 I'll go really quickly because I think that a lot of the points have already been made through the discussion. So this is basically, we discussed the policy framework yesterday, but the issues are applicable across medicine, many of these. And I do need to acknowledge all the people who worked on this policy framework. And so what I'm going to be doing is talking about the clinically relevant issues and the recommendations that are made for advocacy that the college will be focusing on. And so these are the ones I picked out as the clinical issues. So there are a lack of tools for NGS interpretation. We've talked about the need for a clinical variant database and it's genotypes plus phenotypes. So and inherited as well as somatic, I think are both needed. And not only phenotype, but potentially outcomes data also. And then we need reference genomes for different racial and ethnic groups. This was discussed earlier, but there's some question, I guess, as to whether you need the race-ethnicity differences. But the more your patient is different than the reference genome, the more variants you get. And the more irrelevant variants you get because it has to do with race-ethnicity difference. And in addition, we need potentially normal genomes because the reference genomes that we are using, you might miss calls that are incidental findings of, you know, in the patient or in the reference genome. So this whole issue of reference genomes for clinical testing is, I think, a very important issue to define what it is we do need and what's best. We feel the gene patents limit patient access and restrict medical practice. So CAP is on the U.S. Supreme Court case. Oral arguments were heard in April and the decision is expected in June against, from Myriad. HIT, we're generating extremely large data sets. We need interoperability standards between the instruments, the laboratory information system, the, sorry, EHR and PHR. And so working with policymakers and stakeholders as well as industry partners to participate in national discussions of standards for clinical genomic data, storage, and management. And incorporate standards eventually when these standards are developed, CAP is an accrediting body under CLIA, and so we would include these standards in the accreditation processes for laboratories doing this testing. There is regulatory uncertainty about the oversight for laboratory-developed tests, and I know Liz said don't ask any questions about LDTs, but the CAP will advocate for rational oversight and is working with the FDA in providing information of both commercial IVD test kits and laboratory-developed tests. We think the uses of these are different, how they're used, and the standards need to reflect those differences, but we do want to promote rigorous laboratory and interpretive standards for clinical genomic testing and strive for a balance between patient safety, the technology advances which are moving really rapidly, and translation of new scientific knowledge into clinical tests for patient care. On genomic consultations, this is not a recognized role for pathologists, although pathologists do provide patient consultations. We need to advocate for pathologists. So this is a very pathology-centric, but it's related to clinical practice. Many pathologists don't have access to the electronic health record of patients, and the only way that they can get patient information is by going through the clinician who ordered the test. And sometimes that's impossible to get that information, and sometimes, state by state, this is actually legislated that you can't have access to the record. So we also need to develop billing codes for genomic consultations, not only for pathologists, but for all physicians. These consultations aren't both for the interpretations and the consultations aren't well reimbursed. And I know this ties into the whole payment reform and how is anything going to be paid in the future, that's a great deal of uncertainty layered on top of this. And we also want to advocate, or even develop, user-friendly model reports like the synoptic reports we have for cancer for genomic tests that are understandable by the ordering provider as well as can be used in the PHR to help patients understand their genomic information. There is a great deal of payment uncertainty for genomics. We think that we should advocate that the interpretation of genomic data is the practice of medicine. And so we also, so that is a controversy with the FDA where the FDA oversight begins and ends. We also think we should advocate for appropriate coverage of genomic and molecular technical and professional work. So CPT codes for genomic tests, that would be on the clinical laboratory fee schedule, but compensation appropriate for the professional time for interpretations. And so this is an issue in molecular pathology testing that everything is on the clinical laboratory fee schedule, and there is a very trivial professional fee of, you know, about $20 that you get for doing any professional interpretation of any test, molecular test. And so that was with the old stacking codes. This hasn't been fixed really with the molecular pathology codes. They're still on the clinical laboratory fee schedule. So we need privacy around genomics but balanced against clinical access. So genomic information does have a high potential for impact on healthcare decision-making, but also for misuse or at least the fear of misuse. So we need to assess the legal and policy needs to assure privacy for generating, storing and protecting the genetic or genomic health information for patients, but advocate for patient privacy protections that allow for clinical access, appropriate clinical access and use. And again, I mentioned the HIV testing issue that was back in the 90s where it was so privacy protected that many physicians couldn't access that information and didn't know that they were treating patients who