Good morning everyone. Thank you all for attending today's session on Operational Considerations for Both Hospitals and ASCs under the Leadership Track presented by Ginger Breezebrook and Nick Morse. I will be moderating. My name is Callie Kalna. And if you have any questions throughout the session, please enter them through the app. And we will be answering them during Q&A. As well, just a note, the slides are available for this session through the app. »» Good morning everybody. It's good to see you. I see a few familiar faces. I'm Ginger Breezebrook. I'm the EVP of Care Transformation with MedAxiom. And we've been doing a lot of work for the last, you're going to see the timelines here coming up, but for the last four or five years related to the transition of care for some of our procedural work into ambulatory surgical centers. So that's really what we're going to concentrate on for this next 45 minutes. And again, we really appreciate you joining us today. So I'm actually going to start with a couple of questions so we can gauge. So just raise your hand and I will say it out loud for our friends that are virtual. But how many of you work in organizations that currently have an ambulatory surgical center where cardiovascular procedures are being performed? So looking across, I'm going to say it's less than 5%. How many of you this has come across your radar or your organization has been thinking about it or planning for it? I would say 20-30%, which you're going to see just about matches the geographic breakdown of the U.S. and some of the considerations around this. That being said, I fully expect that if I repeated those questions three to five years from now, I'd see a lot more hands. So this is not a fad. It's not a transition in which just a small percentage of us will realize. I think it is something that will become very mainstream over the next three to five years. And I will explain why. And Nick will go through a fair amount of the regulations and why it isn't a just do it. Because there's a lot of things that go behind it and a lot of considerations. So I want to start with just kind of walking you through the landscape and a little bit around definitions of ambulatory surgical centers. So when you start to think about the way and the places and the sites of service where we deliver our care, in cardiovascular typically we kind of focus on the hospital and the ambulatory office. And so for some of us, we also have hospital outpatient departments that kind of sit somewhere in the middle depending on our model and our organizational structure. But what sits behind all of that are, and it always comes back to the dollar, but our fee schedules that actually define those places of service in a way that also creates regulations and rules about the way we deliver care and how we get paid, or if we can even get paid, or if we can deliver care. So ambulatory surgical centers is a designation that, and again Nick's going to go through a lot of those rules and regulations and definitions. But I want you to understand on the front end because I think it's really important. It's a designation that not only equates a clinical site of care, but it's also a reimbursement site of care. So it has its own fee schedule. It has its own rules. And you can't just decide you're going to take a cath lab and put it away from the hospital and call it an ambulatory surgical center. So just kind of keep that in mind as we walk through these next few slides. And then Nick will get into some of the details around those regulatory rules and things. So back to keeping that in mind, we do have the ability, when you start to think about what we can do in these ambulatory surgical centers, there's a whole breadth of CV services that we're currently providing other places that we now have the ability for some of us, for certain states, to provide those in an ASC. So endovascular, peripheral vascular care, interventional radiology, sometimes they get involved in the vascular space and we'll see some of those services, vein. Now many of you may have vein programs and you're currently doing that in your office-based setting. But we do have the ability to do those in ambulatory, surgical or in ASC. Coronary catheterizations and percutaneous intervention. So we're going to talk about that in just a minute. And then some level of cardiac rhythm management, we're going to talk about that as well. So kind of thinking about how you're framing this, we can start to think about this as a new site of care in which we take services that we're currently rendering in other parts of our organization and we create a new location for that. And I'm going to walk you through why would we do that and what are the considerations we need to think about when making that decision. So what are some of those considerations? The first one is just the different procedure options. And I walked you through broad. I'm going to show you the codes here in just a minute, be very specific about what we're allowed to do there and what we're not. It also has to do with your federal, state and local regulations. And I'm going to talk a little bit about that, but I'm going to save much of that for Nick. Local market dynamics, and I'm going to talk about that too related to your payer considerations because sometimes there's good reasons and sometimes economically there's not such great reasons and we need to understand that if we're going to make a good decision. Patient volumes, because the spoiler alert is, this is not incremental volume. These are procedures we are already doing. We're just choosing to put them in a different place. So why would we want to do that? And then physician participation, again, not new services for them. It's the same services that are already rendering, but we're asking them to do it in a new location. So why would they want to do that? And what is the win in there for them? So we're going to talk about that. So I'm not going to read through all of this, and I think you have access to these slides. But in 2024, these are all the CPT codes that are cardiovascular-specific that can currently be rendered in an ambulatory surgical center. So the fee schedule for an ASC includes all of these and allows for reimbursement. So again, quick summary, what's in there? We've got left heart cath, right heart cath, percutaneous interventions, peripheral vascular management, angiograms as well as interventions. We've got device implants, so pacemaker, ICD, loop recorders, some of those sorts of things. We'll talk a little bit later about what you don't see in there yet and maybe some things that are coming down the pike. I will say that this list does seem to get a little bit longer each year. I don't know if there's a whole lot new coming down for next year, but otherwise year over year we have seen a fair amount of growth as far as what we can do. So that's number one. Which procedures? We kind of got to think about what we're allowed to do, where we currently offer those services. And if we're going to start in with an ASC, what are the services that we think we want to include there? The second set of consideration is, can we? So I mentioned earlier there's some state