[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

[[Page 49741]]

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]
BILLING CODE 4120-01-P