Welcome you to San Diego Heart Rhythms 2025, the 46th annual meeting of the Heart Rhythm Society. If you have not already done so, please download the hashtag HRS2025 mobile app from the app store. There is a QR code, you can submit your questions or you can go up to the mic and ask questions at the end of every speaker. And now, without further ado, I would like to invite Amy Tucker, who is visiting us from Sanger Heart and Vascular Institute to speak on innovative device clinic business plans and what works. And by the way, I'm Uma Srivatsa from UC Davis, Sacramento, California. And my co-chair is Chris Liu, welcome. Thanks, Uma. We wanna welcome you to this third and final business of EP session. And we're gonna be talking about how innovations will help to keep EP from going extinct. Thanks, Amy. All right, thank you everybody for hanging in till the final hour here. I am going to talk today about some innovative device clinic business plans in 10 minutes or less. So I thought, you know, the device clinic is a revenue generating department. So I wanna focus on some billing and coding issues, misconceptions, and spend some time on that. And then talk about just some key factors that influence device clinic revenue. So I wanna start out here with business considerations for in-person CIED evaluations that we've experienced in our organization. So we all know that in-clinic device evaluations require direct supervision. And that's with the provider in the general vicinity, immediately available, but not necessarily in the room when we perform the test. That is a CMS guideline and a requirement. And here's what happens at our institution. Our physicians have to leave the office. We're in an ambulatory office. We have to cancel device clinic patients. We lose revenue. That is a waste of time. And it's also inconvenient for our patients who are either on their way into the office or there already. And I wanna bring your attention to this slide because this is relatively new as of 2021. APPs can now act as supervising providers for level two diagnostic tests. And so when a physician has left the office and we have an APP in the office, we don't lose that revenue. We don't have to cancel patients. We move along as we go. This is probably one of the biggest misconceptions of device clinic billing that I have seen. Many organizations think that they have to charge for an in-person interrogation because the final parameters of the device don't change after the interrogation and this is false. So the interrogation is the interrogation only. That's if you're doing a battery check and you just need to pull some information out of the device. Programming includes iterative adjustments, which is what we do when we test a device. The final program parameters do not have to change at the end of the check. What's the impact of this on in-person evaluations? Well, an in-person interrogation is exactly the same as a remote transmission. You get the same exact information. So when you bring the patient into the office and do an interrogation, that's gonna fall into the 90-day remote monitoring period if you have your patients on a recurring 91-day schedule. We can't charge for both remote and interrogation. So we're gonna lose that revenue. People need to charge for the programming fee in clinic if you are testing, you qualify for billing this in-programming charge. And you can bill as many in-person charges for checks in the office as often as is medically necessary. So let's move over into remotes, which is another big deal. Pacemakers, ICDs, and CRTD devices, the interval scheduling is 90 days. For ICMs, that is 30 days. Here's what happens with these remote transmissions. If I write up a report for my provider on January 1st and he signs that report 93 days later, we're gonna get reimbursed for that, professional fee and the technical fee. But I've got my patients on a recurring 91-day schedule. And so after January 1st, on April 1st, 91 days later, I'm gonna write that report up again and the doctor then signs it on the day that I write up that report. When the physician signs that report, that is the date of service. And if he signs on the same day, we lose that professional fee and we have to write it off. So there's a big revenue loss there. So I went ahead and talked about this before I talked about, showed you the slide. I think this is important and I'll tell you what we did at our institution is we looked at this CMS guideline. This is what our billing and coding experts and our mid-revenue cycle experts are looking at when they are determining how often we can bill and when the date of service is, whether it's the date of the interrogation or the date of the interpretation by the physician. Look at this, 24 or 48 hours, 30-day period. That is a wearable Holter monitor or an event monitor. That is not an implanted device and with interval-based remote monitoring. So at my institution, we worked hard, hours and hours of meetings, to convince our legal compliance and our revenue billing and coding cycle to allow us to link the date of service to the date of the encounter. The guidelines for this are very vague. You have to really pull in the people who will look at all of these rules and give you approval to do so. But what that's gonna do for us is generate more revenue that we're losing now. And the last thing that I want to talk about, I have flown through this, I'm so sorry. Billing during the 90-day post-surgical period. This is another big misconception and what happens is people think, oh, you can't bill for that wound check in that first 90 days, which is absolutely true. But you can bill for the diagnostic test. So pacemakers, ICDs, and CRT devices, for remote monitoring, just require 30 days of remote data. So on day 31, post-implant, you can bill for that remote transmission, it's a diagnostic test, but you cannot bill for the wound check. For an ILR, you need 10 days of data in that device. So on day 11, post-implant, you technically can bill for that diagnostic test. Again, you can't bill for the wound check for the full 90-day post-surgical period. And again, what I mentioned earlier was in-person evaluations can be billed as often as is medically necessary so we can bring those patients in. And remember that the interrogation, in-person interrogation, is possibly where you are going to lose revenue. I ended up including this CPT coding summary because I wanted to just bring attention to if you can see the in-person interrogation, those are the codes you wanna stay away from, 93288, 93289. When you are checking these devices, with the exception of the loop recorder, you're going to bill anything from 93279-8081-828384 even if you don't make changes to the parameters at the end of the chat. Also, the 93297 now, 93297 is the heart failure diagnostics. That is a global code now, and 93298 is for ILR interrogation. So I really flew through that because I was afraid that I was gonna go over my 10 minutes, but thank you very much. Thank you, Amy. Thank you, Amy. So we're going to have a dedicated time at the end of the session for questions and answers. So our next speaker is Brett Atwater from Inova Health, and he'll be talking about a successful hub-and-spoke model for atrial fibrillation care. Great. Thank you to the committee chairs and for the opportunity to speak about the hub-and-spoke model. Let's see if this will come up here. There we go. So actually, change the title of the talk to The Hub-and-Spoke Model Fails Patients in the Care of Atrial Fibrillation, and I'm going to go through the data that I created to help understand how the hub-and-spoke model works for AFib care and try to convince you why maybe that's not the best way in the United States for us to manage atrial fibrillation. So I'll go through first what is the hub-and-spoke healthcare model in the U.S. I'll orient you to Northern Virginia, which is where our