81_FR_52066 81 FR 51915 - Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee

81 FR 51915 - Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee

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

Federal Register Volume 81, Issue 151 (August 5, 2016)

Page Range51915-51916
FR Document2016-18545

This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC reviews and evaluates medical literature and technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.

Federal Register, Volume 81 Issue 151 (Friday, August 5, 2016)
[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Pages 51915-51916]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3335-N]


Medicare Program; Request for Nominations for Members for the 
Medicare Evidence Development & Coverage Advisory Committee

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the request for nominations for 
membership on the Medicare Evidence Development & Coverage Advisory 
Committee (MEDCAC). Among other duties, the MEDCAC provides advice and 
guidance to the Secretary of the Department of Health and Human 
Services (the Secretary) and the Administrator of the Centers for 
Medicare & Medicaid Services (CMS) concerning the adequacy of 
scientific evidence available to CMS in making coverage determinations 
under the Medicare program.
    The MEDCAC reviews and evaluates medical literature and technology 
assessments, and hears public testimony on the evidence available to 
address the impact of medical items and services on health outcomes of 
Medicare beneficiaries.

DATES: Nominations must be received by Tuesday, September 6, 2016.

ADDRESSES: You may mail nominations for membership to the following 
address: Centers for Medicare & Medicaid Services, Center for Clinical 
Standards and Quality, Attention: Maria Ellis, 7500 Security Boulevard, 
Mail Stop: S3-02-01, Baltimore, MD 21244 or send via email to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for 
the MEDCAC, Centers for Medicare & Medicaid Services, Center for 
Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 
7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by 
phone (410-786-0309) or via email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Secretary signed the initial charter for the Medicare Coverage 
Advisory Committee (MCAC) on November 24, 1998. A notice in the Federal 
Register (63 FR 68780) announcing establishment of the MCAC was 
published on December 14, 1998. The MCAC name was updated to more 
accurately reflect the purpose of the committee and on January 26, 
2007, the Secretary published a notice in the Federal Register (72 FR 
3853), announcing that the Committee's name changed to the Medicare 
Evidence Development & Coverage Advisory Committee (MEDCAC). The 
current Secretary's Charter for the MEDCAC is available on the CMS Web 
site at: http://www.cms.hhs.gov/FACA/Downloads/medcaccharter.pdf, or 
you may obtain a copy of the charter by submitting a request to the 
contact listed in the FOR FURTHER INFORMATION section of this notice.
    The MEDCAC is governed by provisions of the Federal Advisory 
Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. 2), which sets 
forth standards for the formulation and use of advisory committees, and 
is authorized by section 222 of the Public Health Service Act as 
amended (42 U.S.C. 217A).
    We are requesting nominations for candidates to serve on the 
MEDCAC. Nominees are selected based upon their individual 
qualifications and not solely as representatives of professional 
associations or societies. We wish to ensure adequate representation of 
the interests of both women and men, members of all ethnic groups, and 
physically challenged individuals. Therefore, we encourage nominations 
of qualified candidates who can represent these interests.
    The MEDCAC consists of a pool of 100 appointed members including: 
94 at-large standing members (6 of whom are patient advocates), and 6 
representatives of industry interests. Members generally are recognized 
authorities in clinical medicine including subspecialties, 
administrative medicine, public health, biological and physical 
sciences, epidemiology and biostatistics, clinical trial design, health 
care data management and analysis, patient advocacy, health care 
economics, medical ethics or other relevant professions.
    The MEDCAC works from an agenda provided by the Designated Federal 
Official. The MEDCAC reviews and evaluates medical literature and 
technology assessments, and hears public testimony on the evidence 
available to address the impact of medical items and services on health 
outcomes of Medicare beneficiaries. The MEDCAC may also advise the 
Centers for Medicare & Medicaid Services (CMS) as part of Medicare's 
``coverage with evidence development'' initiative.

