80_FR_63756 80 FR 63554 - Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee

80 FR 63554 - 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 80, Issue 202 (October 20, 2015)

Page Range63554-63555
FR Document2015-26569

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 80 Issue 202 (Tuesday, October 20, 2015)
[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)]
[Notices]
[Pages 63554-63555]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26569]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3325-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.

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

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 Monday, December 7, 2015.

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

[[Page 63555]]

Stop: S3-02-01, Baltimore, MD 21244 or send via email to 
MEDCACnomination@cms.hhs.gov.

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 Maria.Ellis@cms.hhs.gov.

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 CONTACT section of this 
notice.
    The MEDCAC is governed by provisions of the Federal Advisory 
Committee Act, Public Law 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 June 2016, there will be 35 membership terms expiring. Of the 
35 memberships expiring, 1 is an industry representative, 4 are patient 
advocates, and the remaining 30 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 
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: October 13, 2015.
Patrick Conway,
CMS Chief Medical Officer and Director, Center for Clinical Standards 
and Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-26569 Filed 10-19-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                  63554                        Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices

                                                  number for the Public Reading Room is                     Dated: October 15, 2015.                            ADDRESSES:    Submit written comments
                                                  (202) 566–1744, and the telephone                       Fred S. Hauchman,                                     to: Email: oira_submissions@
                                                  number for the ORD Docket is (202)                      Director, Office of Science Policy.                   omb.eop.gov. Please include the FMCS
                                                  566–1752.                                               [FR Doc. 2015–26597 Filed 10–19–15; 8:45 am]          form number, the information collection
                                                                                                          BILLING CODE 6560–50–P
                                                                                                                                                                title, and the OMB control number in
                                                  FOR FURTHER INFORMATION CONTACT:     The                                                                      the subject line of the message.
                                                  Designated Federal Officer (DFO) via                                                                          Comments may also be sent to fax
                                                  mail at: Jace Cujé, Mail Code 8104R,                                                                         number 202.395.5806 to the attention of
                                                  Office of Science Policy, Office of                     FEDERAL MEDIATION AND                                 Desk Officer for FMCS.
                                                  Research and Development, U.S.                          CONCILIATION SERVICE
                                                                                                                                                                SUPPLEMENTARY INFORMATION: For
                                                  Environmental Protection Agency, 1200
                                                                                                          Labor-Management Relations                            additional information, see the related
                                                  Pennsylvania Ave. NW., Washington,
                                                                                                          Information Collection Requests                       60-day notice published in the Federal
                                                  DC 20460; via phone/voice mail at:
                                                                                                                                                                Register at 88 FR 46581 on August 5,
                                                  (202) 564–1795; or via email at:                        AGENCY:  Federal Mediation and                        2015.
                                                  cuje.jace@epa.gov.                                      Conciliation Service.                                   Dated: October 14, 2015.
                                                  SUPPLEMENTARY INFORMATION:       The                    ACTION: Submission for OMB Review:                    Jeannette Walters-Marquez,
                                                  Charter of the BOSC states that the                     Request for Comments.                                 Attorney Advisor.
                                                  advisory committee shall provide advice
                                                                                                          SUMMARY:    The Federal Mediation and                 [FR Doc. 2015–26513 Filed 10–19–15; 8:45 am]
                                                  and recommendations on all aspects
                                                  (technical and management) of the                       Conciliation Service (FMCS) hereby                    BILLING CODE 6732–01–P

