[Federal Register Volume 67, Number 101 (Friday, May 24, 2002)]
[Notices]
[Pages 36611-36613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2141-PN]
RIN 0938-ZA35


Medicare and Medicaid Programs; Application by the American 
Osteopathic Association (AOA) for Approval of Deeming Authority for 
Ambulatory Surgical Centers (ASCs)

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces the receipt of an application 
from the American Osteopathic Association (AOA), for recognition as a 
national accreditation program for ambulatory surgical centers that 
wish to participate in the Medicare or Medicaid programs. The Social 
Security Act requires that the Secretary publish a notice identifying 
the national accreditation body making the request, describing the 
nature of the request, and providing at least a 30-day public comment 
period.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on June 24, 2002.

ADDRESSES: In commenting, please refer to file code CMS-2141-PN. 
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-2141-N, P.O. Box 8013, Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be timely 
received 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 443-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Washington, DC 20201, or Room C5-14-03, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    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: Laura A. Weber, (410) 786-0227.

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, 
Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule 
an appointment to view public comments, phone (410) 786-7197.
    Copies: To order copies of the Federal Register containing this 
document, send your request to: New Orders, Superintendent of 
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date 
of the issue requested and enclose a check or money order payable to 
the Superintendent of Documents, or enclose your Visa or Master Card 
number and expiration

[[Page 36612]]

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I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in an ambulatory surgical center (ASC) provided that 
the ASC meets certain requirements. Section 1832(a)(2)(F)(i) of the 
Social Security Act (the Act) includes requirements that an ASC have an 
agreement in effect with the Secretary and that it meet health, safety, 
and other standards specified by the Secretary in regulations. 
Requirements concerning supplier agreements are located in 42 CFR part 
489 and those pertaining to the survey and certification of facilities 
are set forth in 42 CFR part 488.
    In 42 CFR part 416, we specify the conditions that an ASC must meet 
in order to participate in the Medicare program, the scope of covered 
services, and the conditions for Medicare payment for facility 
services.
    For an ASC to enter into an agreement, a State survey agency must 
first certify that the ASC complies with our conditions or 
requirements. Following that certification, the ASC is subject to 
routine monitoring by a State survey agency to ensure continuing 
compliance. As an alternative to surveys by State agencies, section 
1865(b)(1) of the Act provides that, if the Secretary finds that, 
through accreditation by a national accreditation body, a provider 
entity demonstrates that all of our applicable conditions and 
requirements are met or exceeded, the Secretary will deem that the 
provider entity has met the applicable Medicare requirements.
    Section 1865(b)(2) of the Act further requires that the Secretary's 
findings consider the applying accreditation organization's--
    [sbull] Requirements for accreditation;
    [sbull] Survey procedures;
    [sbull] Ability to provide adequate resources for conducting 
required surveys;
    [sbull] Ability to supply information for use in enforcement 
activities;
    [sbull] Monitoring procedures for provider entities found out of 
compliance with the conditions or requirements; and
    [sbull] Ability to provide the Secretary with necessary data for 
validation.
    Section 1865(b)(3)(A) of the Act requires that the Secretary 
publish a notice within 60 days of receipt of a completed application; 
the notice must--
    [sbull] Identify the national accreditation body making the 
request;
    [sbull] Describe the nature of the request; and
    [sbull] Provide at least a 30-day public comment period.
    In addition, we must publish a finding of approval or denial of the 
application within 210 days from the receipt of the completed request.
    The American Osteopathic Association (AOA) previously applied to us 
for deeming authority which we announced in the Federal Register on 
March 14, 2001 (66 FR 14906). However, the organization withdrew its 
application before a final decision was made. We received a revised 
complete application from AOA on April 18, 2002.

II. Determining Compliance--Surveys and Deeming

    A national accrediting organization may request the Secretary to 
recognize its program. The Secretary then examines the national 
accreditation organization's requirements to determine if they meet or 
exceed Medicare standards. If the Secretary recognizes an accreditation 
organization in this manner, any provider accredited by the national 
accrediting body's program that we have approved for that service will 
be ``deemed'' to meet the Medicare conditions of coverage. To date, 
three such organizations have been recognized to have deeming authority 
for their ambulatory surgical programs: The Joint Commission on 
Accreditation of Health Organizations, the Accreditation Association 
for Ambulatory Health Care, and the American Association for 
Accreditation of Ambulatory Surgery Facilities, Inc.
    The purpose of this notice is to notify the public of the request 
of the AOA for approval of its request that the Secretary find that its 
accreditation program for ASCs meets or exceeds Medicare conditions and 
requirements. This notice also solicits public comments on the ability 
of this organization to develop and apply standards that meet or exceed 
the Medicare conditions for coverage to ASCs. Our regulations 
concerning approval of accrediting organizations are set forth in 42 
CFR [sect] 488.4, 488.6, and 488.8.

