I welcome everyone, we're going to give everybody just a minute here to get to get logged on. So hold tight. We'll be with you in just a second. Welcome, everyone. Okay, looks like we're, we're having quite a few people log into the webinar so let's get started here. Today's webinar is sponsored by one of our industry partners CBRX. And today's webinar is called outsmarting the heart, a novel device therapy targeting the neuro hormonal pathways in heart failure patients. We have a good panel today it's going to be led by Dr. Patrick McCann. Dr. McCann is an advanced heart failure and transplant cardiologist at Prisma Health in Columbia, South Carolina. Joined by joining him is James Kreiner he's got his MHA and he's an executive director at the heart hospital also with Prisma Health. And then we've got Bonnie Hankey. Bonnie is the senior vice president of patient access reimbursement and healthcare economics for CBRX. A couple of housekeeping items that we want to go through today. Down at the bottom you're going to see a couple of different buttons. One is the chat button there you can access the webinar, that's going to be today's presentation you can download that, share that with your colleagues, bring that back to for discussion and so forth. So that is there. If you do have any questions throughout the course of the presentation. There is also a Q&A button, you can access that post your question there in the CBRX team will be monitoring that throughout the course of the presentation, and we'll probably save those questions for the end. So, let's get this party started. If, if I may introduce Dr McCann, turn it over to you and enjoy the day. All right, thanks a lot Chris appreciate it. Thanks to everybody joining us today. Happy to be part of the panel. We'll jump right in to heart failure and where baroreceptor activation therapy plays a role so if you're not that familiar heart failure is pretty significant problem. At 2030 it's estimated to be around 8 million people with significant costs, reaching somewhere around 70 billion by then primarily from hospitalizations for heart failure but we have about a 50% mortality in five years. And despite all of the advances that we've had with medical therapy. We're still seeing a rise in hospitalizations and mortality. So when we talk about heart failure, it's pretty complex pathophysiology and we'll go through a little bit of it here, and what we're targeting specifically with this therapy. So we see a weakened heart significant heart failure symptoms there's kind of a supply demand mismatch. When there's decreased contractility. And when we see that decreased contractility really sets off a neurohormonal cascade, but it also reduces the stretch sense by the baroreceptors at the carotid bulb. Looking at that when we don't see that stretch the nerve fibers there, tell the brain hey something is wrong something's happening here we're not getting the output that we normally should. And as a result, we increase the sympathetic tone we decrease the parasympathetic tone, and all the things that happen in heart failure that we don't want to start to have impacts to us in terms of feeling the symptoms such as shortness of breath fatigue. We get increased heart rate we get remodeling we get fibrosis increased blood pressure all the things from these background neurohormonal systems that are imbalanced. And so looking at this, what we try to do is reduce that imbalance or bring back into balance, both the sympathetic and parasympathetic activity with medications right it's the cornerstone of heart failure. And so when we talk about guideline directed medical therapy it's the four pillars. They're here on the screen and you can see Arnie it's the most favored therapy in terms of RAS blockade and then we have beta blockers as well MRAs and most recently SGLT2 inhibitors. These are outstanding they really have tremendous benefit in helping people live longer feel a little bit better. But there are some limitations to these therapies. And so we can see here, the, this is from HF stats, looking at our current use of guideline directed medical therapy and these are a number of registries. We also have recently the evolution HF that looked at about 270,000 people in US, Japan and Sweden and you can see the number of people on therapy. The bottom there though you can see is what the percentage are at target therapy, which is obviously very low. So we expect us to continue having the outstanding outcomes that we had in clinical trials, when we're not hitting target doses, and we're having decreased utilization of GD&T. I think there's a mismatch there between what's happening in research and what we can apply clinically. And that's what we often see in our heart failure clinic and why we've started implementing device therapy, a little bit more aggressively. And here again, as I mentioned previously, we see heart failure hospitalization volumes going up, both in HEF-PEF and HEF-REF. And as this can, this is likely going to continue as our population ages, especially if we are unable to get people on maximally tolerated doses of GD&T, which requiring four medications is very challenging in terms of compliance, especially when people may have anywhere between four to six additional medications, depending on other comorbidities. So when we look at the staging, we have stage A through D, and it's C is the ones that we're really trying to target here. Your stage D is more for your advanced therapies, such as inotropes or LVADs or cardiac transplant, but stage C is where we can really make a significant impact. And we try to do this earlier in their course of disease. You can sort of see that blue line. That is an overall trajectory of heart failure. We don't have a cure. When I say we, I mean the world. But we have very good therapies that we can implement to try and slow that progression or, if anything, cause remission of heart failure and an improvement in EF. The targeted therapies