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Transcript for June 17, 2009 MEDCAC Meeting file:///F|/cms0506.txt 1 CENTERS FOR MEDICARE AND MEDICAID SERVICES MEDICARE EVIDENCE DEVELOPMENT AND COVERAGE ADVISORY COMMITTEE - - - - - - - - - - - - - - - - - - -x : IN RE: SCREENING GENETIC TESTS : : - - - - - - - - - - - - -- - - - - - x Woodlawn, Maryland Wednesday, May 6, 2009 The above entitled matter came to be heard before the Medicare Evidence Development and Coverage Committee in the CMS Auditorium, 7500 Security Boulevard, Woodlawn, Maryland. file:///F|/cms0506.txt (1 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt file:///F|/cms0506.txt (2 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt __________________________________________________________ COMPOFELICE REPORTING SERVICES, INC. 6671 Farbell Row Columbia, Maryland 21045 (301) 596-2019 (410) 381-2755 (800) 464-3019 FAX (410) 290-7249 file:///F|/cms0506.txt (3 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt file:///F|/cms0506.txt (4 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 2 PANELISTS: ACTING CHAIR: SATY SATYA-MURTI, MD, FAAN PANEL MEMBERS: MARION DANIS, MD NANCY DAVENPORT ENNIS, BA MARK D. GRANT, MD, MPH DANIEL F. HAYES, MD I. CRAIG HENDERSON, MD JAMES E. PUKLIN, MD RANDEL RICHNER, BSN, MPH MAREN T. SCHEUNER, MD, MPH TERESA M. SCHROEDER, BS, MBA JOHN SPERTUS, MD, MPH, FACC JONATHAN P. WEINER, PhD INDUSTRY REPRESENTATIVE: ELEANOR M. PERFETTO, PhD, MS GUEST SPEAKER: W. GREGORY FEERO, MD, PhD GUEST PANELISTS: STEVE GUTMAN, MD NEIL HOLTZMAN, MD ELIZABETH MANSFIELD, PhD CMS LIAISON: MARCEL SALIVE, MD EXECUTIVE SECRETARY: MARIA A. ELLIS file:///F|/cms0506.txt (5 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt file:///F|/cms0506.txt (6 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 3 C O N T E N T S PAGE OPENING REMARKS: MARIA ELLIS 4 DR. STRAUBE 4 DR. SALIVE 13 CMS PRESENTATION AND VOTING QUESTIONS: SANDRA JONES, RN 20 JEFFREY ROCHE, MD, MPH 24 GUEST SPEAKER PRESENTATIONS: WILLIAM G. FEERO, MD, PhD 31 STEVEN TEUTSCH, MD, MPH 63 SCHEDULED PUBLIC COMMENTS: JAN A. NOWAK, MD, PhD, FCAP 105 RICHARD WENSTRUP, MD 112 BRUCE QUINN, MD, MBA 119 CHARIS ENG, MD, PhD, FACP 127 DIANE J. ALLINGHAM-HAWKINS, PhD, FCCMG, FACMG 134 ROGER D. KLEIN, MD, JD 140 BARRY THOMPSON, MD 145 file:///F|/cms0506.txt (7 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt file:///F|/cms0506.txt (8 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 4 1 P R O C E E D I N G S 2 MS. ELLIS: Good morning, everybody. We're 3 about to start the meeting for today. First we will 4 have words from Dr. Barry Straube. 5 DR. STRAUBE: Good morning, I'm Barry 6 Straube. I'm the CMS chief medical officer and 7 director of the office of clinical standards and 8 quality, part of the Coverage and Analysis Group 9 who's putting on this MEDCAC meeting today as part of 10 the office of clinical standards and quality 11 (unintelligible) underlying portfolio of oversight 12 from the management side. 13 I want to welcome this MEDCAC panel. It's 14 an illustrious group of folks, and I appreciate all of 15 you agreeing to be on this panel. 16 I would like to take a minute or two to set 17 the context. I'd also like to welcome everybody in 18 the audience. You represent diverse organizations. 19 We welcome your input and comments during the open file:///F|/cms0506.txt (9 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 20 mike periods. 21 I also, before we started, for those of you file:///F|/cms0506.txt (10 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 5 1 who've been on the MEDCAC and sat on some of these 2 panels before, you know that Dr. Stephen Phurrough had 3 been the director of the Coverage and Analysis Group. When 4 Steve was here, Steve kept reminding me for a total of seven- 5 plus years, which he said was the longest he was in 6 any one place at any one time. But as you probably 7 know, Steve decided to simplify his life a little bit, 8 and he has taken a position as medical officer 9 over at the Agency for Healthcare Research and Quality 10 and will be working on some comparative 11 effectiveness projects. 12 I wanted to mention Steve's name before we 13 started, because he has been so integral to the 14 development of coverage policies and basic principles 15 on some rather innovative new directions we've taken 16 over the last several years. So I suspect we'll be 17 seeing Steve here from time to time, but I did want to 18 acknowledge his leadership. 