Thank you so much for that fantastic introduction and for the course so far, which has been very good and informational. I have some disclosures. I have been involved in a lot of the studies of the technologies that have been talked about here. And I also consult for a lot of companies primarily in helping them with the regulatory process and helping them with lifestyle therapy protocols. So that's one of the big things that I do. So first of all, I just, you know, everybody's on here for the most part, because I think you want to do endoscopic bariatric therapy. But I also want to implore you why gastroenterologists in general should treat obesity. And I'm not trying to single out the bariatric surgeons on here. You're already on board. You already, you are already in agreement with this, but why should we actually really be considered experts in obesity? And one of the reasons is because it really, treating obesity really treats GI diseases. So we have non-alcoholic fatty liver disease, which affects a huge number of patients in the U.S., gallbladder disease, severe pancreatitis, GERD, cancers of the colon, esophagus, pancreas, and liver. These are all obesity related diseases. In addition to that, the GI tract is really integral in the control of food intake. So this is a study from the New England Journal of Medicine in 2011, and it's really one of these landmark studies that really demonstrated how important GI hormones are in the control of food intake, primarily in what they cause in terms of hunger and desire to eat. So in this study, they had patients lose weight over the course of eight weeks or eight to 10 weeks. And this was a very low calorie diet. So they were on taking in about 500 to 800 calories in a liquid meal replacement diet. They lost, went down from about 97 kilograms down to about 83 kilograms, so a significant amount of weight loss. And then they watched them as they regained over time. So they tested them with meal tests, measuring their hormone responses and visual analog scales of hunger and desire to eat at multiple time points. And those time points included baseline, at the time that they had lost the most weight, and then at one year after their highest weight loss, when they were regaining weight. So they had regained 50% of the weight that they had lost by this point. And this is their ghrelin. So ghrelin is a hunger hormone. It's produced in the fundus of the stomach, or 80% of it is produced in the fundus of the stomach. And it really is signaling hunger in between meals. It shuts off when food comes in, and it increases in between meal times. And what you can see here is in the black bar is all of the time points where ghrelin was measured around a meal before weight loss. The blue bars, the blue dashed line, is when they had lost the most weight. So you can see that ghrelin concentrations in relation to a meal go up at every single time point around the meal. So just prior to eating the meal, they're significantly higher. And even at the lowest point before they eat their next meal, or lowest point after eating that meal, they're still higher than they were at baseline. And even as patients regained weight, so at one year after their lowest weight loss, so one year after they had lost weight, the red dashed line shows their ghrelin concentration. So even when they had regained 50% of the weight that they had lost, they still had higher ghrelin concentrations than they did at baseline. And this is associated with an increase in hunger. So this was directly correlated with an increase in hunger that was measured on visual analog scales. In addition to that, GLP-1 with weight loss was also decreased. And in general, what GLP-1 does is it causes patients to be full. So it has an effect of causing fullness. And when patients lose weight, unfortunately, sometimes this goes in the wrong direction. But GLP-1 in general is produced in the small intestine and it signals fullness. So gastric hormones, ghrelin, induces hunger. The small bowel hormones induce satiety. And they are very important to the regulation of food intake. And they're abnormal in patients with obesity. So there are multiple treatments that we have for treating obesity. And we've really focused a lot of this talk on endoscopic bariatric therapies. But we have other therapies as well. So when we think about the therapies in kind of a spectrum, we've got pharmotherapies and lifestyle intensity and high-intensity lifestyle therapy. But we're really getting 5% to 10% total body weight loss with that, with the exception of the GLP-1 receptor agonist. So if we add in the GLP-1 receptor agonist and ozempic, which is not yet approved to treat obesity but has been studied for that, with this gut hormone treatment, we can actually get to somewhere between 5% and 15% total body weight loss. But when you talk about the endoscopic bariatric therapies that are really focusing on the gut, we see between 10% and 20% total body weight loss as we've seen. And I know, and we can talk about this more in a minute. I know in one of our talks that Chris Chapman gave, there was a different, there was a lower amount of weight loss in both of the reshape balloon and the oval-on balloon system in the pivotal trials. But I want everybody to keep in mind, again, that the sham control effect reduces weight loss by about 30% to 40%. And you saw that what Dr. Popoff had presented, that in the clinical registry series, large clinical registry series, that we see that there really isn't much weight loss difference between the two, between the two balloons that are in the stomach. And then, of course, we see that bariatric surgery, which has even more pronounced effects on the GI tract in terms of, you know, removing part of the stomach, rearranging the GI tract, has even more weight loss. And again, somewhere between 15% and really 30% total body weight loss after we kind of settle out when we