[Federal Register Volume 67, Number 78 (Tuesday, April 23, 2002)]
[Rules and Regulations]
[Pages 19678-19682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9875]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 46

RIN 2900-AJ76


Policy Regarding Participation in National Practitioner Data Bank

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends our regulations regarding reporting of 
health care practitioners to the National Practitioner Data Bank 
(NPDB). We are amending the provisions concerning malpractice payment 
reporting by delegating the underlying decision-making to malpractice 
payment review panels; by delegating the actual reporting authority to 
facility directors and the Chief Patient Care Services Officer; by 
establishing new procedures for obtaining information from affected 
health care practitioners and others; and by establishing medical 
reporting criteria for licensed trainees and supervisory health care 
professionals. We also are amending the regulations concerning 
malpractice payment reporting and clinical privileges actions reporting 
by stating that reporting may not be the subject of negotiated 
settlements and that independent contractors acting on behalf of the 
Department of Veterans Affairs (VA) are subject to the NPDB reporting 
provisions. These amendments are necessary to make the reporting 
process more efficient and fair and to ensure that reporting is 
accomplished in

[[Page 19679]]

accordance with the statutory framework.

DATES: Effective May 23, 2002.

FOR FURTHER INFORMATION CONTACT: Kathryn W. Enchelmayer, Director, 
Credentialing and Privileging, Office of Quality and Performance (10Q), 
VHA, Department of Veterans Affairs, 810 Vermont Avenue, NW, 
Washington, DC 20420; (202)-273-7464 (This is not a toll-free number).

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on June 5, 2001, at 66 FR 30141, we proposed to amend our 
regulations set forth at 38 CFR Part 46 concerning the reporting of 
physicians, dentists, and other health care practitioners to the NPDB. 
These regulations concern malpractice payment reporting and clinical 
privileges actions reporting.
    Interested persons were given 60 days to submit comments. The 
comment period ended August 6, 2001. We received comments from two 
commenters. One commenter, a representative of a medical association, 
supported the proposed rule without change. The other commenter, a 
representative of a medical school, suggested that certain changes 
should be made. These comments are discussed below. Based on the 
rationale set forth in the proposed rule and this document, we are 
adopting the provisions of the proposed rule as a final rule with 
certain changes discussed below.
    The medical school representative objected to the regulations based 
on the incorrect assumption that VA would report a health care 
practitioner if the claim constituted a ``nuisance claim'' or ``if the 
status of a given practitioner as a beneficiary [of a malpractice 
payment] cannot be demonstrated.'' No changes are made based on this 
comment. The regulations at Sec. 46.3 provide for reporting only after 
a determination by at least a majority of a review panel that payment 
was related to substandard care, professional incompetence, or 
professional misconduct on the part of the actual health care 
practitioner to be reported.
    The medical school representative asserted that the review panel 
should consist only of members having the same area of expertise as the 
practitioner in question ``or, in the alternative, only panel members 
having such expertise be allowed to vote.'' No changes are made based 
on these comments. Based on a review of the more than 1,100 paid claims 
that have been considered by a review panel since 1997, we have 
concluded that the overwhelming majority of claims do not include 
issues requiring such specialized expertise. Further, the regulations 
at Sec. 46.3(b) allow for the review panel to obtain and consider 
opinions of experts as needed.
    The medical school representative asserted that VA should provide 
legal representation to a health care practitioner during the 
preliminary tort case and during the subsequent process for determining 
whether such individual should be reported to the NPDB. No changes are 
made based on these comments. In matters of dispute, VA must represent 
VA's interest. VA counsel would create a conflict of interest if they 
were also to represent a health care practitioner regarding the 
reporting issues. However, a health care practitioner may obtain 
personal counsel regarding any submissions to the review panel. 
Moreover, as stated in Sec. 46.3(b), any prior statements provided by 
the health care practitioner during the tort consideration process are 
not included in the information provided to the review panel for 
consideration.
    The medical school representative asserted that the review panel 
should be required to obtain all necessary information before making a 
determination on a case. No changes are made based on this comment. 
Under the provisions of Sec. 46.3(b) the review panel is required to be 
provided the documents pertinent to the care that led to the claim, 
including the medical records of the patient whose care led to the 
claim, any report of an administrative investigation board appointed to 
investigate the care, the opinion of any consultant which the panel may 
request in its discretion and, to the extent practicable, written 
statements of the individual(s) involved in the care which led to the 
claim. We believe this is adequate to ensure that a review panel has 
all of the necessary information for making reporting determinations.
    The medical school representative asserted that the review panel 
should be required to articulate in its conclusions the reasons for 
reporting a health care practitioner. We agree and have amended 
Sec. 46.3 accordingly.
    The medical school representative asserted that the reporting 
standards should be based on the local standard of care. No changes are 
made based on this comment. VA is a nation-wide health care system that 
is designed to adhere to one standard of care at all health care 
facilities.
    The proposed rule at Sec. 46.3(b) provides that a health care 
practitioner whose actions are under review will receive a written 
notice from the VA facility director indicating that VA is considering 
whether to report the practitioner to the National Practitioner Data 
Bank because of a specified malpractice payment made, and providing the 
practitioner the opportunity, within 30 days of receipt, to submit a 
written statement concerning the care that led to the claim. Based on 
our further review of this matter, we believe it is necessary to 
lengthen the time period allowed for the health care practitioner to 
respond from 30 days to 60 days to ensure that the practitioner has 
sufficient time to prepare a response.

