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AHLA's Speaking of Health Law
Refining the Legal Framework of the False Claims Act
Adrienne Frazior, Shareholder, Polsinelli, and Jody Rudman, Office Managing Partner, Husch Blackwell, discuss recent legal developments related to the False Claims Act (FCA) and how the FCA is changing. They cover significant cases (SuperValu, Loper Bright, Polansky, Zafirov), circuit splits involving the FCA and the Anti-Kickback Statute, the overall health of the FCA, DOJ’s Civil Rights Fraud Initiative, the renewal of DOJ and HHS’ FCA Working Group, and future areas of increased enforcement.
Watch this episode: https://www.youtube.com/watch?v=ee3d5-8PhS8
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SPEAKER_01:Hello, everyone. Today, we're talking a little bit about the False Claims Act. Jody Rudman and I, Adrian Frazier, will be discussing refining the legal framework of the False Claims Act. We're just going to have a conversation about some of the recent legal developments and nuances in the law that have come about over the last couple of years, and then maybe do a little bit of forward looking and thinking about what we might be seeing in the future. With that, my name is Adrian Frazier. As I mentioned, I'm a shareholder in the Dallas office of Polsonelli. I've been in this role for about three years. And prior to that, I was with the U.S. Department of Justice prosecuting healthcare fraud for 10 years, always in the healthcare space. And now my practice in government investigations also specializes in healthcare. With that, I'll get over to you, Jodi.
SPEAKER_02:Hi, good morning, and it's great to see you, Adrienne. I'm Jody Rudman. I am a partner at Hush Blackwell. I'm the managing partner of Hush Blackwell's Austin office and the practice group leader of our government investigations and white-collar practice nationwide. And I'm also the leader of the firm's False Claims Act working group. And it's never a dull day in the False Claims Act, but we've certainly seen quite a bit of it. interesting litigation over the last couple of years. So that working group within the firm has really blossomed quite a bit in the last couple of years and I'm proud to chair it. And with that said, I think it's probably great just to have a super quick disclaimer that would apply to both of us here, which is that the views we're sharing and the conversation we're having are not meant to be taken as legal advice, nor the views of the firm or certainly the views of the administration. These are just our personal takeaways from what we've seen, studied, read, and been involved in over the last couple of years. A quick note, which is that I also was an AUSA in the Northern District District of Texas. We did not cross paths as colleagues, Adrienne. But anyway, I did spend some time with Department of Justice as well. So that's it.
SPEAKER_01:Yeah, go ahead. Let's start talking about some of the recent cases that we've seen. I imagine your working group has been very busy over the last couple of years as we are really seeing the False Claims Act changing in ways that we hadn't anticipated. And then also seeing some circuit splits that might dictate what the future looks like. Yeah, you're so right.
SPEAKER_02:You really don't have to go back very far to find interesting Supreme Court and circuit court cases that are interpreting various fascinating aspects of the False Claims Act. So it's almost hard to choose from among them. But I thought we might talk today about Schutte or Super Value, Loper Bright, and Polanski. And then more perhaps interesting about Polanski is the dissent that was authored in Polanski and the aftermath of that. Because I think all three of those have really given us not only a resolution of some present dispute, but really an eye toward prognosticating the future of litigation in the False Claims Act.
SPEAKER_01:Do you agree? Oh, absolutely. I mean, I think that we're really seeing the False Claims Act change in certain ways, and that based on some of the decisions, even ones like Loeb or Bright have dictated a little bit about what we might see in the future. And so it's just been such an interesting couple of years.