health system is and our health system, the Inova Health System. I'll talk about the impacts of the hub-and-spoke model on AFib care in our health system, and then the importance of data to eliminate care disparities, which I believe the hub-and-spoke model actually is creating. So the hub-and-spoke model was really advocated for in this very highly influential article that was published in the Harvard Business Review in 2013 titled The Strategy That Will Fix Healthcare, and it's a really sort of attention-grabbing title. It's written by two really famous and influential health economists, Michael Porter and Thomas Lee, and they really brought to bear the idea of value-based care in the United States. And what they said here is, hey, some hospitals are doing things better than others, and we should try to concentrate care into those places that are doing it best. And we should focus on paying for value instead of paying for quantity when it comes to healthcare. And so they made some very specific recommendations for health systems in the United States, including concentrating high volume into fewer locations that do it best, integrating care across multiple locations, and then shifting more routine care to small hospitals and more less routine care to the more specialized hospitals, which they coined as hub hospitals. And then these hub-and-spoke type models that they described should then try to expand their geographic reach. And at the time, the Cleveland Clinic had been extremely effective using this model in the Cleveland metropolitan area, and they said, look at how well it works for Cleveland. This should be done really throughout the United States. And this had an influence on the health system that I work for, the Inova Health System. Prior to my arrival there, they had developed a hub-and-spoke model by acquiring several hospitals in the region. The main hospital is in Fairfax, and then we have sort of spoke hospitals, four spoke hospitals throughout the region. The hub hospital has high volume. We do all our complex work there. We have extraordinary ICU capabilities, super specialists in surgery, EP, for example. Everything was sort of located there. And then we have really, really good, up-to-date, latest available technologies. In the spoke hospitals, they were lower volume, fewer beds in the hospital, lower ICU capabilities, low-risk procedures, a lot of gastroenterology type work there, but not a lot of EP, maybe a cath lab in some of them, but really not a lot of advanced stuff happening there. Northern Virginia is in the D.C. metropolitan region, which is the sixth largest metro area in the United States. Northern Virginia is where most of the suburbs for that live, and we have about 2.2 million people in the most recent census in Northern Virginia. Our health system is located right in the middle of all those suburbanites. We're just over a $6 billion health system. We're organized into service lines, according to what Thomas Lee recommended in that article. We started as the Fairfax Hospital, which was built relatively recently, in 1958. Between 1987 and 2004, we acquired all these other hospitals in the region. And then in 2020, when I arrived on the scene, we had three EP practices with 15 physicians, 15 EPs, all working in the main hospital. No EPs really working in any of the spoke hospitals. So when I first arrived, I wanted to understand the AFib market and where people were living. So this is the main hospital, right in the center of the region. This little square here is the District of Columbia, and this is the Potomac River, which we use as a wall to keep everybody out of Northern Virginia. This is the big hospital, 923 beds. This is the next biggest hospital, which is about 20 miles away, and about a 35 to one hour drive, depending on what traffic looks like. And then we have surrounding that hospital throughout Virginia, these other hospitals, all of which are between 30 and 40 minute drive during good traffic conditions, up to an hour during bad traffic conditions. So I said, okay, well, the hospital's built in the place where the most people live. The population density is darkest green there, so that makes sense. But then when I looked at the population density change between 2010 and 2020, things got a little more concerning for me, and that's because the population density in Fairfax is about as high as people are willing to tolerate, so people keep moving into areas outside of there. It makes sense why we bought the spoke hospitals. That's where the growth is happening. But when we have all the high density and complex care happening here, people are moving to the areas further and further away from where that highly specialized care is being delivered. When I arrived, this is what the ablation volume numbers looked like. This is in 2020, so as COVID was happening. But you can see we did about 500, we did exactly 590 afib ablations, 574 SVT ablations, and 130 VT ablations. So I went to the CDC website and figured out how many people had been hospitalized in the hospitals throughout Northern Virginia. It turned out 18,500 people had been admitted to hospitals with symptomatic atrial fibrillation during that time. So only 590 afib ablations were happening. That means only about 3% of people who are being hospitalized with symptomatic afib at most were receiving an ablation for that, and I thought that was probably underutilization of a highly effective therapy to prevent hospitalization for atrial fibrillation. So I wondered why aren't people being treated with ablation here in our market? And numerous studies have shown a positive relationship between provider and hospital volume and procedure outcome. I understood that. However, this resulted in this hub and spoke model in our market and in a lot of markets. And between 2016 and 2019, about 50 million Americans lived in micropolitan or rural areas in the United States, but only 1,300 afib ablations were performed in that. So while 13.9% of the people live in rural areas, only 2% of ablations were performed in that area, which meant people needed to go to suburban and urban areas to get access to ablation therapy in the United States. So the question I asked was, did centralization of afib care in our health system improve the value of that procedure or simply make afib ablation unavailable to the patients who lived too far away from our hospital? And more importantly, were the travel times reducing access to afib ablation services in our market? There are really interesting studies on this exact question that have been done in other areas of medicine. This is a study about abdominal procedures, and they had 100 patients in a VA hospital waiting for an elective abdominal procedure, and they were asked to imagine that they had resectable pancreatic cancer. And then that procedure, the resection of that pancreatic cancer, had a very high mortality risk in their local hospital, and they had another hospital four hours away by car, and would you be willing to drive that hospital to get a lower mortality risk associated with this resection procedure? And they adjusted what that difference in mortality was going to be and the distance that people would have to travel. And this is the curve that they generated of the relationship between the proportion who said, yeah, I'm going to stay local, and what that difference in mortality was. You can see when there's no difference in mortality, everybody's staying local. They don't want to make that drive. But as the differences in mortality start to go up, then people are willing to make that drive. So about 80% of people are willing to make a drive of four hours or more once the mortality difference reaches 10% between these hospitals four hours away and local, which makes sense to all of us. We would all probably drive that far in order to get to that hospital. But the right side of this curve is really