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 2023 and what to expect in 2024. Laura is the author of the 2023 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.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
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 2023 and what to expect in 2024. Laura is the author of the 2023 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.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
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Speaker 2:This episode of A HLA speaking of Health law is brought to you by A HLA members and donors like you. For more information, visit American health law.org.
Speaker 3:Uh, welcome everyone to today's A HLA podcast where we'll be talking about key trends and developments in healthcare, fraud and abuse, compliance, and enforcement. There are certainly a lot we could cover in today's podcast. Things like recent government initiatives, stark and Kickback Developments, self-disclosure , uh, changes all across the industry. Um, looking at this past 2023 and also going forward , uh, into 2024, we're gonna try to focus on a, on a few areas. Uh , my guest today is Laura Lemley Weidenfeld, and she and I are going to pick a few topics again from this list to focus on today. If, if Laura's name sounds familiar, she's recently, she recently authored a supplement to her, a HLA book titled Legal Issues and Healthcare Fraud and Abuse. She also is a past chair of the Fraud and Comp , uh, the Fraud and Abuse Practice Group here at a HLA . So, very excited to have her on today's podcast. Uh, today's pod podcast is brought to you by the American Health Law Association's Fraud and Abuse Practice Group. I currently chair the pg and our mission is to , uh, advance healthcare fraud and abuse and compliance issues , um, to bring our members and help them to stay informed about these issues as they, they develop. Our vice Chairs are doing a great job of developing webinars, publications, and other content to educate our members on important compliance developments and enforcement trends across the healthcare industry. Um, in many ways, this , uh, this podcast today, this video podcast is a preview to our practice groups year Yearend Review webinar , uh, that currently is slated for Wednesday, January 10th , uh, I think , I think in the afternoon, from two to 3:30 PM Eastern. So please consider registering for that. Laura will be one of the panelists on that webinar , um, that's likely going to be moderated by one of our practice group vice Chairs , uh, Kristen Carter from Johns Hopkins. Um, so again, again, a preview, but lots to talk about today. And Laura, before we get started with the back and forth questions , uh, could you please , uh, introduce yourself?
Speaker 4:Sure. Thanks Joe . And thanks so much for the opportunity to be here with you presenting on this podcast. I'm really excited to be here and thanks to a HLA as well. So , um, I've been practicing in healthcare fraud and abuse for , for over 25 years. I'm currently a partner in the healthcare life sciences practice at Jones Day in the Washington DC office . Earlier in my career, I spent about five years at the Department of Justice investigating and litigating False Claims Act cases that related to healthcare and life sciences . And then , since leaving DOJA long time ago now , um, I've been focusing my practice primarily on defending a wide variety of types of healthcare providers and suppliers, as well as pharmaceutical and medical device manufacturers against government investigations brought by the Department of Justice, including various US attorney's offices, as well as state ags, and also hhs. On the flip side , I also devote a lot of my time to providing fraud and abuse, regulatory and compliance advice to the same types of clients with the goal of trying to keep them from becoming , um, in , from coming into the cross hairs of a government investigation.
Speaker 3:Great , thanks, Laura . And , uh, I'm Joe Wolf. I chair the , um, a HLA Fraud and Abuse Practice Group. Um, and I, I'm also a shareholder with, with Hall Render . Um, my practice , um, includes being the, the leader of the Healthcare Regulatory Practice group at Hall Render. Um, I also focus my day-to-day , uh, efforts on , uh, stark Law Compliance and a kickback compliance physician compensation arrangements , uh, along a kind of a continuum from the development of contracting and compensation process through the development of models, compliance issues related to implementation , uh, self disclosures and, and defensibility issues , um, as well. And , uh, very excited to have Laura on today's podcast. Um, I think now we'll get into, we're gonna get into some of the back and forth on, on issues. I , I wanted to set the stage a bit, and for anyone listening, you know, there , there , we're gonna have the webinar Yearend Review webinar in January. Laura's gonna be a panelist on that. Um, I, I always encourage people to find the Yearend review , uh, uh, slide deck if you can. Bob Hoch always does a , a wonderful job at the Fraud and Compliance Forum. Um, I think this year, Laura, you were part of the topic team that put that package together. Um, others and Gavin Keen , Brian Rourke , uh, Brad Robertson, and just some really strong work. So if you can find that , uh, also, it , it , it always set does a good job of showing what's happened over the past year. Um, going back to the book , uh, first and I , and I would say kind of broadly, I think we can all agree that fraud and abuse continues to be an area of focus within healthcare. It's a very busy area. Um, just going back to Laura's book , um, and her , the , the book this year