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AHLA's Speaking of Health Law
Health Care Fraud and Abuse Trends From 2024 and What to Expect in 2025
Joe Wolfe, Attorney, Hall Render Killian Heath & Lyman PC, speaks with Laura Laemmle-Weidenfeld, Partner, Jones Day, about some of the key health care fraud and abuse trends from 2024 and what to expect in 2025. Laura is the author of the 2024 Cumulative Supplement to the Fifth Edition of AHLA’s Legal Issues in Health Care Fraud and Abuse. From AHLA's Fraud and Abuse Practice Group.
Watch the conversation here.
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Speaker 3:Welcome everyone to today's American Health Law Association podcast, where we will be talking about key trends in developments in healthcare fraud and abuse, compliance and enforcement. In 2024 , uh, so much has happened this past year in healthcare fraud and abuse. Uh, we've had criminal and civil enforcement shifting interpretations under the False Claims Act, the rollout of new compliance, guidance from the OIG and , and now it's implementation a stark in Kickback developments, self-disclosure settlements, advisory opinions, and all of this activity , uh, definitely has impacted healthcare organizations in 2024 , um, is going to drive their contracting and compliance initiatives , uh, going forward into 2025 and beyond. Uh , my guest today is Laura Lemley Lemley Weidenfeld. She and I are going to discuss some of the topics from that list I just touched on , um, over the next half hour or so. Uh, you may remember that she and I recorded a similar podcast last year for the A HLA, if Laura's name sounds familiar. Beyond that , uh, she's very involved in healthcare compliance. Uh, she authored an A HLA book titled Legal Issues and Healthcare Fraud and Abuse, and I think they just issued , um, a the most recent supplement here in 2024 , uh, to the fifth edition of that book. Uh, recently, she's also the, a past chair of the Fraud and Abuse Practice Group here at A HLA , um, as well , uh, on the topic of of A HLA. Today's podcast is brought to you by our fraud and abuse practice group. I currently am in my last year chairing the practice group where our mission is to help our members stay informed about healthcare fraud and abuse and compliance issues. Uh, our vice chairs are doing a great job of developing webinars, publications, toolkits , and other types of content , uh, to educate our , our , our members on important compliance developments and enforcement trends in, in the healthcare industry. Uh , upcoming content we're working on right now is in a webinar session that's gonna be out in December that's going to focus on value-based enterprises. Um , we're also looking at a yearend review webinar , um, a webinar focused on advanced practice provider staffing issues. And we're starting to brainstorm the topic of state level fraud and abuse , um, as well. So , uh, watch for that content in the upcoming months. Um, before we get started with the back and forth, I, I do wanna ask Laura to introduce herself , uh, to tell us about her practice and maybe discuss the new edition of her HLA book that she's currently working on.
Speaker 4:Thanks Joe , and thanks for the opportunity to be here. Um, always fun to do this with you. Um, so I'm a partner at Jones Day in Washington, DC uh, in the Healthcare Life Sciences Practice Group, and I focus my practice on healthcare fraud and abuse issues. So that includes a lot of my time defending clients against government investigations, particularly under the False Claims Act. Also conducting internal investigations for providers and life sciences manufacturers , uh, submitting self or , or , and analyzing whether we need to submit self disclosures, whether to OIG or CMS or DOJ . And then I also spend a fair amount of my time providing compliance and regulatory advice to providers and life sciences manufacturers to hopefully help them keep from becoming targets of investigations much earlier in my career. I spent five years at the Department of Justice Civil Fraud Section here in DC where I spent all of my time investigating and litigating healthcare related False Claims Act cases, especially those that focused on kickbacks and , um, and potential stark law violations. So the book that , um, the book that you're referencing, I've been up , I , um, wrote the fifth edition of Wrote , I'm putting in air quotes because really the original was written by David Mattias at Epstein Becker. And over time was , um, was revised by a number of folks on his team through several editions. And then I just revised it to create the fifth edition. I've done a few supplements. The 2024 supplement is now out and is available. Um, and so, and I'm currently working on starting work on the sixth edition, which is expected to come out sometime next year. No promises on exactly when. It kind of takes a while until we get it, once we get it submitted.