generally are going to be the GD&T, but then comes into your additional device therapies. When the ejection fraction is still less than 35%, we will often use ICDs to help with sudden cardiac death and reduce mortality, as well as CRT devices for patients that have a left bundle branch block greater than 150 milliseconds. The problem with CRT device, though, is that, unfortunately, although it is a very good device in helping people feel better, and we certainly can see improvements in their EF with it, there is a small number of patients that have a class I indication. And even when you look at class I and class II indications, the majority of folks with heart failure still do not meet indication for CRT. Thus, if you have somebody that is not tolerating a substantial amount of GD&T, or maybe is tolerating a substantial amount of GD&T but still having symptoms and is not a candidate for CRT, these patients and years previous have been forced to linger with their heart failure symptoms until they're sick enough to need a transplant or an LVAD. So here are the therapies now that we have. And I won't get into all the valvular therapies. There's been a tremendous improvement in our ability to intervene for valvular heart disease, which usually goes hand in hand with heart failure. But some of the other therapies, certainly we know of remote PA monitoring, which can have substantial benefit in terms of us being able to augment therapy. But those devices by themselves do not change a person's trajectory. It just increases their access to care and allows us to develop a better treatment plan that is more tailored for the patient. The other therapies here, you can see BAT and CCM. And specifically today, looking at Bare Reflex Activation Therapy, this is something we've been utilizing for about the last three years here at Prisma. Understanding that patients that continue to have persistent symptoms, but maybe are not ready for advanced therapies, perhaps we can intervene sooner rather than later with these therapies, such as BAT, and have an improvement by decreasing, or I'm sorry, increasing the bare receptor signaling. And so the stimulation of those bare receptors with this device goes back and tells the brain, hey, things are going okay down here. And we start to bring back into balance that sympathetic and parasympathetic activity. And it's a very simple system. One of the reasons we like it so much is because it is so simple. It is implanted similar to a pacemaker, usually on the right side of the chest, because most patients will have an ICD already implanted on the left. But there's no part of the system that is intravascular. So the lead is tunneled subcutaneously and attached at the carotid bulb. The implant procedure takes maybe about 30 minutes or so now, and patients can go home the same day. So relatively minimally invasive procedure for a device that has a lot of great benefits. And here are some of the benefits, a big one being an increase in exercise capacity, right? So people were able to do more on their six-minute hall walk. And we've seen this consistently in our patients, and it's been sustained now for at least two to two and a half years. We have a few of our patients that are approaching three years here, I believe in the next week or so. And they've continued to have great experience in being able to do more at home and not have as much in terms of heart failure symptoms. The other one is quality of life. So obviously when patients can do more, they feel better. And that is translated here into an improvement in their quality of life, looking at the Minnesota Living with Heart Failure questionnaire. And then obviously with that, as patients can do more, their NYJ class improves. We've certainly had some super responders that have gone back to being completely asymptomatic. But generally, we have had the majority of our patients improve at least by one NYJ class, which is a substantial improvement, right? That goes from somebody that couldn't walk up the stairs to now they can walk up the stairs or walk a little bit farther and complete activities without feeling terribly short of breath or fatigue. So this is us at Prisma. We kind of do a little bit of everything except heart transplant. You can see our numbers there for remote monitoring and VADs. We've had a substantial experience with the Baristim device, primarily because when we started with it, we saw such great benefits for our patients. And we continue to see that as we've used the device. And here's a little bit of our outcomes we recently looked at. In terms of the patients, we've seen a substantial reduction in hospitalizations one year pre and post implant. This was not necessarily noted in BHF, and there's probably a few reasons why that we can go into maybe in the Q&A. But from our experience with this, we've seen a substantial reduction in hospitalizations. We've also noticed a substantial reduction in diuretic use, which is another great marker for improvement for patients with heart failure. So patients to consider, NYJ Class 3 or Class 2 with a recent 3D compensation, EF less than 35% and the NC ProBNP less than 1,600. These were straight from the BHF criteria. You can look at patients also that maybe are CRT non-responders. We've certainly also had some patients that have been hospitalized for heart failure that were on maximally tolerated GDMT, continued to have symptoms, ended up in the hospital, and we went ahead and moved forward with implants to help those patients. So developing a heart failure device program, it's mandatory now. Really, we've got so many devices between PA monitors, BAT, CCM. There's going to be new devices coming in the future years. So we really need to develop that program. And it's just like any other program that we develop in terms of bed or transplant or remote management. You really got to standardize the evaluation, right? So have a template of what you need. And it's very simple for this