RQM+’s Post

Transcript

Namaste, ladies and gentlemen. Today we're here to talk about medical devices and reimbursement, hence the title. Would you like to get reimbursed now if you're a manufacturer and as a manufacturer? You are solely focused only on regulatory approval. Please think again because regulatory approval does not mean you will get paid for every device specimen that gets used. Think about this. Did you know that your study design and even publication strategy can have a significant impact on your eventual reimbursement codes? In other words. Regulatory approval does not guarantee market acceptance and you need to understand, appreciate and plan for geography specific. Reimbursement and you need to do that very well in order to put into a place an entire strategy around it and operationalize the same just as well as you undertake efforts to gain regulatory approvals. Please come and talk to us because in Doctor Dan Lace and team, we have folks who have literally been there and realize reimbursement for numerous medical device manufacturers. Let's get started right away. Dan, welcome. Thank you for joining us and can you please tell us? In short, does the design of a clinical study? Have an impact on a manufacturer's potential to get reimbursed. Well, thanks Jay, thanks for having me. Hey, yeah, it does quite it actually has quite a bit of impact on how things will be reimbursed. You know if it's an inferiority study or if it's a superiority study that may have a great impact on what reimbursement looks like if it's not inferior. Think about it, if it's not inferior, that means it's you know, not worse then so you we pay you, you know payers will look at that and go well then we'll pay you at it not worse than status would probably is going to be, you know the same as. The other comparable product possible. If you need a, if you're doing a superiority study, you then and you prove you proving yourself superior. Now you can kind of bridge that gap with that increase in payment that you may be that you know, that your company may be looking to get. But it really is highly dependent on how the study is designed. And of course, probably more importantly is what's the outcome of this study if it's actually shown that it is, you know, superior or not inferior. And that's one of the things with the 510K, some of the shorter routes to get to approval without clinical trial data, yeah, sometimes players don't know where you sit. Somebody with data usually beats somebody without data. So the design of the trial and even doing a trial along with that result in publication strategy is very important to create that value. Thanks, Jay. Excellent. So, so it is true that regulatory approval is not the same as market access or even the extent of reimbursement that you claim. And to think about it, reimbursement can actually make or break a device. When it eventually gets to the market and of course one must start thinking about reimbursement right from the time the devices are the prototype stage, that's it. I've heard that our regulatory and reimbursement system actually encourage. Or I'd say encourages me two devices. Be that as it may, does the reimbursement system push innovative devices into a corner from a policy and a requirements perspective? Is that even true? And if it is, how does one circumvent the situation from an innovation perspective? Excellent question, Jay. Here's the thing. If I think that the fastest way through, you know, FDA is to do me too kind of, you know, things that require additional data. You know, FDA needs to, you know, review it, but then also you need to develop that data. For review, so the five 10K path then me two path is faster, but and reimbursement and then payers and market access really don't mind that because remember more players in the field, more, you know, competitive pricing strategies can go into play. But if you are a different device, innovative technology with some good robust data, then you show up at the scene, you know, for reimbursement and market access with something that's different, perhaps better and then it's much. You know, that's much better for you as a company in terms of what reimbursement would look like. If you're a me too and it's been around for a while, reimbursement may already be set. So if you've got a way to lower your costs in production, you may, you know, that may be a winning game for you. But most of the time it's more towards, you know, enhanced, you know, product development, new materials, new technology that may make the product more expensive. So you know, premium pricing is something that you're looking. But All in all good wins. OK, So do you work to make sure the product has the best, you know, data available and is you know as best as you can be and be able to demonstrate that with robust data? Remember, keep in mind that the payers and even you know the market is focused on improved quality or lower cost or a balance of both. So do your work to make sure that you get those. There are processes in place for innovative products like ENTAC pass through. Payments, you know that what's being worked on right now, the TCT process. But all of those do take time. So that that's important to keep that at those in mind. It does take time to go through the reimbursement and coding and payment process, but that's why those innovative payment systems were put in place to help, you know, relieve some of that big hurdle that comes with the with the waiting for that. So good. Thanks, Jake. So, so as I'm understanding this dent, a competitive reimbursement strategy may involve trying to figure out whether it's better for your device to fit into an existing reimbursement code or whether you need to design and label your device such that it requires a new reimbursement code that is not only beneficial for you, but could also be difficult for competitors to use it. Yeah. Not only that, let's remember that physicians are trained to operate on the basis of standard of care. But then again, they may sometimes resort to off label device usage for various reasons. But on label considerations are key from a reimbursement perspective. So frankly, it's likely that you as a manufacturer will need experts in the field to help you figure it out. So Dan, just just a few sentences ago. Then did you? Did you, were you trying to make a point? Ohh, no, not at all. I'm just, I'm, I'm agreeing with you, Woolly this one. OK. Doctors are great to do certain things and they like what they do and standard of care. And it takes a little bit to move that standard of care. So there you go. There you go. OK, so, so think of it, reimbursement revolves around policy and a whole lot of items like coding coverage, payment ID, diagnosis codes, ICD procedure codes, CPT codes, DRG codes and such. Yes, it is a complicated system and as manufacturers you need to strategize and plan effectively towards it. Now Dan, at a high level, what does the process of applying for reimbursement look like? Sure. When you say high level, you mean out of the weeds of most of reimbursement processing? Yeah, there's