Paperwork Reduction Act

    This document contains provisions constituting collections of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3520) 
approved by the Office of Management and Budget under control number 
2900-0621.

Executive Order 12866

    This document has been reviewed by the Office of Management and 
Budget under Executive Order 12866.

Regulatory Flexibility Act

    The Secretary hereby certifies that the adoption of this proposed 
rule would not have a significant economic impact on a substantial 
number of small entities as they are defined in the Regulatory 
Flexibility Act, 5 U.S.C. 601-612. This rulemaking proceeding affects 
only individuals. Accordingly, pursuant to 5 U.S.C. 605(b), this 
proposed rule is exempt from the initial and final regulatory 
flexibility analyses requirements of sections 603 and 604.

    The Catalog of Federal Domestic Assistance numbers for the 
programs affected by this document are 64.005, 64.007, 64.008, 
64,009, 64.010, 64.011, 64.012, 64.013, 64.014, 64.015, 64.016, 
64.018, 64.019, 64.022, 64.024, and 64.025.

List of Subjects in 38 CFR Part 46

    Health professions.

    Approved: February 19, 2002.
Anthony J. Principi,
Secretary of Veterans Affairs.

    For the reasons set forth in the preamble, 38 CFR part 46 is 
revised to read as follows:

PART 46--POLICY REGARDING PARTICIPATION IN NATIONAL PRACTITIONER 
DATA BANK

Subpart A--General Provisions
Sec.
46.1   Definitions.
46.2   Purpose.
Subpart B--National Practitioner Data Bank Reporting
46.3   Malpractice payment reporting.

[[Page 19680]]

46.4   Clinical privileges actions reporting.
Subpart C--National Practitioner Data Bank Inquiries
46.5   National Practitioner Data Bank inquiries.
Subpart D--Miscellaneous
46.6   Medical quality assurance records confidentiality.
46.7   Prohibitions concerning negotiations.
46.8   Independent contractors.

    Authority: 38 U.S.C. 501; 42 U.S.C. 11101-11152.

Subpart A--General Provisions


Sec. 46.1  Definitions.

