[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29325-29326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3181-PN]


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

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

ACTION: Proposed notice.

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SUMMARY: This proposed notice announces the receipt of an application 
from the American Diabetes Association (ADA) for continued 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 (the Act) 
requires that we 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: Comment Date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on June 25, 2007.

ADDRESSES: In commenting, please refer to file code CMS-3181-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (Fax) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click 
on the link ``Submit electronic comments on CMS regulations with an 
open comment period.'' (Attachments should be in Microsoft Word, 
WordPerfect, or Excel; however, we prefer Microsoft Word.)
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address Only: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-3181-PN, P.O. Box 8017, Baltimore, MD 21244-8017.

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 (one 
original and two copies) to the following address Only: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-3181-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 (one original and two copies) before the 
close of the comment period to one of the following addresses. 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: Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH 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.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.

FOR FURTHER INFORMATION CONTACT: Joan A. Brooks, (410) 786-5526.

SUPPLEMENTARY INFORMATION:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this proposed notice to assist us in fully 
considering the issues. You can assist us by referencing the file code 
CMS-3181-PN and the specific ``issue identifier'' that precedes the 
section on which you choose to comment.
    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 electronic 
comments received before the close of the comment period on its public 
Web site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on 
CMS Regulations'' 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

[If you choose to comment on issues in this section, please include 
the caption ``Background'' at the beginning of your comments.]

    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

[[Page 29326]]

beneficiary's diabetes, provided certain requirements are met. We 
sometimes use national accreditation organizations to assess whether 
provider entities meet Medicare requirements when providing services 
for which Medicare payment is made.
    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 42 
CFR part 410, subpart H to qualify for deeming authority. The 
regulations pertaining to application procedures for national 
accreditation organizations for diabetes self-management training 
services are specified at Sec.  410.142 (CMS 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 CMS's 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 CMS, 
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)(2) of the Act further requires that we review the 
applying accreditation organization's requirements for accreditation, 
as follows:
    <bullet> Survey procedures,
    <bullet> Ability to provide adequate resources for conducting 
required surveys,
    <bullet> Ability to supply information for use in enforcement 
activities,
    <bullet> Monitoring procedures for providers found out of 
compliance with the conditions or requirements, and
    <bullet> 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(b)(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. 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 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 for 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 decision 
making process, and interviewing the organization's staff.

IV. Notice Upon Completion of Our 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 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, 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: May 11, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicare Services.
[FR Doc. 07-2454 Filed 5-24-07; 8:45 am]
BILLING CODE 4120-01-P