III. Ambulatory Surgical Center Conditions for Coverage and 
Requirements

    The regulations specifying the Medicare conditions for coverage for 
ASCs are located in 42 CFR part 416. These conditions implement section 
1832(a)(2)(F)(i) of the Act, which provides for Medicare Part B 
coverage of facility services furnished in connection with surgical 
procedures specified by the Secretary under section 1833(i)(1)(a) of 
the Act.
    Under section 1865(b)(2) of the Act and our regulations in 42 CFR 
488.8 (Federal review of accreditation organizations) our review and 
evaluation of a national accreditation organization will be conducted 
in accordance with, but not necessarily limited to, the following 
factors:
    [sbull] The equivalency of an accreditation organization's 
requirements for an entity to our comparable requirements for that 
entity.
    [sbull] The organization's survey process to determine the 
following:
    + The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    + The comparability of its processes to that of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    + The organization's procedures for monitoring providers or 
suppliers found by the organization to be out of compliance with 
program requirements. These monitoring procedures are used only when 
the organization identifies noncompliance. If noncompliance is 
identified through validation reviews, the survey agency monitors 
corrections as specified in 42 CFR 488.7(d).
    + The ability of the organization to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner.
    + The ability of the organization to provide us with electronic 
data in ASCII comparable code, and reports necessary for effective 
validation and assessment of the organization's survey process.
    + The adequacy of staff and other resources, and its financial 
viability.
    + The organization's ability to provide adequate funding for 
performing required surveys.
    + The organization's policies with respect to whether surveys are 
announced or unannounced.
    [sbull] The accreditation organization's agreement to provide us 
with a copy of the most current accreditation survey together with any 
other information related to the survey as we may require (including 
corrective action plans).

[[Page 36613]]

IV. Notice Upon Completion of Evaluation

    Upon completion of our evaluation, including our review of comments 
received as a result of this notice, we will publish a notice in the 
Federal Register announcing the results of our evaluation.

V. Response to Public Comments

    Because of the large number of comments 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 time specified in the DATES section 
of this preamble and will respond to them in a forthcoming rulemaking 
document.

VI. Regulatory Impact Statement

    We have examined the impact of this notice as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects; distributive impacts; and equity).
    The RFA requires agencies to analyze options for regulatory relief 
for small businesses, nonprofit organizations, and government 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 in any 1 year (for details, see the 
Small Business Administration's publication that set forth size 
standards for health care industries at 65 FR 69432). For purposes of 
the RFA, States and individuals are not considered small entities.
    Also, section 1102(b) of the Act requires the Secretary to prepare 
a regulatory impact analysis for any notice that may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. Such an analysis must conform to the provisions of section 
603 of the RFA. For purposes of section 1102(b) of the Act, we consider 
a small rural hospital as a hospital that is located outside of a 
Metropolitan Statistical Area and has fewer than 100 beds.
    This notice merely recognizes AOA as a national accreditation 
organization that has requested approval for deeming authority for 
ambulatory surgical centers that are participating in the Medicare 
program. Since these provider entities must be routinely monitored to 
determine compliance with Medicare requirements, we believe that this 
organization's accreditation program has the potential to reduce both 
the regulatory and administrative burdens associated with the Medicare 
program requirements.
    This notice is not a major rule as defined in Title 5, United 
States Code, section 804(2) and is not an economically significant rule 
under Executive Order 12866.
    Therefore, we have determined, and the Secretary certifies, that 
this proposed notice would not result in a significant impact on small 
entities and would not have an effect on the operations of small rural 
hospitals. Therefore, we are not preparing analyses for either the RFA 
or section 1102(b) of the Act.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any 1 year by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $110 million. This notice would have no consequential effect 
on State, local, or tribal governments. We believe the private sector 
costs of this notice would fall below this threshold as well.
    In accordance with Executive Order 13132, this notice would not 
significantly affect the rights of States and would not significantly 
affect State authority. This notice describes only processes that must 
be undertaken to fulfill our obligation to enforce our regulations as 
required by the April 8, 1997 (62 FR 16985) regulation.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Section 1865(b)(3)(A) of the Social Security Act (42 
U.S.C. 1395bb(b)(3)(A)).

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

    Dated: May 17, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-12929 Filed 5-23-02; 8:45 am]
BILLING CODE 4120-01-P