    (a) Act means The Health Care Quality Improvement Act of 1986, as 
amended (42 U.S.C. 11101-11152).
    (b) Claim of medical malpractice means a written claim or demand 
for payment based on an act or omission of a physician, dentist, or 
other health care practitioner in furnishing (or failing to furnish) 
health care services, and includes the filing of a complaint or 
administrative tort claim under the Federal Tort Claims Act, 28 U.S.C. 
1346(b), 2671-2680.
    (c) Clinical privileges means privileges granted by a health care 
entity to individuals to furnish health care.
    (d) Dentist means a doctor of dental surgery or dental medicine 
legally authorized to practice dental surgery or dentistry by a State 
(or any individual who holds himself or herself out to be so 
authorized).
    (e) Director means the duly appointed director of a Department of 
Veterans Affairs health care facility or any individual with 
authorization to act for that person in the director's absence.
    (f) Gross negligence is materially worse than substandard care, and 
consists of an entire absence of care, or an absence of even slight 
care or diligence; it implies a thoughtless disregard of consequences 
or indifference to the rights of others.
    (g) Health care facility means a hospital, domiciliary, outpatient 
clinic, or any other entity that provides health care services.
    (h) Other health care practitioner means an individual other than a 
physician or dentist who is licensed or otherwise authorized by a State 
to provide health care services.
    (i) Physician means a doctor of medicine or osteopathy authorized 
to practice medicine or surgery by a State (or any individual who holds 
himself or herself out to be so authorized).
    (j) Professional review action means a recommendation by a 
professional review panel (with at least a majority vote) to affect 
adversely the clinical privileges of a physician or dentist taken as a 
result of a professional review activity based on the competence or 
professional conduct of an individual physician or dentist in cases in 
which such conduct affects or could affect adversely the health or 
welfare of a patient, or patients. An action is not considered to be 
based on the competence or professional conduct of a physician or 
dentist, if the action is primarily based on:
    (1) A physician's or dentist's association with, administrative 
supervision of, delegation of authority to, support for, or training 
of, a member or members of a particular class of health care 
practitioner or professional, or
    (2) Any other matter that does not relate to the competence or 
professional conduct of a physician or dentist in his/her practice at a 
Department of Veterans Affairs health care facility.
    (k) Professional review activity means an activity with respect to 
an individual physician or dentist to establish a recommendation 
regarding:
    (1) Whether the physician or dentist may have clinical privileges 
with respect to the medical staff of the facility;
    (2) The scope or conditions of such privileges or appointment; or
    (3) Change or modification of such privileges.
    (l) State means the fifty States, the District of Columbia, Puerto 
Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana 
Islands, and any other territories or possessions of the United States.
    (m) State Licensing Board means, with respect to a physician, 
dentist, or other health care practitioner in a State, the agency of 
the State, which is primarily responsible for the licensing of the 
physician, dentist, or practitioner to furnish health care services.
    (n) Willful professional misconduct means worse than mere 
substandard care, and contemplates the intentional doing of something 
with knowledge that it is likely to result in serious injuries or in 
reckless disregard of its probable consequences.


Sec. 46.2  Purpose.

    The National Practitioner Data Bank, authorized by the Act and 
administered by the Department of Health and Human Services, was 
established for the purpose of collecting and releasing certain 
information concerning physicians, dentists, and other health care 
practitioners. The Act mandates that the Department of Health and Human 
Services seek to enter into a Memorandum of Understanding with the 
Department of Veterans Affairs (VA) for the purpose of having VA 
participate in the National Practitioner Data Bank. Such a Memorandum 
of Understanding has been established. Pursuant to the Memorandum of 
Understanding, VA will obtain information from the Data Bank concerning 
physicians, dentists, and other health care practitioners who provide 
or seek to provide health care services at VA facilities and also 
report information regarding malpractice payments and adverse clinical 
privileges actions to the Data Bank. This part essentially restates or 
interprets provisions of that Memorandum of Understanding and 
constitutes the policy of VA for participation in the National 
Practitioner Data Bank.

Subpart B--National Practitioner Data Bank Reporting


Sec. 46.3  Malpractice payment reporting.

    (a) VA will file a report with the National Practitioner Data Bank, 
in accordance with regulations at 45 CFR part 60, subpart B, as 
applicable, regarding any payment for the benefit of a physician, 
dentist, or other licensed health care practitioner which was made as 
the result of a settlement or judgment of a claim of medical 
malpractice. The report will identify the physician, dentist, or other 
licensed health care practitioner for whose benefit the payment is 
made. It is intended that the report be filed within 30 days of the 
date payment is made. This may not be possible in all cases; e.g., 
sometimes notification of payment is delayed, and sometimes the 
malpractice payment review process cannot be completed within the 
timeframe. The report will provide the following information:
    (1) With respect to the physician, dentist, or other licensed 
health care practitioner for whose benefit the payment is made--
    (i) Name;
    (ii) Work address;
    (iii) Home address, if known;
    (iv) Social Security number, if known, and if obtained in 
accordance with section 7 of the Privacy Act of 1974;
    (v) Date of birth;
    (vi) Name of each professional school attended and year of 
graduation;
    (vii) For each professional license: the license number, the field 
of licensure, and the State in which the license is held;
    (viii) Drug Enforcement Administration registration number, if 
applicable and known;
    (ix) Name of each health care entity with which affiliated, if 
known.
    (2) With respect to the reporting VA entity--

[[Page 19681]]

