s only hospital. According to the US Supreme Court’s opinion, After petitioner established his independent practice, the physicians associated with the Astoria Clinic consistently refused to have professional dealings with him. Petitioner received virtually no referrals from physicians at the Clinic, even though the Clinic at times did not have a general surgeon on its staff. Rather than refer surgery patients to petitioner, Clinic doctors referred them to surgeons located as far as 50 miles from Astoria. In addition, Clinic physicians showed reluctance to assist petitioner with his own patients. Clinic doctors often declined to give consultations, and Clinic surgeons refused to provide backup coverage for patients under petitioner’s care. At the same time, Clinic physicians repeatedly criticized petitioner for failing to obtain outside consultations and adequate backup coverage.36 Eventually, this “openly hostile” situation (quoting the US Court of Appeals for the Ninth Circuit) deteriorated to the point that the Astoria Clinic’s physicians initiated and participated in peer review actions that terminated Dr. Patrick’s medical staff privileges. He then sued under the antitrust laws and won a jury verdict of $650,000, which was tripled as required by antitrust law. When damages on the state law claim were added, the total award to Dr. Patrick was more than $2 million. On appeal, the Ninth Circuit found “substantial evidence that [the defendants] had acted in bad faith in the peer-review process” and that the process could be considered “shabby, unprincipled and unprofessional.”37 Ouch. Nevertheless, and despite the fact that the defendants had used peer review for their own financial advantage, the appellate court ruled that the clinic’s doctors were immune from antitrust liability because of the state action doctrine. (See the section on antitrust law in chapter 14.) The US Supreme Court ultimately took the case and reversed the Ninth Circuit Court of Appeals. The high court ruled that Oregon’s peer review law did not amount to state action because “no state actor in Oregon actively supervises hospital peer-review decisions.” Thus, the court held, [T]he state-action doctrine does not protect the peer-review activities challenged in this case from application of the federal antitrust laws. In so holding, we are not unmindful of the policy argument that respondents and their amici have advanced for reaching the opposite conclusion. They contend that effective peer review is essential to the provision of quality medical care and that any threat of antitrust liability will prevent physicians from participating openly and actively in peer-review proceedings. This argument, however, essentially challenges the wisdom of applying the antitrust laws to the sphere of medical care, and as such CH08.indd 322 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 323 is properly directed to the legislative branch. To the extent that Congress has declined to exempt medical peer review from the reach of Law in Action the antitrust laws, peer review is immune from antitrust scrutiny only if the State effectively has made this conduct its own. 38 This decision and the amount of damages awarded to Dr. Patrick sent shock waves through the medical community and made physicians and others understandably more reluctant to participate in peer review, which is a potentially fraught and time-consuming process in the best of circumstances. As a direct result of the trial court verdict in Patrick, and even before the US Supreme Court issued its opinion, Congress passed the HCQIA. The “findings” section of the act summarizes Congress’s rationale: State and municipal authorities may be immune from federal antitrust lawsuits (see chapter 14). Thus, in contrast with the Patrick case, the peer review activities of a government hospital—a taxing district or “hospital authority,” for example— may amount to state action and thus be exempt from antitrust scrutiny. For example, in Crosby v. Hosp. Authority of Valdosta and Lowndes County (93 F.3d 1515, 1530 [11th Cir. 1996]), the US Court of Appeals for the Eleventh Circuit stated, “Because of the control exercised by the [Hospital] Authority over peer review decisions and the statutory context of peer review in Georgia, we conclude that the actions of individual doctors on peer review committees should be considered [state] actions.” Constitutional and statutory requirements relating to fundamental fairness would still apply, of course. • A rise in the number of malpractice cases • The potential for incompetent physicians to move from state to state and start practice anew • The threat of physician liability under the antitrust laws • The need for improved peer review activities39 With these statements as its foundation, the HCQIA grants immunity from most civil money damages to healthcare professionals who engage in appropriate peer review, which is referred to as “professional review activities” (see Legal Brief). This immunity is a powerful defense for the credentialing entity and the individuals who conduct peer review. Legal Brief The HCQIA also authorized the creation of the NPDB as a reporting system for information on the competence The HCQIA was sponsored by Representative Ron of providers, including MDs, DOs, denWyden of Oregon, who specifically referred to the tists, and nurse practitioners. Two cases jury verdict in Patrick as an example of the need to protect persons who perform peer review (89 Cong. decided by the US Court of Appeals for Rec. E2366 [daily ed., June 26, 1986]). the Fifth Circuit in 2008 demonstrate the HCQIA’s effects. CH08.indd 323 02/01/23 2:02 PM 324 T h e L aw o f H e a l th c a re A d mi n i stra ti o n The Poliner Case In Poliner v. Texas Health System, an interventional cardiologist’s catheterization lab and echocardiography privileges at Presbyterian Hospital in Dallas were temporarily suspended while his manner of handling certain patients was being investigated.40 (Today, The Joint Commission would call this type of investigation a “focused professional practice evaluation.”) Quality concerns had been reported to the director of the cardiac catheterization lab and to the chair of the internal medicine department. The bylaws of this not-forprofit hospital allowed for summary suspension of privileges “when the acts of a practitioner through his lack of competence, impaired status, behavior or failure to care adequately for his patients constitutes a present danger to the health of his patients.” Dr. Poliner was given a few hours to decide whether to voluntarily suspend his privileges in lieu of having them summarily suspended and was told not to consult a lawyer.41 Dr. Poliner agreed, albeit reluctantly, to “voluntarily” suspend of his privilege to use the cath lab. In the subsequent litigation, this was viewed as effectively an imposed summary suspension, and the jury looked disfavorably on the pressure for Dr. Poliner to avoid legal counsel. An ad hoc committee of cardiologists convened 29 days later to review a sample of Dr. Poliner’s cases. It chose at random the records of 44 patients and found evidence of substandard care in more than half of them. The committee reported its findings to the hospital’s internal medicine advisory committee (IMAC). The IMAC’s minutes identified the following concerns about Dr. Poliner’s competencies: • • • • Poor clinical judgment Inadequate skills, including in angiocardiography and echocardiography Unsatisfactory documentation of medical records Substandard patient care Based on the evidence before it, the IMAC recommended continued suspension of Dr. Poliner’s cath lab and echocardiography privileges. He requested a hearing, as provided for in the hospital bylaws. The hearing committee (a separate group from the IMAC) upheld the original suspension based on the evidence available at the time, but it recommended that his privileges be reinstated with the limitation that he consult with another cardiologist before performing interventional procedures. After a month, this condition was to be changed to post-procedure review. The hospital’s governing board accepted these recommendations and, subject to these conditions, Dr. Poliner was reinstated. Approximately 18 months later, he filed suit against the hospital and the doctors who had been involved in the peer-review process. CH08.indd 324 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 325 Dr. Poliner’s lawsuit alleged federal and state antitrust violations; violations of the Deceptive Trade Practices Act; and numerous tort claims, including defamation. The case went to a trial by jury on the issue of temporary restrictions of Dr. Poliner’s privileges, and the appellate court summarized the outcome as follows: The jury found for Poliner on his defamation claims. Poliner was able to offer evidence at trial of actual loss of income of about $10,000—but was awarded more than $90 million in defamation damages, nearly all for mental anguish and injury to career. The jury also awarded $110 million in punitive damages. The district court ordered a remittitur of the damages and entered judgment against Defendants.42 By its remittitur, the trial court reduced the verdict to slightly more than $11 million—still a huge amount considering that the actual damages were only about $10,000. The defendants appealed, arguing that the ­HCQIA’s immunity provisions protected them from liability in any amount, and that the case should have been dismissed on that basis. The appellate court agreed, and in doing so, it provided a good summary of the HCQIA’s history and its immunity provisions: remittitur A judge’s order reducing an excessive jury award. Congress passed the Health Care Quality Improvement Act because it was concerned about “[t]he increasing occurrence of medical malpractice and the need to improve the quality of medical care,” and because “[t]here is a national need to restrict the ability of incompetent physicians to move from State to State without disclosure or discovery of the physician’s previous damaging or incompetent performance.” Congress viewed peer review as an important component of remedying these problems, but recognized that lawsuits for money damages dampened the willingness of people to participate in peer review. Accordingly, Congress “grant[ed] limited immunity from suits for money damages to participants in professional peer review actions.” When a “professional review action” as defined by the statute meets certain standards, the HCQIA provides that participants in the peer review “shall not be liable in damages under any law of the United States or of any State (or political subdivision thereof ) with respect to the action.” The statute establishes four requirements for immunity: For purposes of the protection set forth in section 11111(a) of this title, a professional review action must be taken— (1) in the reasonable belief that the action was in the furtherance of quality health care, (2) after a reasonable effort to obtain the facts of the matter, (3) after adequate notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances, and CH08.indd 325 02/01/23 2:02 PM 326 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (4) in the reasonable belief that the action was warranted by the facts known after such reasonable effort to obtain facts and after meeting the requirement of paragraph (3).43 The court found that the actions of the ad hoc committee, the IMAC, the Hearing Committee, and the hospital board fit the definition of “professional review actions” (see Legal Brief) and that there was a “reasonable belief that the action was in the furtherance of quality health care”: The ad hoc committee’s review, upon which the extension of the abeyance rested, speaks for itself. A group of six cardiologists reviewed 44 of Poliner’s cases and concluded that he gave substandard care in more than half of the cases. We conclude that . . . the belief that temporarily restricting Poliner’s cath lab privileges during an investigation would further quality health care was objectively reasonable.44 The court added, “No reasonable jury could conclude that Defendants failed to make a ‘reasonable effort to obtain the facts.’” The piece de resistance of the opinion is its closing language: This case demonstrates how the process provisions of the HCQIA work in tandem: legitimate concerns lead to temporary restrictions and an investigation; an investigation reveals that a doctor may in fact be a danger; and in response, the hospital continues to limit the physician’s privileges. The hearing process is allowed to play out unencumbered by the fears and urgency that would necessarily obtain if the physician were midstream returned to full privileges during the few days necessary for a fully informed and considered decision resting on all the facts and a process in which the physician has had an opportunity Legal Brief to confront the facts and give his explanations. The interplay of these provisions may work hardships on individual physicians, The HCQIA defines a professional review action in part as “an action or recommendation of a professional review body which is taken or made in the conduct of professional review activity, which is based on the competence or professional conduct of an individual physician (which conduct affects or could affect adversely the health or welfare of a patient or patients), and which affects (or may affect) adversely the clinical privileges, or membership in a professional society, of the physician” (42 U.S.C. § 11151(9)). but the provisions reflect Congress’ balancing of the significant interests of the physician and “the public health ramifications of allowing incompetent physicians to practice while the slow wheels of justice grind.” . . . [T]he temporary restrictions [of Dr. Poliner’s privileges] were “tailored to address the health care concerns” that had been raised—[about] procedures in the cath lab— leaving untouched Poliner’s other privileges. Nor was the information relayed to [the chair CH08.indd 326 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 327 of the internal medicine department] “so obviously mistaken or inadequate as to make reliance on [it] unreasonable.” There was an objectively reasonable basis for concluding that temporarily restricting Poliner’s privileges during the course of the investigation was warranted by the facts then known. . . . To allow an attack years later upon the ultimate “truth” of judgments made by peer reviewers supported by objective evidence would drain all meaning from the statute. The congressional grant of immunity accepts that few physicians would be willing to serve on peer review committees under such a threat; as our sister circuit explains, “the intent of [the HCQIA] was not to disturb, but to reinforce, the preexisting reluctance of courts to substitute their judgment on the merits for that of health care professionals and of the governing bodies of hospitals in an area within their expertise.” At the least, It is not our role to re-weigh this judgment and balancing of interests by Congress. IV. Conclusion Not only has Poliner