device, echo, carotids, some blood work, and doing a little bit of a six-minute hall walk and then getting them in to see the surgeon and an EKG as well. And then we systemize the titration. So we titrate about every two weeks after implant. And the idea is there to get patients the benefit from the device as soon as possible. And so when they come back every two weeks, we will evaluate how they're doing. Usually we'll make a change to their diuretics, increase the milliamps on their device, and then bring them back at their last visit. Generally, we will do a six-minute hall walk and some lab work. And then after that, usually they're coming back, you know, three to six months, depending on how well they're doing. And then you course correct as you go along, right? We started, there wasn't a lot of experience in the space when we started. We certainly have had some hiccups along the way. Nothing is linear in terms of growth, but you course correct and you make your adjustments, and the patients will continue to have benefit. And then I think with that, you also have to have a plan to engage your administration. Obviously, this is a little bit of a newer therapy, setting up the program. And so with that, I'll hand this over to Jim and Bonnie to kind of walk through those pieces. Thanks, Pat. Yeah, one thing that is important, just like Pat said, was the organized team on the clinical side. It's just as important to make sure you have a nice, organized team on the administrative side. One thing that probably my biggest recommendation that I would put into play is just making sure. I think any administrator should do this on any high dollar devices that that you're trying to bring into the organization for your clinicians is just have a good organized and understand what your process is. What I would tell you probably a lesson learned for me is when you start looking into your process, you may figure out the process has a lot of gaps or the process from beginning to end, from building the CDM all the way down to costing the device. It's very important to have an organized team. And what we did for Baristim, we got the vendor involved from the beginning. That's definitely one thing that I would recommend. And we joined, you know, created a team that involved coders. We have dedicated coders, cardiac coders here, which I also recommend. But we brought coding in, we brought revenue cycle, revenue integrity. Anybody from beginning to end of the process to make sure that nothing falls through the cracks. I would say use the vendors to educate your coders, to educate the team. And then once you do that, I would say what typically gets left off is everybody trusts that the process is not broken. We have ongoing and routine reviews pretty much of every case. We do quarterly reviews on not just Baristim, but a lot of our other procedures. And during those reviews, we're looking for any outliers, underpayments, no payments. And really putting things in buckets for the different teams, whether it's operationally, we need to do something different. I need to work with Dr. McCann and team to document better. Or even on the finance side, whether, you know, something gets coded inappropriately, supposed to be outpatient and gets flipped inpatient for various reasons. It's very important to make sure that you do routine reviews on all these cases. Again, we do it quarterly. At the beginning, we did it monthly and we did it monthly with the vendor. So, I feel like... We took a process and you'll see later on where we probably missed the mark on some stuff, but it's paid off in the end. So that's my recommendation from developing the Heart Fairy program, whether it's this device or any other device. Thanks, Jim and Dr. McCann. So I'm going to go over really quickly some of the coding and reimbursement resources that we provide at CVRx. And as you all know, when coming to market with a new product typically you have to establish coverage coding and payment unless you are a following device. It needs to be really established from the beginning. What that means is that there can be confusion, there can be a mix of different codes that you're using, but I'm happy to say that where we are right now another goal of ours is to always try to do the best we can to have appropriate payment regardless of site of service. So as you can see from the chart here for late 2024 into 2025 we have very similar payment in the outpatient, the ASC, and the inpatient setting. This allows the physician to easily choose the site of service that most appropriately meets the patient's medical necessity needs. I'm also pleased to say that as of January 2026 we will be moving to Category 1 CPT codes. Currently we have Category 3 codes. There are always some issues with those codes whether it be denials on the prior auth or the fact that there isn't established payment. We do have established payment with five of the seven MACs and that payment ranges in from $600 to $1,100. Once we have those Category 1 codes in place there will be national pricing so there will be more predictability and consistency on that side as well. Next slide. The other thing that's important as Jim said is that from the beginning ensure that you're coding and billing correctly and this is really important to make sure that you are paid appropriately. Leaving off a CPT code or an ICD-10 code can result in inaccurate payment and it's certainly easy enough to do. We do have reimbursement resources such as what I'm sharing here now that walk you through all of the different steps. We also have a team of individuals who can help you through this and as Jim said we are happy to do frequent reviews of cases that you've done making sure that you did get paid correctly and that everything was reported accurately. Next slide. And then like I said in these reimbursement resources we do have sample UB-92s, UB-04s and so that you can see exactly how these should be reported with the codes as well as the claim