    (i) Name and address of the reporting entity;
    (ii) Name, title and telephone number of the responsible official 
submitting the report on behalf of the Federal government; and
    (iii) Relationship of the entity to the physician, dentist, or 
other health care practitioner being reported.
    (3) With respect to the judgment or settlement resulting in the 
payment--
    (i) Where an action or claim has been filed with an adjudicative 
body, identification of the adjudicative body and the case number;
    (ii) Date or dates on which the act(s) or omission(s), which gave 
rise to the action or claim occurred;
    (iii) Date of judgment or settlement;
    (iv) Amount paid, date of payment, and whether payment is for a 
judgment or a settlement;
    (v) Description and amount of judgment or settlement and any 
conditions attached thereto, including terms of payment;
    (vi) A description of the acts or omissions and injuries or 
illnesses upon which the action or claim was based; and
    (vii) Classification of the acts or omissions in accordance with a 
reporting code adopted by the Secretary of Health and Human Services.
    (b) Payment will be considered to have been made for the benefit of 
a physician, dentist, or other licensed health care practitioner only 
if (at least a majority of) a malpractice payment review panel 
concludes that payment was related to substandard care, professional 
incompetence, or professional misconduct on the part of the physician, 
dentist, or other licensed health care practitioner. For purposes of 
this part, a panel shall have a minimum of three individuals appointed 
by the Director, Medical-Legal Affairs (including at least one member 
of the profession/occupation of the practitioner(s) whose actions are 
under review). The conclusions of the panel shall, at a minimum, be 
based on review of documents pertinent to the care that led to the 
claim. These documents include the medical records of the patient whose 
care led to the claim, any report of an administrative investigation 
board appointed to investigate the care, and the opinion of any 
consultant which the panel may request in its discretion. These 
documents do not include those generated primarily for consideration or 
litigation of the claim of malpractice. In addition, to the extent 
practicable, the documents shall include written statements of the 
individual(s) involved in the care which led to the claim. The 
practitioner(s) whose actions are under review will receive a written 
notice, hand-delivered or sent to the practitioner's last known address 
(return receipt requested), from the VA facility director at the time 
the VA facility director receives the Notice of Payment. That notice 
from the VA facility director will indicate that VA is considering 
whether to report the practitioner to the National Practitioner Data 
Bank because of a specified malpractice payment made, and provide the 
practitioner the opportunity, within 60 days of receipt, to submit a 
written statement concerning the care that led to the claim. Inability 
to notify or non-response from the identified practitioner(s) will not 
preclude completion of the review and reporting process. The panel, at 
its discretion, may request additional information from the 
practitioner or the VA facility where the incident occurred. The review 
panel's notification to the VA facility Director shall include the acts 
or omissions considered, the reporting conclusion, and the rationale 
for the conclusion.
    (c) Attending staff (including contract employees, such as scarce 
medical specialists providing care pursuant to a contract under 38 
U.S.C. 7409) are responsible for actions of licensed trainees assigned 
under their supervision. Notwithstanding the provisions of paragraph 
(b) of this section, actions of a licensed trainee (intern or resident) 
acting within the scope of his or her training program that otherwise 
would warrant reporting for substandard care, professional 
incompetence, or professional misconduct under the provisions of 
paragraph (b) of this section, will be reported only if the panel, by 
at least a majority, concludes that such actions constitute gross 
negligence or willful professional misconduct. For purposes of 
paragraph (b) of this section, payment will be considered to be made 
for the benefit of a physician, dentist, or other health care 
practitioner, in their supervisory capacity, if the panel concludes, by 
at least a majority, that the physician, dentist or other health care 
practitioner was acting in a supervisory capacity; that the payment was 
related to substandard care, professional incompetence, or professional 
misconduct of the trainee and not the supervisor; and that the trainee 
did not commit gross negligence or willful professional misconduct. 
Such report will note that the physician, dentist, or other health care 
practitioner is being reported in a supervisory capacity.

    Note to paragraph (c): Licensed trainees acting outside the 
scope of their training program (e.g. acting as admitting officer of 
the day) will be reported under the provisions of paragraph (b) of 
this section.

    (d) The Director of the facility at which the claim arose has the 
primary responsibility for submitting the report to the National 
Practitioner Data Bank and for providing a copy to the practitioner, to 
the State Licensing Board in each State where the practitioner holds a 
license, and to the State Licensing Board in which the facility is 
located. However, the Chief Patient Care Services Officer is also 
authorized to submit the report to the National Practitioner Data Bank 
and provide copies to the practitioner and State Licensing Boards in 
cases where the Chief Patient Care Services Officer deems it 
appropriate to do so. The Director of the facility also shall provide 
to the practitioner a copy of the review panel's notification to the 
Director.

(The Office of Management and Budget has approved the information 
collection requirements in this section under control number 2900-
0621.)


Sec. 46.4  Clinical privileges actions reporting.