was , I believe was a supplement and , and correct me if I'm wrong here, Laura, to your, your a HLA book title, legal Issues and Healthcare Fraud Abuse. I think it's the, that was the fifth edition, was published back in 2020. Um, and your book does a really good job of highlighting some of the big items we're , we're seeing in the industry. Um, we've seen some big changes to the regulations and guidance in the fraud and abuse space. Um, I'd say especially since that big overhaul we had back in 2021 , uh, we're also seeing some different enforcement agencies continuing to actively enforce healthcare fraud abuse laws as well. Um , that that book , uh, Laura's supplement does a good job of hitting on a lot of trends. We're seeing , uh, things like federal agencies aggressively pursuing individuals and entities for potential violations of these laws. Uh, including, and this is gonna be an area we're gonna see continuing to unfold, is , uh, actions related to the, the COVID-19 pandemic. Uh, also the DOJ being active in pursuing healthcare providers in the life sciences , um, and , and manufacturing space for violations of the False Claims Act. Um, those cases have evolved a variety of conduct. Uh, we're still seeing whistleblower activity. Uh, whistleblowers, of course, are , are always a , a , a big part of, of an active in bringing cases forward. Um, they're pursuing those cases even when the government de declines to intervene in them. Uh, the OIG and CMS, again finalized, I preview this before those additions and revisions to the regulations under Anti-Kickback and Stark , uh, all of us working in this space are continuing to evaluate those rule changes. We're applying them in , in , I'm, I'm dealing with this a lot, applying them in new situations as issues come up, but also plugging them into self-disclosure. Um, looking for ways to continue to educate our clients and bring forward those rules to help with initiatives and opportunities going forward. Uh, the book mentions those special fraud alerts , uh, one in case , uh, is that recent , um, uh, fraud alert , uh, discussing skepticism around in-person speaking programs and warning healthcare practitioners of the risks of entering into arrangements with , uh, purported telemedicine companies. Um, and then also the OIG continuing to issue advisory opinions to a range of entities. We just saw a couple of those come out more recently. Um, and, and it , it's nice to see that , uh, front abuse practice group is , has provided content on, you know, how to seek an o an advisory opinion, what that process looks like. And it's good to see healthcare organizations are still seeking that guidance , uh, proactively. So, Laura, your book and , and that supplement really unpacks many of these changes and I think what the anticipated , uh, impact of some of these rule changes will be going forward , uh, both relevant to what's gone on in 2023 and what we need to see in 2024. So thanks so much for putting that together. Uh, thanks for being on today's podcast, and I'm really excited to have you , um, kind of jumping into the back and forth questions , uh, Laura, of , of course, the super value case is getting a ton of attention has gotten a ton of attention this year. Uh , could you talk about that case and , and why it's so important, why it's gotten so much attention?
Speaker 4:Absolutely. So the , the super value case , um, which was, we're referring to a recent Supreme Court decision that came down this year. So that particular case addressed cter , which is the mental state required under the False Claims Act to trigger a violation. So under the False Claims Act , um, in order to be found liable, you have to have not only submitted a claim that was false, but you had to have done so either knowingly as in having actual knowledge or with reckless disregard or deliberate ignorance of the falsity of the claim. And so , um, in recent years, a number of circuit courts have held that the standard that was adopted by the Supreme Court in a completely unrelated case called Safeco Insurance Company of America versus Burr back in 2007 , which was a fair credit reporting case. Um, courts have found that that Safeco standard also applies to the False Claims Act, with respect to the interpretation of ter what TER is required, what Safeco held , and again, in the Fair Credit Reporting Act context, Safeco held that a defendant cannot have acted with the requisite ent IE with knowledge if it acted consistently with an objectively reasonable interpretation of its obligations under the law. So when does this come up? This comes up in situations where , um, the, the, the now defendant in an FCA case at the time before they submitted the claims, we're wrestling with, well, you know, what , what exactly is the requirement here? There's some ambiguity around what a requirement is, and the defendant chooses one interpretation of the requirement, but there are other interpretations possible. And later on, the government says that it adopts a different interpretation and that the defendant did it wrong. And not only did the defendant do it wrong , but they did it knowingly. They at least should have known or acted with reckless disregard or deliberate ignorance. And so this, the Safeco standard has been invoked by a number of defense counsel over the years to try to address this kind of situation. And , um, and what was significant about Safeco and a little different than a lot of other, other , um, false Claims Act , <inaudible> decisions, was that in Safeco, the court had basically said, we don't care what the defendant was thinking as a matter of law. They cannot have acted with the requisite c they cannot have acted