80_FR_76528 80 FR 76293 - Agency Information Collection Activities: Proposed Collection; Comment Request

80 FR 76293 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 80, Issue 235 (December 8, 2015)

Page Range76293-76294
FR Document2015-30891

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 80 Issue 235 (Tuesday, December 8, 2015)
[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76293-76294]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30891]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-R-193 and CMS-R-244]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

ACTION: Notice.

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

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by February 8, 2016.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).
CMS-R-193 Important Message from Medicare (IM)
CMS-R-244 Programs for All-inclusive Care of the Elderly (PACE) and 
Supporting Regulations
    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for

[[Page 76294]]

approval. To comply with this requirement, CMS is publishing this 
notice.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Important Message 
from Medicare (IM); Use: Hospitals have used the IM to inform original 
Medicare, Medicare Advantage, and other Medicare plan beneficiaries who 
are hospital inpatients about their hospital rights and discharge 
rights. In particular, the IM provides information about when a 
beneficiary will and will not be liable for charges for a continued 
stay in a hospital and offers a detailed description of the Quality 
Improvement Organization review process. Please note that this 
iteration proposes non-substantive changes to the form. Form Number: 
CMS-R-193 (OMB Control Number: 0938-0692). Frequency: Yearly; Affected 
Public: Private sector (Business or other for-profit and Not-for-profit 
institutions); Number of Respondents: 6,164; Total Annual Responses: 
24,160,000; Total Annual Hours: 3,624,000. (For policy questions 
regarding this collection contact Evelyn Blaemire at 410-786-1803.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Programs for All-
inclusive Care of the Elderly (PACE) and Supporting Regulations; Use: 
PACE organizations must demonstrate their ability to provide quality 
community-based care for the frail elderly who meet their state's 
nursing home eligibility standards using capitated payments from 
Medicare and the state. The model of care includes (as core services) 
the provision of adult day health care and multidisciplinary team case 
management, through which access to and allocation of all health 
services is controlled. Physician, therapeutic, ancillary, and social 
support services are provided in the participant's residence or on-site 
at the adult day health center. The PACE programs must provide all 
Medicare and Medicaid covered services including hospital, nursing 
home, home health, and other specialized services. Financing of this 
model is accomplished through prospective capitation of both Medicare 
and Medicaid payments. The information collection requirements are 
necessary to ensure that only appropriate organizations are selected to 
become PACE organizations and that we have the information necessary to 
monitor the care provided to the frail, vulnerable population served. 
Form Number: CMS-R-244 (OMB Control Number: 0938-0790; Frequency: Once 
and occasionally; Affected Public: Private sector (Not-for-profit 
institutions); Number of Respondents: 35; Total Annual Responses: 35; 
Total Annual Hours: 740. (For policy questions regarding this 
collection contact John Hebb at 410-786-6657.)

    Dated: December 3, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-30891 Filed 12-7-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                                         Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices                                           76293

