In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Partner, Goodwin Procter, speaks to Charles Oppenheim, Partner, Hooper Lundy, about recent developments to the Stark Law one year after sweeping new regulations were enacted in January 2021. They discuss issues that are new to the health care delivery system that remain unaddressed by the Stark Law regulations, challenges that clients are facing related to COVID-19 waivers, and how clients are navigating the new value-based arrangement exception. Charles is co-author of the brand-new Seventh Edition of AHLA's The Stark Law: Comprehensive Analysis and Practical Guide. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Partner, Goodwin Procter, speaks to Charles Oppenheim, Partner, Hooper Lundy, about recent developments to the Stark Law one year after sweeping new regulations were enacted in January 2021. They discuss issues that are new to the health care delivery system that remain unaddressed by the Stark Law regulations, challenges that clients are facing related to COVID-19 waivers, and how clients are navigating the new value-based arrangement exception. Charles is co-author of the brand-new Seventh Edition of AHLA's The Stark Law: Comprehensive Analysis and Practical Guide. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
The following message and support for a H a is provided by Berkeley research group, a global consulting firm that helps organizations advance in the areas of disputes and investigations, corporate finance, and strategy and operations BRG helps clients stay ahead of what's next for more information, visit think brg.com.
Speaker 2:Good morning. Good afternoon. Welcome to another edition of the American health law association for Anies podcast. I'm your host, Matt Wetzel today, we're talking with Charles Oppenheim at the law firm of hoop Lund based in Los Angeles. Mr. Oppenheim, recently co-authored and released the seventh edition of his American health law association, treatise the stark law, a comprehensive analysis and practical guide, which has been updated, revised, and expanded to account for the array of Reese changes to the physician self-referral or stark law. This includes the 20, 20 value-based and care coordination rules. We're gonna spend a little time today talking with Charles about the updated book and the latest stark law developments. Charles is co-chair of hoop lending's business department. His practice includes all aspects of transactional operat and regulatory health law, including mergers and acquisitions, affiliations, joint ventures, and the formation of integrated delivery systems among Charles's clients are many of the largest healthcare companies and hospital systems in the us. And he's a nationally recognized expert on anti kickback statute in stark law issues. He's got recognized expertise, healthcare gain sharing, pay for performance clinical co-management agreements. And he also creates and implements compliance programs and investigates compliance issues. Charles welcome, you know, Charles, you just released the seventh edition of the HLA stark law, comprehensive analysis and practice guide. You know, I think one of the things that, um, you know, Phil would wanna hear about a little bit is what's new to the seventh edition of the book and, uh, what can, what can readers expect when they, when they get their copy?
Speaker 3:Um, well, there's,<laugh> the, the short answer is there is a whole lot that's new. I mean, the, the new regulations that came out and became effective on January 9th, 2021 are probably the most sweeping, uh, changes to the stark regulations. Um, you know, kind of almost from the inception, I would say, um, in, in many different ways, uh, one, one of the way, one of the ways in which they've really gotten a lot of the most attention and I think of great interest to a lot of, a lot of clients are the new value based arrangement exceptions. Um, and so those are, those are designed to allow people to put together sort of innovative financial relationships with physicians that are designed to increase quality and control costs and improve patient access in a new value based world. And they're designed to sort of bring down some of the barriers that the traditional stark exceptions represented to, um, folks who are trying to do those types of arrangements. And that's, that's gotten a lot of attention and a lot of, um, it's a focus for a lot of clients that I interact with when they're, um, looking at ways to take advantage of the, of the new possibilities presented by these regulations.
Speaker 2:Absolutely. No, the change is pretty, um, pretty driven. Um, are there any sort of, you know, highlights that you'd wanna call out for folks?
Speaker 3:Well, I think what distinguishes this, well, not just this edition, but this book and the, you know, altogether from a lot of other stuff, is that it really, it goes kind of beyond the basics, the basics of just sort of explaining, you know, the law says this, the law says that the law says the other thing, and we really try to analyze how, how the law applies in real life situations that we see all the time that we advise clients about and point out some of the trickier parts, uh, of, of the law when you're applying it to real situations. And we try to offer an abundance of practical tips, um, and advice to clients on, on how to steer clear of the, of the landmines that are out there. Um, so, so I think that's, that's one of the things that really has always distinguished, um, this, this book from a lot of other materials that are out there
Speaker 2:Sort of more the practical, uh, you know, downstream consequences of behavior and actions and thinking through things in a realistic way. Um, you know, just as a, as a health lawyer that works with, uh, you know, all, all manner of, of healthcare clients. I know that's so important and, and practical, especially, you know, when you're dealing with something like the star law, which can be quite, uh, complicated. Um, Charles, what, what drove you to launch this book so many years ago, I've been enjoying reading about, uh, about this book and tell, tell me what, uh, got this started so long ago.
