 for senior Americans isn't just a good idea. It's the law. And I note that of the many people that are depicted here, most of them have passed beyond Medicare coverage. So there is a future after Medicare coverage, but I leave that to the reader as an exercise. That's no fair mark. Now we know something. But the question we ask when we think about expanding Medicare is a simple one. Is this reasonable and necessary for the diagnosis of treatment of an illness or injury for Medicare beneficiaries for our covered population? And over the years, through regulation, we've essentially evolved a process, which we call the National Coverage Determination Process, or NCD process, which guides us through a very stepwise procedure to figure out if something is reasonable and necessary. In the instance of genetic variant testing, just like for so many other diagnostic technologies, we primarily look at evidence that the item or service, in this case, testing for genetic variants, improves clinically meaningful and perhaps more recently patient-centered health outcomes for the Medicare population. And in this way, we're actually pretty much on track with some of the other national organizations which have talked about frameworks for evaluating evidence. For example, this one through the ACC, as Dr. Aronson mentioned. We get advice from non-governmental experts about what kind of evidence we should prefer. And essentially, they tell us that we should look for evidence that has higher value as evidence. It wasn't, for example, more value is associated to our minds in prospective trials, to trials which use controls, which use objective comparators and endpoints, which use techniques to reduce bias, such as randomization or masking, and which are well-powered and appropriately statistically analyzed. That's the kind of classic approach that we favor or prefer. But that doesn't mean that that's what kind of data we're going to get or that people will be motivated to provide. In recognizing this, CMS has tried to use a relatively new formulation of the coverage option, coverage with evidence development, in which data collection is a specific condition of coverage. Dr. Corey and Dr. Berg, writing in Health Affairs in 2008, noted that CED has been used by CMS under certain scenarios and, in fact, has received support from some of the other agencies for development, for example, of cancer biomarkers, related diagnostic technology. One of the instances where CMS actually put its money where its mouth was about this was in the instance of Warfarin test, pharmacogenomic testing for Warfarin response. Now, that was only two years ago, and that's the first of the decisions on a national level that CMS has specifically looked at, particular genetic variants, and whether we should cover them. The status, by the way, of this is that two different groups representing multiple clinical centers have agreed to conduct such studies for us. And again, we, excuse me, again, we went ahead and worked with the submitters or the proposers of these studies to make sure that they were going to be focusing them on questions that were of value to us, especially value in ultimately providing coverage on a non-conditional basis for such testing. Whether or not we use CED, and perhaps this could be said to be true in different times for many different new diagnostic technologies, we feel with Dr. Drazen that, in fact, there is a key step that lies between us and at least the regulatory coverage piece of genetic variant testing, and that is knowing on the basis of reliable trial information whether this information really leads to better clinical outcomes. Now, I don't know how that intersects with the concept of actionability, but that's where CMS is now. I should mention one final thing. CED, by the way, is also a CMS coverage policy. CED policy changes may be happening at CMS, and CMS has announced the availability of a public comment period between now and January 6th, in which the members of the public of any type may send CMS their thoughts about how CED could be improved. Now, there are instructions for how to do this on our website, which is shown on the slide. I would like to, by the way, thank the organizers of the conference for allowing such a relatively new and small program like ours to participate. I also would like to thank my colleague, Dr. Sarah Harding, who's sitting in the back, who's much more involved in the reimbursement and of Medicare decision-making than I am. Thank you. Questions? I wonder if you could describe the mechanism by which a coverage with evidence development program comes into being. So, for example, how was this warfarin' trial? Who brought it forward? Who made the decision? How does this happen? Thank you. I think the question is, how do CED decisions evolve? I think there are perhaps two answers to that. The first one is that to distinguish them from other types of coverage, CED decisions are generally four things which are promising, which are basically safe, and in which there is a difficulty in conducting clinical trials. For example, the type of testing that's required to establish different patient groups or as the intervention itself are not easily available, not easily accessible, and so on. So if those conditions are met, CED may be adopted by CMS as a way of providing coverage because we can't make a coverage decision without additional evidence, and CED allows us to financially support studies which will give us better evidence. Does this bubble up from within CMS or do you have a mechanism for people to apply? How does this, what's the mechanism? Of the coverage decisions that we've done in the past, most of them have arisen from external requests, but not all of them. And does that go through