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MEDCAC Meeting 6/17/2009 - Bayesian statistical methods and Medicare evidence MEDCAC

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This meeting will focus on the use of Bayesian statistics to interpret evidence in making coverage decisions.  The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide some examples of using Bayesian techniques for meta-analyses.

May 12, 2009

Posted Federal Register notice announcing meeting.

May 20, 2009

Posted questions to panel.

June 05, 2009

June 16, 2009

Posted roster, agenda and speaker list for meeting.

June 18, 2009

Posted scoresheet  [PDF, 447KB] from meeting.

August 14, 2009

Posted minutes [PDF, 1.42MB] and transcript [PDF, 472KB] from meeting.
Federal Register Notice
Medicare Evidence Development & Coverage Advisory Committee
June 17, 2009
7:30 AM – 4:30 PM
CMS Auditorium

Cliff Goodman, PhD, Chair
Saty Satya-Murti,Vice Chair
Marcel Salive, MD, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 – 8:00 AM


8:00 – 8:15 AM

Opening Remarks and questions
Maria Ellis/Marcel Salive, MD, MPH/Cliff Goodman, PhD

8:15 - 9:15 AM

Steven Goodman, MD, PhD, Professor, Director, Oncology Biostatistics, Johns Hopkins Bloomberg School of Public Health,
"Bayesian Concepts I: Measuring the Strength of Evidence"

9:15 – 10:15 AM

Donald Berry, PhD, Professor, Chairman, Department of Biostatistics, The University of Texas M.D. Anderson Cancer Center, "Bayesian Concepts II: Use and Interpretation of Bayesian Methods in Design and Analysis of Clinical Trials"

10:15- 10:30AM


10:30 – 11:15 AM

Roger Lewis, MD, PhD, Department of Emergency Medicine, David Geffen School of Medicine at UCLA,"Application of Bayesian Concepts in Clinical Decision Making"

11:15 – 12:00 PM

Sharon-Lise Normand, PhD, Professor, Health Care Policy (Biostatistics), Harvard Medical School, "Application of Bayesian Concepts in Policy Decision Making"

12:00 – 1:00 PM


1:00 – 1:45 PM

Gillian Sanders, PhD, Associate Professor of Medicine, Duke University and Donald Berry, PhD, Professor, Chairman, Department of Biostatistics, The University of Texas M.D. Anderson Cancer Center, "Meta Analyses of ICDs"

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.

1:45 – 2:00 PM

Scheduled Public Comments
(Refer to Speaker List)

2:00 – 2:10 PM

Open Public Comments - (Public Attendees who wish to address the panel will be given the opportunity.)

2:10 – 2:40 PM

Questions to Presenters

2:40 – 3:40 PM

Open Panel Discussion: Dr. Goodman

3:40 – 4:15 PM 

Formal Remarks and Voting - (The Chairperson will ask each panel member to state his or her position on the voting questions)

4:15 – 4:30 PM

Closing Remarks/Adjournment: Dr. Salive & Dr. Goodman

Download meeting minutes. [PDF, 1.42KB]


  1. In assessing the strength of evidence for the effectiveness of a medical intervention that incorporates Bayesian design or analysis, compared to a frequentist approach, please discuss the following:

    1. What are the greatest potential strengths of a Bayesian approach?
    2. What are the greatest potential weaknesses of a Bayesian approach?

    For discussion

  2. How confident are you that potential strengths of Bayesian approaches outweigh the potential liabilities in the design and interpretation of a published study?

    1. In designing studies
    2. In interpreting study results

    1……...................... 2……………...…….. 3………………..….. 4……..………..…….. 5
    Liabilities outweigh                              No difference                                        Strengths outweigh
    Strengths                                                                                                              Liabilities

    For discussion

  3. How confident are you that CMS should incorporate evidence that uses Bayesian approaches in trials or technology assessments submitted for coverage decisions?

    1. Clinical trials
    2. Technology assessments

    1……...................... 2……………...…….. 3………………..….. 4……..………..…….. 5
    CMS should                                     No position                                                   CMS should
    Discourage                                                                                                              Encourage

Download scoresheet [PDF, 447KB]

June 17, 2009

Clifford Goodman, PhD Chair
Senior Vice President
The Lewin Group

Saty Satya-Murti, MD, FANN Acting Chair
Health Policy Consultant

David A. Axelrod, MD, MBA
Surgical Director of Kidney & Pancreas
Dartmouth-Hitchcock Medical Center

John Cox, DO, FACP
Texas Oncology, PA
Methodist Charlton Cancer Center

Mercedes K.C. Dullum, MD
Section of Cardiothoracic Surgery
Cleveland Clinic in Florida Sharon-Lise Normand
Health Care Policy (Biostatistics)
Harvard Medical School

Mark D. Grant, MD, MPH
Associate Director
Technology Evaluation Center
BlueCross BlueShield Association Gillian Sanders, PhD
Associate Professor of Medicine
Duke University

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

William H. Maisel, MD, MPH
Cardiovascular Division
Beth Israel Deaconess Medical Center
Harvard Medical School

Curtis A. Mock, MD, MBA
Senior Regional Medical Director
Consumer Decision Support and
United Healtcare

Joshua P. Prager, MD, MS
Director, California Pain Medicine Center
Director, Center for Rehabilitation of Pain
Syndrome (CRPS)

Industry Representative
Jose Alvir, Dr.PH
Director, Statistics, Outcomes Research
Clinical Research and Development
Pfizer, Inc.

Guest Speakers
Donald Berry, PhD
Department of Biostatistics
The University of Texas M.D.
Anderson Cancer Center

Steven Goodman, PhD
Oncology Biostatistics
Johns Hopkins Bloomberg School of
Public Health

Roger Lewis, MD, PhD
Department of Emergency Medicine
David Geffen School of Medicine

CMS Liasion
Marcel Salive, MD
Division of Medical & Surgical Services
Coverage and Anaylsis Group

Executive Secretary
Maria A. Ellis

Medicare Evidence Development & Coverage Advisory Committee
June 17, 2009



  • Bryan R. Luce, PhD, MBA, Senior Vice President, Science Policy, United BioSource Corporation