[Federal Register Volume 66, Number 208 (Friday, October 26, 2001)]
[Notices]
[Pages 54262-54263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25770]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Center for Medicare & Medicaid Services

[CMS-3076-PN]


Medicare Program: Application by the Indian Health Service for 
Recognition as a National Accreditation Organization for Accrediting 
American Indian and Alaska Native Entities To Furnish Outpatient 
Diabetes Self-Management Training

AGENCY: Center for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed notice.

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SUMMARY: In this proposed notice, we announce the receipt of an 
application from the Indian Health Service (IHS) for CMS recognition as 
a national accreditation organization for accrediting American Indian 
and Alaska Native 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 November 26, 2001.

ADDRESSES: In commenting, please refer to file code CMS-3076-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: Center for Medicare and 
Medicaid Services, Department of Health and Human Services, Attention: 
HCFA-3076-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 C5-14-03, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    Comments mailed to the above addresses may be delayed and received 
too late for us to consider them.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Eva Fung, (410) 786-7539, or 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 Center for 
Medicare and 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 (410) 
786-7195 or (410) 786-5241.

I. Background

    Section 4105 of the Balanced Budget Act of 1997 authorized expanded 
Medicare coverage for outpatient diabetes self-management training when 
ordered by the physician (or qualified non-physician 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. 
Reliance on accreditation organizations is authorized by section 1865 
of the Social Security Act (the Act) and our regulations in 42 CFR part 
410, subpart H. A national accreditation organization must have an 
agreement in effect with the Secretary and must meet the standards and 
requirements specified in section 1865(b)(2) of the Act and 42 CFR part 
410. The applicable regulations require a national organization 
applying to become a body accrediting entities that furnish such 
training to use one of three types of quality standards: CMS's own 
standards, the standard developed by a national advisory group 
(referred to as the NSDSMEP), or other standards that we determine meet 
or exceed our standards. The accreditation organization, after being 
approved and recognized by CMS, may accredit an entity to meet one of 
the sets of quality standards in Sec. 410.144 (Quality standards for 
deemed entities).
    The regulations pertaining to application procedures for national 
accreditation organizations for diabetes self-management training 
services are at Sec. 410.142 (CMS process for approving national 
accreditation organizations). 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.
    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 CMS's. 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 will deem those entities as meeting the 
applicable Medicare requirements. Section 1865(b)(2) of the Act further 
requires

[[Page 54263]]

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 supplying 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 CMS-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 Indian 
Health Service's (IHS) request for the Secretary's approval as a 
national accreditation organization for accrediting American Indian and 
Alaska Native entities to furnish outpatient diabetes self-management 
training services. The IHS proposes to endorse the NSDSMEP as its 
quality standards. This notice also solicits public comments on the 
ability of the IHS to develop and apply its standards to entities 
furnishing outpatient diabetes self-management training services that 
meet or exceed the Medicare conditions for coverage.
    We understand the current template for the proposed notice includes 
only the identity of the organization seeking to become an accrediting 
body, but no other information on its proposed program to inform those 
proposing to comment in response to the notice. Since our regulation 
highlights the quality standards as a key factor in our determination 
of whether or not to accept an entity as an accrediting body, some 
basic information on this subject would make comments we receive more 
useful and relevant to our decision, both in the IHS case and in other 
cases.

III. Outpatient Diabetes Self-Management Training 
ServicesConditions 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 (CMS process for approving national accreditation 
organizations) and 410.143 (Requirements for approved accreditation 
organizations), we evaluate a national accreditation organization based 
on (but not necessarily limited to) the criteria set forth in 
Sec. 410.142(b), and we review the ongoing responsibilities of an 
approved accreditation organization.
    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. For oversight activities, we may conduct an onsite visit to 
inspect the approved accreditation organization's operations and office 
in order to assess its 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 decision making process, and interviewing the 
organization's staff.

IV. Notices Upon Completion of Evaluation

    The process for becoming an accrediting body, as outlined in the 
regulation, includes two Federal Register notices. The first notice 
would solicit comments on the accreditation organization's proposed 
accreditation program. Upon completion of our evaluation, including 
evaluation of comments received as a result of this notice, we will 
publish the second notice announcing CMS's approval or disapproval of 
the organization as an accrediting body.

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 notice 
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)

    Dated: October 1, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-25770 Filed 10-25-01; 8:45 am]
BILLING CODE 4120-01-P