regulatory pieces. And I'm going to go into more details related to what you actually have to do. But a key one of these is a Certificate of Need. And some of us live in Certificate of Need states. Those are the fuchsia purple states on this map. And what that means is that within those states you actually have to submit for a Certificate of Need to be able to put a center up. For the states that are dark blue, there are no Certificate of Need laws in those states. So it is not up to the state. You still have to get state licensure. And there's some rules and regulatory things that you have to do. But there could be 500 CVASCs in those states, nobody's counting. In the red ones people are counting just as they do with hospital beds and cath labs and other spaces and that kind of thing. And then the mid-blue, they have a CON law, but right now there's no CON law that's applicable to an ASC. So you just have to kind of look at the legal standing or what's required in those states. So first consideration are which procedures? Second consideration is what does my state allow me to do and what do I need to do in order to get permission if that's the case? The third consideration is understanding your local market. So basically what this means is, as I mentioned earlier, what you have here is a scenario where these are not incremental. So I'm not going to be adding more CAVs and PCIs and opening up a whole new line of business for my service line. What I really am doing is I'm transitioning services and procedures that I'm already doing in my hospital lab. They may be considered hospital outpatient department and they may be considered inpatient for my hospitalized patients. But I'm not necessarily growing. Now this could increase your capacity and it can be considered a market growth strategy, especially if you are capacity-constrained on your hospital side. But you have to really understand, if I'm already doing 1,000 PCI and I've got six labs in my hospital side doing that work, if I open up an ASC, it's not that I'm adding 400 more. It's more likely I'm going to transition 400 of those 1,000 out to my ASC. And in many cases that can be a very good thing. I'm actually going to talk about that next. In other cases it's a, why would we do that? So we have to kind of understand all of that. So when you start to look at, should I add an ASC to my, I'm going to call it my service portfolio, one of the big questions you have to ask is, what about my volumes and which procedures and then what sort of numbers are we expecting, and what should we and what's reasonable for us? The second challenge, and I've got some additional details in a couple slides, has to do with the economics behind it. So I mentioned earlier that think about that ASC, it has a different fee schedule. So the way we're reimbursed for those services is different. It's less. The concept is the cost of care is less because my facility doesn't sit within my hospital walls. So my overall cost of care in that space is quite a bit less. It's not a 24-7 sort of scenario. It's Monday through Friday, 7 a.m. to 5 p.m. and my staffing is limited and I don't have all the other infrastructure that I'm trying to support. So my overall cost of care is less. So therefore the reimbursement is less. So back to that, this isn't necessarily incremental. This is a transition of services that I'm currently providing in my hospital base at a higher reimbursement, but wait a minute, also at a higher cost, transitioning them into a lower cost setting of care, but at a little lower reimbursement. So back to my why would I do that? Well, we have a number of reasons why we would do that. Number one, if you are in an environment where you're in value-based payer contracting and they're looking at your overall cost of care, this is a great way to minimize and decrease your cost of care for these patient populations. The second reason is if you have most of us are very facility-constrained in our hospitals. I was in two different hospitals last week, both of them urban, both of them locked in and there is no more square footage without going up for them to add more cath labs, more prep recovery rooms, more of all the things that we need in the hospital. And as we heard in the last talk, we have a lot happening in the structural heart space. We have a lot happening in some of the more advanced therapy space. And so when you start to look at some of these very basic low-acuity elective coronary procedures, peripheral procedures in some of our implants, they're a great way to decant our acute care settings. And so if you're in an environment where you're looking at needing to add another cath lab or another EP lab, you might want to think about we can add that as an ASC, move it outside of the hospital walls. And that does a great, it helps me with my overall capacity management. It's also, and we're going to, I'll mention this too again, there's a pretty good patient satisfaction with all of this related to their experience. It's easy in, it's easy out. It's much less of a busy environment. And so again, we're talking about elective procedures, patients walking in out of the parking lot for their procedure that day, it's a much better environment for that sort of experience for them. The third area of consideration I'll call partner alignment opportunities. And there's probably a whole talk that could be given on this. But ASCs right now from an ownership model do have the environment or ability to create some joint venture ownership that include physicians and physician entities. So we're seeing a number of markets that are engaging and adding an ASC as part of a physician alignment, physician ownership type strategy. I don't mean owning the physicians, I mean partnering with the physicians in a different way than what we have historically related to our employment agreements or some of our integration models. So this has actually been a nice win from a physician agency perspective with the ability to do some joint ventures and some interesting ownership models with that. For those of you that have been around a while, if you remember back in the day of the old heart hospitals, 15 years ago or so we could do that at a hospital level. Regulatory wise we haven't been able to do that in over a decade. But this ASC provides some ability to do that. So again, different relationships with our physicians. And then I mentioned the payer contracts already. So if we're in an environment, and most of us are even if we don't realize it, where we're trying to control utilization costs of care, this is a great way to do that. Because the overall cost of care for these patients is quite a bit less than if we do it in the hospital. So let's talk a little bit about regulations. Because we can't do, I mean everything we do has a level of regulation again to keep our patients safe, keep us safe and make sure we have what we need. So at a minimum, these centers all include, every single state you have to have a state license. And there are different states have different requirements for what that license is. But just like anything else that we do, you've got to apply for the license and receive the license before you can