Introduction to Healthcare
and Public Health in the US
Regulating Healthcare
Lecture c
This material (Comp1_Unit6c) was developed by Oregon Health and Science University, funded by the Department of Health
and Human Services, Office of the National Coordinator for Health Information Technology under Award Number
IU24OC000015.
Regulating Healthcare
Learning Objectives
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Describe the role of accreditation, regulatory bodies, and professional
associations in healthcare in the US. (Lecture a)
Describe the basic concepts of law in the United States: the legal system,
sources of law, classification of laws, the court system, and the trial
process. (Lecture b)
Describe legal aspects of medicine involving the Affordable Care Act,
professional standards in healthcare, medical malpractice, Tort reform, and
Medicare and Medicaid Fraud and Abuse (Lecture c)
Describe key components of the Health Insurance Portability and
Accountability Act (HIPAA) and current issues of privacy and patient safety
in the US (Lecture d)
Discuss the need for quality clinical documentation for the use of the health
record as a legal document, communication tool and a key to prove
compliance for healthcare organizations. (Lecture e)
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
2
Affordable Care Act (ACA)
• Major reworking of healthcare financing and
delivery
• Phased in from 2010 through 2018
• Court challenges pending
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
3
ACA Elements
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Better access to insurance
Health care quality improvement
Improved public health
Health care workforce training
Increased Medicaid and Medicare payments
Overall system change
http://www.healthcare.gov/law/introduction
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
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Titles of the ACA
I.
Quality, Affordable Healthcare for All
Americans
II. The Role of Public Programs
III. Improving the Quality and Efficiency of
Healthcare
IV. Prevention of Chronic Disease and Improving
Public Health
V. Healthcare Workforce
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
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Titles of the ACA (cont’d)
VI. Transparency and Program Integrity
VII. Improving Access to Innovative Medical
Therapies
VIII. Community Living Assistance Services and
Supports Act (CLASS Act)
IX. Revenue Provisions
X. Reauthorization of the Indian Healthcare
Improvement Act
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
6
ACA Timeline
(HealthCare.gov, nd.)
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
7
State Medical Practice Acts
• Define the practice of medicine
• Regulate how medicine will be practiced within
the state
• Establish medical board
– Set standards for licensing physicians
– Create process for disciplining physicians
– Investigate complaints about physicians
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
8
Standards of Care
6.5 Figure: Diagram showing a few of the many sources that can contribute to a medical standard of care. (OHSU, 2010)
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
9
Informed Consent
• Requirement that patient be fully informed and
give consent to treatment
• Process of communication between doctor and
patient
• Required legally and ethically
• Absence can result in liability
– Battery
– Negligence
Health IT Workforce Curriculum
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Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
10
Informed Consent Process
• Physician or other healthcare professional explains:
– The risks and benefits of the proposed
treatment
– Other options, including no treatment
• Patient has opportunity to ask questions and get
satisfactory, understandable answers
• If desired, patient takes time to discuss the situation
with others
• Patient has opportunity to communicate the decision
to physician or treatment team
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
11
Tort Law and Malpractice
6. 6 Chart: Diagram showing how Tort law is the part of private or civil law that deals with malpractice (OSHU, 2010).
Health IT Workforce Curriculum
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Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
12
Elements of Malpractice
• The defendant had a duty of reasonable care to
the injured party
• The defendant did not meet the minimum
standard of care or failed to obtain informed
consent
• Failure to meet the standard of care was the
proximate cause of the injury
• The injury resulted in damages
Health IT Workforce Curriculum
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Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
13
Statute of Limitations
• Time limit for filing a lawsuit
– Short as 6 months
– Long as 4 years
• Discovery rule
– Time limit starts when the malpractice is
discovered, rather than when it was allegedly
committed
Health IT Workforce Curriculum
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Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
14
“Good Samaritan” Laws
• Apply in emergencies
• Protect people who do not have an obligation to
help
• Rescuer must use common sense
• Rescuer must not act beyond expertise and
capabilities
Health IT Workforce Curriculum
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Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
15
Tort Law Reform
• Pre-trial screening panels
– Panel reviews case at an early stage and
gives an opinion about merit
• Certificate of merit
– Patient must present certificate from qualified
medical expert in order to file a lawsuit
• Attorney fee limits
– Limits on percentage and/or total amount
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
