Hello everyone. Welcome to our session. First disclosure is that this is my first virtual presentation, so bear with us. We definitely miss seeing everybody in live interactions and all the hugs and reunions, but the one positive that I've noted on virtual assembly is that I'm not going to be returning home sleep-deprived and five pounds heavier. I've been able to attend several on-demand sessions on my Peloton, so thank you to the AA PM&R staff for helping us pull this off and helping me battle the bulge. So I thought I would first initiate our conversation really with a review of what PM&R BOLD is and so PM&R BOLD is a strategic effort driven by the needs of the specialty to ensure of the thriving future of physiatrists. Together, the specialty of PM&R has been boldly discussing its future. We envisioned new practice models and areas of opportunity to expand the impact of our care. Now working to advance the specialty focused on actionable strategies to make the new vision of physiatry a reality. This session is part of the action that we are taking to engage members in this effort. So what is the vision for physiatry? Well, physiatrists are essential medical experts in value-based evaluation, diagnosis and management of neuromuscular and disabling conditions. Physiatrists are indispensable leaders in directing rehabilitation and recovery and in preventing injury and disease. And physiatrists are vital in optimizing outcomes and function early and throughout the continuum of care. So now I would like to introduce our faculty and panelists. Kevin and I are, I'm Jared Cottrell by the way, and Kevin Connero are the co-chairs of the Musculoskeletal Care Practice Area within BOLD. This assembly marks our third assembly holding forums discussing and molding our BOLD initiative. The first year in summary really was to present the vision to the members at large. The second year we discussed several examples of different models that were in existence already. And this year we are engaging potential policymakers and payers to help us understand the future of medicine to further advance our vision. This assembly marks Tony Kyoto's first year with the assembly for the new pain and spine rehabilitation practice area. So for further information about our BOLD initiative please, including strategic plans and the BOLD initiative goals and objectives, please feel free to look at the academy website. There's extensive information to be found there. So with that I'll pass this to Kevin for further discussion. Thank you Jared. We've enjoyed this experience working on this for the last couple years. We feel that we've reached a good point in terms of what physiatry is going to look like in terms of musculoskeletal medicine. This is all coming from great input from so many members who have put this together. So obviously appreciate that. We have a great panel today as well. Chris Ritter and Dr. Durden, Mark Durden, are going to join us in a little bit. So what does the future of musculoskeletal physiatry look like? You know we think that in this new model of care that physiatry is going to work really closely with primary care and we're going to really take hold of all non-emergent musculoskeletal medicine with them as partners. And how are we going to do this in a sense? You know we're going to do this by being their partners, create timely access for patients, be good stewards or judicious use of imaging, medications, procedures, etc. But also in the setting of creating good outcomes for patients obviously. So this value-based care approach we're going to handle it from both areas. We think that we're going to really focus on patient and patient education. You know through interacting with patients directly, through other telehealth approaches, etc. But we're going to be really there for the patients. We're going to provide costly, cost-effective, timely care as well. And then really primary care doctors, health systems, patient groups are going to want to work with physiatry because we provide this great care. And doing this well will also allow us to be part of the shared decision-making process for patients. And then beyond that we are going to also be impactful in population health models for patients regarding musculoskeletal medicine. And you know being aware of other things external and extrinsic things that affect patients like mood issues, weight, etc. in musculoskeletal medicine. We're going to be that holistic view of musculoskeletal medicine. And this is going to make us happy because we know we're really helping patients. And we know that we have the skill set to do this well given the training that we get in residency and internship, etc. to really look at all facets of care for these patients. And as physiatrists we know that we work really well with teams. And this is a very much a team-based approach to care. So our new team physiatry model is pain and spine. And we'll let Tony talk about that. Sounds great. Thank you very much. I want to acknowledge the great team of physiatrists who were part of this group that put this all together. We couldn't have put this all together without all of their their work and energy. I also want to thank Dr. Weinstein for his leadership, the Board of Governors for their support, and the AAPM and our professional staff who provided a lot of the energy and organization to make this work happen. So in the area of pain management and spine rehabilitation, our future we see is that physiatrists are recognized as the preferred providers for pain management and spine rehabilitation care. Physiatrists provide that care throughout the continuum of pain and spine care. So that means acute, chronic, and acute exacerbations of chronic disorders are all going to be part of the group of patients that are going to be seeking out physiatrists for their care. Pain management is a team sport and physiatrists direct a comprehensive multidisciplinary and interdisciplinary teams in order to use the biopsychosocial model of care to have patients achieve their highest level of function and quality of life. We certainly see that function is the secret sauce of physiatrists and that's a very important part of what we bring to pain management that we