0001 1 2 3 4 5 6 7 8 9 10 11 CENTERS FOR MEDICARE AND MEDICAID SERVICES 12 Medicare Coverage Advisory Committee 13 14 15 16 17 18 19 March 12, 2003 20 21 Baltimore Convention Center 22 100 West Pratt Street 23 Baltimore, Maryland 24 25 0002 1 Panelists 2 3 Chairperson 4 Harold C. Sox, MD 5 6 Voting Members 7 Wade M. Aubry, MD 8 Norman Daniels, PhD 9 Alan M. Garber, MD, PhD 10 Clifford Goodman, PhD 11 Tracy R. Gordy, MD 12 Mark Slaughter, MD 13 Louise Woerner 14 15 Consumer Representative 16 Linda A. Bergthold, PhD 17 18 Industry Representative 19 Eileen C. Helzner, MD 20 21 22 23 24 25 0003 1 Panelists (Continued) 2 3 Non-Voting Guest Panelists 4 George J. Agich, PhD 5 Stephen Gottlieb, MD 6 Joanne Lynn, MD, MA, MS 7 Ileana L. Pina, MD 8 Julie Swain, MD 9 10 CMS Liaison 11 Steve E. Phurrough, MD, MPA 12 13 Executive Secretary 14 Kimberly Long 15 16 17 18 19 20 21 22 23 24 25 0004 1 TABLE OF CONTENTS 2 3 Page 4 Opening Remarks 5 Kimberly Long 6 6 Steve E. Phurrough, MD, MPA 7 7 8 CMS Presentation of Request and Voting/Discussion Questions 9 Perry Bridger 13 10 11 Requestor's Presentation: Thoratec 12 Eric Rose, MD 20 13 James W. Long, MD, PhD 30 14 Leslie Miller, MD 40 15 Eric Rose, MD 48 16 17 Scheduled Public Comments 18 Mario C. Deng, MD 50 19 James K. Kirklin, MD, FACC 55 20 William A. Baumgartner, MD 59 21 Robert L. Kormos, MD 64 22 Clyde W. Yancy, MD 69 23 24 25 0005 1 TABLE OF CONTENTS (Continued) 2 3 Open Panel Deliberations 4 Lead Methodological Reviewer 5 Wade M. Aubry, MD 74 6 Lead Clinical Reviewer 7 Mark Slaughter, MD 81 8 Questions to Presenters 90 9 10 Luncheon Recess 146 11 12 Open Public Comments 13 (Waived by two speakers) 147 14 15 Open Panel Deliberations/Formal Remarks and 16 Vote 148 17 18 Discussion on discussion questions 202 19 20 Closing Remarks 21 Kimberly Long 22 23 Adjournment 24 25 0006 1 PANEL PROCEEDINGS 2 (The meeting was called to order at 8:04 a.m., 3 Wednesday, March 12, 2003.) 4 Ms. Long: Good morning and welcome, committee 5 chairperson, members and guests. I am Kimberly Long, an 6 executive secretary for the Medicare Coverage Advisory 7 Committee. The committee is here today to discuss and make 8 recommendations concerning the quality of the evidence and 9 related issues for the use of a ventricular assist device as 10 destination therapy in end-stage heart failure patients who 11 are not eligible for a heart transplant. 12 The following announcement addresses conflict of 13 interest issues associated with this meeting and is made part 14 of the record to preclude even the appearance of impropriety. 15 The conflict of interest statute prohibits special government 16 employees from participating in matters that could affect 17 their or their employers' financial interests. To determine 18 if any conflict existed, the Agency reviewed all financial 19 interests reported by the committee participants. The Agency 20 has determined that all members may participate in the 21 matters before the committee today. With respect to all 22 other participants, we ask in the interest of fairness that 23 all persons making statements or presentations disclose any 24 current or previous financial involvement with any firm whose 25 products or services they may wish to comment on. This 0007 1 includes direct financial investments, consulting fees and 2 significant institutional support. 3 Now I would like to turn the meeting over to Dr. 4 Steve Phurrough. 5 Dr. Phurrough: Thank you, Kim. I am Steve 6 Phurrough, I am the acting director for the coverage and 7 analysis group at the Center for Medicare and Medicaid 8 Services, and we want to thank all the panel members for the 9 efforts they have made to be part of this meeting today. 10 It's a very timely and exciting topic, a topic that 11 we think will generate a significant amount of discussion 12 today, and we look forward to your comments and 13 recommendations as to the evidence that's going to be 14 presented here today. 