E8-30162. Medicare Program; Meeting of the Medicare Evidence Development & Coverage Advisory Committee-February 25, 2009

AGENCY:

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

ACTION:

Notice of meeting.

SUMMARY:

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (“Committee”) will be held on Wednesday, February 25, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the requirements for evidence to determine if diagnostic use of genomic testing in beneficiaries with signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will also discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

DATES:

Meeting Date: This meeting will be held on Wednesday, February 25, 2009 from 7:30 a.m. until 4:30 p.m., eastern standard time (e.s.t).

Deadline for Submission of Written Comments: Written comments must be received at the address specified in the ADDRESSES section of this notice by 5 p.m., e.s.t on January 29, 2009. Once submitted all comments are final.

Deadlines for Speaker Registration and Presentation Materials: The deadline to register to be a speaker and to submit powerpoint presentation materials and writings that will be used in support of an oral presentation, is 5 p.m., e.s.t. on January 29, 2009. Speakers may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentation materials must be received at the address specified in the ADDRESSES section of this notice.

Deadline for All Other Attendees Registration: Individuals may register by phone or via e-mail by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m., e.s.t. on Wednesday, February 18, 2009.

Deadline for Submitting a Request for 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 contact the Executive Secretary as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5 p.m., e.s.t. Friday, February 18, 2009.

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.

Submission of Presentations and Comments: Presentation materials and written comments that will be presented at the meeting must be submitted via e-mail to [e-mail] or by regular mail to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice.

FOR FURTHER INFORMATION CONTACT:

Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500 Security Boulevard, Baltimore, MD, 21244 or contact Ms. Ellis by phone at 410-786-0309 or via e-mail at [e-mail]

SUPPLEMENTARY INFORMATION:

I. Background

MEDCAC, formerly known as the Medicare Coverage Advisory Committee (MCAC), provides advice and recommendations to CMS regarding clinical issues. (For more information on MCAC, see the December 14, 1998 Federal Register (63 FR 68780.)) This notice announces the February 25, 2009, public meeting of the Committee. During this meeting, the Committee will discuss the requirements for evidence to determine if diagnostic uses of genomic testing in beneficiaries with signs or symptoms of disease improves health outcomes in Medicare beneficiaries. Background information about this topic, including panel materials, are available at http://ww.cms.hhs.gov/​coverage. We encourage the participation of appropriate organizations with expertise in the evidence regarding this use of genomic testing.

II. Meeting Format

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. Your comments should focus on issues specific to the list of topics that we have proposed to the Committee. The list of research topics to be discussed at the meeting will be available on the following Web site prior to the meeting: http://www.cms.hhs.gov/​mcd/​index_​list.asp?​list_​type=​mcac. We require that you declare at the meeting whether you have any financial involvement with manufacturers (or their competitors) of any items or services being discussed.

The Committee will deliberate openly on the topics under consideration. 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 topics under consideration. At the conclusion of the day, the members will vote and the Committee will make its recommendation(s) to CMS.

III. Registration Instructions

CMS' Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the deadline listed in the DATES section of this notice. Please provide your full name (as it appears on your state-issued driver's license), address, organization, telephone, fax number(s), and e-mail address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified the seating capacity has been reached.

IV. Security, Building, and Parking Guidelines

This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following:

• Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel.
• Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
• Inspection, via metal detector or other applicable means of all persons brought entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, 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 presentation or to support a presentation.

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. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: December 11, 2008.

Barry M. Straube,

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