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MEDCAC Meeting 5/16/2012 - Evidentiary Characteristics for Coverage with Evidence Development (CED)

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The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review desirable characteristics of evidence appropriate for Coverage with Evidence Development (CED).  CED provides Medicare payment for items and services while generating clinical data to demonstrate their impact on health outcomes.   While CED has produced some gains in innovation, our experience over the last few years indicates we still have room to improve the CED process. Our intended outcome is to mature CED so that it fulfills its potential as a mechanism that simultaneously supports evidence basedinnovation and enables CMS to make better informed evidentiary decisions that improve health outcomes for Medicare beneficiaries. 


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.
March 26, 2012 Posted questions to panel.
May 9, 2012 Posted agenda, roster and speakers list.
May 10, 2012 Posted presentations and written comments.
May 18, 2012 Posted scoresheet [PDF, 27KB] from meeting.
October 2, 2012 Posted minutes [PDF, 118KB] and transcript [PDF, 352KB] from meeting.
Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
May 16, 2012
7:30 AM – 4:30 PM

Clifford Goodman, PhD, Chair
Steve Phurrough, MD, MPH, Vice Chair
Tamara Syrek Jensen, JD, Deputy Director, Coverage & Analysis Group
Maria Ellis, Executive Secretary

               
7:30 –  8:00 Registration
8:00 – 8:15 Opening Remarks – Maria Ellis/Tamara Syrek Jensen, JD/Clifford Goodman, PhD
8:15 – 8:30 CMS Presentation & Voting Questions – Louis Jacques, MD
8:30 – 9:15 Scheduled Public Comments
(Refer to Speaker List)
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.
9:15 - 9:30 Open Public Comments
Public Attendees who wish to address the panel will be given that opportunity.
9:30 - 10:15Question 1 – Allan Korn, MD, FACP
10:15 - 10:30BREAK
10:30 - 11:15Mark McClellan, MD
11:15 - 12:00Question 2 – Sean Tunis, MD
12:00 – 1:00 LUNCH (on your own)
1:00 - 1:45 Question 3 – Lewis Sandy, MD, FACP
1:45 – 2:30 Question 4 – Lewis Sandy, MD, FACP
2:30 - 3:45 Question 5 – Rick Kuntz, MD
3:45 – 4:15Additional Comments
4:15 - 4:30 Final Speaker Comment
Closing Remarks/Adjournment:  Tamara Syrek Jensen/Dr. Goodman
Download meeting minutes [PDF, 118KB]
Definitions

Binary Coverage Paradigm:

    “Yes or No” final coverage decision without planned reconsideration of prespecified clinical outcomes.

Non-Binary Coverage Paradigm*:

    Qualified coverage decision that may evolve as evidence base changes over time, with planned reconsideration based on the achievement of prespecified clinical outcomes.

*CED is an example of a non-binary coverage paradigm.

Question 1

Are there significant, practical differences between binary and non-binary coverage paradigms?

If the answer favors “Yes” please discuss the advantages and disadvantages of non-binary paradigms.

Question 2

Can an evidentiary threshold be defined to invoke CED?

     If the answer favors “Yes” please discuss how this threshold should be identified.

     If the answer favors “No” please discuss the impediments and recommend strategies to overcome them.

Question 3

How would an evidentiary threshold to invoke CED be influenced by the following?

  1. whether the item or service is a diagnostic v. a therapeutic technology;
  2. the severity of the disease;
  3. the safety profile of the technology;
  4. the availability of acceptable alternatives for the same disease/condition
  5. other factor(s)
  6. a combination or tradeoff involving two or more of the above
Question 4

How would an evidentiary threshold to invoke CED be influenced if the outstanding questions focused only on the generalizability of a strong but narrow evidence base to

  1. additional settings;
  2. additional practitioners;
  3. broader clinical indications for related or unrelated diseases#?

# An example of a related condition might include a different stage of the same cancer. An example of an unrelated condition might include the use of a cancer drug for a rheumatologic disease.

Question 5

Can an evidentiary threshold be defined to trigger an evidentiary review to determine if CED should cease, continue or be modified?

     If the answer favors “Yes” please discuss how this threshold should be identified.

     If the answer favors “No” please discuss the impediments and recommend strategies to overcome them.

     Please discuss whether the factors identified in Questions 3 and 4 are relevant to Question 5.