SPEAKER_02:Agreed. So, yeah, let's start with Schuette or Super Value. And apologies to Schuette if I'm saying that wrong. I have heard it said several different ways. So maybe I should say Super Value just to keep it clean. But in any event, this case was decided by the Supreme Court in 2023. And the takeaway of this case has to do with the scienter aspect or the mental state aspect requisite to establish a False Claims Act claim. And the debate in circuit split that ultimately led to the Supreme Court's decision in super value was whether we look at the mental state of a False Claims Act defendant from the standpoint of an objective interpretation of the administrative regulation or statute or whatever is being alleged to have been violated, as opposed to a subjective view of that state of mind. And the import of super value or shooty is that we look at the defendant's mental state from a subjective standpoint. What was the defendant really thinking, acting on, interpreting, basing its decisions on and doing as opposed to what might an objective analysis look like? And that's really important for so many reasons. I mean, number one, it resolves that circuit split and those who are relying on the objective interpretation analysis obviously need to go a different direction, but It creates, Adrienne, in my assessment, you know, some significant fact issues that not only take us out of the world of, you know, early, in some instances, resolution of cases because subjective intent, knowledge, mental state is a fact-driven inquiry. But also, and I think this impacts perhaps, you know, the going forward work or going forward behavior of, you know, folks. but really what what do those emails say? What did the advice say? What meetings were had in which discussions of this statute or regulation were had and decisions made? So all of those facts, I think, become far more woven into the narrative of the False Claims Act case, the investigation, and ultimately its outcome than perhaps in those circuits where the objective standard was being applied. what do you think about that? Well,
SPEAKER_01:this makes me think about, you know, we, you and I were both prosecutors and this makes me really think about jury selection, how we would always cover intent with juries and say, you know, it's not possible for us to look inside someone's mind, but we can tell intent through a variety of factors. We could tell, you know, we always use a handshake example. You reach the hand out, the other person reaches their hand back out. You can tell that they were intending to shake your hand, to greet you in some way, right? So we always use all these types of examples to get to intent. I'm curious as to what you're seeing, you either in this case or any that have come from it in terms of how the government or the relators are now proving intent, subjective intent, because it is so much harder than like an objective standard.
SPEAKER_02:Right, right. Not sure I'm seeing, you know, proof positive yet, but I certainly believe that an even stronger focus on those, you know, then current, you know, emails or, you know, meeting notes, meeting minutes, emails, other communications that have to do with decisions that were made, why they were made, interpretations. One, you know, one issue, I can't say I've seen this, you know, brought to bear, but I sort of you know, looking in a crystal ball, think there may be some focus in a going forward way on when it becomes strategically wise to consider even waiving privilege so as to, you know, address, you know, maybe the advice of counsel defense because subjective intent now is so important and that may be part and parcel of advice that counsel
SPEAKER_01:rendered. What do you think? I think that's an excellent point. I mean, really what you seek out counsel on really can dictate what your intent is in that situation. And if you receive legal counsel on a certain issue and it changes the course of your actions, obviously that's going to go back to what your subjective intent was at the time. I also think you're completely right. Emails are always, right? Emails, text messages, conversations with individuals that can be recollected are really where we see the focus on proving intent in a variety of cases. And I definitely anticipate we'll see that here too.
SPEAKER_02:Well, let's move to Loeberbreit. This is the Supreme Court's major decision in 2024 as it relates to Chevron deference, because Loeberbreit, of course, overruled the four decades of Chevron deference jurisprudence that preceded it. And the takeaway, of course, from overturning Chevron is that we are back to a system, a pre-Chevron system of not giving agencies what some might call sort of carte blanche deference and standing back and saying, well, this is how they've interpreted an otherwise ambiguous statute. And so we'll defer to that as the court and let that guide the the case going forward. Instead, under Loeb or Bright, courts are now to interpret statutes of their own accord, ambiguous statutes, that is. And deference to the agency's legal interpretation is no longer dispositive. I think that is going to, for a long time, create some really interesting litigation in the False Claims Act space, which is so heavily dependent at times on agency regulation or agency interpretation of statute or even rulemaking or sub-regulatory guidance. And now there is opportunity anew for litigants to come back to the text of the statute and say, you know, this regulation or this guidance or this sub-regulatory guidance or rulemaking should not bear any part in an analysis of our conduct and And instead, we need to go right back to the four corners of this statute and make a decision under that. And I just believe that creates just a myriad of opportunities for those in the False Claims Act space to be returning to the text of the statute and making arguments about and in defense of conduct alleged to have violated the False Claims Act in their favor. What do you think
SPEAKER_01:about that? Well, I think that's right. I think that the things that are going to stick around even after Loper Bride are still agency fact-finding and discretionary actions. And so that might be a little bit nuanced to it. But yes, and I also am thinking about this in terms of intent again, as we were just talking about. If agency action is no longer given the deference that it once was, how might that affect an individual's intent as they go forward trying to navigate some of these issues, realizing that the agency may have found things to be one way or may have had a decision on one issue, and how would that affect it if looking forward you know that the courts no longer give deference to that? I mean, I'm just thinking kind of as we're talking about some of this and the cases as they're woven together and they affect one, you know, each other kind of as we go forward. But low per bride, I mean, this has been a huge area in my practice. I mean, in the False Claims Act cases that I've worked on, it has always come up. It just seems like it's constantly something that we're saying, okay, the law has changed on this. How do things look going forward now that we know that the agency is not going to be given the same deference?