failed to rebut the statutory presumption that the peer review actions were taken in compliance with the statutory standards, the evidence independently demonstrates that the peer review actions met the statutory ­requirements. . . . We REVERSE the judgment of the district court and RENDER judgment for Defendants.45 The Kadlec Case In Poliner, the HCQIA achieved its purpose of promoting quality care, and the defendants were held to be immune from liability. Kadlec Medical Center v. Lakeview Anesthesia Associates stands in contrast and demonstrates the difficulties that can be encountered if the HCQIA’s provisions are not followed.46 Interestingly, both cases were before the Fifth Circuit Court of Appeals at roughly the same time. When the chain of events leading to this lawsuit began, Dr. Robert Berry was a licensed anesthesiologist. He was part of a group medical practice known as Louisiana Anesthesia Associates (LAA) that had an exclusive contract to provide anesthesia services at Lakeview Regional Medical Center in southeast Louisiana. He also was a man with a drug problem. When officials at Lakeview and his partners at LAA learned of his substance abuse, Dr. Berry was fired “for cause” by LAA, his practice group, and he was not permitted to return to Lakeview, the hospital where he had privileges and where LAA had an exclusive contract. However, no one at LAA or Lakeview reported these facts to the hospital board, the Louisiana Board of Medical Examiners, or the NPDB. After leaving LAA and Lakeview, Dr. Berry obtained locum tenens (or “traveling physician”) privileges in Shreveport, Louisiana, and eventually CH08.indd 327 02/01/23 2:02 PM 328 T h e L aw o f H e a l th c a re A d mi n i stra ti o n applied through a staffing firm for a similar position at Kadlec Medical Center in Richland, Washington. On receipt of the application, Kadlec conducted its usual background check, including making inquiries to LAA and Lakeview about Dr. Berry’s performance history. LAA’s response was false and misleading, and Lakeview’s was vague (presumably for fear of a lawsuit for defamation or malicious interference with his professional relations). In the absence of negative background information, Kadlec granted anesthesia privileges to Dr. Berry. Eventually, his narcotics problem led to the near death of a patient, who was left in a permanent vegetative state. To defend and settle the resulting lawsuit, Kadlec and its insurance carrier paid more than $8 million in damages. They then sued LAA and Lakeview to recover the money, alleging that the defendants had misled Kadlec directly and by failing to comply with their reporting obligations. In the end, the group practice was held liable for misrepresentation, but Lakeview was not found liable because, although its actions might have been unethical, it had no legal duty under Louisiana law to respond, and the response it sent was so vague that it contained no substantive information. Apparently, in Louisiana, if you don’t say anything, you can’t misrepresent anything. Note that evolving legal standards and reporting obligations might well lead to a different outcome in a similar tragic case. A lengthy excerpt from the court of appeals’ decision is given at the end of this chapter (see The Court Decides). Lessons from Poliner and Kadlec Poliner and Kadlec demonstrate the continuing importance of professional review (peer review) activities today. The courts and the public at large want hospitals and physicians to monitor quality and patient safety ever more carefully than they did in the past, and payment and accreditation standards require more quality assessment as well. Electronic records facilitate meeting these expectations, compliance with which seem a reasonable exchange for a grant of immunity from tort liability under the HCQIA and state laws.47 In addition, various provisions of the ACA mandate that more attention be paid to the quality of healthcare and emphasize the dangers of impaired or incompetent physicians. One commentator predicts that, despite the hospital’s exoneration in Kadlec, hospitals generally can “anticipate an expanded obligation to disclose risky physician behavior”: Just as physicians are not simply service providers, and patients not simply courted consumers, hospitals are not simply doctors’ workshops. . . . [They] CH08.indd 328 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 329 are increasingly being held liable for the negligent actions of nonemployee physicians. They are increasingly viewed as having a duty to their patients to appropriately monitor the quality of care provided by staff physicians, employed or not, and to credential only those who practice safely and competently. In addition, hospitals face increased obligations to monitor the quality of care provided within their facilities and to report impaired or unsafe physicians. When hospitals can be held responsible under the theories of vicarious liability or negligent credentialing, they have a heightened need for complete credentialing information.48 Applying a patient-centric framework to this topic, the commentator sees the healthcare system as a web of relationships, not a series of bilateral transactions: “Although they are likely to be unaffiliated businesses, in the credentialing process hospitals are part of a relational web that aims to ensure high-quality patient care.”49 This vision was what the HCQIA was implicitly promoting, and it would seem to be consistent with the current trend of hospital–physician integration. Similarly, another commentator argues for increasing institutions’ responsibility for quality and patient safety. He calls this model of fiduciary duty “protective intervention”: Fiduciary duties are expanding in tandem with expanded tort obligations. . . . The recognition of institutional responsibility to better handle informed consent, disclosure of data, and revelation of errors turns the hospital finally into a recognizable legal fiduciary with an obligation to protect its patients from harm from third parties. This duty of “protective intervention” captures the more intense obligations whose shadows we can see cast by regulatory initiatives and institutionassumed obligations. Hospitals now have to collect data on adverse events and report them to the state regulators and to patients in many states. They have to manage and coordinate their care to protect their patients. It is no longer a world in which the hospital is little more than a brick shell for physicians, with a loose contract relationship with patients. A fiduciary duty provides the building blocks for remedies that strengthen the patient’s recovery opportunities. . . . Such an expansion . . . strengthens the hands of internal hospital risk managers and compliance officers, as they advise administrators of the increasing necessity of implementing modern data mining, electronic medical records, reporting of adverse events, and better coordination and management of the institution. And it properly imposes on hospital managers a higher duty to protect their patients, their beneficiaries, from harm to the greatest extent possible. They have become “fiduciaries,” stewards of their patients’ safety.50 CH08.indd 329 02/01/23 2:02 PM 330 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Confidentiality of Peer Review Records Poliner and Kadlec also raise the question of the confidentiality of peer review records. Plaintiffs’ attorneys in medical malpractice cases want access to negative assessments, and physicians who challenge adverse actions taken against them want access to the peer review records to support their claims of bad faith and conspiracy on the part of the reviewers. Conversely, hospitals have a strong interest in preserving the confidentiality of these records. To be most effective, the peer review process must be an honest and candid evaluation of a practitioner’s activities. Confidentiality of the peer review committee’s minutes and deliberations is essential to a full and honest process. As the court in Bredice v. Doctors Hospital, Inc. stated in 1973, There is an overwhelming public interest in having [peer review] meetings held on a confidential basis so that the flow of ideas can continue unimpeded. . . . Confidentiality is essential to effective functioning of these staff meetings; and these meetings are essential to the continued improvement in the care and treatment of patients. Candid and conscientious evaluation of clinical practices is a sine qua non of adequate hospital care. To subject these discussions and deliberations to the discovery process, without a showing of exceptional necessity, would result in terminating such deliberations. Constructive professional criticism cannot occur in an atmosphere of apprehension that one doctor’s suggestion will be used as a denunciation of a colleague’s conduct in a malpractice suit.51 This view has been reaffirmed over the years. For example, in 1992, the Fifth Circuit Court of Appeals wrote, “As Congress has recognized, peer review materials are sensitive and inherently confidential, and protecting that confidentiality serves an important public interest [citing the HCQIA] . . . [T]he ­medical peer review process ‘is a sine qua non of adequate hospital care.’”52 Following the line of reasoning begun in Bredice, state legislatures addressed the confidentiality issue in the early 1970s. Today, all jurisdictions have some form of legislation establishing a degree of peer review privilege. For example, the Georgia statute provides the following: [T]he proceedings and records of medical review committees shall not be subject to discovery or introduction into evidence in any civil action against a provider of professional health services arising out of the matters which are the subject of evaluation and review by such committee; and no person who was in attendance at a meeting of such committee shall be permitted or required to testify in any such civil action as to any evidence or other matters produced or presented during the proceedings of such committee or as to any findings, recommendations, evaluations, opinions, or other actions of such committee or any members thereof.53 CH08.indd 330 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 331 The statutes vary from state to state on such matters as the type of legal proceeding to which they apply; whether the information is protected from discovery, admission into evidence, or both; the type of information and the nature of the committee whose records are confidential; and exceptions to the protection. Therefore, the application of the privilege is also likely to vary from state to state and even from court to court, depending on the facts of the case. Furthermore, almost universally the privilege does not apply to records, such as medical records and routine business records, created for purposes other than peer review. National Fraud Data Banks As mentioned earlier, one aspect of the HCQIA was the creation of the NPDB to promote patient safety and quality of care. Entities that conduct professional review activities are supposed to report to the NPDB any significant adverse peer review actions taken against practitioners and to query the NPDB during the credentialing process to procure an applicant’s disciplinary history. Entities that fail to do so can lose their immunity protections. Certain malpractice judgments and settlements as well as state licensing board actions are also to be reported. In addition to the NPDB, in 1996 Congress mandated creation of the Healthcare Integrity and Protection Data Bank (HIPDB) “to combat fraud and abuse in health insurance and health care delivery.”54 The HIPDB was intended to augment other tools, and useful information found in the HIPDB and the NPDB can help alleviate the problem of incompetent physicians who cross state lines to begin a new practice. Nevertheless, the two data banks are somewhat redundant, and many—particularly the NPDB—were skeptical about them from the outset. Hospitals and other providers were reluctant to report incidents to the data banks, a good deal of information was out of date or inaccurate, and physicians who were wrongly reported had difficulty clearing their names. Even the US Department of Law in Action Health and Human Services (HHS), the agency that administers the Medicare and The National Practitioner Data Bank website is Medicaid programs, failed to report all of http://www.npdb.hrsa.gov, and a history of the its adverse actions against providers to the NPDB can be found at http://www.npdb.hrsa.gov/ HIPDB as required by law.55 topNavigation/timeline.jsp. Recognizing these deficiencies, Although not perfect, if used correctly, HHS strengthened its compliance efforts the NPDB can significantly thwart physicians’ and improved the NPDB/HIPDB sysattempts to move to a new location and receive hospital privileges unencumbered by their past tem. Furthermore, the ACA required wrongdoings. that the duplication between the data banks be eliminated and the HIPDB be CH08.indd 331 02/01/23 2:02 PM 332 T h e L aw o f H e a l th c a re A d mi n i stra ti o n discontinued.56 This change was implemented in 2013, and there is now a single database for submitting queries and receiving responses (see Law in Action). Quality Issues and Accountable Care Organizations Exclusive Contracts with Physicians For many years, hospitals have entered into exclusive contracts with physicians and physician groups to staff such departments as radiology, emergency, anesthesiology, and pathology. Kadlec provides one example. These arrangements have withstood legal challenges as an appropriate business decision when they were aimed at overall improvement in the quality of patient care, and not as a disparagement of any particular provider.57 In Adler v. Montefiore Hospital Association of Western Pennsylvania,58 the plaintiff, Dr. Adler, had been employed by a private hospital for six years as the part-time director of the cardiology laboratory with full medical staff privileges. When Montefiore evolved into a teaching hospital, it hired a full-time director, Dr. Curtiss, to replace Dr. Adler. Dr. Curtiss was then granted exclusive privileges to perform cardiac catheterizations, a change that significantly limited the number of procedures Dr. Adler was permitted to perform. In Dr. Adler’s subsequent lawsuit, the exclusive arrangement was upheld as reasonably related to the hospital’s purposes, especially because it was a teaching institution. Catheterization, the court held, was a laboratory procedure—more like radiology than surgery. The exclusive contract was considered part of the hospital’s effort to ensure the quality of care and improve efficiency. Accordingly, the hospital had not violated Dr. Adler’s rights to due process and equal protection because he was obliged to yield to reasonable rules intended to benefit the hospital’s patients, the physicians, the university’s medical students, and the public. Although this case was decided more than 40 years ago, Adler is still cited when courts refuse to intervene in hospitals’ decisions to confer exclusive privileges