00001 1 2 3 4 5 6 7 8 9 10 11 CENTERS FOR MEDICARE AND MEDICAID SERVICES 12 Medicare Evidence Development & Coverage 13 Advisory Committee 14 15 16 17 18 19 20 January 30, 2013 21 22 Centers for Medicare and Medicaid Services 23 7500 Security Boulevard 24 Baltimore, Maryland 25 00002 1 Panelists 2 Chairperson Rita Redberg, MD, MS 3 Vice-Chair 4 Art Sedrakyan, MD, PhD 5 Voting Members Jeffrey W. Cozzens, MD, FACS 6 Raymond E. Faught, Jr., MD A. Mark Fendrick, MD 7 Steven Gutman, MD Paula E. Hartman-Stein, PhD 8 Susan A. Levine, DVM, MS, PhD Theresa Miskimen, MD 9 Curtis Mock, MD, MBA Jerrold Rosenbaum, MD 10 Amy E. Sanders, MD, MS Robert K. Zeman, MD 11 CMS Liaison 12 Louis Jacques, MD 13 Industry Representative Brian Seal, RPh, MBA, PhD 14 Guest Panel Members 15 Peter Herscovitch, MD file:///F|/MEDCAC/PG013013-summation.txt[03/05/2013 7:18:14 AM] Constantine G. Lyketsos, MD, MHS 16 Invited Guest Speakers 17 Paul Aisen, MD Randall J. Bateman, MD 18 Mark Mintun, PhD Steven D. Pearson, MD, MSc, FRCP 19 William Thies, MD 20 Executive Secretary Maria Ellis 21 22 23 24 25 00003 1 TABLE OF CONTENTS 2 Page 3 Opening Remarks Maria Ellis/Louis Jacques, MD/ 4 Rita Redberg, MD 4 5 Introduction of Panel 7 6 CMS Presentation and Presentation of Voting Questions 7 Joseph Hutter, MD 10 Brijet Burton Coachman, MPP, MS, PA-C 13 8 Presentations by Invited Guest Speakers 9 Paul Aisen, MD 15 Randall Bateman, MD 32 10 Steven Pearson, MD, MSc 47 William Thies, MD 69 11 Mark Mintun, MD 82 12 Scheduled Public Comments Stephen Salloway, MD, MS 101 13 Howard Fillit, MD 106 Norman L. Foster, MD 111 14 Sam Gandy, MD, PhD 115 Carl Sadowsky, MD 118 15 Mykol Larvie, MD, PhD 122 Richard Wahl, MD 127 16 Richard Frank, MD, PhD 131 David Kuhlmann, MD 136 17 Michael D. Devous, Sr., MD 142 Teng J. Ong, MD 147 18 Open Public Comments 19 Rathan Subramaniam, MD 150 Lou Bordicco 151 20 Questions to Presenters 152 21 Panel Discussion, Final Remarks and Voting 22 Questions 248 file:///F|/MEDCAC/PG013013-summation.txt[03/05/2013 7:18:14 AM] 23 Closing Remarks and Adjournment 282 24 25 00004 1 PANEL PROCEEDINGS 2 (The meeting was called to order at 3 8:09 a.m., Wednesday, January 30, 2013.) 4 MS. ELLIS: Good morning, and welcome, 5 committee chairperson, vice chairperson, 6 members and guests. I am Maria Ellis, the 7 executive secretary for the Medicare Evidence 8 Development and Coverage Advisory Committee, 9 MedCAC. The committee is here today to discuss 10 beta amyloid positron emission tomography in 11 dementia and neurodegenerative disease. 12 The following announcement addresses 13 conflict of interest issues associated with 14 this meeting and is made part of the record. 15 The conflict of interest statutes 16 prohibit special government employees from 17 participating in matters that could affect 18 their or their employers' financial interests. 19 Each member will be asked to disclose any 20 financial conflicts of interest during their 21 introduction. We ask in the interest of 22 fairness that all persons making statements or 23 presentations disclose if you or any member of 24 your immediate family owns stock or has another 25 formal financial interest in any company, 00005 1 including Internet or e -commerce organizations, 2 that develops, manufactures, distributes and/or 3 markets consulting, evidence reviews or 4 analyses, or other services related to beta 5 amyloid positron emission tomography in 6 dementia. This includes direct financial 7 investments, consulting fees, and significant 8 institutional support. If you haven't already 9 received a disclosure statement, they are 10 available on the table outside of the room. 11 We ask that all presenters please 12 adhere to their time limits. We have numerous 13 presenters to hear from today and a very tight 14 agenda, and therefore cannot allow extra time. 15 There is a timer at the podium that you should 16 follow. The light will begin flashing when you 17 have two minutes remaining and then turn red 18 when your time is up. Please note that there 19 is a chair for the next speaker, and please 20 proceed to that chair when it is your turn. We 21 ask that all speakers addressing the panel 22 please speak directly into the mic and state 23 your name. 24 For the record, voting members present file:///F|/MEDCAC/PG013013-summation.txt[03/05/2013 7:18:14 AM] 25 for today's meeting are Dr. Art Sedrakyan, 00006 1 Dr. Jeffrey Cozzens, Dr. Raymond Faught, Jr., 2 Dr. A. Mark Fendrick, Dr. Steven Gutman, 3 Dr. Paula Hartman-Stein, Dr. Susan Levine, 4 Dr. Theresa Miskimen, Dr. Curtis Mock, 5 Dr. Jerrold Rosenbaum, Dr. Amy Sanders and 6 Dr. Robert Zeman. A quorum is present and no 7 one has been recused because of conflicts of 8 interest. 