WyAMSS NPDB presentation_NickHealey

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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:
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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.
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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?
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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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