[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Pages 30587-30588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15186]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2476-PN]


Medicare and Medicaid Programs; Application by the American 
Association for Accreditation of Ambulatory Surgery Facilities for 
Continued Deeming Authority for Ambulatory Surgical Centers

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the American Association for Accreditation of 
Ambulatory Surgery Facilities (AAAASF) for continued recognition as a 
national accrediting organization for ambulatory surgical centers 
(ASCs) that wish to participate in the Medicare or Medicaid programs. 
The statute requires that we publish, within 60 days of receipt of an 
organization's complete application, a notice identifying the national 
accrediting body making the request, describing the nature of the 
request, and providing at least a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on July 27, 2009.

ADDRESSES: In commenting, please refer to file code CMS-2476-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the instructions under 
the ``More Search Options'' tab.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-2476-PN, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-2476-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments before the close of the comment period 
to either of the following addresses: a. For delivery in Washington, 
DC--Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Room 445-G, Hubert H. Humphrey Building, 200 
Independence Avenue, SW., Washington, DC 20201
    (Because access to the interior of the Hubert H. Humphrey 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 persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636. 
Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following Web site as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that Web site to view public comments.
    Comments received timely will also 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 1-800-743-3951.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from an ambulatory surgical center (ASC) provided 
certain requirements are met. Section 1832(a)(2)(F)(i) of the Social 
Security Act (the Act) establishes distinct criteria for facilities 
seeking designation as an ASC. Regulations concerning provider 
agreements are at 42 CFR part 489 and those pertaining to activities 
relating to the survey and certification of facilities are at 42 CFR 
part 488. The regulations at 42 CFR part 416 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 ASCs.
    Generally, in order to enter into a provider agreement with the 
Medicare program, an ASC must first be certified by a State survey 
agency as complying with the conditions or requirements set forth in 
part 416 of our regulations. Thereafter, the ASC is subject to regular 
surveys by a State survey agency to determine whether it continues to 
meet these requirements. There is an alternative, however, to surveys 
by State agencies.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary as 
having standards for accreditation that meet or exceed Medicare 
requirements, any

[[Page 30588]]

provider entity accredited by the national accrediting body's approved 
program would be deemed to meet the Medicare conditions. A national 
accrediting organization applying for deeming authority under part 488, 
subpart A, must provide us with reasonable assurance that the 
accrediting organization requires the accredited provider entities to 
meet requirements that are at least as stringent as the Medicare 
conditions. Our regulations concerning the reapproval of accrediting 
organizations are set forth at Sec.  488.4 and Sec.  488.8(d)(3). The 
regulations at Sec.  488.8(d)(3) require accrediting organizations to 
reapply for continued deeming authority every 6 years or sooner as 
determined by us. The American Association for Accreditation of 
Ambulatory Surgery Facilities (AAAASF) term of approval as a recognized 
accreditation program for ASCs expires November 26, 2009.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.8(a) 
require that our findings concerning review and reapproval of a 
national accrediting organization's requirements consider, among other 
factors, the applying accrediting organization's: requirements for 
accreditation; survey procedures; resources for conducting required 
surveys; capacity to furnish information for use in enforcement 
activities; monitoring procedures for provider entities found not in 
compliance with the conditions or requirements; and ability to provide 
us with the necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from the receipt of a complete 
application to publish notice of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of 
AAAASF's request for continued deeming authority for ASCs. This notice 
also solicits public comment on whether AAAASF's requirements meet or 
exceed the Medicare conditions for coverage for ASCs.

III. Evaluation of Deeming Authority Request

    The AAAASF submitted all the necessary materials to enable us to 
determine its application to be complete on May 1, 2009. Under Section 
1865(a)(2) of the Act and our regulations at Sec.  488.8 (Federal 
review of accreditation organizations), our review and evaluation of 
AAAASF will be conducted in accordance with, but not necessarily 
limited to, the following factors:
    <bullet> The equivalency of AAAASF's standards for an ASC as 
compared with CMS' ASC conditions for coverage.
    <bullet> AAAASF'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 AAAASF's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
--AAAASF's processes and procedures for monitoring ASCs found out of 
compliance with AAAASF's program requirements. These monitoring 
procedures are used only when AAAASF identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at Sec.  488.7(d).
--AAAASF's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
--AAAASF's capacity to provide us with electronic data and reports 
necessary for effective validation and assessment of the organization's 
survey process.
--The adequacy of AAAASF's staff and other resources, and its financial 
viability.
--AAAASF's capacity to adequately fund required surveys.
--AAAASF's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
--AAAASF'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).

IV. 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.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, 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, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

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

    Dated: June 11, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-15186 Filed 6-25-09; 8:45 am]
BILLING CODE 4120-01-P