[Federal Register Volume 71, Number 208 (Friday, October 27, 2006)]
[Notices]
[Pages 63021-63023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18058]


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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 
[email protected]; 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 [email protected] or Janet Brock at 410-786-2700 or e-mail 
at [email protected]; 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