[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36528-36529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3201-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--August 20, 2008

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

ACTION: Notice of meeting.

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SUMMARY: This notice announces that a public meeting of the Medicare 
Evidence Development & Coverage Advisory Committee (MedCAC) 
(``Committee'') will be held on Wednesday, August 20, 2008. The 
Committee generally provides advice and recommendations concerning the 
adequacy of scientific evidence needed to determine whether certain 
medical items and services are reasonable and necessary under the 
Medicare statute. This meeting will focus on the oncologic indications 
of 2-[F-18] Fluoro-D-Glucose (FDG) positron emission tomography (PET) 
for nine cancers (brain, cervical, small cell lung, ovarian, 
pancreatic, testicular, prostate, bladder, and kidney). The panel will 
review the scientific evidence of the impact of PET as part of a 
management strategy to improve patient-centered outcomes. The panel 
will also consider data generated under a current national coverage 
determination that provides coverage for PET for specified cancers when 
additional data are prospectively collected. The meeting will discuss 
the various kinds of evidence that are useful to support requests for 
Medicare coverage in this field. This meeting is open to the public in 
accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, 
section 10(a)).

DATES: Meeting Date: The public meeting will be held 7:30 a.m. until 
4:30 p.m., d.s.t. on Wednesday, August 20, 2008.
    Deadline for Submission of Written Comments: Written comments must 
be received at the address specified in the ADDRESSES section of this 
notice by 5 p.m., d.s.t. on July 21, 2008. Once submitted, comments are 
final.
    Deadlines for Speaker Registration and Presentation Materials: The 
deadline to register to be a speaker, and to submit Powerpoint 
presentation materials and writings that will be used in support of an 
oral presentation, is 5 p.m., d.s.t. on Monday, July 21, 2008. Speakers 
may register by phone or via e-mail by contacting the person listed in 
the FOR FURTHER INFORMATION CONTACT section of this notice. 
Presentation materials must be received at the address specified in the 
ADDRESSES section of this notice.
    Deadline for All Other Attendees Registration: Individuals may 
register by phone or via e-mail by contacting the person listed in the 
FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m., 
d.s.t. on Wednesday, August 13, 2008.
    Deadline for Submitting a Request for 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 contact the Executive Secretary as specified in the FOR 
FURTHER INFORMATION CONTACT section of this notice no later than 5 
p.m., d.s.t. Friday, August 8, 2008.

ADDRESSES:
    Meeting Location: The meeting will be held in the main auditorium 
of the Centers for Medicare & Medicaid Services, 7500 Security Blvd, 
Baltimore, MD 21244.
    Submission of Presentations and Comments: Presentation materials 
and written comments that will be presented at the meeting must be 
submitted via e-mail to [email protected] or by regular 
mail to the contact listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice by the date specified in the DATES section of 
this notice.

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for 
MedCAC, Centers for Medicare & Medicaid Services, Office of Clinical 
Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500 
Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone 
(410-786-0309) or via e-mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    MedCAC, formerly known as the Medicare Coverage Advisory Committee 
(MCAC), provides advice and recommendations to CMS regarding clinical 
issues. (For more information on MCAC, see the December 14, 1998 
Federal Register (63 FR 68780).) This notice announces the August 20, 
2008, public meeting of the Committee. During this meeting, the 
Committee will review the scientific evidence of the impact of PET as 
part of a management strategy to improve patient-centered outcomes. The 
Committee will focus on evidence regarding the use of FDG PET to inform 
the treating physician on cancer diagnosis, staging, detecting 
metastatic disease and detecting recurrence. Background information 
about this topic, including panel materials, will become available at 
http://www.cms.hhs.gov/coverage.

II. Meeting Format

    This meeting is open to the public. The Committee will hear oral 
presentations from the public for approximately 30 minutes. The 
Committee may limit the number and duration of oral presentations to 
the

[[Page 36529]]

time available. Your comments should focus on issues specific to the 
list of topics that we have proposed to the Committee. The list of 
research topics to be discussed at the meeting will be available on the 
following Web site prior to the meeting: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=mcac.
    We require that you declare at the meeting whether you have any 
financial involvement with manufacturers (or their competitors) of any 
items or services being discussed.
    The Committee will deliberate openly on the topics under 
consideration. 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 topics under consideration. At the conclusion of 
the day, the members will vote and the Committee will make its 
recommendation(s) to CMS.

III. Registration Instructions

    CMS' Coverage and Analysis Group is coordinating the meeting 
registration. While there is no registration fee, individuals must 
register to attend. You may register by contacting the person listed in 
the FOR FURTHER INFORMATION CONTACT section of this notice by the 
deadline listed in the DATES section of this notice. Please provide 
your full name (as it appears on your state-issued driver's license), 
address, organization, telephone, fax number(s), and e-mail address. 
You will receive a registration confirmation with instructions for your 
arrival at the CMS complex or you will be notified the seating capacity 
has been reached.

IV. Security, Building, and Parking Guidelines

    This meeting will be held in a Federal government building; 
therefore, Federal security measures are applicable. We recommend that 
confirmed registrants arrive reasonably early, but no earlier than 45 
minutes prior to the start of the meeting, to allow additional time to 
clear security. Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.
     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means 
of all persons brought entering the building. We note that all items 
brought into CMS, whether personal or for the purpose of presentation 
or to support a presentation, 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 presentation or to support a presentation.

    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 prior to 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).

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: June 17, 2008.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-14649 Filed 6-26-08; 8:45 am]
BILLING CODE 4120-01-P