[Federal Register Volume 59, Number 230 (Thursday, December 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29560]


[[Page Unknown]]

[Federal Register: December 1, 1994]


[FR Doc. 94-29567 Filed 11-30-94; 8:45 am]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

45 CFR Part 60

RIN 0905-AE38

 

National Practitioner Data Bank for Adverse Information on 
Physicians and Other Health Care Practitioners: Amendments to Data Bank 
Regulations to Comply With Court Order and Technical Correction

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final regulations.

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SUMMARY: This final rule amends the existing regulations governing the 
National Practitioner Data Bank for Adverse Information on Physicians 
and Other Health Care Practitioners (the Data Bank), codified at 45 CFR 
part 60, authorizing the reporting and release of information 
concerning: Payments made for the benefit of physicians, dentists, and 
other health care practitioners as a result of medical malpractice 
actions or claims; and certain adverse actions taken regarding the 
licenses and clinical privileges of physicians and dentists. This final 
rule revises Secs. 60.2 and 60.7 to require reporting only by entities 
which make medical malpractice payments, deleting the reference to 
reporting by persons (individuals). It also clarifies the reference to 
``professional society'' in Sec. 60.9.

EFFECTIVE DATE: This regulation is effective December 1, 1994.

FOR FURTHER INFORMATION CONTACT:
Thomas C. Croft, Director, Division of Quality Assurance, Bureau of 
Health Professions, Health Resources and Services Administration, Room 
8-67, 5600 Fishers Lane, Rockville, Maryland 20857; telephone number: 
(301) 443-2300.

SUPPLEMENTARY INFORMATION: The Department is revising the provision 
requiring reporting of medical malpractice payments, as directed by an 
order issued by the United States District Court for the District of 
Columbia on November 16, 1993, in the case of American Dental 
Association, et al. v. Donna E. Shalala, Secretary, HHS, Civ. No. 90-
2673 (SSH). This order is the result of the decision of the Court of 
Appeals for the District of Columbia Circuit which reversed a decision 
by the District Court. The Court of Appeals held that the Department's 
interpretation of the Health Care Quality Improvement Act, as reflected 
in its regulations, was inconsistent with the statute. The Court found 
that the Department expanded the law in interpreting the term 
``entity'' to include persons with respect to the reporting of medical 
malpractice payments to the Data Bank. Accordingly, the Department is 
revising Secs. 60.2 and 60.7 (a), (b), and (c) of the regulations to 
delete the reference to ``person'' (``individual'') regarding the 
requirement to report medical malpractice payments.
    For purposes of reporting medical malpractice payments, a 
professional corporation or other business entity (even if it is 
comprised of a sole practitioner) which makes a payment for the benefit 
of a named practitioner must report that payment to the Data Bank. 
However, if a practitioner, rather than a professional corporation or 
other business entity, makes a payment out of his or her personal 
funds, the payment is not reportable. This is because the statute 
requires ``[e]ach entity * * * which makes a payment'' to report that 
payment.
    The Department has removed (voided) from the Data Bank those 
reports of medical malpractice payments in which the payment and report 
could be identified as having been made by an individual (i.e., a 
natural person, not a corporate or other business entity). The 
practitioners affected and all queriers who received copies of the 
reports have been notified, according to regular, established 
procedure, that the Department had removed these reports from the Data 
Bank. If a practitioner who received such notice determines that the 
report should not have been voided, e.g., if the payment was in fact 
made by an entity rather than an individual, the entity should resubmit 
a report of that payment to the Data Bank. Section 60.7(c) of the Data 
Bank regulations provides that any entity which fails to report 
information on a payment required to be reported to the Data Bank is 
subject to a civil money penalty of up to $10,000 for each such payment 
involved.
    The Data Bank will continue to process and enter reports into the 
Data Bank as they are received. However, the Data Bank will screen on a 
weekly basis, for several months, medical malpractice payment reports 
made to the Data Bank so as to identify and remove any reports of 
medical malpractice payments made by individuals (as opposed to 
entities). The Department will inform the affected practitioners and 
any queriers who may have received copies of these reports that the 
reports have been removed from the Data Bank. If a practitioner 
receiving such notice determines that the report should have remained 
in the Data Bank, e.g., if the payment was (actually) made by an entity 
(such as a professional corporation, professional association, or other 
business entity) the entity should submit a report of that payment to 
the Data Bank.
    All medical malpractice payment reports accepted by the Data Bank 
(i.e., all reports which have been properly completed) will be 
processed and entered into the Data Bank in accordance with established 
procedure, and the weekly screening will be discontinued two months 
after this rule is issued. After that date, any practitioner who has 
reported to the Data Bank a medical malpractice payment made by that 
practitioner out of his or her own personal funds should void that 
report. This should be done by submitting to the Data Bank an 
additional reporting form and checking the box in section two marked 
``void previous report.''
    Please note that the preceding discussion applies only to the issue 
of payments made by individuals out of personal funds. This is distinct 
from the issue of a payment made on behalf of a professional 
corporation or other business entity that is comprised of a sole 
practitioner. In such case, the Department construes the payment as 
having been made on behalf of the sole practitioner, and therefore 
reportable (assuming that the payment was made by an entity rather than 
by the sole practitioner out of his or her personal funds).
    The regulations also clarify the reference to ``professional 
society'' in Sec. 60.9 to indicate that it applies only to adverse 
actions taken with respect to physicians or dentists. This 
clarification is a technical correction for the consistency of the 
regulations with the authorizing statute. It is not intended to affect 
the reporting of actions to the Data Bank concerning physicians, 
dentists, and other health care practitioners.
    If a professional society previously reported an adverse action on 
a health care practitioner other than a physician or dentist and did so 
based on the mistaken belief that the statute or regulations required 
this report, the entity may either void this report or permit it to 
remain in the Data Bank as a discretionary report under the authority 
of 42 U.S.C. 11133(a)(2).

