[Federal Register Volume 73, Number 207 (Friday, October 24, 2008)]
[Notices]
[Pages 63483-63485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3205-PN]


Medicare Program; Application by the American Association of 
Diabetes Educators (AADE) for Recognition as a National Accreditation 
Organization for Accrediting Entities To Furnish Outpatient Diabetes 
Self-Management Training

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces the receipt of an application 
from the American Association of Diabetes Educators (AADE) for 
recognition as a national accreditation program for accrediting 
entities that wish to furnish outpatient diabetes self-management 
training to Medicare beneficiaries. The statute 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: To be assured consideration, comments must be received at one of 
the addresses provided below no later than 5 p.m. on November 24, 2008.

ADDRESSES: In commenting, please refer to file code CMS-3205-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 specific 
issues in 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-3205-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-3205-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

[[Page 63484]]

    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original) before the close of the 
comment period to one of the following addresses:
    a. 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. 7500 Security Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-9994 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: Joan A. Moliki, (410) 786-5526.

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 
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 Medicare requirements when providing 
services for which Medicare payment is made.
    Under section 1865(a)(1) of the Social Security Act (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 42 CFR 410, subpart H to qualify for deeming 
authority. The regulations pertaining to application procedures for 
national accreditation organizations for diabetes self-management 
training are specified at Sec.  410.142 (CMS process for approving 
national accreditation organizations). One of the regulations requires 
national accreditation organizations applying for deeming authority to 
provide us with reasonable assurance that the accrediting organization 
requires accredited entities to meet requirements that are at least as 
stringent as our requirements.
    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 
us, may accredit an entity to meet one of the sets of quality standards 
in Sec.  410.144 (Quality standards for deemed entities).
    Section 1865(a)(2) of the Act further requires that we review the 
applying accreditation organization as follows:
     The organization's requirements for accreditation,
     Survey procedures,
     Ability to provide adequate resources for conducting 
required surveys,
     Ability to supply information for use in enforcement 
activities,
     Monitoring procedures for providers found out of 
compliance with the conditions or requirements, and
     Ability to provide us with necessary data for validation.
    We then examine 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(a)(3)(A) of the Act requires that we publish a notice identifying 
the national accreditation body making the request within 30 days of 
receipt of a completed application. The notice must describe the nature 
of the request and provide at least a 30-day public comment period. We 
have 210 days from receipt of the request to publish a finding of 
approval or denial of the application. If we recognize 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 for coverage.

II. Provisions of the Proposed Notice

    The purpose of this notice is to notify the public of the American 
Association of Diabetes Educators (AADE'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 AADE to develop standards that meet or exceed the 
Medicare conditions for coverage, and apply them to entities furnishing 
outpatient diabetes self-management training.

Conditions for Coverage and Requirements for Outpatient Diabetes Self-
Management Training Services

    The regulations specifying the Medicare conditions for coverage for 
outpatient diabetes self-management training services are located in 42 
CFR parts 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(a)(2) of the Act and our regulations at Sec.  
410.142 (CMS process for approving national accreditation 
organizations) and Sec.  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 conduct on-site inspections of a national accreditation 
organization's operations and office to verify information in the 
organization's application 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.

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

[[Page 63485]]

Register announcing the result of our evaluation.

III. 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. Chapter 35)

IV. 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.
    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare-Hospital Insurance Program; and No. 93.774, Medicare-
Supplementary Medical Insurance Program)

    Dated: October 9, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-25195 Filed 10-23-08; 8:45 am]
BILLING CODE 4120-01-P