[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57308-57310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2208-PN]
RIN 0938-AZ59


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice with comment period acknowledges the 
receipt of an application from the American Osteopathic Association 
(AOA) for continued recognition as a national accreditation program for 
hospitals that wish to participate in the Medicare or Medicaid 
programs. Section 1865(b)(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.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on October 25, 2004.

ADDRESSES: In commenting, please refer to file code CMS-2208-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.)
    2. By 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-2208-
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 hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. 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; Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH 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.)

[[Page 57309]]

    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.

FOR FURTHER INFORMATION CONTACT: Marjorie Eddinger (410) 786-0375.

I. Background

[If you choose to comment on issues in this section, please include the 
caption ``Background'' at the beginning of your comments.]

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a hospital facility provided certain requirements 
are met. Sections 1861(e) of the Social Security Act (the Act) 
establishes distinct criteria for facilities seeking designation as a 
hospital. 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 482 specify the conditions that a Hospital must meet to 
participate in the Medicare program.
    Generally, to enter into an agreement, a hospital provider must 
first be certified by a State survey agency as complying with the 
conditions or standards set forth in part 482 of our regulations. Then, 
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(b)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national 
accreditation organization that all applicable Medicare conditions are 
met or exceeded, we would ``deem'' those provider entities as having 
met the requirements. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation.
    If an accreditation 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 accreditation organization applying for 
approval of deeming authority under 42 CFR part 488, subpart A must 
provide us with reasonable assurance that the accreditation 
organization requires the accredited provider entities to meet 
requirements that are at least as stringent as the Medicare conditions. 
Our regulations concerning 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 accreditation organizations to reapply for 
continued approval of deeming authority every 6 years or sooner as 
determined by CMS.
    The AOA's term of approval as a recognized accreditation program 
for hospitals expires March 31, 2005.

II. Approval of Deeming Organizations

    [If you choose to comment on issues in this section, please include 
the caption ``Approval of Deeming Organizations'' at the beginning of 
your comments.]
    Section 1865(b)(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 reapplying accreditation 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(b)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an accreditation organization's complete 
application, a notice identifying the national accreditation 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 our 
receipt of a completed application to publish approval or denial of the 
application.
    The purpose of this proposed notice is to inform the public of our 
consideration of AOA's request for approval of continued deeming 
authority for hospitals. This notice also solicits public comment on 
whether AOA requirements meet or exceed the Medicare conditions for 
participation for hospitals.

III.Evaluation of Deeming Authority Request

[If you choose to comment on issues in this section, please include the 
caption ``Evaluation of Deeming Request'' at the beginning of your 
comments.]

    On June 30, 2004, AOA submitted all the necessary materials to 
enable us to make a determination concerning its request for reapproval 
as a deeming organization for hospitals. Under section 1865(b)(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 standards for hospitals as compared 
with our comparable 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 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 providers or 
suppliers found out of compliance with AOA program requirements. These 
monitoring procedures are used only when AOA identifies noncompliance. 
If noncompliance is identified through validation reviews, the 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 capacity to provide us with electronic data in ASCII 
comparable code, 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.
    + 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).

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 published for comment, 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 will respond to the public comments in the 
preamble to that document.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we

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will publish a final notice in the Federal Register announcing the 
result of our evaluation. In accordance with the provisions of 
Executive Order 12866, the Office of Management and Budget did not 
review this proposed notice.

V. Regulatory Impact Statement

    In accordance with Executive Order 12866, this notice was not 
reviewed by the Office of Management and Budget.

    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; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: September 10, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-21196 Filed 9-23-04; 8:45 am]
BILLING CODE 4120-01-P