think is different and that is a real game changer in the marketplace. One of the advantages of physiatrists in provision of pain management and spine care is the breadth of care that they provide. Pharmacological management, restorative therapies, injection therapies, minimal invasive procedures are all things that are in the toolbox of physiatrists. Physiatrists are well versed to coordinate behavioral health, patient education, complementary and integrative therapies to bring to bear in management of our patients. If we can go on to the next slide. It's also important in this value-based healthcare system that physiatrists be good financial stewards and that is something that we are well known for and for which there is evidence to support our taking on a leadership role in this area. And so we see physiatrists as being providers that both the primary care providers and specialists including spine surgical specialists or for patients throughout the spectrum of pain conditions in order to manage these patients. Physiatrists in this field use best evidence and emerging technologies. We demonstrate value of physiatrists-led multi-disciplinary care teams through patient-reported and functional outcomes data and comparative effectiveness research. We envision that pain management and spine rehabilitation physiatrists will be seen as optimal go-to providers early and through the continuum of care and we are uniquely equipped to provide the most optimal, safe and efficient patient-centered care. So now I'm going to hand off to our panelists. Hi, I just wanted to introduce myself. My name is Mark Durden. I'm a physiatrist. I graduated from Indiana University School of Medicine and then got my PM&R training at Northwestern at what was called RIC at the time. Since that time, I then moved to the new Indiana University School of Medicine PM&R program in my early in my career. I was practicing as a physiatrist for approximately 20 years. About eight years ago, I was asked to join a Medicare Administrative Contractor and I felt that that was a good fit for a physiatrist because that's something that the Medicare Administrative Contractors, also known as MACs, had not had in their specialty set. So I started for doing first durable medical equipment. I did that for five years with one of the contractors and then moved over to the Medicare A&B. Since that time, I've been continuing to work with the Medicare A&B program. We are developing policies, which we will talk about today and this as it directly relates to pain and spine. And I will also then, part of my other part of my job duties is that I work for the appeals process for Medicare. And that is basically that if something is denied by Medicare, there is a right to appeal and as that part of that right to appeal, you go before an administrative law judge at one of the steps of the appeal process. I tend attend those hearings for Medicare and wait for the adjudication process to take place, but I present the Medicare side of things and why something was not documented as being sufficiently provided or sufficiently documented to meet Medicare coverage criteria. And now I'll turn the time over to Chris to introduce herself. Hey everyone, my name is Chris Smith-Ritter. I'm the director of the patient care models group at the Innovation Center. And it's really fun to come on this panel because I've never met Dr. Durden before, but so we'll see where we are in terms of our understanding of the program. I have been with the Medicare program for 25 years. Prior to coming to the Innovation Center, I ran the physician fee schedule, the hospital outpatient prospective payment system, the ambulatory surgical center payment systems, and overall managed most hospital lab, Part B drugs, docs, ASCs, the whole thing that's not chronic care or post acute care, the way we tend to separate it in the Medicare program. And about four years ago, I came to the Innovation Center, which for those of you who aren't familiar with it, the Centers for Medicare and Medicaid Innovation was created under the Affordable Care Act. Its purpose is to try and change how we think about healthcare. The statute or the law that was written is very broad. It says we can create and fund models that improve quality and reduce cost. Either or, they can reduce costs and keep quality the same, can improve quality and keep costs the same, or ideally both. It's a very, very broad statute and it comes with the authority to waive many of the laws and Medicare regulations in order to test a model and see if there's a way to kind of get ourselves out of fragmented fee for service. And so most of what we do at the Innovation Center is try and rethink how to get all of the oars rowing in the right direction. We try to think through whether there's too much maybe payment incentive that's creating fragmented care, whether paying for coordinated care can be better for the physician and better for the patient, how to bring in that patient centered care or shared decision making. And each model that we craft is designed to try and address kind of each of those issues. And so within the Innovation Center, there is multiple areas. One is dedicated to population health, one is dedicated to state and Medicaid programs and preventive health, and there's one dedicated to specialty care. And that's my area. I have the specialty care and in particular, I have the bundled payment for care initiative model, advanced model, which is the huge bundles model that the Medicare program runs, and I have the comprehensive care for joint replacement model, which is the mandatory joint replacement model. And I think that's probably a lot. I would say anything more about me, my doctorate's from the George Washington University in public administration and public finance. So why don't we go ahead and take some questions. Excellent, Chris. Thank you so much and thank you both, Chris and Mark, for joining us. One housekeeping piece, if any of you that have not been on this platform, there's a question and answer section that you can post questions to us and we can then advance them to our panelists. So to start off the questions, Mark, I would like to ask what is your perspective on current and future