Speaker 3:Well, you know, I, I started dealing with the stark law kind of, almost from the beginning when the law was first, uh, enacted and, and, um, you know, I was an associate at the time. So I was kind of just at that at right stage in my career for kind of the senior partners in my firm to say, well, this looks like an important new area. Let's stick some eager young lawyer into this and, and make sure that, that, that, that associate learns it. And, you know, then we have somebody to go to when we have these issues. And so I've been, I've been doing this stuff since, since the early nineties. And, um, the first edition of this book came out in 1998 and it was to some degree, it was a byproduct of an, of an, of an extensive comment letter that I submitted on behalf of a client to CMS commenting on the first set of proposed regulations, identifying a lot of issues in those proposed regulations, identifying things that, uh, regulations didn't address that were problem area of the statute itself. And I basically sort of took that long comment letter and then just built it out with real life, examples of things that I had analyzed for clients where the law was really tricky and complicated. And non-intuitive, and I just sort of built that out together with, you know, um, additional materials and sort of, and I, I saw I saw a need for it. You know, I, the other that I saw were out there on stark were just, you know, just introductory stuff that just said, you know, Hey loss says a, B and C, and I wanted to take it further than that, and really help people, um, who are struggling with applying to law on a day to day matters.
Speaker 2:Well, certainly, um, that's a, it's a great background for how this, uh, origin needed. And, and I can certainly see how the practical element came into play as well. Given the comment letter, uh, that you'd originally written, uh, you know, uh, you mentioned unaddressed issues, problem areas, certainly they're different now than they were, uh, in 98, certainly they're different now, uh, than they were when Pete stark first authored the law in the eighties. Um, what would you say are some of the unaddressed issues that are still being faced, um, or that are new, uh, to the healthcare delivery system, uh, that are unaddressed into the current stark, uh, regs or even the revised regs from earlier this year?
Speaker 3:You know, some of, some of, and I, you know, it's strong to say that they're unaddressed are some of the them are addressed and sometimes even addressed repeatedly, but they continue, um, to be very challenging when you actually start trying to apply'em in real life situations. And, and it's interesting I'm working through right now, some issues, and these come up a lot, a lot of hospitals for example, have hired, um, mid-level per practitioners, you know, nurse practitioners, physician assistants, and they hired them to help with inpatient care and, and patient throughput and an issue that keeps coming up again. And again, is when that happens are, should, does that somehow then create a stark issue because as you have community physicians who, you know, are otherwise just medical, medical staff members on the hospitals, medical staff don't have a financial relationship with the hospital, um, per se. But if these, if these community physicians are seeing inpatients in the hospital, are the hospital employed, mid-levels effectively free services, those physicians, because they're helping to do stuff. The physicians would otherwise have to have done themselves on their patients who are admitted to the hospital, or, you know, or can you say no, those, uh, those mid levels hired by the hospital are really just helping to deliver a higher quality of care. They're benefiting the hospital, they're benefiting the patient, but they don't constitute a financial benefit to the physicians. And those arrangements can be pretty tricky in fact, intensive to analyze. And I don't think it's that, um, necessarily like the fault of the stark regulations that don't kind of get into that because that, that can sometimes be some of the hardest places where, you know, you're trying to analyze an arrangement and there's not always a clear answer at what point does an arrangement like this, cross the line and have to be considered a financial relationship with the physician, as opposed to not crossing in line and just being viewed as something that creates a high, higher level of care in the hospital.
Speaker 2:Well, I, I think that's an interesting area and, um, it really demonstrates the complexity, not only of, you know, the relationships at issue, but also, uh, the complexity of the stark law and regulations themselves and how they're applied. Um, you mentioned this particular issue, but another question that I have, you know, given your expertise in stark and, and healthcare fraud abuse, what's top of mind for your clients right now, we're at a pivotal moment where, uh, you know, some would say still, you know, in the height of the pandemic, some see us, uh, you know, coming out the end, uh, the, some light at the end of the tunnel. Uh, but, uh, the healthcare delivery system of course, is taken the brunt of, uh, the impact, uh, on co uh, from COVID. Um, you know, maybe besides that, or because of that, what's going on with your clients right now, what are they thinking about and what are they focused on?
