MEDCAC Meeting

CMS Evidentiary Priorities

10/22/2007

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Issue

On October 22, 2007 CMS will convene a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) entitled Evidentiary Priorities for the Medicare Program. Numerous issues affect the health and healthcare of our Medicare beneficiaries. Certain disease processes account for a large percentage of services provided to our beneficiaries. Specific treatments and healthcare delivery processes have a great impact on beneficiaries’ outcomes.

The purpose of this MedCAC is to assist CMS in developing priorities for evidence development for issues of major importance to the Medicare program and the Medicare population. These issues will provide a framework for the scientific community interested in developing evidence that will impact the health of Medicare beneficiaries.

We have assembled a MedCAC panel qualified to discuss research priorities with the most potential to the Medicare population. High profile experts from the scientific community will serve on this panel. Experts from the NIH institutes will present the most relevant research topics. The CDC, AHRQ, and Medicare representatives will describe data resources available in their respective agencies. .

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.

Presentations and Written Comment:

We are soliciting comments from the scientific community on prioritizing these issues for the Medicare population. Presentations and written comments must be received by September 17, 2007 5:00pm, est. Presentations once submitted are final. We recommend presentations to be in Power Point.

Please email your presentations to MedCACpresentations@cms.hhs.gov

Registration:

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 maria.ellis@cms.hhs.gov by phone or e-mail. 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. 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 October 15, 2007.

Security:

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 government issued 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 (rear trunk and engine) 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.

All visitors must be escorted in areas except for the lower and first floor levels in the Central Building.

Actions Taken

September 5, 2007

Announced MedCAC meeting and posted Federal Register notice [PDF, 406KB].

September 7, 2007

Posted questions to panel.

October 18, 2007

October 24, 2007

Posted presentations [PDF, 955KB] from meeting.

October 30, 2007

Agenda

Agenda
Medicare Coverage Advisory Committee
October 22, 2007
8:00 AM - 4:30 PM
CMS Auditorium
Barbara McNeil, MD, PhD, Chair
Barry M. Straube, MD CMS Chief Medical Officer
Director, Office of Clinical Standards and Quality
Michelle Atkinson, Executive Secretary

7:30 - 8:00 AM

Registration

8:00 - 8:15AM

Opening Remarks—M. Atkinson / B. Straube, MD, MPA/ Barbara McNeil, MD, PhD

8:15- 8:25 AM

CMS Welcome Presentation - Herb B. Kuhn

8:25 - 8:40AM

CMS Presentation - Rosemarie Hakim, MS, PhD

8:40- 8:55AM

Peter Savage, FAHA, Special Advisor for Clinical Research, Office of the Director, NHLBI

8:55 - 9:10 AM

Martin L. Brown, Ph.D., Chief, Health Services and Economics Branch, Applied Research Program Division of Cancer Control and Population Sciences National Cancer Institute

9:10 - 9:20AM

Susan Nayfield, MD, Chief of the Geriatrics Branch, National Institute on Aging

9:20 -9:35 AM

Michael Schoenbaum, PhD, Senior for Mental Health Services, Epidemiology, and Economics Advisor, Division of Services and Intervention Research, National Institute of Mental Health

9:35- 9:50AM

Judith Fradkin, M.D. Director, Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK, NIH

9:50 - 10:05AM

Walter Koroshetz, MD, National Institute of Neurological Disorders and Stroke

10:05 - 10:20AM

Madeline K. Turkeltaub, CRNP, PhD, FAAN, Deputy Director, Extramural Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases

10:20 - 10:35AM

Rick Ferris, MD, National Eye Institute

10:35 - 11:15AM

Scheduled Public Comment (Refer to the Speakers List)

11:15 - 11:35PM

Open Public Comments

11:35 - 12:00PM

Questions to Presenters

Public Attendees who wish to address the panel will be given that opportunity

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Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

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12:00- 1:00PM

LUNCH (On your own)

1:00- 4:00PM

Initial Open Panel Discussion: Dr. McNeil

4:00 - 4:25 PM

Final Open Panel Discussion: Dr. McNeil

4:25 - 4:30 PM

Closing Remarks / Adjournment: Dr. Straube, Dr. McNeil

4:30 PM

ADJOURN

Minutes

Panel Voting Questions

CMS Evidentiary Priorities in Medicare

Questions

  1. Which diseases represent the greatest burden to Medicare beneficiaries?

  2. Which diseases and their treatments are the costliest to the Medicare Program?

  3. Where are our greatest deficits in knowledge about the most important diseases and their treatments in the Medicare population as discussed in Questions 1 and 2?

