[Federal Register Volume 71, Number 165 (Friday, August 25, 2006)]
[Notices]
[Pages 50430-50432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3166-N]


Medicare Program; Meeting of the Medicare Coverage Advisory 
Committee--November 30, 2006

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

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SUMMARY: This notice announces a public meeting of the Medicare 
Coverage Advisory Committee (MCAC) (``Committee''). The Committee 
provides guidance and advice to CMS on specific clinical topics under 
review for Medicare coverage. This meeting concerns spinal fusion for 
the treatment of low back pain secondary to lumbar degenerative disc 
disease (DDD), generally, and to identify areas where current data is 
deficient and additional research is necessary.
    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 Thursday, 
November 30, 2006 from 7:30 a.m. until 4:30 p.m., e.s.t.
    Registration Deadline: For security reasons, individuals must 
register by the close of business on November 23, 2006. In addition, 
request for special

[[Page 50431]]

accommodations must be received by close of business on November 23, 
2006.
    Presentation and Written Comments Deadline: Written comments and 
presentations must be received by 5 p.m., October 30, 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 
auditorium of the Centers for Medicare & Medicaid Services, 7500 
Security Blvd, Baltimore, MD 21244.
    Registration: Individuals must 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 must be 
submitted to Michelle Atkinson, Executive Secretary for MCAC, Centers 
for Medicare & Medicaid Services, OCSQ-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: Michelle Atkinson, Executive Secretary 
for MCAC, 410-786-2881; [email protected]; 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 Coverage Advisory Committee 
(MCAC) (``Committee''), which provides advice and recommendations to 
CMS about clinical issues.
    This notice announces the November 30, 2006 public meeting of the 
Committee. During this meeting, the Committee will discuss evidence and 
hear presentations and public comments concerning spinal fusion for the 
treatment of low back pain secondary to lumbar degenerative disc 
disease. The clinical outcomes in the Medicare population will be 
discussed. The Committee will review evidence including: (1) What are 
the most informative measures of clinical outcomes; (2) indications; 
(3) clinical outcomes for the different surgical techniques and 
components; (4) complications; (5) harms and adverse events; (6) 
persistence of benefits and harms over time; and, general applicability 
to the Medicare population in routine practice. In addition to 
evaluating the available data, the Committee will identify areas in 
which the current data are deficient and in which additional research 
is warranted.
    Background information about this topic, including panel materials, 
are available at http://www.cms.hhs.gov/center/coverage.asp.

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 the Executive Secretary for MCAC (see FOR FURTHER INFORMATION 
CONTACT) 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 whether 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 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. Register by contacting Maria Ellis at the address 
specified in the ADDRESSES section of this notice by November 23, 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 or to Michelle Atkinson, Executive Secretary 
for MCAC, at the address specified in the ADDRESSES section of this 
notice by November 23, 2006.
    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 November 23, 2006.

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 to support 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

[[Page 50432]]

meeting. The public may not enter the building more than 45 minutes 
prior to the convening of the meeting.

    All visitors must be escorted in areas except for the lower and 
first floor levels of 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: August 11, 2006.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services.
 [FR Doc. E6-13938 Filed 8-24-06; 8:45 am]
BILLING CODE 4120-01-P