forms so that you can see where all of the various parts go. Next slide. And then lastly and I think this is probably one of what I would say are the most important factors and that is ensuring that you get proper prior authorization. Aside from Medicare traditional beneficiaries most of the patients that you will see need to have prior authorization. We do have a team in-house that can help you with your prior authorization. They can either do it from beginning to end or they can jump in at any point should you have a denial. We strongly recommend that if you get denials out of the chute that you appeal those denials as we all know that very few of those are actually appealed but when you do appeal them there is a much better chance that you will ultimately get them approved and the patient will have access to the therapy. If in fact you prefer to do the prior authorization yourself we are certainly happy to provide different tools and resources that you can use to help with the success of your prior authorization as well and our team is there to help out. Like I said before wherever you would like them to jump in and fill in some of the blanks or follow up on authorizations that are taking longer than expected. And I'll hand it back over to Jim for some PRISMA specific details. Thanks Bonnie. Yeah I wanted to I mean as you can see here I think it's very important from the beginning to most administrators probably fully understand their payer mix. I think it's important she makes a very good point. We had to have a strong process put in place for authorizing certain payers especially at the beginning. I've got a few examples where we struggled getting payments but we've since resolved that just working with the different payers. But you can see here you know we're not doing them in an ASC but inpatient and outpatient. Probably the biggest advantage I would say for PRISMA is now being able to use DRG 276 for our inpatient population. We struggled with some underpayments in that space for a while but we've since moved on from that. You can see we've done 62 implants here at Richland and 45 in Greenville. Probably the big focus I would say at the bottom you can see kind of the beginning of the program of where we stood. That process I talked about reviewing cases. These are things that we found or bubbled up in the process. All of these are older cases. Since November of 23 we've actually been paid out on all our cases. We had one I think under reimbursed case that we actually went back to the to the payer and got it resolved. But you can see prior to that we probably out of those five because we did the review process on a quarterly basis we were able to rebuild two of those that didn't go out appropriately and got paid. The other three was was a particular payer that had fell out of the network for a period of time. Then probably the bigger one of underpayment or lower payments where all of these are prior to the recent change in October. You can see on the inpatient side we were struggling a little bit. That said I will tell you some things. This is on the reimbursement for the case itself but we also leverage a cost avoidance on readmissions. As Dr. McCann clearly showed the decrease in readmissions was was key for for me as an administrator. I mean it's an easier sell if I got to go justify any sort of high dollar devices. But also more importantly now these inpatients are going to fall under the DRG276 that's going to pay a lot better than in the past. Next slide. Thank you Jim. Thank you Bonnie. In summary before we get to the Q&A when we're looking at patients for barostem therapy EF less than 35 percent. Class three or class two with the recent 3D compensation. Patients that are symptomatic despite treatment with GDMT that has been maximized as much as possible. I will tell you that is certainly where we are targeting more now for our patients as those early class three late class two patients that we've tried everything we can with medical therapy but they're still having symptoms. And then NT pro BNP less than 1600. Overall it's nice that we have this device just as heart failure has grown. This expands our therapeutic options and allows us to tailor therapy to individual patients with a little bit more of a unique aspect. And then we've had great results. I showed you our reduction of hospitalizations. We've also seen reductions in diuretic use. We've had outstanding outcomes for sustained periods of time now to if not three years for some of our patients since we've been implanting. And we continue to see patients that come back in and tell us how they are feeling so much better how they're getting back to living. And that is one of the most rewarding parts in utilizing this therapy for our patients. That was great Dr. McCann. Thank you very very much. And again thanks to the CVRX team. Before we get to Q&A just a reminder if you do have some questions there's a Q&A button at the bottom of your screen. You can click on that and you'll be able to enter your questions there. Also in the chat section just a reminder that the presentation that Dr. McCann and the team just gave is there and you'll be able to download that and share that with your team. I do have a couple of questions that have come in already but please pose your questions as they come in. First and foremost I want to say congrats to the team for the category one codes. That sounds huge. Jim this might be for you. How do you determine whether a patient should be inpatient or outpatient? I would say we leave most of that probably to the clinicians. When Dr. McCann comes to us or wants to wants to do a varicose implant I think there are times where you know if he feels like that the right time for the patient is actually inpatient I would say now since October it's going to be a lot easier to answer but more importantly I would say the clinical team is probably more driving that now than necessarily me. And with that in terms of inpatient or