80_FR_58010 80 FR 57824 - Medicare and Medicaid Programs; Continued Approval of the American Association of Diabetes Educators as an Accrediting Organization for Diabetes Self-Management Training Programs

80 FR 57824 - Medicare and Medicaid Programs; Continued Approval of the American Association of Diabetes Educators as an Accrediting Organization for Diabetes Self-Management Training Programs

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 186 (September 25, 2015)

Page Range57824-57825
FR Document2015-24357

This final notice announces our decision to approve the American Association of Diabetes Educators (AADE) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training (DSMT) to Medicare beneficiaries.

Federal Register, Volume 80 Issue 186 (Friday, September 25, 2015)
[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57824-57825]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3315-FN]


Medicare and Medicaid Programs; Continued Approval of the 
American Association of Diabetes Educators as an Accrediting 
Organization for Diabetes Self-Management Training Programs

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

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: This final notice announces our decision to approve the 
American Association of Diabetes Educators (AADE) for continued 
recognition as a national accreditation program for accrediting 
entities that wish to furnish outpatient diabetes self-management 
training (DSMT) to Medicare beneficiaries.

DATES: This final notice is effective September 25, 2015 through 
September 27, 2021.

FOR FURTHER INFORMATION CONTACT: Kristin Shifflett, (410) 786-4133; 
Jacqueline Leach, (410) 786-4282.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
outpatient diabetes self-management training (DSMT) when ordered by the 
physician (or qualified non-physician practitioner) treating the 
beneficiary's diabetes, provided certain requirements are met by the 
provider. Pursuant to our regulations at 42 CFR 410.141 (e)(3), we use 
national accrediting organizations (NAOs) to assess whether provider 
entities meet Medicare requirements when providing DSMT services for 
which Medicare payment is made. If a provider entity is accredited by 
an approved accrediting organization, it is ``deemed'' to meet 
applicable Medicare requirements.
    A NAO must meet the standards and requirements specified by the 
Secretary of the Department of Health and Human Services in our 
regulations under part 410, subpart H, to qualify for deeming 
authority. The regulations pertaining to application procedures for 
NAOs for DSMT are specified at Sec.  410.142 (CMS process for approving 
national accreditation organizations).
    A NAO applying for deeming authority must provide us with 
reasonable assurance that the accrediting organization requires 
accredited entities to meet requirements that are at least as stringent 
as our requirements.
    We may approve and recognize a nonprofit organization with 
demonstrated experience in representing the interests of individuals 
with diabetes to accredit entities to furnish DSMT. The 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).
    Section 1865(a)(2) of the Social Security Act (the Act) requires 
that we review the applying accreditation organization's requirements 
for accreditation, as follows:
     Survey procedures.
     Ability to provide adequate resources for conducting 
required surveys.
     Ability to supply information for use in enforcement 
activities.
     Monitoring procedures for providers found out of 
compliance with the conditions or requirements.
     Ability to provide CMS with necessary data for validation.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-approval of an 
accreditation program is conducted in a timely manner. The Act provides 
us 210 days after the date of receipt of a complete application, with 
any documentation necessary to make the determination, to complete our 
survey activities and application process. Within 60 days after 
receiving a complete application, we must publish a notice in the 
Federal Register that identifies the national accrediting body making 
the request, describes the request, and provides no less than a 30-day 
public comment period. At the end of the 210-day period, we must 
publish a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice

    On April 24, 2015, we published a proposed notice in the Federal 
Register (80 FR 23009) entitled ``Application by the American 
Association of Diabetes Educators for Continued Deeming Authority for 
Diabetes Self-Management Training,'' announcing the receipt of an 
application from AADE for continued recognition as a national 
accreditation program for accrediting entities that wish to furnish 
outpatient diabetes self-management training to Medicare beneficiaries.
    In that notice, we detailed our evaluation criteria. Under section

[[Page 57825]]

