[Federal Register: December 27, 2002 (Volume 67, Number 249)]
[Notices]               
[Page 79124-79125]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de02-112]                         


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Centers for Medicare & Medicaid Services


[CMS-3105-N]


 
Medicare Program; Meeting of the Medicare Coverage Advisory 
Committee--February 12, 2003


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


ACTION: Notice.


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SUMMARY: This notice announces a public meeting of the Medicare 
Coverage Advisory Committee (the Committee). The Committee provides 
advice and recommendations to us about clinical issues. Among other 
things, the Committee advises us on whether adequate evidence exists to 
determine whether specific medical items and services are reasonable 
and necessary under Medicare law. The Committee will discuss and make 
recommendations concerning the quality of the evidence and related 
issues for the use of implantable cardioverter defibrillators (ICDs). 
We received a request from Guidant Corporation to cover ICDs for 
patients with a prior myocardial infarction and a left ventricular 
ejection fraction of <=.30. We are taking the opportunity to review all 
indications for ICDs. Notice of this action is given under the Federal 
Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)).


DATES: The Meeting: The public meeting announced will be held on 
Wednesday, February 12, 2003 from 7:30 a.m. until 3:30 p.m., E.S.T.
    Deadline for Presentations and Comments: Interested persons may 
present data, information, or views orally or in writing, on issues 
pending before the committee. Written presentations and comments must 
be submitted to the Executive Secretary by January 29, 2003, 5 p.m., 
E.S.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 January 29, 2003 (see FOR FURTHER INFORMATION CONTACT).


[[Page 79125]]




ADDRESSES: The Meeting: The meeting will be held at the Baltimore 
Convention Center, Room 338-339, One West Pratt Street, Baltimore, MD 
21201.
    Presentations and Comments: Submit formal presentations and written 
comments to Janet Anderson 410-786-2700, janderson@cms.hhs.gov, 
Executive Secretary; Office of Clinical Standards and Quality; Centers 
for Medicare & Medicaid Services; 7500 Security Boulevard; Mail Stop 
C1-09-06; Baltimore, MD 21244.
    Website: You may access up-to-date information on this meeting at 
www.cms.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 (410) 786-9379.


FOR FURTHER INFORMATION CONTACT: Janet Anderson, Executive Secretary, 
410-786-2700, janderson@cms.hhs.gov.


SUPPLEMENTARY INFORMATION: On December 14, 1998, we published a notice 
in the Federal Register (63 FR 68780) to describe the Medicare Coverage 
Advisory Committee (the Committee), which provides advice and 
recommendations to us about clinical issues. A revised charter was 
signed by the Secretary on November 22, 2002. This notice announces the 
following public meeting of the Committee.


Meeting Topic


    The Committee will discuss the evidence, hear presentations and 
public comment, and make recommendations regarding the use of 
implantable cardioverter defibrillators. Background information about 
this topic, including committee materials, is available on the Internet 
at http://www.cms.gov/coverage.


Procedure and Agenda


    This meeting is open to the public. The Committee will hear oral 
presentations from the public for approximately 45 minutes. The 
Committee 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 Committee 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 Committee will 
deliberate openly on the topic. 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 
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.


    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: December 17, 2002.
Robert A. Streimer,
Acting Director, Office of Clinical Standards and , Quality, Centers 
for Medicare & Medicaid Services.
[FR Doc. 02-32652 Filed 12-26-02; 8:45 am]

BILLING CODE 4120-01-P