AHLA's Speaking of Health Law

Top Ten 2025: Fraud and Abuse Issues to Watch

• American Health Law Association

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Based on AHLA's annual Health Law Connections article, this special series brings together thought leaders from across the health law field to discuss the top ten issues of 2025. In the third episode, Joe Wolfe, Attorney, Hall Render Killian Heath & Lyman PC, speaks with Ilene Albala, Partner, Goodwin Procter LLP, about how the new administration could reshape the health care fraud and abuse landscape. They discuss potential impacts on fraud and abuse enforcement and the False Claims Act in particular, possible challenges to the constitutionality of the False Claims Act, and the Anti-Kickback and Stark regulatory outlook. From AHLA's Fraud and Abuse Practice Group.

Watch the conversation here.

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Speaker 1:

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Speaker 2:

A HLA is pleased to present this special series highlighting the top 10 health law issues of 2025, where we bring together thought leaders from across the health law field to discuss the major trends and developments of the year to stay updated on all the major health law news. Subscribe to ALA's New Health Law Daily podcast, available exclusively for premium members@americanhealthlaw.org slash daily podcast .

Speaker 3:

Uh , welcome everyone to today's American Health Law Association podcast, where we'll be talking about key healthcare fraud and abuse issues to watch for in 2025. Uh, today my guest is Eileen Vela from Goodwin Proctor. Eileen and I have worked , have collaborated on a handful of webinars in the past, and , uh, she always brings great perspective on healthcare fraud and abuse trends , uh, especially trends related to the False Claims Act and litigation , um, and investigations related to the False Claims Act. Uh, Eileen and her colleague , uh, Jordan Morin recently authored the fraud and Abuse Issues to watch section of the Top 10 issues in the January, February , February edition of the ALA's Connections Magazine. It's a, it's a great read. Um, it's always a good read, but this one in particular , uh, really captures the, the evolving , uh, issues that are emerging in healthcare, and it's as, it's as active as it's ever been. And so , uh, the article is excellent. Um, today's , uh, podcast is brought to you by the American Health Law Association's Fraud and Abuse Practice Group. Uh , I'm in my final year of chairing the Practice Group, and our mission is to help our members stay informed about healthcare fraud and abuse and compliance issues. So we focus on developing , uh, webinars, publications , um, and other content to educate our members on important compliance developments and enforcement trends in the healthcare industry. If you're not a member of the Practice Group , uh, please consider joining us. Um, uh, we we're always looking for new members and new energy and , and ways to get new people involved. Um, so, but before we get started with the back and forth with Eileen , um, could you go ahead and introduce yourself?

Speaker 4:

Yes. Thanks so much, Joe. I'm delighted to be here with you today. So, as you mentioned, I am Eileen Alba. I'm a partner at Goodwin Proctor in our Washington DC office , uh, and here in our nation's capital . As you mentioned, Joe, we have a a lot going on right now. So my practice focuses on healthcare and life sciences, government enforcement, and False Claims Act defense. Prior to joining Goodwin, I was an assistant US attorney in the Eastern District of Virginia, where I investigated healthcare fraud. And today I help clients navigate the alphabet soup of enforcement and regulatory bodies in the space from DOJ to H-H-S-O-I-G, to the F-D-A-D-E-A and so on.

Speaker 3:

