This transcript has been auto generated
00;00;01;06 - 00;00;23;23
Jonathan Porter
Welcome to another episode of Hush Blackwell's False Claims Act Insights podcast. I'm your host, Jonathan Porter. Last month, a huge False Claims Act trial ended in New Jersey. There aren't a lot of False Claims Act trials, so when they happen, people often take notice. But for some reason this one hasn't really been discussed all that widely. We're fixing that today.
00;00;24;07 - 00;00;53;18
Jonathan Porter
Today we're talking about the qui tam against a Johnson Johnson subsidiary named Janssen Products. This is a case that the Justice Department didn't take, but that the whistleblower took anyway. And it ended very, very badly for the Johnson and Johnson subsidiary. A federal jury concluded that the drugmaker was liable for violating the False Claims Act and found around 160,000 false claims to the government for $150 million in improperly claimed funds.
00;00;53;18 - 00;01;21;17
Jonathan Porter
And spoiler alert, under the False Claims Act, that means Johnson and Johnson subsidiary could be heading for $1,000,000,000 judgment. That's real money, at least to me. We're talking about that trial today in the context of how life sciences companies have financial relationships with physicians. This is a really hot topic. And joining me to talk about this hot topic are two friends who allowed me to grace their panel at last month's annual meeting of the American Health Law Association.
00;01;22;04 - 00;01;43;29
Jonathan Porter
Coincidentally, the three of us had previously agreed to speak about physician arrangements with life sciences companies at the annual meeting. And when we agreed to speak, we had no idea that this huge billion dollar FCA trial was going to wrap up the week for the week before our our speech. And so we were gifted a hot topic to talk about.
00;01;44;10 - 00;02;25;12
Jonathan Porter
Even though the life sciences industry probably doesn't view that trial as a gift. So I'm looking forward to recreating that conversation today on the podcast. I'll introduce Tynan Kugler first and this topic was her idea in the first place. Tynan is a principal at PYA in Atlanta. Tynan focuses her advisory work on helping clients with valuations. Tynan helps with fair market value compensation analyzes, which would have been useful in our recent Stark Law episode, but also very strictly valuing things for life sciences industry, including key opinion leader valuations, which we will discuss in a little bit.
00;02;25;29 - 00;02;52;28
Jonathan Porter
We're also joined by my friend Mara Smith Kouba and Mara is counsel at Bristol-Myers Squibb, where she focuses on commercialization and development of particular product lines for the Excel Pharmaceutical Company. Mara and I are both in leadership at the American Health Law Association, and we're both adjunct law school professors. Mara teaches at Drexel University in Pennsylvania, and she's a true rising star of the life sciences industry.
00;02;52;28 - 00;03;01;21
Jonathan Porter
And so I, I'm so excited to have you both on the podcast. Thanks, Tynan and Mara, for telling our listeners about this really important topic.
00;03;02;02 - 00;03;03;11
Mara Smith Kouba
Thanks so much for having us.
00;03;03;18 - 00;03;06;12
Tynan Kugler
We're glad to be able to get the band back together. Jonathan.
00;03;06;18 - 00;03;19;02
Jonathan Porter
Yeah, I'm excited. So I want to jump right into this Johnson and Johnson subsidiary RFK trial that I mentioned in the open. Tynan, would you get us started by telling our listeners about that trial? What was this case all about?
00;03;19;11 - 00;03;53;17
Tynan Kugler
Sure. So it was an off label marketing case, but the lead theory in the Relator's trial brief was that one purpose of Janssen Products speaker program was to induce or reward prescriptions in violation of the Anti-Kickback statute. Janssen strongly believed that the one purpose theory was legally wrong and thought that the judge should have instructed the jury differently and should have instructed them that Janssen could only have violated the ethics if it both did two things.
00;03;53;20 - 00;04;21;03
Tynan Kugler
One paid doctors in excess of the fair market value for their time spent speaking, and two paid doctors as part of a quid pro quo transaction. So paid speaking fees in exchange for prescribing. So the judge, as Jonathan stated, sided with the relator and thought that the one purpose theory was the technically correct version of the Anti-Kickback statute.
00;04;21;21 - 00;04;45;13
Tynan Kugler
And with that instruction, it's not surprising that the Relator's won the trial. And as Jonathan said, the jury identified 160,000 false claims and $150 million in proper payments because of those claims. The latest is the Janssen is appealing and feels strongly about their chances on appeal. So we'll see where it goes.