SPEAKER_02:Right. And there are plenty of nuances in where deference, as you pointed out, where deference is still appropriate or, you know, to what extent does the statute give the agency authority to interpret? To what extent is what's at issue the agency's own interpretation of its own regulation? There are a lot of sort of under the surface, really important nuances that will be fleshed out in the post-Loper-Bright, particularly as it relates to the FCA, post-Loper Bright FCA world. But I think we're going to see a lot of litigation involving those nuances and involving the import of Loper Bright in the FCA space going forward. Well, it's probably a good time to turn to Polanski. And what's interesting about Polanski is what it... facially stands for, right, this 2023 decision out of the U.S. Supreme Court, but also the dissent in Polanski and what's happened since then. So let's just start with Polanski and what the decision was in Polanski. Do you want to take that one?
SPEAKER_01:You know, I think that the issue that is so interesting in Polanski is that, you know, the government's case was based on the fact that the discovery, part of the arguments was that the discovery being requested of the government in Polanski, a case that the government had not intervened in during the seal period, was burdensome. And I think we're going to see that in some progression through DOJ policy a little bit later on how Polanski is being applied. But yeah, essentially the holding in Polanski was that the government follows federal rule of procedure 41A and can intervene in a case solely for the purpose of dismissing. As you mentioned, the more interesting part of this is Thomas's dissent and also the concurrences with the dissent. So I'll let you talk a little bit about those.
SPEAKER_02:Yeah. So Justice Thomas dissented in Polanski and was joined by, as you pointed out, Justices Barrett and Kavanaugh. And the nature of Justice Thomas's dissent for our purposes is really a discussion and questioning of the whole constitutionality of the QTM device to begin with. And when I say QTM device, just so we're all on the same page, what I mean is the relator-driven aspect of the False Claims Act or False Claims Act litigation. In other words, when the government doesn't intervene and the relator under this QTAM device, you know, maintains, possesses, and still has the opportunity to litigate the case, standing in the shoes, proverbially, of the government. So that's what I mean. And Justice Thomas' dissent writes extensively about the constitutionality of this device. And And... Really, the analysis triggers on Article 2 of the Constitution and the powers that are vested in the executive branch and whether the relator should really properly be permitted to stand in the shoes of the government, so to speak, when the relator hasn't been someone who is appointed by the executive with all of the vetting and so on that takes place under the Appointments Clause of the Constitution. Constitution. So it's an important dissent. As mentioned, Justice Thomas is joined in that by two other justices. Justice Thomas actually reiterated those thoughts and comments in an opinion in the Wisconsin Bell case, which was handed down by the Supreme Court in just this most recent term. So this is an analysis and a thought process and a concern that Justice Thomas continues to have. And in Wisconsin Bell, he was again joined by Justice Kavanaugh in that decision. So the import of that is, you know, what does it mean for those who are litigating against relators in non-intervened False Claims Act cases? And is there an argument or a place for an argument that this device is indeed unconstitutional? There are so who have already decided that issue and come out on the side of saying, no, this Ketam device is not unconstitutional under Article 2. However, there was a recent case in the Middle District of Florida in which the judge granted the defendant in a False Claims Act case a motion for judgment on the pleadings based on the analysis articulated by Justice Thomas in the Polanski dissent. I believe and word is that this particular judge in the Middle District of Florida had previously clerked for Justice Thomas, so that's kind of an interesting connection. But she did grant a motion for judgment on the pleadings and and analyzed her decision under the Appointments Clause of Article 2 of the U.S. Constitution. So that decision is now on appeal before the 11th Circuit, which is, of course, the appeals court that hears cases that arise out of the federal courts in Florida, among other states. I believe that the case is fully briefed. I don't believe, when last I checked, there was an oral argument date yet set in the 11th Circuit. There are plenty of amicus briefs that have been filed on both sides of the equation um but litigants are now bringing um those arguments in other cases even in and including circuits in which those decisions are foreclosed by circuit precedent um and and adrian i think um You might agree with me that at least preserving those arguments in the post-Zafarov, the name of the Middle District of Florida case is Zafarov. And again, I'm going to apologize to the relator in case I'm mispronouncing the relator's last name. But anyway, most people are calling it Zafarov for whatever that's worth. But I think there is benefit to preserving Zafarov arguments, even in circuits where precedent forecloses it because if the tide, you know, shifts in other circuits or eventually if this percolates to the Supreme Court, you know, you will have wanted those arguments preserved from a legal standpoint. Do you agree with that?