include lat bands and all the way up to rheumatic gastric bypass. So when we think about training in obesity, so we're going to really talk about both obesity and endoscopic bariatric therapies. But when we think about the actual training, in terms of, you know, starting with the basics, starting with our fellowship programs, and how are we all trained to begin with? Well, we really have very little obesity training that we've all had to begin with. So with the current obesity core curriculum, obesity is included as part of the nutrition section, but it's really limited in scope. It doesn't delineate between obesity topics that would be for all GI fellows versus those who will really be treating obesity in practice. It doesn't recognize anything with the advances in the primary endoscopic bariatric therapies or advances in endoscopic management of bariatric surgical complications. So it's really limited in scope. And we've tried to address this, and we've put a proposal together for GI fellowship training, and that document has not officially been published yet, but will hopefully be actually out online within the next month or two in GIE. And what we've really put together for fellowship training, and it's important to talk about fellowship training first so we can build on that for what we need to do for physicians in practice, is we've divided things into kind of two separate sections, the endoscopic training and the didactic education. The didactic education is really focusing more on obesity, but also some of the cognitive aspects of the endoscopic bariatric therapies and management of bariatric surgical patients as well. When we think about the endoscopic training, again, it really separates out into those skill sets that we think that everybody in GI practice or who's going through GI fellowship should be able to do. So general training should include general endoscopic procedures in patients who have had bariatric surgery, and then endoscopic procedures in post-bariatric surgery patients. Whereas we need additional training in order to really do more advanced training to do these more advanced procedures. Although for some of these procedures, this doesn't necessarily mean that the fellow has to have an advanced endoscopic year, but certainly more advanced, more additional training with somebody who is trained and actively doing endoscopic bariatric therapies. In terms of the didactic education, we do expect that all fellows at some point, we would like to really introduce this into the curriculum, that all fellows are going to get a basic knowledge of obesity, obesity treatment, as well as the aspects of endoscopy in patients with obesity, endoscopic bariatric therapy, basic concepts, and bariatric surgery basic concepts. But for those GI fellows who want to actually do obesity training, or really manage patients with obesity, we think that they really need to get additional training in terms of both the basic obesity education and pharmacotherapy treatment, as well as hands-on and more conceptual didactic training in endoscopic bariatric therapies, both again, for those primary therapies as well as management of patients after bariatric surgery. That's all well and good, but what do we do for people who are out in practice, and even fellows who are going through fellowship right now, until we get these things in place? That's a really good question that we've really been trying to work on at the ABE. We'll talk about first implementation for what we think fellows need to do. For all trainees, we think that this doesn't really require an obesity expert in the GI division. There are didactic materials that can be used, outside speakers, and then direct clinical care with just endoscopy and outpatient clinics within gastroenterology and other subspecialties. But really for advanced training, this, we think, does require training with an expert, so possibly away rotations if an obesity expert is not within the institution, training courses, and may require advanced therapeutic training for ERCP and EOS-related procedures. In terms of the content, again, this may require training with obesity specialists, maybe extended training with GI obesity specialists or another subspecialty within the institution that's treating obesity. Sometimes endocrinologists do this. There are primary care physicians that sometimes focus on obesity medicine. This may have to be done in an away rotation. And then there's also courses and coursework that can be done through the American Board of Obesity Medicine, and there's a certification pathway that can occur through that. And that's actually available even for people who are in clinical practice right now. So what do we do about physicians who are in practice right now? And again, I'm going to try to separate this out both into endoscopic and the didactic training. So right now, currently, what can you do to help yourself become educated on obesity and management of obesity? And as Dr. Shulman talked about in her talk, that it's really important to understand obesity pathophysiology in order to provide really individualized care plans for patients. Because somebody may come in with an idea of, well, I want to have X, Y, and Z. But when you talk to them, and you do a diet history, and you get an idea of what their eating behaviors are like, and potentially moving forward using other tests that might help us with personalized medicine, is that those therapies might not be as effective as maybe another therapy would be. And really understanding the pathophysiology of obesity is going to help you with that. So there are a number of courses that you can take in order to actually get some of this didactic training. And I put several of these up here. So there's the Blackburn course in obesity medicine. This is actually going to be live streamed this year. And it's going on June 4th to the 6th. So it's still something that you