[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77717-77718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3209-N]


Medicare Program; Meeting of the Medicare Evidence Development & 
Coverage Advisory Committee--February 25, 2009

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, February 25, 2009. The 
Committee generally provides advice and recommendations concerning the 
adequacy of scientific evidence needed to determine whether certain 
medical items and services can be covered under the Medicare statute. 
This meeting will focus on the requirements for evidence to determine 
if diagnostic use of genomic testing in beneficiaries with signs or 
symptoms of disease improves health outcomes in Medicare beneficiaries. 
The meeting will also 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: This meeting will be held on Wednesday, February 
25, 2009 from 7:30 a.m. until 4:30 p.m., eastern standard time (e.s.t).
    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., e.s.t on January 29, 2009. Once submitted all 
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., e.s.t. on January 29, 2009. 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., 
e.s.t. on Wednesday, February 18, 2009.
    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., e.s.t. Friday, February 18, 2009.

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 
at 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 February 25, 
2009, public meeting of the Committee. During this meeting, the 
Committee will discuss the requirements for evidence to determine if 
diagnostic uses of genomic testing in beneficiaries with signs or 
symptoms of disease improves health outcomes in Medicare beneficiaries. 
Background information about this topic, including panel materials, are 
available at http://ww.cms.hhs.gov/coverage. We encourage the 
participation of appropriate organizations with expertise in the 
evidence regarding this use of genomic testing.

II. Meeting Format

    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. 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 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

[[Page 77718]]

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: December 11, 2008.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-30162 Filed 12-18-08; 8:45 am]
BILLING CODE 4120-01-P