the MedCAC? Is that where the level of review takes place? Or who actually does the review when a request like that comes in? Well, the process basically does not necessarily go through the MedCAC. The MedCAC is convened by CMS when there is a question about the kind of evidence that is available that CMS doesn't have the internal expertise to assess or when the question is of such significance that it is felt that a broader degree of input is needed before we can focus on the appropriate evidence on which to make our decisions. So is it true that with the warfarin one, and this is my imperfect recollection, that actually the process that that came about was that the MedCAC considered the question of whether or not that should be a covered benefit and that in the course of the discussion they realized the more evidence was needed and in that case then they made the recommendation that this could be something considered for coverage with evidence development. I do apologize, I can't confirm, I just don't remember. I have a quick question. At our last IOM round table meeting we had a representative from CMS come in and we were talking about genetic testing and one of the comments that he made was that he didn't see that genetic testing was relevant in the Medicare population and I think there's some other people that were at that meeting that it was, he almost kind of wondered why we kept and inviting CMS back. Do you guys am I recollecting that correctly? Yeah. Can you comment on that? Let me comment in two ways. First, although it is primarily a program for those who are 65 and older, it is certainly a program for those who are disabled as well as for those with end stage renal disease. In fact if you look at the statistics about the AIDS distribution in the Medicare population, 80 to 85% and again the figure is in there somewhere are older folks but 10 to 15% are younger folks. So perhaps that would be one concern. The second is that of course people who are older may be more frail medically and let me use the instance of pharmacogenomics may be more susceptible to the effects say of polypharmacy or other types of age related changes which impair their ability either to metabolize or to eliminate drug metabolites and therefore it may in fact be more appropriate to consider genetic testing to prevent harm in our beneficiaries and we do consider prevention of harm to be an important positive benefit to our beneficiaries from such testing. If indeed there's evidence to show that it does. Thank you. Thank you. Yeah, yeah. This is slightly tangential but how does a decision, so from the Medicare population my understanding and certainly with our hospital works is that a Medicare patient has to be seen by an MD medical geneticist cannot be seen and by a licensed genetic counselor for the service to be compensated. How do those decisions get made when they don't seem cost effective for Medicare? Medic, oh sorry, Mark, did you wanna come in? Yeah, I spent years on this. It seems like years, actually it's real years. Genetic counselors are not, we're not represented as billable entities in the original enabling legislation and billable entity decisions have to, cannot be made administratively. So the administration of Medicare CMS cannot add a billable entity. This literally will require an act of Congress for genetic counselors to be added as a billable entity which would allow their services to be reimbursed. So the payers, the Medicare carriers are hamstrung in the sense that they cannot, even though they recognize most of them that in fact genetic counselors would be a much more cost efficient way to manage their benefit, they cannot pay those individuals because they statutorily cannot compensate. So I used to sit in a state Medicare Care Advisory Committee and we always had a mantra that we would recite when these things came up which is yes, it's stupid but it's the government that's consistent. And we would just sort of repeat that over and over again until our blood pressure lowered. So that's the specific entity. The thing that I think is interesting and I wanted you to comment on this because it directly relates is that in the healthcare reform legislation, one of the things that Medicare was now able to do or required to do was to actually pay for preventive medicine benefits which had been statutorily prohibited as long as it's on the United States preventive services task force list. And of course in BRCA testing, the USPSTF has a level B evidence that suggests that BRCA testing can be done if certain criteria are met and that genetic counselors are specifically represented within that. So now you are in quite a dilemma in the sense that you don't have genetic counselors as billable entity yet it is represented in this USPSTF statement which you're required to cover because it's a class B recommendation. How are you dealing with that? Well, in fact, that's a very good question. Thank you, by the way, for answering the initial question. So, Will, one of the concerns that I guess CMS has had for a long time is how do we deal with preventive services in the Medicare law? It's pretty clear that Congress is the only entity that has the authority to extend Medicare coverage to preventive services benefits as we call them. However, as was pointed out in the new legislation, we now have the authority to at least consider those recommendations of the USPSTF which received a grade A or B evidentiary recommendation. And we were also allowed to look for the first time and I'm not sure exactly of the legal ease but essentially at the expenditures that must be made to enable these to happen. Recently, CMS has issued a series of five decisions, supporting preventive services benefits, for example, for counseling, for