AHLA's Speaking of Health Law
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AHLA's Speaking of Health Law
Key Considerations Related to Medical Device, Pharmaceutical, and Biotech Arrangements
With the increased scrutiny on kickbacks regarding medical device, pharmaceutical, and biotech arrangements, there has been an uptick in enforcement activity specific to the use of physicians, advanced practice providers, and other health care providers who consult, speak, serve as advisory board members, or otherwise lend their expertise. Tynan Kugler, Principal, PYA, Mara Smith Kouba, Counsel, Bristol Myers Squibb, and Jonathan Porter, Partner, Husch Blackwell LLP, discuss key regulatory and compliance considerations associated with recent medical device, pharmaceutical, and other biotech settlements (including the Janssen case) and how life sciences companies can navigate the current enforcement environment while engaging physicians and other providers. Tynan, Mara, and Jonathan spoke about this topic at AHLA’s 2024 Annual Meeting in Washington, DC. From AHLA’s Fraud and Abuse and Life Sciences Practice Groups.
Tynan, Mara, and Jonathan recently authored an AHLA article on a related case, Biohaven Pharmaceutical Holding Company Ltd. or Biohaven.
Learn more about AHLA's 2025 Annual Meeting in San Diego, CA here.
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Speaker 2:ALA's, popular Health Law daily email newsletter is now a daily podcast exclusively for a HLA premium members. Get all your health law news from the major media outlets on this new podcast. To subscribe and add this private podcast feed to your podcast app, go to American health law.org/daily podcast .
Speaker 3:Well, welcome everyone. We're so grateful to have everybody here today. My name is Tynan Kugler , and I was fortunate enough to join Mara Smith , Cuba and Jonathan Porter at the 2024 annual meeting in Washington, dc and we're glad to be back together for some follow up conversation on continuing trends and developments related to medical device, pharmaceutical, and biotech arrangements. Um, in particular, those that include physicians and other providers that are party to the arrangement. So, we'll, we'll have some good updates, some good dialogue, and after some brief intros, we'll, we'll summarize our annual meeting discussion just at a very high level to , to tee up some of the things we'll talk about today, and then talk about some updates and continued challenges that we're seeing from each of our respective vantage points. So I am, again, Tynan Kler . I'm a principal with PYA in our Atlanta office, and spend the bulk of my time in compensation and service valuations. Several of , uh, the , the last several years have been spent in the, the key opinion leader, healthcare provider space, and am always interested in hearing perspectives from the field , uh, that Mara and Jonathan bring . So, Mara, I'll kick it over to you , um, for your intro.
Speaker 4:Thanks so much. It is so great to be back. We, we always have a good time when the three of us are together talking about these topics. Um , my name is Mara Smith Kuba , and I am a regulatory council at Bristol Myers Squibb . Um, so in my day-to-day work, I do a lot of advising on the regulatory structures and the way that we sort of oversee our medical and commercial organization in response to regulatory decisions, actions, things going on in the industry. So a lot of applying what's going on out there into an organization , um, addressing both US and global considerations. And I'll pass it over to Jonathan .
