Concepts and Strategies To

Neuroimaging in the Diagnosis of Alzheimer’s Disease and Dementia April 5, 2004 Bethesda, Maryland The Neuroscience and Neuropsychology of Aging Program, National Institute on Aging (NIA), DHHS and The Centers for Medicare and Medicaid Services (CMS), DHHS Welcome and Introduction Neil Buckholtz, Ph.D., National Institute on Aging I’ll be your timekeeper. Susan Molchan, my colleague, will be introducing me at the end. But, I want to right now introduce Susan Molchan, also from the National Institute on Aging, to make some comments, and she’ll be introducing Dr. Steve Phurrough from CMS. Susan Molchan, M.D., National Institute on Aging Thanks for coming, everybody, this morning, especially this morning. We’re all supposed to be springing ahead. I’m just going to give you a little background on how this meeting came about and why it came about. It arose, from what I understand, 1 essentially from a request from CMS, or from Tommy Thompson to CMS, to have an expert panel meet to provide them with information on the question of the value of PET in the early diagnosis of Alzheimer’s disease. CMS then initiated a meeting with NIA last August to discuss the formation of such an expert group. And, after meeting with us in August, we all decided to hold a meeting in the Spring, this meeting, to address specific questions that CMS has on the diagnosis of dementia and Alzheimer’s disease, and what PET adds to that diagnosis. We’ll also be getting information on the role of other imaging modalities, on MRI and SPECT, and what role they play in early diagnosis. Lots of research, of course, has been done in MCI and Alzheimer’s disease, looking at various regions, especially in MRI. Everybody would agree, I think, that we’ve assembled a stellar group here today, with top scientists in Alzheimer’s disease imaging and public health research, as well as leaders from the two advocacy organizations, the Alzheimer’s Association and the American Association of Geriatric Psychiatry. So, I think our CMS colleagues and everybody attending here today will leave with an up-to-date overview on the state of Alzheimer’s diagnosis and on the issues to consider in evaluating the use of imaging technologies in the diagnosis of Alzheimer’s disease. So, I’m going to introduce my colleague from CMS, Steve Phurrough, and he’ll give an overview of the perspective from CMS. Steve Phurrough, MD, MPH, The Centers for Medicare and Medicaid Services 2 Thank you, Susan. Again, I’m Steve Phurrough. I’m the Director of the Coverage and Analysis Group at CMS. It’s our job in this particular group at CMS to make decisions about the kinds of things that we’re going to pay for, and we have been doing this in a very formal, evidence-based fashion for about a decade or so. And, about half of that period of time, for close to five years, we have been addressing some issues around Alzheimer’s disease. We first addressed it formally in what we call our National Coverage Decision Process. That’s our evidence-based process for looking at the particular technologies or services that we are being asked to provide reimbursement for. We produced one of our decisions in December of 2000 where, after consultation with a number of folks, we first chose to not provide reimbursement for PET scans in Alzheimer’s disease. And, the recommendation at that particular time was that we undergo some reviews with our advisory panel; our organization has a Coverage Advisory Panel, who then provided us some additional suggestions and guidelines, and we produced, with a number of people’s input about this time last year, a fairly extensive discussion of whether we should broadly cover the use of PET scans in the diagnosis of Alzheimer’s disease. At that particular time, we continued what we called our non-coverage. However, at that particular time, the Secretary thought it important that the information gathering continue, and he directed us to both look at an expert panel to address the issue, as well as a demonstration project. And, we immediately came to NIA to discuss with them the potential of assisting us in the expert panel. 3 We want to express our thanks and appreciation to NIA for putting this together. We think this is a superb agenda, a superb group of people today to help us answer the questions of the appropriate imaging techniques for Alzheimer’s disease, what’s the state of the art, and perhaps more importantly, what else do we need to know as we look at issues around the diagnosis of Alzheimer’s disease. Even since that time, since we first began talking with NIA late last summer, we do have another request now for more narrow coverage of PET scanning in Alzheimer’s disease. And you have, in your little blue folder, some questions that we are interested in answering, some fairly specific questions around what’s the appropriate use of imaging in the diagnosis of Alzheimer’s. And, so, we hope to hear some of that discussion today so that as we, once again, look at the issue, we are able to use your knowledge in our attempts to most appropriately provide for our beneficiary population. We obviously have, in our Medicare population, large numbers and ever-growing numbers of patients with Alzheimer’s disease. We certainly are interested in the appropriate treatments and appropriate diagnostic technologies and look forward to the discussions today to help us achieve that benefit. Thank you all again for coming and, gain, special thanks to NIA for helping us with that. Neil Buckholtz, Ph.D., National Institute on Aging Thank you, Steve and Susan. I have just a few announcements to make before we actually get started. Actually, we’re running a little early, which is good, so that’ll give 4 us some more time for the discussion section. Each of the presentations this morning will be 20 minutes. We’ve decided to hold the questions until the discussion sections. I think that’s probably going to be a little more efficient. So, if you have questions, please write them down and, then, we’ll have a very open discussion section for each of the sections that we have. Because some of the presenters had to come in at different times and leave at different times, we’ve set it up so that, for example, John Trojanowski, who really should be in the first section, is going to be a little later. And, so, the way we’ve broken it up is that there will be actually two discussion sections after the break, one on the first set of presentations and then another one on the second set of PET presentations. So, it’s a little funny when you look at the actual agenda, but that’s why, because we have some speakers who are having to come in a little later and leave a little earlier. I’m going to be the timekeeper for the presentations. We’ve found that this is a very high-tech solution to keeping people on time. I have various cards here – (laughing) – which I’ll put up and make sure that people can see. And, this is the one, “We have no more time.” So, I will come up and kind of gently nudge you off and have the next speaker come up. So, I’ll be sitting over there, so for the speakers, please keep an eye on the time. We will have a working lunch, because we’re on a very tight schedule, and we need to get people out absolutely by 5:00. And, as I say, some people have to leave a little earlier. The Federal employees have to pay for their lunches and, so, if you will 5 please check with Vicki Hill out here, if the Federal people want to have lunch. Everybody else is covered, so you don’t have to worry about it. So, with that, as I say, we’re running a little early, which is okay. I would like to introduce the first speaker, Ron Peterson from the Mayo Clinic, who’s going to be talking about accuracy of clinical diagnosis of Alzheimer’s disease and differential diagnosis. Yes? (Inaudible/off microphone) Oh, right. The speakers need to mention any conflicts of interest that they have before they begin speaking. Thank you. Ron Peterson, M.D., Ph.D., Mayo Clinic Thanks, Neil. While we’re getting loaded up here, I’ll just say that I do consult for Elan Pharmaceuticals and, actually, probably independent of this activity, but might be relevant, I’m forging a new consulting relationship with GE, actually, as we speak, get some research funding from Pfizer and ETSI through the Alzheimer’s Disease Cooperative Study, and that’s it. I’m not on any speaker’s bureaus. My task this morning is to sort of set the groundwork or the foundation for interpreting some of the subsequent information. In other words, if we’re talking about making the diagnosis of Alzheimer’s disease, at what point do we start? That is, where do you start introducing various technological advances and what’s the baseline? So, the baseline, I think most people feel, is with a clinical diagnosis. And the point being, then, who makes that diagnosis and how can we augment that? And, I think most people feel, in the fields, that this should be made by a clinician.

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