different types of conditions, for the detection of certain types of diseases. And in fact, there is a lot of interest in other USPSTF recommendations that may possibly come to our attention. Could I ask if my colleague, Sarah Harding, might have any further comments about that issue in terms of any of its aspects? I'm Sarah Harding. I'm not sure that I do. I think to sort of the end of Mark's question, how is CMS dealing with it? Sort of like a dentist might examine a crocodile, just very carefully and perhaps a little too slowly in my own personal opinion that's off of CMS. But I think that the issues that CMS tends to face are balancing between wanting to keep up with the pace of the technology and what's being developed and needing to reconcile with what the law tells us we have to do. And both are extremely complicated areas that aren't always understood very well from one side to another, so it's not easy. If I may just break in, thank you, Sarah, to mention that in addition to the coverage issues which I've tried to talk about briefly here, there are an awful lot of other issues that are required by Medicare's enabling statutes, as Sarah mentioned, to allow either an institution to participate in Medicare, to determine whether a service is covered under what's considered a benefit category within the Medicare program, which is set up as a series of defined benefits. Again, there's more to it than I've had at time or actually the knowledge to discuss properly. I do hope that anyone who's interested would go to our website and please read the entire website. We'd be so delighted to think that someone did. I have the two Howard's that want to talk about. As moderator, I have prerogative and I just feel compelled to add on to Mark's comment about genetic counselors and coverage and the National Society of Genetic Counselors has drafted a bill and looking for sponsors to introduce it to add language to the Social Security Act to have genetic counselors as independent providers. And some states where licensure has been passed and I think there's about 13 or 15 states that that's happened have been successful in negotiating with third-party payers within that state for coverage as well. So there is some movement, but as you know, trying to get a bill passed is extremely difficult. So, all right, Howard. So I'm, I think, going to state the obvious, but Ned stated clearly yesterday that EGAP and USPSTF are not secret government death panels. They are independent organizations. A true statement. The problem is that CMS often refers to such bodies to establish policies. And further, unfortunately, CMS is often looked to as a leader, so other payers and decision-makers will. Not always, but sometimes follow CMS. So regrettably sometimes and happily other times, EGAP, USPSTF and similar actually do wind up setting government policy and therefore care needs to be taken. Howard. I think some of the frustration you hear at these sorts of meetings, and I know you have to go to all these and I feel sorry for you, but the, unlike the FDA or some of the other regulatory bodies or payers, there isn't a clear point of engagement with CMS. And if we're lucky enough to spot you where Louie Jacques in the bar, then we can get some work done. But otherwise, it's really one of the, it's like, you know, Noah's Ark. You can only be enter from the top and have to be let into it. You know, there is no door. And so there, one thing you could do is have, in some way, a way for the genetics community, including the pharmacogenetics community, to be able to engage with you. So at least we can vent if not actually help you make progress. Well, I thank you if I could just make the comment that in the United Kingdom, the National Health Service has the great advantage that they have the interest and the attention, apparently, of the House of Lords. Now, we don't have a House of Lords in the United States that I'm aware of. So we are unfortunately bereft of that opportunity. I am sorry. Would anyone of our colleagues like to talk about the positive impact of the House of Lords on public policy, let's say, in a more general sense? Yes. Sorry. Oh, yeah, none. So I was deciding whether to say anything, but she challenged me. So one of the things that from a policy standpoint, people need to recognize is that coverage decisions aren't based on evidence only. And I think the sooner we can actually accept that and figure out how to allow impact by all the other stuff, politics, special interests, and advocacy, we're in trouble. And so my worry about the task force, and it's no longer my circus or my monkey, so I don't have to worry too much, but that this automatic tie to coverage will start to bring influences into the discussion that have nothing to do with evidence. And at least in my pure vision, the way I would do it, were I a Lord, would be to have evidence be the starting point and then have something sit in between, say the task force or the evidence-based recommendation and the coverage decision, a place where you could bring in the politics, the advocacy and the special interests to kind of fight it out and make decisions like happen in every state legislature every year that are based partially on evidence, or at least hopefully partially on evidence, partially on ideology and politics, partially on the economics. So the more that we can recognize that the evidence is just a building block and that rarely do we make really important decisions based on evidence alone, I'm sorry, I just, I've recognized that, we have to have some intervening body and the mistake, sorry, in my opinion, of the way they put the ACA together was this direct link, which I would never have done. So the challenge was not so much to you. No, I know. As