Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)-October 22, 2007

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice announces a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (“Committee”) entitled CMS Evidentiary Priorities for Medicare. The Committee generally provides advice and recommendations about whether scientific evidence is adequate to determine if certain medical items and services are reasonable and necessary under the Medicare statute.

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 Monday, October 22, 2007 from 7:30 a.m. until 4:30 p.m., d.s.t.

Deadline for Presentations and Written Comments: Send written comments and presentations to the address specified in the ADDRESSES section by 5 p.m., d.s.t. on September 17, 2007.

Deadline for Meeting Registration: For security reasons, individuals wishing to attend this meeting must register by 5 p.m. d.s.t. on October 15, 2007.

Deadline for Submitting 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 notify the Executive Secretary as specified in the FOR FURTHER INFORMATION CONTACT section of this notice.

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: Register by contacting Maria Ellis 410-786-0309, or Maria.Ellis@cms.hhs.gov; Centers for Medicare & Medicaid Services, OCSQ-Coverage and Analysis Group,C1-09-06, 7500 Security Blvd., Baltimore, MD 21244.

Presentation and Comment Submission: Submit presentations and comments to Michelle Atkinson, at MedCACpresentations@cms.hhs.gov.

Web Site: You may access up-to-date information on this meeting at http://www.cms.hhs.gov/FACA/02_aspTopOfPage .

Submission of 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 and presentations to the Executive Secretary at the address specified in the ADDRESSES section of this notice. Presentations once submitted are final. No further changes to the presentation will be accepted after submission.

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, Executive Secretary for MedCAC, Centers for Medicare & Medicaid Services, OCSQ-Coverage and Analysis Group, C1-09-06, 7500 Security Blvd., Baltimore, MD 21244. 410-786-2881; Michelle.Atkinson@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Meeting Topic

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 CMS about clinical issues. The MCAC was subsequently rechartered as the Medicare Evidence Development and Coverage Advisory Committee (MedCAC).

This notice announces the October 22, 2007 public meeting of the Committee. This meeting is to assist CMS in developing priorities for evidence development for issues of major importance to the Medicare program and the Medicare population to provide a framework for the scientific community advancement of research projects that concern Medicare beneficiaries. Certain disease processes account for a large percentage of services provided to our beneficiaries and specific treatments and healthcare delivery processes have a great impact on beneficiary outcomes. The end product of the MedCAC is a priority list of research topics with the most potential impact on Medicare and Medicare beneficiaries to contribute to the body of medical evidence specific to the Medicare populations. Background information about this topic, including panel materials, is available at http://www.cms.gov/coverage.

II. Meeting Procedures

This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 30 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 do the following:

• Notify the Executive Secretary as specified in FOR FURTHER INFORMATION CONTACT section of the notice.
• Submit the following to the address specified in the ADDRESSES section of this notice by the date specified 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.
• 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_aspTopOfPage.

We require that you declare at the meeting whether 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. Register by contacting Maria Ellis as specified in the ADDRESSES section of this notice by the date as specified in the DATES section of this notice. Please provide your name (as it appears on your government-issued identification), address, organization, telephone, and fax numbers, and e-mail address.

You will receive a registration confirmation with instructions in preparation 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 the date specified in the DATES 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 allowing 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.
• Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
• Passing through a metal detector and inspection of items brought into the building. We note that 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.

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)