II. Provisions of the Notice

    As of January 2017, there will be 31 membership terms expiring. Of 
the 31 memberships expiring, 3 are industry representatives, 1 is a 
patient advocate, and the remaining 27 membership openings are for the 
at-large standing MEDCAC membership.
    All nominations must be accompanied by curricula vitae. Nomination 
packages should be sent to Maria Ellis at the address listed in the 
ADDRESSES section of this notice. Nominees are selected based upon 
their individual qualifications. Nominees for membership must have 
expertise and experience in one or more of the following fields:
     Clinical medicine including subspecialties
     Administrative medicine
     Public health
     Biological and physical sciences
     Epidemiology and biostatistics
     Clinical trial design
     Health care data management and analysis
     Patient advocacy
     Health care economics
     Medical ethics
     Other relevant professions
    We are looking particularly for experts in a number of fields. 
These include cancer screening, genetic testing, clinical epidemiology, 
psychopharmacology, screening and diagnostic testing analysis, and 
vascular surgery. We also need experts in biostatistics in clinical 
settings, dementia treatment, minority health, observational research 
design, stroke epidemiology, and women's health.
    The nomination letter must include a statement that the nominee is 
willing to serve as a member of the MEDCAC and appears to have no 
conflict of interest that would preclude membership. We are requesting 
that all curricula vitae include the following:
     Date of birth
     Place of birth
     Social security number
     Title and current position
     Professional affiliation
     Home and business address
     Telephone and fax numbers
     Email address
     List of areas of expertise
    In the nomination letter, we are requesting that nominees specify

[[Page 51916]]

whether they are applying for a patient advocate position, for an at-
large standing position, or as an industry representative. Potential 
candidates will be asked to provide detailed information concerning 
such matters as financial holdings, consultancies, and research grants 
or contracts in order to permit evaluation of possible sources of 
financial conflict of interest. Department policy prohibits multiple 
committee memberships. A federal advisory committee member may not 
serve on more than one committee within an agency at the same time.
    Members are invited to serve for overlapping 2-year terms. A member 
may continue to serve after the expiration of the member's term until a 
successor is named. Any interested person may nominate one or more 
qualified persons. Self-nominations are also accepted. Individuals 
interested in the representative positions must include a letter of 
support from the organization or interest group they would represent.

    Dated: July 26, 2016.
Kate Goodrich,
Director, Center for Clinical Standards and Quality, Centers for 
Medicare & Medicaid Services.
[FR Doc. 2016-18545 Filed 8-4-16; 8:45 am]
 BILLING CODE 4120-01-P



                                                                                 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices                                          51915