SPEAKER_01:Yeah, I mean, I think it's such an interesting case and such an interesting twist, really based off of the dissent in Polanski. And it's definitely worthwhile to preserve those arguments, right? Because we are seeing a shift and we don't know exactly how this is going to go. I mean, the dissent sometimes is the first inkling that the case, that the law may change, right? I mean, and even though the False Claims Act has been around since, you know, the mid-1800s and it's been, and these relator provisions are just so well established, we are seeing a change here. The Zafirov case, and I hope I'm saying it correctly too, I think it's a bit like Daubert, you know, there's always a little bit of a debate about it. But that case really caused kind of an earthquake through the relators bar, right? As everyone was thinking, what does this mean for the cases that we're bringing? How is this going to shake out? And it's going to be a little bit of time before we know because it will go the 11th Circuit and it may go all the way to the Supreme Court. It is such just an interesting, nuanced decision. So yes, it'll be interesting to see. Those of us who do defense work, of course, we're also, you know, extremely curious to see what this is going to turn out to be because it could have a huge on our clients who have False Claims Act work occurring and also just on whistleblower protections and whistleblower considerations that we're always advising our clients on in terms of making sure that you are paying attention to compliance and paying attention to individuals who are raising concerns in your company. If the I'm not saying that those should go away. Obviously, we're concerned about compliance. We want to make sure that companies are doing what they need to do to listen to people who have issues. But it just changes their dynamics so much.
SPEAKER_02:Yeah. No, that's a really good point. I mean, whistleblower retaliation will be around regardless of how Zafirov is ultimately decided at the highest levels. But Yeah, but the impact of a post-Zaparov world, if that gains traction in ways that ultimately reach the Supreme Court and find favor in a majority opinion, really will, I think, require some post-Zaparov analysis of, you know, what do we do now? Yeah. So, yeah. Well, let's move then into kind of what may be percolating. I think you and I both have identified an interesting space in where we think there might be a circuit split that sees its way to the court. Kind of depends, I think, on how some other circuits come out on this question. But it's the interplay between two statutes that we both have quite a bit of experience in with our clients or at the government. And that's the interplay between the anti-kickback statute and the False Claims Act. There has been some questions since the 2010 AKS amendment about exactly what type of causation is required to Turn an AKS violation or an alleged AKS violation into a False Claims Act liability. And maybe you can put a finer point on that before we talk about the courts on either side of the
SPEAKER_01:split. Sure. So the issue percolating right now is the circuit split regarding causation. The First Circuit and a couple of other circuits, the 6th and the 8th, have taken one position. I'll let you delve into that in a little bit. The Third Circuit has taken a different approach. And when we talk causation, we're talking about the specific language in the 2010 AKS Amendment that deals specifically with claims that result from an AKS violation and whether or not those are false. And the different circuits have been looking at this in a different way, really trying to interpret what resulting from means. What kind of causation does that actually address? And, you know, we are 15 years from the 2010 amendment, but here we're still dealing with some of the details and how that should be interpreted. And I know when I was looking at the AKS in the context of healthcare fraud in a criminal context, really, it seemed to be, these amendments seem to be broad authority to bring a lot of cases under the anti-kickback statute. And then to also look at kind of the loss amount attributed to the anti-kickback violations in a certain way. It was a very expansive view. And now we're seeing it under the False Claims Act really being limited in certain ways. So I'll go into the Third Circuit's position. They have determined that the government must only prove a causal connection between a kickback and a claim. And they are relying specifically on Congress's intent to strengthen the whistleblower kickback cases in bringing about the 2010 amendments. that is, you know, a little bit different than what we're seeing elsewhere. And so some of the other circuits that we think, you know, we've got one on one side, the third circuit, and I think there's what three on the other side. Um, we've got the first circuit, the sixth circuit and the eighth circuit. So it's really a shift. It seems towards more of the, um, the first circuits position. So let me have you go into that a little bit.
