[Federal Register Volume 77, Number 121 (Friday, June 22, 2012)]
[Notices]
[Pages 37678-37680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3262-PN]


Medicare and Medicaid Programs; Application From American 
Association for Accreditation of Ambulatory Surgery Facilities for 
Continued Approval of Its Ambulatory Surgery Facilities Accreditation 
Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: This proposed notice with comment period 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 
surgery centers (ASCs) wish to participate in the Medicare or Medicaid 
programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on July 23, 2012.

ADDRESSES: In commenting, please refer to file code CMS-3262-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 ``Submit a 
comment'' instructions.
    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-3262-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-3262-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) 786-7195 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:
Georganne Kuberski, (410) 786-0799.
Patricia Chmielewski, (410) 786-6899.
Cindy Melanson, (410) 786-0310.

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.

[[Page 37679]]

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in an ambulatory surgery center (ASC) that meet 
certain requirements. 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 an agreement, 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. However, ASC's have an 
alternative to surveys by State agencies for participation in the 
Medicare program.
    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 would 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 provider entity accredited by the national 
accrediting body's approved program would be deemed to have met the 
Medicare conditions. A national accrediting organization applying for 
approval of its accreditation program 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 approval 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 approval of 
its accreditation program every 6 years or as determined by CMS.
    American Association for Accreditation of Ambulatory Surgery 
Facilities (AAAASF's) current term of approval for their ASC 
accreditation program expires November 27, 2012.

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 approval 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 
CMS 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 approval of its ASC accreditation 
program. This notice also solicits public comment on whether AAAASF's 
requirements meet or exceed the Medicare conditions for participation 
for ASCs.

III. Evaluation of Deeming Authority Request

    AAAASF submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its ASC 
accreditation program. This application was determined to be complete 
on April 27, 2012. Section 1865(a)(3)(A) of the Act, requires that 
within 60 days of receipt of an organization's complete application to 
be a CMS-approved accrediting organization, 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. Under section 1865(a)(2) of the Act and our regulations 
at Sec.  488.8 (Federal review of accrediting organizations), our 
review and evaluation of AAAASF would be conducted in accordance with, 
but not necessarily limited to, the following factors:
     The equivalency of AAAASF's standards for an ASC as 
compared with CMS' conditions for coverage.
     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 an ASC 
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 or complaint surveys, 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 CMS 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 CMS 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 (44 U.S.C. 35).

V. Response to Public 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

[[Page 37680]]

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.

    (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 12, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-15293 Filed 6-21-12; 8:45 am]
BILLING CODE 4120-01-P