on designated physician groups, even when the contracts have restricted the medical staff privileges of other qualified and competent physicians.59 In addition to bringing due process arguments, plaintiffs have challenged exclusive service contracts as violating federal or state antitrust legislation. The underlying purpose of antitrust law is to foster competition in the marketplace, and the argument is that exclusive contracts reduce competition and amount to a “group boycott.” For the most part, however, the challenges have not been successful because an exclusive contract is seen as a CH08.indd 332 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 333 reasonable restraint of trade that actually promotes competition among hospitals and is consistent with efforts to promote high-quality care.60 (Antitrust cases are discussed in chapter 14.) Economic Credentialing Ideally, decisions on medical staff privileges are based on physician competence and the quality of care. However, the institution’s financial stability depends on providing care at a cost that will be reimbursed. When physicians’ utilization patterns begin to affect the bottom line negatively, financial considerations may creep into credentialing decisions. This practice is known as economic credentialing. Although there is no standard definition of the term, the AMA defines it—disapprovingly—as “the use of economic criteria unrelated to quality of care or professional competence in determining a physician’s qualifications for initial or continuing hospital medical staff membership or privileges.”61 Whether economic criteria are permissible is a matter of considerable dispute, and the outcome of any legal challenge might depend on particulars of the practice environment in a given geographic area. At least two scenarios provide a motive for economic credentialing. The first is admission of patients to an acute care hospital when those patients could be served more economically on an outpatient basis or in another type of inpatient facility (e.g., skilled nursing facility, inpatient hospice, nursing home). The dearth of reported decisions suggests that the utilization review and case management function, rather than the credentialing process, is coping with this situation adequately. Given hospitals’ incentive to keep costs as low as possible, this supposition is likely true. The second scenario involves a kind of loyalty oath. Hospitals ask their physicians whether they have any financial interest in a competing facility, such as another hospital, an imaging center, or an ambulatory surgery center. If they do, hospitals sometimes condition these physicians’ medical staff privileges on their agreement not to use those other facilities (or to use them only a certain percentage of the time) if the same services can be provided at the hospital. This scenario raises issues under both state and federal laws. A 1978 case upheld this practice. In Cobb County-Kennestone Hospital Authority v. Prince,62 a government hospital purchased a whole-body computed tomography (CT) scanner and then resolved that “if a treatment, procedure, diagnostic test or other service is ordered for a patient . . . [a]nd that procedure, test or service is routinely offered by the Hospital, then the [hospitalized] patient will receive that service within the confines of the Hospital complex.”63 Some staff physicians—who privately owned and operated a CT scanner outside the hospital complex—challenged this policy as an arbitrary restriction on their medical judgment. In upholding the hospital’s CH08.indd 333 02/01/23 2:02 PM 334 T h e L aw o f H e a l th c a re A d mi n i stra ti o n policy as reasonable and “strikingly similar” to exclusive service contracts, the Supreme Court of Georgia observed that [The hospital’s resolution] is reasonable and reflects a well intentioned effort by the Authority to deal with the intricate and complex task of providing comprehensive medical services to the citizens of our state. The pre-eminent consideration in the adoption of such a resolution by the Authority was the health, welfare and safety of the patient. The Authority’s resolution is a reasonable and rational administrative decision enacted in order for the Authority to carry out the legislative mandate that it provide adequate medical care in the public interest. The resolution does not invade the physician’s province. Although he is required to use the facilities and equipment provided within the hospital complex for testing rather than similar facilities and equipment outside, he is nevertheless free to interpret the results of such tests and free to diagnose and prescribe treatment for all his patients.64 A 2006 case, however, did not defer to the hospital administration. In Baptist Health v. Murphy,65 the defendant, a multihospital system, adopted a policy to deny staff appointments or clinical privileges “to any practitioner who, directly or indirectly, acquires or holds an ownership or investment interest in a competing hospital.”66 The policy—apparently a revenueenhancing measure—was challenged by cardiologists who had an ownership interest in another hospital and held medical staff privileges at both Baptist Health and the other facility. The trial court issued a preliminary injunction against enforcement of the policy, and the Supreme Court of Arkansas affirmed that decision, holding that the hospital’s actions amounted to an intentional, tortious interference with the physicians’ business relationships with their patients: Defendant knew that the adoption of the economic credentialing policy would inevitably result in a disruption of the relationship between Plaintiffs and a significant number of their patients. The economic credentialing policy was adopted with the intention of forming a relationship with the Plaintiffs’ patients, potential patients, and referring physicians who were required to use its facilities by establishing relationships with cardiologists other than the Plaintiffs. Defendant, by adopting the economic credentialing policy, intended to disrupt the business expectancies arising out of Plaintiffs’ relationships with their patients and with referring physicians with whom they have established patterns of referral. Further, by adopting the economic credentialing policy, Defendant intended to disrupt and interfere with the doctor-patient relationship existing between Plaintiffs and their patients and Plaintiffs’ ability to provide health care to their patients. Defendant’s actions are an attempt to secure treatment of patients at Defendant’s facilities and not Plaintiffs’ facilities.67 CH08.indd 334 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 335 After further hearings the Supreme Court of Arkansas again affirmed the decision to enjoin Baptist Health’s policy;68 thus, economic credentialing now appears to be legally objectionable in Arkansas. As the HHS Office of Inspector General notes, “In addition to the antikickback statute, hospitals should make sure that their credentialing ­policies comply with all other applicable Federal and State laws and regulations, some of which may prohibit or limit economic credentialing.”69 Thus, hospital administration would be well advised to seek legal counsel when considering adopting a policy that sets economic criteria or establishes a loyalty standard for medical staff appointments and privileges. Furthermore, the ACA amended the physician self-referral (Stark) law and placed severe limitations on physicians’ ability to own or invest in hospitals.70 Physician-owned hospitals that did not have a Medicare provider agreement before December 31, 2010, may not participate in the M ­ edicare program. Those that did have a provider agreement may continue to ­participate—but only under certain significant conditions that address facility expansion, conflicts of interest, bona fide investments, patient safety issues, and conversion of facilities. If these amendments to the Stark self-referral law remain in place, issues such as those raised in Baptist Health may become moot because physician ownership of hospitals will be severely limited. (The Stark law and other fraud statutes are discussed more fully in chapter 9.) Medical Staff Issues in Accountable Care Organizations The premise of the ACA was that fundamental change is needed in the US healthcare system. One of the act’s most significant changes regarding medical staff was the creation of the Medicare Shared Savings Program, under which groups of providers, organized as ACOs, “work together to manage and coordinate care for Medicare fee-for-service beneficiaries.”71 In other words, ACOs are meant to improve quality, coordinate care in varied settings, and reduce unnecessary costs; they have the ultimate goals of helping patients get the right care at the right time and avoiding duplication of services. A successful ACO—one that delivers high-quality care and reduces costs to the Medicare program—will share in any savings that it generates for the government. ACOs and similar shared savings models outside Medicare continue the trend of hospital–physician alignment, which began with physicianhospital organizations in the 1990s. As the economics of physician practice changed and cost-containment pressures increased, employment by a hospital or integrated delivery system became an attractive option for many physicians. An increasing percentage of physicians, particularly new graduates, now choose to become employees of large groups or healthcare systems. Under health reform, hospitals have new reasons to strengthen the bond with their medical staffs. CH08.indd 335 02/01/23 2:02 PM 336 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Whether as an ACO or otherwise, hospital–physician relationships take a variety of forms: joint ventures; facility leasing; management contracts; and outright employment of the physician by a hospital, clinic, medical foundation, faculty practice plan, or hospital-owned group practice. As ACOs become common and as more physicians become employees, these integrated relationships will add new management challenges and will strain the traditional legal concepts of medical staff privileges. As discussed in chapter 4, when the concept of employment at will applies, employees are not entitled to substantive or procedural due process and can be dismissed without a hearing, prior notice, or cause. Employed physicians are typically at-will employees; their medical staff privileges, however, are a different matter. Unless the employment contract makes employment and staff privileges coterminous, the hospital must take separate action and follow regular medical staff procedures if it wants to revoke the privileges of a physician it has dismissed from employment. Similarly, a hospital’s decision not to renew an exclusive service contract—with a radiology group, for example—usually does not require due process but depends on the terms of the contract. For example, in a Minnesota case, a municipal hospital (a state actor) had an unwritten at-will arrangement with its director of pathology. When the hospital terminated the contract, the physician filed suit, arguing that he should have been afforded formal due process. The court disagreed. Although loss of the directorship position made his medical staff privileges virtually worthless—pathologists do not normally admit and treat patients, after all—that directorship “stemmed solely from his oral contract with the hospital, not [from] his staff membership. Accordingly . . . we must distinguish the termination of a contractually created director’s position from the termination or reduction of staff privileges.”72 These traditional viewpoints may Legal Brief need to be reconsidered and contractual and bylaws provisions reexamined Members of a physician group that provides excluas physicians become more involved in sive services for certain hospital departments hospital governance under an ACO or (e.g., pathology, radiology, anesthesiology) must other integrated arrangement (see Legal be members of both the group and the hospital Brief). The concept of economic credenmedical staff. Contracts between the hospital and tialing discussed earlier may also need to the group should provide that if physicians leave be reviewed. In short, the idea of hospithe practice, their medical staff appointments end and they must reapply for privileges to contal–physician alignment—being as it is all tinue practicing in the facility. These contractual about money and control—will present arrangements will need to be reviewed if the myriad new issues in the realm of medical physician group becomes part of an ACO with the staff privileges, perhaps for the courts but hospital. certainly for hospital administration. CH08.indd 336 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 337 Complementary and Alternative Medicine, Integrative Healthcare In his 1982 Pulitzer Prize–winning book The Social Transformation of American Medicine, Professor Paul Starr chronicles how physicians gradually assumed a dominant role in the US medical establishment. He notes that a century ago, physicians had much less prestige and influence than they have today. They were in competition with faith healers, herbalists (Thomsonians), eclectics (botanics), homeopaths, midwives, naturopaths, hydropathists, osteopaths, chiropractors, and others. The field changed after the famous Flexner Report, issued in 1910, prompted reforms in medical education to systemize it and increase its scientific grounding; when medical education caught up with medical science, allopathic physicians consolidated their power. While this shift had a number of positive effects, it also—in combination with discriminatory medical school admissions criteria—limited the ability of women and practitioners of color to provide healthcare. By the time of the Great Depression, one survey reported that “all the non-M.D. practitioners combined—osteopaths, chiropractors, Christian Scientists and other faith healers, midwives, and chiropodists—took care of only 5.1 percent of all attended cases of illness [in the study].”73 Ever since, as one law review article remarked, “Organized medicine . . . has fought to maintain a firm grip on the philosophy of health care generally, as well as on the specific treatments patients should have available to them.”74 By the 1950s, “mainstream medicine” had essentially suppressed some healers (e.g., homeopaths, eclectics), but it reluctantly acceded to the licensure of others (e.g., osteopaths) who had scientific training. By the mid1960s, the grip that physicians once held had loosened such that Medicare defined a physician as an individual holding any of these degrees: doctor of medicine (MD), doctor of osteopathic medicine (DO), doctor of dental surgery (DDS), doctor of dental medicine (DMD), doctor of podiatric medicine (DPM), doctor of optometry (OD), and doctor of chiropractic (DC).75 This definition holds today. Now the field is changing again. In an ironic twist, some practices that were once disdained are gaining acceptance through policies designed to promote wellness and prevention. State