1865(a)(2) of the Act and our regulations at Sec.  410.142 and Sec.  
410.143, we conducted a review of AADE's national accreditation 
organization based on the criteria set forth in Sec.  410.142(b), which 
include, but are not limited to the following: (1) A review of the 
national accreditation organization's operations and office to verify 
information in the organization's application and assess the 
organization's compliance with its own policies and procedures; (2) 
evaluating accreditation results or the accreditation status decision 
making process; and (3) interviewing the organization's staff.
    The April 24, 2015 proposed notice also solicited public comments 
on the ability of AADE to continue to develop standards that meet or 
exceed the Medicare conditions for coverage and apply them to entities 
furnishing outpatient services. We received no public comments in 
response to our proposed notice.

IV. Provisions of the Final Notice

    AADE's application to continue as an accredited NAO to deem 
entities for the purposes of DSMT is approved for a period of 6 years. 
The accreditation is effective on September 25, 2015. This approval is 
subject to renewal subsequent to the receipt of an application from the 
AADE and subject to review, evaluation, and approval of its program.
    Based on our review and observations described in section II of 
this final notice, we approve AADE as a national accreditation 
organization for entities furnishing DSMT that request participation in 
the Medicare program, effective September 25, 2015 through September 
27, 2021.

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.).

    Dated: September 16, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-24357 Filed 9-24-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                  57824                       Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices

                                                  identified through validation reviews or                DEPARTMENT OF HEALTH AND                              accredited entities to meet requirements
                                                  complaint surveys, the State survey                     HUMAN SERVICES                                        that are at least as stringent as our
                                                  agency monitors corrections as specified                                                                      requirements.
                                                  at § 488.9(c).                                          Centers for Medicare & Medicaid                         We may approve and recognize a
                                                     ++ AAAASF’s capacity to report                       Services                                              nonprofit organization with
                                                  deficiencies to the surveyed facilities                 [CMS–3315–FN]
                                                                                                                                                                demonstrated experience in
                                                  and respond to the facility’s plan of                                                                         representing the interests of individuals
                                                  correction in a timely manner.                          Medicare and Medicaid Programs;                       with diabetes to accredit entities to
                                                                                                          Continued Approval of the American                    furnish DSMT. The accreditation
                                                     ++ AAAASF’s capacity to provide                                                                            organization, after being approved and
                                                                                                          Association of Diabetes Educators as
                                                  CMS with electronic data and reports                                                                          recognized by CMS, may accredit an
                                                                                                          an Accrediting Organization for
                                                  necessary for effective validation and                                                                        entity to meet one of the sets of quality
                                                                                                          Diabetes Self-Management Training
                                                  assessment of the organization’s survey                                                                       standards in § 410.144 (Quality
                                                                                                          Programs
                                                  process.                                                                                                      standards for deemed entities).
                                                     ++ The adequacy of AAAASF’s staff                    AGENCY:  Centers for Medicare &                         Section 1865(a)(2) of the Social
                                                  and other resources, and its financial                  Medicaid Services (CMS), HHS.                         Security Act (the Act) requires that we
                                                  viability.                                              ACTION: Final notice.                                 review the applying accreditation
                                                     ++ AAAASF’s capacity to adequately                                                                         organization’s requirements for
                                                                                                          SUMMARY: This final notice announces                  accreditation, as follows:
                                                  fund required surveys.                                  our decision to approve the American                    • Survey procedures.
                                                     ++ AAAASF’s policies with respect                    Association of Diabetes Educators                       • Ability to provide adequate
                                                  to whether surveys are announced or                     (AADE) for continued recognition as a                 resources for conducting required
                                                  unannounced, to assure that surveys are                 national accreditation program for                    surveys.
                                                  unannounced.                                            accrediting entities that wish to furnish               • Ability to supply information for
                                                     ++ AAAASF’s agreement to provide                     outpatient diabetes self-management                   use in enforcement activities.
                                                  CMS with a copy of the most current                     training (DSMT) to Medicare                             • Monitoring procedures for
                                                  accreditation survey together with any                  beneficiaries.                                        providers found out of compliance with
                                                  other information related to the survey                 DATES:  This final notice is effective                the conditions or requirements.
                                                  as CMS may require (including                           September 25, 2015 through September                    • Ability to provide CMS with
                                                  corrective action plans).                               27, 2021.                                             necessary data for validation.
                                                  IV. Collection of Information                           FOR FURTHER INFORMATION CONTACT:                      II. Application Approval Process
                                                  Requirements                                            Kristin Shifflett, (410) 786–4133;                       Section 1865(a)(3)(A) of the Act
                                                                                                          Jacqueline Leach, (410) 786–4282.                     provides a statutory timetable to ensure
                                                    This document does not impose                         SUPPLEMENTARY INFORMATION:                            that our review of applications for CMS-
                                                  information collection requirements,                                                                          approval of an accreditation program is
                                                  that is, reporting, recordkeeping or                    I. Background
                                                                                                                                                                conducted in a timely manner. The Act
                                                  third-party disclosure requirements.                       Under the Medicare program, eligible               provides us 210 days after the date of
                                                  Consequently, there is no need for                      beneficiaries may receive outpatient                  receipt of a complete application, with
                                                  review by the Office of Management and                  diabetes self-management training                     any documentation necessary to make
                                                  Budget under the authority of the                       (DSMT) when ordered by the physician                  the determination, to complete our
                                                  Paperwork Reduction Act of 1995 (44                     (or qualified non-physician practitioner)             survey activities and application
                                                  U.S.C. 3501 et seq.).                                   treating the beneficiary’s diabetes,                  process. Within 60 days after receiving
                                                  V. Response to Public Comments                          provided certain requirements are met                 a complete application, we must
                                                                                                          by the provider. Pursuant to our                      publish a notice in the Federal Register
                                                    Because of the large number of public                 regulations at 42 CFR 410.141 (e)(3), we              that identifies the national accrediting
                                                  comments we normally receive on                         use national accrediting organizations                body making the request, describes the
                                                  Federal Register documents, we are not                  (NAOs) to assess whether provider                     request, and provides no less than a 30-
                                                  able to acknowledge or respond to them                  entities meet Medicare requirements                   day public comment period. At the end
                                                  individually. We will consider all                      when providing DSMT services for                      of the 210-day period, we must publish
                                                  comments we receive by the date and                     which Medicare payment is made. If a                  a notice in the Federal Register
                                                  time specified in the DATES section of                  provider entity is accredited by an                   approving or denying the application.
                                                  this preamble, and, when we proceed                     approved accrediting organization, it is
                                                  with a subsequent document, we will                     ‘‘deemed’’ to meet applicable Medicare                III. Provisions of the Proposed Notice
                                                  respond to the comments in the                          requirements.                                            On April 24, 2015, we published a
                                                  preamble to that document.                                 A NAO must meet the standards and                  proposed notice in the Federal Register
                                                    Upon completion of our evaluation,                    requirements specified by the Secretary               (80 FR 23009) entitled ‘‘Application by
                                                  including evaluation of comments                        of the Department of Health and Human                 the American Association of Diabetes
                                                  received as a result of this notice, we                 Services in our regulations under part                Educators for Continued Deeming
                                                  will publish a final notice in the Federal              410, subpart H, to qualify for deeming                Authority for Diabetes Self-Management
                                                  Register announcing the result of our                   authority. The regulations pertaining to              Training,’’ announcing the receipt of an
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  evaluation.                                             application procedures for NAOs for                   application from AADE for continued
                                                                                                          DSMT are specified at § 410.142 (CMS                  recognition as a national accreditation
                                                    Dated: September 16, 2015.                            process for approving national                        program for accrediting entities that
                                                  Andrew M. Slavitt,                                      accreditation organizations).                         wish to furnish outpatient diabetes self-
                                                  Acting Administrator, Centers for Medicare                 A NAO applying for deeming                         management training to Medicare
                                                  & Medicaid Services.                                    authority must provide us with                        beneficiaries.
                                                  [FR Doc. 2015–24356 Filed 9–24–15; 8:45 am]             reasonable assurance that the                            In that notice, we detailed our
                                                  BILLING CODE 4120–01–P                                  accrediting organization requires                     evaluation criteria. Under section