knowingly if they acted consistent with an objectively reasonable interpretation of their obligations under the law. So we don't even look to their intent. We just look to was that a reason objectively reasonable interpretation? Did they act consistent with it? If so, there cannot be the answer under the , under the under, in that case, the Fair Credit Reporting Act, but you know, a lot of arguments that it applies to the False Claims Act as well. So this idea had been bubbling around for a while , since 2007 . It had been starting to gain some traction with Circuit Courts, and in the case United States XU versus Super Value . Um, the Seventh Circuit had joined four prior circuits in holding that the Safe Coast Standard applied with equal force to the False Claims Act, the enter provision, and they granted summary judgment for the defendant. So the super value case involved Medicaid drug pricing. The question was whether that pharmacy retailer had reported appropriately its usual and customary pricing to Medicaid. Um, the , the allegation was that they had violated the False Claims Act because they had reported their retail cash prices as being their usual and customary prices, whereas instead, they should have , um, reported the lower amounts that they were charging certain qualifying customers under their discount program discount , that those discounted prices are what actually should have been the usual and customary prices . And all of that, of course, then drives what Medicaid reimburses. So the District Court found in the Seventh Circuit affirm that they should have reported that lower discount price as part of the usual and customary, but the Seventh Circuit said, notwithstanding that Seventh Circuit focused then on, well, the fact that they thought the guidance on what they were actually supposed to report wasn't clear and certainly wasn't clear at the time at which they were submitting their claim. And the Seventh Circuit said, an objectively reasonable person could have thought that their interpretation was correct . And since there had been no authoritative guidance to the contrary , at that point in time , they said , as a matter of law Super could not have acted with the actual knowledge , reckless disregarded, deliberate ignorance requirement of the False Claims Act. The Supreme Court considered that and unanimously disagreed with it and overturned the seventh Circuit decision the Supreme Court focused on, instead of saying, as a matter of law, if it's confusing and you acted in a inconsistent with an objectively reasonable standard, you're as a matter of law, you can't have violated the statute. They said, no, no, no, no. We're gonna look at what the defendant actually was thinking at the time. We're gonna take that subjective approach, not an objective approach, and we're gonna look at their thinking. And a defendant can be liable if one of three things, number one, if they actually knew that their contact was unlawful, number two, if they were aware of a substantial risk of unlawfulness, and they intentionally avoided learning about the conduct legality, which sounds a lot like rec reckless disregard, deliberate ignorance , um, or number three, if they were aware of such a substantial and unjustifiable risk, but submitted the claims. Anyway, that one I sort of wrestle with. I'm not really sure what that third one means, and there's probably gonna be litigation now about what it means to take in an unjustifiable risk. But I think the key takeaways, regardless of what exactly that language does or doesn't mean, I think there's some key takeaways. Number one, if there are multiple possible interpretations of a law or regulations that is not enough to protect you, you, a defendant , um, a potential defendant in the future, right? A provider, a manufacturer against claims that you committed fraud . By adopting one of those multiple interpretations, the government and the courts are gonna hold you to a duty to try to find out which one of those interpretations was correct and to act consistently with that correct interpretation. Number two, unfortunately, the decision doesn't give any guidance about what you're supposed to do when you still can't get a clear answer about which is correct. And that , which is where we find our clients, I'm sure, Joe, you , you find this all the time too, healthcare providers and , and pharma and device manufacturers are constantly risk trying to figure out what exactly is it that we're supposed to be doing. And that's, that's why <laugh> , that's why the healthcare lawyers , um, stay busy, right? But we don't always have a clear answer. Um, in fact, we often don't have a very clear answer on those , on those difficult questions. So there's no clear guidance about what exactly you're supposed to do when that happens. Um, so given that situation, you know , our recommendation has been, I , and I think this is kinda what providers are gonna need to do, when you're faced with unclear guidance and there's no clear answer as to what you're supposed to do , I think it's a really good idea to document which approach you're taking and why you're taking it, why you think this interpretation makes more sense than the others. And then, of course, acts consistently with this interpretation so that if , if and when the government comes knocking later, you, there's, there's not a question, you know , well, there's a question, but you can respond to the question of what were you thinking with, here's exactly why we were thinking, and here's exactly why we thought that we were justified , um, in taking that approach. Is it a satisfactory answer? No, it's not. But I think that's, that's where we're left right now.
