[Federal Register Volume 72, Number 17 (Friday, January 26, 2007)]
[Notices]
[Pages 3853-3854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3169-N]


Medicare Program; Renewal and Renaming of the Medicare Coverage 
Advisory Committee (MCAC) to Medicare Evidence Development Coverage 
Advisory Committee (MedCAC) and a Request for Nominations for Members 
for the Medicare Evidence Development & Coverage Advisory Committee

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the renewal and name change of the 
Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence 
Development Coverage Advisory Committee (MedCAC). It also requests 
nominations for consideration for membership on the Medicare Evidence 
Development & Coverage Advisory Committee (MedCAC).

DATES: Nominations will be considered if postmarked by March 12, 2007.

ADDRESSES: Nominations for membership must be sent by mail, fax, or e-
mail, to one of the following addresses: Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, Mail Stop: 
C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244, Attention: 
Michelle Atkinson; via fax to (410) 786-9286; or e-mail to 
[email protected].
    Copies of the Charter: To obtain a copy of the Secretary's Charter 
for the MedCAC submit a request to: Centers for Medicare & Medicaid 
Service, Office of Clinical Standards and Quality, Mail Stop C1-09-06, 
7500 Security Boulevard, Baltimore, MD 21244, Attention: Maria Ellis or 
via e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Michelle Atkinson, (410) 786-2881, 
Nominations; Marie Ellis, (410) 786-0309, Copies of the charter.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 14, 1998, we published a notice in the Federal Register 
(63 FR 68780) announcing the establishment of the Medicare Coverage 
Advisory Committee (MCAC). The Secretary signed the initial charter for 
the Medicare Coverage Advisory Committee on November 24, 1998. The MCAC

[[Page 3854]]

advised the Secretary of the Department of Health and Human Services 
(DHHS) and the Administrator of the Centers for Medicare and Medicaid 
Services (CMS), as requested by the Secretary, whether medical items 
and services were reasonable and necessary under Title XVIII of the 
Social Security Act (the Act).
    The MCAC consisted of a pool of 100 appointed members. Members were 
selected from among authorities in clinical medicine of all 
specialties, administrative medicine, public health, biologic and 
physical sciences, health care data and information management and 
analysis, patient advocacy, the economics of health care, medical 
ethics, and other related professions such as epidemiology and 
biostatistics, and methodology of trial design. A maximum of 88 members 
are standard voting members, 12 are nonvoting members, 6 of whom are 
representatives of consumer interests, and 6 of whom are 
representatives of industry interests.

II. Provisions of This Notice

A. Renewal of the Charter and the Renaming of the Committee

    This notice announces the signing of the MedCAC charter renewal by 
the Secretary on November 24, 2006. The charter will terminate on 
November 24, 2008, unless renewed by the Secretary. The new charter 
makes the following changes:
     Redesignates the Committee from the MCAC to Medicare 
Evidence Development Coverage Advisory Committee.
     Gives the MedCAC an explicit responsibility to advise CMS 
as part of its coverage with evidence development (CED) activity. The 
CED initiative involves the issuance of national coverage 
determinations that include, a condition of payment, requirements for 
developing additional clinical data on a particular medical technology.
     Formalizes the role of patient advocates on the MedCAC 
role. By establishing the patient advocate as a permanent MedCAC role, 
CMS is ensuring that beneficiary community is represented on the 
panels. These advocates will identify issues most important to 
patients, communicate the patient perspective, and vote on the 
Committee's recommendations with patients' general interests in mind.
    To accompany the changes in the MedCAC charter, we have issued a 
guidance document entitled, ``Factor CMS Considers in Referring Topics 
to the Medicare Evidence Development and Coverage Advisory Committee.'' 
This document is consistent with Section 731 of the Medicare 
Prescription Drug Improvement, and Modernization Act (MMA) of 2003, and 
is in line with our goal of continuing to develop a more open, 
transparent, and understandable national coverage process.

B. Request for Nominations

    As of May 2007, there will be 28 terms of membership expiring, 2 of 
which are nonvoting consumer representatives, 1 of which is a nonvoting 
industry representative and 6 voting patient advocates. Accordingly, we 
are requesting nominations for both voting and nonvoting members to 
serve on the MedCAC. Members are invited to serve for overlapping 4 
year terms. A member may serve after the expiration of the member's 
term until a successor takes office. Any interested person may nominate 
one or more qualified persons. Self-nominations are also accepted. We 
have a special interest in ensuring that women, minority groups, and 
physically challenged individuals are adequately represented on the 
MedCAC. Therefore, we encourage nominations of qualified candidates 
from these groups. Nominees are selected based upon their individual 
qualifications and not as representatives of professional associations 
or societies.
    The MedCAC functions on a committee basis. The committee reviews 
and evaluates medical literature, reviews technology assessments, and 
examines data and information on the effectiveness and appropriateness 
of medical items and services that are covered or eligible for coverage 
under Medicare. The Committee works from an agenda provided by the 
designated Federal official that lists specific issues, and develops 
technical advice to assist us in determining reasonable and necessary 
applications of medical services and technology when we make national 
coverage decisions for Medicare.
1. Membership Criteria
    Nominees for voting membership must have expertise and experience 
in one or more of the following fields: clinical medicine of all 
specialties, administrative medicine, public health, patient advocacy, 
biologic and physical sciences, health care data and information 
management and analysis, the economics of health care, medical ethics, 
and other related professions such as epidemiology and biostatistics, 
and methodology of trial design.
2. Submission of Nominations
    All nominations must be accompanied by nomination letter and 
curricula vitae. Nomination packages must be sent to the address 
specified in the ADDRESSES section this notice. The nomination letter 
must include--(1) A statement that the nominee is willing to serve as a 
member of the MedCAC and believes that he or she does not have a 
conflict of interest that would preclude his or her committee 
membership; and (2) specify whether the nominee is applying for a 
voting position, consumer representative; industry representative or 
patient advocate. The curricula vitae must include the following: (1) 
Date of birth; (2) place of birth; (3) social security number; (4) 
title and current position; (5) professional affiliation; (6) home and 
business addresses; (7) telephone and fax numbers; (8) e-mail address; 
and (9) list of the nominee's areas of expertise. 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 conflict of 
interest.

    Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: January 11, 2007.
Barry M. Straube,
 Chief Medical Officer, Director, Office of Clinical Standards and 
Quality, Centers for Medicare &Medicaid Services.
 [FR Doc. E7-1113 Filed 1-25-07; 8:45 am]
BILLING CODE 4120-03-P