I'm Telling! NPDB and Wyoming BOM

Reporting ObligationsWyAMSS 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. 33- 26-402;• 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

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