83 FR 61639 - 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 83, Issue 231 (November 30, 2018)

Page Range		61639-61640
FR Document		2018-26090

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 MEDCACs fundamental purpose is to support the principles of an evidence-based determination process for Medicare's coverage policies. MEDCAC panels provide advice to CMS on the strength of the evidence available for specific medical treatments and technologies through a public, participatory, and accountable process.

Federal Register, Volume 83 Issue 231 (Friday, November 30, 2018)

[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61639-61640]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3374-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 MEDCACs fundamental purpose is to support the principles of an 
evidence-based determination process for Medicare's coverage policies. 
MEDCAC panels provide advice to CMS on the strength of the evidence 
available for specific medical treatments and technologies through a 
public, participatory, and accountable process.

DATES: Nominations must be received by Monday, January 7, 2019.

ADDRESSES: You may mail nominations for membership to the following 
address: Centers for Medicare & Medicaid Services, Center for Clinical 
Standards and Quality, Attention: Leah Cromwell or 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

[[Page 61640]]

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 
website 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, 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: 
90 at-large standing members (10 of whom are patient advocates), and 10 
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 2019, there will be 20 membership terms expiring. Of the 
20 memberships expiring, 1 is an industry representative and the 
remaining 19 membership openings are for the at-large standing MEDCAC 
membership.
    All nominations must be accompanied by curricula vitae. Nomination 
packages should be sent to Leah Cromwell or 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.

III. Collection of Information

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

    Dated: November 21, 2018.
Kate Goodrich,
Director, Center for Clinical Standards and Quality, Chief Medical 
Officer, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-26090 Filed 11-29-18; 8:45 am]
BILLING CODE 4120-01-P

Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices 61639

address: CMS, Office of Strategic Secretary shall establish a process under DEPARTMENT OF HEALTH AND
Operations and Regulatory Affairs, which the sponsor of a Prescription HUMAN SERVICES
Division of Regulations Development, Drug Plan (PDP) that provide
Attention: Document Identifier/OMB prescription drug benefits under Centers for Medicare & Medicaid
Control Number ll, Room C4–26–05, Medicare Part D may request, beginning Services
7500 Security Boulevard, Baltimore, in plan year 2020, that the Secretary [CMS–3374–N]
Maryland 21244–1850. provide on a periodic basis and in an
To obtain copies of a supporting electronic format standardized extracts Medicare Program; Request for
statement and any related forms for the Nominations for Members for the
of Medicare claims about its plan
proposed collection(s) summarized in Medicare Evidence Development &
enrollees. Section 50354 of the BBA
this notice, you may make your request Coverage Advisory Committee
using one of following: further specifies that PDP sponsors
1. Access CMS’ website address at receiving such Medicare claims data for AGENCY: Centers for Medicare &
website address at https://www.cms.gov/ their corresponding PDP plan enrollees Medicaid Services, HHS.
Regulations-and-Guidance/Legislation/ may use the data for: (1) Optimizing ACTION: Notice.
PaperworkReductionActof1995/PRA- therapeutic outcomes through improved
Listing.html. medication use, (2) improving care SUMMARY: This notice announces the
2. Email your request, including your coordination so as to prevent adverse request for nominations for membership
address, phone number, OMB number, healthcare outcomes, such as on the Medicare Evidence Development
and CMS document identifier, to preventable emergency department & Coverage Advisory Committee
Paperwork@cms.hhs.gov. visits and hospital readmissions, and (3) (MEDCAC). Among other duties, the
3. Call the Reports Clearance Office at for any other purposes determined MEDCAC provides advice and guidance
(410) 786–1326. appropriate by the Secretary. Section to the Secretary of the Department of
FOR FURTHER INFORMATION CONTACT: 50354 also states that the PDP sponsor Health and Human Services (the
William Parham at (410) 786–1326. may not use the data: (1) To inform Secretary) and the Administrator of the
SUPPLEMENTARY INFORMATION: coverage determinations under Part D, Centers for Medicare & Medicaid
(2) to conduct retroactive review of Services (CMS) concerning the
Contents adequacy of scientific evidence
medically accepted conditions, (3) to
This notice sets out a summary of the available to CMS in making coverage
facilitate enrollment changes to a
use and burden associated with the determinations under the Medicare
different PDP or a MA–PD plan offered
following information collections. More program.
detailed information can be found in by the same parent organization, (4) to The MEDCACs fundamental purpose
each collection’s supporting statement inform marketing benefits; and (5) for is to support the principles of an
and associated materials (see any other purpose the Secretary evidence-based determination process
ADDRESSES). determines is necessary to include in for Medicare’s coverage policies.
order to protect the identity of MEDCAC panels provide advice to CMS
CMS–10691 Data Request and individuals entitled to or enrolled in on the strength of the evidence available
Attestation for PDP Sponsors Medicare, and to protect the security of for specific medical treatments and
Under the PRA (44 U.S.C. 3501– personal health information. This technologies through a public,
3520), federal agencies must obtain proposed information collection request participatory, and accountable process.
approval from the Office of Management would allow the PDP sponsor to submit DATES: Nominations must be received
and Budget (OMB) for each collection of a request to CMS for claims data for its by Monday, January 7, 2019.
information they conduct or sponsor. enrollees and to attest that it will adhere ADDRESSES: You may mail nominations
The term ‘‘collection of information’’ is to the permitted uses and limitations on
defined in 44 U.S.C. 3502(3) and 5 CFR for membership to the following
the use of the Medicare claims data that address: Centers for Medicare &
1320.3(c) and includes agency requests are listed in 42 CFR 423.153. Form
or requirements that members of the Medicaid Services, Center for Clinical
Number: CMS–10691 (OMB control Standards and Quality, Attention: Leah
public submit reports, keep records, or number: 0938–TBD); Frequency:
provide information to a third party. Cromwell or Maria Ellis, 7500 Security
Occasionally; Affected Public: Private Boulevard, Mail Stop: S3–02–01,
Section 3506(c)(2)(A) of the PRA
sector; Number of Respondents: 63; Baltimore, MD 21244 or send via email
requires federal agencies to publish a
Total Annual Responses: 68; Total to MEDCACnomination@cms.hhs.gov.
60-day notice in the Federal Register
concerning each proposed collection of Annual Hours: 1.36. (For policy FOR FURTHER INFORMATION CONTACT:
information, including each proposed questions regarding this collection Maria Ellis, Executive Secretary for the
extension or reinstatement of an existing contact Kari Gaare at 410–786–8612.) MEDCAC, Centers for Medicare &
collection of information, before Dated: November 27, 2018. Medicaid Services, Center for Clinical
submitting the collection to OMB for Standards and Quality, Coverage and
William N. Parham, III,
approval. To comply with this Analysis Group, S3–02–01, 7500
Director, Paperwork Reduction Staff, Office Security Boulevard, Baltimore, MD
requirement, CMS is publishing this of Strategic Operations and Regulatory
notice. 21244 or contact Ms. Ellis by phone
Affairs.
(410–786–0309) or via email at
Information Collection [FR Doc. 2018–26052 Filed 11–29–18; 8:45 am]
Maria.Ellis@cms.hhs.gov.
amozie on DSK3GDR082PROD with NOTICES1

Type of Information Collection BILLING CODE 4120–01–P
SUPPLEMENTARY INFORMATION:
Request: New collection (request for a
new OMB control number); Title of I. Background
Information Collection: Data Request The Secretary signed the initial
and Attestation for PDP Sponsors; Use: charter for the Medicare Coverage
Section 50354 of the Bipartisan Budget Advisory Committee (MCAC) on
Act of 2018 (BBA) provides that the November 24, 1998. A notice in the

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Document Created: 2018-11-30 04:36:12
Document Modified: 2018-11-30 04:36:12

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Nominations must be received by Monday, January 7, 2019.
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]
FR Citation		83 FR 61639

83 FR 61639 - Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 231 (November 30, 2018)

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