 I was the last, Genomic Medicine 4, I gave an overview of the pay-as meeting at the end of October. You'll be relieved to know, I'm not going to give the same overview again. But I thought I was asked to just come up here and give a brief overview of one or two of the things that we've been working on since. Felly ddim yn ddechrau'r meddwl i'r ddaeth yma yn gwneud bod fuddio'r meddwl i buildings. Mae'r idea nodi wedi eisiau eu gofaloedd y cabrabyn Rhianburce ac eich gwahanol o'r lluniau gweld ym newydd yn y tro cyfyrdd iechyd, ac mae yna'r ffordd o'r ysgrifennu. Lywodraeth, whereotau, gallai atgarbu'r ysgrifennu yw eu ffwrdd i o'r cyfwyffordd cyfïdd mewn gyfodog. We also learned about the arrangement between United Health and Genomic Health regarding Oncotype DX, reimbursant, and so on. There's a summary of the entire proceedings that's on the web and available. These were the main action items that came out of the meeting. The first one, the white paper, was just summarising some of the things that we learned, some of the emerging themes from the workshop and just getting out there, some of the there are these creative solutions that people can consider. I'm not going to talk much about that. I'm going to talk a little bit about the data sharing, legal and policy issues. I'm going to mention the research on physician ordering of genetic tests. Mark is going to say a word or two about that after I'm done. The last time I was saying that they hadn't yet been taken up, these still haven't been taken up and it looks like unless we do something about these ourselves, they'll come up with this different solution. Those people who volunteer to do those have not been able to lead those efforts. The first one was the observation that there are all these tests that are out there with a clear lack of demonstrated clinical utility. Are there criteria we could create to prioritise some of those if we're going to fund some research? The second one was conceptually, is there some kind of way we could set up an infrastructure model that could perform some clinical utility research to develop some of the evidence? What I was going to do is return to these and some of the things you want to think about at the end. Going back to the data sharing, legal and policy issues, the discussion that we had at the meeting around this is commonly discussed as a lot of information that's already out there if only we could mine it. Some of these creative solutions for coverage of evidence developments and so on, they require data sharing of data between payers, test developers and perhaps physician officers, academia and so on. So we had an initial call to discuss this issue. Brad Maylon was on the call as well as Kate Coller for Mawin's group. We discussed all the various laws that might apply, some of which of course we're familiar with, HIPAA and the common rule. There are also state laws and then there was one which quite frankly I had not heard of before, the Financial Services Modernisation Act, which payers have to pay attention to. But what became apparent was that we really need to define exactly what we want to do here because depending on who's sharing their data with whom and for what purpose, whether it's aggregated or not, whether these laws apply are very different. So I think what we can conclude from that conversation, we need to really better define the scenarios that we're looking at and to conduct some further research. Since the call, we've not made a great deal of progress on this, but I have a new staffer coming on to my branch in the next month and that's going to be one of the things that she's going to be working on. So another, of course, again, is another common theme that comes out of a lot of these meetings is that often physicians don't know exactly what it is they may order the wrong test, they have sufficient knowledge and so on. And so Mark has been leading a group of stakeholders to discuss what we might want to do about this. We've had, it's very much the information gathering stage at the moment we've had a couple of calls. Ira Lubin at the CDC has talked about research he's done, including her to report research to physicians. Chris Miller at Arup Labs has talked about the research they've done where they often find that physicians are simply ordering the wrong test or reordering the same test or lots of pro practices there. And we also have heard from Becky Turner, she's at Palmetto GBA, which is one of the, one of the max that was talked about at the CMS talk yesterday. They cover California, Nevada and Hawaii. And Palmetto has been famous, I guess in the last year or two, in that they've been doing a lot of work in setting up the MaldiEx program to better track exactly what it is they're paying for. And so what they've found is often physicians are, or a lot of the test ordering they see is inappropriate for the Medicare patients which they serve. So once I'm done I will pass it on to Mark to say a little bit more about what we've learnt on that so far. So that's where we are with the payers meeting. I also wanted to let you know about one or two other things that are going on. NHGRI is involved with HHS on a project which emerged out of NHGRI achieving a GIPRA goal. I don't know how familiar you all are with GIPRA, but this is a law which was established during the Clinton years where each agency in the federal government has to establish benchmarks and to meet those benchmarks to show that the government is performing well. And NHGRI had one to where we were tracking lowering the costs of sequencing and we had to meet certain thresholds within a certain amount of time. And HHS was particularly excited by NHGRI achieving this goal and they said well what more can we at HHS do to help foster the clinical use of