[Federal Register Volume 76, Number 33 (Thursday, February 17, 2011)]
[Proposed Rules]
[Pages 9295-9297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 5b
RIN 0906-AA91
Privacy Act; Exempt Record System
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This proposed rule would exempt the system of records (09-15-
0054, the National Practitioner Data Bank for Adverse Information on
Physicians and Other Health Care Practitioners, HHS/HRSA/BHPr) for the
National Practitioner Data Bank (NPDB) from certain provisions of the
Privacy Act. The exemption is necessary due to the recent expansion of
the NPDB under section 1921 of the Social Security Act to include the
investigative materials compiled for law enforcement purposes reported
to the Healthcare Integrity and Protection Data Bank (HIPDB). The
system of records for the HIPDB has an exemption from certain
provisions of the Privacy Act. In order to maintain the exemption for
the HIPDB investigative materials, which are now also available through
the NPDB, it is necessary to expand the same privacy act exemptions for
the HIPDB to the NPDB. This rule specifically seeks public comments on
the proposed exemption.
DATES: To assure consideration, public comments must be delivered to
the address provided below by no later than 5 p.m. on April 18, 2011.
ADDRESSES: You may submit comments in one of the three ways listed
below. The first is the preferred method. Please submit your comments
in only one of these ways, so that no duplicates are received.
Federal eRulemaking Portal. You may submit comments
electronically to http://www.regulations.gov. Click on the link
``Submit electronic comments on HRSA regulations with an open comment
period.'' Submit your actual comments as an attachment to your message
or cover letter. (Attachments should be in Microsoft Word or
WordPerfect; however, we prefer Microsoft Word.)
By regular, express or overnight mail. You may mail
written comments to the following address only: Health Resources and
Services Administration, Department of Health and Human Services,
Attention: HRSA Regulations Officer, Parklawn Building Rm. 14A-11, 5600
Fishers Lane, Rockville, MD 20857. Please allow sufficient time for
mailed comments to be received before the close of the comment period.
Delivery by hand (in person or by courier). If you prefer,
you may deliver your written comments before the close of the comment
period to the same address: Parklawn Building Room 14A-11, 5600 Fishers
Lane, Rockville, MD 20857. Please call in advance to schedule your
arrival with one of our HRSA Regulations Office staff members at
telephone number (301) 443-1785.
Because of staffing and resource limitations, and to ensure that no
comments are misplaced, we cannot accept comments by facsimile (FAX)
transmission.
In commenting, please refer to RIN 0906-AA91. Comments are
available for public viewing on the Federal eRulemaking portal at
http://www.regulations.gov. Comments received on a timely basis will be
available for public inspection as they are received in Room 14A-11 of
the Health Resources and Services Administration's offices at 5600
Fishers Lane, Rockville, MD, Monday through Friday of each week
(Federal holidays excepted) from 8:30 a.m. to 5 p.m. (phone: 301-443-
1785).
FOR FURTHER INFORMATION CONTACT: Director, Division of Practitioner
Data Banks, Bureau of Health Professions, Health Resources and Services
Administration, Parklawn Building, 5600 Fishers Lane, Room 8-103,
Rockville, MD 20857; telephone number: (301) 443-2300.
SUPPLEMENTARY INFORMATION: On January 28, 2010, the Health Resources
and Services Administration published a final rule in the Federal
Register (75 FR 4656) designed to implement section 1921 of the Social
Security Act (herein referred to as section 1921). Section 1921 expands
the scope of the NPDB. Section 1921 requires each state to
[[Page 9296]]
adopt a system of reporting to the Secretary certain adverse licensure
actions taken against health care practitioners and health care
entities by any authority of the state responsible for the licensing of
such practitioners or entities. It also requires each state to report
any negative action or finding that a state licensing authority, a peer
review organization, or a private accreditation entity has finalized
against a health care practitioner or entity. Practically speaking,
Section 1921 resulted in, among other consequences, the transfer of the
vast majority of information contained in the HIPDB to the NPDB.
The HIPDB was created by the Health Insurance Portability and
Accountability Act (HIPAA) of 1996, Public Law (Pub. L. 104-191), which
required the Secretary, acting through the Office of Inspector General
(OIG) and the United States Attorney General, to establish a new health
care fraud and abuse control program to combat health care fraud and
abuse.
Groups that have access to this information include all
organizations eligible to query the NPDB under the Health Care Quality
Improvement Act of 1986 (hospitals, other health care entities that
conduct peer review and provide health care services, state medical or
dental boards and other health care practitioner state boards), other
state licensing authorities, agencies administering federal health care
programs, including private entities administering such programs under
contract, state agencies administering or supervising the
administration of state health care programs, State Medicaid Fraud
Control Units, and certain law enforcement agencies, and utilization
and quality control peer review organizations (referred to as QIOs) as
defined in Part B of title XI of the Social Security Act and
appropriate entities with contracts under section 1154(a)(4)(C) of the
Social Security Act. Individual health care practitioners and entities
can self-query.
