05-1503. Medicare Program; Meeting of the Medicare Coverage Advisory Committee-March 29, 2005

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The 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. This meeting concerns usual care of chronic wounds. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

DATES:

The public meeting will be held on Tuesday, March 29, 2005 from 7:30 a.m. until 4:30 p.m. e.s.t.

Deadline for Presentations and Comments: Written comments and presentations must be received by February 3, 2005, 5 p.m., e.s.t.

Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, are asked to notify the Executive Secretary by February 3, 2005 (see FOR FURTHER INFORMATION CONTACT).

ADDRESSES:

The meeting will be held in the auditorium at the Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244.

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 Kimberly Long, by e-mail at [e-mail] or by mail to the Executive Secretary for MCAC, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C1-09-06, Baltimore, MD 21244.

Web site: You may access up-to-date information on this meeting at www.cms.hhs.gov/​mcac/​default.asp#meetings.

Hotline: You may access up-to-date information on this meeting on the CMS Advisory Committee Information Hotline, 1-877-449-5659 (toll free) or in the Baltimore area [phone].

FOR FURTHER INFORMATION CONTACT:

Kimberly Long, Executive Secretary, by telephone at 410-786-5702 or by e-mail at [e-mail].

SUPPLEMENTARY 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 us about clinical issues. This notice announces a public meeting of the Committee.

Meeting Topic: The Committee will discuss evidence, hear presentations and public comment and make recommendations regarding the standard treatment of chronic wounds. Discussion will address such usual care treatment as cleansing, debridement, dressings, compression, off-loading and antibiotics. Members will also review factors necessary for quality clinical trials that address other wound healing technologies. The Committee will not discuss other treatments that may be used when wounds do not heal.

Background information about this topic, including panel materials, is available on the Internet at http://www.cms.hhs.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 and submit the following by the Deadline for Presentations and Comments date listed in the DATES section of this notice: 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. The questions will be available on our Web site at http://www.cms.hhs.gov/​mcac/​default.asp meetings. If the specific questions are not addressed, your presentation will not be accepted. 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.

Registration Instructions

The Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register by contacting Maria Ellis at 410-786-0309, mailing address: Coverage and Analysis Group, OCSQ; Centers for Medicare & Medicaid Services; 7500 Security Blvd, Mailstop: C1-09-06; Baltimore, MD 21244, or by e-mail at [e-mail]. Please provide your name, address, organization, telephone and fax number, 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.

Because the meeting is located on Federal property, for security reasons, any persons wishing to attend this meeting must register by close of business on January 17, 2005. In order to gain access to the building and grounds, participants must show to the Federal Protective Service or guard service personnel, government-issued photo identification and a copy of their registration confirmation. Individuals who have not registered in advance will not be allowed to enter the building to attend the meeting.

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: January 21, 2005.

Sean R. Tunis,

Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services.