Notice2021-20943
Medicare Program; Application by the American Diabetes Association (ADA) for Continued CMS Approval of Its Diabetes Outpatient Self-Management Training Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 27, 2021
Effective
September 27, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 184 (Monday, September 27, 2021)</title>
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[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53317-53319]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> A detailed comparison including a crosswalk between the
organization's standards and the CMS quality standards described in
Sec. 410.144(a).
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> The name and address of each person with an ownership or
control interest in the organization.
<bullet> Documentation that demonstrates its ability to furnish CMS
with electronic data in CMS-compatible format.
<bullet> A resource analysis that demonstrates that its staffing,
funding, and other resources are adequate to perform the required
accreditation activities.
<bullet> 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.
<bullet> 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
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</html>Indexed from Federal Register on September 27, 2021.
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