[Federal Register: August 25, 2006 (Volume 71, Number 165)]
[Notices]
[Page 50430-50432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au06-75]
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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 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 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; Michelle.Atkinson@cms.hhs.gov; 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