15 I want to make a special welcome to the new members 16 of the MCAC who are attending for the first time today and 17 hope you will find this a very challenging and exciting time, 18 and challenge you to be members in the future also. 19 I would like to remind the guests and the members 20 in the audience today that we do have two times for public 21 comments, one for those who have previous to this meeting 22 requested time, and then there is an open public comment time 23 period. For both groups of people, there are disclosure 24 forms that you need to have in hand that you will read prior 25 to your comments, whether it's during the scheduled time or 0008 1 during the open public time. If you don't have those forms, 2 they are out at the front desk and you can get them. 3 Again, thank you very much for your attendance, and 4 now I would like to introduce the panel chairman, Dr. Hal 5 Sox. 6 Dr. Sox: Well, we're going to start off by 7 introducing the panel members, or allowing them to introduce 8 themselves and then we'll go right into the presentation and 9 the data. 10 I'm going to, in terms of running the meeting, if 11 you'll just put your hand up when you want to be recognized, 12 I will note your name and try to take people in order. And I 13 prefer informality, so I'm going to call you by first name if 14 I can. So, what I would like to do now is have each of the 15 panel members introduce themselves by name, state your major 16 affiliation, your employer and what you do, and then it's 17 real important that you state for the public record any 18 financial interests that you have from Thoratec or a 19 competitor, and also if you've served on any other advisory 20 panel that's considered the topic of left ventricular assist 21 devices, this is the time to let everybody know about it. 22 And with the exception of the MCAC consumer and industry 23 reps, if you have been contacted by anybody with a financial 24 interest in this meeting, you should so state at this point 25 so we have that all on the public record. 0009 1 So Joanne, do you want to start? 2 Dr. Lynn: I'm Joanne Lynn. I am a physician. I 3 work with the Washington Home Center for Palliative Care 4 Studies and the Rand Corporation. I have no stock in 5 Thoratec or a competitor's company. I have no financial 6 support from Thoratec or a competitor. I don't serve on any 7 other panel that has considered this issue and I have not 8 been contacted by any party prior to the meeting to discuss 9 today's topic. 10 Dr. Gottlieb: I'm Steven Gottlieb, director of 11 heart failure and transplantation at the University of 12 Maryland. I do not have any stock or other formal financial 13 interest. I am a co-investigator of the Intrepid trial at 14 the University of Maryland. And I am not on any committees 15 and have had no contacts. 16 Dr. Sox: Anybody contacted you? 17 Dr. Gottlieb: No. 18 Dr. Pina: I'm Ileana Pina. I'm director of heart 19 failure transplant, Case Western Reserve University in 20 Cleveland and University Hospitals of Cleveland. I have no 21 stock or any financial interests in Thoratec or any 22 competitor's company, and I have no financial support from 23 Thoratec. I served on the FDA advisory panel for devices 24 which looked at and approved at the LVAD as destination 25 therapy. I have not been contacted by anyone. 0010 1 Dr. Agich: I am George Agich. I'm chairman of the 2 department of bioethics at the Cleveland Clinic Foundation. 3 I have no stock in Thoratec or a competitor company. I have 4 not received financial support from Thoratec or a competitor, 5 and I have not served on any other advisory panel and have 6 not been contacted by anyone prior to this meeting. 7 Dr. Swain: I'm Julie Swain, a cardiovascular 8 surgeon, and I serve as a consultant to the FDA and I was one 9 of the primary clinical reviewers when the REMATCH study was 10 brought to the FDA. I have no financial interests and I have 11 not been contacted by anyone with financial interests. 12 Dr. Bergthold: I'm Linda Bergthold. I'm a senior 13 consultant with Watson Wyatt Worldwide. We are consultants 14 to Fortune 1000 companies about their health benefits. And I 15 am also a researcher and participate in various research 16 projects at UC San Francisco, and I have done so in the past 17 at Stanford. I have no financial support from any of these 18 folks, I do not currently serve on any other committees, 19 although I have served on the MCAC in the past, and I have 20 not been contacted by any members of the public, which 21 actually is kind of a shame since I'm the consumer rep here, 22 but that's the truth.