  4. How do we approach the problem of increasing the evidence base for the most important diseases and their treatments in the Medicare population as discussed in Questions 1 and 2?

  5. Please provide a priority list of diseases and their treatments that are most critical to increasing the evidence base for making coverage decisions that affect the Medicare population based on your discussions of the above questions.

Contact Information

Invited Presenters List

October 22, 2007 MedCAC
Invited Presenters List

Peter Savage, FAHA
Special Advisor for Clinical Research,
Office of the Director, NHLBI
Bethesda, Maryland

Martin Brown, PhD
Chief
Health Services and economics Branch
Applied Research Program Division of Cancer Control and Population Sciences
National Cancer Institute
Bethesda, Maryland

Susan Nayfield, MD
Chief of the Geriatrics Branch,
National Institute on Aging
Bethesda, Maryland

Michael Schoenbaum, PhD
Senior for Mental Health Services Epidemiology, and Economics Advisor
Division of Services and Intervention Research
National Institute of Mental Health
Bethesda, Maryland

Judith Fradkin, MD
Director, Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Bethesda, Maryland

Walter Koroshetz, MD
Deputy Director, National Institute of Neurologic Disorders and Stroke
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland

Madeline Turkeltaub, CRNP, PhD, FAAN
Deputy Director, Extramural Program,
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Bethesda, Maryland

Rick Ferris, MD
National Eye Institute
Bethesda, Maryland

Edward J. Sondik, Ph.D.
National Center for Health Statistics
Centers for Disease Control and Prevention
Hyattsville, MD

Roster

October 22, 2007 MedCAC
Roster

Barbara McNeil, MD, PhD CHAIR
Acting Dean
Harvard Medical School
Boston, MA

Mark D. Grant, MD, MPH
Senior Scientist
BlueCross BlueShield Association
Chicago, IL

Mark A. Hlatky, MD
Professor, Health Research and Policy and Cardiovascular Medicine
Stanford University School of Medicine
Stanford, CA

Deborah Schrag MD, MPH
Memorial Sloan-Kettering Cancer Center
New York, NY

Ruth Bush, MD, MPH
Associate Professor
Division of Vascular Surgery
Houston, TX

Karl Matuszewski, MS, PharmD
University Healthsystem Consortium (UHC)
Clinical Practice Advancement Center
Oak Brook, IL

Nancy Davenport-Ennis, BA
CEO
Patient Advocate Foundation
Newport News, VA

Leslie B. Fried, JD
American Bar Association
Commission on Law & Aging
Washington, DC

Industry Representative
Peter Juhn, MD, MPH
Vice President, Evidence & Regulatory Policy
Johnson & Johnson, Inc.
New Brunswick, NJ

Consumer Representative
Linda A. Bergthold, PhD
Santa Cruz, CA

Past Administrator
Thomas A. Scully, J.D.
Welsh, Carson, Anderson & Stowe
New York, NY

Guest Panel members
Jean Slutsky, PA, MSPH
Director, Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
Rockville, MD

Michael A. Jacobs, MD
Chief of Orthopedic Surgery
Good Samaritan Hospital
Baltimore, MD

Sean Tunis, MD, MSc
Director, Center for Medical Technology Policy
Baltimore MD

CMS Liaison
Barry M. Straube, MD
CMS Chief Medical Officer
Director, Office of Clinical Standards and Quality

Executive Secretary
Michelle Atkinson

Speaker List

Medicare Coverage Advisory Committee
October 22, 2007

SPEAKER LIST



* 9 MINUTES PER SPEAKER*
  • Steven Glassman, MD, Orthopedic Surgeon, Spine Institute, Professional Society Coalition Task Force on Lumbar Spine Fusion, and Daniel K. Resnick, MD, University of Wisconsin Medical School

  • William Weintraub, MD, American Heart Association (AHA)

  • Randy Burkholder, Associate Vice President, Policy, PhRMA

  • Ann-Marie Lynch, AdvaMed

Associated NCA

Associated Technology Assessment