could still register for at this time. There's the Cornell obesity, the Columbia Cornell obesity course. Again, they have put this online at this time because of the issues with COVID. The TOSS review course is another option. So this actually occurs at the same time as Obesity Week, which is in November every year. Obesity Week is at this point still planned on being a live course or live conference. But they are also planning and putting in all of the planning in place for being able to do it virtually if we're not able to do it live. But this is also a good succinct option, although the rest of Obesity Week has a lot of obesity education that you could get in addition to this review course. And there's also the Obesity Medicine Association. So they have two courses that they put on, both a spring course and a fall course. And again, they're offering this May course is now going to be virtual as well. The nice thing about all of these courses is that if you decided that you wanted to move towards getting a certification in obesity medicine is that these courses count towards the amount of credits that you have to get for face-to-face learning to sit for the American Obesity Medicine Board. So for the Obesity Medicine Board, you have to have a total of 60 credits in education in obesity. 30 of these have to come from face-to-face courses. All of the courses that I listed here qualify for that. And then there's 30 credits that you can get online. So the other important thing to recognize, again, is that the American Board of Obesity Medicine does have other resources that are online on their website that will allow you to do online learning. Again, in basic obesity, pathophysiology, and treatment with pharmacotherapy. And they even do go through, in all of these courses, do also do a lot of education around bariatric surgery as well. So what about endoscopic training? So right now, this is a little bit challenging. So we've got industry-sponsored training. And this is different for each industry sponsor. So in some cases, this is on-site training. And in some cases, this is group training that you, as a practitioner, would have to travel to the training. And these occur a few times a year. And a lot of these companies also will have additional case support. So they may have one of their product specialists that comes and actually helps to give you product support during your first couple of cases. The other thing to remember is that some of these things that, and again, some of these will give a certificate of completion. And this is important because your hospital may require that, that you have this certificate of completion, that you've done this training. And that, in many cases, will allow you to be able to do that. I can tell you that I was at Washington University before moving to Colorado. And because I had been involved in most of the studies, I didn't have to have a Certificate of Completion. But when I moved to Colorado, they did require me to have a Certificate of Completion for these procedures before I was allowed to do them. Some of these industry-sponsored training also require a certain number of previous cases, so maybe a number of previous EGDs that you have to have performed before this, or a certain number of PEG placements in the case of AspireAssist that you might have to have done and documented before you can actually get training by the company. Sometimes these also require purchasing devices or equipment as well prior to getting the actual training. So these are all things to kind of keep in mind when you're deciding that you are going to invest in training that you may also have to invest in devices or equipment as well. And the other thing to remember that I just, you know, want to bring up is, and this has been brought up already as well in this, in some of these talks, is that especially for a gastroenterologist that is already doing a lot of procedures, you may already really be adept at a lot of the techniques that you need in order to do these procedures. If you're already doing PEG placements, AspireAssist placement of the A-tube is really the, exactly the same as a pull, as doing the, doing it, putting a PEG tube in with the pull PEG technique, removing an intragastric balloon is, although you do have to deflate the balloon before you remove it, it's very much similar to foreign body removal. And most of us are experienced with foreign body removal. And so we're able to not only, you know, do the foreign body removal of the balloon as we're taught, but we can also do some problem solving if things come up, just like we have to do with other foreign bodies that we remove. In terms of training fellowships, and this is both for fellows and then people who are already out of fellowships, is that there's a few centers that offer training outside of traditional fellowships. There are some of us that will have fellows, or even practitioners that are already out in practice that come and actually do kind of like an away rotation for a certain number of months to get experience in doing these procedures. SAGES and ASMBS also has a program called Be Safe. This is a didactic video series. They do have a hands-on portion, but the hands-on portion is more for skill verification, less so for actually providing education or the actual hands-on development of those skills. And then right now, there is the ASGE STAR certificate program in suturing. So this is not specific to bariatrics, but it does teach important skills in endoscopic suturing. And I think that this STAR certificate program in suturing really gives you a good basic foundation that you can build off of in order to do the suturing endoscopic bariatric therapies, including endoscopic sleeve gastroplasty and gastric outlet revision. Oops, that does not mean to do that. All right, so looking to the future, and this is what we have been really kind of focused on. And as everybody