licensing is reaching naturopaths, acupuncturists, midwives, and Eastern Medicine practitioners, among other schools. As one court stated in a 2001 case involving a state health plan’s insurance coverage, [T]here are many medical schools in the United States that are teaching alternative approaches to some traditional practices. As more and more doctors become familiar with alternative practices, we can anticipate the availability and increasing utilization of . . . alternative treatments. . . . CH08.indd 337 02/01/23 2:02 PM 338 T h e L aw o f H e a l th c a re A d mi n i stra ti o n If a licensed alternative medical provider indicates that the treatment is based on sound medical, biological or scientific principles; widely prescribed and recognized by other alternative medical providers; and considered efficacious and safe, the [state health plan] should not reject the treatment solely because traditional doctors do not yet utilize the treatment or are completely unfamiliar with the practice. In that instance, the new treatment should be carefully evaluated under the other provisions of the plan, and not automatically excluded solely because no traditional physician is as yet prescribing [it].76 Legal Brief CAM is recognized by the National Institutes of Health (NIH), which houses the National Center for Complementary and Integrative Health (formerly the National Center for Complementary and Alternative Medicine), the federal government’s “lead agency for scientific research on the diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine” (42 U.S.C. § 287c-21; see also National Center for Complementary and Integrative Health, About NCCIH, https://nccih. nih.gov/about [https://perma.cc/LTL6-645P] [last modified September 24, 2017]). CAM and integrative medicine are mentioned numerous times in the health reform legislation. Such treatments are part of an interdisciplinary, patient-centered “medical home” and are included in a new NIH council on prevention and health promotion. Furthermore, the ACA’s definition of the “health care workforce” encompasses “all health care providers with direct patient care and support responsibilities, such as . . . licensed complementary and alternative medicine providers [and] integrative health practitioners” (ACA §§ 3502, 4001, and 5001). For an example of an integrative healthcare program in a university’s physician practice group, see Integrative Medicine, UTMB Health, http:// fammed.utmb.edu/education/integrative-medicine [https://perma.cc/N8GE-LQW5] (last visited June 18, 2022). CH08.indd 338 The treatments to which this court referred are an essential component of integrative healthcare—a philosophy that focuses not only on the conventional treatment of a patient’s condition but also on the whole person (mind, body, spirit) to promote health and wellness. When used in conjunction with a physician’s prescribed therapies, the nontraditional treatments are complementary; when used in isolation, they are alternative. Collectively, the term for such treatments is complementary and alternative medicine (CAM) (see Legal Brief). By adopting CAM principles, physicians and other licensed practitioners who practice integrative healthcare incorporate some of the very practices the medical establishment scorned two or three generations ago: acupuncture, naturopathy, massage therapy, yoga, meditation, herbalism, Ayurveda, hypnotherapy, midwifery, and shamanism, to name a few.77 Respecting and incorporating traditional healing modalities from a patient’s culture can also have immense benefits for hospitals’ diversity, equity, and inclusion goals. CAM principles are seen as entirely consistent with the ACA’s emphasis on cost reduction, coordinated care, chronic disease management, and reducing health disparities, and they are fast becoming part of integrated systems’ offerings. 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 339 These practices are also gaining recognition as disciplines worthy of licensure in their own right. State licensure of naturopaths is now common; and state licensure or regulation of other CAM providers is no longer unusual.78 Legal Issues and Credentialing for Complementary and Alternative Medicine and Integrative Healthcare Providers Over the years, some CAM and integrative healthcare practitioners have been charged with practicing medicine without a license or, if licensed, for unprofessional conduct.79 Otherwise, research reveals only a few reported cases involving these practitioners, and in those cases CAM was only tangentially related to the issue (e.g., regulatory enforcement for misleading advertising, the revocation of a physician’s license because of fraud or gross negligence).80 In contrast with years ago—when osteopaths, for example, challenged their exclusion from medical staffs—research reveals no recent cases in which nonphysician CAM and integrative healthcare practitioners have sought and been denied medical staff privileges. In independent practice, the liability issues of massage therapists or herbalists, for example, are theirs alone. However, in a hospital setting, the corporation must consider respondeat superior issues and questions about licensure, credentialing, scope of practice, medical supervision, professional liability insurance, and health plan coverage, among others. No single answer can address the myriad questions involved because there is no standard system for credentialing CAM and integrative healthcare providers, and the educational requirements and licensing vary widely from state to state.81 Organizations will have to address these questions independently as CAM and integrative healthcare become more popular. Society is more health conscious than ever, and CAM and integrative healthcare have regained credibility. As one article commented, “Legislative recognition trumps medical recognition,”82 but licensure and scope of practice vary by state. How the issues surrounding hospital credentialing will play out over time remains to be seen, but—as discussed earlier—the general principle remains that decisions should be based on individual merit rather than discrimination against an entire class of providers. Chapter Summary This chapter discussed the following topics: • Medical staff privileges • The governing board’s role • Non-MD practitioners CH08.indd 339 02/01/23 2:02 PM 340 T h e L aw o f H e a l th c a re A d mi n i stra ti o n • • • • • Peer review Confidentiality of peer review records Quality assurance Economic credentialing Complementary and alternative medicine Vocabulary credentialing privileging remittitur Discussion Questions 1. Who has ultimate responsibility for decisions about medical staff membership, and why? How should this responsibility be fulfilled? 2. What differences are there, if any, between the due process standards that apply to public hospitals and those that apply to private hospitals? 3. What categories of professionals are permitted membership on the medical staff? 4. What issues of confidentiality and liability does the hospital’s peer review function present? 5. Explain how the HCQIA establishes an “objective reasonableness” requirement rather than a subjective “good faith standard” for peer review committees. 6. What are the medical staff privileges of contract physicians and CAM and integrative healthcare providers? 7. Research the status of economic credentialing in your state and the effects of the Baptist Health case and similar decisions. 8. Explain the concept of the ACO and its role in the 2010 health reform legislation. CH08.indd 340 02/01/23 2:02 PM 341 C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew The Court Decides Kadlec Medical Center v. Lakeview Anesthesia Associates 527 F.3d 412 (5th Cir. 2008) Reavley, Circuit Judge Kadlec Medical Center and its insurer, Western Professional Insurance Company, filed this diversity action in Louisiana district court against Louisiana Anesthesia Associates (LAA), its shareholders, and Lakeview Regional Medical Center (Lakeview Medical). The LAA shareholders worked with Dr. Robert Berry—an anesthesiologist and former LAA shareholder—at Lakeview Medical, where the defendants discovered his on-duty use of narcotics. In referral letters written by the defendants and relied on by Kadlec, his future employer, the defendants did not disclose Dr. Berry’s drug use. [Note: Dr. Berry was not technically an employee of either Kadlec or Lakeview Medical, although he did have staff privileges at both facilities. In common with most laypeople, some judges have a difficult time understanding the concept of privileges in the healthcare context.] While under the influence of Demerol at Kadlec, Dr. Berry’s negligent performance led to the near-death of a patient, resulting in a lawsuit against Kadlec. Plaintiffs claim here that the defendants’ misleading referral letters were a legal cause of plaintiffs’ financial injury, i.e., having to pay over $8 million to defend and settle the lawsuit. The jury found in favor of the plaintiffs and judgment followed. We reverse the judgment against Lakeview Medical, vacate the remainder of the judgment, and remand. I. Factual Background Dr. Berry was a licensed anesthesiologist in Louisiana and practiced with Drs. William Preau, Mark Dennis, David Baldone, and Allan Parr at LAA. From November 2000 until his termination on March 13, 2001, Dr. Berry was a shareholder of LAA, the exclusive provider of anesthesia services to Lakeview Medical (a Louisiana hospital). In November 2000, a small management team at Lakeview Medical investigated Dr. Berry after nurses expressed concern about his undocumented and suspicious withdrawals of Demerol. [The findings were discussed with Dr. Berry’s LAA partners, who confronted him with the evidence, but his drug-related problems continued and his performance deteriorated. In March 2001, Lakeview CEO Max Lauderdale] . . . decided that it was in the best interest of patient safety that Dr. Berry not practice at the hospital. Dr. Dennis and his three partners at LAA fired Dr. Berry and signed his termination letter on March 27, 2001, which explained that he was fired “for cause”: [You have been fired for cause because] you have reported to work in an impaired physical, mental, and emotional state. Your impaired condition has prevented you from properly performing your duties and puts our patients at significant risk. . . . [P]lease consider your termination effective March 13, 2001. At Lakeview Medical, Lauderdale ordered the Chief Nursing Officer to notify the administration if Dr. Berry returned. Despite recognizing Dr. Berry’s drug problem and the danger he posed to (continued) CH08.indd 341 02/01/23 2:02 PM 342 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) patients, neither Dr. Dennis nor Lauderdale reported Dr. Berry’s impairment [or discipline] to the hospital’s Medical Executive Committee, . . . to Lakeview Medical’s Board of Trustees, . . . to the Louisiana Board of Medical Examiners or to the National Practitioner’s Data Bank. . . . After leaving LAA and Lakeview Medical, Dr. Berry briefly obtained work as a locum tenens (traveling physician) at a hospital in Shreveport, Louisiana. In October 2001, he applied through Staff Care, a leading locum tenens staffing firm, for locum tenens privileges at Kadlec Medical Center in Washington State. After receiving his application, Kadlec began its credentialing process. Kadlec examined a variety of materials, including referral letters from LAA and Lakeview Medical. LAA’s Dr. Preau and Dr. Dennis, two months after firing Dr. Berry for his on-thejob drug use, submitted referral letters for Dr. Berry to Staff Care, with the intention that they be provided to future employers. The letter from Dr. Dennis stated that he had worked with Dr. Berry for four years, that he was an excellent clinician, and that he would be an asset to any anesthesia service. Dr. Preau’s letter said that he worked with Berry at Lakeview Medical and that he recommended him highly as an anesthesiologist. Dr. Preau’s and Dr. Dennis’s letters were submitted on June 3, 2001, only sixty-eight days after they fired him for using narcotics while on-duty and stating in his termination letter that Dr. Berry’s behavior put “patients at significant risk.” On October 17, 2001, Kadlec sent Lake­ view Medical a request for credentialing information about Berry. The request included a detailed confidential questionnaire, a delineation of privileges, and a signed consent for release of information. The interrogatories on the questionnaire asked whether “[Dr. Berry] has been subject to any disciplinary action,” if “[Dr. Berry has] the ability (health status) to CH08.indd 342 perform the privileges requested,” whether “[Dr. Berry has] shown any signs of behavior/ personality problems or impairments,” and whether Dr. Berry has satisfactory “judgement” [sic]. Nine days later, Lakeview Medical responded to the requests for credentialing information about fourteen different physicians. In thirteen cases, it responded fully and completely to the request, filling out forms with all the information asked for by the requesting health care provider. The fourteenth request, from Kadlec concerning Berry, was handled differently. Instead of completing the multi-part forms, Lakeview Medical staff drafted a short letter. In its entirety, it read: This letter is written in response to your inquiry regarding [Dr. Berry]. Due to the large volume of inquiries received in this office, the following information is provided. Our records indicate that Dr. Robert L. Berry was on the Active Medical Staff of Lakeview Regional Medical Center in the field of Anesthesiology from March 04, 1997 through September 04, 2001. If I can be of further assistance, you may contact me at (504) 867-4076. The letter did not disclose LAA’s termination of Dr. Berry; his on-duty drug use; the investigation into Dr. Berry’s undocumented and suspicious withdrawals of Demerol that “violated the standard of care”; or any other negative information. The employee who drafted the letter said at trial that she just followed a form letter, which is one of many that Lakeview Medical used. Kadlec then credentialed Dr. Berry, and he began working there. After working at Kadlec without incident for a number of months, [Dr. Berry’s performance began to deteriorate again in November 2002. He seemed sick on occasion and exhibited mood swings. On 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew November 12, he again appeared sick, several of his surgery patients suffered adverse effects, and he almost passed out during one procedure.] . . . Kimberley Jones was Dr. Berry’s fifth patient that morning. She was in for what should have been a routine, fifteen minute tubal ligation. When they moved her into the recovery room, one nurse noticed that her fingernails were blue, and she was not breathing. Dr. Berry failed to resuscitate her, and she is now in a permanent vegetative state. . . . Jones’s family sued Dr. Berry and Kadlec in Washington. Dr. Berry’s insurer settled the claim against him. . . . Western, Kadlec’s insurer, settled the claim against Kadlec. [Western’s payout was approximately $8.25 million.] .... III. Discussion A. The Intentional and Negligent Misrepresentation Claims The plaintiffs allege that the defendants committed two torts: intentional misrepresentation and negligent misrepresentation. The elements of a claim for intentional ­misrepresentation in Louisiana are: (1) a misrepresentation of a material fact; (2) made with intent to deceive; and (3) causing justifiable reliance with resultant injury. To establish a claim for intentional misrepresentation when it is by silence or inaction, plaintiffs also must show that the defendant owed a duty to the plaintiff to disclose the information. To make out a negligent misrepresentation claim in Louisiana: (1) there must be a legal duty on the part of the defendant to supply correct information; (2) there must be a breach of that duty, which can occur by omission as well as by affirmative misrepresentation; and (3) the breach must have caused damages to the plaintiff based on the plaintiff’s reasonable reliance on the misrepresentation. 