Speaker 5:Thanks, Mara. Yeah. I'm Jonathan Porter . I'm a partner at Hush Blackwell in the firm's healthcare and white collar groups. Before Hush Blackwell, I was a federal prosecutor where I focused mainly on healthcare matters, and now I, now I get to help healthcare and life sciences clients with federal investigations, complex compliance issues and the like. So , uh, I also teach white collar crimes and adjunct law professor at Mercer Law in Macon, Georgia. And since this is an A HLA podcast, I'll mention that I'm a vice chair of ALA's Fraud and Abuse Practice Group. We are always looking for people to contribute. So , uh, if you're listening and you wanna contribute, reach out to me. We'll , we're happy to plug you in. Um, and I'm always excited when I get to team up with Mara and Ty in talk about hot topics in life sciences enforcement. This is, this is gonna be exciting. So , uh, with those introductions, we'll get into the substance of this podcast, how life sciences companies can have relationships with providers that don't cross any type of enforcement line. Uh, as Tynan mentioned, the three of us, we gotta speak together on this topic at ALA's annual meeting back in June of last year, 2024. Um, I'm gonna spend a few minutes with a summary of what we talked about there, and then we will give some updates and talk about how this enforcement landscape impacts how life sciences companies ought to think about enforcement risk. So at the annual meeting , uh, we told attendees about a bunch of ways that some life sciences companies have tried to gain the attention of healthcare professionals and how some of those ways have resulted in enforcement trouble. Uh, so for example, we talked about the perpetual boogeyman that our speakers programs , um, and how regulators try very hard to discern between good educational programs on, you know, important new devices or drugs. Um, so that's on the one hand. The other hand is sham speaker programs like getting paid to speak to an empty room. Uh , one of those is, is good, the other one not so good. And, and , but that , you know, drawing the line between those not always easy. Um, there's a lot of gray area between those . So we talked a lot about speaker programs. We talked about a $12 million settlement , um, from mid last year in which a spinal device manufacturer, they settled with DOJ over allegations that it was giving kickbacks to physicians in the form of sham consulting fees, and also paying for IP that both sides knew was worthless. That's a unique one to me, papering over kickbacks using intellectual property rights as a cover. That's that . We talked about that. Um, at the annual meeting . At the annual meeting, we also talked about how key opinion leaders, as Tynan said , uh, key opinion leaders is a big new thing. Um, there's enforcement risk that's unique to healthcare. We talked about that. We also talked about how physician owned distributorships , um, they get a lot of attention in the form of fraud alerts. Uh, there was a US Senate , uh, subcommittee that investigated , uh, pods, physician owned distributorships. But in reality, we talked about how DOJ really is only settled a small number of those cases on misusing physician owned distributorships. We even talked about how OIG put out an advisory opinion back in 2022 that approved of a physician owned distributorship that sought to distribute the physician owner's own in invention. Um , we talked about all of those creative ways that life sciences companies seek to find alternative arrangements with physicians. Um, and I also recall us talking about how, from a big picture perspective, the advent of the CMS Open Payments database may have a large impact on enforcement in this space, since it's a public database and therefore possible of being a public dis public disclosure bar for whistleblowers. But also since the any kickback statute, it's a willfulness statute. That means you can only violate it if you have a mindset determined to do something that the law forbids. It's hard to make out an allegation that they're the , that a company is , um, paying for whatever benefit that, that it plugs into a , uh, publicly available database. I, I don't know about YouTube, but I'd imagine if I ever wanted to commit a willful federal offense, I'd probably be inclined to hide it so no one found out about it, rather than post it for all the world to see. Uh, and so maybe enforcement in this space is complicated by the CMS Open Payments system. Uh , we talked about all those things, but the big thing we covered at a HLA annual meeting was a big false Claims Act trial that wrapped up a week or two before our presentation. And if there's one thing to know about the trio that is Mara tied into me, it is that we are up to speed on the big issues facing the life sciences and healthcare sectors. Uh, so you better believe we talked about that big, huge trial , um, at, at annual meeting. So that huge trial was a subsidiary of Johnson and Johnson called Janssen Products. It was a declined keam . So , uh, it was a whistleblower against a pharmaceutical company, the , uh, Janssen , uh, without DOJ involvement. And the whistleblower won and was in line and may still be in line for a potentially billion dollar judgment. So that case vastly oversimplified, was about marketing efforts by the pharmaceutical company aimed at prescribing physicians. Um, the whistleblower said that those marketing efforts were kickbacks and also advocating for off-label uses. The jury actually rejected the kickback theory, but found against the pharmaceutical company on the off-label marketing theory. And the case was, and is big news for the life sciences and healthcare industries because of the exact test the jury was given to determine whether false claims had occurred. So it had a somewhat easy to meet test for the whistleblower at trial. It didn't require the whistleblower to show, but for causation , uh, that the off-label marketing actually changed any particular prescriber's mind. And it also had a fairly easy test for whether CMS would've allowed a pharmacy benefit manager to pay for the drug, had it known the exact way that it was being marketed. So those, for those reasons , um, the the Janssen Products trial was actually really big news. And since our presentation at a HLA annual meeting, a lot has happened in that case and in this life sciences alternative physician arrangement world in general that we're gonna talk about now. Um, and I'm gonna talk about the updates to Janssen plus a couple other noteworthy developments. And then Mara's gonna shed some, some light on what this enforcement landscape means to those , uh, advising physician , uh, advising life sciences companies, and then Tynan's gonna explore some implications relating to compensation for services. But before we kick off that next part, the updates to Jansen and everything else, Mara and Tyin, did I miss anything that we talked about at, at annual meeting, or should I jump right into the, the Janssen updates?