19 We are -- we do have a posting right now for file:///F|/cms0506.txt (11 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 20 that position. It's a very, very important position 21 in the context of what's going on in health care right file:///F|/cms0506.txt (12 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 6 1 now, so insofar as the panel, the audience, or anyone 2 who know people who might be suited for that position, 3 you're welcome (unintelligible) to go to our website 4 (unintelligible.) 5 I'd also like to acknowledge that we have a 6 new chair and co-chair of MEDCAC, who, I guess, will 7 officially be in July or June assuming their roles. 8 One is Dr. (unintelligible) who will be chair of 9 MEDCAC. We have with us this morning, who is the 10 acting chair for the moment and will be the co-chair 11 is Dr. Satyi Satya-Murti, who will be chairing today's 12 MEDCAC Meeting. 13 (Whereupon, there were technical 14 difficulties with the audio.) 15 About a year and a half ago, I sat down with 16 a coverage group, and we decided that we really needed 17 to try to get ahead of the game or get caught up, 18 frankly, with where genetics were going. So we've 19 been doing some internal work. We've been working file:///F|/cms0506.txt (13 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 20 very closely with the secretary's advisory committee 21 on genetic health in society and decided mid-last file:///F|/cms0506.txt (14 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 7 1 year that we needed to do some MEDCAC meetings on the 2 issue of genetics and genetic testing. So we had, as 3 you know, a panel that met in February looking at the 4 issue of Warfarin testing -- Warfarin genetic testing 5 to determine whether or not those tests were helpful 6 in the management of patients who were being treated 7 with Warfarin therapy. 8 As you know, that panel came out with a 9 variety of recommendations. But the final, most 10 important piece was that the evidence was not quite 11 there that the panel would recommend that we should 12 cover that particular test without restriction. But 13 at the same time, there was sufficient evidence that 14 it might have some benefit. So we invoked the 15 coverage with evidence development option that we have 16 in national coverage decisions. 17 And just Monday of this week, we announced 18 the proposed decision for genetic testing with 19 Warfarin therapy, which we're proposing we will cover, file:///F|/cms0506.txt (15 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 20 but only under the conditions of coverage with 21 evidence development. So that's the first toe-in-the- file:///F|/cms0506.txt (16 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 8 1 water that we at CMS have taken on this. There's been 2 lots and lots and lots of interest, and we're anxious 3 to see what the comment period will bring for the 4 Warfarin testing issue. 5 But it's time to keep moving forward, and 6 that's the context of today. And I think it's very 7 relevant, in that President Obama has a large number 8 of priorities that he wants to embark on. But in the 9 health care world in particular, we do know that his 10 priorities include increasing accessibility to medical 11 care and to tests when relevant, increasing 12 affordability of the general health care system, and 13 then finally invoking both personalized medicine, but 14 population health at the same time. 15 And although one might think that the two 16 are in conflict, I think they are complementary, that 17 is, we need to assure that our general population is 18 taken care of from a population-base perspective, that 19 as many people as possible need to have access to file:///F|/cms0506.txt (17 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 20 services that are important and necessary for them. 21 But at the same time, we're all individuals, and we file:///F|/cms0506.txt (18 of 675) [7/2/2009 9:30:22 AM] file:///F|/cms0506.txt 9 1 have to take into account that special uniqueness that 2 each and every one of us as patients may have.
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