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                                                                              Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices                                         57825

                                                  1865(a)(2) of the Act and our regulations               DEPARTMENT OF HEALTH AND                                 We may approve and recognize a
                                                  at § 410.142 and § 410.143, we                          HUMAN SERVICES                                        nonprofit organization with
                                                  conducted a review of AADE’s national                                                                         demonstrated experience in
                                                  accreditation organization based on the                 Centers for Medicare & Medicaid                       representing the interests of individuals
                                                  criteria set forth in § 410.142(b), which               Services                                              with diabetes to accredit entities to
                                                  include, but are not limited to the                     [CMS–3316–FN]                                         furnish DSMT. The accreditation
                                                  following: (1) A review of the national                                                                       organization, after being approved and
                                                  accreditation organization’s operations                 Medicare and Medicaid Programs;                       recognized by CMS, may accredit an
                                                  and office to verify information in the                 Continued Approval of the American                    entity to meet one of the sets of quality
                                                  organization’s application and assess                   Diabetes Association as an                            standards in § 410.144 (Quality
                                                  the organization’s compliance with its                  Accrediting Organization for Diabetes                 standards for deemed entities).
                                                  own policies and procedures; (2)                        Self-Management Training Programs                        Section 1865(a)(2) of the Social
                                                  evaluating accreditation results or the                                                                       Security Act (the Act) requires that we
                                                                                                          AGENCY:  Centers for Medicare &                       review the applying accreditation
                                                  accreditation status decision making                    Medicaid Services (CMS), HHS.                         organization’s requirements for
                                                  process; and (3) interviewing the                       ACTION: Final notice.                                 accreditation, as follows:
                                                  organization’s staff.
                                                                                                                                                                   • Survey procedures.
                                                                                                          SUMMARY: This final notice announces
                                                     The April 24, 2015 proposed notice                                                                            • Ability to provide adequate
                                                  also solicited public comments on the                   our decision to approve the American                  resources for conducting required
                                                  ability of AADE to continue to develop                  Diabetes Association (ADA) for                        surveys.
                                                                                                          continued recognition as a national
                                                  standards that meet or exceed the                                                                                • Ability to supply information for
                                                  Medicare conditions for coverage and                    accreditation program for accrediting
                                                                                                                                                                use in enforcement activities.
                                                                                                          entities that wish to furnish outpatient
                                                  apply them to entities furnishing                                                                                • Monitoring procedures for
                                                                                                          diabetes self-management training
                                                  outpatient services. We received no                                                                           providers found out of compliance with
                                                                                                          (DSMT) to Medicare beneficiaries.
                                                  public comments in response to our                                                                            the conditions or requirements.
                                                                                                          DATES: This final notice is effective
                                                  proposed notice.                                                                                                 • Ability to provide CMS with
                                                                                                          September 25, 2015 through September                  necessary data for validation.
                                                  IV. Provisions of the Final Notice                      27, 2021.                                                We then examine the NAO’s
                                                                                                          FOR FURTHER INFORMATION CONTACT:                      accreditation requirements to determine
                                                     AADE’s application to continue as an
                                                                                                          Kristin Shifflett, (410) 786–4133;                    if they meet or exceed the Medicare
                                                  accredited NAO to deem entities for the
                                                                                                          Jacqueline Leach, (410) 786–4282.                     conditions as we would have applied
                                                  purposes of DSMT is approved for a