interesting, and that is despite really escalating differences in mortality for this procedure, a lot of people are still unwilling or unable to make that drive. And of particular interest is that when you get to the very far right side of that curve, which isn't shown there, and you increase the difference in mortality to 100%, meaning you're guaranteed to die on the operating room table, 10% of surveyed patients said, no, I'm still having it local. I'd rather die than drive four hours to get that surgery. And there were some predictors that they looked at for what would drive somebody to make such a decision. And not surprisingly, older age, fewer years of formal education, and socioeconomic status were the biggest predictors of this. So if you don't have money to make that drive, or you're old and can't make that drive because you can't see well, or you don't have a driver's license anymore, you can't make the drive, you're going to die on the table locally instead of making the drive. So I wondered if those same things would drive differences in EP access. So I looked at the distance of site of care to determine whether that increased the probability that you'd avoid ablation in our market. First I wanted to see where are people accessing care. So Blue is our hub hospital, and you can see the majority of people are actually accessing care in our emergency departments outside of the hub. That's a big problem when we only offer ablation in the hub hospital. So 4,800 ER visits in our system for AFib at the main hospital, and the majority, almost 6,000, seeing people in ERs at the spoke hospitals. And then when I looked to see what the probability of receiving an ablation within a year of that ER visit was, it was 1.9%. If you came to the Fairfax ER, you're going to get an ablation at the Fairfax hospital. And as the distance and the travel time increased, you got further and further away from that hub hospital, the probability of receiving ablation as a treatment option for that symptomatic atrial fibrillation dropped off pretty dramatically. And you can see the P value starts to go up, and it becomes statistically significantly different 12 miles away from the hub hospital. And people stopped being willing to make that drive, which in our traffic is a 30-minute drive. So people aren't willing to drive 30 minutes to have an ablation. They'd rather continue to have episodes of AFib that resulted in symptoms bad enough to get to the ER and then subsequently hospitalized. So we made some changes to the way we do things. In 2021, we started an ablation program at the hospital furthest away from our main hospital, and that was pretty complicated because travel time is difficult. So we did a really intense work with our local Aerovac company. We had a dummy get into the helicopter and fly to the main hospital. We showed that it was a 23-minute trip from our EP lab at the spoke to the main hospital operating room. Felt like that was safe, and we were able to get that done. We opened a multidisciplinary AFib center. We opened up a fifth lab in the hub to accommodate additional patients there. We hired some new electrophysiologists. We added some additional clinics in the spokes. And then we started AFib ablation program in a second hospital, and these are the results of having done that. This is the growth in the probability of having an ablation within a year of showing up to the ER. It climbed dramatically in the hub because we had better access to that AFib center. This is the date that we started that ablation program at the Loudoun Hospital. You can see an immediate return on investment by having done that, and the probability of getting an ablation if you show up to the outside ER now is approaching what it is in the main hospital. This is a control hospital. We didn't put the ablation program in there until the end, 2023, and you can see no difference. And so it really was putting the ablation program into the spoke hospital, delivering the care where the patients want it, which is close to their home, allowed us to see improvements in the access to care. Obviously, this increased the amount of ablation that we're doing. We went from 590 cases to 1,282 cases in 23. This year we're doing over 1,500 cases, so it works to grow AFib if you put the services into the hospitals where the people live. So in summary, value-based care is great. It unfortunately creates probably some healthcare deserts in the more rural parts of the country. Some people simply aren't willing to drive or unable to drive to the hub to get access to care. And health systems that identify opportunities to help break down these systems and deliver care where people want it, which is close to home, likely are going to reap a large return on investment while improving AFib care into the communities that need it. Thank you. Thank you so much, Brett. Now we'll have a debate. Third party to monitor devices, benefits and challenges. To speak on the pro side is Blaron, and on the con side is James Alred. They will go first, and then they will do a rebuttal each. Okay, thank you for this opportunity. Okay, so third party to monitor devices, benefits and challenges. No disclosures other than I'm CEO of 91 Life and run the AI division there. Before we talk about remote monitoring and just in general patient care, or as we started to work on the platform and work with clients, our principles are around what you know as quadruple aim, which is basically care for patients, population health, and then reduce cost of care, but also improve the well-being of the care team. So, I'm going to make three key arguments here in favor of working with third parties, and there are four other arguments in the rebuttal that I will just sum up in terms of what the future holds and why it's important to now increase the collaboration with third parties. First, I would say, I'm not sure when I saw this topic, I wasn't sure if we're talking just about service, but third party, I guess you mean third party and collaboration in particular includes working with those parties that have developed a platform, and I would say it's imperative now that hospitals and health systems and clinics are working with third parties that have developed cloud software. So this is a representation of some of the steps aggregated in terms of remote monitoring today or as it has been prior to third parties developing these platforms, and you can see there are significant challenges. One would say this is a picture, a representative picture of how things looked or would look in a system that is still going to multiple different sites and downloading reports and then trying to aggregate them and have them signed and so on and so forth. The idea is to have a platform that has zero dependence and has consistency across the different device makers and different devices and ultimately probably replicates every technical function with automation, not just for implanted devices, but beyond that as well. Just to illustrate, this is what would bother the brain of an engineer on a third party site that works with integration, and this would be sort of a unique case within a hospital in terms of how a hospital health system that has Epic, for example, how that integration would work. Bottom line here is third parties are much more equipped to understand the intricacies and difficulties of integration as one of the problems. The other one is automation around scheduling. Someone that's looking at remote monitoring and scheduling comprehensively will have a significant advantage in terms of understanding some of the intricacies. And then, of course, as we've seen on multiple occasions and across use cases, there's a significant increase in optimization of billing when it comes to understanding those codes as was the first topic of this discussion. So ideally, you want a single point platform for monitoring of implanted devices as