were HIV positive. And then we need evidence for genomic medicine and we need to, we feel we need to advocate for funding for clinical studies that will generate clinical outcomes data to provide evidence-based support for the clinical usefulness as well as the cost effectiveness of genomic testing. So there are many case studies and there are some small studies. I think on a more population-based level, we need to generate the evidence that genomics is or is not cost effective and improves patient outcomes. I don't think that that's clearly been proven yet. And assure that when these studies are being designed that there is and implemented that they are inclusive of all the needed expertise. So read in there, pathologists need to be included but I made it a broader statement that all kinds of expertise is needed on these interdisciplinary teams. And finally, the final issue that we discuss is genomic medicine and accountable care organizations or health care delivery reform. These seem to be two separate national discussions that are going on. I find them very merged in Vermont. But the promise of genomic medicine is to improve patient outcomes and reduce overall health care costs. We hope that's what it will achieve. This aligns very much with the managed care goals and actually could be synergistic. And so this genomic evidence development needs to happen and then that evidence of the genomic value needs to be shared in the managed care settings. So this College of American Pathologists is developing advocacy approaches to the key issues in this document and we plan an annual update of the policy framework because many people are doing many things and the issues will progress, we think, on an annual basis. So I don't know if you want me to leave this up here or you want me to just end, but these were the topics that I discussed. So that's it. So I think we have time for a couple of questions. Thank you for keeping that short. I just want to ask a question on the reimbursement for interpretation. I don't answer any questions on reimbursement. Can I say that since Liz carved out what we could talk to her about? Well, I'm not sure Liz is the one who directs this to you either. So are you interpreting that as the reinterpretation as well and how do you see that changing if a patient changes insurance? There are huge issues. And insurance, I mean that's one of the issues when you talk about the family implications of genomic information that UK and Canada don't have to deal with, but payers don't want to pay necessarily for family member assessments to help with the patient that you're dealing with. I mean, so there's a great deal of complexity and we also don't know about reinterpretations. We don't know whether those will be ordered, whether the laboratory will just do them because new scientific information is available. And so you push that information out. If it's new information for the patient, you push that out to their clinician, but there's no way of billing for that. There are many reimbursement issues around genomic information and how it will be paid for. This is a combo between what Les talked about and the issues you talked about. And that's the role of the treating clinician. And my understanding is you had consent that the patient signed, correct? Saying you can't pick or choose. Here's what's going to be. Let's just pretend that's a scenario. I guess my question there is, does that make the clinician just a passive pass-through? I mean, there's a clinician sign the consent to say, I am willing to participate in tracking the phenotype of any little genetic thing you find. And I guess at what point do we engage the clinician in that? If I were a patient, I signed the consent, but yes, I agree that I have all these things done. I would anticipate that I would automatically get that back. The clinician is almost, yeah, it's nice that he or she will be there and might do the confirmatory phenotype testing, but I'm the one who signed the consent that says these are all the things I'm going to test. So I'm just wondering, it seems a weird role, and I would also worry as a clinician would I have liability issues if I were sitting on a finding that I did not share, that I thought, well, I've taken care of this person for 40 years. I know this phenotype is not there, therefore I won't hassle. Is this that space and kind of... Well, I don't want to talk for less, but that was basically my question, is ACMG is saying return the result to the clinician, but then there's no guidance for the clinician. The assumption is that they know what to do with that, but I think that's a very large assumption on ACMG's part. So Les, I don't know... Yeah, so we have to strike an appropriate balance here between asking and expecting too much of clinicians and asking or expecting nothing of them. And I think, again, we live in a real world, and when Olympus made, I think they made the first flexible endoscope, no one knew how to use them, and we figured out how to use them, and they work great. And so I think in some ways you have to sort of break out of the cycle of we can't implement it because none of the clinicians are ready for it, and then we can't, because none of the clinicians are ready for it, we can't roll out the technology. And so, and the clinicians also say, don't, we're not going to do your facility genetics CME because there isn't anything out there that's actually clinically useful yet. And so we're in this funny cycle, and we just have to break the cycle, and we do have to stress the system a little bit and push this and make it an issue that people feel like they need to deal with, and it's like, and we're talking with other groups now to say, okay, now we have a CME problem where we need to get clinicians to be comfortable with this and know what these boundaries are, and I think we actually can do it. And the clinicians order complex tests all the time, and their