 I'll preface my remarks, too, by saying I've been there for three months full-time. So this is really the beginning of this process, and I think a wonderful opportunity to talk to you as a group today about some of our thoughts and challenges. So who is Mission Health? Well, we're a large non-profit rural health system in western North Carolina. This is the flagship hospital here in Asheville. The health system really covers 19 counties throughout western North Carolina. And this is the state of North Carolina. And so we're really, catchment is these 19 counties, a very rural area. But about a million people we service in those counties, obviously right across the mountains is Tennessee, and then to the north, Virginia, and to the South Carolina and Georgia. Mission Health System is made up of flagship hospitals at Tertiary Care Regional Reference Center in Asheville, 750-bed hospital. And six smaller hospitals are either part of or affiliated in a number of different ways with Mission Health System. These are scattered throughout the mountains with an additional 300 beds. Our patient demographic is a largely underserved population, mostly Caucasian throughout this area, but it's an extremely stable population. Most people do not move away. They've been living here for generations and generations, and there are opportunities to be following patients for their entire life. Our payer mix, as you might expect in a rural environment, we have 75% Medicare and Medicaid. Obviously challenges that I was interested in speaking further to the CMS representative yesterday. The system is highly rated for quality care. TruVin, previously Thompson Reuters, issued them a top 15 healthcare system for the last two years. Mission Hospital has been in the top 100s over five consecutive years. They've been in the 95th percentile for hospital value-based purchasing despite their payer mix, and it's one of the busiest surgical hospitals in the state. I think currently the vision that the leadership and I have been talking about in bringing a personalized genomic medicine program to this area is really to set up an infrastructure for the eventual onslaught of genomic medicine, including all the things we've talked about here, education, integration of our electronic medical records, integration of all the different service areas, and starting out looking at pharmacogenomic testing, drug gene interactions in both germline and somatic areas, somatic, meaning the tumor areas. I think the future potential is hopefully what we all are here for about personalized genomic medicine is to eventually take an integrated holistic approach where genomic or omic medicine, whatever it might be in the future, is one component of a holistic approach to looking at psychosocial, cultural, economic access and wellness issues as we try to coordinate and be accountable for care for all our patients. The reason I got recruited there is because there is a large support from the senior leadership. Our CEO, Ron Paulus, was the previous director of innovation at Geisinger. Jill Hoggard-Green had been at Intermountain Health, and there is quite a large group that I haven't even listed on here who want to see this happen at Mission Health. So why should Mission Health want to develop a program like this? Well, it is the right thing to do for the community and the patients. I think their philosophy is and has been, it's a new leadership team, that there's a very patient-centered care philosophy, that this will prepare hospitals, clinicians and patients throughout Western North Carolina for the era of genomic medicine. They want to be able to try to provide quality care locally for their patients. Patients do not like to go elsewhere for care. And it also builds on an existing expertise in molecular genetics. They have a Fullerton Genetic Center at Mission, which is really a pretty impressive group of laboratorians and medical geneticists and genetic counselors addressing a spectrum of diseases currently targeted in the pediatric population, developmental disorders, autism, et cetera. And also having an expert genetics laboratory in which they have very sophisticated genetic testing and technology serving not only Western North Carolina, but they get samples in from all over the United States, Europe, and Canada, especially for developmental disorders. And recently brought on a my-seek. So it's kind of a little gem tucked away in the mountains. And I think based on this, there was good opportunity to explore developing a personalized medicine program. Internally, there's a strong infrastructure. What I'm trying to do, meeting with each of the fundamental units within the hospital, pharmacy, pathology, genetics, which has an IT group working with it, and their health information technology group, which has really expanded, and they've put an incredible amount of investment into this area. What I'm trying to do now is get everybody to be talking to each other and looking at this as a whole system rather than just their individual areas. I think I've moved from an academic research setting, or I've been for 30 years, into this clinical care setting. And there's a lot of differences, a lot of opportunities, and a lot of challenges in a non-academic health system that I'm just starting to realize. Now, we do have this internal service line within the hospital. And then there's a variety of clinics, not only in Asheville, but spread throughout this large 19-county region. And so there's quite a bit of outpatient work that goes on as well as inpatient within Mission Hospital. Adding to this complexity is that the physicians in the area are currently in their own private practices, many affiliated with Mission Health System, but they're not employees of the hospital. And so what I've been doing, too, is going out and talking to the different practices to understand their interest and knowledge about genomic medicine and the onslaught of some of this information that they've been reading about. And I think my overall view in trying to develop this appropriate integrated infrastructure lists all the things that everyone has been talking about, and part of the reason why I wanted to come here just to listen is to learn from others who have been trying to do this in a research and a clinical setting, but recognizing that all at the same