00;04;45;23 - 00;05;07;09
Jonathan Porter
Thanks. This is going to be a really, really fascinating appeal to watch. There's a huge gulf between the between the jury instruction that the Relator's counsel wanted and the jury instruction that Janssen products counsel wanted. And I think that that's something that the Third Circuit's going to have to decide, and someone's going to have to think about what this is.
00;05;07;20 - 00;05;32;08
Jonathan Porter
That one purpose theory is actually a really big deal, and I want to sort of call that out right now. So to me, this trial should be a wake up call to the health care industry and to Congress that the Anti-Kickback statute is being enforced in, frankly, a draconian way. The Supreme Court just used that word draconian in the Snyder case to describe how DOJ was enforcing a different bribery statute.
00;05;32;08 - 00;06;06;03
Jonathan Porter
But I think it fits here, too. So if one purpose is the legally correct interpretation of the case, then frankly the case needs to be changed. The False Claims Act is an anti-fraud statute. It's not an invitation to guess whether one purpose of any particular act was to reward referrals or prescriptions. But if this is the law and the instruction that the jurors are going to get in these cases, that I don't see the line at which life sciences companies can have any type of business relationship with anyone who prescribes their drugs or products.
00;06;06;16 - 00;06;26;00
Jonathan Porter
Even if a physician is working with the life sciences company to develop some breakthrough miracle drug, then you want that physician to talk about his or her miracle drug. Wouldn't this same jury instruction create a ton of risk that a jury could be convinced that one purpose of the payments is to reward the physician for prescribing the drug?
00;06;26;13 - 00;06;46;11
Jonathan Porter
That can't possibly be the law, can it? And so I think this case is a really, really big deal. And this appeal that's coming is going to be a really, really big deal. So we've had more I hate to bring the question going to ask you like that, but Mara, I struggle to see how life sciences companies can ensure compliance under this interpretation of the X morrow.
00;06;46;11 - 00;06;49;10
Jonathan Porter
What is the industry supposed to do about this case?
00;06;49;25 - 00;07;17;13
Mara Smith Kouba
So I think that's a great question. Right. So coming out of this case, everybody is aware that this seems to create a new standard. But I think the one thing that all of us on this podcast understand is that we can't ensure anything, right? So we can't ensure compliance with anything. It is always kind of a guess as to what the enforcement trends are going to be, what the enforcement patterns are going to be, what a judge you're going to get in front of, and what facts they're going to actually focus on.
00;07;17;20 - 00;07;48;02
Mara Smith Kouba
So I think that that's sort of the first thing in that sense. I don't necessarily think that it changes the advice that we're giving as a whole to begin. Right. Because when we're in these life sciences companies, when we're advising our clients, the purpose generally we are looking at, I think, for example. So if we go back to the special fraud alert in 2020 that was based on the Novartis case and speaker programs that set out some really clear guardrails, that did change how we were looking at enforcement.
00;07;48;13 - 00;08;14;14
Mara Smith Kouba
I think what this does is it emphasizes where we're emphasizing the risk and sort of the percentage of risk that we're saying it's a much higher risk that we're looking at now. But I don't think necessarily that it shifts the way that we should have been advising all the way along. Right. Because the one purpose should or at least our purpose should always be educating, getting information out there, sharing data.
00;08;14;18 - 00;08;40;28
Mara Smith Kouba
It shouldn't be a larger purpose in terms of inducing. That sort of was long ago in the golden era of pharma that was taken away when we can't give pens out anymore. So the way that we're advising should always be the focus on education, the focus on sharing data, the focus on thought leadership. So we think that it doesn't necessarily shift the way that life sciences companies have in sort of the postwar No.
00;08;40;28 - 00;09;02;08
Mara Smith Kouba
20 plus Novartis world been looking at cases. But what it does do is it really focuses on how we're emphasizing the risk and what steps we're taking to make sure that we're documenting, for example, like ways that we're mitigating these kinds of things and making sure that we're documenting the purpose incredibly clearly. Okay. We're having an in-person meeting with lunch.
00;09;02;17 - 00;09;28;07
Mara Smith Kouba
Why? What information are we sharing? Why does it require an in-person it's using, utilizing, zooming, utilizing virtual events to make sure that we are pivoting for things that are just very simple information sharing. We're moving that to a virtual event or we're at least putting in documentation. Why it's really important for us to be doing the events the way that we are and what the actual spelling out.