job is to make sure that the patient understands what they're getting into, not all the details of everything that's downstream, but to say, okay, we're starting this process, here's some of the kinds of things that could emanate from this process. You need to be comfortable with that, or if you're not comfortable with that, maybe we shouldn't go forward with this right now. And I think that's a very appropriate role for an experienced clinician who understands what this stuff is about to do that. I think the notion that as new information is received, it somehow has to be communicated to the patient may just simply be unrealistic and not really consonant with the way medicine is practiced, which is that people move. There's no guarantee they're going to notify their physician when they do and provide a referring address. And so I think you're going to have chaos if there's any long-term expectation that what genomic information is obtained now is going to be continuously updated throughout the life of the patient unless we create a completely new paradigm of not just genomic medicine, but how medicine is practiced in general. I think, in fact, it creates an interesting opportunity that I don't know how the health care system or the entrepreneurial environment will respond to it, which is we keep talking as though what's going to happen is that we're going to learn something new about a genomic variant already found and it's going to shed new light on the patient's health. And maybe that'll happen almost surely it will, but I'm skeptical about our ability to keep track of the patients. I think the inverse is just as likely and maybe more likely, which is that the patient's phenotype evolves as they get older and they develop a problem that you could look back at the genome sequence and maybe get inside into what that is. You know, their joints become swollen and which of the 10 things that could do that is most likely in this patient and the genome may actually help kind of direct the further work up. And that too won't happen if you had your genome sequence in 2013 in Boston and now you live in California because we don't have interoperable medical records or any realistic sort of conduit to communicate that information. And it raises the question will there be places and groups that will create sort of central storage that will go outside the healthcare system into some sort of entrepreneurial environment where people could draw on that data wherever it is that they live. But anyway, I think we just need to realize that this problem is probably best addressed by just saying this is a snapshot in time. Here's what we know now about you and there's no guarantee that we're going to update this in five years because we don't know where you're going to be. I think you have to be careful given how stressed the system is right now for the average clinician. So the average clinician out there is dealing with new requirements under the ACA for electronic medical records which often don't work very well depending on the institution and how much money your institution spent on electronic medical record for example University of Chicago. We implemented EPIC, the electronic medical record but we still use paper billing forms just to show you how logical some institutions are and how they implement things. Huh? And I think the evolving business of medicine is creating great uncertainty for the average. So I think you can forget it when you're talking to senior primary care physicians that are only trying to figure out how they can get out of what they're doing. I think the real opportunity is in training the new generation. We've been thinking about similar issues in the context of pharmacogenomics is whether there's an opportunity to create a geneticist's light or a pharmacogeneticist's light for primary care physicians. We're calling this potentially some sort of executive training program where you could take primary care physicians and provide them some training enough to have more expertise than their peers and this would be particularly attractive for primary care physicians that are completing residency, taking their first job often at academic medical centers in many cases and might see an opportunity to work as a primary care physician while getting special training in genetics and interpretation and then being a resource for their colleagues. So a result gets returned to a primary care physician and that patient, you know, if the patient's physician doesn't feel comfortable, they know that there's a colleague that they can seek input for, send the patient for a formal consult. And so I think, but to think that you're going to educate senior primary care physicians, I think that's just not going to work. Oh, I would say, first of all, that a lot of times we, in the past, we try to not go with the flow of how medicine is actually practiced. And to your point of sending the data to the patient, almost all private docs, you know, it's their patient and they want to have that control and if they need help, then they'll want to ask. So I think that we have to realize that to get them to use the data we have to fill, go with how data is normally presented through doctors. The other thing, relative to this last point, I'm actually working with the AAN to develop American Academy of Neurology, sorry, to develop training programs and some creative ways to train existing physicians. The neurologist, I was on the science committee, just came off and our last plenary session had two RNA talks in the plenary for neurology. So neurologists have come to the realization that they need to know. So I think there is a need, the question is how to do it, because your points are very well taken. You have to do it with them, not how we want to do it, but how they want to do it. All right, I think we probably need to move on. Next up is Brad, who's going to give an overview of phase one of CSER.