2015-07105. 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).

FOR FURTHER INFORMATION CONTACT:

Maria Ellis, [phone]. Additional information on the MEDCAC, including a copy of the Charter, is available at http://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​MEDCAC.html. A copy of the charter may also be obtained by submitting a request to Maria Ellis via phone or via email 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) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on the quality of evidence on clinical topics under review by CMS.

The MEDCAC consists of a pool of 100 appointed members who serve overlapping 2-year terms. Members shall be invited to serve for two terms (up to 4 years total). Members are selected from among authorities in clinical and administrative medicine, biologic and physical sciences, public health administration, health care data and information management and analysis, the economics of health care, medical ethics, and other related professions, as well as advocates for patients. Of the pool of 100 members, a maximum of 94 members shall be at-large standing members (this includes 6 members who shall be patient advocates) and 6 shall be members representing industry interests. The Secretary or designee appoints a Chair and Vice-Chair from among the pool of at-large members.

II. Provisions of This Notice

This notice announces the renewal of the MEDCAC charter by the Secretary, effective November 24, 2014. The MEDCAC charter is effective for 2 years. Among other things, the new charter states that the committee will hold four to eight meetings over the life of the committee. Formerly, the charter allowed up to 16 meetings over the life of the committee.

The MEDCAC functions on a committee basis. The MEDCAC hears public testimony; reviews medical literature, technology assessments and other relevant evidence; and advises CMS on the strength and weaknesses of that evidence. The MEDCAC also 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 issues related to Medicare coverage, and/or to review and comment upon proposed or existing Medicare coverage policies. The Committee may also be asked to comment on pertinent aspects of coverage proposals being considered and other policies. The Committee works from an agenda provided by a designated Federal official, which lists specific issues to be reviewed.

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

Dated: March 20, 2015.

Patrick Conway,

Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, Centers for Medicare & Medicaid Services.