00;09;28;07 - 00;09;56;06
Mara Smith Kouba
The purpose, I think is really the key because that way there's no I mean, obviously, again, it's all dependent. You can't ensure compliance with anything. You could get somebody who's as you wrote the purpose here, but it seems and again, that's always the case, you know, that that's how some of the cases go. But it's really about framing it in a way that you're dotting the i's and crossing your t's to make sure that the purpose that you understand it to be is very clear when there's nobody to explain.
00;09;56;06 - 00;10;11;16
Mara Smith Kouba
But we had a conversation about the educational purpose. It's just not here, put it in the document. And so I think that that doesn't shift it necessarily in terms of what we should be already advising on, but puts more of an emphasis on the ways to protect against it.
00;10;12;04 - 00;10;33;15
Jonathan Porter
Thanks more. I appreciate that yet. So just sort of doing that returning to first principles thing. Education in health care is good. Whatever the law is, we've got to find a way where we can allow good, legitimate speaker programs to work educating other physicians about results that that your patients are seeing. That should be something that physicians can do.
00;10;33;29 - 00;11;01;13
Jonathan Porter
Obviously, like fake speaker programs are bad. And I think the issue that we're having here is that for four years you heard about all these fake speaker programs and that was the subject of all of these OIG, you know, fraud alerts. And there's got to be a way for us to say, speaker, programs in general are really good, sham speaker programs are bad and signed a line so that the industry can know what's good and what's bad, what's legal and what's not legal.
00;11;01;19 - 00;11;20;10
Jonathan Porter
And that way everyone's got some clarity. And physicians can go about their jobs knowing that they're not going to get rung up or life sciences companies could go about their their jobs without knowing they're going to get run up by a whistleblower who says that one purpose of something is prescriptions. And so there's got to be something here that clicks and makes sense to somebody.
00;11;20;10 - 00;11;38;22
Jonathan Porter
And hopefully the Third Circuit will do something. But, you know, you can't say that every speaker program is a kickback. That's essentially the version of the law that the Johnson and Johnson Subsidiary's jury heard. And so hopefully something's going to happen here in response. So we'll see what that is. Let's talk about a slightly different issue that you time and see in your work.
00;11;38;22 - 00;11;53;27
Jonathan Porter
And that's the key opinion leader and the digital opinion leader. So Tynan tell our listeners what key opinion leaders are and how life science companies engage with key opinion leaders that could cause some enforcement questions in some circumstances.
00;11;54;11 - 00;12;36;12
Tynan Kugler
Sure. And, you know, the key opinion leaders are the ones that are that are doing the educating and the speaking. And so it's important to understand sort of exactly who they are, what they are, and tomorrow's point, how they're being used. But in the context of a life sciences company, you know, for example, a pharmaceutical or a medical device company or even, you know, in the context we've been seeing in electronic medical records companies, a key opinion leaders, an individual who is really considered an expert in their field or specialty, those are the ones that you want to be doing, the kind of educating about devices or drugs that are coming to market, that need
00;12;36;12 - 00;13;04;17
Tynan Kugler
the expertize of somebody who's trusted, well-respected among their peers. And that's often physicians who are doing that work. Sometimes it's other clinical providers, but oftentimes it's physicians. And the reason is because those individuals can provide insights into disease states, they can provide information on existing or future treatments. They can educate on the design of clinical trials in the context of medical devices.
00;13;04;17 - 00;13;30;17
Tynan Kugler
They're able to inform on product design. So there are a number of different things that that expertize lends to those companies that then helps play into the education that ultimately comes from that. So you'll often hear KOLs, but you'll often hear the term CPE, which is a health care provider. So KOLs and CPAs are kind of referred to somewhat synonymously.
00;13;30;17 - 00;14;05;19
Tynan Kugler
And then, you know, the other thing we're seeing is sometimes the alcohol is actually a non clinician, so it could be somebody that is an expert and that's contributing, but that isn't necessarily a clinician. So Jonathan mentioned the digital opinion leader, so we'll add another string, the DOL, and there's similarities between KOLs and dolls. There are differences as well, but a DOL is primarily using digital or social media more prevalently for how they're messaging based on the need that's been identified.