outpatient the majority of time we are looking for this to be an outpatient procedure where folks are getting in getting the procedure going home the same day. However we do have some patients that end up in the hospital we know we've already tried them on everything we can. They continue to have significant symptoms since their hospitalization and instead of waiting for the follow-up and another follow-up which often you know might take anywhere between two to four weeks in terms of getting them through their follow-up period and back for the procedure we'll just go ahead and do it inpatient. You know it gets the patient the care that they need a little more expeditiously and it's something that we're planning on already. So usually it's not somebody coming in to the inpatient round that we haven't seen before that we just go ahead and do this for it's somebody that has already been admitted that we've seen in the in the outpatient clinic multiple times but unfortunately ended up in the hospital despite best efforts. I have another question that was just posted do you have a defined patient care pathway at Prisma? In terms of the care pathway we certainly have a defined titration pathway. As far as getting referrals in we do a fair amount of in-reach and so that usually comes from our inpatient hospital unit that we have as well as an ED heart failure pathway that we have worked to establish. That is usually the care pathway. Now as far as whether patients are qualified or not you know if there's somebody that we are not entirely sure that they might be low output we do we do have a pretty low threshold for completing right heart catheterizations to check invasive hemodynamics although not necessary. I think at times that can be beneficial for us to know so that we're not missing somebody that is truly low output and might need advanced therapies. What we learned early on is that this device works really well for those late class two early class three patients but it is not a salvage therapy and it should not be used as such. So how do you discuss this therapy with your patients and what things are you discussing and focusing on when you're looking at a shared decision making? Yep so a lot of what I talk about with our patients is how they feel about their life. You know when people have significant heart failure symptoms it reduces just about everything that they can do or it takes the joy out of a lot of what they can do because they have to limit themselves and they know that and they know they won't do certain things. So a lot of the discussion that I will usually have with patients is what do you enjoy doing what do you like doing right what do you want to get back to doing what what are you prohibited from by your heart failure symptoms and when we start having that discussion and they start opening up about all the things that they would like to do or be able to accomplish and I say okay well we've got some options here right and and we've tried the medicines do you feel better with the medicines no not not not really that's why I'm still having symptoms great we've tried all this we've got some other options and although it's a it's a surgical procedure it's a minimal surgical procedure you go home the same day and you're likely to feel better with it and that's what we discuss and now that we've been able to see that sustained for people because we've been doing this so long it's great that we can share with them even more information that hey this will continue to help you feel well down the road so that's usually the discussion on you know how this therapy can be beneficial but why it's important to consider and I think when you start really talking to patients about what they want to do and what they can't do because of their heart failure symptoms they become much more engaged right it's not just us coming in and saying oh are you feeling short of breath okay well we can do this it's what's important to you what you know what does life have for you what is your purpose here what are you what are you trying to accomplish because if we're not helping you accomplish what you want to do then I don't think we've done a patient any good right we should be helping them achieve what they want through the medical devices and technology we have if I can just follow up on the comment that you just made you said you know it is an implantable it is a surgical procedure so you're obviously working with the surgeon can you talk a little bit about how you work across departments when you started the program yeah we are very fortunate that we have a great surgical team here the two surgeons that implant our left ventricular assist devices also implant these devices they have a lot of experience with vascular surgery as well and so in setting it up what we've done is they have an administrative assistant in their clinic and generally when we see a patient in our clinic that we think needs to be referred over we will usually get the lab work we'll put in the orders for the carotid send them over to the surgeon and we update her she gets them an appointment usually within a week they get all the imaging they review it go over the procedure and then they schedule it you know once insurance approves and that it's pretty seamless process and a lot of that was set up from the relationships we already had with surgery but it also helps that we have a very aggressive surgeon you know he wants to just make improvements he's 100 percent involved in what we complete on the heart failure side because he sees the back end of it right and we always talk about this boy you know if you could avoid vads and transplants that would be great for patients because it's a challenging lifestyle and so he sees that back end of it and this is an opportunity to intervene sooner and really impact somebody's quality of life hey chris i was gonna add from a from an administrative side going across services we had to do the same as part of the getting this