9 The entire panel, including nonvoting 10 members, will participate in the voting. The 11 voting results will be available on our website 12 following the meeting. I ask that all panel 13 members, please speak directly into the mic, 14 and you may have to move the mic since we have 15 to share. 16 This meeting is being webcast via CMS 17 in addition to the transcriptionist. By your 18 attendance you are giving consent to the use 19 and distribution of your name, likeliness and 20 voice during this meeting. You are also giving 21 consent to the use and distribution of any 22 personal identifiable information that you or 23 others may disclose about you during today's 24 meeting. Please do not disclose personal 25 health information. 00007 1 If you require a taxicab, there are 2 telephone numbers to local cab companies at the 3 desk outside of the auditorium. Please 4 remember to discard your trash in the trash 5 cans located outside of this room. 6 And lastly, CMS guests attending 7 today's MedCAC meeting are only permitted in 8 the following areas of CMS single site, the 9 main lobby, the auditorium, the lower level 10 lobby, and the cafeteria. Any person found in 11 any area other than those mentioned will be 12 asked to leave the conference and will not be 13 allowed back on CMS property again. 14 And now, I would like to turn the 15 meeting over to Dr. Louis Jacques. 16 DR. JACQUES: Good morning. I'm Louis 17 Jacques, I'm the director of the Coverage and 18 Analysis Group and also the designated federal 19 official for this meeting. I have little to 20 say at this point other than to welcome you and 21 thank you for coming. We look forward to a 22 very interesting meeting. 23 DR. REDBERG: I am Rita Redberg, a 24 cardiologist at UCSF Medical Center and chair 25 for the MedCAC panel. I'm very pleased to be 00008 file:///F|/MEDCAC/PG013013-summation.txt[03/05/2013 7:18:14 AM] 1 here to consider all these questions along with 2 the help of the distinguished panel. 3 DR. SEDRAKYAN: Art Sedrakyan, from 4 Weill Cornell Medical College. I'm an 5 associate professor of cardiac surgery and 6 public health and direct the patient-centered 7 comparative effectiveness program, and have no 8 conflicts of interest to disclose. 9 DR. REDBERG: And I have no conflicts. 10 DR. COZZENS: I'm Jeff Cozzens, I'm 11 chief of neurosurgery at Southern Illinois 12 University Medical School. I have no 13 conflicts. 14 DR. FAUGHT: I'm Ed Faught, I'm a 15 professor of neurology at Emory University, and 16 I have no conflicts. 17 DR. FENDRICK: Mark Fendrick, 18 University of Michigan. No conflicts. 19 DR. GUTMAN: I'm Steve Gutman, I work 20 for a regulatory consulting firm, Myraqa, and I 21 have no conflicts. 22 DR. HARTMAN-STEIN: Paula 23 Hartman-Stein, in northeast Ohio, and I'm a 24 clinical geropsychologist. I have no 25 conflicts. 00009 1 DR. LEVINE: I'm Susan Levine, senior 2 vice president of Hayes, Incorporated, which is 3 a health technology assessment company, and I 4 have no conflicts of interest. 5 DR. MISKIMEN: Theresa Miskimen, 6 professor of psychiatry, University Behavioral 7 Health Care, and I have no conflicts. 8 DR. MOCK: Curtis Mock, family 9 medicine geriatrics, medical director, United 10 Healthcare, I have no conflicts. 11 DR. ROSENBAUM: I'm Jerry Rosenbaum, 12 chief of psychiatry at Mass General Hospital 13 and professor of psychiatry at Harvard Medical 14 School. I have no conflicts. 15 DR. SANDERS: I'm Amy Sanders, an 16 assistant professor of neurology at the Albert 17 Einstein College of Medicine, and I have no 18 conflicts. 19 DR. ZEMAN: Hi, I'm Bob Zeman, I'm 20 chair and professor of radiology at George 21 Washington University, and I have no conflicts. 22 DR. SEAL: Brian Seal, director of 23 health outcomes research for Bayer HealthCare. 24 No conflicts. 25 DR. HERSCOVITCH: I'm Peter 00010 1 Herscovitch, director of the positron emission 2 tomography department at the NIH Clinical file:///F|/MEDCAC/PG013013-summation.txt[03/05/2013 7:18:14 AM] 3 Center. I am not representing the NIH here. I 4 have no financial conflicts. 5 DR. LYKETSOS: Good morning, I am 6 Constantine Lyketsos, I'm a professor of 7 psychiatry at Johns Hopkins, chair of 8 psychiatry at Hopkins Bayview, and I also 9 direct the Hopkins Memory and Alzheimer's 10 Treatment Center.