well as wearables at some point and certainly holders and so on and so forth. I'll take one sort of large health system. This is literally I took sort of I asked the question to a practitioner that runs one of the largest health systems in the country, and they're using software only. They're doing remote monitoring themselves but using software as a third party. This is her impressions in terms of what the impact was to the program before and after. Now, in one picture, sort of instead of 1,000 words in such a short debate, I'll say what you had is a rotary phone. Then you got this sort of cell phone large version with the first platforms like Paceheart and so on and so forth. And now with cloud software, you have more of a version of an iPhone. So third, second argument maybe the more critical one is labor services. Are there benefits that warrant both the cost and the challenges of working with a third party? Again, from the same principles of guiding care on the basis of quadruple aim, I'll say that the first one we started 91 Life, my idea was automation to remove labor services. So I was on the opposite side of this argument. And the thought process was, well, if you have good technology, then that should eliminate errors and automate a lot of the stuff and reduce the time the practitioners spend on the different software and platforms and so on. And you get efficiency and financial benefits. So when we looked at sort of what it takes to build a holistic platform that encompasses all these aspects of automation and benefits, then we were driven by this idea first of sort of what are the different aspects of or different alerts and different mechanisms and benefits of monitoring and alerting to different sort of aspects of alerts that come from these devices. So we tried to put a sort of triangular presentation of, let's say, where these fit in this kind of three-dimensional picture of what is the probability of this being an adverse event and then what's the ability to take action. And then what's the sort of the severity of the timeliness of the information. So ultimately, I looked at, with the team, sort of these are all the different aspects and different processes and workflows around remote monitoring. And we're looking at one by one sort of how this works. And I'll say that in conclusion, we realized that the operational realities on remote monitoring of CIDs is far more complex than it would look from an outside perspective, in particular just from a software company or in particular if clinics wanted to do it themselves. So there are benefits related to education and sort of working with the IT department, for example, to make sure that the delivery of these technologies is appropriate. So I'll throw a curveball sort of outside of the plate, so to speak, but other challenges around at what time should you monitor these alerts, you know, nine-time included. I'm not going to go into this, but, you know, something like we've developed this concept of REDD+, which means immediately important to see the physician or to send the information to a physician or a practitioner. And in conclusion, if you look at all of this, basically combined with efficiencies in economies of scale, you come to a realization that working with third parties creates dramatic efficiencies, creates economies of scales, and allows the health system to optimize the device clinic, not just from a point of view of labor service or software, but this sort of collaboration that creates the mechanisms for addressing these alerts and timeliness and scarcity of resources. And I asked the CEO of one of our competitors. In fact, when we realized that service was exigent, at least for now, we partnered first with Ambucor, which we later acquired, and more recently we partnered with Cardiac RMS as well. So here is the perspective of sort of a competitor in the space. Manpower is most challenging, in particular as it comes to geographies where you're going to source all these different sort of clinicians. And then reimbursement challenges also become quite difficult to manage for a small team, in particular the APPs and nurses that are handling 50 different things. And then dramatic differences in patient volumes produce a more consistent and timely output. And this particular service provider said that less than 0.1 percent of the reports were missed. So at least for now, my argument is that we're far away from avoiding third parties as collaborators in the management of devices for remote monitoring of implanted devices. Thank you. Thank you, Blaron. So, you know, as you've seen, we've actually intentionally had our two debate speakers come from industry. So Blaron had a little bit of a challenging topic to actually give the pro without being too pro. And now we have James to give us the con side, actually, also from some industry perspective. James, thank you. So Tom Dearing called me and said hey James would you do this debate I'm like sure I'm happy to and then he said oh by the way you're going to do the antagonistic side of this and he kind of chuckled when he said it and he said I'm sure this can be hard for you I said Tom not at all I said that's my why that's my passion that's what I do every day the reason Amber Seiler and I started CV remote solutions was that we looked in our space and we didn't see a company out there we would trust our patients with and that is our why and that's why we do this and so I'm really actually glad that I can highlight all the important things that you need to think about before you even consider outsourcing to a third party so there's a lot of data already in the space about the benefits of remote monitoring plenty of data there and we just heard from Blair on and I didn't hear one trial not one about the benefits of remote monitoring using a third party do we have any data I'm not so sure that's the case and so I think there is a paucity of data in this space and I was able to visit Blair on in his team in February in New York and I'm glad I did because I was able to see how smart he was and how great of a heart he has and the great people that he surrounds himself by with his team and so because of that I decided I wasn't going to highlight the fact that he's not a clinician or that he's never been in a clinic or he hasn't been a rep and then he really doesn't know what clinicians might even need in this space and I said that wasn't appropriate because he is such a good guy and they're doing such amazing work but there is a paucity of data in the space and when I look at the things that Robin Leahy is doing with pacemake to get this data when I look at Amber Seiler at CV remote solutions and what she's doing to generate this data and I see John Ankeny and his team at evoke and I see all the energy they're putting into this data I feel reassured that we will have that data over time but but just recognize that's not the case clinic disruption is certainly a problem when you bring in an outsider into your clinic they want to change your workflows they need proprietary software and all these other things that can be hard who owns your patient once you turn your patient over to a third party and they lock them into their software how do you protect that patient and their data and what about quality concerns who is following these patients do you know them by name do you know where they're from are they even u.s. based you would think that that would be a given and often it's not and then do you get consistent results it's the same person going to interact with your team every day are you gonna have one of 50 people and 49 of them might have great quality but there's this one that you really don't want taking care of your patient how do you ensure consistency when you're doing this and then he mentioned revenue positivity for the clinic and that's important and and I did say back in February I went to visit player on in his