Download scoresheet [PDF, 27KB]

Clifford Goodman, PhD CHAIR
Senior Vice President
The Lewin Group

Steve E. Phurrough, MD Vice Chair
Chief Operating Officer/Senior Clincal Director
Center for Medical Technology Policy

Renè Cabral-Daniels, JD, MPH
Chief of Staff
National Patient Advocate Foundation

Mark D. Grant, MD, MPH
Director, Technology Assessment
Technology Evaluation Center
Blue Cross Blue Shield Association

Robert McDonough, MD, JD
Head
Clinical Policy Research and Development
Medical Policy and Program Administration
National Medical Services
Aetna, Inc.

James Min, MD
Associate Professor of Medicine, Imaging and Biomedical Sciences
Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center
Associate Professor of Medicine
David Geffen UCLA School of Medicine
Director, Cardiac Imaging Research, Cedars-Sinai Medical Center
Co-Director, Cardiac Imaging
Cedars-Sinai Heart Institute

Sharon-Lise T. Normand, PhD
Professor
Health Care Policy (Biostatistics)
Harvard Medical School

Jeffrey B. Rich, MD
CardioThoracic Surgeon
Mid-Atlantic Cardiothoracic Surgeons, Ltd.

Ryan H. Saadi, MD MPH
Vice President
World Wide Health Economics
Reimbursement and Strategic Pricing
CORDIS Corporation
Johnson & Johnson

J. Sanford Schwartz, MD
Professor of Medicine
Health Management and Economics
University of Pennsylvania

Art Sedrakyan, MD, PhD
Associate Professor and Director
Patient Centered Comparative
Outcomes Research Program
Weill Cornell Medical School
 Industry Representative

Peter Juhn, MD, MPH
President
Therapeutic Resource Centers
Medco Health Solutions, Inc.

Guest Panel Members

Steven Goodman, MD, MHS, PhD 
Associate Dean for Clinical and Translational Research
Professor of Medicine & Health Research and Policy
Stanford University School of Medicine

Jack W. Lasersohn
General Partner
The Vertical Group

Peter J. Neumann, ScD
Professor of Medicine
Clinical Research
Tufts Medical Center

Invited Guest Speakers

Allan Korn, MD, FACP
Senior Vice President, Clinical Affairs and
Chief Medical Officer
BlueCross BlueShield Association

Rick Kuntz, MD
Senior Vice President and Chief Scientific, Clinical, and Regulatory Officer
Medtronic, Inc.

Mark McClellan, MD
Director
Engelberg Center for Health Care Reform
Senior Fellow, Economic Studies
Leonard D. Schaeffer Chair in Health Policy Studies
The Brookings Institute

Lewis G. Sandy, MD, FACP
Senior Vice President
Clinical Advancement
UnitedHealth Group

Sean Tunis, MD
Founder and Director
Center for Medical Technology Policy

CMS Liaison

Tamara Syrek Jensen, JD
Deputy Director
Coverage and Analysis Group

Executive Secretary

Maria Ellis
Coverage and Analysis Group

Medicare Evidence Development & Coverage Advisory Committee
May 16, 2012

SPEAKER LIST
*5 MINUTES PER SPEAKER*

  • Michael J. Mack, MD, STS Past President, Representing: The Society of Thoracic Surgeons


  • Ralph Brindis, MD, Past President, American College of Cardiology, Representing: American College of Cardiology


  • Mark Perman, MD, President, Registry for Prostate Cancer Radiosurgery


  • Norman Foster, MD, Professor, Department of Neurology, Director, Center for Alzheimer’s Care, Imaging and Research, Senior Investigator, The Brain Institute, University of Utah - No Powerpoint Presentation


  • Bruce Quinn, MD, Foley Hoag, LLP


  • E. Elizabeth Halpern, Counsel, Hogan Lovells US LLP, Representing: The Medical Device Manufacturers Association - No Powerpoint Presentation


  • Ann-Marie Lynch, Executive Vice President, Payment and Health Care Delivery Policy, The Advanced Medical Technology Association - No Powerpoint Presentation


  • Alyson Pusey, Director, Reimbursement and Health Policy, Biotechnology Industry Organization - No Powerpoint Presentation


  • Richard Frank, MD, VP, Global Clinical Strategy and Policy Healthcare Systems, GE and Vice-Chair, PET Group Representing: The Medical Imaging & Technology Alliance
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