00;14;05;21 - 00;14;54;05
Tynan Kugler
So you'll see KOLs KPIs, dolls engaged by companies for speaking, consulting and even participating on advisory boards or advisory committees. So the one other thing and Mara touched on this, but you know, as we saw in the Janssen case and in some other cases that are similar because companies need to take care that interactions with KOLs are, you know, free from undue influence, making sure that compensation for the provision of the services they're providing is consistent with fair market value is is an important part of the equation and the process that Mara alluded to earlier, and you mentioned the item that I think doesn't necessarily historically hasn't come up as much, but it's the fair
00;14;54;05 - 00;15;24;20
Tynan Kugler
market value piece of what am I paying that physician? And we've all heard the adage of, well, the physician down the street is paying me $500. So that's what you need to pay me company. But you know, the Interac action also has to be supported by a necessary business purpose. And so the identification of why are we doing this and why am I engaging this physician, or why do I have this advisory board for this product is goes hand in hand with what am I going to pay for the provision of those services?
00;15;24;25 - 00;15;28;07
Tynan Kugler
So lots to think about from a client standpoint there.
00;15;28;17 - 00;15;46;05
Jonathan Porter
Thanks, Tynan. And that's exactly what the Janssen Products attorneys were trying to the point that they were trying to make in their jury instructions that they asked for they didn't get. Was that in order for Janssen products to be shown to violate the anti kickback statute, the jury had to find that they paid doctor in excess of fair market value for the time spent speaking.
00;15;46;05 - 00;16;06;10
Jonathan Porter
And that's that's a that's an instruction that the jury did not hear because the judge didn't agree with it. The judge thought the true test or the anti-kickback statute was this one purpose test. And so that essentially what the judge was saying is it doesn't matter if they're being compensated. Fair market value above the fair market value. Below fair market value, that's immaterial.
00;16;06;10 - 00;16;28;03
Jonathan Porter
So long as one purpose of any payments was to reward prescriptions. And that's an interesting take on the Anti-Kickback statute. Then again, we'll see what the Third Circuit says. So, Mara, let's cover a different vehicle that some physicians have had some trouble with lately, and that's the physician owned distributor or ship. Mara, what are those and what's the enforcement issue with them?
00;16;28;27 - 00;16;57;29
Mara Smith Kouba
So what they are is a much easier question to answer, although it's a pretty clear issue what the enforcement issues are as well. So physician and distributor ships are entities or they're a business where a physician has some sort of ownership interest in it. So they're either manufacturing it, distributing it, selling it. And a lot of this has come in no surprise, sort of the high cost, high revenue generating implantable surgical devices, medical device space.
00;16;58;12 - 00;17;22;02
Mara Smith Kouba
So the question of enforcement is pretty obvious, right? Okay. So a physician has an ownership interest or a relative, you know, the the general kickback rules of some sort, a family member, because we'll talk about that in a minute. But they have some sort of ownership interest in an implantable device or in some device company. And they have an interest in this because this is their specialty.
00;17;22;02 - 00;17;47;11
Mara Smith Kouba
As time was saying, sometimes these calls are seeing things that are unique. They're understanding where there is a need for these types of devices. Right. The enforcement issue is very obvious and is that if they're receiving a lot of revenue from this from a business perspective, there is an incentive for them to be performing additional unnecessary surgeries, surgeries that are a little more expensive than they need to be.
00;17;47;11 - 00;18;07;05
Mara Smith Kouba
There's a lot more of a risk of taking more extreme measures of these surgical procedures because they're receiving a financial benefit or they are incentivizing other people to do it from the financial interest there as well. And so we have seen a ton of action, a ton of interest. I guess these have been a hot topic for sure.
00;18;07;11 - 00;18;31;17
Mara Smith Kouba
We've seen, I think it was in 2013 when we first started seeing things going on. We had the special fraud alert that was very, very much noticing that these were going on and talking about how there are a lot of suspect characteristics. And basically they were all of the ones that you can understand, the ownership interest, the incentivizing, the use of it, the unnecessary surgery, like all of those sort of things that you would think of right away.
00;18;31;17 - 00;19;01;09
Mara Smith Kouba
And then there has also been a great focus on it from the Senate Finance Committee. There's just been a lot of emphasis on looking at these and making sure that actually the enforcement bodies are taking this seriously and are actually enforcing, which is really the interesting component here, which is they don't really seem to be we've seen some settlements, but not nearly as much as you would imagine, for a much for people that work in fraud and abuse and are looking for this, this seems very obvious, right?