time, many different parts of this infrastructure need to be developed. The aspect of awareness, education, communication, and dissemination of accurate information as well as the ELSI issues for the health care provider at the hospital and throughout the region for staff, as well as for the patients and families and the public in this area. Having opportunities for laboratory testing in-house and some expertise in genomic medicine interpretation and application obviously is necessary. Going through the same kinds of concerns, how do we integrate genomic results into the electronic medical record and develop clinical decision support tools? We have a CERNR system. It's for inpatient as well as outpatient. The two systems don't really talk very well to each other. The idea of having apps sitting on top of this would be, I think, a feasible way to try to move this in the right direction. Concerns about how we archive results that are not reported and monitor those over time for clinical relevance and what the approach and the best approach might be. Obviously, with our payer mix, we're very concerned about CMS reimbursement and level of reimbursement for these tests. And after I spoke with our board of directors who was very excited about doing this, obviously the questions I got were, well, give us a cost-benefit analysis, give us an economic analysis, a return on investment, which I don't haven't done yet because I don't know how to do it. And it's one of the things that I think are challenging in this environment. Obviously, it's not just me. There's a team of people. And also, how to measure impact. What are the metrics for impact? And again, that's going to be different in every group. And looking at how we evaluate the success of a program, what are the right outcome measures to be collecting now and be able to compare to measure impact? So I think Mu and Curry will be happy to know that I did remember my public health policy planning, assessment structure. And so I developed different phases of how to look at this program, assessment phase, a planning phase, which is what we're in right now, implementation of pilot demonstration projects, evaluation of those projects, and decisions on whether or not this should be expanded and how to expand, et cetera. And this is nothing different than anyone else has been talking about doing it in a patient-focused environment, where the one goal is quality patient care has been a real opportunity. The assessment phase that I've done, I could keep doing it for six or eight more months. I'll never be done with it, but budgets are due, so I need to come to some kind of a closure on this, is really to go around and look at buying infrastructure, what's the feasibility of really doing a program like this? And I can say overall that there's been considerable support from the clinicians, obviously very much support from the senior leadership, that there is capacity and potential for this infrastructure to really work. And the next step is to try to understand what the kind of demonstration projects that might be appropriate to do. I've proposed a few, some I think are overly enthusiastic. I think I'll find like the rest of you that narrowing it down might be better. But there's three proposals for quality improvement initiatives that are being discussed right now. One, in our pharmacy area, the pharmacists at Mission are very interested in trying to take a leadership role in this area, especially for looking at inpatient pharmacogenomic testing for drugs, the few drugs that have the black box FDA warning in the label, especially what we want to make sure of is doing some of these for the HLA markers. We do have HIV population. The opportunities here, a good part of this is that it goes across service lines for whether it's infectious disease or cardiology or dermatology. The challenges that it goes across service lines, and that's a huge undertaking and maybe very overly enthusiastic to try to get several different service lines up to speed all at the same time. I think our other pilot project that we're discussing right now in cardiology has a lot more comfort level with it. We see about 1,200 patients for stent procedures at Mission Hospital a year. So the discussion of preemptive, preoperative testing for CYP2C19 for clopidogal response makes sense. We also have a single cardiology practice that has its headquarters in Asheville. So it's one group to interact with, and they're already under the Mission umbrella. There's data that the cardiology practice and through the medical records that we have related to in-house complications, readmissions in 30 days, et cetera. And emergency room visits that might be due to cardiac events from these patients. Other practical questions that we have right now we're not set up to run all these tests. We would probably send them to outside labs to do what would be the reimbursement rate, as we did expand this into actual clinical care. What are the measurements for impact of this demonstration project in terms of diffusion of innovation, the adoption rate that goes on, changes in practice patterns in terms of choice of and selection of antiplatelet therapy? How long do we really need to do a project like this with our numbers to actually get to a point of reducing cardiac events because we're doing this kind of testing and really measuring risk avoidance or actually getting to the point where we can show reduction in cost of care? The third area for a pilot project, and these are all considered quality improvement projects from our quality officer. Mission Cancer Care is a new entity. They just built a new cancer center there last year in 2012. From this 19-county region, there's about 3,000 cancer patients that come through each year. The new cancer center is affiliated with UNC at Chapel Hill, where I had spent 20 years. And what I really see, and since cancer is my area, I'd like to have a demonstration project really to get the different practices, the oncologists, as well as the pathologists, on best practices for tumor-marking testing. And I think this speaks to what Deborah talked about yesterday, not only the oncologists ordering the appropriate tests, but also when a tissue sample comes into pathology from a non-small cell lung cancer to ensure that the appropriate tests, EGFR sequencing, if it's