Speaker 3:Thanks, Laura. And I really appreciate that es especially the end. That is, that's, you know, the practical guidance there , um, on, on that case , um, and what providers can do . Um, let's, let's go beyond super value and, and obviously this question's a big lift. What do you see as the, some of the key trends and developments in healthcare fraud and abuse in 2023? And, you know, as, as we think about going forward?
Speaker 4:Sure, there are so many , um, and, you know, we could easily spend a much longer time, but we're gonna keep this fairly limited, so I'm just gonna hit on a few highlights, but , um, there's certainly, for those who are interested, come back in January for the , for the webinar because we'll be spending significantly more time talking about these things , and we're still not gonna hit on absolutely everything , everything I'm sure . So , first of all, in the case , it's been a really interesting year for case law. The Supreme Court considered not only the super value case, but also a different case, Polanski versus executive health resources . That case teed up the question of whether and when DOJ can seek dismissal of a false Claims Act case even over a relator's objection. So this arises sometimes. So, you know, relator , whistleblower, same, same word, same, same concept, brings a case DOJ investigates and decides whether to either intervene in the case, IE take it over, take over the litigation, and leave the litigation, or to decline IE to stand back, in which case the whistleblower can move forward if they wanna . Um, there's some situations where DOJ does not want declines, does not wanna take over the litigation for whatever reason, lets the whistleblower go forward, but decides that the case shouldn't go forward. DOJ decides the case shouldn't go forward for whatever reason. A lot of times , um, it's a combination of they don't really see a lot of merit in the case, and they see a lot of headache for themselves, a lot of expense for themselves, other sorts of litigation risks , whatever the reasoning they, you know, don't, don't always share all of it , um, probably don't ever share all of it, but they have the reason sometimes for wanting to dismiss the case. So occasionally it's not that frequent, but occasionally they will come in and try to dismiss the case. And so there's been a question for a number of years , um, particularly the last, I don't know , four or five years since , uh, Michael g Grantson issued the Grantson memo talking about giving guidance internally for DOJ as to when, what they should consider when they're thinking about seeking to dismiss. Since that time, there's been a little bit of an, of an uptick in the number of times that D ojs sought to dismiss, and there's been a huge uptick in defense counsel talking about this issue. Um, and also in courts, courts considering it, there was a split among the circuits, and the Supreme Court took a very, you know, very unexciting position, but unexciting in the sense that it , you know, it's not particularly sexy, it's pretty straight down the middle. They basically say, DOJ gets to seek dismissal of a false Claims Act case, even over the relator's objection. So long as the DOJ intervened at some point in the litigation, they don't need to have done it initially. They can have declined and then later sought to intervene. But as long as they've intervened, then they're a party, they're the real party in interest, they get to seek to decline it . Um, and the courts are gonna be, you know, incredibly differential to that. So it's now easier for them to dismiss cases, the really, which is kind of interesting and maybe kind of helpful in a very few cases. What I think is gonna be more interesting, though, going down the road, and I'm already sort of looking forward to 2024 here, is the opinions by Justices Thomas and Kavanaugh. They both separately noted the existence of substantial arguments that the <inaudible> provisions are inconsistent with and unconstitutional under Article two of the Constitution. And the private relators cannot represent the United States interest in litigation. And so I think we're alre , we are already seeing that argument being raised in some existing litigation, and I think we're gonna see that argument raised and teed up pretty quickly . Supreme Court has already , you know, at least they have already triggered the , um, indicated that they're interested in taking on that question. So I think it's just a matter of time and probably a short , fairly short amount of time before that gets to the Supreme Court. So that's, that was that piece of, it's interesting. Um, we also saw some interesting developments in cases about alleged in a kickback statute and False Claims Act violations. In the same case as situations where an alleged anti-kickback statute violation gives rise to liability under the False Claims Act. So under the revisions to the Anti-Kickback statute back in 2010 , under the Affordable Care Act, there's new language under New <laugh> News 13 years ago that says, a claim that includes items or services resulting from a violation of this section in the <inaudible> statute , constitutes a false or fraudulent claim for purposes of the False Claims Act. So DOJ is consistently argued that that resulting from language just means downstream from that. If there's a kickback to a person, then every item or service that's billed for anybody referred by that person is per se , false or fraudulent under the False Claims Act. Well, that completely reads out the language resulting from which DOJ and a number of courts have justified by looking to the legislative history and saying, well, if we look to see what Congress was trying to do, they were trying to make it easier for the , for these false claims that cases to be brought predicated on any kickback statute violations. And so , um, so that's what that must mean. And I certainly agree that that is what was going on at the time that they adopted that language. But it kind of ignores the plain language of the statute. And I know I learned in law school that you're supposed to look first to the plain language of the statute, and then if it's not clear, then you look at legislative intent. But I have found in my discussions with d oj , they tend to just sort of leapfrog over that plain