Speaker 4:I think you covered it. I think that's, we, we did talk , we fit a lot into our presentation, so there, there was a lot that we covered, but we had some great conversations there as well. Um, so I think you hit it all.
Speaker 5:Excellent. And we
Speaker 3:Seem to have, we seem to have a knack for cases popping up just before we have podcasts or annual meeting presentations. So Jonathan, I think a couple of those you're gonna touch on, were just recently released as well. So never a dull moment for, for this space.
Speaker 5:Never a dull moment, especially for this, this trio that you're listening to right now, <laugh> . All right . So we'll, we'll jump into some Janssen updates , uh, and then I'll kick it over to Ma and Tynan for, for the, the , the wisdom of, of this podcast. I'm, I'm just reporting the news here. So , uh, as expected , uh, Janssen is not waiving the white flag after losing a trial, they filed two motions that make some pretty good points . Um, and if they lose those motions, I'm sure they're gonna appeal. Uh , so those two motions. One for a new trial and one for judgment , uh, one for judgment as a matter of law , uh, for the non litigators out there. Um , what Jansen is saying is that the court can look at the evidence at trial and change the outcome by either granting a new trial or saying that Janssen should win on legal grounds. Um, are these motions likely to persuade a judge? Probably, probably not. Um, the judge considering these motions , uh, he oversaw the trial and had the ability to step in when the evidence was fresh in his mind. Then , um, and rightly or wrongly, some trial judges instinctively guard their past decisions to preserve an appearance of always, you know, being right and being consistent. Um, but it's not unheard of for trial judges , uh, to reverse course, especially in complex areas like healthcare. Um, one example of a trial judge reversing course , uh, post-trial was about a year ago , uh, following the elfen by trial in Maryland Federal court, Dr. Elfen bein was con convicted of healthcare fraud , uh, relating to his billing of level four e and m codes. Uh , but after trial, the judge granted a , a rule 29 motion that's a criminal motion , um, acquitted Dr. Elfen bein because of, because of the testimony on what exactly is required to bill a level four e and M code, it fell short of, of proving ob uh , objective falsity. And so judges do sometimes reverse course following a trial in , uh, in some complex healthcare arenas. Uh, but it's rare. So back to Janssen, what the defense is arguing in these motions is that the relator failed to prove that any prescriber was actually influenced by any purportedly improper marketing. So causation, that's a key element in the FCA. Um, if so, for example, if Mara speeds on her way to work and then Tynan tries to , tries to defra the government, Mara can't yet, Mara didn't cause tynan to submit a false claim. Those things are separate. Um, but if I knowingly convinced Tynan to defraud the government, then I may have violated the False Claims Act 'cause I caused someone else to, to violate the False Claims Act, usually the way, way that's proven at trial by calling a witness like Tynan who says, look, I wasn't going to defraud the government, but then Jonathan made me do it. He calls me to do it, he convinced me to do it. Um, in Janssen, apparently there weren't any doctors who testified and said, Hey, I prescribed these drugs because Janssen convinced me to do it with off-label promotions, with off, off-label marketing. That's, that's actually a really big deal in the enforcement arena because healthcare regulations are hard. People get into gray areas from time to time. It's one thing to get into a gray area and cause another to do something, but it's totally different thing to get into a gray area, be unclear if that gray area actually meant a difference to anything and then still get demolished under FCA following a trial. And , um, and so that's a, that's a step closer to holding Mara liable for tynan's fraud because Mara was speeding on her way to work. So this, this causation point and what needs to be proved at trial, it is really important. Um, it's a flood waves situation, and that's something that's a big thing the court is looking at right now. So the other really important thing being argued is materiality. Uh, and this is a big issue in declined KET tams. So the whistleblower didn't call a witness from CMS or, or any PBM, they just asked the jury to assume that CMS or A PBM wouldn't pay for the drugs prescribed because of off-label purposes. But CMS and PBMs are still paying for the drugs at issue in the trial, even after learning everything at trial. This is highly publicized. Um, knowing that many of the prescriptions are being written for off-label purposes. What does that mean , uh, in an enforcement landscape where it matters a lot how statements impact government decision making ? It's a dicey proposition to go to trial and not actually hear from the government decision makers . CMS is , uh, notorious for fighting hard to avoid being a witness. Uh , but that, frankly, that leaves an evidentiary gap that Janssen now is pointing out in post-trial motion. So what I've, what I've seen in other cases is a whistleblower that tries to skew , uh, what is material to CMS. And Janssen is saying that the evidence that trial didn't prove that the off-label promotions were material to CMS or the PBMs , uh, payment decisions that they wouldn't have been influenced had c uh , had CMS or the PBMs knew exactly what off-label promotions were being made. So those are big arguments that will influence how life sciences enforcement works going forward. So , um, in a minute, I want to hear from Mara and Tynan about how these issues impact how life sciences companies think about their relationships with physicians in terms of risk. But before I do that , um, as Tyna mentioned, there are , uh, DOJ has remained active in this world