[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29331-29332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9780]


-----------------------------------------------------------------------

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 [email protected] 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 
[email protected] 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; [email protected]; 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