appropriate to do alfusion protein, that there needs to be a two-way communication both on the oncologist side and on the pathologist side in terms of roles and responsibilities. Currently, I also would like to streamline the process for tumor-marker testing. Currently, each of the different four oncology practices do send these markers out, but to different reference labs. And some of the markers from the same tissue go to different reference labs. So the ability to be able to compare results across is difficult. So to minimize the number of reference labs that we're using, and also to offer an integrated lab report where, as you might guess, instead of sending out a new lab result every other day to the clinician to have an integrated report, obviously this would be much more feasible doing testing in-house, which is part of the long-range plan. So where am I? I'm in this planning phase of planning for, planning for the demonstration projects, planning for their implementation, their study design, the evaluation of these projects, which ones to prioritize, likely cardiology and oncology will be rolled out. They want to see this done in a relatively short period of time. I'm being asked for budgets. And I'm not yet done with my assessment. But I think we're all at that same time. I think what's pushing this is, unfortunately, in North Carolina they decided not to expand Medicaid. That's where a lot of the opportunity for funding was going to come from. So we really need to be looking at budgets and overall planning for short and long term for a genomic medicine program. So Terry asked me what the challenges were in implementation. Well, I haven't implemented it, so I don't know what they are yet. But in thinking through what that might be and taking the list that she wrote up in the paper that was in genetic medicine, I have a column that says, I think I have it covered in terms of how we're thinking about it. We certainly have institutional acceptance. I think we have clinician acceptance, at least for the ones that I've interacted with so far. We have a plan for clinician understanding, training, education, partnering with NICHPEG and genetic counselors to really have a large training program, an ongoing training program. We do have access and expertise in genomic medicine testing and applications. I think that some of the challenging areas that I'm facing, I mean, all these are challenging for me right now, are looking at conflicting interpretations of benefit and value and what the framework is to look at benefit and value across different service lines and across the system. Certainly, like everyone else, integration of these results into the electronic medical record, I think is doable with clinical decision support. I've been going around and visiting some of the sites that are at least close to me in Tennessee. St. Jude's and at Vanderbilt to see that some of that is, can be rolled out, how much of that can be transferred and translated into our community setting is something to be addressing right now. I think we have a large way to go to try to educate our patient population and families and the public in Western North Carolina so that we don't oversell versus undersell, as well as provide communication tools for the physicians in terms of how to interact and discuss these tests and the results. I think for our group, one of the biggest challenges that I face is in trying to estimate what the reimbursement rates would be trying to estimate return on investment if we can even do that. I mean, the board of directors wants to see numbers. They want to see this done, but they're also used to seeing some numbers. Is a cost-benefit analysis the way to go? Is a cost-minimization analysis? I think those are large questions that any of us have really have a handle on. Maybe in a smaller group-like mission, it may be possible to try to develop some models that might be appropriate. On the ground, the same practical challenges that everyone else has been facing, how really are we going to vet new gene drug interactions? I've been relying on CPIC on part of that committee. It's been a great effort, whether that will continue to go on, opportunities to interact with other efforts that are going on at NHGRI and throughout the rest of NIH. And having another expert advisory council that everyone else has, too, are replicating too many efforts or other opportunities to integrate our efforts as well. What is the best process to archive data and monitor actionability and bring that over into the medical record? What is the best strategy for this group? For preemptive testing, how preemptive should that be? The primary care docs in the area, there's a very strong AHEC. They want to start doing some of this testing. They follow these patients throughout their lives. Are they going to be offering testing when someone just walks in the door? Which I don't think we could handle, nor could anyone afford, or to apply some of the high-risk models in terms of patient characteristics that we can predict with not too much effort in terms of which patients might be developing conditions and have procedures that would be amenable to form a cogenomic testing? Our in-house laboratory has the capacity, but whether or not that's going to be cost and time effective. I mean, our turnaround time would be probably very good in-house, and they know that their quality of care and their quality and quality controls are very well set up in the lab, sending it to another lab just like everyone else. We don't know. I think I'm also in this timing and transition of going from genotyping to genome sequencing in terms of trying to estimate what's that impact in the clinical arena, what's that impact in cost, as well as integration into the electronic medical record. And I think what I'm looking for, too, is models and metrics for economic analysis and impact. And I really want to hear from anyone who's looking at this and wanting to partner in terms of just making sure that we're collecting the right data now so that we can also measure impact later on. So I'll just say that it takes a village with partners, big brothers, big sisters. I'm here to learn from others. I know we talk about lessons learned in common threads, and I think that we are getting to that time frame now where some of these lessons learned could