[Federal Register Volume 63, Number 247 (Thursday, December 24, 1998)]
[Proposed Rules]
[Pages 71255-71257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34066]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
45 CFR Part 60
RIN 0906-AA41
National Practitioner Data Bank for Adverse Information on
Physicians and Other Health Care Practitioners: Medical Malpractice
Payments Reporting Requirements
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This Notice of Proposed Rulemaking (NPRM) proposes amendments
to the existing regulations implementing the Health Care Quality
Improvement Act of l986, establishing the National Practitioner Data
Bank for Adverse Information on Physicians and Other Health Care
Practitioners (the Data Bank). The proposed regulations would amend the
existing reporting requirements regarding payments on medical
malpractice claims or actions in order to include reports on payments
made on behalf of those practitioners who provided the medical care
that is the subject of the claim or action, whether or not they were
named as defendants in the claim or action. These amendments are
designed to prevent the evasion of Data Bank medical malpractice
payments reporting requirements.
DATES: Comments on this proposed rule are invited. To be considered,
comments must be received by February 22, 1999.
ADDRESSES: Written comments should be addressed to Neil Sampson, Acting
Associate Administrator, Bureau of Health Professions (BHPr), Health
Resources and Services Administration, Room 8-05, Parklawn Building,
5600 Fishers Lane, Rockville, Maryland 20857. All comments received
will be available for public inspection and copying at the Office of
Research and Planning, BHPr, Room 8-67, Parklawn Building, at the above
address, weekdays (Federal holidays excepted) between the hours of 8:30
a.m. and 5:00 p.m.
FOR FURTHER INFORMATION CONTACT: Mr. Thomas C. Croft, Director,
Division of Quality Assurance, Bureau of Health Professions, Health
Resources and Services Administration, Parklawn Building, Room 8A-55,
5600 Fishers Lane, Rockville, Maryland 20857; telephone: (301) 443-
2300.
SUPPLEMENTARY INFORMATION: The Assistant Secretary for Health,
Department of Health and Human Services, with the approval of the
Secretary, published in the Federal Register on October 17, 1989 (54 FR
42722), regulations implementing the Health Care Quality Improvement
Act of 1986 (the Act), title IV of Public Law 99-660 (42 U.S.C. 11101
et seq.), through the establishment of the National Practitioner Data
Bank for Adverse Information on Physicians and Other Health Care
Practitioners (the Data Bank). Those regulations are codified at 45 CFR
part 60.
Among other items of information that must be reported to the Data
Bank, section 421 of the Act requires that each entity that makes a
payment in settlement or satisfaction of a ``medical malpractice action
or claim'' must report certain information ``respecting the payment and
circumstances thereof'' (section 421(a)). The information to be so
reported includes ``the name of any physician or licensed health care
practitioner for whose benefit the payment is made'' (section
421(b)(1)). The term ``medical malpractice action or claim'' is defined
for purposes of the Act in section 431(7), to mean--
* * * a written claim or demand for payment based on a health
care provider's furnishing (or failure to furnish) health care
services, and includes the filing of a cause of action, based on the
law of tort, brought in any court of any State of the United States
seeking monetary damages.
Thus, the Act provides for the reporting, by the payer, of any
payment made for the benefit of a health care practitioner resulting
from any ``written claim or demand for payment'' based on ``furnishing
(or failure to furnish) health care services.''
In implementing this requirement in the regulations published on
October 17, 1989, the Secretary included in Sec. 60.7(a), entitled
``Who must report,'' language stating that the provision applies to a
payer who makes a payment ``for the benefit of'' a health care
practitioner
* * * in settlement of or in satisfaction in whole or in part of
a claim or a judgment against such * * * health care practitioner
for medical malpractice. [Emphasis added.]
It has come to the Department's attention that there have been
instances in which a plaintiff in a malpractice action has agreed to
dismiss a defendant health care practitioner from a proceeding, leaving
or substituting a hospital or other corporate entity as defendant, at
least in part for the purpose of allowing the practitioner to avoid
having a report on a malpractice payment made on his or her behalf
submitted to the Data Bank. The
[[Page 71256]]
Department recognizes that this has occurred especially in cases when
the counsel of a self-insured hospital or other self-insured corporate
entity (which employs the defendant health care practitioner) has
actively pursued having the defendant health care practitioner's name
dropped from a proceeding, leaving or substituting the hospital or
other corporate entity as the defendant, to avoid having to report the
practitioner.
