[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36520-36522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2897-PN]


Medicare and Medicaid Programs; Application by the Accreditation 
Association for Ambulatory Health Care for Continued Deeming Authority 
for Ambulatory Surgical Centers

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of a deeming 
application from the Accreditation Association for Ambulatory Health 
Care (AAAHC) for continued recognition as a national accrediting 
organization for ambulatory surgical centers (ASCs) that wish to 
participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) 
of the Social Security Act requires that within 60 days of receipt of 
an organization's complete application, we publish a notice that 
identifies the national accrediting body making the request, describes 
the nature of the request, and provides 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. e.s.t. on July 27, 
2008.

ADDRESSES: In commenting, please refer to file code CMS-2897-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the instructions for 
``Comment or Submission'' and enter the file code to find the document 
accepting comments.
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-2897-PN, P.O. Box 8013, Baltimore, MD 21244----.

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    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 (one 
original and two copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-2897-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 (one original and two copies) before the 
close of the comment period to either of the following addresses:
    a. Room 445-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Washington, DC 20201
    (Because access to the interior of the Hubert H. Humphrey (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 persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. 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: Aviva Walker-Sicard, (410) 786-8648, 
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) authorizes the Secretary to establish 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 part 488. Part 416 specifies 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 an 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. 
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 to surveys by State agencies, which is 
accreditation.
    Section 1865(b)(1) of the Act provides that, if an ASC demonstrates 
through accreditation by an approved national accrediting organization 
that all applicable Medicare conditions are met or exceeded, we will 
deem those ASCs 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 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). Section 488.8(d)(3) requires accrediting 
organizations to reapply for continued deeming authority every 6 years 
or sooner as determined by us.
    AAAHC's term of approval as a recognized accreditation program for 
ASCs expires December 20, 2008.

II. Approval of Deeming Organizations

    Section 1865(b)(2) of the Act and Sec.  488.8(a) of the regulations 
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(b)(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 
AAAHC's request for continued deeming authority for ASCs. This notice 
also solicits public comment on whether AAAHC's requirements meet or 
exceed the Medicare conditions for coverage for ASCs.

III. Evaluation of Deeming Authority Request

    AAAHC submitted all the necessary materials to enable us to make a 
determination concerning its request for reapproval as a deeming 
organization for ASCs. This application was determined to be complete 
on May 2, 2008. Under section 1865(b)(2) of the Act and Sec.  488.8 
(Federal review of accrediting organizations), our review and 
evaluation of AAAHC will be conducted in accordance with, but not 
necessarily limited to, the following factors:
     The equivalency of AAAHC's standards for an ASC as 
compared with CMS' ASC conditions for coverage.
     AAAHC'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.

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    ++ The comparability of AAAHC's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ AAAHC's processes and procedures for monitoring ASCs found out 
of compliance with AAAHC's program requirements. These monitoring 
procedures are used only when AAAHC identifies noncompliance. If 
noncompliance is identified through validation reviews or complaint 
surveys, the State survey agency monitors corrections as specified at 
Sec.  488.7(d).
    ++ AAAHC's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ AAAHC's capacity 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 AAAHC's staff and other resources, and its 
financial viability.
    ++ AAAHC's capacity to adequately fund required surveys.
    ++ AAAHC's policies with respect to whether surveys are announced 
or unannounced, to assure that surveys are unannounced.
    ++ AAAHC'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. Response to Public Comments and Notice Upon Completion of 
Evaluation

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

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 (44 U.S.C. 35 et seq.).

VI. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866 
(September 1993, Regulatory Planning and Review, the Regulatory 
Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354)), the Office 
of Management and Budget did not review this proposed notice.
    In accordance with Executive Order 13132, we have determined that 
this proposed notice would not have a significant effect on the rights 
of States, local or tribal governments.

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

(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 10, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-14647 Filed 6-26-08; 8:45 am]
BILLING CODE 4120-01-P