open up your center. In addition, in order to provide Medicare patients and qualify for reimbursement for Medicare patients, you have to have a Medicare, it's not a license, but you have to be accredited in order to obtain your Medicare approval to provide services in that center. Now right now the accreditation, I'm going to say it's a little bit different type of accreditation than what our ACC accreditation is. Although there's a double piece of this here, and I'll mention it in just a minute. But the four accrediting bodies that are qualified to get you Medicare approval are the American Association for Accreditation of Ambulatory Surgical Centers, Quad A, the Joint Commission, Accreditation Association for Ambulatory Healthcare, AAA, which I find is interesting, and then Healthcare Facilities Accreditation Program. These accrediting bodies are not accrediting or looking at the types of services. They're looking at your facility. They're looking at the safety and the fire safety and electrical safety and your flow and just some very basic things that apply to every ASC, no matter if it's GI or neuro or cardiovascular. They do not specifically look at the cardiovascular portion of this. So there I think is significant opportunity for us to do that work and make sure that we've got these facilities up to where they need to be with all of the experience that we have. So that's kind of that state license requirement and the Medicare approval need. Within that accreditation requirement, I mentioned again, it's not specific to CV. These are very generic things that every ASC has to have, but just a few key ones. Number one, it must operate to provide surgical services not requiring hospitalizations. So this is not a 24-7. If patients need 24-7 care, they need to be in a hospital, not in an ambulatory surgical center. They may not share space with another entity during operating hours. So for those of you that were in the old provider-based billing days or removed some of our imaging centers, it required a lot of rules around where they sit. This also has rules. It cannot be a contiguous facility with your hospital. It has to be separate. It can be on your campus, but it can't just be another cath lab down the hall. It has to be in a different facility in a different space. So that's kind of some of the rules around ambulatory surgical center and hopefully kind of understand where that fits as far as again thinking about it as a site of care that's part of our portfolio and the way we deliver care to our patients. So why CV? Why are we doing CV? And how did that whole thing evolve? So the shift to outpatient and ambulatory care, if you kind of look, I started to kind of walk through some of those things with this slide. But I'm going to take you all the way back to probably aging myself and probably several of us. But well over a decade ago, probably 12-13 years ago, I remember when we first thought about same-day discharge for our PCI patients, for our elected PCI patients. I was a clinical PA on our team. And I remember when I heard about it, and I'm like, there is no possible way we can do that and then let these patients go home the same day. That is absolutely ridiculous. Of course we need to keep these patients overnight. They need to be monitored. Oh wait, we check troponins the next day. All these things that we do the next day that certainly we can't do that. How would we do that if we sent them home? So we had a pretty forward-thinking organization that I worked in. And they went ahead and put together a pilot. And if you all think about when you did your first pilots, we put those patients in hotels right across the street. We called them that night and the next morning. We put a lot of rules around it. And we closely, closely monitored it. Well, a decade later, 15 years later for some of us, and 50%, 60%, 70% of our PCI patients are going home the same day. So we've learned. We got really good at it. We're confident with it. Our patients like it. We actually remember back then, our patients will never want to do that. They're going to want to spend the night. They don't. They don't want to spend the night. So we learned. We've gotten really good at it. In the middle of all that, we also, our reimbursement shifted. So we went from, remember back when PCI was an inpatient procedure? Well, the majority of the time it's outpatient now. So we can keep them overnight. We can keep them for a week, but we're only going to get paid for the outpatient procedure. So again, transitioning 2024, what does that mean for ASCs? So some of the things that we've seen, I mentioned already kind of that transition to same-day discharge. We saw a fair amount of expansion. So many of you not only send your PCIs home same day, but you're sending your device implants home same day. You're sending some of your ablations home same day. We're starting to see a little structural heart stuff go home same day. And we're even shifting away from using hospital beds by opening up our PrEP recovery units longer and potentially keeping those shorts stay. We've got short stay units where we're keeping patients. So lots of shift that's really encouraging us to figure out how to do this work in a lower cost setting and maybe in a less complicated setting from a patient perspective. So back to following the dollars, if we go back to ambulatory surgical center, we saw our first major shift back in January of 2020 when CMS first approved PCI to be reimbursed in an ambulatory surgical center. Like I mentioned, for coronary angiography and PCI it's a pretty natural evolution because of the same-day work that we had done. We found and CMS found that it reduced costs and addressed patient wishes to avoid hospitals. So let's go back to what happened in 2020. We had the big pandemic that affected all of us. And one of the things that we actually, most of us, if not all of us got really good at same-day discharge back then because we didn't have beds and our patients didn't want to stay. So if we weren't willing to send them home same day, we weren't doing services on people. So we had to figure it out. We had to figure it out pretty quickly. And we realized that it worked really well. 2020 now is four and a half years ago, four and a half, three and a half, something close to that. We're coming up to 25. So almost four and a half years ago. Not only has Medicare gotten very comfortable with it, but we're seeing a lot of the private commercial insurers get very comfortable with it. And we're actually starting to see a little bit of steerage. So where we're in markets, and for those a couple of you that raised your hand and said we have an ASC, my guess is you're in a market where the commercial insurers are supporting it and we're also seeing where you have access to it, the commercial insurers are steering towards it. So when you go to get that prior off for those, again, non-Medicare patients or Medicare Advantage patients, they're asking, where are you going to do this? What's your site of service? What's your plan? We'd like to see you do it in the ASC. So people are, those organizations, those payers are picking up on the fact that this is a lower cost of care for