started right these are done in the or so it was important that i partnered with the director of the or you know she's the one that's going to have to be buying these devices and really educating her on what we're doing why we're doing it the finances behind it and kind of what what we're going to do is kind of a dyad team to to ensure that it's a good it's a good idea for her to do in our or great um another question just came in how do you decide between cardiomyems or baristim for a given patient assuming both are indicated yep so i would do the cardiomyems first uh certainly because it allows you to monitor that patient and then you can try to tailor their gmt as much as possible once you have the pa pressures and trying to keep them under their threshold but if that is is not effective then i would move to the uh baristim device as previously mentioned for the um you know if they qualify for it obviously and continue to follow the cardiomyems afterwards we've seen that with a few of our patients uh where we've seen a stabilization of their pa pressures that have a cardiomyems and then had baristim implanted later um questions keep coming in have you seen any other diagnostics that show benefit of baristim right heart cath cardiomyems pa pressure icd a heart failure diagnostics bva etc yeah so that's a that's a great question uh we have actually we are planning to publish a little uh case report that we've seen with bva pre and post implant where the gentleman went from taking 40 of Lasix a day to 40 Lasix once a week and his BVA improved dramatically about a 20% reduction in volume with less diuretics while we titrated the barostim. So that's certainly been a one way of looking at it. The CardioMEMS, as I mentioned previously, we've seen a stabilization of pressures even with less diuretics needed. And then most recently while we've been looking at our hospitalization data, I've also recently started looking through our ICD data for our patients. And we'll probably put all this together in a publication hopefully soon, but we have seen a reduction in the number of atrial arrhythmias for those patients, which has been great to see. There was markers of that in BHF, but obviously it wasn't powered for it. But in our retrospective review, we have seen improvements in hospitalizations, less diuretic use, less arrhythmias, stabilizations of PA pressures. And that all correlates to what we see clinically when patients are feeling better, doing more, staying out of the hospital, all those things. Another question, when a patient comes into your office, how do you decide if he or she may benefit from barostim and what tests you typically order? Yep, so what we're generally looking at is have they been on GDMT long enough, right? And has it been maximized? And if it has, and they're still having symptoms, last three heart failure symptoms or recent decompensation, usually we will talk with them. Previously when we started out, we had such good super responders and then we used it in some patients that were probably more salvage therapy. They were like class four, true class four patients, but they had no other options. We were trying it because they had no other options and they just didn't thrive. They did okay, but they didn't thrive. And so that's why I say it shouldn't be used as a salvage therapy. And from that, we started looking at, should we be doing right heart casts on these patients? You know, to be checking a cardiac index, seeing if it's too low or not. And we've done that a little bit, but as you start to get patients earlier in their trajectory of heart failure, I don't know that the right heart cast is necessary. If somebody is on the borderline, you're a little concerned. I think it's reasonable. Like I said, we have a low threshold to just go ahead and complete it. If we're concerned that somebody might have lower cardiac output, but those early class three, late class two, you've tried all the medicines that you can, and they're still having symptoms, going to the device sooner rather than later has been the change for us. And we continue to see good benefit. I've got another question here, which could go to you, Dr. McCann, also to you, Jim. You know, what do you wish you knew when you started the program? I'll start it from the clinical side and then I'll let Jim take it from the administrative side. What I wish we would have known is how quickly you can titrate, right? So one of the things we used to titrate like on a monthly basis. Now we do it every two weeks and just push it because people feel better. So that was one thing. The other thing that I wish I would have known is, you know, you got to watch the diuretics. Like we see people coming in and they feel better. They're having volume dumps, and you just really got to be cautious with the diuretics. We probably had a little bit of AKI early on with some of our patients because we did not adjust the diuretics, not recognizing, you know, how good of a benefit they would have in terms of their natriuresis. And then the last part is not to be afraid to add back in the GDMT after you're done titrating. So we see a stabilization of blood pressures and sometimes an improvement where people can tolerate more GDMT. And I think it's absolutely necessary to get those patients on additional GDMT to hopefully prolong their remission of symptoms as a complimentary therapy to the device. You know, initially when you can't have as much GDMT on, and then you can start it up because the blood pressures improve for some of these patients, that's a time when you should go ahead and add those medicines back in. Yeah, I would add from an administrative side, some of them have already kind of talked about just ensuring the reviews up front. But I would say one thing that probably me and McCann do a pretty good job about is we always look at all the good outcomes and the bad outcomes for everything that we're doing. And one thing that we could have probably done