Great. Uh , again , thanks. I Eileen. Um, and my name's Joe Wolf. Again, I chair the , uh, ALA's Healthcare Fraud and Abuse Practice Group. Uh, I'm a shareholder at Hull Render and I lead Hull Renders Healthcare Regulatory Practice Group. Uh , my day-to-day work focuses on , uh, physician compensation arrangements, stark and kickback compliance. I do a lot of work in, in the new value-based enterprise space , um, and in government investigations , um, and, and, and do that work nationally. Uh, and , and love , uh, the opportunity to collaborate with someone like Eileen today and, and, and, you know, learn from her , uh, as well. Uh, you know, first of all, I already touched on this, but great job on the Connections article. Um, if you pick up that article, anyone listening in , um, it highlights the top 10 issues in health law for 2025. Um, in the article, I, Eileen discussed really, and I , uh, again, don't wanna steal her thunder, but how the next four years could reshape the healthcare fraud and abuse landscape. And I agree with her on that. Um, for years we've been combating healthcare fraud , um, and that's been a critical priority . That's been a critical priority of the DOJ . Um, now it's a bit of wait and see on whether that remains a priority. And I think Eileen's gonna speak to that. Uh, there's some uncertainty the next , uh, our current administration now could shift enforcement priorities or , and , and cut and reallocate resources. Uh, there could be a remaking of the legal and regulatory , uh, landscape. Now with, with Robert F. Kennedy as the new secretary of HHS and, and Dr. Oz leading CMS. Um, it's, there's, there's obviously , uh, opportunities for , uh, uh, change , um, and likely will be change. Um, and as, as Eileen talked about in the article, healthcare front abuse enforcement is largely driven by the False Claims Act. And it's, you know, it's , it's kean provisions are and , and evolution. There is a big topic. Um, relators are , are still driving , um, enforcement in this space. And as, as she's discussed , will discuss, there's been an uptick in investigations. And , um, everything we're seeing just speaks to and , and previews a really active , uh, healthcare environment related to the False Claims Act. And so a lot of , I think a lot of the discussion we're gonna have today is going to be focused on the False Claims Act. Um, and, and we will touch on some other developments, but that's why I'm so excited to have Eileen , uh, uh, to talk to today . So , um, Eileen, you know, let's go to the first question here. Um, it , it does timestamp us a bit. We're a few days into the new , uh, Trump administration now , um, as you look at 2025 and beyond , um, what are you seeing so far and how might that impact the enforcement space and how the False Claims Act is handled in particular?

Speaker 4:

Yeah, thanks, Joe. So I think the word I would use is whiplash. There's , uh, a lot going on already. And, you know, for context for the , the viewers I served at the Department of Justice under three administrations, Obama, Trump, and , uh, the first , uh, chunk of Biden and the second Trump administration already feels very different. And I, I think, I think our viewers are sensing that as well. So the biggest change that I'm seeing is that, you know, we're barely a weak in, and there's already a real flurry of activity that speed was not there , uh, during the first administration. And a lot of that activity , uh, appears to be aimed at thinning the federal government and namely shrinking the DOJ , or at least certainly shifting its priorities. Anecdotally, I know several prosecutors who are already receiving letters asking them or telling them to leave , uh, or shifting their work , uh, from, you know, one area of DOJ to another, such as immigration, for example. So what does all of that mean for enforcement in the fraud and abuse landscape, and specifically for False Claims Act enforcement, which I follow quite closely, as you mentioned. So, again, we're only, you know, days in, so some of this is, is speculation, but, you know, the natural consequence, of course, of a significantly smaller DOJ , at least from a fraud perspective, it's going to result in cases that are either not brought or investigations that, that really linger. I , I, I do think you're going to see a situation where , um, you know, and, and I , I know I've, I've discussed this with, with many of my , uh, current clients and past clients as well, there is often frustration that , you know, the speed these cases can take quite a lot of time. And so I do have a number of questions, you know, if and when we lose trial attorneys and , uh, AUSAs line attorneys who are working on these cases, you know, what does it mean? I do think that cases that are already, are still high priority , uh, for even this administration from a fraud and abuse perspective, will likely continue to, to remain that way. Uh, but I, I do think that we'll, we'll see some sort of, you know, not insignificant impact on investigations that are, that are ongoing right now. The Senate Judiciary Committee is voting right now, and that really does, does date us a bit. Um, but they're voting right now on Pam Bondy's nomination to be Attorney General. I, I think it, it looks like, you know, she will be confirmed and, and be our next Attorney general. But I did want to highlight that because Senator Grassley presided over her nomination proceedings, and perhaps unsurprisingly to those of us , uh, who are really familiar with Senator Grassley's outspoken role with respect to the Fr False Claims Act. You know , he was really focused on this during her proceedings. And, you know, of course, Senator Grassley is considered to be the architect, right, of the 1986 FCA False Claims Act amendments. But nonetheless, it really was quite notable that, you know, he focused her on, on the False Claims Act. And these, these questions in that first, you know, hour of her , um, five, almost six, you know, plus hour confirmation hearing. So it, you know , it took up, took up space and, and early on , um, in those hearings. And he asked her specifically about her commitment to defending the constitutionality of the False Claims Act if confirmed. She responded that of course, she would defend the constitutionality of the FCA, that she understands the importance of whistleblowers , uh, the FCAs protections. And in her words, the quote unquote money it brings back to our country. And in , and indeed, it, it has brought a significant amount of, of money back , uh, to, to the us . It was interesting, however, and I , I went back and, and replayed this , uh, back and forth between Senator Grassley and , uh, and Ms . Bondy. And it was interesting to note that he also asked her specifically if she would ensure the appropriate staffing and funding levels necessary to prosecute False Claims Act cases. And that's a question that she, she didn't directly address. At least not that part of the question. So I think at the end of the day, Joe, you know, time, time will tell.