343 The defendants argue that any representations in, or omissions from, the referral letters cannot establish liability. We begin our analysis below by holding that after choosing to write referral letters, the defendants assumed a duty not to make affirmative misrepresentations in the letters. We next analyze whether the letters were misleading, and we conclude that the LAA defendants’ letters were misleading, but the letter from Lakeview Medical was not. We also examine whether the defendants had an affirmative duty to disclose negative information about Dr. Berry in their referral letters, and we conclude that there was not an affirmative duty to disclose. Based on these holdings, Lake­view Medical did not breach any duty owed to Kadlec, and therefore the judgment against it is reversed. Finally, we examine other challenges to the LAA defendants’ liability, and we conclude that they are without merit. 1. The Affirmative Misrepresentations. The defendants owed a duty to Kadlec to avoid affirmative misrepresentations in the referral letters. In Louisiana, “[a]lthough a party may keep absolute silence and violate no rule of law or equity . . . if he volunteers to speak and to convey information which may influence the conduct of the other party, he is bound to [disclose] the whole truth.” In negligent misrepresentation cases, Louisiana courts have held that even when there is no initial duty to disclose information, “once [a party] volunteer[s] information, it assume[s] a duty to insure [sic] that the information ­volunteered [is] correct.” Consistent with these cases, the defendants had a legal duty not to make affirmative misrepresentations in their referral letters. . . . Here, defendants were recommending an anesthesiologist, who held the lives of patients in his hands every day. Policy considerations dictate that the defendants had a duty to avoid misrepresentations in their referral letters if they misled (continued) CH08.indd 343 02/01/23 2:02 PM 344 T h e L aw o f H e a l th c a re A d mi n i stra ti o n (continued from previous page) plaintiffs into thinking that Dr. Berry was an “excellent” anesthesiologist, when they had information that he was a drug addict. Indeed, if defendants’ statements created a misapprehension about Dr. Berry’s suitability to work as an anesthesiologist, then by “volunteer[ing] to speak and to convey information which . . . influence[d] the conduct of [Kadlec], [they were] bound to [disclose] the whole truth.” In other words, if they created a misapprehension about Dr. Berry due to their own statements, they incurred a duty to disclose information about his drug use and forcause firing to complete the whole picture. . . . The letter from Dr. Preau stated that Dr. Berry was an “excellent anesthesiologist” and that he “recommend[ed] him highly.” Dr. Dennis’s letter said that Dr. Berry was “an excellent physician” who “he is sure will be an asset to [his future employer’s] anesthesia service.” These letters are false on their face and materially misleading. . . . The question as to whether Lakeview Medical’s letter was misleading is more difficult. The letter does not comment on Dr. Berry’s proficiency as an anesthesiologist, and it does not recommend him to Kadlec. . . . [W]hatever the real reason that Lakeview Medical did not respond in full to Kadlec’s inquiry, Kadlec did not present evidence that this could have affirmatively misled it into thinking that Dr. Berry had an uncheckered history at Lakeview Medical. Kadlec also says that the letter was misleading because it erroneously reported that Dr. Berry was on Lakeview Medical’s active medical staff until September 4, 2001. [The court finds that although Dr. Berry did not return to work at Lakeview after his March 13 termination, technically he was on the medical staff until he formally resigned on October 1.] In sum, we hold that the letters from the LAA defendants were affirmatively misleading, but the letter from Lakeview Medical was not. . . . We now examine the theory that, CH08.indd 344 even assuming that there were no misleading statements in the referral letters, the defendants had an affirmative duty to disclose. . . . [The court proceeds to analyze this issue and concludes, despite “compelling policy arguments,” that Louisiana courts would not impose on the defendants an affirmative duty to disclose possible impairments. Such a duty would exist, according to the court’s reading of Louisiana law, only if there were a “special relationship” between the parties. That relationship apparently would need to be contractual or fiduciary in nature.] 3. Legal Cause .... The LAA defendants . . . argue that Kadlec had multiple warning signs . . . and had it responded with an investigation, plaintiffs’ injuries would have been avoided. . . . The jury . . . concluded that the LAA defendants negligently and intentionally misled Kadlec about Dr. Berry’s drug addiction. By intentionally covering up Dr. Berry’s drug addiction in communications with a future employer, they should have foreseen that the future employer might miss the warning signs of Dr. Berry’s addiction. This was within the scope of the risk they took. Indeed, both plaintiffs’ and defendants’ witnesses agreed at trial that narcotics addiction is a disease, that addicts try to hide their disease from their co-workers, and that particularly in the case of narcotics-addicted anesthesiologists, for whom livelihood and drug supply are in the same place, colleagues may be the last to know about their addiction and impairment. This is not a case where a future tortious act is so unforeseeable that it should relieve the earlier tortfeasor of liability. . . . E. Summary and Remand Instructions .... The district court entered judgment consistent with how the jury allocated fault 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew among the entities it found to be legally responsible for the plaintiffs’ injuries. The jury’s allocation was as follows: Dr. Dennis 20%; Dr. Preau 5%; Lakeview Medical 25%; Kadlec 17%; and Dr. Berry 33%. We have affirmed the liability finding of the jury against the LAA defendants. But now that we have reversed the judgment against Lakeview Medical, the question arises whether there must be a reapportionment of fault with a corresponding change to damages assessed against the LAA defendants. It is possible that 345 this is unnecessary, if under Louisiana law we can simply compare the fault percentages of the remaining parties. But Louisiana law might also require a reapportionment of fault and, therefore, a fresh determination of damages. Because there was no briefing on this issue, we vacate the judgment against the LAA defendants and remand the case to the district court to determine what, if anything, needs to be redone on the apportionment and damages issues, and then to enter judgment against the LAA defendants accordingly. Discussion Questions 1. Kadlec is a decision by a federal court in a lawsuit brought by a plaintiff located in the state of Washington on a question regarding Louisiana state law. Can you explain why the case was filed in Louisiana and why Louisiana law rather than the law of Washington applies? 2. The US Court of Appeals for the Fifth Circuit is headquartered in New Orleans. Many of its judges are likely members of the Louisiana bar. Nevertheless, this federal court is presuming to gauge what a state court would decide if presented with these issues. What procedural mechanism might the district court or court of appeals have used to dispose of the Kadlec case without guessing what the Louisiana courts would do? 3. If this case were to come up today or in your state, how do you think it would be decided? In other words, what differences in law, accreditation standards, hospital practices, or other factors might affect this analysis? ~ ~ Notes 1. The Joint Commission, Introduction to Leadership Structure, in Hospital Accreditation Standards, Standards LD.01.01 through LD.01.07.01 (The Joint Commission, 2009). 2. Med. Staff of Avera Marshall Reg’l Med. Ctr. v. Avera Marshall, 857 N.W.2d 695 (Minn. 2014). 3. Meister v. Avera Marshall Reg’l Med. Ctr., No. A15-1982 (Ct. App. July 25, 2016). 4. See, e.g., Johnson v. Misericordia Community Hosp., 99 Wis. 2d 708, 301 N.W.2d 156 (1981); Sophia Elam v. College Park Hosp., 132 Cal. App. 3d 332, 183 Cal. Rptr. 156, modified, 133 Cal. App. 3d 94 (1982). CH08.indd 345 02/01/23 2:02 PM 346 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 5. See generally, Thomas C. Shields, Guidelines for Reviewing Applications for Privileges, 9 Hosp. Med. Staff 11 (September 1980). See also Leonard v. Board of Directors, Prower County Hosp. Dist., 673 P.2d 1019 (Colo. App. 1983) (the governing board has the authority to reject a medical staff committee’s recommendation and terminate a physician’s privileges); Ad Hoc Executive Comm. of the Medical Staff of Memorial Hosp. v. Runyan, 716 P.2d 465 (Colo. 1986) (the executive committee of the medical staff has no standing to challenge the decision of the board restoring a physician’s privileges). 6. Hayman v. Galveston, 273 U.S. 414 (1927). 7. See, e.g., Sosa v. Board of Managers of Val Verde Memorial Hosp., 437 2d 173 (5th Cir. 1971) (notice of charges “reasonably related to operation of hospital” is required for denial of admission to medical staff); Moore v. Board of Trustees of Carson-Tahoe Hosp., 88 Nev. 207, 495 P.2d 605 (1972), cert. denied, 409 U.S. 879 (1972). 8. See, e.g., Barrett v. United Hosp., 376 F. Supp. 791 (S.D.N.Y., aff’d mem, 506 F.2d 1395 (2d Cir. 1974); Jackson v. Metropolitan Edison Co., 419 U.S. 345 (1974). 9. Barrett, 376 F. Supp. at 800–805. 10. Id. at 799; accord Lubin v. Crittenden Hosp. Ass’n, 713 F.2d 414 (8th Cir. 1983), cert. denied, 465 U.S. 1025 (1984). 11. See, e.g., Arthur F. Southwick, The Physician’s Right to Due Process in Public and Private Hospitals: Is There a Difference? 9:1 Medicolegal News 4 (1981). First expressed more than three decades ago, these insights have proved true. 12. Greisman v. Newcomb Hospital, 40 N.J. 389, 192 A.2d 817 (1963). Some cases are contra; see, e.g., Limmer v. Samaritan Health Serv., 710 P.2d 1077 (Ariz. App. 1985). By statute and accreditation standards, the Greisman position has been vindicated. 13. Greisman, 40 N.J. at 393. 14. Ohio Rev. Code Ann. § 3701.351(B). 15. Cal. Health & Safety Code § 1316. 16. Cal. Health & Safety Code § 1316.5(a)(2). 17. See the “Overview” section of the Medical Staff chapter, the Hospital Accreditation Standards. 18. Sosa v. Board of Managers of Val Verde Memorial Hospital, 437 F.2d 173 (5th Cir. 1971). 19. Id., 437 F.2d at 176–77 (citations omitted; emphasis added). 20. Id., 437 F.2d at 177 (emphasis added). See also Schooler v. Navarro County Memorial Hosp., 375 F. Supp. 841 (N.D. Tex. 1973), aff’d, 515 F.2d 509 (5th Cir. 1975) (when procedural due process is CH08.indd 346 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. CH08.indd 347 347 followed, a hospital may deny staff appointment if there is evidence that the physician displayed an inability to work harmoniously with other doctors and hospital personnel and charged patients excessive fees). Woodbury v. McKinnon, 447 F.2d 839 (5th Cir. 1971). Pollock v. Methodist Hosp., 392 F. Supp. 393 (E.D. La. 1975). See also Jones v. State Bd. of Medicine, 555 P.2d 399 (Idaho 1976) (a statutory requirement that both physicians and hospitals obtain malpractice insurance as a condition of licensure is constitutional); Wilkinson v. Madera Community Hosp., 144 Cal. App. 3d 436, 192 Cal. Rptr. 593 (1983) (a hospital may deny privileges when a doctor’s insurance company is not approved by California Department of Insurance); Kling v. St. Paul Fire and Marine Ins. Co., 626 F. Supp. 1285 (C.D. Ill. 1986) (an agreement between hospital and insurance company requiring staff to carry a minimum amount of malpractice insurance is not subject to jurisdiction of the Sherman Act). Board of Trustees of the Memorial Hosp. v. Pratt, 72 Wyo. 120, 262 P.2d 682 (1953); Peterson v. Tucson Gen. Hosp., Inc., 559 P.2d 186 (Ariz. Ct. App. 1976). Rao v. Board of County Commiss’rs, 80 Wash. 2d 695, 497 P.2d 591 (1972). Selden v. City of Sterling, 316 Ill. App. 455, 45 N.E.2d 329 (1942). Yeargin v. Hamilton Memorial Hosp., 225 Ga. 661, 171 S.E.2d 136 (1969), cert. denied, 397 U.S. 963 (1970). Yeargin v. Hamilton Memorial Hosp., 229 Ga. 870, 195 S.E.2d 8 (1972). Fahey v. Holy Family Hosp., 32 Ill. App. 3d 537, 336 N.E.2d 309 (1975). Moore v. Board of Trustees of Carson-Tahoe Hospital, 88 Nev. 207, 495 P.2d 605 (1972), cert. denied, 409 U.S. 879 (1972). Moore, 88 Nev. at 211, 495 P.2d at 607 (quoting North Broward Hosp. Dist. v. Mizell, 148 So. 2d 1, 5 (Fla. 1962). Moore, 88 Nev. at 211–12, 495 P.2d at 608 (emphasis added). Hospital Accreditation Standards, MS.06.01.01. These competencies were developed jointly by the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties. Hospital Accreditation Standards, MS.07.08.01 and MS.08.01.03. 42 U.S.C. §§ 11101 et seq. Patrick v. Burget, 486 U.S. 94 (1988). Patrick, 486 U.S. at 96. 02/01/23 2:02 PM 348 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 37. Patrick, 486 U.S. at 98 and n.3. 38. Patrick, 486 U.S. at 105–06. 39. See generally, Margo Heffernan, The Health Care Quality Improvement Act of 1986 and the National Practitioner Data Bank: The Controversy over Practitioner Privacy Versus Public Access, 84(2) Bull. Med. Libr. Ass’n 263–69 (1996), https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC299426/pdf/mlab00375-0113.pdf [https://perma.cc/ X2UN-FZCU]. 40. Poliner v. Texas Health System, 537 F.3d 368 (5th Cir. 2008). Footnotes are omitted from the original passages. 41. Poliner, 537 F.3d at n.11. 42. Poliner, 537 F.3d at 370. 43. Poliner, 537 F.3d at 376–77. 44. Poliner, 537 F.3d at 379. 45. Poliner, 537 F.3d at 384–85 (internal citations omitted). 46. Kadlec Medical Center v. Lakeview Anesthesia Associates, 527 F.3d 412 (5th Cir. 2008). 47. For example, Cal. Bus. & Prof. Code § 805 (Deering 1986); Tex. Rev. Civ. Stat. Ann. art. 4495b, § 4.14 (Vernon 1987); Mich. Comp. Laws Ann. §§ 333.16233, 333.16243, 333.21513 (Supp. 1986). 