them. The non-CON states have adopted and we're seeing a number of the CON states switch. I come from Michigan. We're a CON state, but our CON changed a year and a half ago. Our first center went up about a year later and we've got two more centers on the way in the next year or two. So it's happening and it's transitioning. And again, I think, like I said, for those of you that didn't raise your hand with my initial questions, I think it'll look a lot different three to five years from now. And then again, we're seeing a fair amount of dollars being invested in the infrastructure and really getting into supporting, appropriately supporting the care to make sure we have appropriate care and we're monitoring outcomes and people have what they need, which is going to be my big take-home message for all of you here in just a minute. So as we think about shifting that, I mentioned kind of some of those more, what I'll describe as business operations around patient volumes and understanding reimbursement and my economic considerations and my revenue versus my expenses. But let's talk about the clinical part of all of this. So I think there's a few things we really need to understand and think about and control for or maybe solve for. So the first one is quality. So as of right now, outside of a couple of states, Michigan being one of them, I'm very proud of my state, but our CON requires that ASC to be part of a registry. And so those patients, all that patient data when those ASCs come up will be part of a registry to monitor those outcomes. Most of our states do not have that. So right now there's not a lot of requirements from a regulatory perspective. Is it the right thing to do? It's absolutely the right thing to do. So really pushing that. So registry participation, appropriate patient selection. Again we're not a 24-7. We have a transfer agreement in place with our acute care hospital. But we don't have a — we've got ACLS-trained staff and we've got a crash cart. That's all we have. We don't have a code team. We don't have an ICU down the hall. And we don't have an OR one or two floors away. So we have to control for that by our appropriate patient selection and then making sure we have the right infrastructure in place to manage those things and make sure that we're well-trained and very comfortable with that when needed. The reality is though, I mean we're four and a half years into this. We know that these are lower-risk patients. So the requirements and the need for that is incredibly rare, which is a good thing. But we need to be ready and we need to have that structure. So as we again continue to evolve, that's really important. We need to closely scrutinize our outcomes and really monitor that safety. And then patient satisfaction, I mentioned already. For the most part at this point, patients are really satisfied with this when everything goes well. And 99.9% of the time everything goes really well. But we need to monitor that. And then we need to monitor the economics behind it as well. So some of the additional things are, I mentioned that kind of procedural shift. This I think is important for those of you that are on the acute care side. When you start to have, you know, we introduce the ASC, we need to solve for this. But what happens, we're pulling out up to 40% of those elective procedures. When I pull 40% of my basic bread-and-butter work out of my overall population that I'm measuring quality on, it leads me to higher risk. So I just have to make sure that I have adjusted for that and I understand that story within my data or what's happening to my shift of patients. The other piece of that is we are adding staff or shifting staff. So when you start to think about the skill set that's required, but then you think about the hours that I need on my outpatient or in my ambulatory surgical center, that's another piece where sometimes we're seeing staff that come from the acute care side. It's a Monday through Friday, no call, no weekends. So we end up with, we have to be really careful of how we manage all of that, that we don't dilute our acute care pool of staffing when we transition and add ASC. And then I mentioned earlier about those physician relationships and the market dynamics. So lots of things to think about. I guess my couple of take-homes for you would be, number one, ASC is about adding an additional place of service within my current, all the places that we deliver care. It's not incremental. So these aren't a bunch of new patients. It's our existing patients. So how do we manage that shift? I think for those of us that haven't seen it yet in our market, I think there's going to be some economic pressures and reimbursement pressures and payer pressures to really drive that. At the same time, for those organizations that have done this well, this has been a big satisfier for the patients, the physicians. And it's been kind of an innovative, cutting-edge sort of thing that they've been able to be part of, which has created a lot of reward and satisfaction in those places. And then the fourth one is, that it needs to be highly scrutinized. So we need to stay close to it. We need to really encourage, if not regulate and enforce registry participation and quality management and making sure that we take all those things that we learned on the acute care side and we've applied those on the ASC side. So with that, we'll transition to Nick. »» Well, that was perfect. So it's hard to follow Ginger who is smarter and more dynamic, but I'm going to try. So yes, I mean, I'm going to go back because this just really well summarizes what we're looking at here. So many competing factors in what we see is a very clear shift, but a lot of tradeoffs. And so it's really interesting to think through it in this way. So I'm Nick Morse. Let me start there. I'm the Division Vice President of Advocacy for ACC. I've been with the college for 17 years now, which is really hard to believe, but it's true. I checked. So anyway, here we are. I'm going to give you a little bit of the policy landscape. Again, Ginger's covered the nuts and bolts and the operational considerations very well. But there's very clearly an environmental evolution that's going on here. So shifts and starts, but relatively consistent movement in one direction. So it's been essentially what we're looking at here. This breaks down, as Ginger said, on the national, the state and the local level. But by the way, just to take you on a journey here, this is Baltimore City. And this is the headquarters of the Centers for Medicare and Medicaid Services. I don't know if you've been there or not, if you ever get a chance. Maybe you could find better things to do with the day. Nevertheless, super, super important. That's where it happens. So that's CMS in Baltimore City. Okay, so they're doing a lot of work in this space to consider, as Ginger has said, the evolution of care and where Medicare patients fit into that puzzle, what's safe, what's advisable. And ultimately, as you all know well, while there's a whole panoply of different payers and systems out there, Medicare is kind of the driver for where things are going to go, directionally speaking. So what we've seen in