[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 66929-66930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27962]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2901-PN]


Medicare and Medicaid Programs; The American Association for 
Accreditation of Ambulatory Surgery Facilities for Approval of Deeming 
Authority for Rural Health Clinics

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice with comment period acknowledges the 
receipt of a deeming application from the American Association for 
Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition 
as a national accrediting organization for rural health clinics (RHCs) 
that wish to participate in the Medicare or Medicaid programs. The 
statute 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. on November 28, 
2011.

ADDRESSES: In commenting, please refer to file code CMS-2901-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 
notice 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-2901-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-2901-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments only to the following addresses prior to 
the close of the comment period:
    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, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously 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: L. Tyler Whitaker, (410) 786-5236. 
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 rural health clinic (RHC) provided certain 
requirements are met. Sections 1861(aa) of the Social Security Act (the 
Act) establish distinct criteria for facilities seeking designation as 
RHCs. Regulations concerning provider agreements are at 42 CFR part 489 
and those pertaining to activities relating to the survey and 
certification

[[Page 66930]]

of facilities are at 42 CFR part 488. The regulations at 42 CFR part 
491, subpart A, specify the conditions that an RHC must meet in order 
to participate in the Medicare program, the scope of covered services, 
and the conditions for Medicare payment for RHCs.
    Generally, in order to enter into a provider agreement with the 
Medicare program, an RHC must first be certified by a State survey 
agency as complying with the conditions or requirements set forth in 
part 42 CFR part 491, subpart A, of our regulations. Thereafter, the 
RHC 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 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 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. The regulations at Sec.  
488.8(d)(3) require accrediting organizations to reapply for continued 
deeming authority every 6 years or as we determine.

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 
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 a notice of approval or denial of the 
application.
    The purpose of this proposed notice is to inform the public of 
American Association for Accreditation of Ambulatory Surgery Facilities 
(AAAASF's) request for deeming authority for RHCs. This notice also 
solicits public comment on whether AAAASF's requirements meet or exceed 
the Medicare conditions for coverage for RHCs.

III. Evaluation of Deeming Authority Request

    AAAASF submitted all the necessary materials to enable us to make a 
determination concerning its request for approval as a deeming 
organization for RHCs. This application was determined to be complete 
on August 29, 2011. 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 the AAAASF would be 
conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of AAAASF's standards for RHCs as compared 
with CMS' RHC 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 the AAAASF's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
--The processes and procedures AAAASF uses for monitoring RHCs 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).
--The capacity AAAASF uses to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
--The capacity AAAASF uses 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.
--The capacity AAAASF uses to adequately fund required surveys.
--The policies AAAASF uses with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
--The agreement AAAASF uses 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 received 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).

(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: October 13, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-27962 Filed 10-27-11; 8:45 am]
BILLING CODE 4120-01-P