48. Sallie Thieme Sanford, Candor After Kadlec: Why, Despite the Fifth Circuit’s Decision, Hospitals Should Anticipate an Expanded Obligation to Disclose Risky Physician Behavior, 1 Drexel L. Rev. 383, 386 (2009). 49. Id. 50. See Barry R. Furrow, Patient Safety and the Fiduciary Hospital: Sharpening Judicial Remedies, 1 Drexel L. Rev. 439, 483 (2009). 51. Bredice v. Doctors Hospital, Inc., 50 F.R.D. 249, 250–51 (D.D.C 1970), aff’d, 479 F.2d 920 (D.C. Cir. 1973). 52. U.S. v. Harris Methodist Fort Worth, 970 F.2d 94 (5th Cir. 1992). See also Laws v. Georgetown University Hospital, 656 F. Supp. 824, 826 (D.D.C.1987); Mewborn v. Heckler, 101 F.R.D. 691 (D.D.C. 1984). 53. O.C.G.A. § 31-7-143 (2010). 54. National Practitioner Data Bank, HHS, https://www.npdb.hrsa.gov/ [https://perma.cc/LDB2-K4GH] (last visited June 18, 2016). 55. CMS Reporting to the Healthcare Integrity and Protection Internet Bank, OIG Report (Sept. 2010), https://oig.hhs.gov/oei/ reports/oei-07-09-00292.asp [https://perma.cc/B92P-8SGF]. 56. Pub. L. No. 111-148, § 6403. 57. See, e.g., Blank v. Palo Alto-Stanford Hosp. Center, 234 Cal. App. 2d 377, 44 Cal. Rptr. 572 (1965), and Major v. Memorial Hospitals Ass’n, 84 Cal. Rptr. 2d 510, 71 Cal. App. 4th 1380 (1999). CH08.indd 348 02/01/23 2:02 PM C h a p te r 8: Medic al Staff Pr iv ileges and Peer Rev iew 349 58. Adler v. Montefiore Hosp. Ass’n of W. Pa., 453 Pa. 60, 311 A.2d 634 (1973), cert. denied, 414 U.S. 1131 (1974); see also Lewin v. St. Joseph Hosp., 82 Cal. App. 3d 368, 146 Cal. Rptr. 892 (1978). 59. Sokol v. University Hosp., Inc., 402 F. Supp. 1029 (Mass. 1975) (a hospital’s restriction of cardiac surgery to a single surgeon did not violate either antitrust or civil rights statutes); Moles v. White, 336 So. 2d 427 (Fla. Ct. App. 1976) (an exclusive contract for open-heart surgery did not violate state antitrust statutes, constitutional principles, or common law); Dillard v. Rowland, 520 S.W.2d 81 (Mo. App. 1974) (a private hospital that has an affiliation agreement with a university’s medical school may restrict staff appointments to those physicians who also hold a university faculty appointment). 60. See, e.g., Dattilo v. Tucson Gen. Hosp., 23 Ariz. App. 392, 533 P.2d 700 (1975) (an exclusive contract for nuclear medicine did not violate either state or federal antitrust laws); Harron v. United Hosp. Center, Inc., Clarksburg, W. Va., 522 F.2d 1133 (4th Cir. 1975), cert. denied, 424 U.S. 916 (1976) (an exclusive radiology contract does not violate the federal Sherman Antitrust Act or the civil rights statutes). 61. Am. Med. Ass’n Policy H-230.976. 62. Cobb County-Kennestone Hosp. Auth. v. Prince, 242 Ga. 139, 249 S.E.2d 581 (1978). 63. 242 Ga. 150, 249 S.E.2d at 588. 64. Id. 65. Baptist Health v. Murphy, 226 S.W.3d 800 (2006). 66. Baptist Health, 226 S.W.3d at 805. 67. Baptist Health, 226 S.W.3d at 808–9. 68. Baptist Health v. Murphy, 2010 Ark. 358 (2010). 69. HHS Office of Inspector General, Supplemental Compliance Program Guidance for Hospitals, 70 Fed. Reg. 4858, 4869 at n.59 (Jan. 31, 2005). 70. 42 U.S.C. § 1395nn, as amended by Pub. L. No. 111-148, § 6001. 71. ACA § 3022. 72. Engelstad v. Virginia Mun. Hosp., 718 F.2d 262, 268 (8th Cir. 1983). 73. Paul Starr, The Social Transformation of American Medicine 127 (Basic Books 1982). 74. Kathleen M. Boozang, Western Medicine Opens the Door to Alternative Medicine, 24 Am. J. L. & Med. 185, 186 (1998), quoted in Murray v. State Health Benefits Comm., 337 N.J. Super. 435, 767 A.2d 509 (N.J. Super. Ch., 2001). 75. 42 U.S.C. § 1395x(r). CH08.indd 349 02/01/23 2:02 PM 350 T h e L aw o f H e a l th c a re A d mi n i stra ti o n 76. Murray v. State Health Benefits Comm., 337 N.J. Super. 435, 445–46, 767 A.2d 509, 514 (N.J. Super. Ch. 2001). 77. See National Center for Complementary and Alternative Medicine, http://NCCIH.nih.gov/health/whatiscam/#definingcam [https:// perma.cc/4UWC-PHF2]. 78. See Licensure of NDs, North Carolina Ass’n of Naturopathic Physicians, http://ncanp.com/legislation/ [https://perma.cc/JU523JT8] (last visited June 18, 2022). 79. See, e.g., People v. Cantor, 198 Cal. App. 2d Supp. 843, 18 Cal. Rptr. 363 (Cal. Super. 1961) (hypnotist); People v. Amber, 76 Misc.2d 267, 349 N.Y.S.2d 604 (N.Y. Sup. 1973) (naturopathy); Williams v. State ex rel. Medical Licensure Commission, 453 So.2d 1051 (Ala. Civ. App. 1984) (naturopathy and homeopathy); State v. Howard, 337 S.E.2d 598, 78 N.C. App. 262 (N.C. App. 1985) (naturopathy); Sabastier v. State, 504 So.2d 45, 12 Fla. L. Weekly 811 (Fla. App. 4 Dist. 1987) (homeopathy); State Dept. of Health v. Hinze, 441 N.W.2d 593, 232 Neb. 550 (Neb. 1989) (naturopathy); State v. Mountjoy, 891 P.2d 376, 257 Kan. 163 (Kan. 1995) (midwifery). 80. See, e.g., FTC v. Qt, Inc., 448 F. Supp. 2d 908 (N.D. Ill., 2006) (defendants enjoined from falsely advertising their “Q-Ray bracelet” in infomercials as a pain-relieving device); United States v. Lane LabsUSA, Inc., 324 F. Supp. 2d 547 (2004) (defendants enjoined from marketing certain products as treatments for cancer and HIV/AIDS). 81. See generally, David M. Eisenberg et al., Credentialing Complementary and Alternative Medical Providers, 137 Ann. Int. Med. 965 (Dec. 17, 2002). It is noted, by way of comparison, that all states license MDs, DOs, and DCs, but only about half license massage therapists. Only three states license homeopaths who are not also MDs or DOs. 82. Id. CH08.indd 350 02/01/23 2:02 PM CHAPTER FRAUD AND ABUSE LAWS AND CORPORATE COMPLIANCE 9 After reading this chapter, you will • understand the basic federal laws relating to healthcare fraud and abuse and how the Affordable Care Act has affected them; • be able to explain why the 1863 False Claims Act is such a powerful tool when applied to modern healthcare operations; • understand that a violation of either the Anti-Kickback Statute or the Physician Self-Referral Law (also known as “Stark” or the “Stark law” after the name of its congressional sponsor) can support a False Claims Act case even in the absence of other evidence of wrongdoing; • appreciate the importance of the Anti-Kickback Statute’s safe harbors and Stark’s exceptions to properly structured healthcare business arrangements; • know that the other federal and state statutes might also be implicated by fraudulent activities; and • recognize the necessity of maintaining a robust corporate integrity program. Introduction As we all know, healthcare is a multitrillion-dollar industry, and it grows every year. According to the Centers for Medicare & Medicaid Services (CMS), total national health expenditures were $4.1 trillion in 2020—nearly 20 percent of the US gross domestic product. Although 2020 was an atypical year given the vast COVID-19-related expenditures and fewer elective procedures than usual, national health expenditures are projected to continue growing at an average rate of 5.5 percent per year. They are expected to total nearly $6.2 trillion annually by 2028.1 Given the astronomical sums involved, it is no wonder that this sector of the economy is a prime target for malefactors who want to defraud the government and health insurance companies. 351 CH09.indd 351 02/01/23 2:04 PM 352 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Protecting the public fisc is a key impetus behind the government’s efforts to combat improper healthcare billing. It is not, however, the only one. Other motivators include concern that some healthcare payment arrangements promote unnecessary care, encourage harmful overutilization, put financial incentives ahead of patient needs, or lead to unfair competition among providers. Appreciating these broader purposes helps explain how otherwise responsible providers can get ensnared in healthcare fraud and abuse laws. This chapter discusses the three most significant federal laws aimed at curbing healthcare fraud and gives examples of how those laws are enforced. These three laws are the False Claims Act (FCA), the Anti-Kickback Statute (AKS), and Physician Self-Referral Law (commonly known simply as Stark). The chapter also briefly covers state laws aimed at protecting Medicaid expenditures, the federal Civil Monetary Penalties Law (CMP), and the Foreign Corrupt Practices Act (FCPA). The chapter concludes with a review of corporate integrity programs, now a required component of any major healthcare entity. These programs, which go by a variety of names, aim to promote legal compliance and business ethics as well as reduce penalties for lapses that are caught and corrected. Upright organizations must be sensitive to the potential for their employees and independent medical staff members to be implicated in prohibited billing practices, illegal financial arrangements, or other illicit conduct. They must work to maintain high ethical principles not only because an image of moral respectability is good for business but also because such conduct is simply the right thing to do. The Enforcement Climate and Practical Challenges for Healthcare Providers “Follow the money” is often said in the context of corruption scandals, but it could also be the mantra of those who commit healthcare fraud: they wish to follow the money to its source, which in large measure is government healthcare programs. For example, in 2020, Medicare spending totaled $828.5 billion and Medicaid spending was $671.2 billion.2 These numbers are expected to continue to rise as a result of the aging of the population, increased demand for treatment of chronic diseases, and the high cost of new drugs and technology. Government entities—both federal and state—are obvious targets for fraud because of these numbers, and elimination of fraud is therefore a high priority for law enforcement and policymakers. Each year, more resources are allocated to the US Department of Justice (DOJ), the Federal CH09.indd 352 02/01/23 2:04 PM C h a p te r 9 : Fra u d and A b use L aws and C or p orate C om p lianc e 353 Bureau of Investigation, the Offices of the United States Attorneys, the US Department of Health and Human Services (HHS), the HHS Office of Inspector General (OIG), and other enforcement agencies. State attorneys Legal Brief general conduct their own investigations and prosecutions, often working closely with federal officials. Also of In fiscal year 2021, the DOJ obtained more than great importance is the fact that the $5.6 billion in settlements and judgments from FCA allows private individuals who have civil cases involving fraud and false claims. Of firsthand knowledge of fraud to sue on that amount, more than $5 billion related to cases involving the healthcare industry, including drug behalf of the government and to collect and medical device manufacturers, managed care a significant percentage of any proceeds providers, hospitals, pharmacies, hospice organirecovered. zations, laboratories, and physicians. This amount The key federal laws—FCA, AKS, reflects recoveries arising only from federal losses, and Stark—present challenges for even but in many cases the DOJ’s efforts resulted in the most well-intentioned providers. They recoveries for states. Representative fraud settlements include the prohibit activities that are standard and following: acceptable in other businesses. They are complex, difficult to apply, and frequently • Arriva Medical LLC and its parent, Alere Inc., agreed to pay $160 million to settle allegations amended. Their financial penalties (in the that Arriva paid kickbacks to Medicare form of fines, verdicts, or settlements) can beneficiaries by providing them “free” or “no be enormous, especially under the FCA. cost” diabetic testing glucometers and by Criminal penalties, including jail time, are routinely waiving or not making reasonable possible as well, and harm to reputations efforts to collect their copayments for is a definite risk because publicizing the glucometers and diabetic testing supplies. • Apria Healthcare LLC paid $40.5 million to cases is part of the government’s broader resolve allegations that it submitted false deterrence strategy. claims for the rental of costly noninvasive Combating healthcare fraud and ventilators to program beneficiaries who did abuse has been and will continue to be not need the devices or were not using them. a high priority for the DOJ, no mat• St. Jude Medical Inc. paid $27 million to settle ter which political party is in power. In allegations that it knowingly sold defective implantable heart devices and failed to disclose part, this is because the joint DOJ-HHS serious adverse health events in connection with Health Care Fraud and Abuse Control premature battery depletion in those devices. Program recovers more than $8 for every See Justice Department’s False Claims Act $1 spent on its investigations; it returns Settlements and Judgments Exceed $5.6 Billion in more than $4 billion to the US Treasury Fiscal Year 2021: Second Largest Amount Recorded, every year.3 ­Largest Since 2014, DOJ Off. Pub. Aff., Just. News As these statistics show, preventing (Feb. 1, 2022), https://www.justice.gov/opa/pr/ fraud and abuse should be a top priorjustice-department-s-false-claims-act-settlementsand-judgments-exceed-56-billion-fiscal-year ity for healthcare executives, and a basic [https://perma.cc/ZN5P-SMMV]. understanding of the major criminal and civil fraud statutes is therefore essential. CH09.indd 353 02/01/23 2:04 PM 354 T h e L aw o f H e a l th c a re A d mi n i stra ti o n False Claims Act In 1862, the US House of Representatives convened a “Select Committee” to study military contractor fraud. In his report, committee member Charles Van Wyck condemned those who committed the “many frauds that have been exposed” and added, “Worse than traitors in arms are the men who pretend loyalty to the flag, who feast and fatten on the misfortunes of the nation, while patriotic blood is crimsoning the plains of the south and their countrymen are moldering in the dust.” (H.R. Rep. No. 37-50 [1863], at 47. This quotation is often misattributed to President Abraham Lincoln, presumably because the FCA was sometimes known as the “Lincoln Law.”) Among those to whom Van Wyck was alluding was financier J. P. Morgan, who had profiteered by selling defective rifles to the Union Army at a markup of over 600 percent (Matthew Josephson, The Robber Barons: The Great American Capitalists, 1861–1901, 60–61 [1962]). Morgan is known as one of the “robber barons” of the Gilded Age of the late 1800s. The federal government’s main weapon in the war on fraud and abuse is the False Claims Act.4 The FCA was enacted during the Civil War to combat fraud in claims related to the provision of goods and services to the Union Army. Examples given to support passage of the law included military contractors billing the Union Army for lame donkeys and gunpowder cut with sawdust. For more than a century, FCA prosecutions centered on military contracting. In recent decades, however, most cases have related to healthcare billing, primarily Medicare and Medicaid, but other federal programs as well. The FCA has been the US government’s primary mechanism to prevent fraud, waste, and abuse in