SPEAKER_02:Yeah, the, um, First, six and eight have thus far taken a more tailored view of the connection between the in a kickback violation, in a kickback statute violation, and then the false claim. And have stated that in order to trigger liability under the False Claims Act based on an alleged AKS violation, there has to be but for causation. In other words, there has to be proof that the claim submitted to the government payor or the government payment, however it occurred, would not have occurred at all, but for the fact that it was driven by this alleged in a kickback statute violation. That's a tough one. for inquiry, that's a much more narrow inquiry. And I think for purposes of the relator trying to make this False Claims Act argument requires, you know, a much higher burden to try to prove that but for causation. So, you know, it's helpful, obviously, for the, you know, for the defense bar to be able to argue in those circuits that, you know, but for causation. causation can't be established and that there were myriad other reasons why these claims were submitted and why these claims were paid but I guess we have yet to see. I mean, that's four of the circuits. So, you know, yet to see what else may come out and whether, you know, there is a sufficient groundswell in this circuit split to percolate that up. What are you doing? You know, what are you kind of prognosticating there about whether, you know, you think that'll percolate up?
SPEAKER_01:Yeah, well, I think what we're going to be seeing and I've just been hearing a little bit of discussion about this from, you know, a lot of people who are really heavily involved in this space. I think the projection is that we're going to be seeing but for causation, along with false certification of compliance with the anti kickback statute. to be alleged in complaints going forward. That way we're covering all basis, right? So there's kind of two ways to get at it. You've got the but-for causation that the claims would not have been would not have been submitted but for the the kickback and then also false certification with the of compliance with the anti-kickback statute kind of two ways to to move those cases forward that's what i think we're going to see in terms of pleading um with respect to you know how this is going to actually shake out is a little hard to say just because on the one hand we've got the third circuit that has a more lenient standard in just the causal link And then we've got several other circuits taking a tougher view of it. It'll really just have to have to bear out at the Supreme Court and we'll have to see how that ends up going. But I think for the time being, it's wise to plead as much as you can in terms of two different avenues for allegations.