                                                     Dated: August 2, 2016.                               SUPPLEMENTARY INFORMATION:                            public testimony on the evidence
                                                  William N. Parham, III,                                                                                       available to address the impact of
                                                                                                          I. Background
                                                  Director, Paperwork Reduction Staff, Office                                                                   medical items and services on health
                                                  of Strategic Operations and Regulatory                     The Secretary signed the initial                   outcomes of Medicare beneficiaries. The
                                                  Affairs.                                                charter for the Medicare Coverage                     MEDCAC may also advise the Centers
                                                  [FR Doc. 2016–18664 Filed 8–4–16; 8:45 am]              Advisory Committee (MCAC) on                          for Medicare & Medicaid Services (CMS)
                                                  BILLING CODE 4120–01–P
                                                                                                          November 24, 1998. A notice in the                    as part of Medicare’s ‘‘coverage with
                                                                                                          Federal Register (63 FR 68780)                        evidence development’’ initiative.
                                                                                                          announcing establishment of the MCAC
                                                  DEPARTMENT OF HEALTH AND                                was published on December 14, 1998.                   II. Provisions of the Notice
                                                  HUMAN SERVICES                                          The MCAC name was updated to more                       As of January 2017, there will be 31
                                                                                                          accurately reflect the purpose of the                 membership terms expiring. Of the 31
                                                  Centers for Medicare & Medicaid                         committee and on January 26, 2007, the                memberships expiring, 3 are industry
                                                  Services                                                Secretary published a notice in the                   representatives, 1 is a patient advocate,
                                                                                                          Federal Register (72 FR 3853),                        and the remaining 27 membership
                                                  [CMS–3335–N]
                                                                                                          announcing that the Committee’s name                  openings are for the at-large standing
                                                  Medicare Program; Request for                           changed to the Medicare Evidence                      MEDCAC membership.
                                                  Nominations for Members for the                         Development & Coverage Advisory                         All nominations must be
                                                  Medicare Evidence Development &                         Committee (MEDCAC). The current                       accompanied by curricula vitae.
                                                  Coverage Advisory Committee                             Secretary’s Charter for the MEDCAC is                 Nomination packages should be sent to
                                                                                                          available on the CMS Web site at: http://             Maria Ellis at the address listed in the
                                                  AGENCY: Centers for Medicare &                          www.cms.hhs.gov/FACA/Downloads/                       ADDRESSES section of this notice.
                                                  Medicaid Services, HHS.                                 medcaccharter.pdf, or you may obtain a                Nominees are selected based upon their
                                                  ACTION: Notice.                                         copy of the charter by submitting a                   individual qualifications. Nominees for
                                                                                                          request to the contact listed in the FOR              membership must have expertise and
                                                  SUMMARY:   This notice announces the                    FURTHER INFORMATION section of this                   experience in one or more of the
                                                  request for nominations for membership                  notice.                                               following fields:
                                                  on the Medicare Evidence Development                       The MEDCAC is governed by                            • Clinical medicine including
                                                  & Coverage Advisory Committee                           provisions of the Federal Advisory                    subspecialties
                                                  (MEDCAC). Among other duties, the                       Committee Act, Pub. L. 92–463, as                       • Administrative medicine
                                                  MEDCAC provides advice and guidance                     amended (5 U.S.C. App. 2), which sets                   • Public health
                                                  to the Secretary of the Department of                   forth standards for the formulation and                 • Biological and physical sciences
                                                  Health and Human Services (the                          use of advisory committees, and is                      • Epidemiology and biostatistics
                                                  Secretary) and the Administrator of the                 authorized by section 222 of the Public                 • Clinical trial design
                                                  Centers for Medicare & Medicaid                         Health Service Act as amended (42                       • Health care data management and
                                                  Services (CMS) concerning the                           U.S.C. 217A).                                         analysis
                                                  adequacy of scientific evidence                            We are requesting nominations for                    • Patient advocacy
                                                  available to CMS in making coverage                     candidates to serve on the MEDCAC.                      • Health care economics
                                                  determinations under the Medicare                       Nominees are selected based upon their                  • Medical ethics
                                                  program.                                                individual qualifications and not solely                • Other relevant professions
                                                    The MEDCAC reviews and evaluates                      as representatives of professional                      We are looking particularly for
                                                  medical literature and technology                       associations or societies. We wish to                 experts in a number of fields. These
                                                  assessments, and hears public testimony                 ensure adequate representation of the                 include cancer screening, genetic
                                                  on the evidence available to address the                interests of both women and men,                      testing, clinical epidemiology,
                                                  impact of medical items and services on                 members of all ethnic groups, and                     psychopharmacology, screening and
                                                  health outcomes of Medicare                             physically challenged individuals.                    diagnostic testing analysis, and vascular
                                                  beneficiaries.                                          Therefore, we encourage nominations of                surgery. We also need experts in
                                                                                                          qualified candidates who can represent                biostatistics in clinical settings,
                                                  DATES:  Nominations must be received
                                                                                                          these interests.                                      dementia treatment, minority health,
                                                  by Tuesday, September 6, 2016.
                                                                                                             The MEDCAC consists of a pool of                   observational research design, stroke
                                                  ADDRESSES: You may mail nominations                     100 appointed members including: 94                   epidemiology, and women’s health.
                                                  for membership to the following                         at-large standing members (6 of whom                    The nomination letter must include a
                                                  address: Centers for Medicare &                         are patient advocates), and 6                         statement that the nominee is willing to
                                                  Medicaid Services, Center for Clinical                  representatives of industry interests.                serve as a member of the MEDCAC and
                                                  Standards and Quality, Attention: Maria                 Members generally are recognized                      appears to have no conflict of interest
                                                  Ellis, 7500 Security Boulevard, Mail                    authorities in clinical medicine                      that would preclude membership. We
                                                  Stop: S3–02–01, Baltimore, MD 21244                     including subspecialties, administrative              are requesting that all curricula vitae
                                                  or send via email to                                    medicine, public health, biological and               include the following:
                                                  MEDCACnomination@cms.hhs.gov.                           physical sciences, epidemiology and                     • Date of birth
                                                  FOR FURTHER INFORMATION CONTACT:                        biostatistics, clinical trial design, health            • Place of birth
                                                  Maria Ellis, Executive Secretary for the                care data management and analysis,                      • Social security number
                                                  MEDCAC, Centers for Medicare &                          patient advocacy, health care                           • Title and current position
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                                                  Medicaid Services, Center for Clinical                  economics, medical ethics or other                      • Professional affiliation
                                                  Standards and Quality, Coverage and                     relevant professions.                                   • Home and business address
                                                  Analysis Group, S3–02–01, 7500                             The MEDCAC works from an agenda                      • Telephone and fax numbers
                                                  Security Boulevard, Baltimore, MD                       provided by the Designated Federal                      • Email address
                                                  21244 or contact Ms. Ellis by phone                     Official. The MEDCAC reviews and                        • List of areas of expertise
                                                  (410–786–0309) or via email at                          evaluates medical literature and                        In the nomination letter, we are
                                                  Maria.Ellis@cms.hhs.gov.                                technology assessments, and hears                     requesting that nominees specify