federal programs, and it has become the primary way in which alleged violations of the AKS and Stark (both discussed later) are pursued. The FCA establishes liability for anyone who • “knowingly presents, or causes to be presented, to an officer or employee of the United States . . . a false or fraudulent claim for payment or approval”; • “knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government”; • “conspires to defraud the Government by getting a false or fraudulent claim allowed or paid”; or • “knowingly makes, uses, or causes to be made or used, a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the government.” (This provision was added in 1986 to deal with reverse false claims—attempts to avoid paying money owed to the government.) The Krizek Case: An Early, Enduring Example The Krizek case of the early 1990s provides an enduring example of a deceptively straightforward FCA case. George Krizek was a psychiatrist trained at CH09.indd 354 02/01/23 2:04 PM C h a p te r 9 : Fra u d and A b use L aws and C or p orate C om p lianc e 355 Charles University in Prague and Beth Israel Hospital in New York City. He and Legal Brief his wife, Blanka Krizek, were political refugees to the United States (because Dr. Although this chapter focuses on federal fraud Krizek refused to render politically motilaws, each state has its own laws that complement vated psychiatric evaluations on behalf those of the federal government. Thus, both state of the authoritarian regime of Czechoand federal enforcement mechanisms can be in slovakia), and he was lauded as a hero of play for the same conduct, and federal and state the Czech Republic following the fall of agencies often work together to investigate and prosecute wrongdoing. The main focus of state communism there. Dr. Krizek had been laws is protecting the fiscal integrity of Medicaid practicing in Washington, DC, for 21 programs. years when the government filed a false Appendix 9.1 contains a summary of five claims action against him. major fraud statutes as listed by the HHS Office of According to the court, Dr. Krizek Inspector General. was a “capable and competent physician,” many of whose patients suffered from “horribly severe psychiatric disorders and often suffered simultaneously from other serious medical conditions.”5 Many of his patients were also low-income “dual eligibles” (patients covered by both Medicare and Medicaid). The prosecution could not prove that Dr. Krizek rendered inappropriate care, but numerous false claims related to upcoding (assigning a higher-reimbursed code than is warranted) were his downfall. This case was one of the first significant federal prosecutions of healthcare fraud under the FCA. It was triggered by data showing that Dr. Krizek billed Medicare for face-to-face sessions at a much higher level than other area psychiatrists. His was a small practice, with billing and other business matters handled by his wife (who was also charged in the case) and another part-time employee. The evidence showed that Dr. Krizek charged the government for a full face-to-face session—45 to 50 minutes—regardless of whether he spent 20 minutes or two hours with a patient. He argued that even if he spent only half an hour or less with the patient in person, he considered related services—such as medication management and discussions with other ­physicians—to be part of patient care, and therefore he believed that he had not harmed the government. According to Blanka Krizek, he was always thinking of his patients. One piece of evidence related to a statistical sampling of his patients showed that his practice submitted 23 claims for full (45–50 minute) sessions in a single day. The court was impressed with neither Dr. Krizek’s argument nor his management skills: “While Dr. Krizek was a dedicated and competent doctor . . . his billing practices, or at a minimum his oversight of CH09.indd 355 02/01/23 2:04 PM 356 T h e L aw o f H e a l th c a re A d mi n i stra ti o n [the] billing system, was seriously deficient. Dr. Krizek knew little or nothing of the details of how the bills were submitted [on his behalf].”6 The court concluded that Dr. Krizek must be held accountable for his billing system along with those who carried it out. . . . The Court . . . will hold the defendants liable under the False Claims Act on those days where claims were submitted in excess of the equivalent of twelve . . . claims (nine patient-treatment hours) in a single day and where the defendants cannot establish that Dr. Krizek legitimately devoted the claimed amount of time to patient care on the day in question.7 This is an example of a case that should have settled. The Krizeks refused early settlement offers, however, and the government continued its prosecution of the case. The case—one of the first major FCA cases related to healthcare billing—raised many complex and novel legal issues. At one point, Dr. Krizek’s attorneys withdrew, informing the court that they were “unable to continue working with their client.” They were replaced by the Krizeks’ newly minted lawyer daughter, Monika Krizek, and by the pro bono (free) services of a major law firm that the court helped them obtain. Ultimately, they were able to settle the case for approximately the government’s initial offer.8 Among the many interesting aspects of the published Krizek court opinions (four in all), perhaps the most noteworthy is the trial court’s displeasure with how the government handled the case. After years of litigation, the federal district court judge railed at the ongoing prosecution: When it began its case, the Government was seeking over $80 million worth of damages, a figure that the Court of Appeals declared was “astronomical.” Despite the fact that Dr. Krizek is incapable of paying such a sum, the Government continues to relentlessly pursue Dr. Krizek, who is at this point a broken and sick man. The Government’s pursuit of Dr. Krizek is reminiscent of Inspector Javert’s quest to capture Jean Valjean in Victor Hugo’s Les Misérables. While the Government’s vigor in pursuing violators of the law is to be commended, there comes a point when a civilized society must say enough is enough. That point has been reached in this case.9 Echoing the judge’s comments, some view this case as one of overly zealous prosecution of a dedicated, underpaid immigrant physician confused by the complexities of federal billing rules. Others view it as one of blatant overbilling, perhaps to the detriment of vulnerable patients, and in expectation of lax government oversight. Regardless of how one views this early and leading case, it demonstrates the seriousness with which the government CH09.indd 356 02/01/23 2:04 PM C h a p te r 9 : Fra u d and A b use L aws and C or p orate C om p lianc e 357 viewed and continues to view fraud and abuse allegations related to federal healthcare billing. FCA Scienter Requirement The civil FCA includes a scienter (knowledge) requirement. For liability to be found, the defendant must have acted “knowingly.” What does that mean? First-year law students are painfully aware of the Socratic dialogue that could attend the definition of “knowingly.” For example, consider the following classroom dialogue: scienter Knowledge by a defendant that their acts were illegal or their statements were fraudulent. Professor Sanford: Mr. Showalter, what if I sign a claim form, put it in a stamped envelope, and mail it to Medicare? Have I knowingly submitted that claim? Student Showalter: I guess so. Unless you were mentally incompetent, you knew what you were doing. You were mailing a claim form and expecting to get paid. Sanford: How much did I expect to get paid? Showalter: Whatever amount is on the form. Sanford: What if I didn’t look at the amount but just signed a bunch of forms my staff gave me at the end of the day and those forms had errors on them? Showalter: Well . . . [shifting in his seat and beginning to sweat] Sanford: Well, what? Are the forms that have errors on them “false claims”? Showalter: Well, they’re erroneous. But if you didn’t know they had errors and just assumed that your staff were doing their jobs correctly . . . Sanford: Assumed? Never assume anything in this class or any legal matter! Showalter: Sorry. You’re right, of course. Sanford: Let’s consider another case. Suppose that I know my claims contain the occasional error—some are over, some are under—but I think they will all balance out in the end, sort of the “no harm, no foul” approach to billing. And suppose I think that the False Claims Act applies only to overbilling the government on purpose, which I haven’t done. What say you now? Showalter: Hmm. You knew you were submitting a bill, but you didn’t know that the particular bill was wrong, and you didn’t know that submitting incorrect bills is illegal when you should have had a system in place to check them for errors. Good question! So goes this uncomfortable exchange for a few more minutes. In 1986, Congress addressed the issue of scienter by amending the FCA to say that “no proof of specific intent to defraud” is required. Instead, the person must either CH09.indd 357 02/01/23 2:04 PM 358 T h e L aw o f H e a l th c a re A d mi n i stra ti o n One of the Krizek opinions describes the doctor’s conduct being as struthious, a word that means “ostrich-like.” The OIG’s physician education training materials feature a picture of a man with his head in the sand, ostrich-like, as a depiction of what it means to act with “reckless disregard” of the truth or falsity of a claim (A Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse, OIG, https://oig.hhs.gov/ compliance/physician-education/ [https://perma. cc/4VK6-9W8D]). (1) have actual knowledge that the information is false; (2) act in deliberate ignorance of the truth or falsity of the information; or (3) act with reckless disregard of whether it is true or false.10 As stated in the committee report accompanying the 1986 amendment, The Committee is firm in its intentions that the act not punish honest mistakes or incorrect claims submitted through mere negligence. But the Committee does believe the civil False Claims Act should recognize that those doing business with the Government have an obligation to make a limited inquiry to ensure the claims they submit are accurate.11 The Krizek case delved into the practical meaning of “knowingly” in the context of healthcare billing. Although Dr. Krizek was not personally involved in the billing process, the court found that he and his wife (who managed the billing) had submitted the claims knowingly: “These were not ‘mistakes’ [or] merely negligent conduct. Under the statutory definition of ‘knowing’ conduct, the Court is compelled to conclude that the defendants acted with reckless disregard as to the truth or falsity of the submissions.”12 To counter a claim of reckless disregard or deliberate ignorance, healthcare providers must have in place mechanisms to verify the accuracy of their claims. Furthermore, section 6032 of the Deficit Reduction Act of 200513 requires all entities that receive $5 million or more in annual Medicaid payments to have written policies that provide detailed information about the FCA, applicable state laws, the penalties afforded to whistleblowers (qui tam relators), and the role of those laws in preventing fraud, waste, and abuse in federal healthcare programs. These policies must cover all employees, contractors, and agents of the entity. What Makes a Claim “False” Under the FCA? The FCA does not define the word “false.” Among the types of healthcare claims that have been held to be “false” are the following: • Filing claims for services not rendered or not medically necessary • Misrepresenting the time, location, frequency, duration, or provider of services CH09.indd 358 02/01/23 2:04 PM C h a p te r 9 : Fra u d and A b use L aws and C or p orate C om p lianc e 359 • Assigning a higher payment than the procedure or diagnosis warrants (upcoding) • Billing a battery of services (e.g., laboratory tests) separately (unbundling) when they were meant to be billed as a group • Violating the “three-day rule,” which states that outpatient diagnostic procedures performed on any of the three days before hospitalization are deemed part of the Medicare diagnosis-related group payment and are not to be billed separately • Billing for services that are said to have been “incident to” a physician’s services but were not provided under the physician’s direct supervision • Paying “kickbacks” to induce referrals of federally reimbursed healthcare services (a violation of the AKS that then forms the basis for a “bootstrapped” FCA case) • Referring patients to entities in which the physician has a statutorily improper financial interest (a violation of Stark that then forms the basis for a “bootstrapped” FCA case) The last two points deserve particular attention because they might not be obvious to students. Not infrequently, FCA plaintiffs argue that a violation of the AKS or Stark (described in more detail in the following sections) violates the FCA, even though the claim is otherwise legitimate.14 These are known as “bootstrapped” FCA cases. The theory is that the underlying violation of the AKS or Stark renders the related billing “false.” For example, in United States ex rel. Pogue v. American Healthcorp,15 a trial court refused to dismiss an FCA case based solely on violations of the AKS and Stark. (There was no allegation that the care provided was unnecessary or that it was improperly coded for billing.) The court agreed with the relator’s contention that “participation in any federal program involves an implied certification that the participant will abide by and adhere to all statutes, rules, and regulations governing that program.”16 It held, in effect, that AKS and Stark violations create prohibited financial relationships that taint the Medicare claims, and therefore the FCA applies. In 2016, the US Supreme Court held the implied certification rationale to be valid in certain circumstances.17 As explained by the court, not every violation of law connected to billing will support an FCA case. A key legal question will be whether the violation was “material” to the billing— whether the federal government would have paid the bill had it known of the violation. Violations of AKS and Stark are highly likely to be found to be material because one condition of Medicare participation is agreeing to comply with these statutes. In addition, the Affordable Care Act (ACA) codifies the implied certification rationale, at least insofar as the AKS is concerned. The ACA CH09.indd 359 02/01/23 2:04 PM 360 T h e L aw o f H e a l th c a re A d mi n i stra ti o n Legal Brief When the government wants to make regulatory compliance a precondition for payment, it certainly knows how to do so. The Medicare claim form (CMS-1500) states in boldface type: “Any person who knowingly files a statement of claim containing any misrepresentation or any false, incomplete or misleading information may be guilty of a criminal act punishable under law and may be subject to civil penalties.” It also includes the following