language issue as many of the courts have as well. But more of the courts now are focusing on that language and saying, Hmm , well no, it's gotta mean something. And so most recently, both the sixth and the eighth circuits have said, we need to look at the plain language. We're looking at that. And that resulting from means you need but for causation that, but for those kickbacks, the false claims would not, those claims would not have been submitted in order for those claims to be false. Um, DOJ does not agree with that approach. Uh, it is now being teed up as well, currently in the First Circuit where the District of Massachusetts, two different judges have taken two different positions within the space of a couple months. District of Massachusetts, of course, is where Boston is. Boston, US Attorney's office is very active with false claims that cases and kickback cases in particular. So even though that's , um, just one circuit, I think that's going to have an outsized impact whichever way it goes on what happens across the country and what happens across claims that cases . But, so those are all case law . Um, couple other things a little more briefly. I'll note that both DOJ and H-H-S-O-I-G have been issuing more guidance this year. Um, the DO J'S criminal division , so not the False Claims Act post , but the criminal division has issued guidance on self-disclosure , um, saying that there's a presumption that they will decline , uh, to take, to take criminal action , and that they'll impose lower fines in cases of self-disclosure. Of course, that doesn't mean you get off with , you know, scot free because of course you're paying a fine <laugh> , there will be a fine, they're just saying they won't, you know, aggressively pursue you as a , as an open case. Um, they also say, have said that they're providing a safe harbor for self-disclosing violations that are found , um, in situations where merg in merger and acquisition situations . So , um, the safe harbor, which is actually supposed to apply not just to the criminal division, but across DOJ , according to to their policy statement, said that there's a presumption that DOJ is going to decline to take enforcement action against a company that has acquired another company where they're making the disclosure about the , the acquired company, so long as it was a bonafide arms length m and a transaction. And so long as the acquiring company, number one voluntarily self discloses the suspected misconduct with , at the acquired entity within six months of the date of the deal closing, whether the conduct was discovered before or after the acquisition. Um, number two, so long as the acquiring company cooperates with any ensuing DOJ investigations , that's pretty standard. And number three, so long as they fully remediate the misconduct within a year of the closing date , date , also pretty standard, and they pay any applicable restitution or discord . Um, so that's, I think that that's, that's kind of a big deal. And that potentially applies to the civil as well as criminal folks. And then , um, H-H-S-O-I-G completely separate from all that recently issued a new com general compliance guidance document. It doesn't, it, it doesn't really change things very much, but I think it's a very helpful resource. It pulls together and refreshes and updates a lot of, of OIGs prior guidance. It provides links to the earlier guidance, and they say that they're gonna be coming out with new industry specific guidance in the coming year . So I do rec , even though that really isn't a game changer in, in, in any way. It is a very helpful document, and it does talk about a couple things that, you know , like risk assessments that have been in CIAs for a while , but , um, that they're now officially saying everybody should be doing those in their compliance programs. Things like tracking , um, financial arrangements with referral sources, again, also in CIAs for a long time now, they're saying should be a general compliance thing . Um , and also they do emphasize , uh, a focus on private equity. They specifically call out private equity and , and the need to , um, that they think that there's some potential risk from a compliance perspective there . So , um, worth the worth the read. Um , and then with respect to enforcement trends , you know, it , a lot of it's been a continuation of what happened last year and will probably happen next year, but we continue to see a lot of focus on by DOJ on individual liability and also on the potential liability of investors, including private equity firms in both false Claims Act cases , as well as of course, criminal cases. Criminal cases have always focused on individuals largely, but we're seeing a lot of that focus still on FDA cases, more cases involving covid related fraud. Um, and I'll, I'll note on that though, a lot of these COVID cases have been brought by D OJ directly rather than by whistleblowers. My hunch is to why is because a lot of these aren't that huge in dollars, so probably not worth it for whistleblowers to bring and, or whistleblowers, just dunno about them . Um, but d OJ is finding these and bringing a lot of these directly. So along with that, we're seeing an uptick in the number of cases that DOJ is bringing directly rather than just relying on the provision . And then , um, um, there's also been a lot of , um, there's, you know, some focus on tele fraud , which, you know, continues, continues to be the source of a lot of cases. Still not a lot in real, what I think of as real telehealth , um, fraud because, but I think that over time we will be seeing probably an increase in focus on cases there. Certainly, OIG has been talking a lot about telehealth and the , and how to comply with it and things to look out for in telehealth, and they've talked about the importance of it. Um, and I know that a lot of our telehealth clients have been really focusing on making sure that they're buttoned up and doing things, doing things the right way in anticipation of anticipated enforcement. But right now, most of that focus has been on tele fraud , um, which also is related to a continued focus on kickbacks. But, but Joe , lemme ask you, so with kickbacks as sort of a transition, I know you do a lot of work in the stark space, so what kind of compliance issues and trends are you seeing?