Speaker 3:Yeah . Thanks , Laura. And , and thanks for putting together that book. It's a , it's a great resource and, and to all of those before you that, that , uh, contributed to it as well. Um, uh, and I'm Joe Wolf. I chair our , um, the HLA Fraud Abuse Practice Group. Uh, I'm a shareholder at Hull and, and practice group leader at Hull Render. Uh, I like Laura. I have a very national practice focused on fraud and abuse issues. Um, sometimes I, I describe it as my, my practice focus on financial relationships with referral sources, stark and kickback, valu based enterprise models , um, and related compliance matters along that continuum. Um, and so, again, thanks Laura for being here. Um, I think we are , we're gonna start by getting into the content here. Um, Laura and I could talk about a number of things that countless , uh, you know, items in the , in the fraud and abuse space. We're talking about 2024 and , and going forward. But I do think it's helpful to just, you know, try to identify a few areas of concentration first. Um, it's been a very active enforcement environment over the last few years. And in 2024, if you kinda look back just at the data , um, for fiscal year 2023, the OIG said it recovered over 3 billion from criminal and civil en enforcement actions . In its recent spring 2024 report to Congress, the OIG identified a 2.76 billion. So we're actually approaching that 3 billion amount in recoveries, a number of civil and criminal actions in the hundreds, I think 712 civil and criminal actions. Um, they identified a ex high level of exclusions , um, in that data as well. The DOJ in , in some of its recent announcements, if you kind of go back and look at the last couple years, they've recovered , um, over two and a half billion from False Claims Act cases back in 2023. And I think we would anticipate that number's gonna be high again this year when we look at the recover recoveries. So just ongoing enforcement , um, and an uptick enforcement, I think is, is what we're seeing across the market. When we look at kind of areas of focus , um, some , some areas we expected to see develop, and that actually , uh, now we're seeing develop is , is COVID-19 fraud. Uh, the government has a a COVID-19 fraud enforcement task force . Uh, it's seized over nearly one and a half billion in covid relief funds. Um, key areas of enforcement we're seeing in the CO space is , um, air , some of that is, is related to distribution of COVID-19 over the counter , uh, kit products, pathogen panel testing , um, improper use of the paycheck protection program. So those PPP funds , um, improper claims to hrsa, improper use of CARES Act funds. So in that COVID space , um, we're seeing covid FCA cases starting to surface. Now, there have been recent enforcement or lawsuits in the Southern District of New York, for example, related to covid tests , uh, provided to the uninsured we'd seen , we've seen activity in, in the district court for the District of Maryland. Um, beyond covid , uh, the managed care , uh, area continues to be in the cross hairs . The OIG announced a new strategic plan for oversight of managed care for Medicare and Medicaid. Uh, that was announced back in , in August of 2023. And we've seen for a number of years, a , a , a renewed or , or new focus on managed care. But I think that the OIGs announcement really aligns with, with that , uh, focus on the managed care space. The OIG has issued reports related to , uh, managed care, focusing on the misuse of diagnosis codes. Uh , we've seen a few cases , uh, and settlements related to that kind of, of managed care fraud. Uh, we were seeing enforcement in the laboratory testing space. There's been a steady stream of cases there , um, often alleging or , or in some cases alleging that the lab wrongfully induced the ordering of tests. And I think this is, any of us that work in the front of abuse space know that there can be , um, an opportunity for an anti-kickback theory or , uh, an an argument that some of those, the lab testing may not be necessary. And that's what we've seen , um, arise under these cases. Uh, not surprising with the increase in telehealth, we're seeing telehealth enforcement , um, even some recent criminal enforcement , uh, in the telehealth space. Um, we're, we're seeing the industry , uh, processing and , and trying to act on , um, recent OIG compliance guidance. If you remember back in November of 2023, the OIG updated its compliance