the last four years is really a very significant shift from one administration to the next. I mean, let's think about that for a second. In a lot of ways, yes, obviously that's true. But I would posit that in the regulatory space, the shift from the past administration to this one was potentially the most disruptive, certainly the most disruptive I've ever seen. Really wild. So let's hope that that's not the new norm where you have, because, heck, we do have a presidential election coming, maybe you've heard, the idea that massive regulatory programs can be shifted wholesale from one administration to the next is disruptive, to say the least. So let's hope, let's hope that, hope's not a strategy, but nevertheless, let's hope that we don't see swings like that going forward. But I'm going to take you through a little bit of what has happened here. All of that is to say it's difficult to make plans knowing the possibilities for these shifts. But all of that said, the trend line is relatively clear and there is momentum, as Ginger outlined very clearly, states are moving, you know, they're moving in this direction, reforming their certificate of need laws and otherwise, to start to make this more of a reality. This being the performance of these services in the ambulatory surgical center. All right. So in 2019, that was the first big shift, as Ginger said, diagnostic cath is added to the Medicare covered procedures list, in other words, the list of things that you are able to do on Medicare patients in an ambulatory surgical center. A little bit of movement towards site neutrality, site neutrality is sort of the big, the dog that hasn't really barked. Some of this has happened. There's been some shifts, but it's been relatively status quo for the last eight, nine years, with a couple of exceptions. Site neutrality is out there and we know ultimately is that healthcare is more expensive. We spend $4 trillion a year on healthcare, it's not necessarily getting us as much as maybe we'd like to see from a societal standpoint. So it's not like there's no more money coming. If we are expecting to get more money for healthcare, that's probably not going to happen. So all of that is to say, site neutrality represents a very large bucket of money that sits out there and there are some oppositional forces that kind of hold things in stasis, but it's something to watch, sort of a sideline to this discussion. But anyway, the idea obviously pursuant to the $4 trillion question that I just raised is how can we shift services into lower cost settings? Where is that possible? How can we actually derive, with an eye on quality, some savings for the system? That's sort of a big piece of the puzzle for Medicare, clearly. 2020, PCI is added, you've got diagnostic cath, and then the next year PCI is added to the covered procedures list. The ACC at that time called out the importance of quality measurement, registry participation. You all know this better than anyone out there. It's critical to keep an eye on the quality, otherwise what are we really getting? So things are starting to happen here. So 2021 is a seismic event. You have, this is the last rule for the prior administration. On their way out the door, so they didn't know they were out the door when they wrote the rule, that's another conversation, but anyway, they took a big swing at eliminating the inpatient only list and starting to take a harder look at actually adding more and quite rapidly to the covered procedures list for things that could be done in the ASC. We the ACC said, you know, hold on, let's be careful about this, this is kind of a big shift, patient safety, quality, et cetera, need to be paramount. Wow. I mean, like, wow. But then the 2022 rule comes along, new administration, that entire thing is walked back, a total reversal. I don't know if you play Uno, that's an Uno card, reverse. So the inpatient only list is reinstated, the newly added codes to the covered procedure list are yanked back, and a public nomination process was created for new procedures to be considered for addition to the covered procedures list. So that's a big shift. You know, if you were planning your ASC in 2022, you were probably a little whipsawed by this. But anyway, this is where we stand now. We have a nomination process. It's a little more thoughtful. So current status. As Ginger said, we have a pretty clear and good track record for diagnostic cath, PCI, a few other things. EP ablation is sort of the next frontier for services in the ASC. We know it to be true under the public nomination process that some of the ablation codes were nominated for addition to the covered procedures list for Medicare for this rule that just came out, the 2025 proposed rule, and they weren't there. Don't know what happened. CMS declined to take up that nomination. So nevertheless, recognizing where the market is going, certainly where the Heart Rhythm Society and the ACC are doing this work is to examine the considerations for same-day discharge for certain ablation patients, a lot of work being done in this space. Bottom line, it seems as though the consensus emerges that some of these, the right patients, the right procedures can be done safely. And so that's kind of where we're looking to go moving forward. So that being said, the competing pressure here obviously is controlling for quality and controlling for massive explosions in utilization, you know, growth of services, any sort of distortion in the system is going to raise the alarm of CMS. And so what we're also seeing proposed this year is a demonstration project, they have the authority to do this, a demonstration project testing prior auth in the ASCs for a set of procedures, 40 procedures this year. There are some peripheral vascular, a couple of peripheral vascular codes on that list. So that's sort of the only relevant one for cardiovascular. But something to watch, five-year demonstration project on prior auth. So clearly CMS is watching. So here's the landscape. Here's where things stand. About 6200 Medicare Certified ASCs, Ginger walked through this a little bit. This is all on the CMS website. It is both, you know, becoming Medicare Certified as an ASC, it's a simple list of requirements that are blindingly difficult to achieve, right. So that's all on the website. There are also another 5100 give or take according to some data that we uncovered, non-Medicare Certified ASCs. All that is to say, there's a ton of these out there, right. Currently there are 178 CV services on the covered procedures list. But there's not a ton of volume for Medicare patients in the ASC yet. So these are kind of the, looking at this, as Ginger said, it's about 60% the reimbursement delta for ASCs, the payment delta. So it's definitely lower cost, you know, decent throughput with patient selection. You can see the picture emerging here about how this could work. But here are the volumes. This data is taken from 2022 for sort of the blockbuster CV codes that are on the CPL. As you can see, those volume numbers, you've got the payment numbers here, the volume numbers as well. It's not a ton. And so the potential is there for growth. But clearly not a lot of this has taken