                                             submit reports, keep records, or provide                or other for-profit); Number of                         1. Electronically. You may send your
                                             information to a third party. Section                   Respondents: 300; Total Annual                        comments electronically to http://
                                             3506(c)(2)(A) of the PRA (44 U.S.C.                     Responses: 3,700; Total Annual Hours:                 www.regulations.gov. Follow the
                                             3506(c)(2)(A)) requires federal agencies                6,475. (For policy questions regarding                instructions for ‘‘Comment or
                                             to publish a 30-day notice in the                       this collection contact Stuart Caplan at              Submission’’ or ‘‘More Search Options’’
                                             Federal Register concerning each                        410–786–8564).                                        to find the information collection
                                             proposed collection of information,                        Dated: December 3, 2015.                           document(s) that are accepting
                                             including each proposed extension or                                                                          comments.
                                                                                                     William N. Parham, III,
                                             reinstatement of an existing collection                                                                         2. By regular mail. You may mail
                                                                                                     Director, Paperwork Reduction Staff, Office
                                             of information, before submitting the                                                                         written comments to the following
                                                                                                     of Strategic Operations and Regulatory
                                             collection to OMB for approval. To                      Affairs.                                              address: CMS, Office of Strategic
                                             comply with this requirement, CMS is                                                                          Operations and Regulatory Affairs,
                                                                                                     [FR Doc. 2015–30892 Filed 12–7–15; 8:45 am]
                                             publishing this notice that summarizes                                                                        Division of Regulations Development,
                                                                                                     BILLING CODE 4120–01–P
                                             the following proposed collection(s) of                                                                       Attention: Document Identifier/OMB
                                             information for public comment:                                                                               Control Number ll, Room C4–26–05,
                                                1. Type of Information Collection                                                                          7500 Security Boulevard, Baltimore,
                                             Request: New collection (Request for a                  DEPARTMENT OF HEALTH AND
                                                                                                     HUMAN SERVICES                                        Maryland 21244–1850.
                                             new OMB control number); Title of                                                                               To obtain copies of a supporting
                                             Information Collection: Data Collection                 Centers for Medicare & Medicaid                       statement and any related forms for the
                                             for Medicare Beneficiaries Receiving                    Services                                              proposed collection(s) summarized in
                                             Beta Amyloid Positron Emission                                                                                this notice, you may make your request
                                             Tomography (PET) for Dementia and                       [Document Identifiers: CMS–R–193 and                  using one of following:
                                             Neurodegenerative Disease Use: In the                   CMS–R–244]
                                                                                                                                                             1. Access CMS’ Web site address at
                                             Decision Memorandum #CAG–00431N                                                                               http://www.cms.hhs.gov/
                                             issued on September 27, 2013, CMS                       Agency Information Collection
                                                                                                     Activities: Proposed Collection;                      PaperworkReductionActof1995.
                                             determined there is sufficient evidence                                                                         2. Email your request, including your
                                             that the use of beta amyloid PET is                     Comment Request
                                                                                                                                                           address, phone number, OMB number,
                                             promising in 2 scenarios: (1) To exclude                AGENCY: Centers for Medicare &                        and CMS document identifier, to
                                             Alzheimer’s Disease (AD) in narrowly                    Medicaid Services.                                    Paperwork@cms.hhs.gov.
                                             defined and clinically difficult                        ACTION: Notice.                                         3. Call the Reports Clearance Office at
                                             differential diagnoses; and (2) to enrich                                                                     (410) 786–1326.
                                             clinical trials seeking better treatments               SUMMARY:   The Centers for Medicare &                 FOR FURTHER INFORMATION CONTACT:
                                             or prevention strategies for AD. CMS                    Medicaid Services (CMS) is announcing                 Reports Clearance Office at (410) 786–
                                             will cover one beta amyloid PET scan                    an opportunity for the public to                      1326.
                                             per patient through Coverage with                       comment on CMS’ intention to collect
                                             Evidence Development under section                      information from the public. Under the                SUPPLEMENTARY INFORMATION:
                                             1862(a)(1)(E) of the Social Security Act,               Paperwork Reduction Act of 1995 (the                  Contents
                                             in clinical studies that meet specific                  PRA), federal agencies are required to
                                             criteria established by CMS. Clinical                   publish notice in the Federal Register                  This notice sets out a summary of the
                                             studies must be approved by CMS,                        concerning each proposed collection of                use and burden associated with the
                                             involve subjects from appropriate                       information (including each proposed                  following information collections. More
                                             populations, and be comparative and                     extension or reinstatement of an existing             detailed information can be found in
                                             longitudinal. Radiopharmaceuticals                      collection of information) and to allow               each collection’s supporting statement
                                             used in the scan must be FDA approved.                  60 days for public comment on the                     and associated materials (see
                                             Approved studies must address defined                                                                         ADDRESSES).
                                                                                                     proposed action. Interested persons are
                                             research questions established by CMS.                  invited to send comments regarding our                CMS–R–193 Important Message from
                                             Clinical studies in this National                       burden estimates or any other aspect of                 Medicare (IM)
                                             Coverage Determination (NCD) must                                                                             CMS–R–244 Programs for All-
                                                                                                     this collection of information, including
                                             adhere to the designated timeframe and                                                                          inclusive Care of the Elderly (PACE)
                                                                                                     any of the following subjects: (1) The
                                             meet standards establish by CMS in the                                                                          and Supporting Regulations
                                                                                                     necessity and utility of the proposed
                                             NCD. Consistent with section 1142 of                                                                            Under the PRA (44 U.S.C. 3501–
                                                                                                     information collection for the proper
                                             the Social Security Act, the Agency for                                                                       3520), federal agencies must obtain
                                                                                                     performance of the agency’s functions;
                                             Healthcare and Quality (AHRQ)                                                                                 approval from the Office of Management
                                                                                                     (2) the accuracy of the estimated
                                             supports clinical research studies that                                                                       and Budget (OMB) for each collection of
                                                                                                     burden; (3) ways to enhance the quality,
                                             CMS determines meet specifically                                                                              information they conduct or sponsor.
                                                                                                     utility, and clarity of the information to
                                             identified requirements and research                                                                          The term ‘‘collection of information’’ is
                                                                                                     be collected; and (4) the use of
                                             questions.                                                                                                    defined in 44 U.S.C. 3502(3) and 5 CFR
                                                                                                     automated collection techniques or
                                                To qualify for payment, providers                                                                          1320.3(c) and includes agency requests
                                                                                                     other forms of information technology to
                                             must prescribe beta amyloid PET for                                                                           or requirements that members of the
                                                                                                     minimize the information collection
                                             beneficiaries with a set of clinical                                                                          public submit reports, keep records, or
                                                                                                     burden.
                                             criteria specific to each cancer. Data                                                                        provide information to a third party.
                                             elements will be transmitted to CMS for                 DATES: Comments must be received by                   Section 3506(c)(2)(A) of the PRA
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                                             evaluation of the short and long-term                   February 8, 2016.                                     requires federal agencies to publish a
                                             benefits of beta amyloid PET to                         ADDRESSES: When commenting, please                    60-day notice in the Federal Register
                                             beneficiaries and for use in future                     reference the document identifier or                  concerning each proposed collection of
                                             clinical decision making. Form Number:                  OMB control number. To be assured                     information, including each proposed
                                             CMS–10583 (OMB control number:                          consideration, comments and                           extension or reinstatement of an existing
                                             0938–NEW); Frequency: Annually;                         recommendations must be submitted in                  collection of information, before
                                             Affected Public: Private sector (Business               any one of the following ways:                        submitting the collection to OMB for