team and gosh Fifth Avenue we were right there at Radio City Music Hall at MoMA and the plaza and I said I wonder how far we are from Trump Tower and I looked up and I could see it because we were two blocks away and I said gosh I think there probably is a revenue opportunity for the clinic and maybe we should keep that within the hospital system because our hospitals are struggling financially today and it's not unreasonable to keep that resource there and your hospital is going to have to expend resources from IT and security and legal and all these other things you have to keep that in mind and this recently came to mind reliability of service because this letter just came out from Phillips on April 2nd to Geneva clients and it said as of June 30th you're no longer gonna have service from Geneva and the software platform that you use is going away now what disruption is that to a clinic and what are they gonna do we know they can't turn things around overnight we know that they are going to be challenges faced in situations like that like that right what about internal disruptions of communication our AFib clinic at Cone Health can pull off their care link website and their loop patients who've had AFib and they know immediately how much AFib they've had real-time in clinic well there are third parties that actually take away your complete access to things like care link how do you continue to have successful communication internally when that happens and who's overseeing this remote monitoring third-party company do they have a physician doing that do they have anyone doing that do they have a super smart mathematician from Wall Street doing that who is overseeing the quality in that clinic and I think that's really going to be important I think in 2025 any legit remote monitoring company should have a full time electrophysiologist managing quality and overseeing operations I don't think that's unreasonable to ask and then private equity we could talk about that all day there's so many studies out there that talk about private equity and its harmful effects on health care and unfortunately the majority of third parties are now owned by private equity and here's a review of when you look at things like health outcomes when you look at cost of patients and payers when you look at cost of operation and you look at quality the majority of these studies when looking at private equity show harm services tied to software what if you love your software but you don't particularly love their service can you uncouple those could you use any software platform you want and maybe look for a better service provider I would argue that you should be able to do that just because someone has really fun software doesn't mean you should have to accept subpar service that comes with that but as we know it can be really hard to uncouple the two I think we should keep that in mind and what about your staff you know people who've outsourced for two or three years now often have people in their clinic who have never read a remote and so what does that mean for the future of that clinic I think it's very important for clinics to have clinicians in the clinic reading remotes and what about your fellows to have exposure to these kinds of things I think can be valuable to your team AI I think is a term that we love to throw around today and I think we have to demand as clinicians critical appraisal of the data coming through and how it's looked at by AI and then patient consent your patients data is out there you've got a third party involved quality this care that shouldn't they maybe have some input into their own care should they maybe be able to consent into this and then if you're in your clinic and like Anne-Marie who really talks about quality improvement like what if you and your clinic want to know what your compliance rates are and your connectivity rates are and your errors and all these things when you turn things over to a third party largely you lose the ability to do that inside certainly there could be legal and liability concerns this could be another portal for cyber hacks or issues with your patient health information and this one right here if you don't hear anything else I'm saying today I want you to hear this compliance with hospital policies insurers and government bodies is essential and if you're not careful you will end up in big trouble as has been shown the DOJ is not playing with these allegations and things of remote monitoring companies and anti kickback and some of these other things it's incredibly important that you see that you'd say what gosh James these are a lot of examples but they're all industry why do I need to worry about that as a clinician well because the DOJ is now coming after practices as well and so what you can't do is say oh yes remote monitoring company you're gonna charge me $15 a month for this loop recorder and you're gonna do all the technical work I think I'll just charge Medicare 70 and I'll pocket 55 that's illegal and a lot of third parties are doing that and a lot of well-meaning clinicians and clinics are going to be in trouble if they don't heed that and so met med axiom recently has put out a resource on their website that I want you to know about I want you to go look at it if you're thinking about working with a third party just to make sure that you're compliant because again these violations for anti-kickback are real we recently partnered and did an international survey of systems across the country and and what we asked 471 folks 75% who were clinical 85% with more than 55 years of experience was would you outsource your remotes are you today and would you and so this is not one CEO from a competitor but this is 470 well-meaning clinicians and what they said was no thank you Round rebuttal. It's a great job, James, I actually want to take your points and use them as our marketing materials. There's all these questions you talk about. First of all, if hospitals should not pay for any service in which other companies make money, they should have their own taxi service and make their own computers and their own bricks and so on and so forth. So not the strong argument there, but other things, you know, as a judge in Bronx Science, I've learned that one of the most important things in the debate is there has to be a vehement agreement around a point for two people to even debate. So this is where I agree with you vehemently, James. If you're going to outsource your remote monitoring, then it better be to people that are as invigorated, as passionate, and as obsessed about doing this right as you are. So again, going with the same principles of quadruple aim, and looking forward, because a lot of what James was talking about is the difficulties of current state, then I say that you have two options, maybe three, and you can remain intransigent and keep doing things the old way, or secondly, you can be a follower. But if you're in the bandwagon of working across the industry and collaborating and sort of looking at the R&D opportunities and shared intelligence, then you're going to both improve your clinic, your services to patients, as well as contribute to a global improvement and become participants or stakeholders rather than followers in this process. So my wife's an interventional cardiologist, so if you want to sort of defeat a physician these days, you just throw the word AI and some magic happens. So here you go, James, I'm throwing AI. This is why we started the company. We have more than 60 engineers, more than half of them have an IQ over 140, so our obsession was not to increase the top line and to provide service and go get private equity money. We've gotten zero dollars from VC or private equity. The other remote monitoring companies, most of them, unfortunately, are still losing money. But the idea has been from the beginning for us to galvanize the physicians to empower