E6-704. Medicare Program; Meeting of the Medicare Coverage Advisory Committee-March 30, 2006

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 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. The charter also permits the MCAC to develop recommendations about other specific issues of Medicare coverage. This meeting concerns authoritative drug compendia that may be used in determining the medically accepted indications of drugs and biologicals used in an anti-cancer chemotherapeutic regimen under Part B of the Medicare program. 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 Thursday, March 30, 2006 from 7:30 a.m. until 4:30 p.m. e.s.t.

Deadlines: Deadline for Presentations and Comments: Written comments and presentations must be received by February 27, 2006, 5 p.m., e.s.t.

Deadline for Registration To Attend Meeting: For security reasons, individuals wishing to attend this meeting must register by close of business on March 23, 2006.

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 March 23, 2006 (see FOR FURTHER INFORMATION CONTACT).

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, Executive Secretary, by telephone at 410-786-2881 or by e-mail at [e-mail].

Web site: You may access up-to-date information on this meeting at http://www.cms.hhs.gov/​FACA/​02_​MCAC.asp#TopOfPage.

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 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.

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 and hear presentations and public comments regarding the desired characteristics of published authoritative compendia that may be used by CMS to determine the medically accepted indications of drugs and biologicals employed in an anti-cancer chemotherapeutic regimen under Part B of the Medicare program, section 1861(t)(2) of the Social Security Act.

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 DATES section of this notice: a brief statement of the general nature of the evidence or arguments you wish to present, the names and addresses of proposed participants, and 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 our Web site at http://www.cms.hhs.gov/​FACA/​02_​MCAC.asp#TopOfPage. We require 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 March 23, 2006.

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 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 demonstration or to support a demonstration.

Parking permits and instructions will be issued upon arrival.

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: December 12, 2005.

Barry M. Straube,

Acting Chief Medical Officer and Acting Director, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services.