[Federal Register: October 27, 2006 (Volume 71, Number 208)]
[Notices]
[Page 63021-63023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc06-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3174-N]
Medicare Program; Meeting of the Medicare Coverage Advisory
Committee--December 13, 2006
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 (``MCAC'' or ``the Committee''). MCAC
provides guidance and advice to CMS on specific clinical topics under
review for Medicare coverage. This meeting concerns reconsideration of
the Medicare clinical trial policy.
Notice of this meeting is given under 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,
December 13, 2006 from 8 a.m. until 4:30 p.m., e.s.t.
Registration Deadline: For security reasons, registration must be
made no later than 5 p.m. on November 29, 2006. Requests for special
accommodations must be received by 5 p.m. on November 29, 2006.
Presentation and Written Comments Deadline: Written comments and
presentations must be received by November 13, 2006, e.s.t.
Presentations once submitted are final. No further changes to the
presentation can be accepted after submission.
ADDRESSES: Meeting Location: The meeting will be held in the main
[[Page 63022]]
auditorium of the Centers for Medicare & Medicaid Services, 7500
Security Blvd., Baltimore, MD 21244.
Registration: Individuals who intend to register may register by
contacting Maria Ellis at (410) 786-0309; e-mail to
Maria.Ellis@cms.hhs.gov; or by regular mail to Maria Ellis, Centers for
Medicare & Medicaid Services, OCSQ-Coverage and Analysis Group, C1-09-
06, 7500 Security Boulevard, Baltimore, MD 21244.
Presentation and Comment Submission: Interested persons may present
data, information, or views orally or in writing on issues pending
before the Committee. Presentation and written comments can be
submitted by e-mail or by regular mail to Kimberly Long or Janet Brock,
Executive Secretary for MCAC, Centers for Medicare & Medicaid Services,
Office of Clinical Standards and Quality, Coverage and Analysis Group,
C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244.
Web Site Address for Additional Information: You may access up-to-
date information on this meeting at http://www.cms.hhs.gov/FACA/02_MCAC.asp#TopOfPage
.
FOR FURTHER INFORMATION CONTACT: Kimberly Long or Janet Brock,
Executive Secretaries for MCAC; Kimberly Long at 410-786-5702 or e-mail
at Kimberly.Long@cms.hhs.gov or Janet Brock at 410-786-2700 or e-mail
at Janet.Brock@cms.hhs.gov; or contact by regular mail to Kimberly Long
or Janet Brock, Executive Secretary for MCAC, Centers for Medicare &
Medicaid Services, OCSQ-Coverage and Analysis Group, C1-09-06, 7500
Security Boulevard, Baltimore, MD 21244.
SUPPLEMENTARY INFORMATION:
I. Meeting Topic
In the December 14, 1998 Federal Register (63 FR 68780), we
published a notice to describe the Medicare and Coverage Advisory
Committee (``MCAC'' or ``the Committee''), which provides guidance and
advice to CMS on specific clinical topics under review for Medicare
coverage.
This notice announces the December 13, 2006 public meeting of the
Committee. During this meeting, the Committee will discuss evidence and
hear presentations and public comments concerning the clinical trial
policy National Coverage Determination (NCD) reconsideration. On July
10, 2006, CMS posted on its Web site for a 30-day public comment
period, information to initiate the NCD reconsideration and we received
numerous comments.
The MCAC will discuss three important proposed changes to the
Medicare clinical trial policy: (1) Review the set of standards for
qualified studies; (2) recommend processes through which a trial is
determined to meet those standards; and (3) advise on the items and
services provided to Medicare beneficiaries in qualified studies. In
addition to evaluating the available data, the Committee will provide
recommendations on the content and implementation of the clinical trial
policy National Coverage Determination (NCD) reconsideration.
Background information about this topic, including panel materials,
are available at http://www.cms.hhs.gov/coverage.
II. Meeting Procedures
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 one of the Executive Secretaries for MCAC and submit the
following to the address listed in the ADDRESSES section of this notice
by the date listed in the DATES section of this notice: (1) A brief
statement of the general nature of the evidence or arguments you wish
to present; (2) the names and addresses of proposed participants; and
(3) a written copy of your presentation. Your presentation should
consider the questions we have posed to the Committee and focus on the
issues specific to the topic. The questions will be available on the
following Web site: http://www.cms.hhs.gov/FACA/02_MCAC.asp#TopOfPage.
We require that you declare at the meeting information pertinent to
your relationship with the topic, such as, for example, financial
involvement or institutional support. The Committee will also allow a
15 minute unscheduled open public session for any attendee to address
issues specific to the topic.
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. At the conclusion
of the day, the members will vote and the Committee will make its
recommendation.
III. Registration Instructions and Requests for Special Accomodations
The Coverage and Analysis Group is coordinating meeting
registration. While there is no registration fee, individuals must
register to attend. All persons interested in attending must register
by contacting Maria Ellis at the address specified in the ADDRESSES
section of this notice by November 29, 2006.
Please provide your name, address, organization, telephone
number(s), fax number(s), and e-mail address. You will receive a
registration confirmation with instructions for your arrival at the CMS
complex. You will be notified if the seating capacity has been reached.
Persons attending the meeting who are hearing or visually impaired,
or have a condition that requires special assistance or accommodations,
must submit their request with their registration information to one of
the Executive Secretaries listed in the FOR FURTHER INFORMATION CONTACT
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. In planning your
arrival time, we recommend that you arrive reasonably early to allow
additional time to clear security.
In order to gain access to the building and grounds, individuals
must present photographic identification to the Federal Protective
Service or Guard Service personnel before being allowed entrance.
Security measures also include a full inspection of vehicles,
inside and exterior areas, at the entrance to the grounds. In addition,
all individuals entering the building must pass through a metal
detector. All items brought to CMS, whether personal or for the purpose
of or support of a demonstration, 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 demonstration or to support a
demonstration.
Parking permits and instructions will be issued upon arrival.
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. Visitors must be
escorted in all areas except for the lower and first floor levels of
the Central Building.
[[Page 63023]]
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: October 17, 2006.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. E6-18058 Filed 10-26-06; 8:45 am]
BILLING CODE 4120-01-P