on the board can tell you, I've been really pushing everybody and everybody's been putting in a ton of work on this, but we are putting together a STAR certificate program in bariatrics for the ASGE. So this will be online learning that would be included in GILeap and also in-person components. And it's gonna be modular. So we'll have basic obesity. So that will be entirely online, but it will be a series of educational videos, as well as pre and post-testing to really give you that basic obesity knowledge that you need in order to be able to at least do some basic obesity management. We'll have a modular section on gastric devices. So again, this would be kind of a separate module that will include both pre and post-testing, as well as a hands-on weekend course like any of the other STAR programs. We'll have a suturing for primary and secondary obesity treatment segment, and then also endoscopic management of bariatric surgical complications. So other than the basic obesity module, all of the other modules will be in separate weekend programs. You don't actually have to do all of them. So let's say you decide you only wanna do gastric devices, or you're just gonna start with gastric devices and you don't know if you wanna do suturing or not. This allows you to be able to focus on the therapies that you think that you want to do and you don't have to do the other ones. The only thing that you do have to do before doing the hands-on modules is you do have to finish the basic obesity course. Our goal for this is to have our launch in 2021. So we're working hard to be able to get to that, to be able to get to that goal, and hopefully we'll be able to make it. So what about current and future challenges? Well, first of all, we totally understand finding the time can be difficult. There's a trade-off for practicing physicians in time for training. There's those didactic glide courses, they all take time. And then the hands-on training that we talked about, even in the ASGE STAR program format, that's still a weekend away learning these therapies. There's also resources. Training of physicians currently in practice may require initial investment in devices like we talked about, devices or other components. And then costs related to both didactic and endoscopic training. So those are the costs that are direct costs that you have to pay for the program, but also the time cost of being away from your practice. And then there's also further research that we need. Right now, we don't have current measures to assess the competency in endoscopic training for these therapies. We do have some theories that tell us about how long it might take to become competent or when people were first starting to do these therapies, how many procedures they needed to do in order to get their total time down. But we don't know exactly what that looks like for the typical practitioner. We also don't have quality metrics or benchmarks right now. So we do need further work on that. And then we also need further work on the effect of simulators on time to competency. And I showed an example here of an endoscopic simulator for per-string transoral outlet reduction that has been developed by Chris Thompson at the Brigham. And using these kinds of simulators may significantly reduce the amount of time that it will take at these other hands-on courses in order to really develop competency. So in other words, developing competency with a simulator that maybe you have much more access to and you're able to practice on more to really develop those skills to reduce the amount of time that it takes you to advance your skills when it comes to actually doing these procedures in a human. So in summary, as we've talked about already, obesity affects almost 40% of the population. Obesity significantly contributes to many GI diseases and the treatment of those GI diseases really requires the treatment of obesity in order to effectively treat these diseases. Gastroenterologists should treat obesity. The gut plays a major role in control of food intake and treatments that target the GI tract or gut hormones produced by the GI tract are the most effective therapies to date. Current pathways exist for practicing physicians to acquire training and more training options will be available soon. And we certainly acknowledge the difficulties in acquiring training right now. So with that, I am going to... And future studies, of course, are needed to determine benchmarks for competency. And with that, I'm going to switch gears. This talk was originally supposed to be focused on training, but we've also, in the past two weeks, have really kind of ramped up our focus on helping practitioners in this COVID time where we know we've had a lot of drop-offs in cases. We haven't been able to do these endoscopic bariatric therapies. And so we've really also put a big focus on trying to give physicians the tools that they need in order to approach their local and regional insurance carriers in order to get some coverage for these procedures. Because I think that's one of the biggest barriers for everything that we're doing for developing the training, for doing all these things. It's really getting people to do these procedures or getting physicians to do these procedures. And in order for that to happen, we probably really need to have better coverage of these procedures. So we really want to have a big push for that. So this is a reimbursement toolkit for endoscopic bariatric therapies. And currently, most insurers consider endoscopic bariatric therapies experimental, but in many cases, they have not included all relevant data in their policy and guideline decisions. So the ASGE ABE toolkit includes materials to help with third-party payer interaction so that we can try to move the needle on getting approval and coverage for these procedures. And we go over some main discussion points. And really these main discussion points