[Federal Register Volume 67, Number 101 (Friday, May 24, 2002)]
[Rules and Regulations]
[Pages 36539-36541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Chapter I

Centers for Medicare & Medicaid Services

42 CFR Chapters IV and V

[CMS-3088-FC]
RIN 0938-AL38


Office of Inspector General--Health Care; Medicare and Medicaid 
Programs; Peer Review Organizations: Name and Other Changes--Technical 
Amendments

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule with comment period.

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SUMMARY: In accordance with the Secretary's announcement of his quality 
initiative, this technical regulation revises all references to ``peer 
review organization'' and ``PRO'' in chapters I, IV, and V of title 42 
of the Code of Federal Regulations. This regulation also makes 
conforming changes to the general definitions section.

DATES: Effective date: May 24, 2002.
    Comment date: Comments will be considered if we receive them no 
later than 5 p.m. on July 23, 2002, at the appropriate address, as 
provided below.

ADDRESSES: In commenting, please refer to file code CMS-3088-FC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. Mail written comments (one original and 
three copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-3088-FC, P.O. Box 8010, Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
timely in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (one original and three copies) to one of the following 
addresses:
    Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201, or Room C5-16-03, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for commenters wishing to retain a proof of filing by 
stamping in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Valerie Mattison-Brown, (410) 786-
5958.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments

    Comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, at the headquarters of the Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850, Monday through Friday from 8:30 a.m. to 4 p.m. To 
schedule an appointment to view public comments, call (410) 786-9994.

I. Background

    Currently, the Social Security Act uses the term ``utilization and 
quality control peer review organizations'' to describe those entities 
which contract with CMS for the performance of the functions prescribed 
by title XI of the Social Security Act. The CMS regulations at 42 CFR 
400.200, currently define a ``peer review organization as an 
organization that has a contract with CMS, under part B of title XI of 
the Social Security Act, to perform utilization and quality control 
review of the health care furnished, or to be furnished, to Medicare 
beneficiaries.''
    In November 2001, the Secretary of the Department of Health and 
Human Services (HHS) launched a quality initiative to provide Medicare 
and Medicaid beneficiaries and their families with easy to understand, 
comparative information for selecting quality sources of healthcare 
such as nursing homes and hospitals. The peer review organizations will 
be instrumental in promoting this initiative. In accordance with the 
Secretary's quality initiative to provide Medicare and Medicaid 
beneficiaries and their families with user friendly quality 
information, we are changing the name of peer review organizations to 
quality improvement organizations to better reflect their 
responsibilities. The definition and function of these organizations 
will remain the same. Therefore, we are revising all references to 
``peer review organization'' and ``PRO'' in chapters I, IV, and V of 
title 42 of the Code of Federal Regulations (CFR).

II. Provisions of the Final Rule with Comment Period

    In 42 CFR chapters I, IV, and V we are revising all references to--
    [sbull] ``Peer review organization'' to read ``quality improvement 
organization'';
    [sbull] ``Peer review organizations'' to read ``quality improvement 
organizations'';
    [sbull] ``PRO'' to read ``QIO'';
    [sbull] ``PRO's'' to read ``QIO's''; and
    [sbull] ``PROs'' to read ``QIOs''.
    In addition, we are making the following conforming changes in 
[sect] 400.200 (General definitions):
    [sbull] Removing the definition of ``peer review organization'';
    [sbull] Removing the definition of ``PRO'';
    [sbull] Adding the definition of ``quality improvement 
organization''; and
    [sbull] Adding the definition of ``QIO''.

III. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and times specified in the DATES 
section of this preamble, and, when we proceed with a subsequent 
document, we will respond to the comments in the preamble to that 
document.