them, and not just physicians, but the entire clinical team with intelligence from data and from big data, so there's actionable intelligence in improving care and solving the problem that we have in healthcare generally. And electrophysiology is a great breathing ground for that. So if AI were to work, this is how things should work. You go from high tech through data science, and ultimately you get precision medicine. Ultimately, the objective here is to restore the trust and the power of the physician-patient relationship. If physicians are going to become stakeholders in this new age of healthcare 3.0, digital health, and AI for precision medicine, throwing a lot of terms out there, then the only way they're going to do this is by participating intently, and as they participate, they ask for their stake for making this contribution. Otherwise, they're going to be passive, and you're right, data is going to belong to somebody else. They're going to do all this work, and you're going to have this dichotomy of disintermediating the physicians in which we do not believe. So ultimately, we see this sort of integration where you have integration of data, concise insights to physicians, the doctor-patient decide the care, negotiate with the rest of the system. It looks complex. You know, this is how AI and medicine for the EP would look like. That's something I can debate in two minutes, but I'll just leave you with a quote from what's considered the godfather of deep learning. His students are the ones that created OpenAI, pretty much, and Geoffrey Hinton said, we need AI to give doctors superpowers. The way to do that is to work with third parties that are mathematicians like me, technologists, and physicians. This is a union of people with the strength, the power, and the intelligence to change medicine and not to, what did Dr. Hinton say, not to live in the status quo, James. Thank you. I agree with Blair, and I think the importance of collaboration is huge, and what's at stake here is our patient and their care, and so it absolutely makes sense to do what he said. And do I think that clinics should own their own patients? Absolutely. And do I think they should do it themselves? I do. But the reality is there are a lot of challenges, and when you think of staffing, it's near impossible to do that today, and when you look at all the barriers that these often overwhelmed and burned out teammates have, it's near impossible, and so there is certainly opportunity for collaboration with others. Again, I want to reflect back to this recent international survey we did. It was in last month's Heart Rhythm 02. Please go look at it. In that, 42% of the responders said that they felt like they had very insufficient staffing in their clinic, and 25% felt like they had somewhat to very inefficient workflows, and so there's so much opportunity, and for us to collaborate together is important. There's so many burdens that they talked about. I want you to just please go read that. It was really enlightening. So I think outsourcing has really just gotten a bad name. I want to challenge you to smart source, okay, with your patients. I think you should know your staff's limitations, be engaged with them, and find a way to augment what they're doing with third parties when necessary. I think you should partner with very dependable and high-quality companies when needed when demands are high and at the right point. You should look at device clinic optimization, and you should look at consulting by well-meaning, experienced clinicians, because they can really help you and your team, and then I think you should incorporate the experience and quality support of others to do even better things, heart failure, research collaborations, patient education, staff education. There's huge opportunities. I want to finish with this slide. Ten things I want you to consider before you outsource. These are the ten things, and the first one is references, references, references. This isn't the first time someone's outsourced. Talk to people around you. This is a community. You know, what has gone well and what hasn't? Learn from other people. Expect and demand quality. People reading your remote should be certified, and there should be a quality assurance program in place with the company you're partnering with, and again, I think there should be a full-time electrophysiologist associated with that team. I feel like we should uncouple software and service when we can, because I think you can do one great or the other, but it's very rare that you can do both great all the time. I think it should be U.S.-based. I think they should publish what their compliance rates are, what their error rates are, and things like that. I think it shouldn't be a side hustle. I think this should be what they're committed to for you and your patients. It's what you're paying for. It's what you should expect. AI is great, and we need to look at large volumes of patients in which the AI was applied and critically appraised. I think, you know, 91 Alive's doing a great job. I think Implicity's working hard on that, and I think that that's something that we should expect and demand, potentially with FDA oversight, Medicare compliance, we've already talked about, cybersecurity measures, and then finally, feel free to ask them, you know, have you been terminated early from an account? If so, like, why? It's not unreasonable to ask, and are you having legal or DOJ investigations? You could probably look them up. That's important for you to know. I think if you do these 10 things, you can smart source, collaborate, and do great things for your patients. Thank you, guys. I think that was a phenomenal debate. When we were putting this session together, we were discussing whether we should just have talks, but debates poke holes in each other's topics, and they bring out a lot of thought-provoking questions, and so, which they both did, and from the audience, there is a question. If you do remote, but the patient came in to check a lead, you can still charge both? You can, technically. Because the in-person evaluation is medically necessary. You're checking a lead. You can't test via remote. So this is open for discussion and question-answers. Please just identify yourself and where you're from, then. So my question is, remote monitoring. Develop a heart failure monitoring protocol. I think there are some pitfalls to developing where you might start to cancel out some of the other pacemaker interrogations. They're trying to tell me something about how that works. If you could try to explain the timing of the heart failure coding, remote coding, as well as how you can time it to get the maximum amount of revenue. So the heart failure diagnostics are a completely different set of diagnostics. You can bill for the CID check, and you can also bill for the ICM fees that live within that device. Of course, the pacemaker and the ICD and the CRT are every 90 days. That's that 90-day billing interval. And heart failure diagnostics are 30. So interestingly, you can, back in the day, when we were, when we did not have heart failure diagnostic nurses, which we have now at Sanger Heart and Vascular Institute that take care of triage HF and heart failure and cardiomyems and the Zoll patch, the device clinicians were doing that work. And when we interpreted the ICM diagnostics, we billed the professional fee. You can't bill the technical fee because we just billed the technical fee for the CID check, but you can bill that professional fee because, again, ICM diagnostics are completely different. Did that answer your question? Yeah. So basically, they shouldn't cancel each other out, heart failure and remote monitoring. They should not. Now, cardiomyems cannot be billed. This is probably not what you were asking. The ICM diagnostics that live in the device can be billed. Technically on that same day, for some