                                                  ORD’s research program. The BOSC is                     announces the submission of the
                                                  federal advisory committee chartered                    following public information collection
                                                  under the Federal Advisory Committee                    request (ICR) to the Office of                        DEPARTMENT OF HEALTH AND
                                                                                                          Management and Budget (OMB) for                       HUMAN SERVICES
                                                  Act (FACA), 5 U.S.C., App. 2.
                                                                                                          review and approval in accordance with
                                                  Additional information about the BOSC                                                                         Centers for Medicare & Medicaid
                                                                                                          the Paperwork Reduction Act of 1995
                                                  is available at: http://www2.epa.gov/                                                                         Services
                                                                                                          (Pub. L. 104–13). The information
                                                  bosc.
                                                                                                          collection request is the Notice to                   [CMS–3325–N]
                                                     This meeting is open to the public.                  Mediation Agencies (Agency Form F–7),
                                                  Any member of the public interested in                  OMB control number 3076–0004. No                      Medicare Program; Request for
                                                  receiving a draft agenda, joining the                   comments were received pursuant to                    Nominations for Members for the
                                                  teleconference, or making a presentation                FMCS’s prior 60-day notice in the                     Medicare Evidence Development &
                                                  during the teleconference may contact                   Federal Register on August 5, 2015.                   Coverage Advisory Committee
                                                  Jace Cujé, DFO, via any of the contact                 This information collection request was
                                                  methods listed in the FOR FURTHER                       previously approved by OMB.                           AGENCY: Centers for Medicare &
                                                  INFORMATION CONTACT section above.                        OMB is interested in comments on                    Medicaid Services, HHS.
                                                  Proposed agenda items for the meeting                   specific aspects of the collection. The               ACTION: Notice.
                                                  include, but are not limited to, the                    OMB is particularly interested in
                                                  following: presentation and discussion                  comments that:                                        SUMMARY:   This notice announces the
                                                                                                            (1) Evaluate whether the proposed                   request for nominations for membership
                                                  of the subcommittee’s draft responses to
                                                                                                          collection of information is necessary                on the Medicare Evidence Development
                                                  the charge questions and approval of the
                                                                                                          for the proper performance of the                     & Coverage Advisory Committee
                                                  final draft letter report prior to its
                                                                                                          functions of the agency, including                    (MEDCAC). Among other duties, the
                                                  submission to the BOSC Executive
                                                                                                          whether the information will have                     MEDCAC provides advice and guidance
                                                  Committee.
                                                                                                          practical utility;                                    to the Secretary of the Department of
                                                     Written Statements: Written                                                                                Health and Human Services (the
                                                                                                            (2) Evaluates the accuracy of the
                                                  comments for the public teleconference                                                                        Secretary) and the Administrator of the
                                                                                                          agency’s estimates of the burden of the
                                                  must be received by noon Monday,                                                                              Centers for Medicare & Medicaid
                                                                                                          proposed collection information;
                                                  November 2, 2015, Eastern Time, so                                                                            Services (CMS) concerning the
                                                                                                            (3) Enhance the quality, utility, and
                                                  they can be distributed to the BOSC                                                                           adequacy of scientific evidence
                                                                                                          clarity of the information to be
                                                  SHC Subcommittee prior to the                           collected; and                                        available to CMS in making coverage
                                                  teleconference. Written comments                          (4) Minimize the burden of the                      determinations under the Medicare
                                                  should be sent to Jace Cujé at the                     collections of information on those who               program.
                                                  address listed in the FOR FURTHER                       are to respond, including the use of                    The MEDCAC reviews and evaluates
                                                  INFORMATION CONTACT section or through                  appropriate automated, electronic                     medical literature and technology
                                                  regulations.gov, Docket ID No. EPA–                     collection technologies or other forms of             assessments, and hears public testimony
                                                  HQ–ORD–2015–0611.                                       information technology.                               on the evidence available to address the
                                                     Information on Services for                            Burden: FMCS receives                               impact of medical items and services on
                                                  Individuals with Disabilities: For                      approximately 14,400 responses to the                 health outcomes of Medicare
                                                  information on access or services for                   form Notice to Mediation Agencies                     beneficiaries.
                                                  individuals with disabilities, please                   (OMB No. 3076–004).                                   DATES:  Nominations must be received
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  contact Jace Cujé at (202) 564–1795 or                   Affected Entities: Private sector                   by Monday, December 7, 2015.
                                                  cuje.jace@epa.gov. To request                           employers and labor unions involved in                ADDRESSES: You may mail nominations
                                                  accommodation of a disability, please                   interstate commerce that file notices for             for membership to the following
                                                  contact Jace Cujé, preferably at least ten             mediation services to the FMCS and                    address: Centers for Medicare &
                                                  days prior to the meeting, to give the                  state, local and territorial agencies.                Medicaid Services, Center for Clinical
                                                  EPA as much time as possible to process                 DATES: Comments must be submitted on                  Standards and Quality, Attention: Maria
                                                  your request.                                           or before November 19, 2015.                          Ellis, 7500 Security Boulevard, Mail