of policing, what I'll call creative kickbacks to prescribers. Uh, so it's not just whistleblowers, DOJ is still very active. So I'll cover a couple of those, and then we will kick it over to the smart people for their analysis. Um, but real quick, two, two recent settlements, because as Tynan said, there's always , uh, new stuff breaking as we're recording podcasts or speaking at annual meeting. So in November of 2023, DOJ announced a $47 million settlement with a pharmaceutical company that was giving free breath test kits to healthcare providers as an inducement to prescribe its drugs. Um, way oversimplified here. Uh, the test, the , the , the , the , the kit tested breath for low sugar levels that caused GI issues in the drug treated GI issues. Um, so then , uh, second , uh, settlement, actually days before we're , we're recording this , uh, in mid-December, a medical device distributor settled with DOJ over claims that the distributor was providing , um, healthcare providers with an inventory management system. Uh, it sounds like maybe it's software , uh, as an inducement to order the distributors products. Uh, frankly, for those of us who have read the legislative history of the anti kickback statute, and that's a very small number , um, I'm one of them , um, I think Congress would be surprised that the a KS would be used to outlaw breath tests and inventory management software. You know, when I was a federal prosecutor, my a KS cases largely involved cash kickbacks. Mm-hmm <affirmative> . Um , juries get cash. Uh, but here we are, life sciences companies sliding across the table to healthcare providers, not bags of cash, but breath tests and software that this is the enforcement landscape that we're in. Um, and it's not, you know, it's not easy for life sciences companies to figure out what's okay and what's not okay. And so now I get to throw it over to Mara to talk about how life sciences companies are supposed to analyze this landscape. Mara, tell the good members of a HLA how life sciences companies can educate physicians on their drugs and products, identify patients who could benefit from their drugs and products without crossing this enforcement line that we've been talking about. So we've moved past our bags of cash for speaking to an empty room kickback environment into a more nuanced one. So, Mara, how are life sciences companies supposed to respond to all of this?
Speaker 4:Well, obviously I have all of the answers, and you'll be able to go back and create your programs and have no issues whatsoever. That's obviously not how it works. And I do wanna thank Jonathan . He very much undersells what an expert he is in this field, and how we would not be able to do this without all three of us here. Um, so how do we navigate this landscape? It , it's not easy, right? We're looking at so many different considerations at this point. Um, at , I'll start with Janssen, right? Because that's the big one that's really going to impact the way that we're looking at things. Um, without that causation, everything that we do in the life sciences industry is really focused on treating a patient appropriately. And anybody who's worked in this space knows that a patient can be treated appropriately using off-label indications that's within the purview of the HCP to make that decision. Whether or not we have the product indicated for that, whether or not we have data for that, that is within the scope of what the healthcare professional can do once the product is on the market. So where does that, where does that lie? We want, for example, label and we want label extensions. We want additional indications. And the question becomes, we're generating data on that. We want HCPs to be treating appropriately. And now with this Janssen finding, there really is a lot of gray in terms of how, how life sciences companies can appropriately share information while that will allow HCPs to treat patients appropriately and effectively and without causing harm, but also while walking this very narrow line of not violating any laws and any kickback laws and any off-label claim laws. And so the question becomes, how is that information shared? I don't have the answer to that, certainly do not have the answer. But what I can say is when we're looking at this, and I think this really goes for a lot of the conversations that we have today, is starting by talking to your clients about intent. So what is the intent of the material that you're creating? What is the intent of the data that you wanna generate? What is the intent of the program that you want to host? Let's talk about the intent because it , at a certain point, right? A lot of our commercial and medical teams are trying to use the same data for different things. There's claims data and then there's education. Um, and so we're really looking at what is the intent of this piece? What are we looking to do in this situation? Because then it helps us look at the guardrails that we need to be considering. If the goal is to get information out there, and it's just to get the data, how do we share that off-label data in a way that's responsive and reactive or in a way that's like just essential for key individuals to know? And how are we, like how are we doing that ? So that's the number one. What is the intent of that? Why are we doing it? Because that helps inform the strategy that allows you to get the right people in the room, and it allows you also to distinguish your commercial activities from your medical activities. It allows the , the intent really helps drive, I mean , I always say to my clients like, everything should be about education, right? Like, we should always be educating because the decision ultimately is with the HCP. So what, what kind of information are we trying to get out there? The red flag, and we see this all the time, right? Like the low hanging fruit is speaker programs. There are so many different ways to do those, and we often are trying to make sure that it's