One of the primary purposes of these data will be use of this
information by a federal or state government agency charged with the
responsibility of investigating or prosecuting a case where there is an
indication of a violation or potential violation of law, whether civil,
criminal, or regulatory in nature. The information in this system may
also be used in the preparation for a trial or hearing for such
violation. Specifically, this proposed rule would exempt this data bank
from certain provisions of the Privacy Act.\1\ This exemption is
intended to protect, from release to the record subject, information on
law enforcement queries to the data bank. It would also exempt the data
bank from Privacy Act access and amendment procedures in order to
establish access and amendment procedures in the NPDB regulations.
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\1\ Subsections (c)(3), (d)(1)-(4), and (e)(4)(G) and (H) of the
Privacy Act, in accordance with 5 U.S.C. 552a(k)(2) and proposed 45
CFR 5b.11(b)(2)(ii)(L).
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While subjects will have access to information on all other queries
to the data bank, disclosure of law enforcement queries could
compromise ongoing investigation activities. The premature disclosure
of the existence of a law enforcement activity to an outside party (who
may also be the subject of the investigation) could lead to, among
other things, the destruction or alteration of evidence and the
tampering with witnesses.
Record subjects are guaranteed access to, and correction rights
for, substantive information reported to the NPDB. The procedures,
appearing in 45 CFR part 60, use the Privacy Act access and correction
procedures as a basic framework while, at the same time, providing
significant additional rights (such as automatic notification to the
record subject of any report filed with the data bank). Data bank
subjects also have broader rights on NPDB correction procedures,
including the right to file a statement of disagreement as soon as a
report is filed with the data bank.
Economic and Regulatory Impact
The Office of Management and Budget has reviewed this proposed rule
in accordance with the provisions of Executive Order 12866 and the
Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by Executive
Orders 13258 and 13422, and has determined that it will have no major
effect on the economy or federal expenditures. Executive Order 12866
directs agencies to assess all costs and benefits of available
regulatory alternatives and, when rulemaking is necessary, to select
regulatory approaches that maximize net benefits, including potential
economic, environmental, public health, safety distributive and equity
effects.
The Secretary has determined that this proposed rule is not a
``major rule'' within the meaning of the statute providing for
Congressional Review of Agency Rulemaking, 5 U.S.C. 801, and has
determined that it does not meet the criteria for a significant
regulatory action. In addition, under the Small Business Enforcement
Act (SBEA) of 1996, if a rule has a significant economic effect on a
substantial number of small businesses, the Secretary must specifically
consider the economic effect of a rule on small business entities and
analyze regulatory options that could lessen the impact of the rule.
The Secretary has reviewed this proposed exemption in accordance with
the provisions of the SBEA and certifies that this proposed exemption
will not have a significant impact on a substantial number of small
entities. Specifically, as indicated above, while the reports of
adverse actions to the NPDB will be known to the subjects of the
records in the data bank, the access and use of such information by law
enforcement agencies would not be known to the subjects of the records.
As a result, we believe that disclosure of this information could
compromise ongoing law enforcement activities.
Similarly, it will not have effects on state, local, and tribal
governments and on the private sector such as to require consultation
under the Unfunded Mandates Reform Act of 1995.
The Secretary has reviewed this proposed rule in accordance with
Executive Order 13132 regarding federalism, and has determined that it
does not have ``federalism implications.'' This rule would not ``have
substantial direct effects on the states, or on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.''
The proposals made in this notice of proposed rulemaking, if
implemented, would not adversely affect the following family elements:
family safety, family stability, marital commitment; parental rights in
the education, nurture and supervision of their children; family
functioning, disposable income, or poverty; or the behavior and
personal responsibility of youth, as determined under section 654(c) of
the Treasury and General Government Appropriations Act of 1999.
Paperwork Reduction Act
This proposed rule does not have any information collection
requirements.
Dated: December 22, 2010.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
Approved: January 19, 2011.
Kathleen Sebelius,
Secretary.
List of Subjects in 45 CFR Part 5b
Privacy.
[[Page 9297]]
Accordingly, 45 CFR part 5b is proposed to be amended as set forth
below:
PART 5b--PRIVACY ACT REGULATIONS
1. The authority citation for part 5b continues to read as follows:
Authority: 5 U.S.C. 301, 5 U.S.C. 552a.
2. In Sec. 5b.11, add paragraph (b)(2)(ii)(L) to read as follows:
Sec. 5b.11 Exempt systems.
* * * * *
(b) * * *
(2) * * *
(ii) * * *
(L) Investigative materials compiled for law enforcement purposes
for the National Practitioner Data Bank (NPDB). (See Sec. 60.16 of
this title for access and correction rights under the NPDB by subjects
of the Data Bank.)
* * * * *
[FR Doc. 2011-3513 Filed 2-16-11; 8:45 am]
BILLING CODE 4165-15-P