[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11130-11132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3259-PN]


Medicare Program; Application by the American Association of 
Diabetes Educators (AADE) for Continued 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 for continued 
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 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on March 26, 2012.

[[Page 11131]]


ADDRESSES: In commenting, please refer to file code CMS-3259-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 this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    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-3259-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-3259-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 before the close of the comment period 
to either of the following addresses:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 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. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 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 FURTHER INFORMATION CONTACT: Jacqueline Leach, (410) 786-4282. 
Kristin Shifflett, (410) 786-4133. Maria Hammel, (410) 786-1775.

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 (DSMT) when ordered by the 
physician (or qualified non-physician practitioner) treating the 
beneficiary's diabetes, provided certain requirements are met. Pursuant 
to our regulations at 42 CFR 410.141(e)(3), we use national accrediting 
organizations to assess whether provider entities meet Medicare 
requirements when providing services for which Medicare payment is 
made. If a provider entity is accredited by an approved accrediting 
organization, it is ``deemed'' to meet applicable Medicare 
requirements.
    Under section 1865(a)(1)(B) 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 part 410, subpart H, to qualify for deeming 
authority. The regulations pertaining to application procedures for 
national accreditation organizations for DSMT 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 our requirements.
    We may approve and recognize a nonprofit 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'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.
    <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(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) request for the Secretary's 
approval of its accreditation program for outpatient DSMT services. The 
AADE submitted all the necessary materials to enable us to make a 
determination concerning its request for re-approval as a deeming 
organization for DSMTs. AADE was initially accredited on March 27, 
2009, for a period of 3 years. This application was determined to be 
complete on January 13, 2012. This notice also solicits public comments 
on the ability of the AADE to continue to develop standards that meet 
or exceed the Medicare conditions for coverage, and apply them to 
entities furnishing outpatient DSMT.

[[Page 11132]]

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 
DSMT 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 decision 
making 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 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.

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.

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

    Dated: February 10, 2012.
Marilyn Tavenner,
Acting CMS Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-4277 Filed 2-23-12; 8:45 am]
BILLING CODE 4120-01-P