Centers for Medicare & Medicaid Services (CMS), HHS.
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)).
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.
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.Start Further Info
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).End Further Info End Preamble Start Supplemental Information
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. Start Printed Page 29332
- Clinical outcomes for the different treatment options.
- 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.Start Signature
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