alternative payment models for MSK and pain spine rehab as we have described them in our Envision Futures? And just a warning, Chris, this is coming to you next. So the current pain models, sorry, the current practices have been done with the bundled system have been well talked about, and actually Chris is an expert in those areas, so I'll leave a lot of this to her. But one of the things that we learned about in the bundled care systems, which I think is going to be critical in our future, is that we learned what essentially worked and didn't work with some of the bundled care system, particularly when it came to total front replacement, and of course that's right up Chris's alley. One of the things I thought that was interesting was that it was an incentive based program that CMS would give money to hospitals and then hospitals would pay the physicians and then there would be potential shared benefit. There was also some payment even allowed for the beneficiaries. But one of the things that was I think beneficial and we learned was that advertising and seminars are somewhat effective in bringing patients into these bundled care systems, so that's something that is reasonable for us to consider for our future as well. But one of the things that I believe was also very critical in the past that we learned from the bundled system was that case managers were actually the critical piece that kept this from fragmenting. The U.S. healthcare system has been described as being somewhat fragmented and in the bundled care system, one of the critical elements was these case managers. I also think that we learned that physicians still steer the ship a little bit when it comes to the bundled care system. Therefore, the issue then really for a group of physiatrists is where do we want to steer this ship? If we've learned that they do have some impact on the way that a bundled care system is being taken care of and processed, then where and what do you want to get to? And I think that the vision that has been outlined by PM&R BOLD is really an essential document so that we start with the end in mind. A lot of the things in that PM&R BOLD statement is that things are not going to be accomplished right away, but there are a lot of things that I believe that are doable. One of the other things that I think, before I turn this over to Chris, is that we learned in those systems and what we need to have for our future bundled systems is that we need to have a framework, a very precise framework of how we want to effectuate these types of systems and then learn from the data. Figure out what did we see when it comes from the data and how things were actually where the rubber met the road. Because it's great to talk ethereally, but then really the data tells you where and how things actually transpired. And I'll turn the time over to Chris to get her insight. Okay, so this is the, I read through the PM&R BOLD. I certainly think that it's terrific to be thinking about how to get into payment models and generally think about how to get into value-based care more broadly. I would say, so a couple of things wearing the Innovation Center hat. First to echo what Dr. Durden said, for sure we know from all of our research that the successful organizations that come into any of the bundles are, one, they have the finance, I mean, it's really, this should not be rocket science, right, like there's an organizational commitment. There's usually a leader, a physician, clinician, or champion that is at the organization that's doing it. There's culturally a commitment to provide resources at some level, maybe not a ton, but some, that anybody who tends to engage in value care has diversified in multiple different value care arrangements. It's not okay just to put your toe in the water. Putting your toe in the water doesn't really get you very far. You have to, if you're gonna invest in a case management structure, investing in it across multiple areas makes a lot of sense. Those tend to be those areas of success that we see across all of the organizations that participate generally in any of our innovation models. And so I think definitively that case management structure, however it's operationalized, and people do it in a way that's not just a case management structure, it's a case management structure that's not just a case management structure, that's not just a case management structure. And so I think that's a really important thing to be able to have a team of folks that are focused on it. I think we see much more success again when there's an embracing of that team care broadly, I would say in the Innovation Center, we rarely do an individual model specific to an individual specialty. Mostly what we would be looking to do is to try and broaden up the models that we have to be available to a lot of different entities. In the Bundled Payment for Care Initiative Advanced, one of the downsides of this model is that it initiates at the time of a surgical procedure or an inpatient admission. So that's something we're working on. And right now, but I would say right now it allows a physician group to be responsible and take the risk. And it also allows an institution to be responsible and take the risk. However, the risk in the bundles models is definitely reasonably high. So an individual physiatrist, for example, may or may not be interested in jumping in at that level. We're very mindful that there needs to be opportunities for maybe smaller practices as well, depending on where individual practices kind of, how they affiliate, whether they're on their own or with a different institution. I would say opportunities right now to participate are either going to be through the population health models. And that would be through a secondary entity that would have like an ACO or a direct contracting entity that already has an arrangement on MSK care or spine. Sorry, or spine care. And then I think other options would be through any new bundles that we would be bringing up through the specialty area. I think in particular, we've been working on a, we've been working slowly but surely behind the scenes on a low back pain and osteoarthritis bundle that is an upstream bundle that would initiate