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                                                  51916                          Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices

                                                  whether they are applying for a patient                 any of the following subjects: The                      Care Prepayment Plans (HCPPS), and
                                                  advocate position, for an at-large                      necessity and utility of the proposed                   PACE Organizations
                                                  standing position, or as an industry                    information collection for the proper                 CMS–10630 The PACE Organization
                                                  representative. Potential candidates will               performance of the agency’s functions;                  (PO) Monitoring and Audit Process in
                                                  be asked to provide detailed information                the accuracy of the estimated burden;                   42 CFR part 460
                                                  concerning such matters as financial                    ways to enhance the quality, utility, and               Under the PRA (44 U.S.C. 3501–
                                                  holdings, consultancies, and research                   clarity of the information to be                      3520), federal agencies must obtain
                                                  grants or contracts in order to permit                  collected; and the use of automated                   approval from the Office of Management
                                                  evaluation of possible sources of                       collection techniques or other forms of               and Budget (OMB) for each collection of
                                                  financial conflict of interest. Department              information technology to minimize the                information they conduct or sponsor.
                                                  policy prohibits multiple committee                     information collection burden.                        The term ‘‘collection of information’’ is
                                                  memberships. A federal advisory                         DATES: Comments must be received by                   defined in 44 U.S.C. 3502(3) and 5 CFR
                                                  committee member may not serve on                       October 4, 2016.                                      1320.3(c) and includes agency requests
                                                  more than one committee within an                                                                             or requirements that members of the
                                                                                                          ADDRESSES: When commenting, please
                                                  agency at the same time.                                                                                      public submit reports, keep records, or
                                                     Members are invited to serve for                     reference the document identifier or
                                                                                                          OMB control number. To be assured                     provide information to a third party.
                                                  overlapping 2-year terms. A member                                                                            Section 3506(c)(2)(A) of the PRA
                                                  may continue to serve after the                         consideration, comments and
                                                                                                          recommendations must be submitted in                  requires federal agencies to publish a
                                                  expiration of the member’s term until a                                                                       60-day notice in the Federal Register
                                                  successor is named. Any interested                      any one of the following ways:
                                                                                                            1. Electronically. You may send your                concerning each proposed collection of
                                                  person may nominate one or more                                                                               information, including each proposed
                                                  qualified persons. Self-nominations are                 comments electronically to http://
                                                                                                          www.regulations.gov. Follow the                       extension or reinstatement of an existing
                                                  also accepted. Individuals interested in                                                                      collection of information, before
                                                  the representative positions must                       instructions for ‘‘Comment or
                                                                                                          Submission’’ or ‘‘More Search Options’’               submitting the collection to OMB for
                                                  include a letter of support from the                                                                          approval. To comply with this
                                                  organization or interest group they                     to find the information collection
                                                                                                          document(s) that are accepting                        requirement, CMS is publishing this
                                                  would represent.                                                                                              notice.
                                                                                                          comments.
                                                    Dated: July 26, 2016.                                   2. By regular mail. You may mail
                                                  Kate Goodrich,
                                                                                                                                                                Information Collection
                                                                                                          written comments to the following
                                                  Director, Center for Clinical Standards and             address: CMS, Office of Strategic                        1. Type of Information Collection
                                                  Quality, Centers for Medicare & Medicaid                Operations and Regulatory Affairs,                    Request: Revision of a currently
                                                  Services.                                               Division of Regulations Development,                  approved collection; Title of
                                                  [FR Doc. 2016–18545 Filed 8–4–16; 8:45 am]              Attention: Document Identifier/OMB                    Information Collection: Collection of
                                                  BILLING CODE 4120–01–P                                  Control Number ll, Room C4–26–05,                     Encounter Data From: Medicare