the appropriate venue. Those are really easy ones to handle. It's the sharing of data where I start to see the concerns or what the materials that are being created, the decks that we're having , the conversations with key opinion leaders that we're having. That's where we really start seeing the , those sort of gray areas. So the first thing, again, intent, always looking at the intents that we can build that content out. The second thing is having really good systems for documentation. I think that that's another key element of this, is documenting the engagements, ensuring that your field teams really understand what they're supposed to be documenting, how they're supposed to be documenting it. Make the systems easy for your sales team to understand so that they're not, we do this every day as lawyers in this space. We know the trigger words, we know the language. And I always say some of my best clients are the ones that ask for the reasoning behind it. And I'm always trying to give the reasoning. But the people who really want to understand, and I love that, many of my clients want that, but that is maybe not getting communicated all the time to the field. Understanding the big picture we're , as Jonathan mentioned, we see this stuff every day . We're looking at it, we're reading regulations for fun, like this is what we do. Um, but this is not everybody's life. And so we wanna make it as easy as possible for the field teams and for everybody who's out there sharing this information and engaging with HCPs to document appropriately. Because if we ha once you have the intent, and once you ha can create systems that match the intent of the pieces that you're creating, the documentation is much easier. And it makes it easier to demonstrate. We weren't going in for the purpose of influencing, we weren't going in for the purpose of trying to get an HCP to prescribe off-label. This was in response to a question that the HCP had asked previously. Or we have a history of the HCP asking these types of complex questions. And that's why we knew that we needed to loop in our field medical teams. So there really is the documentation piece is that once you have the intent, you need to be able to show what the intent was and how that intent followed through in the execution. So I think that those are some really big ones and the training regular trainings that have that sort of holistic background where it's not just, you know, the laws don't do these things, but really understanding and explain. I always say I'm talking about the landscape. So I, you know, the laws, I know the laws, but we're looking at the landscape and where it seems like the government is having their focus at this point. We, we seem to be past speaker programs. And again, that seems like everybody knows, right? We're not taking people to, and not everybody, 'cause we still see the cases come up, but we're not taking them to golf courses. We're not taking them on cruises and fancy dinners and things like that. But we are still seeing this new way that the government is coming up with ways to bring claims against life sciences companies. So those are some really big ways that I think in house you can intention, documentation and training are the big overarching ways to get ahead of this. Um, the other thing too is looking at some of the other cases that Jonathan was talking about is looking at your relationships and looking at your contracting in your relationships. Again, there's an intent there. I always say I , I came from a transactions background. So being in the role that I'm in now, I always ask how do we as an organization intend to work with this vendor? How are we trying to engage whether it is an EMR vendor, whether it is, like you were mentioning, are we partnering or, or working with a device that is not a combination product? So if we see a device that again, may be helpful in monitoring something or maybe part of the treatment process , um, but is not part of a combination device or a combination product, what is our relationship with that company? What again, is the intent? Is it an educational piece that this is a resource for HCPs or are we actually part of bringing that device to HCPs? And because it seems like that's gonna be an added value. Again, it's not the bags of cash, but it's going to be something that we really consider a value in this space. So really considering how we're thinking of those and looking at what those contracts say , what the relationship looks like there, what we're contracting for on sort of a small level, but we're also seeing it with labs. So we're seeing it with sort of partnerships all the way across the board is that we really want to be careful and intentional about the way that we're engaging. And I , it's not an added value for the HCP, it's looking at, it all goes back to the intent. What is the intent of the reason that we are engaging? Is it to su it should never be to prescribe the drug. It should always be to help the physician make the appropriate treatment decision. And so that's kind of the framework that I try to get all of my clients to understand is that everything that we're looking at is to support decision making . It is not to support the prescribing of the drug. It is to support the HCPs ability to understand what appropriate patients may , what needs to be considered for appropriate patients , um, in , in this space or that are appropriate for the drug or the products that were , were manufacturing marketing. Um, so it really goes down to still, and I think that's part of the concern with Janssen, right, is that a lot of the hc, they didn't have HCP witnesses who felt that they had done anything because of the marketing. And so it really seems like we're going to be looking into a space where a lot of our work has to be reactive. And that's why it's so important to document things is that we really have to be clear that this was not something that we were out going and , and trying to