I'm Telling! NPDB and Wyoming BOM Reporting Obligations WyAMSS November 2015 Nick Healey Dray, Dyekman, Reed & Healey, PC To tell or not to tell? That is the question. • MSP's are often on the front lines of the question: Is this action against Dr. X reportable? • Question that comes with responsibility • Reporting a provider to the NPDB or Wyoming Board of Medicine comes with consequences (maybe not what they once were?) • MSP's need to understand hospital's obligations to report to both NPDB and Wyoming BOM. • MSP is often the NPDB-registered user. Basic idea behind NPDB reporting Early-mid 1980's: • Hospitals and medical staffs were afraid to conduct or share the results of peer review for fear of litigation. • Physicians that were subject to peer review would sue the hospital and medical staff (individual physicians) on many bases: • • • • Conspiracy to restrain trade; Violation of physician's due process rights; Slander/libel Breach of contract Health Care Quality Improvement Act of 1986 • Patrick v. Burget: US Supreme Court reinstated $2,000,000 (1980's $!) jury verdict against medical staff for "bad faith" peer review. • HCQIA commonly seen as Congress' response to Patrick, intended to encourage peer review. • Timing is a bit off – HCQIA passed in 1986, Supreme Court decided Patrick in 1988. HCQIA • Created the NPDB - repository of peer review outcomes. • Congress saw 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". • Provided hospitals and medical staffs with immunity from being sued if peer review process met HCQIA requirements. • Congress: "...overriding national need to provide incentive and protection for physicians engaging in effective professional peer review". • Wyoming law (Wyo. Stat. 35-2-609(d)) provides similar protection from state law claims (and confidentiality for peer review materials). Healthcare Integrity and Protection Database (HIPDB) • NPDB was originally only for physician reporting. • Recall Congress's comment regarding "incompetent physicians". • Congress created HIPDB in 1996 (in HIPAA) for reporting criminal and civil health care judgements, and licensing actions, against health care providers and suppliers. • 2012: ACA merged the HIPDB and NPDB. • Still different reporting requirements, depending on whether they were previously reported to HIPDB or NPDB, but everything now reported to NPDB. Sources of NPDB reporting guidance • Laws and commentary • Health Care Quality Improvement Act (42 U.S.C. Section 11101) • A surpisingly easy read! • NPDB regulations (45 C.F.R. Part 60) • National Practitioner Data Bank Guidebook (2001 & 2015) • Previous version is no longer available, but is helpful if you can find it. • 2015 revisions may be confusing. • HRSA (Health Resources & Services Administration) NPDB reporting webpage (http://www.npdb.hrsa.gov/hcorg/aboutReporting.jsp) • NAMSS • American Health Lawyers Association (Health Law Wiki: HCQIA) • NPDB reporting obligations are technical and definition-driven. • When in doubt, go back to the HCQIA definitions. Basic NPDB reporting obligations • Hospitals must report 2 categories of actions: • Professional review actions (peer review) that adversely affects physician's clinical privileges for more than 30 days. • Surrender of clinical privileges while under investigation or in return for not conducting investigation (for professional incompetence or conduct) Malpractice settlements or judgments • Hospital's insurer's obligation for hospital-employed physician. • But interests of insurer, hospital and physician may split if insurer makes payment on behalf of physician. • Not hospital's money, • Hospital's insurer caps its exposure BUT • Physician (not hospital) gets reported to the NPDB. • Questions may arise for the MSP. Professional review action (42 USC 11151(10)) • Action/recommendation (or decision not to take/make) of • A "professional review body" • Taken or made in the conduct of "professional review activity" • 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...of the physician. Professional review body (42 USC 11151(11)) • A health care entity (hospital, group practice or professional society that has a formal peer review process); • the governing body or • any committee of a health care entity which conducts professional review activity. • Includes any committee of the medical staff…when assisting governing body in a professional review activity. • Bylaws should clearly outline committee roles in peer review process to avoid confusion about reportability. Professional review activity (42 USC 11151(9)) An activity of a health care entity with respect to an individual physician— • to determine whether the physician may have clinical privileges with respect to, or membership in, the entity, • to determine the scope or conditions of such privileges or