Evidentiary Characteristics for Coverage with Evidence Development (CED)

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=63 | meeting_date=2012-05-16

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.

Actions Taken: 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. Webcast of meeting Registration Information about visiting CMS Driving directions to CMS Recommended hotels Agenda: 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 - 10:15 Question 1 - Allan Korn, MD, FACP 10:15 - 10:30 BREAK 10:30 - 11:15 Mark McClellan, MD 11:15 - 12:00 Question 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 - 4:15 Additional Comments 4:15 - 4:30 Final Speaker Comment Closing Remarks/Adjournment: Tamara Syrek Jensen/Dr. Goodman Issue: 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. Minutes: Download meeting minutes [PDF, 118KB] Other Material: Transcript 1 Panel Voting Questions: 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? whether the item or service is a diagnostic v. a therapeutic technology; the severity of the disease; the safety profile of the technology; the availability of acceptable alternatives for the same disease/condition other factor(s) 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 additional settings; additional practitioners; 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] Roster: 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 Speakers List: 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