hold yet. I would also say it's important to note for this data, this only represents Medicare fee for service. This doesn't cover the Medicare Advantage population and doesn't cover volume for obviously commercial patients. Another big thing to watch, quality reporting. This is the current, the ASC Quality Reporting Program, this is the current list of quality measures. So you can see it's parsimonious. There's a lot of potential for growth in this space as well. And we would probably posit that that's appropriate. One thing to watch for this year in the proposed rule for the ASC Quality Reporting Program is the addition of some health equity and social drivers of health measures that will be coming online in the subsequent years. Significant addition, I think we can continue to expect significant additions to this program. Definitely something to take a look at the proposed rule if you're operating in this space. Make sure you're keeping an eye on that. And so here's just the landscape by state of Medicare Certified ASCs ranked from most to least. I don't know that there's a whole story here other than to say that again, as Ginger said, the state laws ultimately are going to be determinative. Is this allowed in the state or is it not? And how restrictive are the Certificate of Need laws? Commercial payers, disclosure, my wife works at UnitedHealth. We don't talk about work. But it seems like everybody in this space hates everybody over there. So keep that. We keep that separate. But anyway, insurers love this, it's cheaper. So with some obvious caveats, I think you're going to continue to see some pretty, I think it's fair to say, substantial interest in the commercial insurance market to getting patients into the ASC where appropriate. But again, it's going to come down to the state law in most cases. So I'm going to wrap up here by taking you through some recent state developments. This is the Mississippi Statehouse. I've never been to Jackson. I love Johnny Cash, but I've never been down to Jackson. So that's what it looks like. So I'm not going to read you through these. There's a lot of words on a slide. But suffice it to say, there is progress. And this is actually, regardless of what CMS is doing, the immediate changes are most likely going to occur in the state houses across the country. So keep an eye on what's going on in your state capital. That's where these shifts will happen. Ginger referenced Michigan, a lot of work going on there. Pennsylvania is super, super hot on this as well. They don't have a CON, but they do have a very significant restriction on CV procedures. And so that's been an ongoing battle in Pennsylvania. And more recently, South Carolina and Tennessee, some pretty significant movements in the CON space to make this appear to be a little bit more possible. As you can see by what Tennessee has done in particular with the relaxation of the Certificate of Need, one of the things that we know we have to watch here is patient selection and the impact on the hospitals, who's getting things done in the hospital if all of the low-risk, less expensive, quick and easy patients are moved to the ASC. Policymakers are going to be watching that too. So the balance is obviously going to be critical to watch. But in Tennessee, the requirements here are that you're serving a specific number of TennCare enrollees and that you're providing charity care in the ASC as well. So clearly a counterbalance to that draining away that policymakers are going to be very concerned about. Nevertheless, a lot going on, highly complex, clear trend line with some opposing factors. I think I'll stop there. Thank you. So for all of you that don't realize how influential our regulatory environment is, our laws are, CMS, all the things, but the amount of time, energy, intelligence, influence that the college has developed under Nick's leadership, that has the ability to move things. When we talk about trend, Nick and I had this conversation earlier, I said when it really comes to transforming, if we don't start with policy, we're very limited with what we can do. So for all of you that didn't realize, the college has a lot of energy and intellect in that space. So anyway, it's worth getting to know. You're too nice. Thank you, Ginger. A couple other things that I think are really helpful to understand some of the leg in this is that from a, so if you go back to 2020 when the original PCI ruling came through for a covered procedure list or it ended up on the CPL, it takes probably a minimum of 18 months to go from, I think we're going to have an ASC, to opening the doors and being the ability to take care of patients and get paid to take care of patients. There's somewhere between, it can be as short as six weeks, but I've never seen it six weeks. It's usually more like 12 to 24 weeks. Once you get your center going and you've got your state license, you've got your center accreditation, and you have the ability to take care of patients, it's an additional upwards, like I said, even up as much as 24 weeks, but let's just say 12 to get your Medicare reimbursement number, your P-10 number. And you have to have a center that's actually functioning and has the ability, has staff, can see patients, in some cases is taking care of patients in order for you to get the site visit and get everything signed off so you can get reimbursed. Well if you think about our cardiovascular patients, majority of our patients are 65 and older, that Medicare piece is really, really important. So anyway, it's an 18-month at a minimum, and if you have to build a new facility, you're not just repurposing, it's probably 24 months. The other piece is there's, as Nick pointed out, there's thousands of ASCs in the country right now, but they're GI, neuro, pain management, ophthalmology, and so if you think about those, that's why they're called surgery centers. We don't really do surgery, we do procedures. They don't have C-arms and cath tables. You can't just, okay, Tuesday is going to be CV day in our GI center. Our centers have to be built as a cath lab, EP lab, with the functions and the technology. They're not a multidisciplinary sort of surgical center, procedure center. So that adds another layer of complexity. Certainly it's the right thing to do, just like our cath labs are not in our ORs, right? If you think about the way we do things at the hospital. So it's a significant time, even when CONs change, it's going to be a year or two, even two and a half years before you're going to start to actually see patients taken care of in these markets. »» Great. Well, we have quite a few questions here. Most burning is, staffing is a widespread issue. How will we keep at the hospital, keep staff at the hospital when these ASCs offer no weekends, holidays, or call? »» I don't know that we have a great solution for that. There's a couple of considerations. One is, because it's reimbursed under a different fee schedule, it has a different tax ID. And so when it comes to sharing staff, you have to it's very, you have to track everything very specifically in the way that you account for the staff and the way they're paid. It's again, two very different. For those of you