membership, or • to change or modify such privileges or membership. • Question: does the action adversely affect clinical privileges or membership? If not, then not reportable. • This is where adding "conditions" to privileges/membership (counseling) become sticky. Action or recommendation • Action or recommendation is relatvely simple. • Recommendation wrinkle – • But based on professional competence or professional conduct?. • Minimum membership/ privileges minimum requirements: No, unless those requirements are themselves professional conduct or competence requirements. • WHAT IF under Bylaws, minimum requirements require sufficient evidence of clinical competence? • Physician fails to demonstrate, denied privileges. Reportable? • What evidence was required to demonstrate? Peer references? 5 successful cases at the hospital? Recommendations reportable? • "Proffessional review action" includes action or recommendation that may affect clinical privileges. • Recommendation not defined (HCQIA, NPDB regs or Guidebook Glossary) • Under many Bylaws, MEC recommends action to governing body, which makes final decision. Reportable? Recommendations reportable? • Probably not (though I've heard it argued otherwise). • Basic reporting requirement is (1) "professionl review action" that (2) lasts more than 30 days. • Usually doesn't affect clinical privileges or membership until governing body adopts, so even though a recommendation may be a "professional review action", +30 days requirement isn't met. • This is where HCQIA's dual purposes (immunity and reporting) may come into play and being needlessly complicating. Professional conduct or competence – Medical records? • Physicians argue that medical record-keeping has little to do with practicing medicine. • NPDB Guidebook (2001): Maybe reportable. • NPDB Guidebook (2015): Maybe reportable BUT if the result of automatic suspension or administrative action, DON'T report. • NPDB also takes contrary position in same Guidebook. • However, may still be reportable to Wyoming BOM (Section 402(a)(xxvii)(G)) • BUT NPDB Guidebook (2015), Q&A 31 (p. E-49) – "cut and paste" Professional conduct or competence - Code of Conduct? • "Professional conduct…which adversely affects or could adversely affect the health or welfare of patients". • Many courts have held that serious, typical Code of Conduct issues (ie. the ability to get along with others) are critical to patient safety. • See NPDB Guidebook (2015), p. E-45 (Q&A 17) – outbursts of anger could reasonably be concluded to pose an imminent threat to patient safety. • What's the motivation for your Code of Conduct? Professional conduct or competence – Code of Conduct? • NPDB regulations exclude from "professional review action" even though they are "professional conduct": • Fees, advertising or acts intended to solicit business; • Association with a specific group practice or professional society; • Participation in group health plans, prepaid health plans etc. Investigations • Another term that causes lots of confusion – not defined by HCQIA, NPDB regs or Guidebook. • Investigation is not reportable – only resignation of privileges/membership during or to avoid investigation. (NPDB Guidebook (2015), p. E.34. • NPDB interprets "investigation" expansively. • End of the investigation is better described than beginning. Investigations – begin and end? • NPDB Guidebook – Investigation begins when the medical staff bylaws say it begins (unless we don't think it does). • Runs from beginning of health care entity's "inquiry" (NPDB Guidebook (2015), p. E-34) • Not limited to health care entity's "gathering of facts". • Does this mean it begins with the complaint? • Routine fact-gathering is not "investigation" – so if the process of investigating every complaint made is automatic, probably not the start of "investigation". • NPDB Guidebook (2015) – Formal, targeted process focused on the practitioner in question. • OPPE is not "investigation" • FPPE is not "investigation" if it is automatic. Investigations – begin and end? • Ends when the body in charge of the investigation formally closes the investigation or takes action. • Medical staffs used to conduct the investigation, then give the physician a chance to resign before making a recommendation. • No longer permitted to do that. • Doe v. Leavitt (1st Cir. 2009) – concerned mostly with when investigation ends, but also included "accepting the complaint" as part of "professional review activity". Investigations • Any resignation or nonrenewal, for any reason, during an investigation is reportable. • Physician doesn't need to know the investigation has started (NPDB Guidebook (2015), p. E-33-34) • Resignation to avoid investigation • Is the physician's intent in resigning relevant? Arguably, yes. • Can the physician resign