program guidance. Um, it, it's publishing new guidance on its website. Um, they're , they're maintaining the historic , um, guidance around the seven elements of an effective compliance program. Um, but now we're seeing this sort of dual , uh, approach regarding the guidance where you have , um, the, the program guidance at a higher level, and then the issuing of specific compliance program guidance for different types of facilities or activities. And so that, that new , um, kind of approach and organization is going to drive how healthcare organizations think about compliance. Uh, the DOJ announced new corporate whistleblower programs. Uh , we saw constitutional challenges to the ketan provisions of the FCA. Um, we, of course, have seen the overruling of Chevron. Um, and beyond that, some historic, very large , um, enforcement actions in the stark and kickback space. Um, and, and I think lastly, we're , we, like many years have saw , uh, we , we are seeing the OIG , um, issuing a number of advisory opinions. Um, if you wanted to carve up those from the last few years, they, they did focus on the life sciences , uh, area of healthcare patient assistance programs, and we saw a number of other advisory opinions. Those are always a good read 'cause they do , uh, help you distill how the OIG is thinking about anti-kickback analysis. Um, lastly, just a number of self-disclosure , um, and settlements that give us a better understanding of, of where areas of risk are and , and how they may be resolved. Laura mentioned earlier, she works in the self-disclosure areas . I do as well. Um, in, in many ways it's a luxury to frame up , um, and seek , um, uh, resolution rather than , um, you know, deal with, with the unknowns or potential whistleblower risk down the road. And so we're still seeing healthcare organizations pursue self-disclosure , um, as well. So that's a sort of a laundry list of, of different areas that we've seen development with over this past year. I think they're, they're going to drive some of the tone next year. But , um, I'm gonna turn things to Laura here with a question to her. Um, you know, Laura, one of the most consistent themes in enforcement this year has been the government's continued focus on financial arrangements between providers and referral sources. I think that underpins several of the topics. Uh, I just listed labs, telehealth, stark settlements. Um, uh, it seems that a high percentage of this year's FCA settlements have involved kickback allegations, and maybe to a lesser, but still significant extent , uh, extents several or several self-referral type allegations. Um, why is it that that financial relationships provide such fertile ground for enforcement matters from your perspective?
Speaker 4:Sure. So, and I agree with you, it , it, I would , I've been struck over the course of the year how many kickback, and to a lesser extent stark, but overall financial relationship cases, DOJ has been bringing, that seems to be a common thread through so much of the enforcement, which, you know, 10 years ago, I don't think was really the case. But I think there's a few reasons for that, right? So, one of the most basic is that in order to get business, some kinds of entities like labs, which are an enforcement priority, durable medical equipment, suppliers, enforcement , uh, priority pharmacies, pharma and device manufacturers, all of them need physicians to order their product for patients. They can't do it themselves. They can't just sell directly to the patients, or if, if somehow they're able to, Medicare certainly isn't gonna pay for those without a physician order. So the physician really is a gatekeeper as OIG has referred to them for many, many, many years in a very literal sense. So they've gotta convince physicians to order those items or services, or they go out of business. So obviously there are legitimate ways to do that, legitimate ways to convince physicians that their items or services are better or should be ordered when they actually are <laugh> , presuming that they are. But , um, sales and marketing folks are always getting creative and thinking about ways to market that is their job, right? To be creative. Um, but sometimes those creative approaches can push or even cross the line. And that's in, you know, legitimate healthcare providers, legitimate manufacturers that really do have something of value that patients actually need. Even they can get into a gray area and