[Federal Register: September 24, 2004 (Volume 69, Number 185)]
[Notices]
[Page 57308-57310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se04-73]
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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