Medicare Program; Meeting of the Executive Committee of the Medicare Coverage Advisory Committee-November 7, 2000

AGENCY:

Health Care Financing Administration (HCFA), HHS.

ACTION:

Notice of meeting.

SUMMARY:

This notice announces a public meeting of the Executive Committee (the Committee) of the Medicare Coverage Advisory Committee (MCAC). The Committee will hear and discuss presentations from interested parties and deliberate the scientific evidence and potential clinical utility concerning FDG Positron Emission Tomography (PET). 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 will be held on November 7, 2000, from 8 a.m. until 4 p.m., EST.

Deadline for Presentations and Comments: October 31, 2000, 5 p.m., EST.

Special Accommodations: Persons attending the meeting who are hearing-impaired and require sign language interpretation, or have a condition that requires other special assistance or accommodations, are asked to notify the Executive Secretary by October 31, 2000.

ADDRESSES:

The meeting will be held at the Baltimore Convention Center, One West Pratt Street, Baltimore, Maryland 21201.

Presentations and Comments: Submit formal presentations and written comments to Constance A. Conrad, Executive Secretary, Office of Clinical Standards and Quality, Health Care Financing Administration, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244.

Website: You may access up-to-date information on this meeting at www.hcfa.gov/quality/8b.htm.

Hotline: You may access up-to-date information on this meeting on the HCFA Advisory Committee Information Hotline, 1-877-449-5659 (toll free) or in the Baltimore area (410) 786-9379.

FOR FURTHER INFORMATION CONTACT:

Constance A. Conrad, Executive Secretary, 410-786-4631.

SUPPLEMENTARY INFORMATION:

On April 27, 1999, we published a notice in the Federal Register (64 FR 22619) to describe the Medicare Coverage Advisory Committee (MCAC), which provides advice and recommendations to HCFA regarding clinical issues.

In that notice, we announced that we would generally give at least 30 days advance notice of MCAC public meetings. We also stated that persons wishing to make presentations should submit the presentations to us at least 20 days before the meeting. We now realize that this could create a problem if we shorten the 30-day notice for the meeting. In some instances, there may be less than 20 days before the meeting, making it impossible to afford the public that amount of time to submit materials. Finally, it has also been our practice to afford the public an additional period of up to 20 days following an MCAC meeting to submit any further comments they may have. Experience has shown that there will be instances when public interest in prompt consideration of an issue outweighs the 30-day advance notice, the 20-day pre-meeting deadline for presentation materials, and the 20-day post-meeting deadline for submission of additional comments.

This notice clarifies that we may not apply the 30-day notification, the 20-day pre-meeting presentation deadline, or the 20-day post-meeting deadline for submission of additional comments when it is in the public interest to reach an expeditious decision with respect to a coverage matter, and when we are assured that parties interested in the topic of the meeting are well aware of HCFA's consideration, and have ample time to establish and document their positions. Therefore, this notice announces the following public meeting of the MCAC, which is being convened under the terms of the exception policy detailed above. This exception policy is being exercised in the interest of reaching an expeditious decision on the scientific evidence of FDG PET.

Current Panel Members: Harold C. Sox, MD (Chairperson); Thomas V. Holohan, MD (FACP); Leslie P. Francis, JD, PhD; John H. Ferguson, MD; Robert L. Murray, PhD; Alan M. Garber, MD, PhD; Michael D. Maves, MD, MBA; Frank J. Papatheofanis, MD, PhD; Ronald M. Davis, MD; Daisy Alford-Smith, PhD; Joe W. Johnson, DC; Robert H. Brook, MD, ScD; Linda A. Bergthold, PhD; Randel E. Richner, MPH.

In addition, to augment the panel's consideration of PET coverage issues, HCFA has asked Dr. Richard Klausner, Director of the National Cancer Institute (NCI) to designate a representative to participate in the MCAC review. Dr. Ellen Feigal, Deputy Director of the Division of Cancer Treatment and Diagnosis of the NCI, will serve as the NCI representative. The Division of Cancer Treatment and Diagnosis is a national program of funding cancer research in biomedical imaging, diagnostics, radiation biology and therapy, drug discovery and development, and clinical trials.

Meeting Topic: The Committee will hear and discuss presentations from interested parties and deliberate the scientific evidence of FDG PET.

Procedure and Agenda: This meeting is open to the public. The Committee will hear oral presentations from the public and may limit the number and duration of oral presentations to the time available. If you wish to make formal presentations, you must notify the For Further Information Contact, and submit the following by the Deadline for Presentations and section of this notice: a Comments date listed in the DATES brief statement of the general nature of the evidence or arguments you wish to present, the names and addresses of proposed participants, and an estimate of the time required to make the presentation. 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 public presentation, we will make a presentation to the Committee, after which the Committee will deliberate openly. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time, except at the request of the chairperson. The Committee will then allow an open public session for any attendee to address issues specific to the topic. Following the open session, the members will vote, and the Committee 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)