language: states that “a claim that includes items or services resulting from a violation of the [AKS] constitutes a false or fraudulent claim for purposes of [the civil FCA].”18 Thus, compliance with the AKS is a precondition for payment, and noncompliance will support an FCA claim. The Medicare claim form adds weight to this position (see Legal Brief ). Qui tam Relators and Government Investigators A unique feature of the FCA is its provision for qui tam relators. Although NOTICE: This is to certify that the foregoing relators are often referred to as “whistleinformation is true, accurate and complete. I understand that payment and satisfaction blowers,” especially in the media, in some of this claim will be from Federal and State respects, they are more like bounty huntfunds, and that any false claims, statements, ers. The FCA allows a person with inside or documents, or concealment of a material knowledge to serve as a plaintiff and file fact, may be prosecuted under applicable an FCA suit on behalf of the government Federal or State laws. against entities or individuals. If the case This notice appears to turn what would otherwise results in a monetary recovery (either by be an implied certification into an express condisettlement or court decision), the qui tion for payment. tam plaintiff will collect a share of the money. Of course, the government can initiate an FCA case on its own. It can be alerted to potential fraud issues by data mining, billing audits, hotline reports, or media stories, among other sources. The OIG often leads the investigations, and the resulting cases are brought by the DOJ. At least 31 states also have false claims statutes that authorize private individuals to file suit on behalf of the government. These laws are a separate basis for liability, independent of the federal FCA, and they can be used for recovery in cases involving Medicaid and other state programs. The standards and defenses under state law differ from those under the federal statute. Any person with information about healthcare fraud can be a qui tam relator. Here, a “person” is defined as “any natural person, partnership, corporation, association, or other legal entity, including any State or political subdivision of a State.”19 The relator must file the complaint, which is immediately placed under seal (not made public or given to the defendant) pending an investigation, and file a copy with the US attorney general and the local US attorney. CH09.indd 360 02/01/23 2:04 PM C h a p te r 9 : Fra u d and A b use L aws and C or p orate C om p lianc e 361 The government then has 60 days, plus extensions for good cause, to deterLegal Brief mine whether to pursue the case. The government is statutorily obligated to Qui tam (“he who”) is shorthand for a Latin phrase investigate the claims. The investigation that means “he who sues for the king as well as (which usually takes longer than 60 days) for himself.” In such a case, the plaintiff (relator) is typically led by the OIG and involves a files suit as a kind of “private attorney general” variety of investigatory techniques includon behalf of the government. The government ing issuance of subpoenas for billing and can choose to take over the prosecution, but if it declines to do so the relator can proceed alone. other records. If the government decides Federal qui tam cases are cited as United to take over the case (to “intervene”), the States ex rel. [name] v. [name of defendant]. Ex rel. relator will receive 15 to 25 percent of means “by the relation of ” (or, more loosely, “at the any amount recovered. If the government request of ”) and indicates the name of the relator. declines to intervene, the relator may still pursue the matter and, if successful, will receive up to 30 percent of the recovery (see Legal Brief). Most FCA cases are now initiated by relators. Where the government declines to intervene, the cases are typically dropped, and the lawsuit is never unsealed. To file suit, the potential qui tam plaintiff and the allegations must meet certain conditions. The same allegations or transactions must not have been disclosed publicly at an earlier date—unless the qui tam plaintiff is the original source of the previously disclosed information. Original source means someone who gave the government the information in the first place or who has information additional to that previously disclosed.20 Federal law provides a remedy for relators who are discharged, demoted, harassed, or otherwise discriminated against because they filed a qui tam case.21 Given the financial incentives and the protection against employment-related retaliation, the qui tam lawsuit has become a common and effective means of combating fraud and abuse. If a healthcare provider learns (e.g. through a subpoena or other official government inquiry) that it is the target of a qui tam lawsuit, it should act promptly to retain knowledgeable legal counsel, halt any routine document destruction, and prohibit retaliatory employment action against the known or suspected relator. FCA Penalties: Civil, Criminal, and Exclusion Because of the way the civil FCA calculates penalties, verdicts and settlements in civil fraud cases can be enormous. Furthermore, temporary or permanent exclusion from Medicare and Medicaid participation—a possibility for serious violations of the fraud laws—can amount to a “death sentence” for healthcare providers and administrators. And offenders convicted of criminal offenses can receive massive fines and lengthy jail terms. CH09.indd 361 02/01/23 2:04 PM 362 T h e L aw o f H e a l th c a re A d mi n i stra ti o n United States v. Lorenzo provides an example of how quickly civil penalties can add up. Dr. Lorenzo, a dentist, billed Medicare for “consultations” on nursing home residents. Medicare did not cover these dental services, and Dr. Lorenzo’s examinations, according to the court, “were nothing more than the oral cancer screening that previously had been done as part of a routine dental examination. None of these examinations had been conducted at the request of an attending physician or because of a specifically identified medical concern.”22 The government proved that Dr. Lorenzo had submitted 3,683 false claims, and, as a result, he had received overpayments totaling $130,719.20. The FCA allows monetary damages of up to three times the overpayment plus a per-claim penalty that, at the time, had a maximum of $10,000 per fraudulent claim. Applying this formula, the court assessed damages of approximately $19 million, nearly 150 times the amount of the fraud. This decision was rendered in 1991, when the FCA’s per-claim penalties were much lower than they are today. In 2015, Congress amended the statute to allow agencies to update the per-claim penalties regularly for inflation. The adjustments are published in the Federal Register, and they serve as a prime example of how important administrative law has become. As of December 2021, the range of perclaim penalties for cases prosecuted by the DOJ was $11,803 to $23,605. That means, for example, that for two fraudulently submitted Medicare claims worth $100 each, the possible FCA penalties could be three times the damages (or $600) plus $23,605 for each claim (or $47,310) for a total of $47,910. Thus, today, Dr. Lorenzo’s fraudulent billing could result in fines of more than $86 million—and that amount is before the addition of statutorily authorized attorneys’ fees. Some agencies’ monetary penalty ranges are even higher. For example, the Railroad Retirement Board set a range of $12,537 to $25,076 for claims submitted to that agency for retirement, disability, or Medicare benefits.23 Curiously, the term claim was not defined in the FCA, and over the years, its meaning has been a matter of considerable dispute. This is especially so in healthcare where, for example, each line item on a billing form could be considered a separate claim. Therefore, using the DOJ penalty range for 2022, up to $23,605 in penalties could be assessed for each false code. By this line of reasoning, 20 false codes could result in a fine of nearly half a million dollars plus three times the amount of money the government paid for the false claims. The definition of claim was addressed in one of the Krizek appeals court decisions. The court held that each billing form was one claim, irrespective of the number of false codes it contained. The court asserted that the form was merely one request for payment of the total sum it represented.24 CH09.indd 362 02/01/23 2:04 PM C h a p te r 9 : Fra u d and A b use L aws and C or p orate C om p lianc e 363 This definition seems logical and is consistent with other cases defining a claim as “a demand for money or for some transfer of public property.”25 A separate provision of federal law makes filing false claims a criminal offense.26 If convicted, an organization will be subject to huge monetary penalties, perhaps in the millions of dollars depending on the amounts falsely claimed. An individual who is convicted of submitting a criminal false claim may likewise be given a huge fine and may be sentenced to up to 10 years in prison. Although potential risk to patients’ health is an important factor in the government’s decision to proceed criminally, the possibility of criminal prosecution is not limited to rogue actors. The DOJ’s policy for criminal prosecution of corporate employees and executives is expressed in the 2015 “Yates Memorandum”27 (so called because it was written by Sally Yates, who later became the acting US attorney general). Titled “Individual Accountability for Corporate Wrongdoing,” this memo stresses that one of the most effective ways to combat corporate misconduct is to hold individuals responsible, not just the corporate entity. Of course, the standards of proof are higher in criminal prosecutions than in civil cases. In a civil FCA action, the standard is merely “a preponderance of the evidence”—in other words, it is more likely than not that the defendant did what is alleged. In criminal FCA cases, the government must prove beyond a reasonable doubt that the defendant knew the claim was false. For this reason, and because the penalties in civil actions are already severe, fewer criminal false claims cases are brought than civil cases. A further incentive to avoid submitting fraudulent claims is the threat of the so-called death penalty (exclusion from Medicare and Medicaid). The OIG has the authority under the 1981 Exclusions Statute to exclude individuals and entities from federally funded healthcare programs for a variety of reasons, including a liability or conviction for Medicare or Medicaid fraud. Those that are excluded can receive no payment from federal healthcare programs for any items or services they furnish, order, or prescribe, and they cannot be employed by any provider of health benefits funded directly or indirectly by the United States. The OIG maintains a “List of Excluded Individuals/Entities” (LEIE). Anyone who hires an individual or entity on the LEIE may be subject to civil monetary penalties under the CMP, which is described in more detail later in this chapter. To avoid CMP liability, healthcare entities must routinely check the list to ensure that new hires and current employees are not on it. (In the case of healthcare systems and facilities, this is typically done by a compliance or human resources department, and it is a recommended procedure for even small provider practices.) CH09.indd 363 02/01/23 2:04 PM 364 T h e L aw o f H e a l th c a re A d mi n i stra ti o n COVID Connection As part of its effort to respond to the pandemic, the federal government released hundreds of billions of dollars in various forms of aid. Not surprisingly, some of this aid was diverted for improper purposes. Using the FCA (and other laws), the DOJ is pursuing those who misused COVID-19 relief funds. The splashiest prosecutions in 2020 and 2021 targeted malefactors who spent money from the Paycheck Protection Program to buy luxury goods rather than to support their employees. (See Katie Benner, Justice Dept. Announces Dozens of Fraud Charges in Small-Business Aid Program, N.Y. Times [Sept. 10, 2020], https://www. nytimes.com/2020/09/10/us/politics/ppp-fraudcoronavirus.html [https://perma.cc/ADU6-7RL3]). Healthcare providers, among the biggest recipients of COVID-19-related funds, should anticipate audits into their use of this money. In 2021, the DOJ established a COVID-19 Fraud Enforcement Task Force and charged several healthcare providers with fraudulently using COVID-19 relief funds, among other improper pandemic-related activities (such as forging vaccine cards). Any individual may be excluded who (1) has a direct or indirect ownership or control interest in a sanctioned entity and has acted in “deliberate ignorance” of the information; or (2) is an officer or a managing employee of a convicted or excluded entity, irrespective of whether the individual participated in the offense.28 Any excluded person who retains ownership or control or who continues to serve as an officer or a managing employee in such entity may be fined $20,000 for each day the relationship continues.29 Anti-Kickback Statute In some industries, it is acceptable to reward those who refer business to you. However, in the Federal health care programs, paying for referrals is a crime. —HHS Office of Inspector General30 The 1972 federal law that has come to be known as the Anti-Kickback Statute prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by a federal healthcare program (e.g., drugs, supplies, or healthcare services for Medicare or Medicaid patients). Remuneration includes anything of value, and it can take many forms besides cash, such as free or reduced rent, expensive hotel stays and meals, or excessive compensation for medical directorships or consultancies. The AKS applies to “any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government.”31 Thus, unlike the FCA, which applies to all federal payments, the AKS applies only to federal healthcare payments. The AKS was passed a few years after the establishment of Medicare and Medicaid, amid concerns about rising program costs and evidence of overutilization of healthcare services linked to improper financial incentives. It covers the payers of “kickbacks” (those who offer or pay remuneration) as well as the recipients of the kickbacks (those who solicit or receive the CH09.indd 364 02/01/23 2:04 PM C h a p te r 9 : Fra u d and A b use L aws and C or p orate C om p lianc e 365 remuneration). Note that the term kickback has an inherently negative connotation. Each party’s intent is a key element of their liability under the AKS. A key section of the AKS reads as follows: (1) Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— (A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or (B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program, shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than ten years, or both. (2). Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person— (A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or (B) to purchase, lease, order, or arrange