prior to surgery with the goal. And this also shouldn't come as a surprise. I think several payers have this down as well to preclude potentially surgery or work on emphasizing conservative treatment before we get to surgery. And that feels like, that's still probably, I would say, 18 months to two years out. It can take up to three and a half years to put a model together. And it does require, as with everything else, it'll go through all the traditional clearances and hurdles that come. And in this case, without opining politically, certainly we are changing potentially administration. So we'll need to see how all of that sort of plays out. So I don't know if that helps, but those are like the opportunities that we would have through the Innovation Center. And I think that Physiatry certainly fits in there. I don't know if they have a model unto themselves or what they're really doing is trying to figure out how to work as a team into several different opportunities. And then Chris, on that same token, Dr. Weinstein asked a question. You know, in the models, in the innovation models, what is the view of Physiatry specifically? And are we viewed differently than other providers on what we do and what value we bring to the table? Viewed differently, no love. I guess I would say there's definitely a strong emphasis on trying to retool value, right? And a focus on trying to make sure that we're doing it in a patient-centered way. So to the extent that Physiatry is allowing or helping patients maybe avoid surgery or move them along in a way that's more value focused or more consistent with their goals, I think that that's all that would matter. And we would take that approach to anybody. Even for our surgeons that are participating, when they, for our bundles models, again, they're looking very closely at how they're performing and what they're doing and how they're changing their care. So I don't know that it's Physiatry. I don't think there's a view to Physiatry as much as those are our values. And anytime we go into any particular space of medicine, I mean, I could take the same thing and tell you about rheumatology or I could take it the same thing and we could have a discussion about how we're gonna handle injections and ophthalmology. It's that same focus that comes into everything we put together. Thank you. Another question that's coming through similar to this prior one is, there was an earlier session today that spoke about entry point to musculoskeletal care being orthopedic surgery as opposed to Physiatry. And somebody's asking, are there any innovative ways we could do to access this non-surgical approach before jumping to a surgeon's perspective? You know, I'll put this to both of you, Mark and Chris. So I'll- I'll start. Yeah, I'll go ahead and start. The issue, I think, if Physiatrists want to be on the front line, they have to be as- have a critical mass to be able to handle that patient population that's coming in on the front line. So that is kind of beyond a model system. That's actually a field issue. From my perspective, and when I was in practice full time, you know, if you aren't able to see somebody six to eight weeks down the road, that's unacceptable in trying to set up a system that says, we want to be on the front line, because you can get in to see an orthopedic surgeon or a family doc within, you know, a couple of days. So that's actually going to be a field effort, not necessarily a payment bundled effort that needs to be addressed from my perspective, because that is the biggest hurdle that I think, there's not enough PM&R docs out there, or even physician extenders that are out there that are PM&R trained to be the front line providers at this point, in my opinion. I think that the, I think there's been a real emphasis sort of, so I would say in the health policy or in the model development space, there's been a lot of discussion about what we would call the upstream bundle. And I'll take like two minutes to explain why it's really challenging for us, but something we're exploring. The traditional bundled payment has to have an initiating point. And then there's a payment that's established and there are different payment methodologies for addressing them. That could be a prospective capitated payment, it could be a retrospective target price assessment of your fee for service spend. All of that has to initiate at a particular point in time. Today, the easiest way to identify an initiating point has been at the time that someone is discharged because that is a clean and obvious place that the initiation of a care happens broadly, that we can tell kind of one step removed either from claims or easily collected information as a payer. And we all know, and everybody here has all of their own headaches about EHRs and what information is or isn't available for sure. For our purposes though, that bundle as it currently initiates never takes into account the decision for surgery. And it is a flaw to some degree in the model as it structures. It's not like there's a problem with the bundles. It just hasn't, it largely addresses managing that care from the discharge onward rather than managing it from the upstream piece. And physiatry, I presume would be important on both sides of that equation. And so getting to an upstream bundle for us where you could initiate at the point that someone presents, for example, with radiculopathy and an initial pain identification, right, maybe a referral from a primary care physician or maybe they've arrived at the hospital and it's their first injection, like that may be the sweet spot that one might wanna try and pick up. Right now, we're trying to figure out how to grab that spot. If we can do it and if we can do it in multiple places, it certainly feels like musculoskeletal is a key place where you'd want to be able to encourage that conservative care first. And I mean that in a very mindful way. There are certainly some patients that appear and must go to surgery immediately and that's an automatic decision and that's an easy decision. It's almost like those are the easiest patients get them out of the way right away. Then there's this group of folks who are a little bit more gray and that's the group