[Federal Register Volume 65, Number 206 (Tuesday, October 24, 2000)]
[Notices]
[Pages 63604-63605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27410]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-3058-N]


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.

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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

[[Page 63605]]

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)

    Dated: October 20, 2000.
Jeffrey L. Kang,
Director, Office of Clinical Standards and Quality, Health Care 
Financing Administration.
[FR Doc. 00-27410 Filed 10-20-00; 3:37 pm]
BILLING CODE 4120-01-U