are kind of summarized here, that obesity and obesity-related diseases have significant human and monetary costs. So, and the average weight loss with endoscopic bariatric therapies is associated with reduction in cardiovascular disease endpoints, medium-term reduction in hemoglobin A1c, and that's out to four years, reduction in fibrosis and non-alcoholic fatty liver disease, which is really important because fibrosis and non-alcoholic fatty liver disease is what's correlated with mortality outcomes, both for cardiovascular disease in patients with non-alcoholic fatty liver disease and in the liver disease-specific outcome. And we also do compare to bariatric surgery, not because we want to replace bariatric surgery, but because we want to show how this is a nice complement to bariatric surgery. So we have lower weight loss on average than sleeve gastrectomy and room-wide gastric bypass, but we have lower morbidity and lower mortality. And we also have indications for patients with a lower BMI. And again, this really complements bariatric surgical procedures that are already covered and allows an insurance plan to be able to provide better obesity care for a wider range of patients. The two main components are best practices for coding, and this includes a number of things that we're going to talk about in a second, and presentation for payers. And we're going to talk about how to use these. So the best practices in coding for obesity procedures includes a coding overview. So what are the codes that we can potentially use if we talk to a payer? And what are the unlisted codes that we have to use for certain things? We also give CPT code examples for comprehensive 12-month endoscopic bariatric therapy programs. So that includes codes for dieticians as well as for the physician follow-ups. We also give tips for payments, contacting insurers to determine coverage of services, appealing a denial claim, and reimbursement options. We also, as you can see here, have a sample letter for submitting a coverage request to a payer, or if you're going to try to appeal a denial. And then one of the other main components of this is we have a detailed description of the current relevant literature, and we have, to go along with that, a zip file that contains all of those papers. So you can not only give the insurance company the summary of the data, you can give them the papers as well. And that's important when they're actually making these policy decisions, because then they have to acknowledge that they at least have those documents, and hopefully they would include them when they include their bibliography of references when they talk about decision-making in their policies for coverage of bariatric procedures. In terms of the presentation, it covers the topics to discuss with the payers. Again, obesity-related disease burden and financial costs, the level of weight loss needed to reduce disease burden. And then this is an important point, and it also comes back to the point that we talked about earlier in this presentation, is that it's really important, especially with talking with payers, and what payers really want to see is what happens in clinical practice. Again, the randomized sham-controlled trials, they lower weight loss in general in endoscopic bariatric therapies. But aside from that, payers have also seen the effect of randomized controlled trials on different weight loss medication therapies as well. What they really want to see is what happens in clinical practice. In clinical practice, if I approve this for my covered patient, what kind of weight loss can I expect to see? And so that's what this presentation really focuses on, is the clinical data that has been published. And it's important to note that we have some good clinical data in the US. We have a registry series for Obera that's 321 patients, and we have a prospective registry for Obalon patients that includes 1,343 patients. So we've got really large numbers that we can share with insurers to say, look, we get the amount of weight loss, which is essentially 10% total body weight loss or more that is really associated with a reduction in these hard endpoints of cardiovascular disease, fibrosis and non-alcoholic fatty liver disease and long-term control of diabetes. We see benefits of endoscopic bariatric therapies that are described in these slides and comparison with already covered bariatric surgeries and how endoscopic bariatric therapies complement surgical therapy. All of these slides are referenced and there's detailed references on the slides. And then with each slide, as you can kind of see here, although you can't see what's actually written, you can see that there are additional talking points for each slide and details on the studies that have been referenced on the slides. And that's an important thing too, that you do want to make sure that you know when you're talking to a payer and you're presenting this data, please look at those details because you do wanna be able to talk intelligently about the data that you're presenting and wanna be able to have all of that really at your fingertips when you're giving your presentation. So how do you obtain this toolkit? Well, our goal is to have a link available on the ABE website by mid-May with this toolkit. It will also include instructions for how to use the toolkit. One of the reasons why we're asking you to request the toolkit is that we do wanna do follow-up with you. So we wanna find out, did this help you? Do you have any comments? Do you have any suggestions for optimizing the toolkit and making it better? Because our goal is to really give you a tool to be able to, again, move the needle on insurance coverage for these patients. So we wanna make it and improve it as we get more information back. And that is it.

gastroenterologists

obesity

GI diseases

endoscopic bariatric therapies

training

insurance coverage

literature