of folks that we'd like to catch upstream before we kind of walk down. In the musculoskeletal space, a lot also depends on what kind of replacement is a little different than the determination for spine surgery, for example, which is a little bit more of an art. And so right now, what we've been trying to do is tackle that upstream because I think we feel very strongly that there is a huge value add that I think physiatry would fall right into in that upspace. Part of it is a question for our kind of operationally figuring out how to put that marker down in a way that makes sense. And quickly, I'll say one caveat of the statute by which we're sort of constrained is that there has to be a way to do independent evaluation, which means we have to be able to have a comparison group. It's not as simple as finding an institution and being like, listen, could you guys just start flagging patients as they hit your pain management clinic? It really has to be much more rigorous than that. And that's where we kind of, it takes us a long time to figure out how to work that through. I don't know if that helps, but I really think that is the future of bundles and we're working, but we're not there yet. We've got a couple of years to go. And so- I'm not staying vain, sorry. I was gonna ask, Dr. Standard asked this question. When considering extended bundles for spine or joint issues that are not procedure-driven, what sort of outcomes or goals would be there to determine the end of the bundle? It's easy for a surgical procedure to do that, but back in joint pain doesn't have that same clean endpoint. And this is for both you guys. Do you wanna go first, Dr. Durden? So I'll take a swing at it. As you talked about the bundled care system, it really is, and I think you have to understand what the bundle definition is, and that is an episode of care that is trying to improve quality and decrease the cost. And not necessarily financial costs, it's all types of costs. So I think what Chris is bringing up is, and she was discussing, was how do you define that episode of care? Most of the time at this point, most of the bundles have used a chronological thing, 30 days after, 60 days after something starts. But one of the things that the field will have to do, in my opinion, is to be able to first define what's gonna initiate that episode of care, and then what period of time you wanna have that in. And that will depend on what I would consider be the natural history of whatever disorder you're trying to address. So if it is a chronic, sorry, an acute lumbar strain, generally you could say, well, within six to eight weeks that the muscular injury is gonna improve, or a whiplash injury, that that should have a certain trajectory that 57% or 54% will get better within three to four weeks, and then you get 90, 95%, maybe 99%, depending on where you read in the literature, within six to eight weeks. And so there's where you can define that episode of care. And that's how I think that PM&R is gonna have to address it if they're going to try to do it as a bundled model. And I think that commentary definitely reflects some of the conversations we've been having around this concept as we've been working to try and give it more space. We certainly agree it's not the same as a discharge from surgery where we can tell you, the bundles right now are 90 days, we've done them in terms of 30, 60, or 90 days. I think here, when we started thinking about it, we were looking at about a year, and then there's lots of issues for us in terms of what happens at the end of that year. If you have a patient that's still maybe having pain, are they in a management phase? We don't wanna set up something that has folks in care, and then once they leave the model, they immediately go to surgery because they're out of that managed care. So I think we've struggled with how long, we've certainly asked some folks what they think, we've heard anything from a year to like three years. I think there's no way we could create appropriate risk adjustment for three years and hold a particular physician, or entity, or team of physicians, team of physiatrists, and PTs, and docs, all accountable for three years. So it's a great question, and I don't know that I know exactly the answer right now, we've been focused on a 12 month time period. So Dr. Anaswamy added in, would a tool like the start back tool be a good way to identify patients for the entry into an upstream bundle for spine? I am not familiar with that. I'm not familiar with that either. But I'm happy to look into it. Great. Go ahead. Dr. Kyoto, do you have any questions that you'd like to add in? Sure. What criteria do you use when figuring out if regenerative medicine should be a billable and reimbursable activity? And are you talking about, I'll give my two cents and then turn it over to Dr. Durden, but first, are you talking about generally speaking for the Medicare program? Or are you talking about when we consider how to, oh, for the Medicare program writ large. So the way the Medicare program pays, I guess there's two pieces always, and Dr. Durden, you maybe do this more than me, so you should chime in. There's coverage and there's payment. And then there's how the payment is structured. So for any given service, we would look, for a physician service, we would look to the CPT code book to start. That's where we would start. And then if there was a payment for additional services that the Medicare program felt was appropriate, we would create our own HCPCS code or a new code to reflect that service. And it would be valued similarly and put on the fee schedule. I would say typically though, the key indication for what's considered a unique and new service in that case under the traditional program is coming from the CPT code committee, and then it's valued by the RUC, and certainly that has a long history. I would say beyond that, obviously recently the Medicare program has put in place several care management and other codes that are available uniquely through the Medicare program, and those are always available. To the extent that a service is included, either it's a hospital service or it's gonna be included in a broader bundle that is part of a traditional