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                                             76294                       Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices

                                             approval. To comply with this                           Number: CMS–R–244 (OMB Control                        (hereinafter referred to as Language
                                             requirement, CMS is publishing this                     Number: 0938–0790; Frequency: Once                    Preservation) (HHS–2014–ACF–ANA–
                                             notice.                                                 and occasionally; Affected Public:                    NL–0778); (6) Native Language
                                                                                                     Private sector (Not-for-profit                        Preservation and Maintenance—Esther
                                             Information Collection
                                                                                                     institutions); Number of Respondents:                 Martinez Immersion (hereinafter
                                               1. Type of Information Collection                     35; Total Annual Responses: 35; Total                 referred to as Language—EMI) (HHS–
                                             Request: Extension of a currently                       Annual Hours: 740. (For policy                        2014–ACF–ANA–NB–0780); (7)
                                             approved collection; Title of                           questions regarding this collection                   Environmental Regulatory Enhancement
                                             Information Collection: Important                       contact John Hebb at 410–786–6657.)                   (hereinafter referred to as ERE) (HHS–
                                             Message from Medicare (IM); Use:                                                                              2014–ACF–ANA–NR–0777); and new
                                                                                                        Dated: December 3, 2015.
                                             Hospitals have used the IM to inform                                                                          FOAs for FY2016—(8) Native Language
                                                                                                     William N. Parham, III,
                                             original Medicare, Medicare Advantage,                                                                        Community Coordination
                                             and other Medicare plan beneficiaries                   Director, Paperwork Reduction Staff, Office
                                                                                                     of Strategic Operations and Regulatory                Demonstration Project (hereinafter
                                             who are hospital inpatients about their                 Affairs.                                              referred to as NLCC) (HHS–2016–ACF–
                                             hospital rights and discharge rights. In                                                                      ANA–NS–1168); and (9) Native Youth
                                                                                                     [FR Doc. 2015–30891 Filed 12–7–15; 8:45 am]
                                             particular, the IM provides information                                                                       Initiative for Leadership, Empowerment,
                                                                                                     BILLING CODE 4120–01–P
                                             about when a beneficiary will and will                                                                        and Development (hereinafter referred
                                             not be liable for charges for a continued                                                                     to as Native Youth I–LEAD) (HHS–
                                             stay in a hospital and offers a detailed                                                                      2016–ACF–ANA–NC–1167) . This
                                                                                                     DEPARTMENT OF HEALTH AND
                                             description of the Quality Improvement                                                                        notice of public comment also provides
                                                                                                     HUMAN SERVICES
                                             Organization review process. Please                                                                           additional information about ANA’s
                                             note that this iteration proposes non-                  Administration for Children and                       plan for administering the programs.
                                             substantive changes to the form. Form                   Families                                              DATES: The deadline for receipt of
                                             Number: CMS–R–193 (OMB Control
                                                                                                     [CFDA Numbers: 93.581, 93.587, 93.612,                comments is 15 days from the date of
                                             Number: 0938–0692). Frequency:
                                                                                                     93.340]                                               publication in the Federal Register.
                                             Yearly; Affected Public: Private sector
                                             (Business or other for-profit and Not-for-                                                                    ADDRESSES: Send comments in response
                                                                                                     Request for Public Comment on the                     to this notice via email to Lillian Sparks
                                             profit institutions); Number of                         Proposed Adoption of Administration
                                             Respondents: 6,164; Total Annual                                                                              Robinson, Commissioner,
                                                                                                     for Native Americans Program Policies                 Administration for Native Americans at
                                             Responses: 24,160,000; Total Annual                     and Procedures
                                             Hours: 3,624,000. (For policy questions                                                                       ANACommissioner@acf.hhs.gov.
