[Federal Register Volume 86, Number 79 (Tuesday, April 27, 2021)]
[Notices]
[Pages 22211-22213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3412-PN]


Medicare Program; Application by American Diabetes Association 
(ADA) for Continued CMS Approval of Its Diabetes Outpatient Self-
Management Training Program

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

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the American Diabetes Association (ADA) for continued 
recognition as a national accrediting organization (AO) for accrediting 
entities that wish to furnish diabetes outpatient self-management 
training services to Medicare beneficiaries.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, by May 27, 2021.

ADDRESSES: In commenting, refer to file code CMS-3412-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three 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-3412-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-3412-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Shannon Freeland, (410) 786-4348.
    Caroline Gallaher, (410) 786-8705.
    Lillian Williams, (410) 786-8636.

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 website as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that website to view public comments. CMS will not post on 
Regulations.gov public comments that make threats to individuals or 
institutions or suggest that the individual will take actions to harm 
the individual. CMS continues to encourage individuals not to submit 
duplicative comments. We will post acceptable comments from multiple 
unique commenters even if the content is identical or nearly identical 
to other comments.

I. Background

    Diabetes outpatient self-management training services are defined 
at section 1861(qq)(1) of the Social Security Act (the Act) as 
``educational and training services furnished (at such times as the 
Secretary determines appropriate) to an individual with diabetes by a 
certified provider (as described in paragraph (2)(A)) in an outpatient 
setting by an individual or entity who meets the quality standards 
described in paragraph (2)(B), but only if the physician who is 
managing the individual's diabetic condition certifies that such 
services are needed under a comprehensive plan of care related to the 
individual's diabetic condition to ensure therapy compliance or to 
provide the individual with necessary skills and knowledge (including 
skills related to the self-administration of injectable drugs) to 
participate in the management of the individual's condition.''
    In addition, section 1861(qq)(2)(A) of the Act describes a 
``certified provider'' as a physician, or other individual or entity 
designated by the Secretary of the Department of Health and Human 
Services (the Secretary), that, in addition to providing diabetes 
outpatient self-management training services, provides other items or 
services for which payment may be made under this title. Section 
1861(qq)(2)(B) of the Act further specifies that a physician, or such 
other individual or entity, must meet the quality standards established 
by the Secretary, except that the physician or other individual or 
entity shall be deemed to have met such standards if the physician or 
other individual or entity meets applicable standards originally 
established by the National Diabetes Advisory Board and subsequently 
revised by organizations who participated in the establishment of 
standards by such Board, or is recognized by an organization that 
represents individuals (including individuals under this title) with 
diabetes as meeting standards for furnishing the services.
    Section 1865 of the statute also permits the Secretary to use 
accrediting bodies to determine whether a provider entity meets 
Medicare regulatory quality standards, such as those established for 
diabetes outpatient self-management training service programs. A 
national AO must be approved by CMS and meet the standards and 
requirements specified in 42 CFR part 410, subpart H, to qualify for 
Medicare deeming authority.
    Our regulations pertaining to the application procedures for 
diabetes outpatient self-management training AOs seeking CMS approval 
are set forth at Sec.  410.142. A national accreditation organization 
applying for deeming authority must provide CMS with reasonable 
assurance that it requires the diabetes outpatient self-management 
training suppliers it accredits to meet the CMS' quality standards, the 
National Standards for Diabetes Outpatient Self-Management Education 
and Support (NSDSMES) standards, or an alternative set of standards 
that meet or exceed our requirements that have been developed by that 
AO and have been approved by CMS. (See Sec.  410.144.)

[[Page 22212]]

    Section 410.142(a) states that ``CMS may approve and recognize a 
nonprofit organization with demonstrated experience in representing the 
interests of individuals with diabetes to accredit entities to furnish 
training.'' Therefore, diabetes outpatient self-management training AOs 
must be not-for-profit organizations. The national 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.

