The Meaning of “Investigation” in a Peer Review Matter

1. The Meaning of “Investigation” in a Peer Review Matter  CAMSS Education Forum May 7, 2014 Glenda M. Zarbock, Esq. Hanson Bridgett LLP 415-995-5088 gzarbock@hansonbridgett.com Lori C. Ferguson, Esq. Hanson Bridgett LLP 916-551-2813 lferguson@hansonbridgett.com

2. What We’ll Cover • Spotlight on the term “investigation” • Legal context • Range of possible meanings • Perspectives from MBC, NPDB, etc. • Recommended approach

3. Why does the meaning of “investigation” matter? • Reporting to • Medical Board of California • National Practitioner Data Bank

4. Potential Consequences of Failing to Report Failure to submit Section 805 Report Unintentional: up to $50,000 fine for CEO and Chief of Staff Willful: up to $100,000 fine for CEO and Chief of Staff Licensure action for “unprofessional conduct” against Chief of Staff Failure to submit NPDB Report Loss of protections under HCQIA (limits on damages against medical staff and medical staff members)

5. Legal context: where “investigation” appears in medical staff laws • California statutes – MBC reporting • Business & Professions Code § 805(c) • Business & Professions Code § 805.01(a)(2) • Federal law – NPDB reporting • Title 22, United States Code § 11133 - HCQIA • Title 45, Code of Federal Regulations, § 60.12

6. Medical Board of California Reporting Business & Professions Code § 805(c) If a licentiate takes any action listed in paragraph (1), (2), or (3) after receiving notice of a pending investigation initiated for a medical disciplinary cause or reason . . ., the chief of staff of a medical or professional staff or . . . the chief executive officer or administrator of any licensed health care facility . . . where the licentiate is employed or has staff privileges or membership . . ., shall file an 805 report with the relevant agency within 15 days after the licentiate takes the action.

7. Medical Board of California Reporting Business & Professions Code § 805(c) Resigns or takes a leave of absence from membership, staff privileges, or employment. Withdraws or abandons his or her application for staff privileges or membership. Withdraws or abandons his or her request for renewal of staff privileges or membership.

8. Medical Board of California Reporting Business & Professions Code § 805.01 • Requires submission of report within 15 days after peer review body recommends restrictive action • Denial of application for privileges or membership • Termination or revocation of membership, staff privileges, or employment • Restrictions are imposed, or voluntarily accepted, on staff privileges, membership, or employment for 30 days or more

9. Medical Board of California Reporting Business & Professions Code § 805.01 • After “formal investigation” • Based on determination that any of these acts may have occurred: • Serious deviations from standard of care involving death or serious bodily injury to patients • Misuse of controlled substances or alcoholic beverages • Excessive prescribing of controlled substances • Sexual misconduct with patients

10. NPDB Reporting Title 45, Code of Federal Regulations § 60.12 Reporting adverse actions taken against clinical privileges. (a) Reporting by health care entities to the NPDB. (1) Actions that must be reported and to whom the report must be made. Each health care entity must report to the NPDB and provide a copy of the report to the Board of Medical Examiners in the state in which the health care entity is located the following actions: . . .

11. NPDB Reporting Title 45, Code of Federal Regulations § 60.12 (ii) Acceptance of the surrender of clinical privileges or any restriction of such privileges by a physician or dentist: (A) While the physician or dentist is under investigation by the health care entity relating to possible incompetence or improper professional conduct, or (B) In return for not conducting such an investigation or proceeding,

12. Range of Possible Meanings OPPE FPPE Departmental review Interdisciplinary Peer Review Committee review Formal investigation initiated by Medical Executive Committee

13. Range of Possible Meanings • After formal investigation and during course of any MEC corrective action recommendation that doesn’t trigger a report • Behavior plan or performance improvement plan • Physician required to attend PACE • Reappointment process

14. The meaning of “investigation” according to… California law: "Formal investigation" means an investigation performed by a peer review body. (Bus. & Prof. Code § 805.01(a)(2)) "Peer review body"includes (i) A medical or professional staff of any [general acute care hospital].(§ 805(a)(1)(B)) • This language does not limit investigations only to the MEC or ad hoc committees appointed by the MEC. However, MEC is charged with acting on behalf of the medical staff.

15. The meaning of “investigation” according to… Merriam Webster’s Collegiate Dictionary (11th Ed., 2003) Investigate: • “to observe or study by close examination and systematic inquiry.” • “to conduct an official inquiry” • Under this definition, investigation appears to include fact-gathering process.

16. The meaning of “investigation” according to… Attorney representing Medical Board of California (Jane Zack Simon, Esq., 2013 CAMSS Annual Education Forum) “From MBC perspective, assumption is that if there is a problem with a physician at your facility and you need to address that problem, it is most likely reportable.” “Peer review body is defined to include all review by committees or medical/professional staff of the quality of professional care provided by medical staff.” • View is so broad that even FPPE is arguably included

17. The meaning of “investigation” according to… Attorney for National Practitioner Data Bank (Cynthia Grubbs, RN, JD, Acting Deputy Director, US Department of Health & Human Services, Bureau of Health Professions, Division of Practitioner Data Banks on 2/10/11 at American Health Lawyers Association Conference) Reports are required for resignations during: • FPPE • Reappointment process • Investigation by department chair • Broadest view of scope of term “under investigation”

18. The meaning of “investigation” according to… Proposed Revised National Practitioner Data Bank Guidebook: Guidelines For Investigations • Not controlled by definitions in bylaws or policies and procedures • Must be focused on the practitioner in question • Must concern the professional competence and/or professional conduct of the practitioner in question • Generally should be the precursor to a professional review action • Considered ongoing until decisionmaking authority takes final action or formally closes the investigation. • Not routine review of cases • Not routine review of particular practitioner

19. The meaning of “investigation” according to… Proposed Revised National Practitioner Data Bank Guidebook Reports are required for resignations during: FPPE triggered by an event involving professional competence and centered on the physician’s performance outside the scope of a routine review

20. The meaning of “investigation” according to… Secretary of U.S. Department of Health & Human Services (oversees NPDB) Background: OR nurse filed a complaint against an MD alleging he threatened her Next day, the MEC temporarily suspended the MD’s privileges and appointed an Ad Hoc Committee to investigate 6 days later, the AHC reported its finding to the MEC that the nurse reasonably perceived the MD’s actions as threatening.

21. The meaning of “investigation” according to… Secretary of U.S. Department of Health & Human Services (oversees NPDB) Background (cont’d): 3 days later, the MEC met to discuss the AHC report. It proposed that the MD return to work on condition he agree to proctoring and psychological evaluations 6 days later, the MD rejected the proposal and voluntarily relinquished clinical privileges, and hospital accepted his resignation. Hospital reported resignation to NPDB under view that MD resigned while “under an investigation.” Physician disputed hospital’s report, contending that the hospital’s investigation had ended when AHC presented its report to the MEC.

22. The meaning of “investigation” according to… Secretary of U.S. Department of Health & Human Services Secretary denied the MD’s challenge Conclusion: hospital was required to file the report because the MD resigned while he was still “under an investigation.” It found “[a]n investigation is . . . considered ongoing until the health care entity’s decision making authority takes a final action or formally closes the investigation.” Physician appealed all the way to the federal court of appeals.

23. The meaning of “investigation” according to… Federal appellate court (1st Circuit) Court upheld Secretary’s interpretation Consistent with purpose of HCQIA - to improve quality of health care by encouraging hospitals to identify and discipline practitioners who engage in unprofessional behavior. Supported by legislative history of HCQIA. Congress was concerned that “hospitals too often accept ‘voluntary’ resignations of incompetent doctors in return for the hospital’s silence about the reasons for the resignations.” Rejected MD’s interpretation because it creates a gap between end of fact-gathering and taking final disciplinary action. Allowing MD to resign during gap would undermine goal of reporting. Note: medical staff bylaws cannot frustrate the Secretary’s definition. (Doe v. Leavitt (1st Cir. 2009) 552 F.3d 75)

24. The meaning of “investigation” according to… Take-away from the Doe case: Investigation includes the fact-finding process by ad hoc committees appointed by the MEC An investigation is considered ongoing until the health care entity takes a final action or formally closes the investigation

25. Questions that remain unresolved • If the MEC has not initiated an investigation, does an investigation exist for reporting purposes? • What about FPPE or proctoring initiated to address problem? • What about an inquiry by Department members that results in recommendation for corrective action to MEC?

26. Questions that remain unresolved • Are resignations reportable to the MBC and NPDB in the same circumstances? • NPDB reporting: resignation while “under an investigation” • Section 805 reporting: resignation “after receiving notice of a pending investigation” • Since reporting statutes are not identical, should different definitions apply?

27. Recommended Approach

28. Questions and Discussion