2010-30761. Medicare Program; Renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice announces the renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).

ADDRESSES:

Copies of the Charter: To obtain a copy of the Secretary's Charter for the MEDCAC submit a request to: See FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:

Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone [phone]) or via e-mail at [e-mail].

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 MCAC on November 24, 1998. The MCAC was originally established to provide independent guidance and expert advice to CMS on specific clinical topics. In 2007 the Charter was renewed and the name MCAC was modified to Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to more accurately reflect the Committee's role. The MEDCAC is advisory, with the final decision on all issues resting with CMS. Under the current charter, the MEDCAC advises the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the CMS, on the quality of evidence on clinical topics under review by CMS.

The MEDCAC consists of a pool of 100 appointed members. Members are selected from 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. There are 94 at-large standing voting members. Six of the members are patient advocates and six are nonvoting members representing the industry interest.

II. Provisions of this Notice

This notice announces the signing of the MEDCAC charter renewal by the Secretary on November 23, 2010. The new charter makes the following changes:

• There are 4-8 meetings per year.
• A period of service for the Chair and Vice-Chair of no more than 4 years.

The MEDCAC functions on a committee basis. The MEDCAC—(1) Hears public testimony; (2) reviews medical literature, technology assessments and other relevant evidence and advises CMS on the strength and weaknesses of that evidence; (3) advises CMS of any evidence gaps that may exist and recommends the types of evidence that should be developed to fill those evidentiary gaps. The Committee may be asked to develop recommendations about specific clinical issues under review and to review and comment upon proposed or existing Medicare coverage policies. The Committee may also be asked to comment on pertinent aspects of proposals being considered and other policies. The Committee works from an agenda provided by the designated Federal official that lists specific issues.

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: November 16, 2010.

Barry M. Straube,

CMS Chief Medical Officer, Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services.