sequencing, whether it's whole genome sequencing, whole exome sequencing or whatever. So this is something that we've been working on for a while now and this goes beyond coverage and reimbursement per se and this would be focused on anything that really fits within the agencies within HHS. So it's still in the very early stages. HHS has paid for a contractor to look through reports that have been done over the past few years, whether it's the genomics round table, the IOM or SACJHS, and to pull out any recommendations for HHS or agencies within HHS for specific actions they could take. And they're also forming a number of expert panels. So there's a number of people in the room here actually will be contacted by HHS or the contractor if they haven't done already. Jeff Ginsburg, Dan Rodden, Sessions, Deborah Leonard and Bruce Corff, they're all on the list of people that they may contact. The basic question they'll be asking will be what is it that HHS should be doing that they aren't doing, whether it's NIH, CDC, ARC or whoever. And following up from that there's going to be this trans HHS working group which is going to take all this information and decide what should be done. And while I'm talking about this, I should acknowledge Anseldyn Stewart, way in the back there who's leading this project at HHS. So something else we also are doing within DIPC is we're tracking what's been going on with regard to coverage and reimbursement. This was brought up yesterday but in passing. But I was mentioning that we really want to keep an eye on U.S. preventive services. The last meeting, we really want to keep an eye on U.S. preventive services task force recommendations because they have heightened power for want of a better word now in that any recommendation that's an A or B from the U.S. PSTF has to be covered by non-grandfathered plans per the Affordable Care Act. And the MIPA, the revised law for Medicare, it also allows Medicare to cover preventive services that they wouldn't otherwise be able to cover that are U.S. PSTF A's and B's. And so there is little within the task force recommendations that pertain to genomics specifically. But there was a recommendation, excuse me, to 2005 on BRCA testing. But there was a question as to whether the recommendation covered the genetic counselling or whether it covered the testing itself. And so of course this had important ramifications for the Affordable Care Act and what private plans were going to be required to cover. So since Genomic Medicine 4, the Department of Labour and HHS and the Treasury have put out an FAQ and one of the things they clarified that they expect the coverage both of the genetic counselling and the testing. So that's just an FYI. And something else that you may, just in passing, may also be interested in is a recent MedCAC meeting. MedCAC stands for Medicare Evidence Development Coverage Advisory Committee. And they are the advisory committee for the coverage group within Medicare. And their role is to assess the level of evidence for a test and say, does this meet clinical validity? Is there clinical utility to this test? And Medicare, this did not determine Medicare decisions but they use this information to help advise, inform the decisions. So they had a meeting on 1 May and what they were focused on was a tissue of origin test where you have cancers where you don't know where the primary site is. There are a number of tests that are out and they are now that claim using panel looking at active across a bunch of genes and using an algorithm they can predict where the primary site is. So they looked at three different tests and they found moderate evidence of clinical validity but little evidence of utility. And it was interesting to watch the discussion. I think it was very emblematic of what we're facing in terms of how there was little evidence out there to demonstrate some of the tests that certain promising we may ultimately want to see covered. So this is my last slide. The top two things I have here are the criteria for the prioritising tests and the idea, the conceptual of some kind of way in which clinical utility research could be performed. These are the things that I've just thrown up there as other things that we might want to consider and thinking more about and which I brought up at Genomic Medicine for. Mark mentioned yesterday the fact that genetic councillors aren't covered as independent providers under Medicare. I don't know how much that is. We want to prioritise or work on, promote. Then I wonder, but we're done. I don't know what button I hit here. It says end of slideshow. Does that mean I'm cut off? I can take a hint. So we rarely really try to define what tests are appropriate for coverage right now and where there's clear clinical utility. Are there tests that if tied to some kind of creative solution whereby there's ongoing gathering of information tied to coverage for a while, like a coverage of evidence development kind of thing. Are there tests or services or things that are out there that are valuable? One of the challenges I think that we face is some of the things that we would like to see for genomic medicine aren't necessarily appropriate for the Medicare population, aren't necessarily for over 65s. And yet Medicare is often used as a benchmark for private coverage healthcare insurers. So do we want to think about the fact that there may be services or testing that we want to see covered but isn't covered by Medicare and how do we want to go about that? So I guess the last thing, the last bullet actually is a bit repetitive analysis of what's covered and what we think ought to be covered. So I'll leave those up for there, but I'll turn it over to Mark to talk more about the physician ordering of testing, a group that he's been leading.