06-2568. Medicare Program; Request for Nominations for Members of the Medicare Coverage Advisory Committee and Notice of Meeting of the Medicare Coverage Advisory Committee-May 18, 2006

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute.

This notice also announces a public meeting of the MCAC. The meeting will address the use of non-invasive imaging technologies versus cardiac catheterization in the diagnosis of coronary artery disease. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

Nominations: Deadline and Address: Nominations will be considered if postmarked by April 23, 2006 and mailed to the Executive Secretary (see FOR FURTHER INFORMATION CONTACT).

Secretary's Charter: Obtain a copy of the Secretary's Charter for the Medicare Coverage Advisory Committee from Maria Ellis, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop: 1-09-06, Baltimore, MD 21244; [phone]; [e-mail]. This charter is also posted on the following Web site: http://www.cms.hhs.gov/​FACA/​downloads/​mcaccharter.pdf.

Meeting: Date and Location: The public meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, on Thursday, May 18, 2006, from 7:30 a.m. until 4:30 p.m., e.d.t.

Presentation and Comments: Interested persons can present data, information, or views orally or in writing on issues pending before the Committee. Please submit written comments to the Executive Secretary by mail or email (see FOR FURTHER INFORMATION CONTACT).

Deadline for Written Comments and Presentations: Written comments and presentations for the public meeting must be received by April 24, 2006, 5 p.m., e.d.t. The presentation that will be submitted must be your final presentation; no further changes will be accepted.

Deadline for Registration to Attend Meeting: For security reasons, individuals wishing to attend this meeting must register by close of business on May 11, 2006.

Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or who have a condition that requires special assistance or accommodations, are asked to notify the Executive Secretary by May 11, 2006 (see FOR FURTHER INFORMATION CONTACT).

Web site: You may access up-to-date information on this meeting at http://www.cms.hhs.gov/​FACA/​02_​MCAC.asp#TopOfPage.

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, Executive Secretary, Centers for Medicare & Medicaid Services, Central Building 01-09-06, 7500 Security Boulevard, Baltimore, MD 21244; [phone]; [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

A. Nominations

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 charter was renewed and will terminate on November 24, 2006, unless renewed again by the Secretary.

The MCAC is governed by provisions of the Federal Advisory Committee Act (Pub. L. 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).

The MCAC consists of a pool of 100 appointed members. Members are 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, and 12 are nonvoting members (6 of which are representatives of consumer interests, and 6 of which are representatives of industry interests).

The MCAC 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.

B. Meeting

On December 14, 1998, we published a notice in the Federal Register (63 FR 68780) to describe the Medicare Coverage Advisory Committee (MCAC), which provides advice and recommendations to us about clinical issues. This notice announces a public meeting of the Committee.

The Committee will discuss evidence and hear presentations and public comments regarding the use of non-invasive imaging technologies versus cardiac catheterization in the diagnosis of coronary artery disease.

Background information about this topic, including panel materials, is available on the Internet at http://www.cms.hhs.gov/​coverage/​.

II. Provisions

A. Nominations

As of December 2006, there will be 50 terms of membership expiring, 3 of which are non-voting consumer representatives, and 4 of which are non-voting industry representatives. Accordingly, we are requesting nominations for both voting and non-voting members to serve on the MCAC. Nominees are selected based upon their individual qualifications, and not as representatives of professional associations or societies.

We have a special interest in ensuring that women, minority groups, and physically challenged individuals are adequately represented on the MCAC. Therefore, we encourage nominations of qualified candidates from these groups.

All nominations must be accompanied by curricula vitae. Nomination packages must be sent to the Executive Secretary (see FOR FURTHER INFORMATION CONTACT).

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.

We are also seeking nominations for seven non-voting representatives, three of which are consumer representatives and four of which are industry representatives. Nominees for this position must possess appropriate qualifications to understand and contribute to the MCAC's work.

The nomination letter must include a statement that the nominee is willing to serve as a member of the MCAC 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, e-mail address, and list of areas of expertise. In the nominations letter, we are requesting that the nominee specify whether applying for a voting position, a consumer representative position, or an industry representative position. Potential candidates will be asked to provide detailed information concerning matters such as financial holdings, consultancies, and research grants or contracts in order to permit evaluation of possible sources of conflict of interest.

Members are invited to serve for overlapping 2-year terms. A member can serve after the expiration of the member's term until a successor takes office. Any interested person can nominate one or more qualified persons. Self-nominations are also accepted.

B. Meeting

This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. The Committee can limit the number and duration of oral presentations to the time available. If you wish to make formal presentations, you must notify the Executive Secretary named in the FOR FURTHER INFORMATION CONTACT section and submit the following by the Deadline for Written Comments and Presentations date listed in the Meeting section of this notice: A brief statement of the general nature of the evidence or arguments you wish to present, the names and addresses of proposed participants, and a written copy of your presentation. Your presentation should consider the questions we have posed to the Committee and focus on the issues specific to the topic. The questions will be available on our Web site at http://www.cms.hhs.gov/​FACA/​02_​MCAC.asp#TopOfPagemeetings. We require that you declare at the meeting whether or not you have any financial involvement with manufacturers of any items or services being discussed (or with their competitors).

After the public and CMS presentations, the Committee will deliberate openly on the topic. Interested persons can observe the deliberations, but the Committee will not hear further comments during this time, except at the request of the chairperson. The Committee will also allow a 15 minute unscheduled open public session for any attendee to address issues specific to the topic. At the conclusion of the day, the members will vote and the Committee will make its recommendation.

1. Registration Instructions

The Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend: Register by contacting Maria Ellis, Coverage and Analysis Group, OCSQ; Centers for Medicare & Medicaid Services; 7500 Security Blvd, Central Building C1-09-06, Baltimore, MD 21244; [phone]; [e-mail]. Please provide your name, address, organization, telephone and fax number, and email address.

You will receive a registration confirmation with instructions for your arrival at the CMS complex. You will be notified if the seating capacity has been reached.

This meeting is located on Federal property; therefore, for security reasons, any individuals wishing to attend this meeting must register by close of business on May 11, 2006.

2. Security, Building, and Parking Guidelines

This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security.

In order to gain access to the building and grounds, individuals must present photographic identification to the Federal Protective Service or Guard Service personnel before being allowed entrance.

Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all individuals entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration.

Parking permits and instructions will be issued upon arrival.

Note:

Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes before the convening of the meeting.

All visitors must be escorted in areas other than the lower and first floor levels in the Central Building.

Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2); 42 U.S.C. 217(a), section 222 of the Public Health Service Act, as amended.

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

Dated: February 23, 2006.

Barry M. Straube,

Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services.