[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57825-57826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3316-FN]


Medicare and Medicaid Programs; Continued Approval of the 
American Diabetes Association as an Accrediting Organization for 
Diabetes Self-Management Training Programs

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

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve 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 (DSMT) to Medicare 
beneficiaries.

DATES: This final notice is effective September 25, 2015 through 
September 27, 2021.

FOR FURTHER INFORMATION CONTACT: Kristin Shifflett, (410) 786-4133; 
Jacqueline Leach, (410) 786-4282.

SUPPLEMENTARY INFORMATION: 

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 by the 
provider. Pursuant to our regulations at 42 CFR 410.141(e)(3), we use 
national accrediting organizations (NAOs) to assess whether provider 
entities meet Medicare requirements when providing DSMT 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.
    A NAO must meet the standards and requirements specified by the 
Secretary of the Department of Health and Human Services in our 
regulations under part 410, subpart H, to qualify for deeming 
authority. The regulations pertaining to application procedures for 
NAOs for DSMT are specified at Sec.  410.142 (CMS process for approving 
NAOs).
    A NAO 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 DSMT. 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(a)(2) of the Social Security Act (the Act) 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.
     Ability to provide CMS with necessary data for validation.
    We then examine the NAO's accreditation requirements to determine 
if they meet or exceed the Medicare conditions as we would have applied 
them.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-approval of an 
accreditation program is conducted in a timely manner. The Act provides 
us 210 days after the date of receipt of a complete application, with 
any documentation necessary to make the determination, to complete our 
survey activities and application process. Within 60 days after 
receiving a complete application, we must publish a notice in the 
Federal Register that identifies the national accrediting body making 
the request, describes the request, and provides no less than a 30-day 
public comment period. At the end of the 210-day period, we must 
publish a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice

    On April 30, 2015, we published a proposed notice in the Federal 
Register (80 FR 24253) entitled ``Application by the American Diabetes 
Association for Continued Deeming Authority for Diabetes Self-
Management Training,'' announcing the receipt of an application from 
the ADA for continued recognition as a national accreditation program 
for accrediting entities that wish to furnish outpatient DSMT to 
Medicare beneficiaries.

[[Page 57826]]

    In that notice, we detailed our evaluation criteria. Under section 
1865(a)(2) of the Act and our regulations at Sec.  410.142 and Sec.  
410.143, we conducted a review of ADA's NAO based on the criteria set 
forth in Sec.  410.142(b), which include, but are not limited to the 
following: (1) A review of the NAO's operations and office to verify 
information in the organization's application and assess the 
organization's compliance with its own policies and procedures; (2) 
evaluating accreditation results or the accreditation status decision 
making process; and (3) interviewing the organization's staff.
    The April 30, 2015 proposed notice also solicited public comments 
on the ability of ADA to continue to develop standards that meet or 
exceed the Medicare conditions for coverage and apply them to accredit 
entities to furnish training. We received no public comments in 
response to our proposed notice.

IV. Provisions of the Final Notice

    ADA's application to continue as an accredited NAO to deem entities 
for the purposes of DSMT is approved for a period of 6 years. The 
accreditation is effective on September 25, 2015. This approval is 
subject to renewal subsequent to the receipt of an application from the 
ADA and subject to review, evaluation, and approval of its program.
    Based on our review and observations described in section III of 
this final notice, we approve ADA as a NAO for entities furnishing DSMT 
that request participation in the Medicare program, effective September 
25, 2015 through effective September 27, 2021.

V. 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.).

    Dated: September 17, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-24358 Filed 9-24-15; 8:45 am]
 BILLING CODE 4120-01-P