Speaker 3:

Great. Uh , and thanks, thanks for that, that , uh, really thoughtful answer. Um, you know, Eileen, aside from, you know, his legacy and history with the False Claims Act , um, from your perspective, why would Senator Grassley be so interested in understanding , uh, the new Attorney General's views as to defending the constitutionality of the FCA? You know , what do you think is happening in the current case law that would bring doubt to the const, to the constitutionality of the, the False Claims Act?

Speaker 4:

Yes. No, that's a, that's a great question, Joe. So, you know, Senator Grassley's question to Pam Bonde during her , uh, nomination hearing, it was not merely an academic question asking her about the constitutionality and, and whether she would defend the False Claims Act, it's quite timely. So on September 30th , uh, of 2024, a federal judge from the Middle District of Florida issued a groundbreaking decision, invalidating the Ketan provision of the False Claims Act. So this was the decision in Zov that found that a relator bringing a Keam suit qualifies as an officer of the executive branch who is improperly appointed in violation of the appointments clause of Article two of the US Constitution over objections from the government, which actually had declined to intervene in the underlying KET tam . The court dismissed the case with prejudice on the basis of its constitutional holding. So this decision will likely be appealed , uh, to the 11th Circuit and could ultimately be decided by the Supreme Court, which we're all watching. I'm certainly watching because three justices , uh, in Polanski , uh, justices Kavanaugh Barrett and Thomas have already questioned whether the false claims acts . Ketan provision violates Article two . So I fully expect to see companies, defendants raising this issue in ke tam suits from here on out. So his, his question is, is quite timely. Let me ask you a question for a second, Joe, if that's okay. So, I know , uh, that you do a lot of work in the anti-Kickback and Stark space, and you mentioned the appointment of RFK Junior and Dr. Oz. I'm curious to know, do you expect them to remake the , uh, kickback or Stark regulatory landscape? What are you watching in this space?

Speaker 3:

Yeah, thanks Eileen. And, and we are mostly here to , to listen to you, but I'll , I'm happy to answer a couple questions as well. Um, uh, you know, this is not the first Trump administration, and so we have , um, witnessed already how the, the first Trump administration handled the Stark Law and the Kickback Statute, and in many ways , um, they, they did not look at scaling it back. They actually revamped it and built in some , um, very innovative components related to, to value-based arrangements. And so, when I go back in time, and I think about the last administration, if that's the most telling future , uh, we, we saw innovation , um, under the Stark and Kickback. We saw , um, a relaxation of some of the , um, some of the, the more rigid , uh, components of , of the , the Stark and Kickback exceptions and safe harbors to provide a bit more flexibility. And that was very welcomed that last time around. And so, you know, I'm hoping we see more of the same , um, an interest in innovation, an interest in, in finding ways that we can transition , uh, payment models and, and, and how healthcare contracting aligns with , uh, concepts like care coordination and enhanced quality and , um, uh, cost savings to , uh, payers , whether it's the government or, or private payers , um, to transition us from healthcare payment and delivery based on volume towards value. So , um, you know, that's what I'm hoping to see from a regulatory standpoint. Um, I do think from kind of at, at the ground level , uh, because of the , uh, ongoing pipeline of , of FCA cases involving Stark and Kickback , we're gonna continue to see , um, these cases , uh, being unsealed , um, just along that normal pipeline. I , uh, you know, we're, we continue to see that. We've seen some large , um, settlements, especially , uh, in my area around physician compensation arrangements. I think we will , uh, continue to , uh, see that as well. And so , uh, we kind of hopefully are seeing innovation on the regulatory side. Um, and then , um, you know , maybe more of the same on the enforcement side. I say that because there has been no slowdown , um, in government investigations , uh, everyone I'm talking to, and in my own experience seeing , uh, a a steady , steady stream of, of CIDs , um, and investigations still continuing , we'll see how that's impacted by the change in administration. But , uh, because of that kind of lag time on the pipeline of cases, I think we'll still see that. Um, so appreciate the , the question. Um, I think we could wrap up maybe with a , with a final question for you , uh, Eileen, when you , uh, do , do you just have any final thoughts for our audience , uh, and looking back at 2024, looking forward to 2025, some things to watch out for or just some final thoughts?

