[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 [email protected], 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 [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
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 [email protected], 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:
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 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