Speaker 3:I think Laura , um, you do do a lot of work in, in the Stark space. Um, kinda looking back at this past year, there's been a , a , a lot of development, I would say. When we had the end of the public health emergency, there was some immediate attention on how healthcare, what healthcare organizations did during the public health emergency. Many conducted a stark or, or compliance type audit, so they could determine, you know, what kind action they'd take in if they were relying on a waiver , um, including like a stark , um, uh, COVID-19 waiver, had they appropriately documented that. Um, the test , of course been whether you , uh, utilize that arrangement to achieve , uh, achieve a COVID-19 purpose. Um, that was a big , uh, area early on. Um, there's been an ongoing , uh, focus on understanding and continuing to evaluate the, the recent stark guidance. Uh, we have seen more flexibility in the recent rules around the writing and getting your signatures and , um, the new de minimus exception for payments under $5,700, for example. But , uh, healthcare organizations are using those in application. Um, some of the recent guidance from that, most that rulemaking , uh, I've seen that apply in the self-disclosure context where the government came back and said, look , um, could, could, could you apply this concept to this arrangement that are , is already in the self-disclosure protocol? Might that change the analysis? So that was interesting to see that , uh, play out. Um, the rule changes also created, I'd, I'd say a bit more certainty around , uh, the volume and value standard. I've seen that , um, be impactful to how arrangements are being analyzed, more guidance on fair market value and commercial reasonableness. Uh, that continues to be an area that I would say is, is, is challenging. Uh, the government did give us , uh, guidance on extenuating circumstances being relevant to the analysis. And I think with financial pressures , uh, in the healthcare , uh, industry and, and healthcare organizations trying to continue to recruit and, and build their , uh, physician enterprise, that they're continuing to work through those fair market value and commercial reasonableness issues. Um, there've been some data issues that have impacted physician compensation and particular , um, you know, how survey data was collected and, and how it was impacted by COVID-19 . Um, how it was impacted by changes to the physician fee schedule in recent years has , uh, led to some , uh, destabilizing impact in the , in some of the survey data. Um, and so healthcare organizations have had to work through that. Um, when we think about individual arrangements, especially arrangements where physicians and apps are working collaboratively , um, there's been more attention in that, in that space as well. There was a recent advisory opinion , uh, on that issue. Um, it was a , a focus, an area of discussion at the most recent HLA fraud and compliance forum. So that, that's been an area that I've seen healthcare organizations looking at how are physicians and advanced practice providers , um, working together. Um, some of the issues around , uh, maybe some billing guidance that may be changing, where in a shared care situation, the provider doing 51% of the, the time-based activity may be where the bill , uh, falls. Uh, healthcare organizations have been trying to get their arms around that change in the guidance. Uh, we had a new exception for physician wellness programs that went into the statute , uh, this past year. Uh, I think that's an , an a new opportunity for healthcare organizations to, to develop wellness programs for their physicians. Um, and also the new value-based rules. Um, I've seen a lot of movement in this area. Uh, over the past year , uh, healthcare organizations have had a chance to , uh, examine and educate their business leaders on how they might use the new value-based enterprise rules as an opportunity to advance their care models . So , um, that's an area , uh, that, that I've seen , uh, in this stark , uh, space that's been , uh, uh, getting lots of attention. And, and I've been doing a lot of work in that space. Uh, we've had a number of, of enforcement actions , uh, along the start line of in , in the Stark space. Um, and I think that the allegations are often, of course, blended together, but many of the, the recurring stark issues are , we're still seeing those , um, emerge in the cases. There've been a