payment, not under any kind of separate model, that there might be a determination to not pay separately. Those services would be bundled in and that would happen under each individual fee schedule. And then finally, a coverage determination as to whether something is reasonable and necessary is an entirely sort of separate process that is done. We would set a payment rate for any new service irrespective of whether a coverage determination had been made and then coverage is made mostly uniquely at the max where Dr. Durden is, and he can tell you a little bit more about that, or unusually at the national level if something is determined to be non-covered. It's kind of a long and arduous process. Dr. Durden. So you did a very good job of describing Medicare because Medicare is a complex entity. One of the things that I found to simplify in my mind as I got into the Medicare program was exactly what you described. I brought it down to there's the coverage criteria, there's coding, and then there's payment. And those three steps kind of fall together. But for physicians, I think typically we run into what is deemed to be a pejorative statement when they say the service that you gave was not reasonable and necessary. And I would first like to describe why and how that is adjudicated or at least thought of when Medicare looks at something. And then you take one more step back first, though, is to look at something before I can talk about regenerative medicine, I got to talk about Medicare. And so Medicare has defined, it's a defined benefit program. And defined benefits are, you know, it could be as wide as a skilled nursing facility benefit, or a physician visit benefit, or it could be very narrow when you think of diabetic shoes, or dental services. And those are very narrow benefits. So first think of these things in benefits. Then if you're thinking of coverage criteria, think of this in terms of what determines the criteria. And I think if you can think of this in a linear approach, it helps you. First is the statutes. So you have the laws that are developed by Congress. Then from there, they develop the regulations, the Code of Federal Regulations, the CFR. That is then defined something. And then from there, you can have a policy determination, such as a national coverage determination, which is done by CMS, or you can have a local coverage determination, which is done by your Medicare administrative contractors. So there's things that define those policies and determine what would be reasonable and necessary. And then we also have the manual, the internet-only manual. And then there's the program integrity manual. There's the Medicare benefit policy manual. There's the Medicare claims processing manual, and many more. So the manuals then describe what is covered or a coverage criteria. I think one of the things that physicians don't realize when we talk about Medicare and things that are covered is what is reasonable and necessary. I mean, we use that term a lot, but I think if I could help you define that, it would help you in determining the answer to this question. Reasonable and necessary. Reasonable is that it's necessary to treat this injury or illness. So if you've got a broken toe and you do chiropractic manipulation on the neck, that's not necessary, right? It's got to be specific to that specific injury or illness. Reasonable. What does reasonable mean? Reasonable, in general, means that it's safe and effective. And those are usually determined by FDA and some other types of programs in general. And so when someone says, well, if something's FDA approved, then it should be used and paid for by Medicare. Not true. Because think of it reasonable. Reasonable is more than just safe and effective. It's also that it's not experimental, and it has to be reasonable in type, duration, frequency, intensity, et cetera. So let me give you an example in that context. Physical therapy. Physical therapy is reasonable in type. It's therapy. Physical therapy. It has to be reasonable in the frequency and duration. So, you know, it's three times a week for X number of weeks. And then also the intensity of the services or other kind of things. Is it you do it five hours a day or do you do it 50 minutes a day? So all of those things are factors that are determined by reasonable and necessary. So when Medicare says that's not reasonable and necessary, it's not meant that physicians made a bad decision or they're providing bad care. It just means that for that particular entity and the services that were provided, they don't meet together. They don't have that it's safe, effective, it's not experimental, and it has to be reasonable and all the other criteria. So having put that as the background, I think then the answer to the question. The question was, how do you figure out if regenerative medicine is billable by Medicare or payable? Remember, billable just means you submitted codes. That doesn't mean you're going to get paid. So then, and Chris defined that very well. She said, you know, you got payment. So just because you provide a service and you bill a service, it doesn't necessarily mean you get paid for a service. It has to meet all these criteria. When it comes to regenerative medicine and specifically in that example, remember the orthobiologics are many, right? We have three basic categories, the orthobiologics, you've got the blood products, you've got the stem cells, and you've got some of the extracellular matrix things that are there. So when you're talking about regenerative medicine, what part of the orthobiologics are you talking about and which ones have been adequately studied and which ones have no longer become experimental? And so if it never moves off of the realm of being experimental, that there's not a sufficient number of clinical studies to determine that it's not experimental, then it's never going to meet the coverage criteria for Medicare because it's not reasonable. So kind of moving backwards on the dial. So- Mark, can I interrupt real quick? Who determines if it's experimental or not? Sure. Actually, the field or the literature determines that. And then that's codified in the policy. It could be codified as an LCD or local coverage