influence , influence the promotion. It really, we should be showing that this is responsive ad boards market research. Those are also helpful ways to inform what HCPs need to understand or what they're seeing in the gaps of their understanding. A lot of times that's my question is, right , why are we doing this? What gap are we looking to fill? What is there information that's not out there? How are we providing something to these HCPs that informs their treatment that may not already exist from another third party? Um , so those are sort of the , the considerations that I have there. And I briefly touched on it , um, with the EMR systems, but we can talk about that a little bit later. But we're seeing all of the different ways that we can help educate HCPs, which is the goal is educating HCPs so that they understand the treatment landscape. Because we've done tons of research on these products. Like we've thought about it, we've had studies, we've worked with different individuals, we've had clinical trials , we know the product and we want to share that information in a way that's helpful for physicians to utilize our treatment. Um, it's just finding the right ways to do that and walking this very narrow line, it appears , um, of not really, and as I say to all my clients, it's a gray area. We're doing our best to mitigate the risks, but you don't know. I tend to hope and trust that like the government is not going to look at a single instance as a violation. They're looking for patterns. They're looking for habits, which is why we always aim to keep a culture of compliance and a culture of having these conversations and documentation. Because you don't know, you don't know who's going to be a whistleblower. You don't know who's going to see something wrong. So it's a very delicate line that we're just all doing our best to navigate because next week there may be a new case where they found one person had made one comment. I, Jonathan , I don't know, you can tell me if that's something you'd you'd bring. Um, but I think that largely we're just trying to create a culture of compliance where we're really putting the right processes and trainings in place to avoid these things. Um, but now Tynan's gonna talk a little bit about the things that she's seeing in her space and how you can work to ensure that the compensation is appropriate , um, as well and the valuation is appropriate.
Speaker 3:You know, it , and it's so interesting because some of the things that you've both touched on are things that we look at when we're looking at what's the value, what is something worth , um, the , the facts and circumstances. And I think this also ties back to Janssen. 'cause when you read that motion, there's a lot that goes into, well, what are the facts and circumstances of this particular arrangement, this particular transaction, this particular situation. And um, we, we often find that, you know, you've seen one KOL relationship, you've seen one KOL relationship. And while companies and organizations try and standardize that , um, you , you still have to be really thoughtful about the facts and circumstances within that standardized approach. So when, when Mara talks about intent, one of the things that, that we think about from an intent perspective is what's the need for the service? And so having the documented need to support the commercial reasonableness of why you are engaging a KOL or an HCP , um, is, is really important as part of the process. So it's not just what am I paying that individual? Uh , but , or, you know, how am I remunerating them, but what's the reason and the , the the need behind this. So I think the other thing that, that, you know, both Mara and Jonathan touched on is that, and Jonathan, you can correct me if I'm wrong, but I think one of the things the DOJ would do if they were to come in is, is look and see how robust your , what is your compliance program? What is your process? Do you have a a a process for assessing need? And you know, obviously if you do, it's, it's, it's a better fact pattern than it than if you, if you don't, because then you can't, you can't do the things that that Mara mentioned. The, the other thing is, I think it's harder for, you've got companies across the spectrum, right? That are trying to implement all of this. You've got, you know, smaller medical device companies that are solely, you know, just trying to get their device up, develop to market, but know they need key opinion leaders and HCPs as part of that process, but might not have the, the level of sophistication necessarily that, that a Amara at Bristol Myers Squibb does. So that's where I think, you know, for us it's the education of what's needed and why. And then it's, it's starting that education with, with the company so that they then are equipped to provide the education that Mara mentioned internally. 'cause depending on the decentralized nature of an organization, some of the things that I think ma you talked about get lost when it goes from legal compliance then , then to the field who are out there, oftentimes the ones that are , um, engaging and wanting to engage those HCPs and KOLs. So there's really good data out there from adv me and others about sort of what some good policies and fundamental things are from a comp perspective and also from a, a commercial reasonableness or needs perspective. But just a couple of things that, that, you know, we're starting to see , um, from the, from the, the, the dollar side of the house is the difference between a key opinion leader and how we pay for a key opinion leader, which has often been , um, sort of time-based. So we look at what is the ask of the, of the HCP or the key opinion leader? Is it to participate in a not advisory board, attend a certain number of meetings? Is it we want you to come and speak at an event we have all the other things we have to make sure are reasonable if we're gonna pay you to do that. But those are has have historically been based