II. Approval of Accreditation Organizations

    Section 1865(a)(2) of the Act and Sec.  410.142 require that our 
findings from review of a national AO's application consider, among 
other factors, the applying AO's requirements for accreditation; survey 
procedures; resources for conducting required surveys; capacity to 
furnish information for use in enforcement activities; monitoring 
procedures for provider entities found not in compliance with the 
conditions or requirements; and ability to provide the Secretary with 
the necessary data for validation.
    Section 1865(a)(3) of the Act and Sec.  410.142(d) require that we 
publish, within 60 days after receipt of an organization's complete 
application, a notice identifying the national accrediting body making 
the request, describing the nature of the request, and providing at 
least a 30-day public comment period. Section 1865(a)(3)(A) of the Act 
further states, we have 210 days from the receipt of a complete 
application to publish notice of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of the 
American Diabetes Association's (ADA's) submission of an application 
requesting renewal of the CMS approval for its diabetes outpatient 
self-management training accreditation program. This notice also 
solicits public comment on whether ADA's requirements meet or exceed 
the NSDSMES, which are the accreditation standards used for 
certification of the diabetes outpatient self-management training 
programs accredited by the ADA, pursuant to Sec.  410.144(b).

III. Evaluation of Deeming Authority Request

    The ADA submitted all the necessary materials to enable us to make 
a determination concerning its request for renewed CMS approval of its 
diabetes outpatient self-management training accreditation program. 
This application was determined to be complete on March 1, 2021. Under 
section 1865(a)(2) of the Act and our regulations at Sec.  410.142, our 
review and evaluation of the ADA's application will be conducted in 
accordance with, but not necessarily limited to:
     The requirements and quality standards the ADA uses to 
accredit entities to furnish diabetes self-outpatient management 
training.
     The accreditation process used by ADA to determine the 
following:
    ++ Frequency of accreditation.
    ++ Copies of accreditation forms, guidelines, and instructions to 
evaluators.
    ++ The accreditation review process and the accreditation status 
decision making process.
    ++ The procedures used to notify a deemed diabetes outpatient self-
management training entity of deficiencies in its diabetes outpatient 
self-management training program and the procedures used to monitor the 
correction of those deficiencies.
    ++ The procedures used to enforce compliance with the accreditation 
requirements and standards.
    ++ Detailed information about the individuals who perform 
evaluations for the AO.
    ++ A description of the AO's data management and analysis system 
for its accreditation activities and decisions, including reports, 
tables, and other displays generated by that system.
    ++ A description of the AO's procedures for responding to and 
investigating complaints against an approved entity, including policies 
and procedures regarding coordination of these activities with 
appropriate licensing bodies, ombudsmen programs, and CMS.
    ++ A description of the AO's policies and procedures for 
withholding or removing a certificate of accreditation for failure to 
meet the AO's standards or requirements, and other actions the AO takes 
in response to noncompliance with its standards and requirements.
    ++ A description of all types (for example, full or partial) and 
categories (for example, provisional, conditional, or temporary) of 
accreditation offered by the AO, the duration of each type and category 
of accreditation, and a statement identifying the types and categories 
that will serve as a basis for accreditation if CMS approves the 
organization's, application.
    ++ A list of all of the approved entities currently accredited to 
furnish diabetes outpatient self-management training and the type, 
category, and expiration date of the accreditation held by each of 
them.
    ++ The name and address of each person with an ownership or control 
interest in the AO.
    ++ Documentation that demonstrates ADA's ability to furnish CMS 
with electronic data in CMS-compatible format.
    ++ A resource analysis that demonstrates that ADA's staffing, 
funding, and other resources are adequate to perform the required 
accreditation activities.
    ++ A statement acknowledging that, as a condition for approval and 
recognition by CMS of its accreditation program, ADA agrees to comply 
with the requirements set forth in Sec. Sec.  410.142 through 410.146.
    ++ Additional information CMS requests to enable it to respond to 
the AO's request for CMS approval and recognition of its diabetes 
outpatient self-management training accreditation program.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.

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.).

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.
    The Acting Administrator of the Centers for Medicare & Medicaid 
Services (CMS), Elizabeth Richter, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.


[[Page 22213]]


    Dated: April 22, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-08751 Filed 4-26-21; 8:45 am]
BILLING CODE 4120-01-P