reason, cardiomyems, the 9-3-2-6-4, you cannot bill that on the same day that you bill for a CID check. Thank you. Yeah. Jay Schloss from Cincinnati. This is kind of a follow-up to the idea of heart failure billing. I'm just curious what maybe a poll of anyone and anyone wants to jump in. Who does the reads and gets the revenue for those 30-day heart monitor billings? And I think in our institution, they're being done by electrophysiologists. And our stance on that is these are our patients. We're kind of like radiologists, if you will. Like a radiologist would read an X-ray and share the results with someone else. And maybe a more pressing clinical matter is these heart failure reads are not isolated. They also include a ton of arrhythmia and device integrity data, which our heart failure colleagues are really not qualified to read. So we'd have to overread them anyway. So I just wonder what other people do, if there's any turf wars over that that other people have been in. I can tell you across 100,000 or more patients we're following, there's a lot of political decision around that in different accounts. And the reality is, it can be an either, right? So my practice, we had electrophysiology just like you following these. And in a lot of places, they have huge, robust heart failure programs, such as Sanger, where the heart failure team 100% owns that, I think. Maybe not quite 100%. But I think what we often find as a value of outsourcing is that we have the same team, and I can triage it either way. And so let's say heart failure's like, we worry about missing a fractured lead, we worry about a LV lead that's not captured, we don't want to miss that, or VT or AF or whatever. We have the same people reading the heart failure that reads that remote, and so they can turf that over to EP, and then they can turf the appropriate heart failure over the other way, and vice versa. It's kind of putting the clinical onus on the third party, which I don't think any of us want them to take responsibility for a missed fractured lead. That's us, not you or the third party. We're ultimately responsible. You made the point that the consistency of, we should never rely upon them to make clinical decisions. So if a fractured lead never even made it past an electrophysiologist, that would be bad. I agree. They're still going to see any alerts that come through. And so ideally that fractured lead would be on there. Ideally the heart failure diagnostics are pretty straightforward, and the heart failure team can be triaged to those. But whether you do them third party or internally, the politics are largely the same. Sure. And just to supplement that, so we have both cases where service people are monitoring outside and clinics that are doing it internally. Alerts will go typically to the electrophysiologist. The monthly heart failure reports will go to the heart failure physician. So if the service company is providing service, they will charge the technical fee just the same. But the professional fee in Epic, for example, or other EMR will be dropped for the EP on alerts and 90-day monitoring, and then for the heart failure physician and 30-day monitoring. So these can sort of both work in conjunction. Yeah, I hear. It ends up in a big practice. It's a pretty big, you know, it's a business meeting, right? This is a pretty big revenue source. So I can see the political battles. I still would say we would still have to overread, and we're not really thrilled with the idea of overreading and not being compensated. I think the unfortunate part, though, I really believe in this technology and this opportunity for patients. And largely, we don't get past the politics, and the patient might be the one that suffers. Yeah, obviously, we're not letting that happen. Actually, I have a quick follow-up to that, which is what you mentioned about, you know, missing something. So, you know, where does the liability lie when there are third-party vendors involved? So the expectation is that the professional fee and what's generated there is on the clinic. And the expectation is that the clinicians are looking at these remotes also, you know, to get that professional fee. And so I think largely, it lies on the physician who's doing that work. Tom? Tom Daring, Atlanta, Georgia. First of all, James and Blairon, I want to thank you for a very engaging debate. I thought it was wonderful. I actually thought you won, James. No offense, Blairon, but, you know, in the real world, I think we would prefer that all of this be done in-house. But for a variety of reasons, which you both enumerated, that's not the way it's going to be going forward. And that's why, you know, you left to go into industry. Some people would say you went to the dark side, but I'm actually going to say you went to the light gray side, you know? So I think, you know, and we need to do all those things that you listed as your, you know, items on that last page. If you do that, will you continue to work with the partners outside, and you'll continue to be able to assess quality, to assess how you can do a better job, and to have continuous quality improvement, which I think is key. So thank you both for doing that. There's no right or wrong. There's no absolute answer. Brett, I have a quick question for you, if you don't mind. You know, there's a lot of debates about private equity and all about ASCs, and, you know, it's a very sexy topic right now. You know, a lot of people of power in our society have weighed in on it. You know, and one of the concerns I have with ASCs, and we're actually having a Hyde Park debate on that Sunday, is that, you know, although you can have a backup plan, and although you can, you know, have all the things in place to make it safe, you know, there's always a small possibility, and it is small, that you could develop a complication in an elective procedure that is, at present, designed to improve quality of care, not duration of care. So having a life-threatening complication, which will occur very rarely, but will occur, if we're going to acknowledge it, is the problem. So you've done a great job with opening up other ablation centers at a hospital. We've done the same thing in our institution. What safeguards have you put there, and do you think it is actually safer and better than doing it in an ASC? And pretend there are no fiscal reasons for doing the ASC, because I think between joint ventures on the part of hospitals, versus using outside capital, et cetera, to build your ASC, that could be made neutral if we had insightful leaders at health care systems. So assuming that that's not the case, what have you put in place, and what would you recommend be done as you're opening up an ablation center, because it's a delicate bouncing act. We don't want the same problem that could occur in an ASC to occur in a small hospital far away with the same transfer problems. How do you address that? Yeah. First of all, you have to have physicians who believe that this could be done safely, performing these procedures. You have to have a hospital CEO who believes that it can be done safely. You have to have lab staff that believes it can be done safely, and you need to have an ICU team that you can count on at the Spoke Hospital, the regional hospital. If any of those pieces aren't in place, this is a non-starter. You don't begin a program. If you have those pieces in place, then you develop a transfer protocol that makes sense. And it really comes down to your relationship with your cardiac surgeon, and the people who support that cardiac surgeon to be able to get that patient into the operating room safely and effectively and quickly. And we're fortunate, because we're aligned. We're in the same health system. We have the same name on our paycheck. And so that makes it easy. ASCs present a different spin on that, which is that they're frequently not owned by the same health system, and in