[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]
BILLING CODE 4120-01-P