                                             regarding this collection contact Evelyn                AGENCY: Administration for Native                     Comments will be available for
                                             Blaemire at 410–786–1803.)                              Americans, ACF, HHS.                                  inspection by members of the public at
                                                2. Type of Information Collection                    ACTION: Notice for public comment.                    the Administration for Native
                                             Request: Revision of a currently                                                                              Americans, 330 C Street SW.,
                                             approved collection; Title of                           SUMMARY:   Pursuant to Section 814 of the             Washington, DC 20201.
                                             Information Collection: Programs for                    Native American Programs Act of 1974                  FOR FURTHER INFORMATION CONTACT:
                                             All-inclusive Care of the Elderly (PACE)                (NAPA), as amended, the                               Carmelia Strickland, Director, Division
                                             and Supporting Regulations; Use: PACE                   Administration for Native Americans                   of Program Operations, ANA (877) 922–
                                             organizations must demonstrate their                    (ANA) is required to provide members                  9262.
                                             ability to provide quality community-                   of the public an opportunity to                       SUPPLEMENTARY INFORMATION: Section
                                             based care for the frail elderly who meet               comment on proposed changes in                        814 of NAPA, as amended, requires
                                             their state’s nursing home eligibility                  interpretive rules and general                        ANA to provide notice of its proposed
                                             standards using capitated payments                      statements of policy, and to give notice              interpretive rules and general
                                             from Medicare and the state. The model                  of the proposed adoption of such                      statements of policy. The proposed
                                             of care includes (as core services) the                 changes at least 30 days before the                   clarifications, modifications, and new
                                             provision of adult day health care and                  changes become effective. In accordance               text will appear in the eight FY 2016
                                             multidisciplinary team case                             with notice requirements of NAPA,                     FOAs: SEDS, SEDS–AK, SEEDS,
                                             management, through which access to                     ANA herein describes its proposed                     Language Preservation, Language—EMI,
                                             and allocation of all health services is                interpretive rules, general statements of             ERE, NLCC, and Native Youth I–LEAD.
                                             controlled. Physician, therapeutic,                     policy, and rules of agency procedure or              This notice serves to fulfill this
                                             ancillary, and social support services                  practice as they relate to the Fiscal Year            requirement.
                                             are provided in the participant’s                       (FY) 2016 Funding Opportunity
                                             residence or on-site at the adult day                   Announcements (FOA) for the following                 A. New Funding Opportunity
                                             health center. The PACE programs must                   programs: (1) Social and Economic                     Announcements (FOAs)
                                             provide all Medicare and Medicaid                       Development Strategies (hereinafter                     ANA will offer two new FOAs in FY
                                             covered services including hospital,                    referred to as SEDS) (HHS–2014–ACF–                   2016. The proposed changes to FOA
                                             nursing home, home health, and other                    ANA–NA–0776); (2) Social and                          content and policies described in this
                                             specialized services. Financing of this                 Economic Development Strategies-                      Notice of Public Comment also will be
                                             model is accomplished through                           Alaska (hereinafter referred to as SEDS–              applicable to the new FOAs described
                                             prospective capitation of both Medicare                 AK) (HHS–2015–ACF–ANA–NK–0960);                       here:
                                             and Medicaid payments. The                              (3) Native Asset Building Initiative                    1. Native Youth Initiative for
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                                             information collection requirements are                 (hereinafter referred to as NABI) (HHS–               Leadership, Empowerment, and
                                             necessary to ensure that only                           2015–ACF–ANA–NO–0954); (4)                            Development (I–LEAD) FOA; 42 U.S.C.
                                             appropriate organizations are selected to               Sustainable Employment and Economic                   2991b (HHS–2016–ACF–ANA–NC–
                                             become PACE organizations and that we                   Development Strategies (hereinafter                   1167): ANA plans to publish a new FOA
                                             have the information necessary to                       referred to as SEEDS) (HHS–2014–ACF–                  to support projects that will take a
                                             monitor the care provided to the frail,                 ANA–NE–0779); (5) Native Language                     comprehensive, culturally-appropriate,
                                             vulnerable population served. Form                      Preservation and Maintenance                          approach to ensure all young Native


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Document Created: 2015-12-14 13:27:49
Document Modified: 2015-12-14 13:27:49
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
ActionNotice.
DatesComments must be received by February 8, 2016.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation80 FR 76293 

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