00;19;01;09 - 00;19;28;22
Mara Smith Kouba
Like there is a great incentive to if you have an ownership interest in something that is a high revenue generating procedure, you're probably going to have a financial interest in utilizing your product, whether or not it's the best product for the patient, which I think is in the Lifesciences industry. What we're always going for, right? We want appropriate treatments for appropriate patients and that that's what we're really solving for, which is why we should be incentivizing.
00;19;29;03 - 00;19;59;12
Mara Smith Kouba
We should be incentivizing physicians to use their best judgment, to make their best choices. So we've just seen a lot of interest in this area for obvious reason from the, I guess, the life science inside the government side. But not enough action, I think, is what we're really seeing from the at least the Senate Finance Committee perspective. There have been a couple of settlements that all sort of followed the same pattern of unnecessary surgeries, surgeries that ended up with people being more harmed than they should have because they weren't necessary.
00;19;59;12 - 00;20;18;26
Mara Smith Kouba
And the sort of the incremental steps of treatment were not taken. And so we see a lot of them, but actually really recently in 2022, there was I think it was the OIG issued an advisory opinion on a case that was kind of surprising in which it was very clear that there was a financial benefit to and it was a family.
00;20;18;26 - 00;20;43;26
Mara Smith Kouba
I think it was a father and daughter and some family members that were involved in this business. But what she said was that it was actually a permissible arrangement because it was a legitimate business that it operated and it sold things internationally, domestically and internationally. It ran as a functional business. And so despite the volume of use on their end, it was not in violation of HHS, which I thought was interesting.
00;20;43;26 - 00;21;22;05
Mara Smith Kouba
So sort of back to your your earlier point, it seems like they're saying, well, like sham companies are a real problem here, but it's not these legitimate companies for what it's worth. And I mean, as a life sciences attorney, I sort of understood that. Right, because if you are actually the standard of treatment where you are the best thing out there and there is a legitimate a legitimate example of ways that this is something that has been adopted and utilized internationally by lots of large companies or like lots of peers, have decided that this is the gold standard for medical device or surgical implant treatment.
00;21;23;01 - 00;21;42;07
Mara Smith Kouba
It makes sense in some ways, that rationale, but I think it also makes it harder to draw the line because if you're creating a product, don't you think that the reason you're creating it is because ideally the goal is to help other people in. The goal is to help the patients that you're seeing and to get them really faster.
00;21;42;11 - 00;22;02;11
Mara Smith Kouba
So we definitely see both sides of it, but I think we're going to need to see more enforcement to have a better understanding of what it is that the government actually looking at in terms of a violation or permissible under the law. Because I think that it's really you're seeing the settlements, right. Which follow the exact pattern of what you would expect.
00;22;02;11 - 00;22;18;27
Mara Smith Kouba
It's a very clear kickback type of relationship. But this sort of murky, murky, it's a little bit because it's like, yes, obviously we want people to have the best treatment, but there's no denying that they received financial benefit from that use.
00;22;19;08 - 00;22;42;26
Jonathan Porter
Thanks. More yet, it's going to be really interesting. Like you said, there's been a lot of interest in this, but also not a lot of enforcement. And so this is one of those areas I'd love to see how the line gets drawn. The fact that you've now got a favorable advisory opinion that says a pod can be okay so long as you employ, you know, dozens of people and that you are have some legitimacy in your operations.
00;22;43;02 - 00;23;07;17
Jonathan Porter
That's not I mean, it's clear you can't do like a sham pod. But where's the line between Sham and this fully operational thing that OIG just approved of? I don't know where that is. To me, that's a bit of a blurry line, which is not ideal in enforcement. So we'll see where this goes. So time and give us your parting wisdom on pods, KOLs and all other acronym based position arrangements.
00;23;07;26 - 00;23;16;23
Jonathan Porter
And when OIG puts out fraud alerts and we see no action on the enforcement front, what should the healthcare and life sciences industries take from that?
00;23;16;23 - 00;23;54;00
Tynan Kugler
Yeah, so you know, the time from either alert or advisory opinion publication to enforcement is, is one that I have actually always found intriguing. And I think that the case with both of those that Mara talked about are, you know, they're great from the standpoint and that they're, I think, really good checklists and takeaways from things that people should be looking at so we can use them to a degree is a little bit of a roadmap, but, you know, the fact is that typically what will happen is there are multiple instances of likely concerning activity that occur.