determination. It could be codified as a national coverage determination. Those are usually the ways that it's ways to being determined reasonable and no longer experimental. I was going to throw in, I thought maybe this question also had an implication for models in terms of like, as we move forward, is there a way to generate, is there a way to change how reimbursement happens for regenerative medicine that is unique or new, or there's an additional payment that's going to be made that's part of a model that's not going to be part of the traditional payment that Dr. Durden is talking about, which is, I think you did a better job than I did, Dr. Durden, but it is a complicated program. And a lot of times people will come in when we talk about the model to new models to ask like, how do I get more here in exchange for all that care management that I'm doing? So I thought if that's of interest, I could just spend a second on like how the payment happens through the models and where there might be more or less additional payment. We have some models right now, like our oncology care model, where a proactive payment is made per beneficiary, per member, I'm sorry, per beneficiary, what do we call it? We call it the MIOS payment. I'm going to forget what the last piece is, but essentially while someone's in chemotherapy, so they're under active management, there is an additional payment that goes to the oncology practice that is enrolled. It's $160 for each month for that patient that is aligned to the practice as part of the model. And then what ends up happening is once we get to the end of their chemotherapy, we will go back and do a reconciliation and we will see if over the course of that chemotherapy, the practice was able to keep their total costs underneath their prior costs for average patients that look like the patient that's being treated. So that MIOS payment is an upfront sort of loan on the back end, then it's assessed as part of a total cost of care. So additional payment is made upfront each time, so to help the practice pay for the case manager, but then the reduced for us, we go and look and make sure, did that practice reduce, for example, total visits to the ED or were they able to manage their nausea without additional emergency visits? Were they able to use their nurse line more? Could they preclude some additional side effects from that chemotherapy that could happen? And if that's true, if at the end of the day and or because we're in cancer care, did we do a better job of having someone enroll in hospice? And if at the end of the day, it looks like all of that has been both improved care, it's a quality adjusted and reduced cost, then the practice keeps all of that payment because we, the Medicare program made out on the back end, right? So we didn't pay the hospital, we didn't pay someone else. Instead, you, the practice took home that additional payment. That's one model that we use at the innovation center as we look at payment structures. I would say that is one approach and we also use that in our primary care first model now and in our CPC plus model in primary care. Other models tend to look at making a broader sort of target payment. We say you, a team of people, maybe in the bundle side, if you're managing a people, we'll tell you what our ultimate target price is. And I think Dr. Durden was mentioning this earlier. And then we're not going to make an additional fee for service payment to you. You're not going to send me a claim and I would send additional payment for regenerative medicine. Maybe it's care management for regenerative medicine. That's not what would happen. What would happen is up front, we would tell you guys, you know what, if you can keep this entire joint underneath, this would be the classic, right? Underneath 22,000, all 90 days, everything. Then whatever, if you only spent 20 or 18 or 19 or whatever it was, because you took out SNF, because you did better physical therapy, whatever it might be, then we're telling you up front, we'll take like 200 off the top and we send the rest to you. That's a second model that we use pretty regularly. And then a third one I would say is we take it and put it all together and make a capitated payment. So we would say for a radiation oncology model right now, we say to them, here's the total amount. Radiation oncology tends to be pretty established regimen. You're going to go so many times. So we're going to give you X amount. We'll pay you 50% at the first visit and 50% when you end. And you know how much you're getting, right? This is a little bit more managed care ask, but it's not quite insurance risk because it's very focused just on radiation oncology. It doesn't, if you have cardiac conditions, that's not being assessed, right? It's just, here's what you get for the regimen and spend it, don't spend it. That's what you get. It is highly unlikely that we would actually make a separate, like here's a new thing that you can do in regenerative medicine and we would make you a payment for that. I would say typically the models tend to avoid work kind of going back into the fee for service mode for that, for all of those reasons. So those three structures I just talked about tend to be the types of structures that we would be looking at under a model. And there wouldn't be a way to get additional payment for a unique service, but certainly for managing the care or for a group of services, we might consider an additional payment. Chris, could you also maybe address coverage with evidence determinations and the NCD? There's an NCD 130 where Medicare will cover the routine costs of a clinical trial. So there's actually some additional ways that you can get some payments from Medicare when it hasn't crossed that threshold of being non-experimental. That would help you. Yeah, you're 100% correct. Certainly for some national coverage determinations, if there's not enough evidence, but there's a desire to, and Dr. Durden, you may know more than I, but we definitely have this roadmap of coverage with clinical evidence development and we're willing to pay for the service so long as there's a data collection exercise going on and that specified as part of the requirements. So