[Federal Register: April 24, 2009 (Volume 74, Number 78)]
[Notices]
[Page 18728-18730]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap09-70]
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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