80_FR_58011 80 FR 57825 - Medicare and Medicaid Programs; Continued Approval of the American Diabetes Association as an Accrediting Organization for Diabetes Self-Management Training Programs

80 FR 57825 - Medicare and Medicaid Programs; Continued Approval of the American Diabetes Association 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 Range57825-57826
FR Document2015-24358

This final notice announces our decision to approve the American Diabetes Association (ADA) 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 57825-57826]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3316-FN]


Medicare and Medicaid Programs; Continued Approval of the 
American Diabetes Association 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 Diabetes Association (ADA) 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 
NAOs).
    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.
    We then examine the NAO's accreditation requirements to determine 
if they meet or exceed the Medicare conditions as we would have applied 
them.

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 30, 2015, we published a proposed notice in the Federal 
Register (80 FR 24253) entitled ``Application by the American Diabetes 
Association for Continued Deeming Authority for Diabetes Self-
Management Training,'' announcing the receipt of an application from 
the ADA for continued recognition as a national accreditation program 
for accrediting entities that wish to furnish outpatient DSMT to 
Medicare beneficiaries.

[[Page 57826]]

    In that notice, we detailed our evaluation criteria. Under section 
1865(a)(2) of the Act and our regulations at Sec.  410.142 and Sec.  
410.143, we conducted a review of ADA's NAO 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 NAO'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 30, 2015 proposed notice also solicited public comments 
on the ability of ADA to continue to develop standards that meet or 
exceed the Medicare conditions for coverage and apply them to accredit 
entities to furnish training. We received no public comments in 
response to our proposed notice.

IV. Provisions of the Final Notice

    ADA'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 
ADA and subject to review, evaluation, and approval of its program.
    Based on our review and observations described in section III of 
this final notice, we approve ADA as a NAO for entities furnishing DSMT 
that request participation in the Medicare program, effective September 
25, 2015 through effective 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 17, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-24358 Filed 9-24-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                                              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
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                                                    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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                                                  57826                       Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices

                                                     In that notice, we detailed our                      DEPARTMENT OF HEALTH AND                              7500 Security Boulevard, Baltimore,
                                                  evaluation criteria. Under section                      HUMAN SERVICES                                        Maryland 21244–1850.
                                                  1865(a)(2) of the Act and our regulations                                                                       To obtain copies of a supporting
                                                  at § 410.142 and § 410.143, we                          Centers for Medicare & Medicaid                       statement and any related forms for the
                                                  conducted a review of ADA’s NAO                         Services                                              proposed collection(s) summarized in
                                                  based on the criteria set forth in                      [Document Identifiers: CMS–10519 and                  this notice, you may make your request
                                                  § 410.142(b), which include, but are not                CMS–10583]                                            using one of following:
                                                  limited to the following: (1) A review of                                                                       1. Access CMS’ Web site address at
                                                  the NAO’s operations and office to                      Agency Information Collection                         http://www.cms.hhs.gov/Paperwork
                                                  verify information in the organization’s                Activities: Proposed Collection;                      ReductionActof1995.
                                                                                                          Comment Request                                         2. Email your request, including your
                                                  application and assess the
                                                                                                                                                                address, phone number, OMB number,
                                                  organization’s compliance with its own                  AGENCY: Centers for Medicare &                        and CMS document identifier, to
                                                  policies and procedures; (2) evaluating                 Medicaid Services, HHS.                               Paperwork@cms.hhs.gov.
                                                  accreditation results or the accreditation              ACTION: Notice.                                         3. Call the Reports Clearance Office at
                                                  status decision making process; and (3)                                                                       (410) 786–1326.
                                                  interviewing the organization’s staff.                  SUMMARY: The Centers for Medicare &
                                                                                                                                                                FOR FURTHER INFORMATION CONTACT:
                                                     The April 30, 2015 proposed notice                   Medicaid Services (CMS) is announcing
                                                                                                                                                                Reports Clearance Office at (410) 786–
                                                  also solicited public comments on the                   an opportunity for the public to
                                                                                                                                                                1326.
                                                  ability of ADA to continue to develop                   comment on CMS’ intention to collect
                                                                                                          information from the public. Under the                SUPPLEMENTARY INFORMATION:
                                                  standards that meet or exceed the
                                                                                                          Paperwork Reduction Act of 1995 (the                  Contents
                                                  Medicare conditions for coverage and
                                                                                                          PRA), federal agencies are required to
                                                  apply them to accredit entities to                                                                              This notice sets out a summary of the
                                                                                                          publish notice in the Federal Register
                                                  furnish training. We received no public                 concerning each proposed collection of                use and burden associated with the
                                                  comments in response to our proposed                    information (including each proposed                  following information collections. More
                                                  notice.                                                 extension or reinstatement of an existing             detailed information can be found in
                                                                                                          collection of information) and to allow               each collection’s supporting statement
                                                  IV. Provisions of the Final Notice
                                                                                                          60 days for public comment on the                     and associated materials (see
                                                     ADA’s application to continue as an                  proposed action. Interested persons are               ADDRESSES).
                                                  accredited NAO to deem entities for the                 invited to send comments regarding our                CMS–10519 Physician Quality
                                                  purposes of DSMT is approved for a                      burden estimates or any other aspect of                    Reporting System (PQRS) and the
                                                  period of 6 years. The accreditation is                 this collection of information, including                  Electronic Prescribing Incentive
                                                  effective on September 25, 2015. This                   any of the following subjects: (1) The                     (eRx) Program Data Assessment,
                                                  approval is subject to renewal                          necessity and utility of the proposed                      Accuracy and Improper Payments
                                                  subsequent to the receipt of an                         information collection for the proper                      Identification Support
                                                                                                          performance of the agency’s functions;                CMS–10583 Data Collection for
                                                  application from the ADA and subject to
                                                                                                          (2) the accuracy of the estimated                          Medicare Beneficiaries Receiving
                                                  review, evaluation, and approval of its
                                                                                                          burden; (3) ways to enhance the quality,                   Beta Amyloid Positron Emission
                                                  program.                                                                                                           Tomography (PET) for Dementia
                                                                                                          utility, and clarity of the information to
                                                     Based on our review and observations                 be collected; and (4) the use of                           and Neurodegenerative Disease
                                                  described in section III of this final                  automated collection techniques or                      Under the PRA (44 U.S.C. 3501–
                                                  notice, we approve ADA as a NAO for                     other forms of information technology to              3520), federal agencies must obtain
                                                  entities furnishing DSMT that request                   minimize the information collection                   approval from the Office of Management
                                                  participation in the Medicare program,                  burden.                                               and Budget (OMB) for each collection of
                                                  effective September 25, 2015 through                                                                          information they conduct or sponsor.
                                                                                                          DATES:  Comments must be received by                  The term ‘‘collection of information’’ is
                                                  effective September 27, 2021.
                                                                                                          November 24, 2015.                                    defined in 44 U.S.C. 3502(3) and 5 CFR
                                                  V. Collection of Information                            ADDRESSES: When commenting, please                    1320.3(c) and includes agency requests
                                                  Requirements                                            reference the document identifier or                  or requirements that members of the
                                                                                                          OMB control number. To be assured                     public submit reports, keep records, or
                                                    This document does not impose                         consideration, comments and                           provide information to a third party.
                                                  information collection requirements,                    recommendations must be submitted in                  Section 3506(c)(2)(A) of the PRA
                                                  that is, reporting, recordkeeping or                    any one of the following ways:                        requires federal agencies to publish a
                                                  third-party disclosure requirements.                      1. Electronically. You may send your                60-day notice in the Federal Register
                                                  Consequently, there is no need for                      comments electronically to http://                    concerning each proposed collection of
                                                  review by the Office of Management and                  www.regulations.gov. Follow the                       information, including each proposed
                                                  Budget under the authority of the                       instructions for ‘‘Comment or                         extension or reinstatement of an existing
                                                  Paperwork Reduction Act of 1995 (44                     Submission’’ or ‘‘More Search Options’’               collection of information, before
                                                  U.S.C. 3501 et seq.).                                   to find the information collection                    submitting the collection to OMB for
                                                    Dated: September 17, 2015.                            document(s) that are accepting                        approval. To comply with this
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                                                                                                          comments.                                             requirement, CMS is publishing this
                                                  Andrew M. Slavitt,
                                                                                                            2. By regular mail. You may mail                    notice.
                                                  Acting Administrator, Centers for Medicare              written comments to the following
                                                  & Medicaid Services.                                    address: CMS, Office of Strategic                     Information Collection
                                                  [FR Doc. 2015–24358 Filed 9–24–15; 8:45 am]             Operations and Regulatory Affairs,                      1. Type of Information Collection
                                                  BILLING CODE 4120–01–P                                  Division of Regulations Development,                  Request: Revision of a currently
                                                                                                          Attention: Document Identifier/OMB                    approved collection; Title of
                                                                                                          Control Number ____, Room C4–26–05,                   Information Collection: Physician


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Document Created: 2018-02-26 10:19:51
Document Modified: 2018-02-26 10:19:51
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 57825 

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