number of, of large cases over the last year , um, in the ranges of 45, 50, 60, 70 million. Um, so those are, and , and more. And so those , some of those are in the settlement phase, some are through self-disclosure. Um, I'm seeing, you know, that's kind of above the radar what we're seeing , um, you know, in the industry that's, that's public. Um, I , I do think that we're seeing an uptick in investigations as well. Um, you know, that that's not as public. Um, and I think we'll continue to see that. I think there's, there's, there's going to be emerging emerging , um, CIDs and, and we're just seeing an uptick in that kind of activity. Um, can beyond that , um, the government, and especially in the settlement space, if we think about the self-disclosure protocol , uh, CMS published some recent summary data on that, and I think it does show like how many self-disclosure are getting, they're kind of going through the pipeline. Um, if you look back to 2021 and , uh, to 2022, we saw 27 self disclosures in , in 2021, up to 104 in 2022. I'm interested to see , um, as we , as the value , uh, the data , uh, is , is released for this year, I'm guessing we're gonna continue to see a , a very large number of those self-disclosure being moved forward. Um, and then lastly, value-based care models . Um, I, I , I alluded to it earlier, but I think healthcare organizations are starting to get their eyes around this idea that if we create, or we can use a value-based enterprise model , uh, in order to develop incentives that achieve some kind of value-based pur purpose care coordination, quality or cost containment, and that the government made those rules , uh, largely flexible and there just may be a , a lot of opportunity to work in get in advanced models in that space. And so , um, excited to see, I , I do think that in , uh, post covid world, we have seen a , a bit of a , a return to reexamining , um, um, internal processes and trying to achieve process improvement , um, as well as, as we've seen a bit more stability , uh, this past year. And so I think that's something I'll, I'll , uh, I I , that will unfold in 2024 as well, just kind of revisiting how healthcare organizations are handling , um, the contracting process and how they set compensation, how they do financial analysis and how they conduct audits. So they're gonna kind of examine themselves a a bit. I saw that happening in 2023. So , uh, Laura, thanks for that question. Um, as we look to 2024, if you had your kind of crystal ball , uh, what, what do you see happening? What do you , what do you see as the big areas as we, as we look to the next year?
Speaker 4:So there's so much going on <laugh> , um, but I think, you know, in my world, really a continuation of a lot of what I was talking about before, I think we are gonna see more litigation on that question of the causal link between alleged kickback violations and false claims under the False Claims Act. Um, you know, does it get up to the Supreme Court next year? Dunno about that timing wise , but , um, I think it, it continues its pathway to the Supreme Court next year, probably, I think we're gonna see litigation on this question of whether the false claims, ex provisions are constitutional, and I'm curious to see what the, what flavor that takes and sort of where that goes. I don't think that would knock out the whole false claims , is that by any means. But, you know, maybe that would mean that Relators can't move , can't continue on their own. If DOJ declines, I don't know, it'd be interesting to see what the, what judges and ultimately the is due with that. I think we're gonna continue seeing lots and lots of enforcement cases, like you were saying, continued CIDs , um, continued subpoenas in in some districts. Um, and I think some of those are gonna continue to relate to COVID-19, right? It always takes a few years for, you know , stuff happens and then it takes a few years for it to percolate for DOJ to get, you know, get , get , figure out what the allegations may be , issue subpoenas, start investigating this for things to become public. So I think we're gonna be seeing more and more there. And a continuation of kickback cases. I, those seem to now be, at one point they were, you know, just a small subsection of false claims that cases , and it seems like now they're a huge proportion of false claims that case is being brought. So how about you? What do you , what do you see coming down the pike?