SPEAKER_02:I think you're so right about covering both bases from the relator's standpoint. And what you say is like a great, perfect segue into what I think we should maybe move to next in this conversation. And that is, you know, is the False Claims Act alive and well? And if so, you know, where are we going to likely see False Claims Act enforcement activity here in the next few years? And I think the goal maybe of this part of the conversation is to kind of of give folks eyeballs on what we think we're seeing. And in addition to that, perhaps they might have some takeaways about preparing you know, their own businesses or, you know, their own advice to their clients or if they are on the client side, you know, their own internal advice to to minimize risk in this area. So let's just start with, you know, is the False Claims Act alive and well? I personally would say yes. Absolutely. I think there can be no doubt about that. I mean, the 2024 statistics, which were published in January of 2025, indicated recoveries and settlements and judgments of almost$3 billion and the highest number of FCA lawsuits ever. A little bit of shifting in the numbers about where those play out in the world of healthcare versus other universes, but I think we would be remiss if we said that the False Claims Act is not alive and well. And indeed, some of the memoranda issued within the Department of Justice that are publicly available do indicate a desire or even instruction and admonition to folks to be using the False Claims Act in certain matters moving forward. So do you agree with that? And then where do you think we're going to see enforcement activity that we maybe might not have seen as much of
SPEAKER_01:here to date? Well, I agree with you that it is alive and well, even though we are seeing like in this APAROP decision being chipped away at a little bit, I will say with respect to the Department of Justice, the False Claims Act is having a moment. It is definitely an enforcement tool that the government is using in more ways than they previously have in new and different ways, I think, ways that we haven't really seen before. And while this discussion really is focused on health care, some of this veers a bit away from healthcare, but also encompasses like, I think about this in terms of like academic institutions, you know, where healthcare is a focus for certain, you know, academic institutions that really are in that space, because that is part and parcel with what the Department of Justice is really looking at. So let me just back up a little bit and say, First thing is that the DOJ has created a civil rights fraud initiative, and this is going to be led by DOJ's civil fraud section and then also the civil rights division. So combining the fraud aspect and then civil rights together in order to pursue cases with a little bit of different topics than we have seen the False Claims Act used in the past, but using that as its enforcement tool. And as part of that initiative, all the U.S. Attorney's Offices, of which there are 93 in the United States, must identify an AUSA from each office to work on the initiative, along with the Civil Fraud Section and the Civil Rights Division. So the first part of this, as we have seen recently, is in the DEI space. The government is seeking to use the False Claims Act in order to pursue companies and institutions that may be violating certain provisions of the Civil Rights Act. And so this is going to target knowing violations of civil rights laws, including but not limited to Title IV, Title VI, and Title IX of the Civil Rights Act of 1964, where companies, the allegation is that they falsely certify compliance with those laws. That typically is going to be in an implied certification theory versus a false certification theory or more of an overt kind of demonstration of a false claims act. What do you think about that in terms of using the implied certification with the anti-discrimination laws?
SPEAKER_02:Yeah, well, I think that's exactly where enforcement activity will be grounded is right there in implied or expressed false certification. I mean, we know from Escobar, the 2016 Supreme Court decision that implied false certification as a theory is alive and well. I'm not sure that in this new space of enforcement activity in the civil rights context that it will necessary because I think there may be express certifications that will need to be made about compliance, which will then, if alleged to have been violated, lead to investigative and enforcement activity. But either way, I think you're right that it is the certification aspect that will ultimately create the pathway to enforcement activity if there is going to be any.
SPEAKER_01:Yes, and those DEI provisions and the anti-discrimination, the focus of the Department of Justice in the memos that have been released is to target universities and federal contractors that they believe are not complying with those laws. So that's the focus there. With respect to federal contractors, though, there is a push to have federal contractors certify compliance with the anti-discrimination laws, which could create more of that express issue and creating a False Claims Act risk that maybe previously wasn't either anticipated or maybe wasn't there. So that's going to be a shift that we're going to be seeing. Stepping away from the broader scheme and looking a little more specifically in healthcare, there's also a focus on gender transition care and a targeting of pharmaceutical companies that manufacture drugs used in connection with gender transitioning care and using the False Claims Act in those contexts too. So We were talking the other day about as these things develop, we haven't seen any just yet because it's just so new. These priorities are so new that we just haven't seen yet them play out. But it is interesting to think that there may, one of the things that may have to come about from this is proving an actual violation of a civil rights law. If you're certifying that you are in compliance with it, then we need to now prove that that law has actually been violated in order to get to the False Claims Act legislation. And so that might just be kind of something that's interesting coming up. The other thing, too, is just I always consider it kind of a notice issue, but the materiality provision of the False Claims Act, whether the government would have paid these claims, had it known that the certification was incorrect. As we discuss in kind of just preparing for our conversation today, this has been all over the news. So there have been so much speculation. so much executive orders coming out and DOJ policies being written on this, that it would be hard to say that companies wouldn't know that this is the government's priority right now and that the government intends not to pay claims that have some sort of violation of an anti-discrimination law. So it'll just be interesting, I think, as we see the case law develop on that to see how that really plays out in the future if those cases do come about.