00;23;54;09 - 00;24;19;04
Tynan Kugler
The result of which is an alert or the, you know, in the case of an alert, not necessarily advisory opinion. But when you think about where both the speaker program fraud alert and the quote, positive pod advisory opinion came out, you know, they came out at times when folks were focused on legitimately other topics, namely COVID, because they both came out sort of early on in the in the COVID pandemic.
00;24;19;04 - 00;24;44;18
Tynan Kugler
And so, you know, there's typically a delay from when alerts or opinions, etc., are published. And when we see enforcement, you know, COVID or no COVID, I think we're starting to see that enforcement activity and it's going to continue. I think so tomorrow's that I think we're going to, you know, just kind of have to just wait and see as to what continues to come to play and what we can glean from there.
00;24;44;18 - 00;25;14;16
Tynan Kugler
You know, the final comment is the other thing that I think COVID really showed us is that the speed with which drugs, medical devices can come to market can really be expedited. And to me, what that translates to is that there's likely going to be an increase in demand for KOLs HTTPS dollars because the the pace with which, you know, those individuals are going to potentially be requested is going to increase.
00;25;14;23 - 00;25;46;10
Tynan Kugler
So kind of parting thoughts for me are that, you know, there's really no time like the present to evaluate or reevaluate, you know, the value. So compensation as well as the need for services, especially those services for which an organization is compensating for. So get your house in order. It's always a good time to take a look at what you have and put the things in place that we've been talking about here today.
00;25;46;23 - 00;26;10;16
Jonathan Porter
Get your house in order. Indeed. My sense is that the whistleblower bar typically follows big trials. And I promise you there, even though a lot of people aren't really talking about this Janssen products trial, the whistleblower bar without a doubt is talking about they're going to continue to talk about it while it's on appeal. And so get your house in order because the whistleblower bar is looking for the next billion dollar case.
00;26;11;01 - 00;26;37;16
Jonathan Porter
You know, sorry to be the bearer of bad news there. And more and more, I want I keep giving you these prefaces where I paint this doom and gloom picture that I throw to you. So I apologize for all of that. We'll give you the final question, Mara, and the final the final statement. What are some of the best practices that our listeners, both in the life sciences industry and for health care providers, what can they benefit from with the enforcement landscape that we've talked about, how can our listeners ensure compliance?
00;26;38;00 - 00;27;09;27
Mara Smith Kouba
So again, I'll say we can never ensure compliance. We can hope for the best always. But I listen, I am never making promises and, you know, understanding the government know this. I will never make a promise that I can ensure anything. But I think sticking with the theme of like keeping your house in order is really where we have to start, because it has to be training, great training your employees, at least from a life science is training your clients, ensuring that they're training their people.
00;27;09;27 - 00;27;27;06
Mara Smith Kouba
And it has to be at every level. Right. We want to make sure that communication is consistent across that there is an understanding not only of the laws but also of the language that we should be using around the law. I think it's very easy for sometimes a field team or people who are a bit more removed from the law department.
00;27;27;06 - 00;27;50;29
Mara Smith Kouba
We always forget that as lawyers, there are people out here that don't think about this. All of the time. So making sure that your people, your marketing teams, that everybody who's communicating understand the goal is always to be educating, to be facilitating educational discussions, to be thought leader discussions and thought leader sharing. So really under one number one is the training component.
00;27;50;29 - 00;28;26;11
Mara Smith Kouba
You need to make sure that everybody understands at a very core level so that their language reflects it. And then I think the second part, as I said earlier, is document hing. So making sure that you have documented purposes is really going to be key here as we're looking at the one purpose, I think documenting the legitimate need, documenting, for example, in this pot, talking about what is the legitimate need for this product and making sure that the notes, like the physician notes that they recognize this is why this treatment is necessary.
00;28;26;20 - 00;28;51;09
Mara Smith Kouba
So I think that all of those are document, document, document, train, train, train are some really big ones. And then I think just ensuring that you're keeping track of what's going on, hearing your pivoting your compliance programs to reflect the responses of this. Again, it really shouldn't be a total shift in the way that things are being done, but it really should be a shift in the risk that it presents.
00;28;51;09 - 00;29;13;11
Mara Smith Kouba
So when you're talking to leadership about I think that for a while we've stopped again during the egregious speaker programs, we stopped doing the free trips to the Bahamas or wherever we're going. So I think that people understand that and programs have evolved past those kind of considerations. But now we're looking at a world where it's a little bit more gray.
