[Federal Register Volume 66, Number 124 (Wednesday, June 27, 2001)]
[Notices]
[Pages 34223-34225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16025]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-3072-PN]
Medicare Program; Application by the American Diabetes
Association (ADA) for Recognition as a National Accreditation Program
for Accrediting Entities to Furnish Outpatient Diabetes Self-Management
Training
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed notice.
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SUMMARY: In this proposed notice, we announce the receipt of an
application from the American Diabetes Association (ADA) for
recognition as a national accreditation program for accrediting
entities that wish to furnish outpatient diabetes self-management
training to Medicare beneficiaries. Section 1865(b)(3) of the Social
Security Act requires that the Secretary publish 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.
DATES: We will consider comments if we receive them at the appropriate
address, as provided below, no later than 5 p.m. on July 27, 2001.
ADDRESSES: In commenting, please refer to file code HCFA-3072-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission. Mail written comments (one original and
three copies) to the following address ONLY: Health Care Financing
Administration, Department of Health and Human Services, Attention:
HCFA-3072-PN, P.O. Box 8016, Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be timely
received in the event of delivery delays.
If you prefer, you may deliver (by hand or courier) your written
comments (one original and three copies) to one of the following
addresses: Room 443-G, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201, or Room C5-16-03, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
[[Page 34224]]
Comments mailed to the above addresses may be delayed and received
too later for us to consider them.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Joan A. Brooks, (410) 786-5526.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: Comments received timely will be
available for public inspection as they are received, generally
beginning approximately 3 weeks after publication of a document, at the
headquarters of the Health Care Financing Administration, 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 (410) 786-7195 or (410) 786-5241.
I. Background
Under the Medicare program, eligible beneficiaries may receive
outpatient diabetes self-management training when ordered by the
physician (or qualified nonphysician practitioner) treating the
beneficiary's diabetes, provided certain requirements are met. We
sometimes use national accrediting organizations to determine whether
an entity meets some or all of the requirements that are necessary to
provide a service for which Medicare payment can be made. Accreditation
is authorized by section 1865 of the Social Security Act (the Act) and
our regulations in 42 CFR part 410, subpart H.
Under section 1865(b)(1) of the Act, a national accreditation
organization must have an agreement in effect with the Secretary and
meet the standards and requirements specified by the Secretary in part
410, subpart H. The regulations pertaining to application procedures
for national accreditation organizations for diabetes self-management
training services are at Sec. 410.142 (HCFA process for approving
national accreditation organizations). A national accreditation
organization applying for deeming authority must provide us with
reasonable assurance that the accrediting organization requires
accredited entities to meet requirements that are at least as stringent
as HCFA's. We may approve and recognize a nonprofit or not-for-profit
organization with demonstrated experience in representing the interests
of individuals with diabetes to accredit entities to furnish training.
The accreditation organization, after being approved and recognized by
HCFA, may accredit an entity to meet one of the sets of quality
standards in Sec. 410.144 (Quality standards for deemed entities).
Section 1865(b)(1) of the Act, provides that if the Secretary finds
that accreditation of an entity by a national accreditation body
demonstrates that all of the applicable conditions and requirements are
met or exceeded, the Secretary shall deem those entities as meeting the
applicable Medicare requirements. Section 1865(b)(2) of the Act further
requires that the Secretary's findings consider the applying
accreditation organization's requirements for accreditation, its survey
procedures, its ability to provide adequate resources for conducting
required surveys and its ability to supply information for use in
enforcement activities, its monitoring procedures for entities found
out of compliance with the conditions or requirements, and its ability
to provide the Secretary with necessary data for validation. The
Secretary then examines the national accreditation organization's
accreditation requirements to determine if they meet or exceed the
Medicare conditions as we would have applied them. Section
1865(b)(3)(A) of the Act requires that the Secretary publish within 60
days of receipt of a completed 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.
In addition, the Secretary has 210 days from receipt of the request to
publish a finding of approval or denial of the application. If the
Secretary recognizes an accreditation organization in this manner, any
entity accredited by the national accreditation body's HCFA-approved
program for that service will be ``deemed'' to meet the Medicare
conditions of coverage.
II. Purpose
The purpose of this notice is to notify the public of the American
Diabetes Association's (ADA's) request for the Secretary's approval of
its accreditation program for outpatient diabetes self-management
training services. This notice also solicits public comments on the
ability of the ADA to develop and apply its standards to entities
furnishing outpatient diabetes self-management training services that
meet or exceed the Medicare conditions for coverage.
III. Outpatient Diabetes Self-Management Training Services
Conditions for Coverage and Requirements
The regulations specifying the Medicare conditions for coverage for
outpatient diabetes self-management training services are located in 42
CFR part 410, subpart H. These conditions implement section 1861(qq) of
the Act, which provides for Medicare Part B coverage of outpatient
diabetes self-management training services specified by the Secretary.
Under section 1865(b)(2) of the Act and our regulations at
Secs. 410.142 (HCFA process for approving national accreditation
organizations) and 410.143 (Requirements for approved accreditation
organizations), we review and evaluate a national accreditation
organization based on (but not necessarily limited to) the criteria set
forth in Sec. 410.142(b).
We may visit the prospective organization's offices to verify
information in the organization's application, including, but not
limited to, review of documents, and interviews with the organization's
staff. We may conduct onsite inspection of a national accreditation
organization's operations and office to verify information and assess
the organization's compliance with its own policies and procedures. The
onsite inspection may include, but is not limited to, reviewing
documents, auditing documentation of meetings concerning the
accreditation process, evaluating accreditation results or the
accreditation status decisionmaking process, and interviewing the
organization's staff.
IV. Notice Upon Completion of Evaluation
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a notice in the
Federal Register announcing the result of our evaluation.
V. Responses to Public Comments
Because of the large number of 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 notice and will respond to them in a forthcoming rulemaking
document.
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget did not review this notice.
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb).
(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare-
Hospital Insurance Program; and No. 93.774, Medicare-Supplementary
Medical Insurance Program)
[[Page 34225]]
Dated: June 17, 2001.
Thomas A. Scully, Administrator,
Health Care Financing Administration.
[FR Doc. 01-16025 Filed 6-26-01; 8:45 am]
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