Medicare Program; Meeting of the Medicare Coverage Advisory Committee-July 14, 2004

AGENCY:

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

ACTION:

Notice of meeting.

SUMMARY:

This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). This Committee 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. The Committee will discuss and make recommendations regarding using transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) to treat severe angina.

Notice is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)).

DATES:

The Meeting: The public meeting will be held on Wednesday, July 14, 2004 from 7:30 a.m. until 3:30 p.m. e.d.t., at the Holiday Inn Inner Harbor, 301 West Lombard Street, Baltimore, MD 21201.

Special Accommodations: For anyone attending the meeting who is hearing or visually impaired, or who requires special assistance or accommodations, please notify the Executive Secretary by June 25, 2004 (see FOR FURTHER INFORMATION CONTACT).

Presentations and Comments: Interested persons may present data, information, or views orally or in writing on issues pending before the Committee. Please submit written comments to Michelle Atkinson, by email at matkinson@cms.hhs.gov or by mail to the Executive Secretary, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C1-09-06, Baltimore, MD 21244.

Deadline for Presentations and Comments: Written comments must be received by June 25, 2004, 5 p.m., e.d.t.

Web site: You may access up-to-date information on this meeting at www.cms.gov/coverage.

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, Executive Secretary, by telephone at 410-786-2881 or by e-mail at matkinson@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

On December 14, 1998, we published a notice in the Federal Register (63 FR 68780) to describe the Medicare Coverage Advisory Committee, which provides advice and recommendations to us about clinical issues. This notice announces a public meeting of the Committee.

Meeting Topic: The Committee will discuss the evidence, hear presentations and public comment, and make recommendations regarding the use of transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) for treatment of severe angina. TMR is a surgical technique that uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached due to diseased or clogged arteries; PMR is a subset of this technique which is less invasive and is used as a late or last resort to relieve symptoms of severe angina in patients suffering ischemic heart disease who are not amenable to direct coronary revascularization interventions such as angioplasty, stenting, or open coronary bypass. Background information about this topic, including panel materials, is available on the Internet at http://www.cms.gov/coverage.

Procedure: 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 named in the FOR FURTHER INFORMATION CONTACT section of this notice, and submit the following by June 25, 2004, 5 p.m., e.d.t.: A brief statement of the general nature of the evidence or arguments you wish to present, and the names and addresses of proposed participants. A written copy of your presentation must be provided to each Committee member before offering your public comments. Your presentation must address the questions asked by CMS to the Committee. If the specific questions are not addressed your presentation will not be accepted. The questions will be available on the CMS Web site at http://www.cms.gov/coverage/mcac. We request that you declare at the meeting whether or not 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.

Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).

(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program)