be applied and trying to understand the strategies for expanding programs like this and sustaining them and whether we should be continuing to look at distinct diseases and distinct treatments versus pathways and systems, which seem to be the direction that we're going or want to go, at least in the cancer arena. And I think through pharmacogenomics, too, it lays that landscape. And to also, as we're trying to develop our electronic medical record systems in our HIT, to not lose sight of where we may want to be down the road. And I put on here a rapid learning systems to be able to use our electronic medical record to abstract information from that to add to a knowledge base where we're learning from daily clinical experience. And I want to see that happening to some degree in our area now so that we can be a participant in these rapid learning systems that I think are really taking off. So I'll end here. And thank you for inviting me to speak here. I have our mission health aim up here, which really goes hand in hand with genomic and personalized medicine. So questions, comments? I know I'm the last thing between you and coffee and donuts out there. All right, thanks very much. Questions? Hi, thanks for the great talk. You mentioned being in a small rural setting, some of these doctors follow their patients throughout their lives. Can you comment on incidental findings or basically who they might, what would be the propensity of these doctors to share those results with the family members of these patients since they might know them? If you could just comment on that. Yeah, I think that because they're such a relationship that's developed between the providers and the patients in the area, it's a really tight community not only of providers and patients, but between providers too. And so there is many of the docs know each other's patients and families, and many of the families have great trust in their doctor. So I think it provides for an opportunity to have more at risk family member testing. It follows the model that they've used in genetics, and certainly that has worked well throughout the region. I also think that the physicians, especially the primary care physicians and the other providers as well, would look towards the genomic medicine team or the personalized medicine team at mission as part of an opportunity as a bridge for consultation services similar, but not as similar as what we have in genetic counseling. But that kind of a, I can't know everything. I haven't been trained to the level where I'm really that comfortable. Can you help me as part of a consultation service? And I think that that's part of what our genomic medicine group at mission is there to provide as an interdisciplinary group of people. Yes, Jeff? Yeah, congratulations to you and to Mission for having this vision for community-based medicine. I think it's a welcome addition to this group. And also, I get the impression from what you say, because one, your leadership is committed to this. Two, that you're there. And it sounds like you have engagement of the practicing community that you may have some more nimbleness and flexibility than some of the other institutions that are around the table in doing things. So we might really learn a lot from you about implementation that we have been struggling to do in systems like Duke or other academic centers that have a number of functional problems, I'll just call it that. Yeah, and I agree. And I think that part of it is that it is a smaller group and there's less complexity. There's not this whole other academic research part. And that's what I'm hoping for as well. So I think it would be a great two-way street. I'd love to learn from you. And if we can be there to try to understand what's happening in a community setting and to help that be successful and to define what that really means. So one quick recommendation is that yesterday, from Carol and Clancy, we heard about the practice-based research networks, community-based practices. And at least one other, such as community hospital-like mission, sounds like El Camino is one of those that is really trying to break into this space. So the one thing to think about is whether you might coalesce around other similar types of institutions and organizations that have problems that are much more or challenges that are similar to yours to coalesce and become more organized in this area. Yeah, actually, there is a genomic medicine consortium made up of community hospitals who are interested in rolling this out. And I actually contacted Lynn Dowling at El Camino and she said, wow, you could do this at your hospital. And I'm like, oh, business model, here we go. So I think there is that opportunity. But I think having a partner, having some big brothers or big sisters too, because I think we're all have different levels of comfort of how to roll this out and really don't want to reinvent the wheel. And it just seems like so many of our issues are similar in concept. They may not be similar in implementation. Congratulations again, this is Urban Bodger from Mount Sinai, New York. And we have engaged with a large community health network in an urban environment in New York City Institute for Family Health. And it is reassuring and refreshing to see that the sentiments that you pick up in your environment of the strong bond between the primary care provider who is in the trenches in the community health center and the patients, that that is something that we need to bring into the equation as we think about how to deliver genomic information in a complex disorder risk prevention type setting. And so that is something that was clearly voiced very strongly by the primary care providers that we are interacting with. And it's very interesting to hear your finding very similar issues. And that's something we really should expand on and see how we can really turn this into a positive force. Right. And I think with the, I'm not sure how many medical homes are actually going to be developing and are coordinating in accountability of care. But that may lend to that type of relationship even in populations where it's not this stable kind of small town interaction that will remain to be seen. All right. I think we need to take our break now. We'll take a 15 minute break and reconvene at 11.05. It's a challenge. It is.