get , and get into trouble that way by pushing the envelope too far. And that's not even taking into consideration, like lack of medical necessity, labs pushing tests that really aren't medically necessary for the patients at all. Well, how are , why are physicians gonna write orders for those? Well, a kickback helps, otherwise, there's not really any reason that they would. So , um, I , and I say this as though there's a clear line of where kickback starts and there really isn't. It's, it's a risk zone . There is gray area around a lot of conduct, and whether it crosses over into, you know, is it actual remuneration, is it actually intent? Um, it, it's not as cut and dry as often the government would, would think in a vacuum that it is, or would think in retrospect that it's, and then on there's the whole issue of fraud , which you mentioned earlier where, and I don't think of this as being real legitimate telehealth, which there is a lot of it , um, but I think of it as being true tele fraud , where physicians are fraudsters are just using the system and they're paying physicians on telehealth platforms to order tests or DME or compounded drugs for individuals who aren't even real patients in the worst case scenario. And we see this over and over in the criminal prosecutions. The physicians never see or talk to or follow up with these patients. And the physicians are ordering items and services that these patients don't even need or want. They're expensive and claims are getting submitted to federal healthcare programs. Um, so, you know, those sort of, those two flavors and variations of those, I think those constitute why kickbacks and are always gonna be a risk area. Um, and then on the flip side, I think DOJ is getting increasingly aggressive, and we've been saying this for years, but they just continue on the spectrum of aggressiveness and creativeness about what a kickback really is, what is remuneration under the any kickback statute. And every year it seems like things that most of us wouldn't have thought of as actually being a kickback, even us, even those of us who see a kickback in lots of things. 'cause that's what we do. DOJ is still surprising, even us. So certainly I would hope that every licensed healthcare provider, every sophisticated, even semi sophisticated device or pharma manufacturer today knows the kickbacks are illegal and generally knows what they are, and knows that it's not just money in a paper bag under the table. Their understanding of what a kickback is has not kept up with the DOJs and the Relators bar's perception. So DOJ and the Relators Bar are always a few steps ahead of where the rest of us are. And then some of our clients are a few steps behind where we are . So I think that there's a lot of , um, inadvertent tripping up of on, you know, a KS issues. And certainly, you know, then under the Stark Law, which I know you do a lot of Joe strict liability statute, there's so many ways to screw up under the Stark Law. So many ways that clients think they're doing right, they're trying to do right, but they goof just in one little thing, the construction of whether, you know , one particular thing is DHS or not, or is it really personally performed or not, or what does that mean? So many ways to screw up. And then once you've got a screw up , you've got a Stark Law violation. If you're not under the exception, as, you know, it doesn't necessarily mean you've got a false Claims Act violation. There is still some, some knowledge required, some it deliberate ignorance or reckless disregard at least. But , um, so I think when you put all of that together, there's so much that can go wrong, <laugh> , and it underpins so many of the other themes of, you know, medical necessity that so many of the enforcement matters, even if they don't start off as focused on the kickback violation or focused on potential Stark law violations very quickly, they follow the money and then they see that as being an inherent part of whatever was going on.
Speaker 3:Yeah . Thanks, Laura. I really appreciate , uh, that answer. The , uh, I think a second question here for you is, you , you talked about anti-kickback , uh, the anti-kickback statute is a criminal statute, and although it's often in , although it's often enforced through the the False Claims Act , uh, is there anything we should, we should be focusing in on with respect to the criminal enforcement side of healthcare from your perspective?
