[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Pages 58414-58415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3240-N]


Medicare Program; Meeting of the Medicare Evidence Development 
and Coverage Advisory Committee--November 17, 2010

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, November 17, 2010. 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 currently available evidence regarding 
the clinical benefits and harms of on-label and off-label use of 
Autologous Cellular Immunotherapy Treatment of Metastatic Prostate 
Cancer. 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 on Wednesday, 
November 17, 2010 from 7:30 a.m. until 4:30 p.m., Eastern Standard Time 
(EST).
    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. EST, October 18, 2010. 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., EST on Wednesday, October 18, 2010. 
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 online at http://www.cms.gov/mcd/index_list.asp?list_type=mcac via e-mail at <a href="/cdn-cgi/l/email-protection#91dcd4d5d2d0d2cec3f4f6f8e2e5e3f0e5f8feffd1f2fce2bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="0c4149484f4d4f535e696b657f787e6d786563624c6f617f2264647f226b637a">[email protected]</span></a>, or by phone 
by contacting the person listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice by 5 p.m. EST, Wednesday, November 10, 2010. We 
will be broadcasting the meeting via Webinar. You must register for the 
Webinar portion of the meeting at https://webinar.cms.hhs.gov/_a7/txmetaprostatemedcac1117/event/registration.html by 5 p.m. EST, 
Wednesday, November 10, 2010.
    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., EST Friday, November 5, 2010.

ADDRESSES: Meeting Location: The meeting will be held in the main 
auditorium of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, 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 <a href="/cdn-cgi/l/email-protection#2568404166646655574056404b5144514c4a4b56654648560b4d4d560b424a53"><span class="__cf_email__" data-cfemail="cc81a9a88f8d8fbcbea9bfa9a2b8adb8a5a3a2bf8cafa1bfe2a4a4bfe2aba3ba">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#054864776c642b4069696c76456668762b6d6d762b626a73"><span class="__cf_email__" data-cfemail="0b466a79626a254e676762784b68667825636378256c647d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    The 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 
November 17, 2010, public meeting of the Committee. During this 
meeting, the Committee will discuss the currently available evidence 
regarding the clinical benefits and

[[Page 58415]]

harms of on-label and off-label use of Autologous Cellular 
Immunotherapy Treatment of Metastatic Prostate Cancer. Background 
information about this topic, including panel materials, is available 
at http://www.cms.hhs.gov/center/coverage.asp. We encourage the 
participation of appropriate organizations with expertise in the use of 
Autologous Cellular Immunotherapy Treatment of Metastatic Prostate 
Cancer.

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 online at http://www.cms.gov/mcd/index_list.asp?list_type=mcac, via e-mail at <a href="/cdn-cgi/l/email-protection#c78a82838486849895a2a0aeb4b3b5a6b3aea8a987a4aab4e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="632e26272022203c3106040a10171102170a0c0d23000e104d0b0b104d040c15">[email protected]</span></a>, or by phone 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.
    You must register for the Webinar portion of the meeting at https://webinar.cms.hhs.gov/_a7/txmetaprostatemedcac1117/event/registration.html by the deadline listed in the DATES section of this 
notice.

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:
    <bullet> Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.
    <bullet> 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.
    <bullet> 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 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: September 8, 2010.
Barry M. Straube
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-23582 Filed 9-23-10; 8:45 am]
BILLING CODE 4120-01-P


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