[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24253-24255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10171]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3316-PN]


Medicare and Medicaid Programs; Application by the American 
Diabetes Association for Continued Deeming Authority for 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 for continued recognition as a 
national accreditation program for accrediting entities that wish to 
furnish outpatient diabetes self-management training to Medicare 
beneficiaries.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on June 1, 2015.

ADDRESSES: In commenting, refer to file code CMS-3316-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-3316-PN, P.O. Box 8010, Baltimore, MD 
21244-8010.
    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-3316-PN, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written ONLY to 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, 
call

[[Page 24254]]

telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members.
    Comments erroneously 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: 

Kristin Shifflett, (410) 786-4133.
Jacqueline Leach, (410) 786-4282.

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 accrediting organization must have an agreement in effect with 
the Secretary of the Department of Health and Human Services (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 the 
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).

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act further requires that we review the 
applying accreditation organization's requirements for accreditation, 
as follows:
     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 organization that is making the request for 
approval or renewal within 60 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 CMS recognizes an accreditation organization in 
this manner, any entity accredited by the national accreditation 
organization's program for that service will be ``deemed'' to meet the 
Medicare conditions for coverage.

III. Evaluation of Deeming Authority Request

    The purpose of this notice is to notify the public of the American 
Diabetes Association (ADA) request for the Secretary's approval of its 
accreditation program for outpatient DSMT services. The ADA submitted 
all the necessary materials to enable us to make a determination 
concerning its request for re-approval as a deeming organization for 
DSMTs. ADA was initially accredited on October 27, 2009 for a period of 
6 years. This application was determined to be complete on March 13, 
2015. This notice also solicits public comments on the ability of the 
ADA to continue to develop standards that meet or exceed the Medicare 
conditions for coverage, and apply them to entities furnishing 
outpatient 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 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 on-site 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. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

[[Page 24255]]

V. 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. 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.

    Dated: April 21, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-10171 Filed 4-29-15; 8:45 am]
 BILLING CODE 4120-01-P