                                             VerDate Sep<11>2014   17:55 Oct 19, 2015   Jkt 238001   PO 00000   Frm 00057   Fmt 4703   Sfmt 4703   E:\FR\FM\20OCN1.SGM   20OCN1


                                                                               Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices                                               63555

                                                  Stop: S3–02–01, Baltimore, MD 21244                     authorities in clinical medicine                      appears to have no conflict of interest
                                                  or send via email to                                    including subspecialties, administrative              that would preclude membership. We
                                                  MEDCACnomination@cms.hhs.gov.                           medicine, public health, biological and               are requesting that all curricula vitae
                                                  FOR FURTHER INFORMATION CONTACT:                        physical sciences, epidemiology and                   include the following:
                                                  Maria Ellis, Executive Secretary for the                biostatistics, clinical trial design, health          • Date of birth
                                                  MEDCAC, Centers for Medicare &                          care data management and analysis,                    • Place of birth
                                                  Medicaid Services, Center for Clinical                  patient advocacy, health care                         • Social security number
                                                  Standards and Quality, Coverage and                     economics, medical ethics or other                    • Title and current position
                                                  Analysis Group, S3–02–01, 7500                          relevant professions.                                 • Professional affiliation
                                                  Security Boulevard, Baltimore, MD                         The MEDCAC works from an agenda                     • Home and business address
                                                                                                          provided by the Designated Federal                    • Telephone and fax numbers
                                                  21244 or contact Ms. Ellis by phone
                                                                                                          Official. The MEDCAC reviews and                      • Email address
                                                  (410–786–0309) or via email at                                                                                • List of areas of expertise
                                                  Maria.Ellis@cms.hhs.gov.                                evaluates medical literature and
                                                                                                          technology assessments, and hears                        In the nomination letter, we are
                                                  SUPPLEMENTARY INFORMATION:                              public testimony on the evidence                      requesting that nominees specify
                                                  I. Background                                           available to address the impact of                    whether they are applying for a patient
                                                                                                          medical items and services on health                  advocate position, for an at-large
                                                     The Secretary signed the initial
                                                                                                          outcomes of Medicare beneficiaries. The               standing position, or as an industry
                                                  charter for the Medicare Coverage
                                                                                                          MEDCAC may also advise the Centers                    representative. Potential candidates will
                                                  Advisory Committee (MCAC) on
                                                                                                          for Medicare & Medicaid Services (CMS)                be asked to provide detailed information
                                                  November 24, 1998. A notice in the
                                                                                                          as part of Medicare’s ‘‘coverage with                 concerning such matters as financial
                                                  Federal Register (63 FR 68780)
                                                                                                          evidence development’’ initiative.                    holdings, consultancies, and research
                                                  announcing establishment of the MCAC
                                                                                                                                                                grants or contracts in order to permit
                                                  was published on December 14, 1998.                     II. Provisions of the Notice                          evaluation of possible sources of
                                                  The MCAC name was updated to more                         As of June 2016, there will be 35                   financial conflict of interest. Department
                                                  accurately reflect the purpose of the                   membership terms expiring. Of the 35                  policy prohibits multiple committee
                                                  committee and on January 26, 2007, the                  memberships expiring, 1 is an industry                memberships. A federal advisory
                                                  Secretary published a notice in the                     representative, 4 are patient advocates,              committee member may not serve on
                                                  Federal Register (72 FR 3853),                          and the remaining 30 membership                       more than one committee within an
                                                  announcing that the Committee’s name                    openings are for the at-large standing                agency at the same time.
                                                  changed to the Medicare Evidence                        MEDCAC membership.                                       Members are invited to serve for
                                                  Development & Coverage Advisory                           All nominations must be                             overlapping 2-year terms. A member
