[Federal Register: March 25, 2005 (Volume 70, Number 57)]
[Notices]               
[Page 15341-15342]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr05-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3151-N]

 
Medicare Program; Meeting of the Medicare Coverage Advisory 
Committee--May 24, 2005

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). The Committee provides advice and 
recommendations about whether scientific evidence is adequate to 
determine whether certain medical items and services are reasonable and 
necessary under the Medicare statute. This meeting concerns the 
treatment of vertebral body compression fractures. Notice of this 
meeting is given under the Federal Advisory Committee Act (5 U.S.C. 
App. 2, section 10(a)).

DATES: This public meeting will be held on Tuesday, May 24, 2005 from 
7:30 a.m. until 4:30 p.m. e.d.t.

Deadlines

    Deadline for Presentations and Comments: Written comments and 
presentations must be received by May 4, 2005, 5 p.m., e.d.t.
    Deadline for Registration to Attend Meeting: For security reasons,

[[Page 15342]]

individuals wishing to attend this meeting must register by close of 
business on May 16, 2005.
    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 notify the Executive 
Secretary by April 19, 2005 (see FOR FURTHER INFORMATION CONTACT).

ADDRESSES: The meeting will be held in the auditorium at the Centers 
for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 
21244.

FOR FURTHER INFORMATION CONTACT: Michelle Atkinson, Executive 
Secretary, by telephone at (410) 786-2881 or by e-mail at 
michelle.atkinson@cms.hhs.gov


Hotline

    You can access up-to-date information on this meeting on the CMS 
Advisory Committee Information Hotline, 1-877-449-5659 (toll free) or 
in the Baltimore area, (410) 786-9379.

Website

    You can access up-to-date information on this meeting at 
http://www.cms.hhs.gov/mcac/default.asp#meetings.


Presentations and Comments

    Interested persons may present data, information, or views orally 
or in writing on issues pending before the Committee. Please submit 
written comments to Michelle Atkinson, by email at 
michelle.atkinson@cms.hhs.gov or by mail to the Executive Secretary for 

MCAC, Coverage and Analysis Group, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Mail Stop C1-09-06, Baltimore, MD 21244.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 14, 1998, we published a notice in the Federal Register 
(63 FR 68780) to describe the Medicare Coverage Advisory Committee 
(MCAC), which provides advice and recommendations to us about clinical 
issues. This notice announces a public meeting of the Committee.
    Meeting Topic: The Committee will discuss evidence, hear 
presentations and public comment, and make recommendations regarding 
vertebral body compression fractures. The MCAC will discuss scientific 
evidence on the effectiveness of vertebroplasty and kyphoplasty 
procedures in the Medicare population. Committee members will be given 
a presentation reviewing the current literature and also receive public 
comments to assist in the discussions and recommendations regarding the 
net health outcomes of vertebroplasty and kyphoplasty procedures.
    Background information about this topic, including panel materials, 
is available on the Internet at http://www.cms.hhs.gov/coverage/.


II. Procedure

    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 the Executive Secretary named in the FOR FURTHER INFORMATION 
CONTACT section and submit the following by the Deadline for 
Presentations and Comments date listed in the Deadlines section of this 
notice: A brief statement of the general nature of the evidence or 
arguments you wish to present, and the names and addresses of proposed 
participants. A written copy of your presentation must be provided to 
each Committee member before offering your public comments. Your 
presentation must address the questions asked by CMS to the Committee. 
The questions will be available on our Web site at http://www.cms.hhs.gov/mcac/default.asp
 meetings. If the specific questions 

are not addressed, your presentation will not be accepted. We request 
that you declare at the meeting whether or not you have any financial 
involvement with manufacturers of any items or services being discussed 
(or with their competitors).
    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. The Committee will 
also allow a 15 minute unscheduled open public session for any attendee 
to address issues specific to the topic. At the conclusion of the day, 
the members will vote and the Committee will make its recommendation.

III. Registration Instructions

    The Coverage and Analysis Group is coordinating meeting 
registration. While there is no registration fee, individuals must 
register to attend. You may register by contacting Maria Ellis at 410-
786-0309, mailing address: Coverage and Analysis Group, OCSQ; Centers 
for Medicare & Medicaid Services; 7500 Security Blvd, Mailstop: C1-09-
06; Baltimore, MD 21244, or by e-mail at Mellis@cms.hhs.gov. Please 
provide your name, address, organization, telephone and fax number, 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.
    This meeting is located on Federal property; therefore, for 
security reasons, any individuals wishing to attend this meeting must 
register by close of business on May 16, 2005.

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 allowing 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 inspection of vehicles, inside and 
out, 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 demonstration or 
to support a presentation, are subject to inspection. CMS 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 presentation.
    Parking permits and instructions will be issued upon arrival by the 
guards at the main entrance.


    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. 93.774, Medicare--Supplementary 
Medical Insurance Program)

    Dated: March 9, 2005.
Sean R. Tunis,
Director, Office of Clinical Standards and Quality, Centers for 
Medicare & Medicaid Services.
[FR Doc. 05-5594 Filed 3-24-05; 8:45 am]

BILLING CODE 4120-01-P