Speaker 4:So I think there is, I think a lot of us who think of ourselves as healthcare lawyers who do a lot of fraud and abuse work, or healthcare fraud litigators or healthcare fraud enforcement defenders , um, we need to focus on the False Claims Act primarily. And I think the reason for that is that the false , there's so much regulatory gray area, it gets so complicated that a lot of the most interesting legal issues come up in the civil context under the False Claims Act, because they, most of them probably aren't great candidates for the criminal side. And also, realistically, what's driving False Claims Act enforcement? Well, that's been the False Claims Act itself. It's whistleblower provisions, the fact that relators whistleblowers can bring cases and then they can get a portion of the government's recovery, they and their lawyers. So I , I think that's where a lot of the interesting work has been. A lot of the more complex gray area, and frankly, a lot of the space where the, where a lot of our clients as healthcare lawyers are more at risk in that FDA space, or at least that's how we've generally been perceiving it for many years. And that's where the , realistically, that's where most of the enforcement has been. Most of the criminal enforcement to date has been on what I think of as being low hanging fruit. So it's, you know, it's the really blatant examples of billing for stuff that's not being provided or that, that telehealth tele fraud scheme I described earlier. Yeah , the really egregious examples. And typically not, you know, well-respected, well-established , um, corporate entities that may some , you know, maybe a corporate entity, but small, a lot of individuals. But I think that may be starting to change. I mean, the, I think that, you know, it seems like the criminal division is trying to get a little bit more of the healthcare fraud pie, maybe get a little bit more respect in the healthcare fraud community. Um, just this past September, as you mentioned, they rolled out their corporate whistleblower awards pilot program that offers financial rewards to individual whistleblowers , um, who are , um, blowing the whistle on specific corporate crimes. And the program applies to violations relating to crimes involving private healthcare benefit programs, not just public. Well, that's a huge change because the False Claims Act, of course, to have a violation of the False Claims Act, you have to have federal funds involved. So it's gotta be Medicare, Medicaid, maybe va , maybe tricare , um, but it's gotta be a federal healthcare program. So this really expands the possibility of where whistleblowers could be drawing from in terms of, you know, blowing the whistle. Um, so in addition to that, the criminal division rolled out a pilot program in April in voluntary self-disclosure for individuals. Um, they also have corporate self-disclosure programs, but this , but in April, this new program focused on individuals under that individuals can be eligible for a non-prosecution agreement if they bring forward, actionable, original information about criminal conduct that might otherwise go undetected or be impossible to prove. So I don't think it's a big leap to say that if you put those two together, if somebody individually is aware of some fraud and has been involved in it and is a little worried, they can then go self disclose it, and I don't see, you know, they might even be able to find a way to, to get some sort of whistleblower protection very not dissimilar to what's available under the False Claims Act. Um, certainly being , having had some involvement in the fraud doesn't preclude you from getting some recovery. Um, the False Claims Act, you know , the Congress at the time in enacting the False Claims Act talked about setting a rogue to catch a rogue. So it'll be interesting to see what happens in the criminal context with those. And then, you know, the criminal division, unlike the civil division, civil division usually leaves to H-H-S-O-I-G to focus on compliance. That's, you know, that's what H-H-S-O-A-G does. Civil division generally does not get involved in that, but the criminal division likes to talk about it a lot , um, and look at it for, you know, under the sentencing guidelines, they have to look at that. So in September, again, the criminal division updated their corporate compliance guidance to focus on strengthening mechanisms to support internal compliance related reporting, mitigate the risks of a a and other emerging technology, and to ensure that each company's compliance team has adequate access to data and other resources they need to perform data analysis and other monitoring functions. So the criminal division is really think kind of making a play for, for some more involvement and more respect and more acknowledgement , um, by the healthcare community. So I think that while many of us are more accustomed to focusing on the civil division, the False Claims Act , um, and maybe just sort of dismissing the criminal division as, oh, they take the low hanging fruit, we're not, you know , we're not dealing with that. Most of our clients aren't in that vote . I think we need to rethink that, and I think we need to be , um, a lot less dismissive if we have been dismissive, and we really should be keeping an eye on what they're doing over , um, in the criminal division, and particularly in criminal frauds here in dc . Um, they're kind of making a land grab that could affect us all. They're smart lawyers and they've got a lot of strong tools and , um, you know, they've made very clear they want to be in this space and they want to be as relevant as the civil division. So that may have some impact on whether some cases, particularly under these new whistleblower provisions get brought to the civil division or the criminal division. So some of our clients who always felt pretty safe about not fo not being the cross airs of the criminal division , uh, um, I , I don't think we should take that for granted anymore, and that's a big change.
