05-5594. Medicare Program; Meeting of the Medicare Coverage Advisory Committee-May 24, 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 the treatment of vertebral body compression fractures. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

DATES:

This public meeting will be held on Tuesday, May 24, 2005 from 7:30 a.m. until 4:30 p.m. e.d.t.

Deadlines

Deadline for Presentations and Comments: Written comments and presentations must be received by May 4, 2005, 5 p.m., e.d.t.

Deadline for Registration to Attend Meeting: For security reasons, individuals wishing to attend this meeting must register by close of business on May 16, 2005.

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 April 19, 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.

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, Executive Secretary, by telephone at [phone] or by e-mail at [e-mail]

Hotline

You can 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].

Website

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

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 [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.

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 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 vertebral body compression fractures. The MCAC will discuss scientific evidence on the effectiveness of vertebroplasty and kyphoplasty procedures in the Medicare population. Committee members will be given a presentation reviewing the current literature and also receive public comments to assist in the discussions and recommendations regarding the net health outcomes of vertebroplasty and kyphoplasty procedures.

Background information about this topic, including panel materials, is available on the Internet at http://www.cms.hhs.gov/​coverage/​.

II. 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 Deadlines 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.

III. 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.

This meeting is located on Federal property; therefore, for security reasons, any individuals wishing to attend this meeting must register by close of business on May 16, 2005.

IV. Security, Building, and Parking Guidelines

This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security.

In order to gain access to the building and grounds, individuals must present photographic identification to the Federal Protective Service or Guard Service personnel before being allowed entrance.

Security measures also include inspection of vehicles, inside and out, 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 demonstration or to support a presentation, are subject to inspection. CMS cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a presentation.

Parking permits and instructions will be issued upon arrival by the guards at the main entrance.

Note:

Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting.

All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building.

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: March 9, 2005.

Sean R. Tunis,

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