[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31361-31362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3264-PN]


Medicare and Medicaid Programs; Application by American 
Osteopathic Association/Healthcare Facilities Accreditation Program 
(AOA/HFAP) for Continuing CMS-Approval of its Ambulatory Surgery Center 
(ASC) Accreditation Program

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from American Osteopathic Association/Healthcare Facilities 
Accreditation Program (AOA/HFAP) for continued recognition as a 
national accrediting organization for ambulatory surgery centers (ASCs) 
that 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 June 25, 2012.

ADDRESSES: In commenting, refer to file code CMS-3264-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    You may submit comments in one of four ways (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-3264-PN, P.O. Box 8016, 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 (one 
original and two copies) to the following address only: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-3264-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 before only to 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, 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 section entitled SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Barbara Easterling, (410) 786-0416, 
Patricia Chmielewski, (410) 786-6899 or 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

    Section 1865(a)(3)(A) of the Social Security Act (the 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. 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 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. 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 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 
approval of its accreditation program under part 488, subpart A, must 
provide us with reasonable assurance that the

[[Page 31362]]

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 sooner as determined by CMS.
    The American Osteopathic Association/Healthcare Facilities 
Accreditation Program's (AOA/HFAP) current term of approval for their 
ASC accreditation program expires October 23, 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 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 AOA/
HFAP's request for continued approval of its ASC accreditation program. 
This notice also solicits public comment on whether AOA/HFPA's 
requirements meet or exceed the Medicare conditions for coverage for 
ASCs.

III. Evaluation of Deeming Authority Request

    AOA/HFAP 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 March 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 AOA/HFAP will be conducted 
in accordance with, but not necessarily limited to, the following 
factors:
     The equivalency of AOA/HFAP's standards for an ASC as 
compared with CMS' ASC conditions for coverage.
     AOA/HFAP'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 AOA/HFAP's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
     AOA/HFAP's processes and procedures for monitoring an ASC 
found out of compliance with AOA/HFAP's program requirements. These 
monitoring procedures are used only when AOA/HFAP 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).
     AOA/HFAP's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
     AOA/HFAP'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 AOA/HFAP's staff and other resources, and 
its financial viability.
     AOA/HFAP's capacity to adequately fund required surveys.
     AOA/HFAP's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
     AOA/HFAP'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--Ambulatory surgery center 
Insurance Program; and No. 93.774, Medicare--Supplementary Medical 
Insurance Program)


    Dated: May 16, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-12823 Filed 5-24-12; 8:45 am]
BILLING CODE 4120-01-P