better with Baristim, you know, we slow played it and mainly just, we wanted to see the outcomes, but probably the financial side as well, just to make sure. And we probably would have done more devices. I mean, to be honest with you, some of the stories that I hear the team talk about is why we're doing this. So I would say that that's probably one of the things that, I mean, be smart about it, but don't be afraid to get in and just do it. It's definitely a tool I feel that you gotta have in your toolbox. Just like McCann has said, it's for the right population of patients. But if you don't have it in the building, then you're not gonna get it. And to that point, I think that there's a larger patient population than what we recognize, right? Because not everybody can tolerate all the GDMT at maximal doses all the time and they continue to have symptoms. It's challenging. And so I think that population is much larger than what we recognize. We're just starting to see a little bit of the tip of the iceberg in utilizing this device. And another question from a member, Jim, how do you feel that this therapy can bring patients in earlier to your heart failure service and how do you facilitate that? Yeah, so we have multiple different ways that we try to track patients. But one of them is we do have an InView tool. It's a tool that really looks for patients that need certain therapies that aren't getting the therapies they need. Right now, we are looking at incorporating this therapy into that, which if there's patients that fit clinically, we'll use obviously Dr. McCann's guidance on what that looks like and what he would like to see happen. But I think there's an opportunity for us to find these patients that need this therapy and then have a good streamlined process to get them there. Okay, another question. Is there a timeframe that you start to consider barostim therapy for a patient after they have been on GDMT? For instance, patients being on GDMT for three months before an ICD? Yeah, so standard of care is ICD, obviously, if the EF has not improved to reduce the risk of sudden cardiac death. I think the approach is a little different for us. We talk about all therapies right up front with our patients. And so generally, I will draw them kind of the Georgiotti graph and everybody's probably seen that to some extent where there's a decline and there's little dips in between. And we'll tell them, our first goal is gonna be with GDMT. We got these medications, these are important ones, and we're gonna try to titrate them aggressively over the next one to two months to try and help improve your condition. If that is not working, then next comes these interim device therapies. And we may consider these depending on if we need to do any other evaluation such as a right heart cath. And so they know like up front, oh, okay, we're gonna try medicines first. If medicines don't work, we have these backup devices. If backup devices don't work, we have advanced therapies. What I often tell patients is, my crystal ball is just as fuzzy as anybody else's. I can't tell you exactly how you're going to respond to all these therapies yet. But what I can tell you is that we have many options. And the first options are medicine. The second options are these devices now with Baristim and potentially CCM depending on the patient. And then the last ones are advanced therapies and or palliative care if necessary. But we have that talk up front. So everybody's aware up front of what the options potentially are. And if they do great with GDMT, wonderful. But if they haven't recovered their EF, they're still having symptoms, they're gonna get ICD or CRT first if they're a candidate. If they are not, they'll get the ICD. And when we put the ICD in, we also talk with them about that, hey, this is not gonna make you feel better. It's gonna prevent sudden cardiac death, but it's not gonna make you feel better. So we're doing this to prevent sudden cardiac death. We'll give you some time to heal up from it and recover. And then if you're still having symptoms as we're managing, we'll consider the Baristim to help you with your heart failure symptoms. You had mentioned you do in-reach and I'm not sure if you've got patients that do self-referrals, but any recommendations for a private practice that are interested in offering Baristim through an affiliated hospital? Yeah, I think that's a unique opportunity for private practices if they're not implanting to have the hospital that can do the implant and then get those patients back to you, right? It's an outpatient procedure, same day they go home and then when they come back, you're talking about five level visits and a device interrogation, which I think, I just had some recent surveys that they're working on trying to develop RVUs around the device interrogation and or manipulation, but it's important that you're offering your patients the best possible therapy. So if it can be implanted here or at another facility and then they come back to you and you do the titration in the clinic, I think that's a win-win for everybody. And then any pointers or tips on getting through the value analysis committee? Yeah, I would tell you, if it shouldn't be hard now, I mean, now that you got DRG 276 is your inpatient side, I mean, anybody that's should have some DRG historicals that they can pull related to that, from a finance standpoint, there shouldn't be an argument. I would tell you, you know, our programs, especially since November of last year, where we cleaned up a lot of our processes, I mean, we're very profitable, it's a viable program, it's something that there shouldn't be a reason from a finance standpoint, there shouldn't be a reason from a finance standpoint. And then on top of that, like I said, I typically will give a couple of patient examples if I have it, you know, you can get that from the vendor if you don't have any specific ones or you can talk about the ones today. I mean, we have