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The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence and hear public testimony on the use of beta amyloid PET imaging for the management of dementia and neurodegenerative disease. CMS is interested in the clinical impact of this technology on health outcomes experienced by patients.
PET is a minimally-invasive diagnostic imaging test. An injected radioactive tracer gives off subatomic particles, known as positrons, as it decays. PET uses a positron camera (tomograph) to measure the decay of these radioisotopes. The rate of tracer decay provides biochemical information on the tissue being studied. Certain PET tracers allow imaging of beta-amyloid plaque in the brain. It has been asserted that identification of such beta amyloid plaque can inform the clinical management of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes cognitive decline.
Medicare currently does not cover beta amyloid PET imaging. Medicare addresses coverage of PET in section 220.6 of the National Coverage Determination (NCD) manual at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part4.pdf
CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED HERE.
August 27, 2012
October 24, 2012
October 31, 2012
January 24, 2013
January 31, 2013
March 5, 2013
Rita Redberg, MD, MSc, Chair
Art Sedrakyan, MD, PhD, Vice Chair
Louis Jacques, MD, Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary
7:30 – 8:00 AM
8:00 – 8:10 AM
8:15 - 8:25 AM
8:25 – 8:45 AM
8:45 – 9:05 AM
9:05 – 9:25 AM
9:25 – 9:45 AM
9:45 – 10:05 AM
10:05 – 10:15 AM
10:15 – 11:00 AM
11:00 – 11:05 AM
Public Attendees who wish to address the panel will be given that opportunity
11:05 – 12:00 PM
12:00 – 1:00 PM
1:00 – 2:00 PM
2:00 – 3:00 PM
The Chairperson will ask each panel member to state his or her position on the voting questions.
3:00 – 4:00 PM
4:00 – 4:30 PM
Download meeting minutes. [PDF, 135KB]
The primary focus of this MEDCAC meeting is the use of positron emission tomography (PET) imaging of brain beta amyloid to inform the clinical diagnosis and management of dementia. Among outcomes, CMS is most interested in patient function and quality of life.
We also seek the panel’s input on whether or not the published evidence identifies patient characteristics that predict improved health outcomes of patients who undergo PET imaging for beta amyloid. CMS recognizes that the impact of a diagnostic test result is generally derived from downstream changes in patient management rather than from the mere administration of the test, and that the avoidance of unnecessary or harmful treatment may also produce improved health outcomes.
Instructions: For the voting questions, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence.
1a. How confident are you that there is adequate evidence to determine whether or not PET imaging of brain beta amyloid changes health outcomes (improved, equivalent or worsened) in patients who display early symptoms or signs of cognitive dysfunction?
1b. If there is at least intermediate confidence (mean score ≥ 2.5 in question 1a), how confident are you that PET imaging of brain beta amyloid improves health outcomes in patients who display early symptoms or signs of cognitive dysfunction?
Please discuss the factors that led to your vote.
If there is at least intermediate confidence that PET imaging of brain beta amyloid improves health outcomes in patients who display early symptoms or signs of cognitive dysfunction (mean score ≥ 2.5 in question 1b), please proceed to question 2a. If not, please proceed to question 3.
2a. How confident are you that there is adequate evidence to identify patient characteristics that predict improved health outcomes of patients who undergo PET imaging for beta amyloid?
2b. If there is at least intermediate confidence there is adequate evidence to identify patient characteristics that predict improved health outcomes of patients who undergo PET imaging for beta amyloid (mean score ≥ 2.5 in question 2a), please identify and discuss the relative weight of those
3. How confident are you that these conclusions are generalizable to the Medicare beneficiary population?
4. Please discuss any evidence gaps and the types of clinical studies that would be needed to confidently close those gaps.
Rita Redberg, MD, MS Chair
Professor of Medicine
UCSF School of Medicine
Division of Cardiology
University of California, San Francisco Medical Center
Art Sedrakyan, MD, PhD Vice Chair
Associate Professor & Director
Patient Centered Comparative
Outcomes Research Program
Weill Cornell Medical School
Jeffrey W. Cozzens, MD, FACS
Attending Physician, Neurosurgery
Chair, Division of Neurosurgery
Southern Illinois University School of Medicine
SIU Physicians & Surgeons, Inc.
Raymond E. Faught, Jr., MD
Professor of Neurology
Associate Chief of Service
Chief, Neurology Service
Emory Neurology, MOT 7085
Emory University Hospital Midtown
A. Mark Fendrick, MD
Department of Internal Medicine
University of Michigan School of Public Health
Steven Gutman, MD
Paula E. Hartman-Stein, PhD
Associate Professor of Psychiatry,
Northeast Ohio Medical University
Senior Fellow, Institute for Life-Span Development and Gerontology
University of Akron
Center for Healthy Aging
Susan A. Levine, DVM, MS, PhD
Technology Assessment/Editor-in Chief
Theresa Miskimen, MD
Vice President, Medical Services
University Behavioral Health Care
University of Medicine & Dentistry of New Jersey
Curtis Mock, MD, MBA
Senior Medical Director
Vice President Medicare Advantage
UnitedHealthcare Medicare & Retirement
Jerrold Rosenbaum, MD
Massachusetts General Hospital
Stanley Cobb Professor of Psychiatry
Harvard Medical School
Amy E. Sanders, MD, MS
Department of Neurology/Einstein Aging Study
Albert Einstein College of Medicine
Robert K. Zeman, MD
Professor and Chairman of Radiology
George Washington University School of Medicine
Diagnostic Radiology Residency Program
Radiologist-in-chief (Radiology and Radiation Oncology)
George Washington University Medical
Faculty Associates, Inc., and Hospital
Brian Seal, RPh, MBA, PhD
Health Economics & Outcomes Research
Bayer HealthCare Pharmaceuticals Inc.
Guest Panel Members
Peter Herscovitch, MD
NIH Clinical Center
Constantine G. Lyketsos, MD, MHS
Johns Hopkins Medicine/Psychiatry & Behavioral Sciences
Invited Guest Speakers
Paul Aisen, MD
Department of Neurosciences
UCSan Diego School of Medicine
Randall J. Bateman MD
Charles F. and Joanne Knight Distinguished Professor of Neurology
Washington University School of Medicine
Mark Mintun, MD
Chief Medical Officer
Avid Radiopharmaceuticals (Avid)
Wholly Owned Subsidiary of Eli Lilly and Company (Lilly)/p>
Steven D. Pearson, MD, MSc, FRCP
Institute for Clinical and Economic Review Massachusetts General Hospital's Institute for Technology Assessment
William Thies, MD
Chief Medical and Scientific Officer
Louis Jacques, MD
Coverage and Analysis Group
Coverage and Analysis Group