you probably need to send us information, whoever's participating in that, whoever's furnishing that service has to do it in a certain way and send us additional information so that we can, at the end of the day, make a determination for ourselves. I'm trying to remember what has recently been under CED, but I don't know that I know off the top of my head. And then we do pay for clinical trial support. When you're in a clinical trial, we'll pay for routine costs. We won't pay for the experimental service itself, but everything else is paid for. I think that lends in. I certainly don't want orthobiologics to take over this discussion, but Dr. Weinstein posed, how is registry data regarding outcomes considered when Medicare accesses value of care? And does Medicare consider comparative effectiveness of physiatry versus other specialties? Certainly, we are looking into ways that we can provide you better data as to why our outcomes are hopefully better. So I'll take a stab at that one. So for the record, I don't know that I know the puts and takes of physiatry per se. There's nothing about a particular specialty that would appeal to us or not appeal to us. It's not about physiatrists versus other forms of physical medicine to the center. What we, I would say, and that's true everywhere, I would say what we would be looking to say is we're looking to achieve a certain outcome, which, and I'll give you an example in a minute, we do use registry data for. We're looking to achieve a certain outcome for the Medicare program. Let's talk about this bundle we've been trying to develop, this upstream bundle. So we would say we welcome comers to come into this bundle. Bring your team. Tell us who you're bringing to the table. We're going to say to you, we need you to have a PT team, or we need you to be able to furnish these services by licensed professionals. You decide how you're going to do it. You need to be able to provide depression screening. You have to be able to provide physical therapy. You have to be able to have at least a surgeon on the team, let's say. We would give you the requirements. We don't care who comes in. I care that whoever comes in shows that they can meet those requirements, and it wouldn't be by specialty. Then to determine whether or not an outcome has been achieved, we absolutely have used registry data. We've started this in our bundles model. We have five registries that we're using now for individual specialties, and we have an agreement with the registry. If they have a participant, if someone's in our bundles and they're also submitting to the registry, we can just take the data directly from the registry to meet all of their quality requirements and use that for our outcomes data. It takes us a process to make the arrangement with the registries, but it's 100% available to us as we work through our models. One sticky wicket that we have as the Medicare program is we can't require people to participate in a registry because that does require money, and so that's something we continue to have to work on. If we were to mandate, not necessarily a model where you're volunteering, but mandate something, then we'd have to figure out how to do a circumvent for the data collection for folks who don't participate. Does that help? It does, and on the same token, can a specialty apply for an innovation award through the Innovation Center as a specialty, as an organization like AAPMNR? Is that something possible, or does it have to be within one single hospital system or several? Usually when you mean to participate in the model. Right now, each individual, it could be. We're not going to dictate to any particular entity who they are. All we're going to say is you have to meet these requirements. Right now, for example, there's the direct contracting model. This is much more high risk. It's not not in the specialty space, but it basically says it's a population model, but I think if you're some specialist, you could take it on depending on who you are. We're going to say if you're willing to take insurance risk, then you can come in and do that. If as a specialty, you wish to be the platform to take insurance risk, you absolutely could. We're not going to tell you not to. We have third parties that come in. We call them conveners. I'm not sure I think that's the best term for them, but they're called conveners, and they basically are third-party risk mitigation, right? They're the interface with the doctors, so you can sign up with a convener, and then that convener signs up with us, right? And so the convener says, I'll sign up with you and take all the insurance risk, and then I'll sign up Dr. Jones to participate in my cardiac model because that's something Dr. Jones wants to do, and we've had a conversation, and we feel good about it, and I'm only going to hold Dr. Jones accountable for 2% of risk. Could a specialty society wear that hat? Yeah, absolutely, they could wear that hat so long as you can sign on the dotted line that you're willing to accept the risk. Awesome. Well, I think it's time. It's four o'clock. We appreciate all the work that's gone into this session. Chris and Mark, we really appreciate you guys being here. Obviously, it's different and not in person in a virtual setting, but to everyone on the panel, thank you guys for doing this, and if it's okay, we hope to bring you guys back again next year in person and obviously meet with you guys, so thanks again. I think this needs to be a half-day session, not a one-hour session, obviously. Yeah, I'll tell you guys something, too. A secret we don't tell everybody is that as the Medicare program, you're always entitled to meet with us because we're a public organization, and we definitely value stakeholder engagement, so you guys have my email, and if you want to reach out and have a conversation, you can always do that or meet with my team that works on CJR or BPCI. That's always available to you. Great. Thank you so much. Thank you. Everyone take care. Bye-bye. Thank you. Bye-bye. Bye.

virtual format

PM&R BOLD

physiatrists

neuromuscular conditions

musculoskeletal care

pain management

primary care collaboration

patient-centered care

innovative payment models

registry data