                                                  Committee (MEDCAC). The current                         accompanied by curricula vitae.                       may continue to serve after the
                                                  Secretary’s Charter for the MEDCAC is                   Nomination packages should be sent to                 expiration of the member’s term until a
                                                  available on the CMS Web site at: http://               Maria Ellis at the address listed in the              successor is named. Any interested
                                                  www.cms.hhs.gov/FACA/Downloads/                         ADDRESSES section of this notice.                     person may nominate one or more
                                                  medcaccharter.pdf, or you may obtain a                  Nominees are selected based upon their                qualified persons. Self-nominations are
                                                  copy of the charter by submitting a                     individual qualifications. Nominees for               also accepted. Individuals interested in
                                                  request to the contact listed in the FOR                membership must have expertise and                    the representative positions must
                                                  FURTHER INFORMATION CONTACT section of
                                                                                                          experience in one or more of the                      include a letter of support from the
                                                  this notice.                                            following fields:                                     organization or interest group they
                                                     The MEDCAC is governed by
                                                  provisions of the Federal Advisory                      • Clinical medicine including                         would represent.
                                                  Committee Act, Public Law 92–463, as                      subspecialties                                        Dated: October 13, 2015.
                                                  amended (5 U.S.C. App. 2), which sets                   • Administrative medicine                             Patrick Conway,
                                                  forth standards for the formulation and                 • Public health                                       CMS Chief Medical Officer and Director,
                                                  use of advisory committees, and is                      • Biological and physical sciences                    Center for Clinical Standards and Quality,
                                                  authorized by section 222 of the Public                 • Epidemiology and biostatistics                      Centers for Medicare & Medicaid Services.
                                                  Health Service Act as amended (42                       • Clinical trial design                               [FR Doc. 2015–26569 Filed 10–19–15; 8:45 am]
                                                  U.S.C. 217A).                                           • Health care data management and                     BILLING CODE 4120–01–P
                                                     We are requesting nominations for                      analysis
                                                  candidates to serve on the MEDCAC.                      • Patient advocacy
                                                  Nominees are selected based upon their                  • Health care economics                               DEPARTMENT OF HEALTH AND
                                                  individual qualifications and not solely                • Medical ethics                                      HUMAN SERVICES
                                                  as representatives of professional                      • Other relevant professions
                                                  associations or societies. We wish to                     We are looking particularly for                     Administration for Children and
                                                  ensure adequate representation of the                   experts in a number of fields. These                  Families
                                                  interests of both women and men,                        include cancer screening, genetic
                                                                                                          testing, clinical epidemiology,                       Statement of Organization, Functions,
                                                  members of all ethnic groups, and
                                                                                                          psychopharmacology, screening and                     and Delegations of Authority
                                                  physically challenged individuals.
                                                  Therefore, we encourage nominations of                  diagnostic testing analysis, and vascular             AGENCY: Administration for Children
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  qualified candidates who can represent                  surgery. We also need experts in                      and Families, HHS.
                                                  these interests.                                        biostatistics in clinical settings,                   ACTION: Notice of reorganization.
                                                     The MEDCAC consists of a pool of                     dementia treatment, minority health,
                                                  100 appointed members including: 94                     observational research design, stroke                 SUMMARY:  Statement of Organization,
                                                  at-large standing members (6 of whom                    epidemiology, and women’s health.                     Functions, and Delegations of
                                                  are patient advocates), and 6                             The nomination letter must include a                Authority. The Administration for
                                                  representatives of industry interests.                  statement that the nominee is willing to              Children and Families (ACF) has
                                                  Members generally are recognized                        serve as a member of the MEDCAC and                   reorganized. The reorganization adds


                                             VerDate Sep<11>2014   17:55 Oct 19, 2015   Jkt 238001   PO 00000   Frm 00058   Fmt 4703   Sfmt 4703   E:\FR\FM\20OCN1.SGM   20OCN1



Document Created: 2015-12-14 15:25:53
Document Modified: 2015-12-14 15:25:53
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 Monday, December 7, 2015.
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 Citation80 FR 63554 

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR