US Reimbursement Fundamentals | LSI Asia '25

Tonya Dowd  0:05  
All right, thanks everyone for coming this afternoon, and thank you to LSI for having PRIA healthcare as a sponsor and me as a speaker today. I appreciate everybody coming today because I think I'm up against another session in the main ballroom that's ask me anything. So thank you for coming. If everybody wants to come, push forward, please, by all means, we can make this intimate and a good conversation. Reimbursement is not that scary, although some people might think it is, but it's not so. Thanks again for coming. I'm Tonya Dowd. I'm with PRIA healthcare. PRIA healthcare is a full service reimbursement and market access consulting firm based in the US, and we focus on us reimbursement and market access for new and novel technologies, mainly in the med just in the med tech space. I have been in the reimbursement space for about 30 years. So I started when I was about two. You know, sort of what I was about to know, I've been my whole career in the reimbursement space, and I would say that what I've learned across, you know, kind of being in the space is, is it reimbursement is not just about the how to get paid. It's about your commercial strategy. Really, how are you going to commercialize your product in the US or any other market for that matter, and successfully commercialize it to where it's profitable. So just kind of keeping that in mind, thinking about this holistically, I'm a strategic consultant. I've been a consultant for and had my own consulting company for over 15 years. I've worked across every disease area, mainly, again, focusing on implantables, durable medical equipment, molecular diagnostics. I've done some biotech as well. I spent about 12 and a half years at Johnson and Johnson in two different capacities, two different companies, and I'm a judge and value framework expert for Medtech Innovator. I think some companies here are going to Medtech Innovator next couple of weeks for the Singapore specific cohort. And I'm also a mentor and judge for creative destruction lab in Toronto. And I'm also a consultant for multiple Biodesign groups across the country in the US, namely Stanford Biodesign. So really happy again to be here today. The learning objectives today are really, you know, learning the fundamentals of us, reimbursement and market access, in the context, again, of early commercial product planning and demonstrated the difference between us, FDA and this and CMS centers for medicare, medicaid services or the payer community, and what each respective entity is looking at for med tech understanding the importance of early planning. I can't stress this enough, early planning is imperative, and why the reimbursement and market access plan should be thought about early on in the process, even in your animal studies, even the R and D phase, okay, and then review some common industry misperceptions and mistakes that I certainly have seen along the way. So we're going to start out with a quiz. This is going to be interactive, and anybody who knows the answer, please shout it out. FDA approval and clearance is all you need for the opportunity to achieve commercial success in the US. Anyone, don't be shy. Come on, false. Thank you very much. Great. Pass that one. If a reimbursement code exists that describes or you think it describes your product or service, you're good to go, and there's nothing else to worry about, true or false. We need to live in this group up, come on. False, absolutely false. I can't tell you how many times I've heard from companies and even clients. Well, we found this code on Google. We googled it, or we chat GPT it now, right, as everybody does, and we found this code that looks like it describes us. So that's all we need to do. We just need to piggyback off of this code, absolutely 100% false. And again, we'll go into the why, as I continue on in the presentation, the market access strategy isn't needed at early stages. It's more of an issue around commercialization phase and after regulatory true or false, false, absolutely 100% false. I don't need to worry about the reimbursement or market access plan, because our company will be acquired before or right after regulatory approval or clearance, and it will be somebody else, somebody else's issue to deal with. Okay, I love this one because it is absolutely false, and I will tell you it's even more so now, because strategics investors, they want to see proof of concept, and they want to see you commercialized, and see really, if you can get traction, the evidence required for FDA clearance or approval will be enough. Enough for commercial and reimbursement, success evidence such as economic evidence and clinical evidence, true or false, every single one of these is false. Okay, absolutely, 100% false. So why are they false? Well, early that's spelled, misspelled. I apologize, early planning is critical, even in the pre clinical stage in your animal studies, understanding and putting together a strategic product plan. We might call it strategic marketing, global strategic marketing, but understanding who your stakeholders are, where your technology fits in the care continuum, your pricing strategy, how your regulatory strategy affects your reimbursement strategy, and vice versa is so important. So early planning is critical in the clinical stage, understanding what endpoints you need in your study to speak to the other entities, aside from FDA. And then, of course, in the commercial stage of market adoption. So you need reimbursement and market access planning you need to continue. It's an iterative process throughout the product life cycle and throughout the product journey, knowing the strategic intent of your product. And this is really important. And unfortunately, I ask too many potential clients and clients, what is your what is the strategic intent of your product? And they say, Tonya, I just want to know about reimbursement. Well, again, reimbursement is not an it's all an island sitting over here it is, in part. It is an integral part of your commercial plan, right? So what is the strategic intent? Are you trying to redefine the standard of care? Are you trying to improve clinical and economic outcomes? Are you true? Are you trying to, in you know, it increased or decreased the cost of care. Or are you developing your product just because Dr Smith in Ohio said you should create this product? Why are you creating it? What is it going to be used for? Where does it fit in the care continuum that currently exists now for the intended patient population? How is the disease or condition, condition currently diagnosed and treated, and what is the patient journey? I can't tell you how many times clients have said, I don't I don't really know, but Dr Smith in Ohio said this will fit right in, and they'll everybody will love it. Not enough. What are the what? Who are the end users? And where do they sit? How are they incentivized? Is it a physician? Is it a hospital? What type of physician? Is it a different, different physicians? What are the referral patterns? It is so imperative to understand really what's happening today, so you can plan for where your product fits and how it's going to be adopted. What is the unmet need? This is so, so critical, and is there an unmet need? And I hate to say there might not be a true unmet need for your product. So really understanding and being truthful with maybe there's not an unmet need. Maybe what's being used now is probably okay. And if there is an unmet need. What are the behavior behaviors that need to change from the providers who are going to use your product, and are they willing to change those behaviors? That's something that is really, I don't think oftentimes tuned in clients are not tuned in enough on is what type of behavior change is going to be necessary to really adopt my technology in a certain care setting. So taking the time to understand them is really critical. Your What is your business model? We call it buy and Bill. That's typically what happens in the medical device industry, where the innovator is selling or the GPO group purchasing organization is selling the product to a hospital, the facility or provider is putting that technology or including it on a claim, and that claim is going to a health plan for reimbursement after the fact I buy and bill or as a subscription model, maybe you're a digital health technology and you're just going to charge a subscription on a monthly basis. What are the incentives, again, and disincentives for market adoption. Having a commercial strategy that's based on how the world worked 15 years ago is not going to work today, and it's not going to work in the future. So understanding in the US in particular, physicians are working for hospital systems. They're employees of hospital systems. Physician groups are now owned by private equity, so understanding what they're incentivized to do and not do is so critical. And then last but not least, what is the intended clinical and economic impact? How do the features and benefits of your product impact the clinical and economic outcomes for the intended patient population, just because you're making a blue widget versus a red widget does not equate to, oh, I can charge a premium price, or this is going to be the greatest thing. Everybody's going to adopt it. You really need to understand how those features and benefits really impact the clinical outcome for the patient. And or indoor economic

Tonya Dowd  10:03  
so when we think about just really fundamentally and in basic terms, there are two reimbursement pathways for new and novel medical technologies. The track to the left, or the road to the left is, I've identified a code I validated that these coding structures will work for my technology, or they're appropriate. There's coverage. The payers are viewing the technology, a technology that's like mine, as medically necessary, and there's payment. So we're just going to piggyback off of, you know, existing technology, or an existing procedure that still requires evidence to show that there's value for the buyer stakeholder. So keep keeping that in mind. Maybe there is no there is no coding pathway you are creating and establishing entirely new reimbursement pathway. You need to go get new codes or establish codes. You need to establish the evidence that's going to be required from payers to determine that your technology is medically necessary, and you need to create new payment pathways. So that is to the right, and that's where a lot of new and novel technologies fall. Why? Because a lot of innovators want a premium price. They want to be differentiated from what's already existing. So kind of knowing if you need to create your own pathway, or you can work on an existing is important. Regulatory and reimbursement processes in the US is not linear. So it's not as if you go to fda, you get your clearance or approval, you go to CMS, Medicare centers for medicare, medicaid services, and you have reimbursement and market access. So not true. We are not a one single system, health plan or health payer in the US, it's not like the NHS in the UK, as an example, there are a multitude of different pairs. So the reality is really this, you are get your clearance and approval, and then you enter the maze of reimbursement, market access, and for that matter, not all FDA pathways for medical devices are created equal, so really understanding the impact and implications of how you get to market or how you're cleared or approved by the FDA is critical, right? Everybody wants to get clearance. They want to find a predicate so they can have a very quick and easy pathway to market, right? It's quick and easy. Well, then what? Then what happens? You want to be like the predicate, but guess what? The predicate might not have reimbursement, right? So you kind of talking out of both sides of your mouth a little bit, right? So understanding, with 510, K clearance, you don't need any data. You need bench data, essentially, right? So you don't need any data. You find a predicate, and you get cleared, and you're on the market de novo, 510 clear. 510 k clearance, a little bit different. You aren't, you know, there's no substantial risk, there is no predicate. And you're on a little bit of a faster track with 510, K de novo. And then you have PMA approval. So that's pre market approval. You have to do rigorous studies, you know, for class three devices, but really understanding how these different FDA pathways impact your technology is going to be critical. And FDA indications are intended use statements important to know for the treatment or diagnosis of a disease or condition, but they don't confirm that a result or outcome can be expected if the product is used. So the latter part the expectation of the outcome. Remember, I talked about that the clinical or indoor economic outcome of using your device is going to be what's going to be needed for the market. So with all due respect to my regulatory colleagues, the regulatory pathway is pretty notice. It's straightforward, but it's pretty well laid out, whereas the reimbursement side, and what you're going to need is not necessarily know your stakeholders. This is so important. There's a multitude of stakeholders in the US and know it. Know who's relevant to your product and who's not. Right? Obviously, FDA, the payers, both the government payers, the commercial payers, understanding which payers also are going to be applicable to your product, or what the people call the payer mix the demographic. So Medicare is for the 65 and older patients with end stage renal disease. Medicaid is for the indigent or poor patient population, a lot of women and children. So if you have a women's health product, you're going to be subject to Medicaid. And that is a state by state kind of rule making process, commercial payers. There's a there's a whole spectrum of 1000s of commercial payers, or, you know, a set number of commercial payers with 1000s of products, I should say so, knowing your payer mix is important, providers and hospital systems, and you know what they're going to want, coding authorities. There's just not one coding authority. Remember, we talked about this. We just find a code on Google. Well, there's not one coding authority. I'll get to that in a minute. There are several so understanding what types of codes are going to be applicable where they're used. And who's actually regulating that? Coding structure is important. Specialty societies. They are absolutely a part of this process. They will make or break they can endorse you. They might not endorse you. They might not like that. You're coming into the market to disrupt the apple cart. So understanding what their take is and bringing them in early in the process, starting the dialog with specialty societies is really important. And in patients, of course, they're depending on the different, you know, disease area you might be in breast care or in a pen or pediatric technology. There's a lot of really active patient advocacy groups out there, so bringing them into the fold is good too. Kind of just looking at taking a deeper dive into kind of three different stakeholders. I always say the value or the value proposition is in the eye of the stakeholder, but with FDA, again, understanding that they evaluate the device, and they're asking the question, does the do the benefits outweigh the risks, and they want to see safety and efficacy for the device, whereas payers, they want to again, understand the impact that the device has on health outcomes and clinical outcomes and the demonstrated effectiveness of those outcomes in the published peer reviewed literature, and that's really important. They don't want to see case series, they don't want to see white papers. They want to see the data in published peer reviewed studies. And does the benefit? Is the benefit really relative to the standard of care? To, you know, use your technology? How is it much better than the standard of care, or is it equivalent? So again, two different perspectives really important. This is why what you the data that you generate for FDA, which, again, for 510, k is nothing, is not sufficient for the payer community, from the hospital system Memorial care is an example of a hospital system in California. They want to know the clinical benefits for the patient. And they want to know, is there adequate reimbursement for this technology? Does it increase the volume of procedures so we still live in a fee for service world. In the United States, make no mistake about it, we talk about value based health care, and you know, blah, blah, but it is a fee for service. Make no mistake, fee for service system in the United States, the more volume you do, the more you're paid. And that's still that's still relevant today. Is there a cost avoidance or a minimal budget impact to adopt the technology from the hospital perspective? Does it actually enhance the hospital's reputation. Think of the Da Vinci robot. The hospitals weren't necessarily getting those through philanthropy. This is what, how they got the actual devices. They wanted to say, we have a Da Vinci robot, right? So does it enhance the reputation of the hospital, and is there strong physician demand and endorsement? And that used to be, or say, the only thing but the primary reason why hospitals would adopt new and novel technologies because there was physician demand. That's not the case anymore. They're an important voice, but they're not the only voice in God. We trust all others bring data. I can't stress enough how important evidence and an end to end evidence generation plan is when you're developing your product and when you're thinking about how you're going to get Mar gain market adoption and traction, so understanding who the primary stakeholders are, and again, who's relevant for your technology. Obviously, patients, providers, hospitals. Is it a private payer? Is it a commercial payer? Is it a government payer entity, and what is the anticipated impact, in terms of the clinical impact that you're going to have your technology is going to have, and understanding the specific endpoints that are going to be required by each stakeholder, and then the metrics that you're going to use to support that evidence, and then the evidence generation plan. Are you? Are you? Do you need to do a randomized control trial? How many patients do you need? What endpoints are going to resonate? Is it a superiority trial, is it equivalent? Equivalency? Trial, observational data. Do you need observational data? Are you going to create a registry? Are you? Do you have fit for purpose, an opportunity to, kind of work with payers, for example, to create fit for per fit for purpose studies? That's kind of a newer term and a newer strategy with relation to being very strategic around what you do in terms of putting together evidence that's going to resonate with certain stakeholders. So understanding this is a framework that was actually is very well documented, and a lot of the payers use, a lot of innovators use that was taken from admin. So I think it. Everybody has probably maybe heard of AdvaMed. They're a lobbying organization in the US for Medtech,

Tonya Dowd  20:06  
kind of getting into the nuts and bolts of reimbursement in the US. You might have heard a lot of individuals say there's three things, coding, coverage and payment, but I'm going to add one more, and that is the benefit category that your technology is going to fall into. And what do I mean by benefit category? What I mean is, is it a benefit category that is actually excluded or included from the payer's viewpoint? So for example, Medicare, CMS does not cover they do not cover hearing aids. Okay? So that is an excluded benefit category, game over. I don't care if you have codes or coverage or payment or whatever, it's game over. So understanding how that benefit category impacts your coding, coverage and payment strategy is important. Is it a durable medical equipment, something that's going to be used in the home, and it's durable over three years period, or three years and more period of time, that's going to have a different coding coverage and payment scenario than something that's implanted in the hospital, for example. So really understanding that is important, codes are only alphanumeric, you know, alpha numeric codes that identify a procedure or device that, again, is put onto a claim and sent to a payer for payment. That's all they are. They have a payment assignment. May or may not have a payment assignment assigned to them, but it's just it's not a guarantee. If you have a code, or you've identified a code, it does not guarantee payment. If you remember nothing else from this presentation, please remember that coverage that is the the Holy Grail. Do the payers believe that your technology is medically necessary or reasonable and necessary by Medicare standards to warrant coverage for the intended patient population. Now note that I say intended patient population. FDA. Everybody wants a broad indication with FDA, right? We want it to be used for everybody. The payers don't want that. They want to know, have you studied your device and technology in a very finite, specific patient population, and how does it work? So again, those are the differences in terms of the the thought process and then payment CPT codes or any Hicks goes, any code might have a payment assignment, but they might not have coverage. So again, even if you have a code with a payment assignment, and there are different payment assignments and different payment methodologies that apply to different care settings. And I'm just speaking about Medicare right now. So in the US physicians are paid differently than if then technologies that are performed in the hospital, outpatient department or inpatient setting the different payment methodology. So understanding what applies to you is important. Makes sense clear as mod, right? So, and I mentioned earlier that there are different different oversight bodies for you, for code sets. So we essentially have different code sets. So when somebody says to me, I have a code, we identified a code, we looked on chat, GPT, and everything's great. Well, what code are you talking about, and, and where, and where is your technology used? Well, it's going to be used in the, you know, in in the in, it's going to be a DME, but we identified an ICD 10 Procedure Code. Well, that doesn't make sense, because that doesn't apply, you know. So it's really understanding. So the ICD 10, and this is used worldwide. 10 diagnosis codes are used worldwide. They are created and established by the CDC and CMS. The procedure codes that are most relevant in the US healthcare system are CPT. Current Procedural coding terminology is what that stands for, and they are owned by the American Medical Association. They're owned and trademarked. It's a very big business for the AMA, make no mistake, very big business, and it's extremely political. ICD 10 procedure codes, on the other hand, are owned and managed by CMS, and they are used for inpatient procedure. So procedures that are done in the hospital inpatient setting, okay, whereas CPT codes are used for physician payment and procedures that are performed in the hospital outpatient setting or the ambulatory surgery center, okay. Picks codes are used for products. So think of durable medical equipment, products, physician administered drugs, you know, kind of other orthotics and supplies, things like that. They are owned and managed by CMS. So again, when I when I just to reiterate, a code is a code is not a code. It's really understanding all of these pieces. And. And the political nature of how they are all established and why, for example, with CPT, a specialty society that's part of the AMA, may not want a new technology innovator coming into the US and creating a new code. Why? Because they own their own code set in the CPT book, essentially, and they don't want to upset the apple cart because they've had a good payment for the past 10 years, or whatever it was. They don't want anything to to change. So, if that makes sense. So really understanding that is protocol from the US payer ecosystem, we kind of touched on this earlier. We have a number, a plethora of different payers in the US, and they all have different perspectives, but we are largely a an employee sponsored health care system from a commercial payer standpoint, meaning that employers think of J and J, think of Boston Scientific. Think of hospital systems. Think of, I'm just thinking of the big companies. Think of Amazon. They are the actual customers of the payers in the United States, okay? And then individually purchase, which is a small amount, and then we have the public payers, or government payers. We have Medicaid, Medicare. And it's important to note, and I have a slide later on in the deck, but I'll mention it here. When we think of Medicare in the US, we think of CMS and fee for service Medicare, but Medicare Advantage, which is actually these are products plan products, health plan products that are managed by commercial payers. About 66 0% of Medicare beneficiaries are now in a managed Medicare plan, which means that some of the policies and reimbursement policies in particular do not from CMS, do not apply to the Medicare Advantage patient population. So again, understanding all of these pieces when we're planning early right, early on is critical. So CMS, I'm not going to belabor this. We have CMS. Is the Medicare and Medicaid Centers for Medicare Medicaid. It funds, it funds and administers the Medicare medicaid program in the United States. We have Medicare. We have Original Medicare. Like I said, That's fee for service. Medicare. We have different, you know, Medicare Part D, which is essentially the our Medicare Part C, excuse me, it was the Medicare Advantage plans. Medicare Part A is hospital payer coverage. Medicare Part B is for physicians and for hospital outpatient services, and Part D is pharmacy. So there's different types of Medicare. How are Medicare coverage decisions made? Is it isn't as if you just go to CMS and you say, just cover my product. In fact, that's like the the less likely path that that companies follow. Why? Because you have to have a significant amount of data already established in order to get a national coverage decision. And if you don't succeed in getting a positive NCD, then all of the Medicare contractors that administer the program throughout the country, and these are all the different Medicare administrative contractors, they actually have to abide by the NCD that exists. So if it's negative, you have no route to actually get local coverage. Okay? So just to not to get too granular about it, but under NCDs, think of the TAVR taver device that is actually, actually under a national coverage decision. And really what that is, is a coverage with evidence development protocol, meaning that CMS says we think you deserve national coverage, but we're going to require all of your all of the hospitals that are using your product to subscribe to and submit their data to a registry. So we need it's coverage with evidence development. So we're as you're developing your evidence. Edwards, we're going to see at the end of the day if it's going to be covered or not. Okay. There is a new pathway. Some people have probably heard of it, called T set, transitional coverage for emerging technologies. It used to be called M set that was disbanded, but T set now exist, and this is an NCD pathway, national coverage decision pathway for devices that have breakthrough designation by the FDA. Okay, usually the FDA and CMS aren't really talking too much, but in this case, they're sort of trying to to align together. Now this is limited. It might sound very exciting because T set proposes to provide national coverage and establish codes and payment for a period of, I think it's four years. It was just established last year, fourth quarter of last year. And guess how many they're only accepting five technologies into the program, five per year. How many breakthrough devices were designated last year by the FDA? Day 125 plus.

Tonya Dowd  30:04  
So my message there is, don't rely on the T set pathway as your reimbursement. You know golden golden you know golden handcuff, essentially, or golden sword. Anyway. It is something that's there. It is also very specific to your technology in terms of what is the impact on the Medicare patient population and and it's, again, it's a pathway that exists, but it's not, it hasn't been well established. I think there's been one technology that's been accepted into it, but it's very, very new. But I want everybody here to really know what that is. There's a lot of buzz about it so and the normal kind of coverage pathway that exists is getting coverage by the local Medicare contractors, also called Max Medicare administrative contractors, through what's called a local covers decision process. And these are all the different Macs in the country. And it's worth noting that out of the 12 Max, many of them oftentimes have differing coverage policies for different for the same technology, so no consistency. I mentioned this earlier. This is a slide I was going to show about the number of enrollees in Medicare Advantage plans. So it's over 50% as of 2024 and that continues to grow significantly every year, meaning that again, companies that think, oh, I don't have to worry about commercial payers because my patient population is Medicare. No, you do, because these Medicare beneficiaries who are enrolled in a managed Medicare plan. They are. It's managed by a commercial payer. And again, the policies that exist with Medicare fee for service do not apply to these these products. Okay, makes sense. So what do what do payers want? Just commercial payers? What do payers want to see as it relates to health outcomes and outcomes, again, that support the clinical utility, clinical outcomes for your technology. They want health outcomes for a very specific patient population. I mentioned that they want economic outcomes for a very specific patient population. They want, the documented impact of the technology of the care relative to the standard of care, and what's the standard of care? Are you going up against something that's already in the market? Are you doing a superiority trial, equivalency trial, well published studies, appropriate, relevant clinical endpoints, and again, fit for purpose studies, which they're now accepting in real world evidence that's more and more accepted now than it ever has been. I think with AI, it'll continue to be more accepted. But really understanding what these individual payers want to see is important. And again, reminding FDA evaluates the device. Payers evaluate the outcomes. So you know, not to belabor it, but they want publications with specific studies for that patient population, real world evidence, you know, studies that showed the durability of the treatment outcome. I think one thing worth mentioning is, anybody have a diagnostic technology in the room? Or so if you have a diagnostic technology, payers don't want to just see the specificity and sensitivity data. They want to know the clinical utility data, what impact is the diagnosis that you're providing going to play pay play on how that patient is treated, how that patient populated, patient is treated. Is it? Is it really going to be different? So that's that's important to understand. Now this is important that payers can have a medical policy. You might say, well, Tony, I'm not going to have all of this data when I first commercialize, when I get my FDA clearance or approval, or even approval from a PMA, I won't have coverage. I'm not going to have any reimbursement. Well, that's not true, because, again, it's an iterative process. So Payers can have a medical policy stating that a service is covered or not covered, and at the same time, payers can also pay for devices and claims on a case by case basis. Okay, so not having all of your ducks in a row in terms of the data right at the onset of commercialization, in fact, most companies don't. 98% of technologies don't have all of the data that's needed, but you can still get payment and coverage on a case by case basis, showing the payer that there is a medical necessity argument to be made for a very specific patient based on their clinical history, etc. Okay, I just, I don't want to bust everybody, you know, oh my gosh. This is terrible doom and gloom. This is, this is really where a lot of technologies fall into when they first initially come to market. Achieving consistent and reliable reimbursement and broad market adoption is an iterative process. I think everybody probably gets that in the US. Yes. How long do you think it takes for a tech, new and novel technology in the US that has to go that pathway to the right, creating their own reimbursement pathway? How long do you think it takes to get and establish consistent and reliable reimbursement? And we want to take a guess, how, five to six months. Okay, that's anybody else? Good. You must have seen the Stanford study. So Stanford Biodesign did a survey in 2021 of new, of innovators with new and novel technologies that had breakthrough status, and their finding was 4.7 years. So whoever said five years, I think two individuals did, is correct. So this is, again, what we say, kind of in the reimbursement world. What we say is establishing consistent and reliable reimbursement is important, and it takes about four, I would say, four and a half, five years absolutely right common mistakes and how to avoid them, having a full focus on the regulatory and R and D path, with no attention to the reimbursement path. Mistake two, not understanding the patient journey, the current workflows and the technology value. Mistake three, not knowing your stakeholders and having that perspective of the one size fits all value proposition for everyone. Remember, everybody's got a different, different viewpoint, not having an end to end, evident evidence, generation plan beyond what's required for clearance for approval by the FDA. And I didn't mention this earlier, but, but I have a lot of clients that say, Well, yeah, we we have a we have a Scientific Advisory Board. Absolutely, it's two or three physicians that we pay. We pay them. They're consultants. Well, yeah, they're your friends and family. They're going to tell you what you want to hear. Go get the devil's advocate feedback and get the voice of customer feedback, not just from your scientific advisory board, but again, who are the stakeholders, payers, other providers, hospital systems, do the primary research to know from the voice of customer what your challenges are going to be developing and mistake six, developing your reimbursement and market access plan based on Coding only. I have a webinar. It's on the web somewhere, and it's about, don't go code shopping. I made that up. That name up, don't go code shopping on chat GPT or Google, because that's not, that's not a reimbursement strategy. And I will tell you in my, in my tenure with Medtech Innovator and with LSI, and just being a consultant and being the space for so long, I often see innovators have, they have on their slide, oh, we have a code. Here it is, and there's the payment, and we're good, and we're going to save the system money, and everything's great. Not going into the detail of what your plan is, we work with a lot of investors who come to us to validate whether or not the technologies they're thinking of, cons you know, of investing in, whether or not their strategy is sound, and if it's realistic. And they are the sophisticated investors, any investors in the room, investors, okay, okay. Investor, sophisticated investor, I'm assuming you want to know beyond like, what you know beyond the code. You want to know the plan. Are the investors we work with want to know the plan. And they know the plan is not going to be easy, but they want to know that the company has invested in finding out what the plan is. So really, really critical. And that's it. And we have almost two minutes. This is my LinkedIn profile. If anybody wants to connect with me but Q and A, I'll open it up. Yes,

Audience Question  38:41  
sounds good. Thank you very much. Very comprehensive review, but I would like to focus on the CMS issue, on very specific points that maybe have for my for me disappeared in your overview. My understanding is CMS is not focused when you say data is not focused on clinical data, that's not the business. The FDA business. They focus on health economics. So I have to prepare as I apply for a new code. Okay, your left side. I think it was a right side, on your side, I have to really to devote attention to the health economic, and I have to prepare for them a report that justify my request for code based on health economic. That's very different that proving to the FDA the efficacy, the safety, etc, etc. So that's question number 1am, I correct? Question number two on this, is it correct that CMS has to respond to be in 30 maximum, 36 months report based on the report I submit on the health economics? Yes or No, approve this your new code. So there's a limit of 36 months. Easy. Correct a question, okay, I want you answer. Is it correct that during the 36 months the CMS is vehicle, whether I'm breakthrough designated a lot to cover me on the cost of the product, not on the procedure, not to the doctor, not to doctor, but by direct cost. Last question is the way I push questions, because, 

Tonya Dowd  40:27  
yeah,

Audience Question  40:28  
would you say that all the other pairs that you mentioned right now, Blue Cross, Blue Shield, etc, etc, etc, are really dependent heavily on the CMS code decision, and they don't have the old mechanism to do the decision by themselves, regardless of what CMS will do.

Tonya Dowd  40:53  
Yeah, no, these are, these are excellent questions, and thank you. I'm going to answer the third one, and they're kind of all interrelated. The third question is that Aetna, Blue Cross, Blue Shield, the different commercial payers do actually have their own technology evaluation committees, absolutely and in fact, they look at specialty society guidelines, utilization management guidelines. They look at outside to outside parties who provide objective data reviews when they make their coverage decisions. Your other question about, does CMS want to see economic data? That is absolutely a no. And in fact, CMS, statutorily speaking, cannot make coverage decisions based on economic value. It is totally counter intuitive to what anybody would think. But in fact, let me just go a bit further to say this from a CMS payment standpoint, CMS has two programs that are offered to incentivize hospitals to adopt new and emerging technologies with additional payments for two to three years. The first is called ntap, new technology add on payment that's an input for the inpatient patient of inpatient procedures. The other is transitional pass through payment, which is for hospital outpatient procedures. The requirements if you don't have breakthrough designation, or you have to be new, you have to prove substantial improvement, clinical improvement, clinical and you have to show cost increase. You have to show your call more costly than the category you would fit into under either of those payment methodologies, hospital, Outpatient Prospective Payment System or Inpatient Prospective Payment System. So again, they're not basing it on the economic value. They're basing it on how much cost additive are you so CMS in and of itself, and there's, remember, coverage, that's a different group, coding, that's a different group at CMS and payment, they're all three disparate groups, and no one's really talking. And I'm not, I'm not exaggerating either. This is, this is, this is really what happens. So you're working with three different groups with three different perspectives, but it's not about the economic value for CMS. It is about the economic value for the commercial payers, and especially the commercial payers who have Medicare Advantage products. So And did I answer all your questions? I think I did. Okay, great. Thank you.

Audience Question 2  43:16  
Thank you, Tonya. Thank you for the all the information. So one question that I have hearing you is with the new initiatives about real world evidence, let's call it trials, right? Do you think CMS and all these agencies will help innovators to get reimbursement? I would call coverage in the future, because the sample size on these trials assume is going to be less based on real world evidence. But how do you cross reference this? How can you help entrepreneurs and innovators on this path

Tonya Dowd  43:56  
to create the evidence that you need coverage 

Audience Question 2  43:58  
exactly based on real world evidence, but that's really well established on the pharma, biotech, but Medtech is just entering that path. How do you be your advice?

Tonya Dowd  44:08  
Yeah, yeah. We have an evidence generation planning team at PRIA, and we do health economics, outcomes research as well as you know, just kind of clinical trial develop. We help develop the protocols and get pair feedback, Voice of Customer feedback from the hospitals. But we help design studies and the endpoints that are going to they're going to resonate. And I think you have to be creative. Not every technology is going to require, or should require, an RCT, right, right? So it's just not feasible. Oh, okay, I think we're out of time, but, but we, we do look at different different data points and different ways to develop the evidence that's going to be needed to resonate, and again, based on the strategy and who the who the stakeholders are that are relevant. So it might not be Medicare, it might not be Medicaid, it might be just commercial. So it really kind of depends, but we do get creative, because it's not a one size. Fits all evidence. Generation plan, okay, if that, if that's helpful, okay, 

Audience Question 2  45:03  
thank you. 

Tonya Dowd  45:05  
Thank you everyone for coming. I appreciate it. Happy to answer additional questions.