patients that have gotten this therapy and that's an easier piece to sell. But from a finance standpoint, I felt like it would be fairly easy now with DRG 276. The other thing I would add is just the critical importance of setting your program up accurately from the beginning to make sure that you're billing, coding, prior authorizing everything correctly. The last thing we wanna have is for you to have any issues with that from the get-go because it can really, you know, cause some issues internally. We are happy to get on a phone call with your staff and walk through the relevant points to make sure that you're set up and good to go from the beginning. Thank you, Bonnie. Jim and Dr. McCann, how are you using EMR to support your patient screening efforts or understanding frequent flyer patients? That's a great question. So we're actually in the midst of developing a heart failure risk score utilizing parameters where it will pop up certainly from the inpatient side on a patient list similar to like what has happened with sepsis when people meet certain criteria and it pops up. We're gonna do the same thing with heart failure and we will likely have a practice advisory pop up for patients that are having worsening heart failure to automate referrals, right? That is the goal is to identify patients earlier rather than waiting until too late. And so that is probably gonna be the biggest way that we use EMR to screen because I just don't think you can hire enough nurse navigators. And then hopefully we will expand that to outpatient practices as well for patients to be able to, or for other clinicians to be able to see what this person's risk score is and hopefully you'll send them over for timely referrals. So we're hoping to go live with it maybe next month. So it's been in the process for about six to eight months of developing it, but. Okay, another question from a member. This is to Bonnie. How does your team support prior authorizations and what challenges do you see that you can help work through? Bonnie, that was to you. Yep, sorry about that. My team is there to help from the beginning all the way through the appeals to the ALJ if necessary. We also have templates that can be used if your office prefers to do them separately or on your own, but we can help out with providing examples of what's worked well with a given payer, where we've struggled with payers and just coordinating between the physicians in the office to make sure that we have all of the relevant information and make sure that prior authorization letter from the beginning covers all of the relevant points. And I would add, it's not that my team does a better job than your team at your facility. It's just that this is all they do. So this is what they're very focused on and they will follow up in a very timely manner so that these patients don't have to wait any longer than necessary to get access to the therapy. Okay, Jim, Dr. McCann, your LVAD center is offering this device affected your LVAD volumes. No, we've been doing this now for a few years. And I think last year was our banner year. We did a little over 40 LVADs. You know, we averaged probably somewhere around 30 a year or so. And so we were up in the forties last year while providing Baristim. So it certainly has not decreased our LVAD volume and consistently over the last two years, we've been increasing the numbers of our LVAD volume. So we have not seen that happen. I think, as I mentioned before, there is such a large patient population that we have not recognized yet in heart failure that are not tolerating their meds and are still having symptoms that you can use this device and avoid using it as a salvage therapy that you're still gonna have be implanting plenty of VADs. It's not gonna affect your VAD numbers. All right, we're getting near the top of the hour. And I don't know if there are any other questions that are coming in, but before we go to closing comments from Dr. McCann and Jim Bonnie, any comments that you'd like to make or any recommendations you would like to have about contacting CVRx? Yeah, I would just say we're here as a resource to your facility. Bring us in early and we'll make sure that you're set up accurately. We can answer any questions that come across. We can even help you out with some of the materials you may need for your VAC assessment. And just no question is too small. Please ask us and we'll make sure that we get you set up correctly from the beginning. And as I mentioned also is we can do any part of the prior off from the beginning to the end or help you out as you go through it. And Dr. McCann, any closing comments about the therapy and the device? Yep, so I mean, I think just reviewing it as far as the correct patients, right? Class three or class two with the recent three decompensation, EF less than 35% with an NT pro less than 1600. But those are the qualifying parameters for the device therapy. But I think again, GDMT is a cornerstone for heart failure but there are a lot of folks that are not gonna be able to tolerate all four pillars at maximal doses and they continue to have significant symptoms. And so I think for all the physicians or clinicians out there that are watching, be open-minded to the fact that we have an opportunity to improve the quality of life for those patients with this device. It is safe, it is easy and patients can get a tremendous benefit for it. So that's what I would say about using varicin therapy. Fantastic, I wanna thank the panel. I also wanna thank CVRX, our industry partner for this presentation. I think it was a terrific and the questions that came across were fantastic. So we will be making this recording available to the membership. But if you have any questions, feel free to reach out to the CVRX team. Thank you again, have a great day, everyone. Thank you.

heart failure

device therapy

Barostim

neurohormonal pathways

GDMT

hospitalizations

Baroreceptor activation

exercise capacity

early intervention