[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53317-53319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20943]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3412-FN]


Medicare Program; Application by the 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: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
American Diabetes Association (ADA) application 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: This final notice is effective on September 27, 2021 through 
September 27, 2027.

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

SUPPLEMENTARY INFORMATION:

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 Act 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 programs. These 
accrediting bodies determine whether a diabetes outpatient self-
management training supplier meets the Medicare regulatory quality 
standards established for diabetes outpatient self-management training 
service programs. A national accrediting organization (AO) must be 
approved by the Centers for Medicare & Medicaid Services (CMS) and meet 
the standards and requirements specified in 42 CFR part 410, subpart H, 
to qualify for Medicare deeming authority.
    Our regulations regarding the application procedures for diabetes 
outpatient self-management training AOs seeking CMS approval are set 
forth at 42 CFR 410.142. A national accreditation organization applying 
for deeming authority must provide CMS with reasonable assurance that 
it will require the diabetes outpatient self-management training 
suppliers it accredits to meet the CMS quality standards, the National 
Standards for Diabetes 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 that have been 
approved by CMS (see 42 CFR 410.144) .
    Section 410.142(a) of our regulations 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, all diabetes outpatient 
self-management training AOs must be not-for-profit organizations.

[[Page 53318]]

    Section 410.142(b) of our regulations require a diabetes outpatient 
self-management training AO to submit specific documents and 
information with their application, as discussed in section II of this 
final notice.

II. Provisions of the Proposed Notice

    On April 27, 2021, we published a proposed notice in the Federal 
Register (86 FR 22211) acknowledging receipt of the American Diabetes 
Association's (ADA's) request for continued CMS approval of its 
diabetes outpatient self-management training accreditation program. In 
that proposed notice, we detailed our evaluation criteria.
    Under section1861(qq) of the Act and our regulations at Sec.  
410.142, we conducted a review of the ADA's diabetes outpatient self-
management training program application using the criteria specified by 
our regulations, which include authorization for CMS to conduct an 
onsite visit to verify information in the organization's application. 
For an onsite visit, the CMS review team travels to the AO's corporate 
office to review specific information and documents. An onsite visit is 
typically part of every application review. However, due to the COVID-
19 pandemic, it was not possible for us to conduct an onsite visit for 
the ADCES. We conducted our review virtually, using remote means to 
access and review the necessary information. During this virtual 
review, we reviewed documentation including the ADA's: (1) Corporate 
policies; (2) financial and human resources records; (3) policies and 
procedures, including those for training, monitoring, and evaluation of 
its surveyors and investigating and responding appropriately to 
complaints against accredited diabetes outpatient self-management 
training suppliers; and (4) survey review and decision-making process 
for accreditation. This is the same information that would have been 
reviewed during an onsite visit.
    Also, as part of the ADA's application review, we reviewed and 
assessed the following documents submitted by the ADA:
     A detailed comparison including a crosswalk between the 
organization's standards and the CMS quality standards described in 
Sec.  410.144(a).
     Detailed information about the organization's 
accreditation process, including all of the following information:

    ++ Frequency of accreditation.
    ++ Copies of accreditation forms, guidelines, and instructions to 
evaluators.
    ++ Descriptions of the following:

--The accreditation review process and the accreditation status 
decision making process.
--The procedures used to notify a deemed entity of deficiencies in its 
diabetes outpatient self-management training program and procedures 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 organization, including all of the following 
information:
    ++ The education and experience requirements for the individuals 
who perform evaluations.
    ++ The content and frequency of continuing education furnished to 
the individuals who perform evaluations.
    ++ The process used to monitor the performance of individuals who 
perform evaluations.
    ++ The organization's policies and practices for participation in 
the accreditation process by an individual who is professionally or 
financially affiliated with the entity being evaluated.
     A description of the organization's data management and 
analysis system for its accreditation activities and decisions, 
including the kinds of reports, tables, and other displays generated by 
that system.
     A description of the organization'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 organization's policies and 
procedures for withholding or removing a certificate of accreditation 
for failure to meet the organization's standards or requirements, and 
other actions the organization 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 organization, 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.
     A list of all of the approved entities currently 
accredited to furnish 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 organization.
     Documentation that demonstrates its ability to furnish CMS 
with electronic data in CMS-compatible format.
     A resource analysis that demonstrates that its 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, it agrees 
to comply with the requirements set forth in Sec. Sec.  410.142 through 
410.146.
     Any additional information CMS requests to enable it to 
respond to the organization's request for CMS approval and recognition 
of its accreditation program to accredit entities to furnish training.
    The April 27, 2021, proposed notice also solicited public comment 
regarding whether the ADA's requirements meet or exceed the NSDSMES, 
which are the accreditation standards used for accreditation of 
diabetes outpatient self-management training programs accredited by the 
ADA, pursuant to Sec.  410.144(b) and Sec.  410.142(e)(1).

III. Analysis of and Responses to Public Comments on the Proposed 
Notice

    CMS received three comments in response to the April 27, 2021 
proposed notice; however, only one of these comments were within the 
scope of the comment solicitation.
    The comment and our response is addressed below.
    Comment: One commenter stated that diabetes outpatient self-
management training, also sometimes referred to as diabetes self-
management education and support is an evidence-based vital service for 
people who have been diagnosed with diabetes, that has been proven to 
enhance their clinical outcomes. The commenter also stated 
``wholehearted'' support for the application submitted by the ADA for 
continued CMS recognition as a national AO for diabetes outpatient 
self-management training programs. The commenter further stated the 
belief that ``it is imperative that the ADA continue to offer its 
services as an AO for outpatient self-management training suppliers.''
    Response: We thank the commenter for their support of the CMS 
diabetes outpatient self-management training program and for their 
recommendation for the approval of the ADA's application.

[[Page 53319]]

IV. Provisions of the Final Notice

A. Comparison of the ADA's Standards and Requirements for Accreditation 
to the NSDSMES and the Medicare Application Requirements

    We compared the ADA's diabetes outpatient self-management training 
accreditation requirements and survey process with the NSDSMES 
requirements and CMS application requirements in 42 CFR part 410, 
subpart H, as described in section II of this final notice.
    We found the ADA's accreditation standards and process to be 
consistent with the NSDSMES standards and CMS requirements.

B. Term of Approval

    Based on the review and observations described in section II of 
this final notice, we have determined that the ADA's requirements for 
diabetes outpatient self-management training meet our requirements. 
Therefore, we approve the ADA as a national accreditation organization 
for diabetes outpatient self-management training program that request 
participation in the Medicare program, effective September 27 2021 
through September 27, 2027.

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.).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, 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.

    Dated: September 22, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-20943 Filed 9-24-21; 8:45 am]
BILLING CODE 4120-01-P