before the committee decides WHETHER to investigate? Arguably, yes, depending on what's considered included in the "investigation". Wyoming Board of Medicine Reporting • Reporting obligation is more broad than NPDB reporting. • Hospital required to report to BOM: ...Any action it takes against a licensee on the grounds that the licensee is impaired, or has engaged in conduct constituting a ground for disciplinary action in W.S. 3326-402; • Section 402 of the Wyoming Medical Practice Act describes all grounds for discipline, including broadly defining "unprofessional conduct". Employees • HCQIA does not require hospitals to report employment actions taken against employed physicians to the NPDB. • Employment action isn't the result of "professional review activity" (NPDB Guidebook (2015), p. E-40), even if result of employment termination is termination of clinical privileges. • Employment actions and medical staff peer review proceedings should be treated seperately. Employees • However, employment actions taken by a hospital against an employed physician may be reportable to Wyoming BOM if taken on a basis under Medical Practice Act s. 402. • If "for cause" termination, action was probably taken on the basis of one of the things in s. 402. • If the physician is employed by a wholly owned subsidiary of the hospital, not considered taken by a "health care entity" unless the subsidiary also has a peer review process (similar to NPDB) • Wyoming BOM is aware of this loophole, and does not like it. Proctors, counseling obligations • Two of the most difficult topics, but common result of peer review proceedings. • Why? • Are they reportable? • Question: Do proctor or counseling requirements "adversely affect" the practitioner's clinical privileges? Proctors • Reportability depends on the level of control the proctor has over the physician's ability to exercise clinical privileges (NPDB Guidebook (2015), p. E-37) • Does the proctor have to "agree" with the physician's choice to exercise the privilege (perform the procedure)? • If yes, then probably "adversely affects" the physician's clinical privileges and is reportable (assuming all other criteria met). (NPDB Guidebook (2015), p. E-47) • Proctor just contemporaneously observes, doesn't grant approval. • Maybe reportable if the proctor must be present for the practitioner to exercise the privilege (NPDB Guidebook (2015), p. E-37) • Retrospective review, not reportable. Counseling (or mentoring) • NPDB Guidebook (both versions) are unclear. • 2001: Q&A 29 (p. E-35) – if an "impaired practitioner" is involuntarily required to enter a rehabilitation program, the professional review action is reportable (assuming all other requirements are met). (2015, Q&A 33, p. E-50) • "Impaired practitioner" is not defined. • 2015 Guidebook usually (but not always) discusses "impaired" in terms of drugs/alcohol. • But Wyoming Medical Practice Act includes "mental illness" in definition of "impaired practitioner". Counseling (or mentoring) • Trend of personality traits now being described as "disorders" in DSM-V. • • • • Narcissistic personality disorder Intermittent explosive disorder Dysthymia (chronic mild depression) – Eeyore Dunning v. War Memorial Hospital (6th Cir. 2013) • Are all these physicians now "impaired physicians"? If yes, then ordering counseling (ie. Rehab), is that reportable? • If the counseling requirement is a condition of maintaining privileges, is that significantly different than a contemporaneous proctor? Probation • Similar to counseling – does probation "adversely affect" the physician's "clinical privileges"? • NPDB Guidebook (2001) seemed to say, "yes" (p. E-18), but it depends on the scope of probation, and who does it. • NPDB Guidebook (2015), p. E-83-84: Peer review organization's recommendation that physician be placed on probation and receive a proctor, must be reported (by the PRO), whether or not the hospital takes action. Temporary clinical privileges • For reporting purposes, NPDB makes no distiction between "temporary" and regular clinical privileges. (NPDB Guidebook (2015), p. E-35) • Many Medical Staff Bylaws allow the CEO and/or Chief of Staff to terminate temporary clinical privileges without going through the hearing process. • More an issue for immunity, but worth noting that termination may be reportable. • Expiration is not. Summary/Precautionary suspension • If it lasts more than 30 days, it's reportable even if peer review process is not complete. (NPDB Guidebook (2015), p. E-35) • Also see Q&A's on E-45 & E.52 • Hospital can subsequently submit a revision to the report, if it doesn't ultimately take action. Questions? • • • • • • • Nick Healey Dray, Dyekman, Reed & Healey, P.C. 204 E. 22nd St. Cheyenne, Wyoming 82001 307.634.8891 Nick.healey@draylaw.com Connect on LinkedIn!