[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