01-29210. Medicare Program; Meeting of the Diagnostic Imaging Panel of the Medicare Coverage Advisory Committee-January 10, 2002

AGENCY:

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

ACTION:

Notice of meeting.

SUMMARY:

This notice announces a public meeting of the Diagnostic Imaging Panel (the Panel) of the Medicare Coverage Advisory Committee (the Committee). The Panel provides advice and recommendations to the Committee about clinical issues. The Panel will hear and discuss presentations from interested persons regarding whether and when it is scientifically justified to use FDG Positron Emission Tomography (PET) or other neuroimaging devices for the diagnosis and patient management of those with Alzheimer's disease (AD). The focus is on the marginal contribution of FDG-PET in various common clinical scenarios to patient outcomes. The following three scenarios will be evaluated:

• Asymptomatic patients who are at high risk of AD due to positive family history.
• Patients with mild cognitive impairment or similar syndrome.
• Patients with dementia.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)).

DATES:

The Meeting: January 10, 2002 from 8 a.m. until 4:30 p.m., E.D.T.

Deadline for Presentations and Comments: December 27, 2001, 5 p.m., E.D.T.

Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, are asked to notify the Executive Secretary by December 20, 2001 (see FOR FURTHER INFORMATION CONTACT).

ADDRESSES:

The Meeting: The meeting will be held at the Baltimore Convention Center, Room 327-328, One West Pratt Street, Baltimore, MD 21201.

Presentations and Comments: Submit formal presentations and written comments to Janet A. Anderson, Executive Secretary; Office of Clinical Standards and Quality; Centers for Medicare & Medicaid Services; 7500 Security Boulevard; Mail Stop C1-09-06; Baltimore, MD 21244.

Web site: You may access up-to-date information on this meeting at www.hcfa.gov/​coverage.

Hotline: You may access up-to-date information on this meeting on the CMS Advisory Committee Information Hotline, 1-877-449-5659 (toll free) or in the Baltimore area [phone].

FOR FURTHER INFORMATION CONTACT:

Janet A. Anderson, Executive Secretary, 410-786-2700.

SUPPLEMENTARY INFORMATION:

On August 13, 1999, we published a notice in the Federal Register (64 FR 44231) to describe the Medicare Coverage Advisory Committee (the Committee), which provides advice and recommendations to us about clinical issues. This notice announces the following public meeting of the Diagnostic Imaging Panel (the Panel) of the Committee.

Current Panel Members:

Frank Papatheofanis, M.D., Ph.D.; Barbara McNeil, M.D., Ph.D.; Carole Flamm, M.D., M.P.H.; Jeffrey Lerner, Ph.D.; Michael Manyak, M.D.; Donna Novak, B.A.; Manuel Cerqueira, M.D.; Kim Burchiel, M.D.; Steven Guyton, M.D.; Sally Hart, J.D.; and Michael Klein, M.B.A.

Meeting Topic:

The Panel will hear and discuss presentations from interested persons regarding FDG Positron Emission Tomography (PET) imaging for Alzheimer's disease (AD), mild cognitive impairment, and dementia.

Procedure and Agenda:

This meeting is open to the public. The Panel will hear oral presentations from the public for approximately 90 minutes. The Panel may 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 Presentations and Comments date listed in the DATES section of this notice: a brief statement of the general nature of the evidence or arguments you wish to present, and the names and addresses of proposed participants. A written copy of your presentation must be provided to each Panel member before offering your public comments. We will request 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 Panel will deliberate openly on the topic. Interested persons may observe the deliberations, but the Panel will not hear further comments during this time except at the request of the chairperson. The Panel will also allow approximately a 30-minute 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 Panel will make its recommendation.

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 14, 2001.

Jeffrey L. Kang,

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