IV. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register to provide a period for public comment before the 
provisions of a rule such as this take effect. We note that such a 
notice is not required when

[[Page 36540]]

applied to rules of agency organization, procedure, or practice. As 
this rule merely reflects the nomenclature change of an organization 
that contracts with the agency, no notice is required. We can also 
waive this procedure if we find good cause that a notice and comment 
procedure is impracticable, unnecessary, or contrary to the public 
interest and incorporate a statement of the finding and its reasons in 
the rule issued. We believe it is unnecessary to undertake notice and 
comment rulemaking as the changes made by this regulation are technical 
in nature and update certain existing regulations without substantive 
change. There is also no impact on program costs. Therefore, for good 
cause, we waive prior notice and comment procedures. As indicated 
previously, we are, however, providing a 60-day comment period for 
public comment.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

VI. Regulatory Impact Statement

    We have examined the impacts of this notice as required by 
Executive Orders 12866 and 13132. We have also examined the impacts of 
this notice according to the criteria set forth in the Unfunded Mandate 
Reform Act of 1995 (Public Law 104-4), the Regulatory Flexibility Act 
(RFA) (Public Law 96-354), and section 1102(b) of the Social Security 
Act.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for rules that constitute significant 
regulatory action, including rules that have an economic effect of $100 
million or more annually (major rules). We have reviewed this rule and 
have determined that it is not a major rule. Therefore, we are not 
required to perform an assessment of the costs and benefits. We have 
also determined that it does not otherwise constitute significant 
regulatory action.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and governmental agencies. 
Most hospitals and most other providers and suppliers are small 
entities, either by nonprofit status or by having revenues of $5 
million to $25 million or less annually (see 65 FR 69432). Individuals 
and States are not included in the definition of a small entity. We 
generally prepare a regulatory flexibility analysis that is consistent 
with the RFA unless we certify that a rule will not have a significant 
impact on a substantial number of small entities. We have not prepared 
an analysis for the RFA because we have determined, and certify, that 
this final rule with comment period would have no significant economic 
impact on small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102 (b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 100 beds. We have not prepared an 
analysis for section 1102(b) of the Act because we have determined that 
this final rule with comment period would not have a significant impact 
on the operations of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandate Reform Act of 1995 also 
requires that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in an expenditure in 
any 1 year by State, local, or tribal governments, in the aggregate, or 
by the private sector, of $110 million or more. We have determined that 
this final rule with comment period would not result in such an 
expenditure.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct compliance costs on State and local governments, preempts State 
law, or otherwise has Federalism implications. We have reviewed this 
proposed rule under the threshold criteria of Executive Order 13132 and 
have determined that it would not have a substantial direct effect on 
the rights, roles, and responsibilities of States or local governments.
    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 400

    Grant programs-health, Health facilities, Health maintenance 
organizations (HMOs), Medicaid, Medicare, Reporting and recordkeeping 
requirements.


    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapters I, IV, and V to read as 
follows:

    1. In 42 CFR chapters I, IV, and V revise all references to ``Peer 
review organization'' to read ``Quality improvement organization''; 
revise all references to ``Peer review organizations'' to read 
``Quality improvement organizations''; revise all references to ``PRO'' 
to read ``QIO''; revise all references to ``PRO's'' to read ``QIO's''; 
and revise all references to ``PROs'' to read ``QIOs''.

    2. The authority citation for part 400 continues to read as 
follows:

    Authority: Secs 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35.


    3. In [sect] 400.200, remove the definitions of ``Peer review 
organization'' and ``PRO'' and add the definitions of ``QIO'' and 
``Quality improvement organization'' in alphabetical order to read as 
follows:


[sect] 400.200  General definitions.

* * * * *
    QIO stands for quality improvement organization.
* * * * *
    Quality improvement organization means an organization that has a 
contract with CMS, under part B of title XI of the Act, to perform 
utilization and quality control review of the health care furnished, or 
to be furnished, to Medicare beneficiaries, formerly known as a peer 
review organization.
* * * * *

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: March 12, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare and Medicaid Services.
    Approved: April 5, 2002.
Tommy G. Thompson,
Secretary.
[FR Doc. 02-12242 Filed 5-23-02; 8:45 am]
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