16
Tort Law Reform (cont’d)
• Periodic payment
– Allows insurers to pay damage awards in
smaller payments over time
• Joint-and-several liability reform
– When there is more than one defendant, limits
the amount that can be recovered from each
• Caps on non-economic damages
– Limit payments for pain and suffering
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
17
Newer
Tort Law Reforms
• Pre-determined non-economic damages
• Administrative compensation systems (“health
courts”)
– Neutral expert witnesses
– Knowledgeable hearing officers
• Disclosure-and-offer programs
– Mistakes are admitted
– Compensation is offered
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
18
Innovative
Tort Reform (cont’d)
• “Safe harbor” for adherence to practice
guidelines based on the latest medical research
• More evidence needed to assess newer reform
proposals
• Affordable Care Act authorizes $50 million in
grants for projects that evaluate the
effectiveness of newer tort reform proposals
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
19
Fraud, Waste, Abuse
• Office of Inspector General (OIG) protects
integrity of Medicare, Medicaid, other
government programs
• Fraud: intentional misrepresentation or
concealment of relevant facts
• Waste: unnecessary costs as a result of poor
management, practices, or controls
• Abuse: excessively or improperly using
government resources
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
20
Federal Fraud and Abuse Laws
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False Claims Act
Anti-Kickback Statute
Stark Law
Exclusion Statute
Civil Monetary Penalties Law
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
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Regulating Healthcare
Summary – Lecture c
• The laws that apply to healthcare are numerous and
complicated
• The system is changing rapidly as a result of the
Affordable Care Act and tort reform proposals
• Still, healthcare providers must:
– Obtain informed consent from their patients
– Act consistently with reasonable standards of
care
– Avoid Medicare/Medicaid fraud, waste, and
abuse
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
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Regulating Healthcare
References – Lecture c
References
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Agency for Healthcare Research and Quality. Patient safety primers: never events. http://www.psnet.ahrq.gov/primer.aspx?primerID=3.
Accessed April 10, 2011.
American Cancer Society. Informed consent. Updated August 10, 2010.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003014-pdf.pdf. Accessed April 11, 2011.
American College of Emergency Physicians Foundation. Emergency manual: legal issues—Good Samaritan laws.
http://www.emergencycareforyou.org/EmergencyManual/Default.aspx?id=200. Accessed April 11, 2011.
American Medical Association. Physician resources: patient physician relationship topics—informed consent. http://www.amaassn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.page. Accessed April 11, 2011.
Federation of State Medical Boards. A guide to the essentials of a modern medical practice act. 10th ed. 2003.
http://www.fsmb.org/pdf/2003_grpol_Modern_Medical_Practice_Act.pdf. Accessed April 10, 2011.
Federation of State Medical Boards. State of the states: physician regulation 2009. http://www.fsmb.org/pdf/2009_state_of_states.pdf.
Accessed April 11, 2011.
Kinney ED. The origins and promise of medical standards of care. Virtual Mentor: American Medical Association Journal of Ethics.
2004;6(12). http://virtualmentor.ama-assn.org/2004/12/mhst1-0412.html. Accessed April 11, 2011.
Mello MM, Kachalia A. Evaluation of options for medical malpractice system reform: a report to the Medicare Payment Advisory
Commission (MedPAC). January 29, 2010. http://www.medpac.gov/documents/Apr10_MedicalMalpractice_CONTRACTOR.pdf.
Accessed April 11, 2011.
Nolo. Medical malpractice basics. http://www.nolo.com/legal-encyclopedia/medical-malpractice-basics-29855.html. Accessed April 11,
2011.
Office of Inspector General. A roadmap for new physicians: avoiding Medicare and Medicaid fraud and abuse.
http://oig.hhs.gov/fraud/PhysicianEducation. Accessed April 11, 2011.
Ohio State Bar Association. Law you can use: Ohio’s “Good Samaritan” law protects volunteers. October 22, 2006.
http://www.ohiobar.org/Pages/LawYouCanUseDetail.aspx?itemID=477. Accessed April 11, 2011.
US Department of Health and Human Services. New tools to fight fraud, strengthen Medicare and protect taxpayer dollars. January 24,
2011. http://www.healthcare.gov/news/factsheets/new_tools_to_fight_fraud.html. Accessed April 11, 2011.
US Department of Health and Human Services. Understanding the Affordable Care Act.
http://www.healthcare.gov/law/introduction/index.html. Accessed April 10, 2011.
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
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Regulating Healthcare
References – Lecture c
Charts, Tables, Figures
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6.5 Figure: Diagram showing a few of the many sources that can contribute to a medical standard of care. OHSU (2010).
6. 6 Chart: Diagram showing how Tort law is the part of private or civil law that deals with malpractice. OHSU (2010).
Images
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Slide 7: Screenshot of the Affordable Care Act (ACA) Timeline. HealthCare.gov (nd.).
http://www.healthcare.gov/law/timeline/index.html. Retrieved Nov. 2011 from the HealthCare.gov website, http://www.healthcare.gov.
Health IT Workforce Curriculum
Version 3.0/Spring 2012
Introduction to Healthcare and Public Health in the US
Regulating Healthcare
Lecture c
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