Speaker 3:Uh , um, I , I feel like I'm reiterating what you're saying . I'll just hit a couple. I think, again, more healthcare investigations of, of, from different agencies. Again, I think that's, that's happening and is going to happen. Um, I, I hit on it before more, I think more value-based, care value-based enterprise type of arrangements. Um, we've both, I think mentioned it, I continued attention on private equity. Um, I've heard this from a , a number of, of sources , uh, is there was a recent announcement of , uh, that , uh, you know, Chuck Grassley and, and , uh, Sheldon , uh, white House are, are launching a , an investigation into a bipartisan investigation, into private equity ownership , um, in , in healthcare. And so it'll be interesting to see that unfold , um, over the next year. Uh, as I mentioned before, continued attention on process improvement. Um, and, and I do think we will see , um, a return to some projects that , uh, healthcare organizations were exploring prior to , uh, the, the pandemic , um, you know, trying to, we're , we're, we've seen movement in the transaction space, obviously a , a focus on, on antitrust and, and whether or not , uh, competition is being advanced or not, but I think we're gonna continue to see , uh, an activity from a deal standpoint, a contracting standpoint. Uh, healthcare organizations try to find ways to be more collaborative in ways that align with the fraud and abuse laws. Um, so that , that's what I see coming up. And I think we've, we've included a lot of, of nuggets as to what's going on and what's going forward throughout this. And so I'm really excited, Laura, to see the , uh, the webinar in January where you dive in more. Um, just one final question for , for you. Um, I'll just give you a chance. Do you , do you have any final thoughts for the podcast audience before we wrap up?
Speaker 4:You know, I think my, I I think my final thought to share is they've all heard so much from both of us about all this different activity that's going on in the fraud and abuse space , um, in enforcement and with respect to, you know, other developments that could ultimately affect enforcement, things to think about. And, and yet there's still so much unknown, or not so much unknown, unknown probably isn't quite the right word, but there is still so much gray area in healthcare rules and regulations generally, and screwing up on, even if they're not fraud and abuse provisions screwing up on those can lead to a fraud and abuse problem. Um, but, and a lot of , I know Congress and CMS really, I think they do try to give clear rules. The problem is once you take those rules and you start applying them to real everyday life , it's not as clear as to exactly what you're supposed to do, because they can't take into account for everything. So I think our clients are gonna continue to struggle in various aspects of how do , are we supposed to do this? What exactly are we supposed to do? What's in, what's out? And I think, and I think even in like in value-based arrangements trying to move forward into that, I think there's been some, some hesitancy by clients to move into that because they're not entirely sure what it means that they can do. And , um, maybe the rules seem, seem overly onerous or, but I think there's also just an element of not being sure. And so I think for all of uncertainty, which all of our clients face day in and day out, I would just give the advice of, you know, figure out what you think the rules are and where, and then document them and make sure, and , you know, for posterity so that you can go back and revisit that when your business people say a year from now, exactly why are we doing it this way? But also so that if you get a subpoena or a CID um, about something two years from now, three years from now, the decision makers may not be there anymore. And so it's, and , and even if they are good chance, they'll have forgotten exactly what they were thinking at the time. So I think it's particularly after the super value decision, I think that really just underscored the importance of when you're in a gray area, make your decision, get good advice, get input, but then once you've got that input from your lawyers and your compliance people, document the decision you're making and why you're making it and save that, because that's gonna be potentially important for , for you to be able to defend yourself later.
Speaker 3:Yeah, that's all great advice, Laura. Um, I did , I would only, yeah , I think that's why we all have it . It's a challenge in this area. Um, and I think why education's so important, this would not be the year I would take off from, from staying in the now and, and staying educated if you work in this, in this space. And, and I think it's important to develop education internally to continuously remind people of these rules because it's, they're very easy to , uh, to kind of lose , uh, to lose some of that , um, um, knowledge over time and as we've seen transition with , in healthcare organizations over in recent years. So education's critically important. Um, and, and thanks everyone for listening into this podcast as an opportunity to stay educated. Uh, thank you so much for your time today. Uh, thanks , uh, to all of you that tuned into our podcast. Uh, thanks to Laura Lemley Weidenfeld for being the guest. Our guest today. Uh, please look for our other podcasts. Um , we've recorded a number of recently that have been , uh, issued , uh, one on that super value case , uh, one on False Claims Act, settlement trends , uh, a recent podcast on financial analysis. And we have more coming , um, in, in the upcoming months. Uh, we're always looking for volunteers within the healthcare fraud and abuse practice group. Uh, please reach out to me if, if you'd like to get involved or any of our vice chairs , uh, reach out to me on LinkedIn , um, and tune into future podcasts , uh, in this space. Thanks for tuning in and have a great afternoon.
Speaker 4:Thanks, Joe . Thanks for listening .
Speaker 2:Thank you for listening. If you enjoyed this episode, be sure to subscribe to a HLA speaking of health law wherever you get your podcasts. To learn more about AHLA and the educational resources available to the health law community, visit American health law.org.