just like regulatory, you know, there's, there's like 05/10 KPMA. But once you get into it, you realize there's 100 standards you have to meet, You have to show this, that and the other. And the same thing is true, exactly the same thing is true, you know, the reimbursement side for payers and for marketing. But the reimbursement, you know, assessment that you know, that we do helps you better than, you know, helps, you know, manufacturers better understand what that playing field looks like. You may be better than comparative devices, OK, But that doesn't mean you may be better compared to other therapies. For example, you know, you may have a great device that's better than other devices, but it's a device that may not be needed at all, OK, let's say for knee replacements or something like that, there's PT, OT, other therapeutic modalities. That come into play. Those are the things that players look at when they're, you know, evaluating products for payment and considerations like that. So having FDA approval, as you said, does not mean you'll get payment approval. But at a high level, there's three major components for getting reimbursement here in the US There are similar throughout the, you know, the entire planet. But at least for right now, the first is coding. You need numbers. It's kind of on a price tag. It describes the product. That's what coding is. It describes the product or the procedure or the application where it's going to be used. If it's software, for example, it helps to describe whether it's our X not RX OTC and all there and all those codes you mentioned ICD 10. For procedure and for other diagnostic coding, all those need to line up, you know, for you to get to the final payment part use the 2nd is that payment part. You know, there's an evaluation process that's done to figure out what exactly is this product worth in the market. So CMS sometimes takes a stab at, you know, through their evaluation committee and their rough committee what that payment might look like. Private payers can do what they want and CMS can set it up so that you know, it's individual entities can do what they want Carrier. You know, specific stuff and then the third is probably the trickiest part and that's coverage because you've got a code and you've got a payment level set, but that doesn't mean people are going to buy your product. That doesn't mean people are going to use your product. So you want to make sure that the coverage side, in other words, the decision making that payers will put into play that process includes your product. You may get, you know, third line, you may be after everything else is excluded or you may be first line if you hire quality and lower cost and. This ties too to what you're, you know, indications may be from FDA, but coverage is probably the trickiest part, but that's, you know, one of the three to repeat those again. Coding. Payment and coverage are the three tenants for getting reimbursement here in the US. Thanks Jack. Got it. Got it. Thank you, Dan. Now Dan, what are some of the key reimbursement policy related challenges that manufacturers may be unaware of? No shortage of those they do, they do change all the time. We've all heard, we've all heard the term value based care, but having a value product that supports and moves forward value based care. May be great for now and driving us to the future, but the US system is based on kind of doing individual things, selling individual items, whether it's a product or procedure. So, umm, that's one thing that you want to be aware of, but you want to make sure that your product still fits into the kind of the way most of the system is working right now, which is basically fixed fee rather than value based. It's a great way to go. We just are moving slowly towards that OK policy about. Let's say breakthrough designation, OK, it we had M you know, MCITA little bit ago that was repealed. We're in the thick of waiting for TCT to come about, but breakthrough status helps you with FDA as you get, you know kind of a little extra focus. But unless you're clinical data shows, you know, breakthrough worthy, OK to change standard of care to change the processes that are already been in place and may have been in place for decades needs some data. So keep that in mind. And then reimbursement factors change regularly from pricing to coding a little less frequently, but still suddenly your code could be combined. And So what you thought you were gonna get paid is now shared with a whole bunch of other folks. Nuances happen all the time. Payer policies can be changed anytime based on new technologies. Even though they may be reviewed annually, they still can change from yes to no or to, you know, add extra nuance and more hurdles that manufacturers may need to go through in order to get. Product on that value add coverage list. So things are changing all the time and it's important to be able to stay on top of all of those as you definitely do not want to not know what's going on. Good man. So for those who are getting into this right, Dan, what are the cornerstones of planning for a successful reimbursement? Hey, people are often asked, so when should we start? And I say yesterday, umm, they is to plan early many times that's the first component for larger manufacturers. Can we make money in this area? And we need to map that out before we even start. But for a lot of a lot of manufacturers, they have a great idea design. It's come through some technology transfer office. Or. You know, some way that it's a great idea, great product, just they're not used to, you know, being in that development pathway. All that said, you know, plan early because you don't want to paint yourself into a corner either in product development, we've got it all developed and it turns out that's an area that's not paid for, not covered or too much competition or any, any a variety of reasons that can cause you to, you know, get yourself stuck there. So having the regulatory and a reimbursement strategy in place early is key. Regulatory pathways like the five 10K for example, you can maybe get through FDA faster, but you need to understand thoroughly what that might look like when you're on the backside of that, OK, you may be fixed into a certain bucket of other, you know, other 510K devices, other me toos, or you may be in a bucket that's that's not covered at all. But keep in mind those coding, payment and coverage components need to be evaluated and you have to have a strategy and a plan to to address those. And bring those into the fold, so to speak. Plan with the end in mind when you start. So plan early and start early. Thanks, Jack. There you have it. Plan early, start early. It's a very nuanced landscape as far as reimbursement is concerned. So regulatory is not your only hurdle because regulatory approval is one thing and reimbursement slash market access is another, which is where you actually get your money back. Thank you very much, Doctor Dan Lace, for sharing your pearls of wisdom on reimbursement. Thank you so much, Jay. Appreciate it. Pleasure.