    (a) VA will file an adverse action report with the National 
Practitioner Data Bank in accordance with regulations at 45 CFR part 
60, subpart B, as applicable, regarding any of the following actions:
    (1) An action of a Director after consideration of a professional 
review action that, for a period longer than 30 days, adversely affects 
(by reducing, restricting, suspending, revoking, or failing to renew) 
the clinical privileges of a physician or dentist relating to possible 
incompetence or improper professional conduct.
    (2) Acceptance of the surrender of clinical privileges, including 
the surrender of clinical privileges inherent in resignation or 
retirement, or any restriction of such privileges by a physician or 
dentist either while under investigation by the health care entity 
relating to possible incompetence or improper professional conduct, or 
in return for not conducting such an investigation or proceeding 
whether or not the individual remains in VA service.
    (b) The report specified in paragraph (a) of this section will 
provide the following information--
    (1) With respect to the physician or dentist:
    (i) Name;
    (ii) Work address;
    (iii) Home address, if known;

[[Page 19682]]

    (iv) Social Security number, if known (and if obtained in 
accordance with section 7 of the Privacy Act of 1974);
    (v) Date of birth;
    (vi) Name of each professional school attended and year of 
graduation;
    (vii) For each professional license: the license number, the field 
of licensure, and the name of the State in which the license is held;
    (viii) Drug Enforcement Administration registration number, if 
applicable and known;
    (ix) A description of the acts or omissions or other reasons for 
privilege loss, or, if known, for surrender; and
    (x) Action taken, date action was made final, length of action and 
effective date of the action.
    (2) With respect to the VA facility--
    (i) Name and address of the reporting facility; and
    (ii) Name, title, and telephone number of the responsible official 
submitting the report.
    (c) A copy of the report referred to in paragraph (a) of this 
section will also be filed with the State Licensing Board in the 
State(s) in which the practitioner is licensed and in which the 
facility is located. It is intended that the report be filed within 15 
days of the date the action is made final, that is, subsequent to any 
internal (to the facility) appeal.
    (d) As soon as practicable after it is determined that a report 
shall be filed with the National Practitioner Data Bank and State 
Licensing Boards under paragraphs (a)(2) and (c) of this section, VA 
shall provide written notice to the practitioner that a report will be 
filed with the National Practitioner Data Bank with a copy to the State 
Licensing Board in each State in which the practitioner is licensed and 
in the State in which the facility is located.

Subpart C--National Practitioner Data Bank Inquiries


Sec. 46.5  National Practitioner Data Bank inquiries.

    VA will request information from the National Practitioner Data 
Bank, in accordance with the regulations published at 45 CFR part 60, 
subpart C, as applicable, concerning a physician, dentist, or other 
licensed health care practitioner as follows:
    (a) At the time a physician, dentist, or other health care 
practitioner applies for a position at VA Central Office, any of its 
regional offices, or on the medical staff, or for clinical privileges 
at a VA hospital or other health care entity operated under the auspice 
of VA;
    (b) No less often than every 2 years concerning any physician, 
dentist, or other health care practitioner who is on the medical staff 
or who has clinical privileges at a VA hospital or other health care 
entity operated under the auspice of VA; and
    (c) At other times pursuant to VA policy and needs and consistent 
with the Act and Department of Health and Human Services Regulations 
(45 CFR part 60).

Subpart D--Miscellaneous


Sec. 46.6  Medical quality assurance records confidentiality.

    Note that medical quality assurance records that are confidential 
and privileged under the provisions of 38 U.S.C. 5705 may not be used 
as evidence for reporting individuals to the National Practitioner Data 
Bank.


Sec. 46.7  Prohibitions concerning negotiations.

    Reporting under this part (including the submission of copies) may 
not be the subject of negotiation in any settlement agreement, employee 
action, legal proceedings, or any other negotiated settlement.


Sec. 46.8  Independent contractors.

    Independent contractors acting on behalf of the Department of 
Veterans Affairs are subject to the National Practitioner Data Bank 
reporting provisions of this part. In the following circumstances, VA 
will provide the contractor with notice that a report of a clinical 
privileges action will be filed with the National Practitioner Data 
Bank with a copy with the State Licensing Board in the State(s) in 
which the contractor is licensed and in which the facility is located: 
where VA terminates a contract for possible incompetence or improper 
professional conduct, thereby automatically revoking the contractor's 
clinical privileges, or where the contractor terminates the contract, 
thereby surrendering clinical privileges, either while under 
investigation relating to possible incompetence or improper 
professional conduct or in return for not conducting such an 
investigation or proceeding.


(Authority: 38 U.S.C. 5705)

3[FR Doc. 02-9875 Filed 4-22-02; 8:45 am]
BILLING CODE 8320-01-P