Speaker 3:Thanks, Laura. Um, I really, really appreciate that perspective. Um, you know, I I, I do a lot of work in the Stark space and I, I just wanted to touch on a couple of compliance trends I'm seeing , um, in, in the Stark space in particular. I think we're seeing a continuation of questions , uh, that are focused on , uh, kind of the Stark Law exceptions. Um, you know, and I, I do , um, when I do that kind of , uh, work, I, I do sort of do the dual analysis, think about Kickback and Stark. Um, at the same time, I think we have 30 plus exceptions and safe harbors each now under the rules. And so that, that can get pretty granular. But there's been a lot of focus, continued focus on the big three standards of fair market value, commercial reasonableness, and, and whether or not arrangements meet the volume or value standard. Um, you know, we, we did have this significant settlement in December of 2023 that did bring back a lot of attention to the Stark Law and Stark Law compliance, and it , it largely focused on , um, those big three standards. So they are a big part of what the industry continues to grapple on the Stark side. Um, we're also seeing healthcare organizations still digesting and, and, and figuring out how to implement some of the new Stark flexibilities, even though they've been around since 2021. Um, ideas around, you know, now you have 90 days to get , uh, both the writing and signature in place related to a financial arrangement. Now you can , um, reconcile discrepancy if there's a payment discrepancy that may not be a stark violation. Um, instead you may be able to reconcile it under some of the new Stark regulations. Um , one area that , um, I, I continue to have questions about is , uh, you know, the indirect stark analysis, you know, there's a three part test related to whether an indirect stark analysis , uh, exists that includes, is there an unbroken chain of financial , um, uh, arrangements, ownership or compensation? Um, there's a second standard that relates to the, whether compensation varies with referrals to , um, an entity down the, the chain. And then a third is a knowledge element. That second part of the test has gotten much more , uh, flexible under the new rules. And many arrangements that used to be determined to be an indirect arrangement now aren't anymore. And so that's a , that's an important area. I'm seeing clients start to recognize that, man, we have a lot of arrangements that we thought Stark applied to historically, but because of these new rules , um, that we may be able to get comfortable that this is not an arrangement that needs to comply with the Stark Law. Um, seeing , um, a a lot of activity around value-based enterprise models, the new value-based enterprise rules have been around for a few years now. I'm seeing healthcare organizations u looking to those value-based enterprise as a secondary , um, analysis related to arrangements that they're, they were planning to enter into , um, already, you know, how can we look at this arrangement that , um, has been in place, but , uh, may we may wanna develop some new features and, and align with these value-based enterprise rules. Could it be a secondary analysis? The other is when they wanna do something truly , uh, new and innovative, and that's something they haven't gra taken on before, how that may align with the value-based enterprise rules. Um, and so I've seen significant uptick in, in the VBE models , uh, this past year , um, even in the, in instances where , um, situations may have involved what might be thought as compliance risk before , um, could we look to the value-based enterprise rules as a new way , uh, to , uh, manage and risk , uh, as well , um, under the Stark Law. Um, we're, we're, I'm also seeing, I think, some, a bit of reconciling of the case law activity that's still coming out and how these rules are structured now. And that mean , what I mean by that is , um, we're still seeing some cases , um, emerging that the facts and circumstances , uh, were during a period of time before recent stark reform. And so we're actually , uh, we're watching cases play out under an old regulatory framework. And I, I've seen clients sort of trying to process that. Um, we're have , we've, we've had , I've had conversations with clients, yeah, that is the way that tho that fact situ fact pattern played out under the old Stark rules, under the new Stark rules , uh, that arrangement may have been compliant. Um, and that may not have been a stark issue. And so we're, we're dealing with a little bit of the case law lagging , um, and interpreting the stark raw rules that were in effect prior to 2021. And I do think we're gonna see healthcare organizations start to , um, uh, at least appreciate that distinction that, that that fact pattern may have been okay under the, under the new rules. And then I think lastly on the stark space , I think we're seeing , um, enhancement of the compliance function. I think during COVID , uh, we did see some compliance programs that, that sort of shrunk down. There were fewer personnel , um, in the compliance department now , uh, they , healthcare organizations have had a chance to build up their compliance function , um, and have now had a few years , uh, within those compliance program people's , uh, a few years under the belt now. And so , uh, now we're , I'm seeing more enhanced compliance function, some more focus on process improvement , um, and also automating some of the contracting functions as well. Part of that I think, is driven by scale. We're seeing healthcare organizations continue , continue to consolidate with that consolidation. They may look to automate and , and develop process improvement. But the other thing I, I think is related to personnel being in those roles for a few years now and , and looking to make their, their process better. Um, and so those are some, some , uh, uh, developments I'm seeing , uh, in the stark space. Um, you know, Laura, as we, we've talked about a lot already , uh, you know, as you look to 2025, if you had a crystal ball, you know, what would you be seeing , uh, for 20 20, 20 25? Uh , I think our listeners would benefit from, from hearing that from you .