                                                  period of 6 years. The accreditation is                 SUPPLEMENTARY INFORMATION:                            them.
                                                  effective on September 25, 2015. This                   I. Background                                         II. Application Approval Process
                                                  approval is subject to renewal
                                                                                                             Under the Medicare program, eligible                 Section 1865(a)(3)(A) of the Act
                                                  subsequent to the receipt of an                         beneficiaries may receive outpatient                  provides a statutory timetable to ensure
                                                  application from the AADE and subject                   diabetes self-management training                     that our review of applications for CMS-
                                                  to review, evaluation, and approval of                  (DSMT) when ordered by the physician                  approval of an accreditation program is
                                                  its program.                                            (or qualified non-physician practitioner)             conducted in a timely manner. The Act
                                                     Based on our review and observations                 treating the beneficiary’s diabetes,                  provides us 210 days after the date of
                                                  described in section II of this final                   provided certain requirements are met                 receipt of a complete application, with
                                                  notice, we approve AADE as a national                   by the provider. Pursuant to our                      any documentation necessary to make
                                                  accreditation organization for entities                 regulations at 42 CFR 410.141(e)(3), we               the determination, to complete our
                                                  furnishing DSMT that request                            use national accrediting organizations                survey activities and application
                                                  participation in the Medicare program,                  (NAOs) to assess whether provider                     process. Within 60 days after receiving
                                                  effective September 25, 2015 through                    entities meet Medicare requirements                   a complete application, we must
                                                  September 27, 2021.                                     when providing DSMT services for                      publish a notice in the Federal Register
                                                                                                          which Medicare payment is made. If a                  that identifies the national accrediting
                                                  V. Collection of Information                            provider entity is accredited by an                   body making the request, describes the
                                                  Requirements                                            approved accrediting organization, it is              request, and provides no less than a 30-
                                                                                                          ‘‘deemed’’ to meet applicable Medicare                day public comment period. At the end
                                                    This document does not impose                         requirements.                                         of the 210-day period, we must publish
                                                  information collection requirements,                       A NAO must meet the standards and                  a notice in the Federal Register
                                                  that is, reporting, recordkeeping or                    requirements specified by the Secretary               approving or denying the application.
                                                  third-party disclosure requirements.                    of the Department of Health and Human
                                                  Consequently, there is no need for                      Services in our regulations under part                III. Provisions of the Proposed Notice
                                                  review by the Office of Management and                  410, subpart H, to qualify for deeming                   On April 30, 2015, we published a
                                                  Budget under the authority of the                       authority. The regulations pertaining to              proposed notice in the Federal Register
                                                  Paperwork Reduction Act of 1995 (44                     application procedures for NAOs for                   (80 FR 24253) entitled ‘‘Application by
                                                  U.S.C. 3501 et seq.).                                   DSMT are specified at § 410.142 (CMS                  the American Diabetes Association for
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                    Dated: September 16, 2015.                            process for approving NAOs).                          Continued Deeming Authority for
                                                                                                             A NAO applying for deeming                         Diabetes Self-Management Training,’’
                                                  Andrew M. Slavitt,
                                                                                                          authority must provide us with                        announcing the receipt of an application
                                                  Acting Administrator, Centers for Medicare              reasonable assurance that the                         from the ADA for continued recognition
                                                  & Medicaid Services.                                    accrediting organization requires                     as a national accreditation program for
                                                  [FR Doc. 2015–24357 Filed 9–24–15; 8:45 am]             accredited entities to meet requirements              accrediting entities that wish to furnish
                                                  BILLING CODE 4120–01–P                                  that are at least as stringent as our                 outpatient DSMT to Medicare
                                                                                                          requirements.                                         beneficiaries.


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Document Created: 2018-02-26 10:20:16
Document Modified: 2018-02-26 10:20:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionFinal notice.
DatesThis final notice is effective September 25, 2015 through September 27, 2021.
ContactKristin Shifflett, (410) 786-4133; Jacqueline Leach, (410) 786-4282.
FR Citation80 FR 57824 

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