                                                                                                          7500 Security Boulevard, Baltimore,                   Advantage Organizations, Section 1876
                                                                                                          Maryland 21244–1850.                                  Cost HMOS/CMPS, Section 1833 Health
                                                  DEPARTMENT OF HEALTH AND                                  To obtain copies of a supporting                    Care Prepayment Plans (HCPPS), and
                                                  HUMAN SERVICES                                          statement and any related forms for the               PACE Organizations; Use: We collect
                                                                                                          proposed collection(s) summarized in                  encounter data or data on each item or
                                                  Centers for Medicare & Medicaid                                                                               service delivered to enrollees of
                                                  Services                                                this notice, you may make your request
                                                                                                          using one of following:                               Medicare Advantage (MA) plans offered
                                                  [Document Identifiers: CMS–10340 and                      1. Access CMS’ Web site address at                  by MA organizations. The MA
                                                  CMS–10630]                                              http://www.cms.hhs.gov/Paperwork                      organizations currently obtain this data
                                                                                                          ReductionActof1995.                                   from providers. We collect this
                                                  Agency Information Collection                                                                                 information using standard transaction
                                                                                                            2. Email your request, including your
                                                  Activities: Proposed Collection;                                                                              forms and code sets. We will use the
                                                                                                          address, phone number, OMB number,
                                                  Comment Request                                                                                               data for determining risk adjustment
                                                                                                          and CMS document identifier, to
                                                  AGENCY: Centers for Medicare &                          Paperwork@cms.hhs.gov.                                factors for payment, updating the risk
                                                  Medicaid Services, HHS.                                   3. Call the Reports Clearance Office at             adjustment model, calculating Medicare
                                                  ACTION: Notice.                                         (410) 786–1326.                                       DSH percentages, Medicare coverage
                                                                                                                                                                purposes, and quality review and
                                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                  SUMMARY:   The Centers for Medicare &                                                                         improvement activities. The data is also
                                                                                                          Reports Clearance Office at (410) 786–
                                                  Medicaid Services (CMS) is announcing                                                                         used to verify the accuracy and validity
                                                                                                          1326.
                                                  an opportunity for the public to                                                                              of the costs claimed on cost reports. For
                                                  comment on CMS’ intention to collect                    SUPPLEMENTARY INFORMATION:                            PACE organizations, encounter data
                                                  information from the public. Under the                  Contents                                              would serve the same purpose it does
                                                  Paperwork Reduction Act of 1995 (the                                                                          related to the MA program and would
                                                  PRA), federal agencies are required to                    This notice sets out a summary of the               be submitted in a similar manner. Form
                                                  publish notice in the Federal Register                  use and burden associated with the                    Number: CMS–10340 (OMB control
                                                  concerning each proposed collection of                  following information collections. More               number: 0938–1152); Frequency:
                                                  information (including each proposed                    detailed information can be found in                  Weekly, bi-weekly, and monthly;
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                                                  extension or reinstatement of an existing               each collection’s supporting statement                Affected Public: Private sector (Business
                                                  collection of information) and to allow                 and associated materials (see                         or other for-profits); Number of
                                                  60 days for public comment on the                       ADDRESSES).                                           Respondents: 691; Total Annual
                                                  proposed action. Interested persons are                 CMS–10340 Collection of Encounter                     Responses: 18,854,605; Total Annual
                                                  invited to send comments regarding our                    Data From: Medicare Advantage                       Hours: 54,054. (For policy questions
                                                  burden estimates or any other aspect of                   Organizations, Section 1876 Cost                    regarding this collection contact
                                                  this collection of information, including                 HMOS/CMPS, Section 1833 Health                      Michael Massimini at 410–786–1566.)


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Document Created: 2016-08-05 06:43:29
Document Modified: 2016-08-05 06:43:29
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.
DatesNominations must be received by Tuesday, September 6, 2016.
ContactMaria Ellis, Executive Secretary for the MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via email at [email protected]
FR Citation81 FR 51915 

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