[Federal Register Volume 77, Number 121 (Friday, June 22, 2012)]
[Notices]
[Pages 37680-37681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3265-PN]


Medicare and Medicaid Programs; Application From the 
Accreditation Association for Ambulatory Health Care for Continued 
Approval of Its Ambulatory Surgical Centers Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Accreditation Association for Ambulatory Health 
Care for continued recognition as a national accrediting organization 
for ambulatory surgical centers that participate in the Medicare or 
Medicaid programs. This notice also solicits public comment on whether 
AAAHC's requirements meet or exceed the Medicare conditions for 
coverage.

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-3265-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 (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-3265-PN, P.O. Box 8016, Baltimore, MD 21244-8016.
    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-3265-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: Lillian Williams (410) 786-8636. 
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.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in an ambulatory surgical center (ASC) provided 
certain requirements are met. Section 1832(a)(2)(F)(i) of the Social 
Security Act (the Act) requires ASCs to meet health, safety, and other 
standards specified by the Secretary. 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, 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 482. Thereafter, the ASC is subject to 
regular surveys by a State survey agency to determine whether it 
continues to meet these requirements. However, there is an alternative 
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 would deem those provider entities as having met the 
Medicare 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

[[Page 37681]]

standards for accreditation that meet or exceed Medicare requirements, 
a 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 their 
accreditation programs every 6 years or as determined by CMS.
    The Accreditation Association for Ambulatory Health Care (AAAHC) 
current term of approval for their ASC accreditation program expires on 
December 20, 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 also 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 approval of its ASC accreditation 
program. This notice also solicits public comment on whether AAAHC's 
requirements meet or exceed the Medicare conditions for coverage.

III. Evaluation of Deeming Authority Request

    AAAHC 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. 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 AAAHC would 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.
    + 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 an ASC 
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 CMS with electronic data 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 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 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 14, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-15309 Filed 6-21-12; 8:45 am]
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