E6-18058. Medicare Program; Meeting of the Medicare Coverage Advisory Committee-December 13, 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” or “the Committee”). MCAC provides guidance and advice to CMS on specific clinical topics under review for Medicare coverage. This meeting concerns reconsideration of the Medicare clinical trial policy.

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

DATES:

Meeting Date: The public meeting will be held on Wednesday, December 13, 2006 from 8 a.m. until 4:30 p.m., e.s.t.

Registration Deadline: For security reasons, registration must be made no later than 5 p.m. on November 29, 2006. Requests for special accommodations must be received by 5 p.m. on November 29, 2006.

Presentation and Written Comments Deadline: Written comments and presentations must be received by November 13, 2006, e.s.t. Presentations once submitted are final. No further changes to the presentation can be accepted after submission.

ADDRESSES:

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

Registration: Individuals who intend to register may register by contacting Maria Ellis at [phone]; e-mail to [e-mail]; or by regular mail to Maria Ellis, Centers for Medicare & Medicaid Services, OCSQ-Coverage and Analysis Group, C1-09-06, 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 can be submitted by e-mail or by regular mail to Kimberly Long or Janet Brock, Executive Secretary for MCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244.

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

FOR FURTHER INFORMATION CONTACT:

Kimberly Long or Janet Brock, Executive Secretaries for MCAC; Kimberly Long at 410-786-5702 or e-mail at [e-mail] or Janet Brock at 410-786-2700 or e-mail at [e-mail]; or contact by regular mail to Kimberly Long or Janet Brock, Executive Secretary for MCAC, Centers for Medicare & Medicaid Services, OCSQ-Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244.

SUPPLEMENTARY INFORMATION:

I. Meeting Topic

In the December 14, 1998 Federal Register (63 FR 68780), we published a notice to describe the Medicare and Coverage Advisory Committee (“MCAC” or “the Committee”), which provides guidance and advice to CMS on specific clinical topics under review for Medicare coverage.

This notice announces the December 13, 2006 public meeting of the Committee. During this meeting, the Committee will discuss evidence and hear presentations and public comments concerning the clinical trial policy National Coverage Determination (NCD) reconsideration. On July 10, 2006, CMS posted on its Web site for a 30-day public comment period, information to initiate the NCD reconsideration and we received numerous comments.

The MCAC will discuss three important proposed changes to the Medicare clinical trial policy: (1) Review the set of standards for qualified studies; (2) recommend processes through which a trial is determined to meet those standards; and (3) advise on the items and services provided to Medicare beneficiaries in qualified studies. In addition to evaluating the available data, the Committee will provide recommendations on the content and implementation of the clinical trial policy National Coverage Determination (NCD) reconsideration.

Background information about this topic, including panel materials, are 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 one of the Executive Secretaries for MCAC 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 information pertinent to your relationship with the topic, such as, for example, financial involvement or institutional support. The Committee will also allow a 15 minute unscheduled open public session for any attendee to address issues specific to the topic.

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. At the conclusion of the day, the members will vote and the Committee will make its recommendation.

III. Registration Instructions and Requests for Special Accomodations

The Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. All persons interested in attending must register by contacting Maria Ellis at the address specified in the ADDRESSES section of this notice by November 29, 2006.

Please provide your name, address, organization, telephone number(s), fax number(s), 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.

Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, must submit their request with their registration information to one of the Executive Secretaries listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

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 that you arrive reasonably early to allow 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 a full inspection of vehicles, inside and exterior areas, 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 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. Visitors must be escorted in all areas except for the lower and first floor levels of 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: October 17, 2006.

Barry M. Straube,

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