[Federal Register Volume 74, Number 78 (Friday, April 24, 2009)]
[Notices]
[Pages 18728-18730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8782]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2299-PN]


Medicare and Medicaid Programs; Application of the American 
Osteopathic Association for Continued Deeming Authority for Hospitals

AGENCY: Centers for Medicare and Medicaid Services (CMS), 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 Osteopathic 
Association for continued recognition as a national accrediting 
organization for hospitals that wish to participate in the Medicare or 
Medicaid programs.
    Section 1865(a)(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. May 26, 2009.

ADDRESSES: In commenting, please refer to file code CMS-2299-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 instructions under 
the ``More Search Options'' tab.
    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-2299-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 to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-2299-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.

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 a hospital provided certain requirements are met. 
Sections 1861(e) of the Social Security Act (the Act) establish 
distinct criteria for facilities seeking designation as a hospital. 
Regulations concerning provider agreements are located at 42 CFR part 
489 and those pertaining to activities relating to the survey and 
certification of facilities are located at 42 CFR part 488. The 
regulations at 42 CFR part 482, specify the conditions that a hospital 
must meet in order to participate in the Medicare program, the

[[Page 18729]]

scope of covered services and the conditions for Medicare payment for 
Hospitals.
    Generally, in order to enter into a provider agreement with the 
Medicare program, a hospital must first be certified by a State survey 
agency as complying with the conditions or requirements set forth in 
part 482 of CMS regulations. Thereafter, the hospital 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 (as redesignated under section 125 of 
the Medicare Improvements for Patients and Providers Act of 2008 
(MIPPA) (Pub. L. 110-275) 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. (We note that section 125 of MIPPA redesignated 
paragraphs (b) through (e) of section 1865 of the Act as paragraphs (a) 
through (d) respectively). 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). The regulations at Sec.  488.8(d)(3) require 
accrediting organizations to reapply for continued deeming authority 
every 6 years or sooner as determined by CMS.
    The American Osteopathic Association's (AOA) term of approval as a 
recognized accreditation program for hospitals expires September 25, 
2009.

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 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(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's request for continued deeming authority for hospitals. This 
notice also solicits public comment on whether AOA's requirements meet 
or exceed the Medicare conditions for participation for hospitals.

Evaluation of Deeming Authority Request

    AOA submitted all the necessary materials to enable us to determine 
its application to be complete on February 20, 2009. Under section 
1865(a)(2) of the Act and our regulations at Sec.  488.8 (Federal 
review of accreditation organizations), our review and evaluation of 
AOA will be conducted in accordance with, but not necessarily limited 
to, the following factors:
     The equivalency of AOA's standards for a hospital as 
compared with CMS' hospital conditions of participation.
     AOA'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's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    + AOA's processes and procedures for monitoring hospitals found out 
of compliance with AOA's program requirements. These monitoring 
procedures are used only when AOA identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at Sec.  488.7(d).
    + AOA's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    + AOA's capacity to provide us with electronic data and reports 
necessary for effective validation and assessment of the organization's 
survey process.
    + The adequacy of AOA's staff and other resources, and its 
financial viability.
    + AOA's capacity to adequately fund required surveys.
    + AOA's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    + AOA'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).

Response to 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.

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).

VI. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.
    In accordance with Executive Order 13132, we have determined that 
this proposed notice would not have significant effect on the rights of 
State, 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)

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)


[[Page 18730]]


    Dated: April 8, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-8782 Filed 4-23-09; 8:45 am]
BILLING CODE 4120-01-P