SPEAKER_02:And then... Sorry, Adrienne, go ahead.
UNKNOWN:Sure.
SPEAKER_01:I was just going to say, just going to move to the working group. Did you have a comment on that?
SPEAKER_02:Well, I thought maybe you might add sort of to the, you know, kind of the bowl of things that may happen. engender quite a bit of enforcement activity moving forward, especially for the healthcare folks. Cybersecurity, I think we are likely to see False Claims Act enforcement against those whose cybersecurity measures are not up to snuff where they have made certifications or implicit certifications that their cybersecurity protocols and measures were significant enough to avoid, you know, data breaches and other risks. I just sort of wanted to put that out there for you. Yeah. What do you think about that?
SPEAKER_01:Well, I think that's likely as well, particularly, you know, with our HIPAA provisions that we have in the healthcare space that are just, you know, such a core facet of data privacy and security and definitely complying or certifying that the program is secure and that it is in place and that it complies with all laws. And then, you know, you know, turning out that it maybe doesn't in some capacity, maybe because there's a data breach or something along those lines. I definitely think we could see the False Claims Act used in those contexts. The interesting thing is that the DOJ and HHS have also created, it's not necessarily a new working group. It is a renewal of a working group put together in the prior Trump administration. It is an FCA working group for collaboration, more hearty collaboration, I think, between DOJ and HHS. And it's got a list of priorities squarely within the healthcare space because obviously health and human services, that's their priority. So I'm just going to run through these real quickly. One would be Medicare Advantage, which we have seen be a big area of enforcement, both civilly and criminally. Drug device biologics pricing, excuse me, drug device and biologics pricing. Barriers to patient access care, looking at network adequacy violations. Kickbacks related to drugs, medical devices, and DME. That'll be so interesting given the circus book that we've been talking about, seeing those cases come about. materially defective medical devices that impact patient safety, manipulation of electronic health record systems to drive inappropriate utilization of Medicare covered products will be an interesting priority. And then the working group has a couple of ways that they're trying to achieve some of these priorities and these goals. And one is through leveraging data mining across agencies to make referrals to DOJ. And that means Coordinating with different agencies, mining the data as DOJ has really developed an expertise, both civilly and criminally, in data mining over recent years. And using that data to make sure that referrals are coming about and that they're timely. You know, looking at the data that is recent to be able to see what recent schemes are happening rather than looking back years before in a more reactive type state. So that's something that we can expect to see. And then coordination on payment suspensions with CMS. So HHS, DOJ, and CMS all getting together and discussing this concept of should a payment suspension be put in place while an FCA investigation is unfolding? Of course, we know that's a huge issue for our clients because it deprives the providers of payment while the investigation is ongoing, which can be a very long-term proposition. And then kind of coming full circle back to Polanski, there's also a focus on coordinating dismissals of key TAMs when the government doesn't intervene. And as we mentioned, the issue in Polanski was this kind of burdensome discovery that the government was undertaking or that was being imposed upon the government, even though they hadn't intervened in the case. And so that is part of the goal in this situation is to make sure that DOJ and HHS are looking at which cases they should move proactively to dismiss that they haven't intervened in either because of the discovery burdens, because the case is not as concrete as they would like to see for a variety of reasons. But I definitely think in this era of government efficiency and really trying to reduce the cost spend of the government, that's something that we can expect to see in the future. That's an excellent
SPEAKER_02:point. Yeah, that's an excellent point. I always love having these conversations with you. I think we are probably out of time on this particular one, but I... certainly welcome the opportunity to do this again. And I want to thank those of you who tuned in and are listening. And thanks to the AHLA for letting Adrienne and I get back together to chat about the False Claims Act. We sure do appreciate the opportunity and hope that this provided some good and interesting takeaways.
SPEAKER_01:Yeah, thank you very much. I always enjoy speaking with you two and always enjoy being a part of AHLA. Thank you.
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