Speaker 4:Wow, that's, isn't that what everybody's asking right now in , in every area of , of life just about and certainly of law going into 2025? So certainly there's gonna be a lot of change over the coming year with the new administration and some unorthodox voices, perhaps for government healthcare leadership positions. But I actually don't expect any drastic changes in fraud and healthcare fraud and abuse enforcement. The Pulse Claims Act brings in a lot of money for the federal government, close to $2 billion a year just in healthcare fraud recoveries. And it's pretty hard for anybody in any party to say they're in favor of healthcare fraud and abuse, or they don't mind, you know, money going flowing out of the system that shouldn't be. In fact, you know, we do see efforts to crack down, generally speaking, on spending , um, you know, the, the new , the new Doge department of government, and I don't even remember what it is , um, trying to cut back on government spending. So I think that continued, at least, if not heavy focus, at least continued allowing these cases to proceed under the False Claims Act, which again, are really being driven in large part by the whistleblowers. I think that's gonna continue. I don't see anybody trying to put a stop to that. There may be some additional focus on the fringes around particular things. It'll be interesting to see, you know, right now, as you talked about earlier, managed care is a big focus of potential fraud. There are a number of enforcement actions out there today under the False Claims Act, in particular, against managed care entities in connection with potential fraud in the way that they operate. And we, we know that at least some of the folks who've been prioritized for new government positions, anything could change. But the folks who are currently being named are very much in favor of managed care for Medicare and Medicaid. So it'll be interesting to see how those two positions collide or coexist, but we also don't know for sure who's even gonna be confirmed in any of those positions. So , um, so don't know that , but I think generally speaking, we're gonna see a continued focus on enforcement. Um, on the jurisprudence side, I'm keeping a close eye on the question of under the anti Kickback statute, what level of causation is required to trigger false claims under the False Claims Act? We're expecting a decision from the First Circuit soon in the Regeneron case, and then, so it'll be interesting to see how that plays out. Um, there's been an issue raised about whether the False Claims Act as a whole or not as a whole, but it's whether it's que tam provisions for whistleblowers, whether those are constitutional under Article two , um, that's been raised and in a number of courts, and the middle district of Florida has held that it is not, that's on its way up to the 11th Circuit, that may well make its way up. I don't think that's gonna drastically, even if the Supreme Court finds, kicks out those provisions and doesn't allow whistleblowers to continue to proceed with cases that the DOJ declined , I think they'll probably still be able to continue to bring those cases. And even if that gets knocked out, the False Claims Act is still gonna be there. And, you know, just like the criminal division just created some new whistleblower provisions, the civil division could do something very similar. So I don't think, no matter what happens there, I don't think we're gonna see the end of whistle blowing , um, as we know it, it, it may just, it may get tweaked a little bit. Um, and then it's always interesting to see how courts are construing the False Claims Act, materiality requirements stemming from the , you know , 2016 Escobar decision. Still a lot of cases on what's material, what isn't material in terms of whether the government actually would pay a claim or not. Um, and so whether the falsity is material or not. So , um, those are fun to watch. I don't expect any major changes. It'd be interesting to track those developments, but, well , you know, same question to you, Joe . What are some areas that you think are gonna see some developments in 2025?