that live in an office base versus a hospital outpatient department, those of you that do imaging will probably experience some of that. It's the same idea. So it's not as easy to say to your acute hospital cath lab staff, okay, well, 25% of you get to be on the ASC next week and we're going to rotate in and out. Because there's a whole set of all your competencies, all of your staffing expenses, it all has to be managed and accounted for separately. So I do have examples of organizations who have figured out a shared model. So we create an environment where we're not diluting our call pool and we're not diluting our skill set in our teams. But it is, you have to really take, you've got to get all the legal people together and the revenue cycle people together and you got to make sure that you're dotting your I's and crossing your T's in order to do that. I do think if I had to kind of, I think that's the best model. Because really what ends up happening is you get your seasoned people that have been doing your work for 20 years and they're kind of burned out and they want something different. This is a really great opportunity for them. And yet we need our seasoned people and the people that know how to do this work on at 1 a.m. on Saturday night when the STEMI comes in and in their structural heart procedures and all of those things. So there's no easy answer. But if you can get all the right people at the table, there are ways to manage some of the ability to share. But it's not an easy straightforward answer. Is an ASC required to be near the main hospital? Is cabbage backup required for PCI? So the answer is they have to have a transfer agreement in place. I'm not going to say, I don't know exactly if there's a mile radius. I believe there is, but I don't want you to quote me. So I'm not even going to go because I'm not positive. But I want to say it's like a 30 miles. It doesn't have to be like across the street. Because I know scenarios where the transfer agreement is with the system where the hospital for the system is farther away than maybe a competitor hospital and the transfer agreement is still with the original system. So you have to have a transfer agreement in place. You have to have protocols, policies. You've got to have mock codes, mock transfers. You've got to have all that stuff in place. You have your crash cart. You need a balloon pump on site. You need all of the pieces that you would have in your regular cath lab when it comes to those emergency pieces. So that's the answer to the first question. The second question was, for the second half of that, cabbage backup. So we actually, we know for quite a few years now that we, many of our centers can do PCI without open-heart service backup or open-heart surgery backup. We've got even some guidelines around that. So the answer is, no. But the transfer center, again this is another one where don't quote me, but I believe the transfer center should have open-heart backup. That's the goal, right. That's the whole reason. You got to get to the center where we can go beyond just percutaneous intervention. So yes. Well, I think that the key takeaway here is that, you know, and I said this too, you know, that the regulations and the requirements are both simple and, you know, blindingly difficult. And so the most direct advice I would give is to, you know, if you're in this space, make sure you know these things. I have the Medicare ASC manual like open on my laptop right now. If you want to see it, I can send it to you. But yeah, I mean you just you have to know these things because nobody thinks about it more than Ginger. And it's like, you know, so you just need to have that stuff at hand I think is the clearest. The other thing I'll add there is that ASCs for CV are generally new, but ASCs are not new as a place of service. And it's been probably 20 years if you really think about some of the GI and eyes and some of the other different procedures. What I get concerned about are the stuff that keeps me up at night is that some of the regulatory bodies around ASC are not familiar enough with CV and they just trust that we're going to do CV right. When that, that's, you know, it's pretty cool they're going to trust us to do it right. But if you look at all those ASC quality measures, there's not a single one of them on there that's CV specific. Wrong side, that doesn't even apply to us. Burns, really doesn't apply to us. So and then there's some general or there's some anesthesia stuff on there, doesn't apply to us. So what I worry about, there's nothing on there that does apply to us. So part of this is also a college effort, grassroots effort, us being experts in this space of owning what this looks like as it evolves, of advocating for the quality, advocating for the right things. And then for those of you that are early adopters in this space that have actually done some of this work, let's learn from each other. How did you put it together? What does that look like? What do you use for your patient selection criteria? And how did you evolve that in your decision-making and what's your medical executive committee? These don't fall under the hospital side. So to have an MEC for case review, we're relying that that ASC center has developed a process for that. Well, if you look at the regulatory, there's a little bit of language in there, but it isn't black and white telling us specifically what we have to do. You can check that box pretty easily. So I do think that there's a lot up to us to educate ourselves and help author what this needs to look like for us and for our patients moving forward to make sure we do make sure that all the right quality and oversight is baked in. Yeah, that's such a good point. And it follows pretty clearly off of what Dr. Dahmer was talking about this morning. Do this before it is inflicted upon you. Because we look at the quality measure list on the ASCQR and it's tiny and it's not terribly specific to CV. I would posit at this stage in the game that's a good thing because it does allow that opportunity for CV to define this and do it well and work with the registries to kind of measure all of these things and make sure that the quality is there and that you have the stats to back it up. Because we know when something gets into regulation, it's thunderingly difficult to change it. And so doing it correctly on the front end where you all are the experts is so, so impactful. Great. »» How can I find out what my state regulations are for setting up an ASC? »» So you can, whoever asked that question, feel free to reach out to us because we may have, I've been doing a lot of the work on the different states. So some of the stuff I have right at my fingertips based because I've recently looked at it. If that's not the case and you're going straight in, go to your website for your state.gov and your healthcare regulations and just that's how I do it. I just start Googling it. Or I call Nick. »» There's no substitute for chapter and verse. Look it up. And if you need guidance on how to look it up, we can certainly help you. But yeah, you have to look. Because it's just, it's different everywhere. »» Questions for Nick. What percent of practicing