on on time. So time, time some hourly rate gets you to a, a , a payment that then goes to that HCP. Well , with the rise of social media, digital opportunities for key opinion leaders to participate, they're now, and we should have said this at the beginning, but it's not just a KOL, there's a new term called A DOL or a digital Opinion leader. And you know, when you think about just general social media, you think about compensating for somebody based on their followers, their number of posts, their number of likes, the , um, their ability to impact an audience or their audience is not going to be something that's measured via time. So then we get into this whole other area of, well, how do we pay a DOL and what are the things that we need to think about to get to the right comp number there? And, and we're having to look at things like, you know, just social media metrics, variables, engagement rates , um, you know, forms of likes, shares and comments. What's the follower profile? Is it a, you know, if you're paying a DOL on behalf of a product, you sh you should have followers and pay for that followership that are going to be educated and, and use that product versus don't pay for followership for people that are teenagers, for example, that might not be utilizing the product. So again, that's kind of an egregious example, but follower demographics, types of touchpoints. There's just a whole new world from an appraisal standpoint about how we're gonna need to be thinking about the different business models that organizations are using. The, the one other piece I'll touch on , um, that Mara mentioned are the EMRs, because that's another area where we're seeing , uh, key opinion leaders or HCPs used where, and it's not just an EMR , but it might be just a software , uh, you know, any kind of software platform where there's a, a provider that is a super user of a product, is passionate about that product, the, the organization, you know, understands that passion and that HCP is a good educator on behalf of that company. Um, so there are things that we look at for purposes of what can we pay that sort of super user , um, you know, for participating on behalf of the company. And I mean, we've sort of seen the gamut there, whether it's, you know, a a physician talking to another physician about their experience with that product that's very different than a physician, a a potential client of that software company going on site to that super user and that super user spending some time with the potential client. Sometimes the physician isn't really the one that's spending time with a potential client, it's the practice administrator, it's the nurse. So that's where we get into, again, the facts and circumstances of who's really, who are you really paying to do the service even though you've got the healthcare provider as the super user , you might be having other people show the client all the benefits and how operationally it works , which you might have a disconnect there in terms of what your compensation is versus who's actually doing the work. So we do a lot of asking questions and we do that so that we can arrive at a number that we know is supporting the intent and the need and the service that the company is paying for . The , the one final thing I'll say, and I I , this kind of, I think gets back to some of what Jonathan said about open payments and then the, the comment about, you know, we're seeing these, you know, creative arrangements I guess where it's not cash payment but it's, you know, inventory management or it's, it's supplies. I mean, we've had issues with supplies in laboratory arrangements for, for a long time. I mean, that's not new, but you know, open payments, we look at open payments as the appraiser because our goal is to look and say, okay, that's a market comp, right? We know companies are paying, companies are reporting providers receiving that compensation are reviewing theoretically. Um, so there is some market data that's available for us as an appraiser. The problem is you can't really get to the actual payment for the service that a physician or A-A-K-O-L has been engaged to do because of how that data's reported. So in other words, you can't get back to an hourly rate to say for these consulting services is what this provider was paid by a b, c company consistent with fair market value. So it's out there, it's low hanging fruit for those that are getting paid a lot, but it will be interesting to see if it evolves into something that we can get sort of under the hood a little bit more with and and determine really what is getting paid versus the aggregate of what , of what's being reported. Um, you know, the other thing is yes, we say the golf trips, the Super Bowl parties, the, you know, presentations in fancy restaurants. I , I think that that, yes, you would think that that's still not happening, but I think it's still happening and I think we're still gonna continue to see it in the absence of good policy, good intent, good support. And then we're gonna see like there was even one case earlier this year that, that had been settled before, but, but it had come back up again and I mean it was a frequent flyer situation where physicians were getting frequent flyer miles gifted to them and it was, you know, obviously then when you looked at that compensation, it was below fair market value. So , um, and those things aren't necessarily reported in, in open payment. So that's Jonathan. I think to your point, sort of how these things are gonna continue to fly under the radar a little bit. Um, and the two that Jonathan mentioned, I think those just came out almost sequentially within the last week or so. Um, so I think we'll have a lot to report in 2025. I think there'll be some continued continuing discussions about , um, what we look at from our perspective. But, but I'm gonna, I'm gonna kick it back over to Tamara for , uh, to see if any of us have parting words and, and, and go from there.