Speaker 3:Yeah, thanks, Laura. Um, you know, I think you, as you mentioned, I think we'll see a continuation somewhat of the same. Um, you know, that , uh, enforcement will continue to to be a priority. Um, I think we'll continue to see big settlements. Part of this is just the pipeline. Um, I mentioned earlier there, there's a lot of of cases in the pipeline. And so there is the, the , the reality, if there's a lot of cases in the pipeline, we're gonna continue to see settlements. Um, you know, two cases in particular that got a lot of attention this past year is one, a large case in, in involving physician compensation that settled in December. Um, you know, I think we'll still see , uh, compensation focused settlements. Uh , there was another case that focused more on physicians receiving a benefit from advanced practice providers. Um, I, I, I think that's gonna continue to be an area that, that receives attention in the industry. Uh, there was an advisory opinion issued on that, on a PP support , um, advanced practice provider support , um, this PA over the past year as well. Um, the last two years at the A HLA Fraud and Compliance Forum, there have been panels discussing, you know, sort of this, this benefit that, that , uh, may be remuneration , um, under the rules. And so I think we're gonna continue to see that , uh, uh, be an , an area of focus , um, more healthcare investigations. Um, I'm seeing , um, you know, anecdotally a a number of significant , uh, investigations , uh, consistently now. Um, we're , we're seeing more and more investigations in our work. Um, we're gonna continue to see , um, I think more attention on value-based enterprise models now that the industry has come around , um, and starting to understand how those can be utilized. And as I mentioned earlier , uh, continued attention , um, on process improvements and trying to, to get these , uh, you know, to, to develop , um, more consistency , um, with regard to contracting beyond that, you know, as you were touching on the case, law developments are, you know, they, they do bring attention. Um, they're , you know, we did see, I , I mentioned earlier, you know, in the state of Florida , um, you know, recently some case law activity about , um, you know, maybe the False Claims Act is unconstitutional. I mean, those draw lots of attention. I think we'll keep seeing , um, those , uh, examples of, of , uh, of, you know, high, high profile , uh, situations involving the False Claims Act. And I think we're gonna see the industry continue to grapple with , um, the, the Chevron , uh, doctrine, the changes related to that. You know, it , it seems that each time, the cases , uh, where the judge is asking the , the , um, the litigators to go back and, and look to plead or supplement their pleadings, that's getting picked up in the industry . And I think we'll continue seeing that as well. So , uh, I think we'll have no slow down in enforcement , uh, in our area. Um, so, so definitely some areas to watch. Uh, Laura, when we reconvene next year, we'll have probably lots to talk about. Um , so , uh, Laura, do you have any final thoughts for our podcast audience today?
Speaker 4:I , you know, only final thought is there's a lot going on. There's a lot to keep track of, make , it's so important now, even more than ever to have an effective compliance program and to be tracking all of the changes. We've, I think you and I have agreed there's probably not gonna be a sea change in enforcement approaches, but I think there's gonna be a lot of change on the regulatory side, or potentially there's gonna be a lot of change. And so it's important to keep an eye on that because changes on that side can then give rise to enforcement problems as to any particular provider, manufacturer. So , um, important to keep an eye on the ball, make sure compliance, if, if there's a whiff of a problem, look into it, fix it, consider self-disclosing so that the a so that a fairly small problem doesn't become a huge problem important every year, but all the more important when there's a lot of change coming down the road.
Speaker 3:Yeah. Thanks Laura. And, and thank you so much for your time today. Uh, thanks also to those of you that have tuned into our podcast , uh, within the HLA and within our practice group, we're always looking for volunteers, so please reach out to me , um, on LinkedIn. Um, reach out to me directly , um, if you'd like to be on a future episode or if you have an idea you think we should be covering, or , uh, if you just want to get involved, we're always looking for , uh, more healthcare attorneys to get involved in this space. We'd, we'd love to find a way to get you in the mix. Uh, thanks for tuning in and, and have a great day. Take care.
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