ACC interventional cardiologists have already made a shift of doing cases at ASC instead of the hospital? »» Yeah, you're giving me a lot of credit for knowing something like that. I don't. I would say, you know, if you, again looking at the Medicare data that we put up for the, again, kind of the CV blockbuster codes that are on the covered procedures list, it's not that much. So people are doing this certainly in commercial environments and states with, you know, they're pretty permissive. There's more of it going on. I think we generally know where those are, you know, Texas, Arizona. If you look at the map, there's definitely a heat map for where this is already happening at pretty high volume. But nationwide, this is still very clearly an emerging movement. Yeah. So I don't know is the short answer there. »» I bet it's single digits. I mean, if you really look at all the states. »» And geographically focused, yeah. »» Companies to help stand up CVASCs exist. What is their stance on encouraging registry participation as a core activity? »» So I think it depends on the company. So there's a number, I didn't get into a lot related to the infrastructure in which an ASC is kind of currently evolving. And you can bucket these into three different environments. One environment is where a hospital system that already owns its hospitals and its cath labs and its hospitals decides that it wants to go ahead, I need another cath lab, I'm going to build an ASC. And it's hospital-owned. And most of the time, you know, they're going to want to roll it under some of their existing infrastructure from a quality perspective. And they're much more likely to go ahead and adopt what they've been doing in their acute care side. And sometimes you'll have some crossover with leadership. The second option is where you have a hospital that wants to do that, but they don't want to take on the operational pieces of it. And they aren't even sure they want to take on the full risk of that. So they move into more of a joint venture. And they may even have a joint venture with some of their physicians. And so they kind of create this co-ownership sort of environment. But they're using a third-party entity to manage it and oversee it. By take and look at that third-party entity, every month I think the list gets longer. Many of those entities are ASC management organizations that have been doing ASCs for a couple of decades, but they don't necessarily know CV. So I think it depends, again, on their, if their bread and butter is non-CV ASCs, they're going to stand up the CV ASC very similar to what they stand everything else up. And right now, the quality piece, there's just not, even in those other disciplines, there's not a lot required. So they see it as an extra cost without something that they have to do. And one of the key things when you saw the reimbursement on this, these management companies are trying to minimize the cost. So their overhead. And so anywhere where it's not a required element, they're potentially not including it in their infrastructure. So where I'm going with this is there are a couple of CV ASC management companies that are being stood up to just do that. And because they know CV, they understand the need for the quality reporting and are going to advocate for those things and they're going to figure out how to do it at the minimal cost and how to bake that in. So some of that has to do with, you know, I can line up all the companies and I'm going to say probably 80% of them, it's not going to be high on their list. They're going to assume that the physicians are doing the right thing and then they'll leave it up to the physician operators that are coming into the centers versus the other 20% that are really looking to build the appropriate infrastructure in there. The third entity, I mentioned there are kind of three personas of organizational ownership. The third one are these large ASC companies that are separate from the hospital system in town. I'm thinking of the, I think it's Ambulatory Surgical Centers of America. I don't know, there's three or four of them that have kind of spread and they are like sole owners of these ASCs and then local physicians just practice out of there. So think about it as they're not really integrated with the hospital system or the overall system. They're a completely separate ownership. And again, for them too, they're really good at ASCs, but CV is a new piece. So it all depends on if they're just trying to roll CV in as no different than the rest of what they do without really understanding the nuances and what's required. »» One last question. How can acute care compete with private practices doing a majority of the lower risk cases in their own labs? »» So that's an excellent question. And in some cases where you're in a market where you've got independent cardiology groups that are separate from the hospital that just happen to practice or perform procedures and take care of patients in your hospital, many, depending on the state, they have the ability to stand up their own ASC with full ownership. And you can go from a Friday to a Monday and 40% of your elective procedures just got pulled out of your acute care hospital and you'll never see them again because they're managing them in their labs. So what we're seeing, that's another area I mentioned kind of early in the talk related to that physician alignment strategy. We're seeing where, because it's a pretty big investment. I mean it's millions of dollars to stand up one of these centers. It's turned into an opportunity for some of that joint venture. So the hospital systems that see this happening or want to get out in front of it are looking at this as an opportunity to partner with those physicians and create a jointly owned center that, yep, the volumes still get pulled out, but they're done in a way where we still all have some ownership of it and some oversight of it and can at least predict it and are ready for it. Now the flip side is you all work at hospitals and the majority of them don't have beds. You're struggling to, you know, again we're doing more and more structural heart. We're moving stuff out of hybrid labs into our cath labs. Our EP programs are burgeoning. We don't have enough beds. We don't have enough labs. We don't have enough prep recovery. We don't have enough parking. So for a lot of you, even though it's an, you know, there's like an economic kind of conflict of interest in all of this, it really is a nice strategy to open up your acute care side for those more advanced procedures, those sicker patients, the transfer patients and all the other things. So it really can, rather than it being a competitive fear, it can be baked into a pretty exciting strategy for how do we best care for the patients that are in our community. And this is a great way to do that for those lower acuity patients. All right, well I think we're out of time, but thank you so much to Ginger and Nick for being here today.

ambulatory surgical centers

cardiovascular procedures

transition of care

state regulations

economic implications

same-day discharge

capacity constraints

regulatory frameworks

CMS policy

quality assurance