[Federal Register: May 25, 2007 (Volume 72, Number 101)]
[Notices]
[Page 29331-29332]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my07-63]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3172-N]
Medicare Program; Meeting of the Medicare Coverage Advisory
Committee--July 18, 2007
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a public meeting of the Medicare
Evidence Development Coverage Advisory Committee (MedCAC or Committee),
formerly the Medicare Coverage Advisory Committee (MCAC). The Committee
generally 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 percutaneous transluminal angioplasty (PTA) and
stenting of the renal arteries.
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, July
18, 2007 from 7:30 a.m. until 4:30 p.m., eastern daylight time
(e.d.t.).
Deadlines for Registration and Request for Special Accommodations:
Registration must be completed no later than 5 p.m., e.d.t. on Monday,
July 9, 2007. Request for special accommodations must be received by 5
p.m., e.d.t. Tuesday, July 10, 2007.
Deadlines for Written Comments and Presentations: Written comments
and presentations must be received by June 18, 2007, 5 p.m., e.d.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 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 by e-mail to Michelle.Atkinson@cms.hhs.gov or by regular mail
to Michelle Atkinson, Executive Secretary for MedCAC, Centers for
Medicare & Medicaid Services, Office of Clinical Standards and Quality,
Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard,
Baltimore, MD 21244.
Registration and Special Accommodations: Individuals wishing to
participate or who need special accommodations, or both, may register
by phone or e-mail by contacting Maria Ellis at 410-786-0309 or
Maria.Ellis@cms.hhs.gov no later than 5 p.m., e.d.t on Monday, July 9,
2007. Persons attending the meeting who are hearing or visually
impaired, or have a condition that requires special assistance or
accommodations, are asked to contact Michelle Atkinson, Executive
Secretary for MedCAC, no later than July 9, 2007.
Web site: 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 MedCAC, 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. 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 CMS about clinical
issues.
This notice announces the July 18, 2007 public meeting of the
Committee. During this meeting, the Committee will discuss evidence and
hear presentations from the public concerning the use of PTA and
stenting of the renal arteries for the treatment of atherosclerotic
renal artery stenosis (ARAS). The clinical outcomes in the Medicare
population will be discussed. MedCAC will review the following kinds of
evidence:
The most informative measures of clinical outcomes.
Indications.
[[Page 29332]]
Clinical outcomes for the different treatment options.
Complications.
Harms and adverse events.
Persistence of benefits and harms over time.
Generalizability 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, is 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 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
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 by phone or e-
mail as specified in the ADDRESSES section. Please provide your full
name (as it appears on your State-issued driver's license), address,
organization, telephone, fax number(s), and e-mail address. You will
receive a registration confirmation with instructions for your arrival
at the CMS complex.
IV. Security, Building, and Parking Guidelines
Because this meeting will be located on Federal property, for
security reasons, any persons wishing to attend this meeting must
register by the dates specified in the DATES section. Individuals who
have not registered in advance will not be allowed to enter the
building to attend the meeting.
The on-site check-in for visitors will begin at 7 a.m. Please allow
sufficient time to go through the security checkpoints at both the
entrance to the grounds and the entrance to the building.
Security measures also include a full inspection of vehicles,
inside and exterior areas (rear, trunk, and engine) 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 a demonstration or
to support a demonstration.
Parking permits and instructions will be issued upon arrival.
Authority: 5 U.S.C. App. 2, section 10(a).
Dated: May 8, 2007.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and
Quality.
[FR Doc. E7-9780 Filed 5-24-07; 8:45 am]
BILLING CODE 4120-01-P