Justification for Omitting Notice of Proposed Rulemaking

    This regulation contains ministerial amendments to the Data Bank 
regulations. Due to the order of the District Court, the Secretary has 
no discretion in this amendment. The other amendments are made to 
conform the regulations to the authorizing statute. Accordingly, the 
Secretary has determined, in accordance with 5 U.S.C. 553(b)(3)(B), 
that notice and opportunity for public comment on the regulation set 
out below are impracticable, unnecessary, and contrary to the public 
interest.

Economic Impact

    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, of benefits, or incentives, of 
equity, and of available information. Regulations must meet certain 
standards, such as avoiding unnecessary burden. Regulations which are 
``significant'' because of cost, adverse effects on the economy, 
inconsistency with other agency actions, effects on the budget, or 
novel legal or policy issues, require special analysis.
    The Department believes that the resources required to implement 
the requirements in these regulations are minimal. This final rule 
simply makes ministerial amendments to the existing regulations to 
comply with the order directed by the U.S. District Court and a 
technical amendment to conform to the authorizing statute. Therefore, 
in accordance with the Regulatory Flexibility Act of 1980, the 
Secretary certifies that these regulations will not have a significant 
impact on a substantial number of small entities. For the same reasons, 
the Secretary has also determined that this is not a ``significant'' 
rule under Executive Order 12866.

Paperwork Reduction Action of 1980

    These amendments do not affect the recordkeeping or reporting 
requirements in the existing regulations for the National Practitioner 
Data Bank for Adverse Information on Physicians and Other Health Care 
Practitioners.

List of Subjects in 45 CFR Part 60

    Health Professions, Insurance companies, Malpractice.

    Dated: September 2, 1994.
Philip R. Lee,
Assistant Secretary for Health.
    Approved: November 22, 1994.
Donna E. Shalala,
Secretary.

    Accordingly, 45 CFR part 60 is amended as set forth below:

PART 60--NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS

    1. The authority citation for 45 CFR part 60 continues to read as 
follows:

    Authority: Secs. 401-432 of the Health Care Quality Improvement 
Act of 1986, Pub. L. 99-660, 100 Stat. 3784-3794, as amended by 
section 402 of Pub. L. 100-177, 101 Stat. 1007-1008 (42 U.S.C. 
11101-11152.)

    2. Section 60.2 is revised to read as follows:


Sec. 60.2  Applicability of these regulations.

    The regulations in this part establish reporting requirements 
applicable to hospitals; health care entities; Boards of Medical 
Examiners; professional societies of physicians, dentists or other 
health care practitioners which take adverse licensure of professional 
review actions; and entities (including insurance companies) making 
payments as a result of medical malpractice actions or claims. They 
also establish procedures to enable individuals or entities to obtain 
information from the National Practitioner Data Bank or to dispute the 
accuracy of National Practitioner Data Bank information.
    3. Section 60.7 is amended by revising paragraph (a); by revising 
the introductory text to paragraph (b), paragraph (b)(2), (b)(2)(i) and 
(b)(2)(iii); and by revising paragraph (c) to reads as follows:


Sec. 60.7  Reportind medical malpractice payments.

    (a) Who must report. Each entity, including an insurance company, 
which makes a payment under an insurance policy, self-insurance, or 
otherwise, for the benefit of a physician, dentist or other health care 
practitioner in settlement of or in satisfaction in whole or in part of 
a claim or a judgment against such physician, dentist, or other health 
care practitioner for medical malpractice, must report information as 
set forth in paragraph (b) to the Data Bank and to the appropriate 
State licensing board(s) in the State in which the act or omission upon 
which the medical malpractice claim was based. For purposes of this 
section, the waiver of an outstanding debt is not construed as a 
``payment'' and is not required to be reported.
    (b) What information must be reported. Entities described in 
paragraph (a) must report the following information:
* * * * *
    (2) With respect to the reporting entity--
    (i) Name and address of the entity making the payment, * * *
    (iii) Relationship of the reporting entity of the physician, 
dentists, or other health care practitioner for whose benefit the 
payment is made;
* * * * *
    (c) Sanctions. Any entity that fails to report information on a 
payment required to be reported under this section is subject to a 
civil money penalty of up to $10,000 for each such payment involved. 
This penalty will be imposed pursuant to procedures at 42 CFR part 
1003.
* * * * *
    3. Section 60.9 is amended by revising paragraph (a)(1)(iii) to 
read as follows:


Sec. 60.9  Reporting adverse actions on clinical privileges.

    (a) * * *
    (1) * * *
    (iii) In the case of a health care entity which is a professional 
society, when it takes a professional review action concerning a 
physician or dentist.
* * * * *
[FR Doc. 94-29560 Filed 11-30-94; 8:45 am]
BILLING CODE 4160-15-M