Speaker 4:

Yes. No, I appreciate that, Joe, and, and, and I did , um, I did wanna also pick up on, on something you just said, which is, which is that lag time? And that that's absolutely the case. So as long as the False Claims Act remains constitutional, I think that we will absolutely continue to see enforcement in this space. And, and the reason is you will have relators, right? You'll have these ke tams that will just continue , um, and they continue , um, in , in , in number. Um, so they're not going away, and the judiciary is not gonna let them sit there. Now, you know, some, some districts , uh, let things linger for longer. I , you know, I come from EDVA from the Rocket Docket where, you know, as an A USA, we had no more than, you know, nine months , um, to, to , uh, investigate even the most complex of, of healthcare fraud matters. Some districts, you know, they, they sit for longer, but the bottom line is they need to keep these moving. And you have a , um, a , a very large and , um, sophisticated plaintiff's bar relators counsel who will continue pushing these. So even if we see a , uh, a slimmed down version of, of , um, you know, civil frauds, for example, I think we absolutely will continue to see these investigations. And to your point on the , on the lag time, they, they take years to , uh, to move forward to investigate, to come to a resolution. And , um, we have seen a record number of civil investigative demands issued , um, in this past year. And so that process and those investigations will, will continue to play out. I I just think that, you know, if if you have only , um, you know, one, one attorney working on, you know, hundreds of cases, I just think the natural consequences that I , I think we probably will see some that will, that will linger, but, but time, time will tell enforcement will continue. Absolutely. I would also just say , um, that on the False Claims Act front, let's also not forget just yet about super value . So you've heard me say this before, Joe, but you know, while I don't believe that the Supreme Court's recent decision in super value was earth shattering, the full impact of that decision is really still playing out. And the big takeaway here from my experience dealing with DOJ , is that they seem to view super value conveniently , um, as a way to apply additional force additional pressure during the negotiation stage. And indeed, a subjective entra standard is more likely to present questions of fact for a fact finder , potentially making it more difficult to defeat FCA claims early in litigation by challenging the sufficiency of plaintiff's, plaintiff's er allegations. And so that's an area , uh, that we're watching quite closely as well. But , uh, so much going on in this space, and , um, such a pleasure talking with you today, Joe. Thank you.

Speaker 3:

Great . Uh , thanks Eileen. And, and thanks. You know, so much for your time today. I know it takes , uh, you know, it , it , it , you do have to, you know, one, take time out of your day, but also prepare and, and try to synthesize everything going on into a short discussion. And I really, really appreciate that. Um, I appreciate everyone for listening in to today's podcast as well. Um, we're always looking for, for volunteers within the A HLA Fraud and Abuse Practice Group , uh, pre please reach out to me on LinkedIn , um, if you'd like to be a guest in a future episode. Um, we have a couple in the pipeline, but we're always looking, looking for more , uh, watch for , uh, recent podcasts that we, we've published. Um, we have , um, a couple of, like I said , uh, uh, future, future podcasts in the pipeline. Watch for those , uh, as well. Um, we'd love to get you involved. We'd love to get you in the mix. Um, thanks again, Eileen, for , um, for being here. Thanks everyone for tuning in and have a great day.

Speaker 5:

Thanks so much.

Speaker 2:

Thank you for listening. If you enjoyed this episode, be sure to subscribe to ALA's speaking of Health Law, wherever you get your podcasts. To learn more about a HLA and the educational resources available to the health law community, visit American Health law.org.