Speaker 4:Yeah. Anything else, Jonathan, you wanna
Speaker 5:Add ? No, I'll , I'll just re repeat Ma something you said it , the , the goal in these investigations is to figure out what the people were intending to do at the time. And so Mara, your advice to paper, it is the best advice to me. Um, if you've got, if you're, if you're doing something where a , a a healthcare provider could receive some benefit in hindsight , uh, paper it, explain why you're doing the thing, explain, hey, here's this new product that we think is gonna help a lot of people. We want people to know the exact situation where the patient , where patients would benefit from it. So if you paper that, it's gonna go a long way if you get investigated to telling the other story, telling the other side of the story. 'cause a whistleblower's gonna tell one story. You've gotta have documents to be able to tell the other side of the story that says, no, we, we were trying to tell healthcare providers, this is the scenario where you, where you order this, this is the , uh, the scenario where, where you prescribe it. So Mara, I'll just credit you for that paper, paper your thinking in real time . I think that's, that's critical in these, in these situations.
Speaker 4:You heard it here. DOJ <laugh> , you heard it here , I'm doing it right,
Speaker 3:<laugh> . Well, and we'll ask for that. If we're asked to write a commercial reasonableness opinion on something like this, we're gonna ask for that piece of paper that says, why are you doing this? 'cause otherwise we, we can't make the determination whether it's reasonable or not. So you , you , you get a two for there.
Speaker 4:And it's also just helpful from like a quality assurance perspective internally to understand how are your field teams understanding the trainings, how are they interpreting things? It just, it's a really good, i I think again, within reason because we don't want people papering everything that they do all the time forever. Um, but it is really important for us to understand the intent behind it and also how effective are our trainings? How effective is what we're, what we're sharing. Because we, that's our goal is for our field teams, for everybody that's in our organization to understand why we're doing what we do. Legal doesn't like being the no legal doesn't, like I always say, you , you don't go in-house because you don't understand the goals of the organization. You don't understand the value of what you're doing. Life science companies are here to help patients. That's our goal. And everything that we do is aligned with that. I'm just, I, the example I use all the time is that an in-house lawyer when you're advising your clients is particularly before it gets to these litigation, to these cases, I go , we're in the healthcare field. Your lawyers should be your general practitioners, your gps, their doctor that you go to for your, your vaccines and for your diet and for your checkups. My goal is to keep you away from these investigations and from these keam actions, which is the ER in my opinion, that's when it's the bleeding is happening and you're trying to stop it. I want you to take your vitamins, I want you to go on your walks, like that's what I'm doing here as your in-house lawyer . So that's the example I always give to my clients is that's why I'm here, is to keep you from the er , um, metaphorically. But I think we've had a great conversation today and I think that particularly with the new administration coming in, there's going to be plenty of decisions and shifts. Um, we have obviously these cases and I think there's also some, the FDA guidance on this IUU should be coming out soon. So I think that we have a lot of things to look forward to in 2025. Um, I'm certainly looking forward to seeing these two at annual meeting , um, in 2025 in San Diego for a HLA , um, a great, it's always my highlight of my year professionally. So I hope that we get to see everybody there. And thanks for tuning in.
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