This practice makes it possible for practitioners whose negligent
or substandard care has resulted in compensable injury to patients to
evade having that fact appear in the Data Bank, since the payment is
arguably not in satisfaction of a claim or judgment against the
practitioner. Such a result is clearly inconsistent with the
Congressional purpose, explicit in the Act, of
restrict[ing] the ability of incompetent [practitioners] to move
from State to State without disclosure or discovery of the
[practitioner's] previous damaging or incompetent performance.
See section 401(2) of the Act. Since the regulation quoted above,
literally read, does permit a result so at odds with the purposes of
the statute, the Secretary proposes to revise it. The Department does
recognize that there are legitimate situations when it is impossible to
identify a practitioner(s) for whose benefit the payment was made. For
example, a situation could occur wherein a power failure causes a heart
monitor to cease functioning leading to an injury or death, which
ultimately leads to a malpractice payment. In these very limited
circumstances, the Secretary proposes to require that the reporter
state the sequence of events that led to the payment, why the
practitioner could not be identified, and the amount of the payment.
The Department will use this information to identify medical
malpractice reporters that appear to make a practice of not identifying
specific practitioners.
The Department proposes to amend paragraphs (a) and (b) of
Sec. 60.7 as follows:
1. Paragraph (a) would be revised by removing the reference to a
claim or judgment ``against such physician, dentist, or other health
care practitioner'' and adding language from section 421(a) of the Act;
and
2. Paragraph (b)(1) would be revised to state explicitly that the
reference in that provision to the practitioner ``for whose benefit the
payment is made'' includes ``each practitioner whose acts or omissions
were the basis of the action or claim.''
A new paragraph (b)(2) would require that in situations where it is
impossible to identify the practitioner for whose benefit the payment
was made, the payor must report a statement of the facts and why the
practitioner could not be identified and the amount of the payment. Due
to the fact that the hospital is no longer the primary place of
practice for many practitioners, new paragraph (b)(2) would further
require the payer to include not only the name of each hospital with
which the practitioner is affiliated, but also the name of each health
care entity with which the practitioner is affiliated. Former
paragraphs (b)(2) and (b)(3) are being redesignated as paragraphs
(b)(3) and (b)(4) respectively.
These changes are intended to make clear that the reach of the term
``practitioner for whose benefit the payment is made'' as it is used in
the Act and the regulations extends to any practitioner whose acts or
omissions were the basis for the action or claim, regardless of whether
that practitioner is a named defendant in a malpractice action. It thus
becomes the responsibility of the payer, during the course of its
review of the merits of the claim, to identify any practitioner whose
professional conduct was at issue in any malpractice action or claim
that has resulted in a payment, and to report that practitioner to the
Data Bank.
The Secretary notes that, consistent with Congressional purpose
explicit in the Act, Sec. 60.7(d), entitled ``Interpretation of
Information'' states:
A payment in settlement of a medical malpractice action or claim
shall not be construed as creating a presumption that medical
malpractice has occurred.
This provision remains in the rule and is one of the basic tenets of
the Data Bank.
Economic Impact
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, of costs, of benefits, of 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 requirement in these regulations are minimal. Therefore, in
accordance with the Regulatory Flexibility Act of 1980 (RFA), and the
Small Business Regulatory Enforcement Act of 1996, which amended the
RFA, 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 does not meet
the criteria for a major rule as defined under Executive Order 12866.
The NPRM would amend the existing reporting requirements regarding
payments on medical malpractice claims or actions in order to include
reports on payments made on behalf of those practitioners who provided
care that is the subject of the claims, whether or not they were named
as defendants in the medical malpractice claim or action. As such, the
proposed rule would have no major effect on the economy or on Federal
expenditures.
Paperwork Reduction Act of 1995
The National Practitioner Data Bank for Adverse Information on
Physicians and Other Health Care Practitioners regulations contain
information collections which have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1980
and assigned control number 0915-0126. One of the approved reporting
requirements will be affected by the proposed amendments. As required
by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3507(d)), the
Department has submitted a copy of this proposal rule to the Office of
Management and Budget for its review of this information collection
requirement.
Collection of Information: National Practitioner Data Bank For
Adverse Information on Physicians and Other Health Care Practitioners.
