E7-1113. 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 &...

AGENCY:

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

ACTION:

Notice.

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 [phone]; or e-mail to [e-mail].

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 [e-mail].

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, [phone], Nominations; Marie Ellis, [phone], 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 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.