The Meaning of “Investigation” in a Peer Review Matter

The Meaning of “Investigation” in a Peer

Review Matter CAMSS Education Forum

May 7, 2014

Glenda M. Zarbock, Esq.Hanson Bridgett [email protected]

Lori C. Ferguson, Esq.Hanson Bridgett [email protected]

What We’ll Cover

Spotlight on the term “investigation”

Legal context

Range of possible meanings

Perspectives from MBC, NPDB, etc.

Recommended approach

2

Why does the meaning of “investigation” matter?

Reporting to

Medical Board of California

National Practitioner Data Bank

3

Potential Consequences of Failing to Report

Failure to submit Section 805 ReportUnintentional: up to $50,000 fine for CEO and Chief of StaffWillful: up to $100,000 fine for CEO and Chief of StaffLicensure action for “unprofessional conduct” against Chief of Staff

Failure to submit NPDB ReportLoss of protections under HCQIA (limits on damages against medical staff and medical staff members)

4

Legal context: where “investigation” appears in medical staff laws

California statutes – MBC reportingBusiness & Professions Code § 805(c) Business & Professions Code § 805.01(a)(2)

Federal law – NPDB reportingTitle 22, United States Code § 11133 - HCQIATitle 45, Code of Federal Regulations, § 60.12

5

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. 6

Business & Professions Code § 805(c)(1)Resigns or takes a leave of absence from membership, staff privileges, or employment. (2)Withdraws or abandons his or her application for staff privileges or membership. (3)Withdraws or abandons his or her request for renewal of staff privileges or membership.


7


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

8


Business & Professions Code § 805.01After “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

9

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: . . . 10

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, 11

Range of Possible Meanings

OPPE

FPPE

Departmental review

Interdisciplinary Peer Review Committee review

Formal investigation initiated by Medical Executive Committee

12

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

13

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. 14


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.

15


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 16


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:FPPEReappointment processInvestigation by department chair

Broadest view of scope of term “under investigation”

17

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


18


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

19


Secretary of U.S. Department of Health & Human Services (oversees NPDB)

Background:OR nurse filed a complaint against an MD alleging he threatened herNext day, the MEC temporarily suspended the MD’s privileges and appointed an Ad Hoc Committee to investigate6 days later, the AHC reported its finding to the MEC that the nurse reasonably perceived the MD’s actions as threatening.

20


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 evaluations6 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.

21


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.

22


Federal appellate court (1st Circuit)Court upheld Secretary’s interpretationConsistent 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)23


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

24

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?

25

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?

26

Recommended ApproachStage in Peer Review Process Likely to

constitute an “investigation”?

OPPE No

FPPE No*

Departmental review No*

Interdisciplinary Peer Review Committee review

No*

Medical Executive Committee formal investigation

Yes

Pendency of MEC corrective action recommendation that DOESN’T trigger a report (behavior plan)

No*

Reappointment process No, unless MD has notice of

impending denial

* Consult with counsel as specific circumstances may warrant report

27

Questions and Discussion

28

The Meaning of “Investigation” in a Peer Review Matter

Documents

Transcript of The Meaning of “Investigation” in a Peer Review Matter