00;29;13;11 - 00;29;34;29
Mara Smith Kouba
And so we're we've talked all day about how this is a blurry line and we're curious where it's going to go. So I think having a finger on the pulse of what those trends are, what's being decided, where those lines are, is really essential to understand how the compliance is going to look in the next 20 years, 30 years of enforcement.
00;29;34;29 - 00;29;54;27
Mara Smith Kouba
Because I think, like time had mentioned, we're just starting to see coming out of COVID what the enforcement landscape looks like. We haven't seen a lot of conversations about what virtual programs look like with virtual education. We haven't seen a lot of enforcement in those spaces. So people are trying new things, but we aren't seeing a lot of the enforcement actions yet.
00;29;54;27 - 00;30;26;16
Mara Smith Kouba
So we think we're really at this pivotal point. And as Tynan said, I can't say it better get your house in order, because if things are documented, if your people are trained, they're not coming after you. For the one guy that said something wrong, they're really coming after you for not having your house, in order for not having those trainings, for not making for not stopping those conversations early on and explaining the rationale and explaining that the purpose actually is education, not driving, prescribing or not driving use.
00;30;26;25 - 00;30;44;00
Mara Smith Kouba
So I think it's a good time to take a step back before we're seeing a lot of these things and making sure that everything is really buttoned up so that when when people come looking, it's very clear to say here was our purpose and we were all aligned on our purpose and there was no other purpose but to educate.
00;30;44;27 - 00;30;59;21
Jonathan Porter
Are those are fantastic tips. I'm grateful that you just shared those with our listeners. I think one of the big takeaways from this is exactly what you said, Mara. You've got to be documenting why it is that you're doing things because as questions come up, you've got to be able to say, No, no, no, we weren't doing this to reward prescriptions.
00;30;59;21 - 00;31;14;25
Jonathan Porter
We were doing this because we had this new drug that we were just launching or the FDA just gave new approvals for. Here's the reason we were doing it. That written down on a piece of paper. I don't think all that onerous of a task. I think it'll save you a lot to show. What were you thinking in the moment?
00;31;14;25 - 00;31;39;15
Jonathan Porter
Were you thinking, let's educate? Or are you thinking, all right? Hey, Dr.. You know, X just wrote a bunch of prescriptions. Let's let Dr. X have some money. I think. I think having some sort of writing really, really helps there. And sort of the last thing I want to say is what's interesting about the Janssen products case, which is the JNJ subsidiary, this was before CMS open Payments database.
00;31;39;15 - 00;32;01;05
Jonathan Porter
The facts of that case were largely before CMS open payments database. So I think it's going to be really interesting to watch enforcement for the time period where that CMS overpayments database is part of the anti kickback statute is going to show a willful contact. You got to show that you knew what the law was and you deliberately did something knowing that the law will beat it.
00;32;01;23 - 00;32;24;17
Jonathan Porter
I don't think when you're a run of the mill criminal does something. They're not going to a government database and registering what they did. In my eyes, I think a jury is going to have a hard time finding willfulness when you go to a CMS government website and log the trip you just took or the, you know, the meal you just had where you spoke, I think that's going to have an interesting impact on enforcement.
00;32;24;25 - 00;32;41;23
Jonathan Porter
And so I'm really curious about this to see what that happens. But we've got a long time before we get those cases. If they come and we've got a short amount of time before the Third Circuit decides this Janssen products case. And so we're going to continue to monitor this. I'm sure I'll do more podcast episodes about this appeal.
00;32;42;00 - 00;33;05;09
Jonathan Porter
But Tynan, Mara, thanks so much for joining the podcast and telling our listeners a little bit about this issue. I'm really excited that you guys were available and willing to recreate the great discussion that we had at the annual meeting. I'm grateful for for your time for our listeners. If you're enjoying this podcast, there's one way that you can sort of help other people find it, and that's to subscribe.
00;33;05;09 - 00;33;28;09
Jonathan Porter
So how are you listening to this right now, I promise you, is probably a subscribe button really close to where your mouse cursor is or phone button, I don't know, whatever that is. You can subscribe pretty easily these days. So hit the subscribe button, we would really appreciate it. Leaving a review really helps as well. So that's just a little ask that the marketing people told me I should be plugging into the back of these and I did it.
00;33;28;09 - 00;33;44;06
Jonathan Porter
So now the marketing people will give me a round of applause. So that's it for this episode. Thanks to our guests and thanks to you for listening. We'll see you next time.