fact are competing with the health system nearby who they're counting on for surgical backup. And so one, I think, missing piece to a lot of conversation about ablation and ASCs is how do you assure you have backup? You can't assume that that hospital who you're competing against and whose revenue you're taking is going to be willing to give you backup, especially not for free. There may need to be financial arrangements for provision of backup, for example. And then how does that impact the financial look at the ASC versus doing these in hospitals? All of that is yet to be determined, I think, in the ablation space. And I know in our health system, we don't have operating rooms and ICU beds sitting available for complications to roll in from competing ASCs, and we're not going to build them. We're not financially incentivized to do so. But we do have space for the patients who are being done in our own hospitals that are outside of the main hub hospital. So that is how we felt comfortable doing it. And we have explored whether to build ASCs into our market and into areas that are pushing the boundaries even further into areas where there are underserved patients. And there are a lot of reasons to think about doing that and a lot of reasons to think about not doing that. But one reason that we could do that, I think, effectively and safely is because we have the ability to back up our own procedures. And that is one part of the ASC model that I still don't have my head around yet about how to do that if you're not aligned with a surgeon. Thank you. And great question and great answer. Brett, by the way, your data was amazing. In California, we still have less than 2% of the patients being referred for ablations. Yeah. So we did that research and published it quite a few years ago. I don't know that it's improved. It's highly dependent on where you live. So if you live in an area with a subway system, your probability of getting ablated is way higher than if you live in an area without a subway system, essentially. Yeah. Yeah. Question? Yeah. Hi. Tim Ball, Waco, Texas. One of the few private EPs. I didn't hear a whole lot about private practice. But we have a fairly small, about 4,500-person device that we follow. And we just recently transitioned to a cloud-based model about six months ago. So our current model is actually have them read by the company we contracted with. And then we actually have them read them again in-house by our in-house techs because the quality is not quite what we're used to, I will say. And so I think it seems like all the cloud-based systems and all the remote folks are eventually going to be going to AI. I mean, I don't think people like to pay the techs over time. And so I was curious your thoughts on what the timeline is going to be for that. You guys see AI taking over those remotes because we're going to have to have techs in clinic. There's no way to get rid of techs in clinic. You're going to have to have people doing in-person checks. You're going to have to have somebody that puts a wand on them. You're going to have to have somebody that tests the leads. Like I don't see that changing any time soon. And so I was just wondering your thoughts on what the timeline is on that. Well, James put it right. Before you can rely on AI, you're going to need to go through a lot more testing and approvals and so on and so forth. But I think another point he made that is strong is that those third-party companies that are building cloud software, they better be ready to provide the software while you manage your own clinic. And more than half of our clients are doing it that way, for example. Because it's not easy to build the same competencies as you have in your own clinic. Now in terms of timeline, what I can say is we've published, well, we're presenting three abstracts in this HRS about some of the work around automating, let's say, the alerts and so on and so forth. I think the collaboration has to be such that as you use AI to automate the collection of data and so on and so forth, you still need a strong collaboration around interpretation and figuring out the workflows, the prioritization of what alerts should go where and how do you, for example, is this alert something that needs to be seen now, does it need to be snoozed as opposed to completely archived, does it show up again? And then math will be great at adjudicating whether something that was irrelevant six months ago suddenly became relevant. For example, you know, first five PVCs maybe are not as critical, but when you get three more, now suddenly you're looking at a different context. So if you ask me, I'd say by sometimes next year, you're going to have a lot more FDA approved methods for automation of data collection and different alert prioritization. And probably within a couple of years, you'll see a lot more automation. Those that are relying heavily on technicians sort of gathering the data and going to the sites and downloading information, they're going to be lacking behind. It's just not going to be financially feasible, as it's not today. That's what I was saying earlier, James. He makes great points about sort of why these companies making money, you should make it internally. Economies of scale dictate that they should be making money because they're much more efficient, but they're not. None of the remote money companies that have taken significant amounts of money are in positive territory yet. So that speaks about the automation that's necessary. And I think by next year, you're going to have probably more consolidation and some of this stuff pan out. I agree. You know, I think collaboration, as he mentioned, is going to be so important. Having clinicians involved in this process. You know, for me, a highlight of my year so far was sitting in his office with his team, hearing about AI and thinking with them collaboratively about moving that needle. That wasn't the dark side. Like that was like seeing things in color instead of black and white and thinking about the excitement of what will come and partnering with people like him. I think there are people in the space who are really doing the right thing for the right reasons, and there are a few that might not. And so as clinicians, we're going to have to really oversee this. And I really think this is if this is a tool applied to a patient to impact care, I really think the FDA approval on that, as you mentioned, is going to be really important just to claim AI is dangerous. And I think that there is machine learning right now today in softwares that are already out there that can make you much, much, much more efficient than if you didn't have them. So we are running out of time in the interest of time. Tom already said that James won, but I want to say that it was a very lively debate which brought out a lot of interesting points. The idea of partnership between the industry and the hospital system and the collaboration and the supervision, ensuring that the certification is appropriate. And also, one other important point that you both brought about, AI, we need data. We need absolutely. And that data has to be in collaboration with the medical community. There needs to be a collaboration between the engineering and medical community. I feel like that idea wins. You all agree? This is why we do have an EP full time on staff, by the way. They want to mention it, but James knows because he was there and talking to her. Great. Thank you so much, guys. That takes our session to the end and that actually takes our business of EP to the end. So we really welcome ideas for future sessions after you finish this meeting.

San Diego Heart Rhythms

electrophysiology

device clinic business models

innovative billing strategies

hub-and-spoke healthcare model

atrial fibrillation care

remote device monitoring

third-party cloud software

AI in healthcare

outsourcing in healthcare