much as it was to CMS. Right. And that is that the task forces that evaluate the evidence and make policies, as has been so eloquently stated, can't possibly cover the entire universe of important questions to answer. Yeah, that's true. So my real concern isn't that a task force will make a wrong recommendation, but rather that silence from a task force can be tacitly taken by CMS as there isn't enough evidence here to act. And I think that's a concern that lack of any statement from a governing body or lack of any statement from an evidence evaluation task force doesn't necessarily mean that it isn't worth doing. Actually, I think Sarah, you were next, right? And then Mark. Yeah, I just wanted to point out and just put on everybody's radar if it's not sort of the living schedule for CMS in terms of, I don't wanna say evaluating, but making decisions about tests, specifically those that end up on the clinical lab fee schedule. There's an ongoing rhythm to the year that every July there is a public meeting where those decisions are openly discussed and everybody is invited to CMS. And that really is the point at which we are able to hear most openly from the public as to why certain tests should be covered, what they may want to charge or what they ought to be reimbursed for. In and of itself, it's a bit of a limited engagement opportunity simply because now we see so many more genetic tests coming down the pipeline than a typical year has seen for clinically related tests. But that is kind of the rhythm and that's the opportunity that CMS at least keeps open. So I would encourage you if you do want to speak out specifically about certain tests that that's definitely an opportunity that is always going to happen every July. And if I could piggyback very quickly on to that. I didn't answer one of the questions specifically and I should have and I'm sorry. There is a mechanism for any individual to submit a national coverage determination request to CMS directly. That information is available through our website. Now we tend to get such requests from professional organizations, professional societies and so on. But anyone can do that. I should mention by the way that that opportunity is only for today and every other day from now on. Thank you. Mark. Yeah, so this, Jeff, this is also directed to you. One other opportunity, just a comment and then I have a question. Another opportunity, although there are now some barriers to this are each state has a career advisor committee and carriers for states have the opportunity at least to a limited degree to make local coverage decisions as long as you're not in conflict with the statute. And so there have been some successful opportunities to create local coverage decisions that in some cases have gone up and become national decisions. Although there used to be a mechanism by which at the annual carrier meeting local coverage decisions could sort of be debated at that level and then potentially moved up. And to my knowledge that has sort of been, that methodology has been eliminated to kind of do that. But that's another way to advocate within the CMS system. What I wanted to talk about was to move away from the policy issues to something else that CMS is heavily involved in that we've referenced several times in the meeting, which is CLIA. And the specific response that I'd like to hear from you, Jeff, is that as we talk about a resource such as this, could you comment on the usefulness or what parts of this might be useful for CLIA as it supervises clinical laboratory services? Thank you, Mark. That's actually much more of a broad question than I can answer for at least two reasons. One is that my own familiarity with CLIA is limited. My work is in the coverage side of the house. As many of you may know, CLIA is an organization enabled by legislation some years ago requiring at least registration of any laboratory in the United States performing tests on human specimen material, which would be used for their diagnosis and care. If I could ask my colleague if she has anything perhaps to add to that. And again, I apologize. I didn't perhaps emphasize this. There is another part of our website which deals much more explicitly with CLIA in all of its thousands of permutations and variations. And I think that might be the best way to answer your question. I'm sorry, I can't give a better one. So we'll let Sarah answer this and then we'll let you sit down, Jeff. Yeah. Grazie. I also am not directly involved with CLIA, so I can't speak for them. But I think generally the kind of information, the kind of things that a group like this could offer to CMS, to CLIA would, and it goes back to a point that was made earlier this morning, is just simply being offering an honest broker and also timely source of information. I think for obvious reasons, CMS does hear from a lot of groups and from a lot of people who are interested in seeing what happens with genetic tests and with pharmacogenomic tests and whatnot. And it's often difficult to sift through what might be considered hype as opposed to the actual availability or the actual reflection of where the technology is. And so I think that it sort of goes both ways and I agree that the mechanism isn't always apparent, but we need to hear from you and groups like this just as much as I think you want to talk to us. And so even hearing back and forth about how that can best happen would be great and would be a step in the right direction. So, and that's one reason that even though we may stand up a lot, Jeff and I keep coming to meetings like this. So that's, it's because it's important. So I would just encourage you to not give up on your frustrations and let us know what more we can do. Thank you. So if I can just extract.