[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49739-49741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20466]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3387-PN]
Medicare and Medicaid Programs; Application From The Compliance
Team (TCT) for Initial CMS Approval of its Diabetes Outpatient Self-
Management Training Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Notice with request for comment.
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SUMMARY: This proposed notice acknowledges the receipt of an
application from The Compliance Team for initial recognition as a
national accrediting organization 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, no later than 5 p.m. on October 23, 2019.
ADDRESSES: In commenting, please refer to file code CMS-3387-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-3387-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-3387-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: Christina Mister-Ward, (410) 786-2441.
Shannon Freeland, (410) 786-4348. 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.
I. Background
Diabetes outpatient self-management training services is 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
[[Page 49740]]
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.
The statute also permits diabetes outpatient self-management
training service programs to be deemed to have met Medicare regulatory
quality standards if they are accredited by an organization approved by
the Centers for Medicare & Medicaid Services (CMS). A national
accrediting organization (AO) must have an agreement in effect with the
Secretary and meet the standards and requirements specified in 42 CFR
part 410, subpart H, to qualify for deeming authority. Our regulations
pertaining to the application procedures to be an approved national
accreditation organization for diabetes outpatient self-management
training 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 AO requires accredited entities to meet
CMS' quality standards, the National Standards for Diabetes Self-
Management Education and Support standards, or alternative requirements
that meet or exceed our requirements that have been developed by a
national accreditation organization and approved by CMS. (See Sec.
410.144 Quality standards for deemed entities.) 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 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 (Quality
standards for deemed entities).
II. Approval of Accreditation Organizations
Section 1865(a)(2) of the Act and Sec. 410.142 require that our
findings concerning review and approval of a national AO's requirements
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
CMS 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
Compliance Team's (TCT's) initial request for CMS approval of its
diabetes outpatient self-management training accreditation program.
This notice also solicits public comment on whether TCT's requirements
meet or exceed the Medicare conditions for certification for diabetes
outpatient self-management training services.
III. Evaluation of Deeming Authority Request
TCT submitted all the necessary materials to enable us to make a
determination concerning its request for initial CMS approval of its
diabetes outpatient self-management training accreditation program.
This application was determined to be complete on July 27, 2019. Under
section 1865(a)(2) of the Act and our regulations at Sec. 410.142, our
review and evaluation of TCT will be conducted in accordance with our
regulations, including:
The requirements and quality standards TCT uses to
accredit entities to furnish training.
TCT's accreditation process 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 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.
++ A description of the organization'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 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.
++ 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.
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we
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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 and
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.
Dated: September 6, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-20466 Filed 9-20-19; 8:45 am]
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