Description: The NPRM would amend the existing reporting
requirements regarding payments on medical malpractice claims or
actions in order to include reports on payments made for the benefit of
those practitioners whose acts or omissions were the basis of the
action or claim, whether or not they were named as defendants in the
medical malpractice claim or action.
Description of Respondents: Business or other for-profit, not-for-
profit institutions.
Estimated Annual Reporting Burden: The section number and the
estimated change in reporting burden are as follows:
[[Page 71257]]
Sec. 60.7
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*Number of Responses per Total Hours per Total hour
respondents respondent responses response burden
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Currently approved burden....... 150 105.33 15,800 .75 11,850
Actual current volume........... 425 44.7 19,000 .75 14,250
Total burden after amendment.... 625 60.8 38,000 .75 28,500
Reporting due to this NPRM...... 300 63.33 19,000 .75 14,250
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*The number of entities reporting payments was underestimated in the last clearance request. The estimate of 150
entities was based on the fact that fewer than 100 large insurers are responsible for 80-85 percent of the
reports. A check of the Data Bank records for 1997 showed that many more entities than expected file one or
two reports per year, and that a total of 425 entities filed reports in 1997. That number is expected to
increase by about 50 percent (rounded to 625) with the change in the regulation. The total number of reports
filed is expected to double from the 1997 level of 19,000 to 38,000 per year. The Department believes that the
resources required to implement the requirement in these regulations are minimal.
There is no reliable way to forecast the increase in medical malpractice reports as a result of this regulation.
However, in conversations with many individuals such as plaintiffs' and defendants' attorneys, representatives
from self-insured health care entities, and malpractice insurers, the most common estimate is that the Data
Bank currently receives reports on 50 percent of the medical malpractice payments being made. Most of the new
reports will not be made by current reporters. Instead, there will be a sizeable increase in the number of new
reporters (estimated at 200), with each new reporter filing only a small number of reports in a single year.
The 63.33 reports per respondent represent an average over all types of respondents, from the large insurers
who submit hundreds of reports per year to the small reporters (mainly self-insured hospitals and other self-
insured corporate entities) that may submit one or two reports per year.
Request for Comment: In compliance with the requirement of section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity
for public comment on proposed data collection projects, comments are
invited on: (a) Whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information shall have practical utility; (b) the
accuracy of the Agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Written comments and recommendations concerning the proposed
information collection should be sent to: Wendy Taylor, Human Resources
and Housing Branch, Office of Management and Budget, New Executive
Office Building, Room 10235, Washington, DC 20503. OMB is required to
make a decision concerning the collection of information contained in
these proposed regulations between 30 and 60 days after publication of
this document in the Federal Register. This does not affect the
deadline of the public to comment to the Department on the proposed
regulations.
List of Subjects in 45 CFR Part 60
Claims, Fraud, Health, Health maintenance organizations (HMOs),
Health professions, Hospitals, Insurance companies, Malpractice,
Reporting and recordkeeping requirements.
Dated: October 3, 1997.
Claude E. Fox,
Acting Administrator, Health Resources and Services Administration.
Approved: August 24, 1998.
Donna E. Shalala,
Secretary.
Accordingly, 45 CFR part 60 is proposed to be 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 sec.
402 of Pub. L. 100-177, 101 Stat. 1007-1008 (42 U.S.C. 11101-11152).
2. Section 60.7 is amended by revising paragraph (a); by revising
the introductory texts to paragraphs (b) and (b)(1); by revising
paragraph (b)(1)(ix); by redesignating paragraphs (b)(2) and (3) as
paragraphs (b)(3) and (4) and by adding a new paragraph (b)(2). As so
amended, Sec. 60.7 reads in pertinent part as follows:
Sec. 60.7 Reporting 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 (or partial settlement) of, or in
satisfaction of a judgment in, a medical malpractice action or claim
shall report information respecting the payment and circumstances
thereof, as set forth in paragraph (b) of this section, 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) of this section must report the following information:
(1) With respect to the physician, dentist, or other health care
practitioner for whose benefit the payment is made, including each
practitioner whose acts or omissions were the basis of the action or
claim--
* * * * *
(ix) Name of each hospital and health care entity with which he or
she is affiliated, if known;
(2) If the physician, dentist, or other health care practitioner
could not be identified--
(i) A statement of such fact and an explanation of the inability to
make the identification, and
(ii) The amount of the payment.
* * * * *
[FR Doc. 98-34066 Filed 12-23-98; 8:45 am]
BILLING CODE 4160-15-P