Speaker 3:I'm gonna answer that question and keep it kind of in stark land. I mean, obviously there's a lot of other, um, is legal issues that are raised, you know, by responding to the COVID 19 pandemic. Um, but, you know, in stark land, one of the things that we had was, um, we got the benefit of COVID 19 waivers that were issued by CMS in recognition that people needed to do all kinds of things, and they needed to do them very quickly. And, um, sometimes the old stark exceptions and rules were a little bit of a hindrance to people reacting quickly to what they had to do to take care of patients in the face of the COVID 19 pandemic. And so they, they allow people to respond with financial relationships, um, that might not otherwise comply with the stark law. Um, but they got a waiver, um, as long as the national health emergency caused by the pandemic is present. And so a lot of, I, I work with a lot of hospitals and continue to do so on arrangements that are intended to, um, allow sort of services to continue in place and allow physicians to treat COVID patients. Um, but also to care for other patients, given all of the going on now with COVID, um, in ways that may be, um, that may be outside of what would've fit into a traditional stark exception, but are, um, but are taking advantage of the waivers, uh, in order to do that and to facilitate those arrangements. So that's something I spent a fair bit of time with clients on. And one thing that people are thinking about now, as we hope and think that at some point, this thing is going to end is, you know, then of course the waivers will expire at the end of the pandemic and then, um, will have to be mindful of that. And if they've put an arrangement into place, uh, under the waiver, you know, then of course, they're gonna have to figure out how to bring that to a graceful end, um, before, before the, uh, waiver ends. So they don't end up with a situation on the other side of the expiration of that waiver that creates a stark issue.
Speaker 2:Absolutely, absolutely. Just the, the ability to pull back from established relationships that might be working really well. Uh, but, uh, at the end of the day, uh, need to comply with, uh, the stark regs. You mentioned, uh, at the, at the top of this, uh, discussion Charles, the, um, the value based, uh, and care coordination, regulat that came out, where would you say have been sort of the top, you know, areas, um, that your clients are interested in or the top areas that have caused either the most questions or the most concern for your clients and, um, you know, any thoughts on how to address those
Speaker 3:Well? Um, what I've done probably most often for Vivi the stark law is, uh, in, in the value based arrangement, exception arena is put together new arrangements that are intended to fit within the value based arrangement, exception, and provide, um, items, uh, or services to physicians and are patients that may constitute remuneration, but are intended to be in further into a value based purpose and are for, you know, the benefit of a particular target, um, patient population. And, and so people have been putting together these sort of innovative arrangements and taking advantage of the new leeway provided by these new exceptions. And that's, that's very useful. And if you can cons and, and it turns out that it, it can be easier to create a value based arrangement and a value based, um, enterprise than people realize it doesn't have to be any fancier than just a hospital, um, structuring a contract with, uh, a medical group or, or a number of different independent physicians. And that could itself be a value based enterprise. You know, if it's, if the arrangement they're constructing is to further value based purposes, you know, to improve quality or access or coordinate care for a particular target patient popul. And so it doesn't ha you don't have to form a new organization and draft bylaws and all that stuff. You can do it just with a simple contractual arrangement. And one of the benefits of the value based arrangement when you strike one with physicians, is that it also, um, unleashes a new, uh, a new safe Harbor on, on kickback and civil money penalty statute that allows you to provide patience with, um, with items or services valued up to$500 a year that benefit them and achieve some of the goals of the value based arrangement. So that's, that's an ancillary benefit. That's not directly stark, uh, but it's, you know, kind of, uh, stark adjacent as it were.
Speaker 2:Absolutely. Absolutely. Let's talk about the future. What would you say Charles are your top three predictions for, uh, health law for fraud abuse for enforcement, uh, uh, that we might, uh, be, uh, be privy to over the next, uh, 12 months.
Speaker 3:Oh my gosh. You, uh,<laugh> um, I, you know, in, in terms of, uh, in terms of all of healthcare, I, I don't know that's a that, uh, but I'm, but in focusing on the narrow, the more narrow subject, I guess, at the stark law, I think, you know, continued enforcement of the stark law, primarily through whistleblower false claims act cases, you know, is, is a trend that just continued to increase. And I believe that there will be more of those. I think, um,<affirmative> a, a lot of those are just based on sort of conventional arrangements that the whistleblower fields are not, um, are not compliant with stark. Often the, you know, the heart of the allegation is that the physicians are, are, um, do not have a fair market value arrangement. For example, they're either overpaid for what they do or are undercharge for what they're getting. Um, those, those continue to get traction. And I, I would expect to see, you know, in, in, in that vein, some similar lawsuits that start to have more of a COVID flavor, you know, you might see people challenging arrangements that were done under the auspices of the COVID waivers that I mentioned a few minutes ago. And you could see whistleblowers challenging that and saying, no, you didn't really meet the waiver, or no, you didn't need the waiver. And so therefore you shouldn't have tried to use it, or, you know, um, other kinds of arguments that whistleblower would make. Um, the other area, I guess, COVID related is, um, just COVID enforcement in general, I think has started to, um, predictably, you know, starting to, to take shape out there. And the government is cracking down on arrangements that they think, uh, represent providers exploiting the COVID pandemic, um, for wrongful ends,
Speaker 2:Charles Oppenheim. Thank you so much for joining us today. Uh, this has been so terrific. Thanks for coming on and, and sharing your insight with, uh, the HLA members.
Speaker 3:Oh, thank you. Thank you so much. Uh, it's it's it is absolutely my pleasure. This
Speaker 2:Has been another addition of the American health law Association's fraud abuse podcast. I'm your host, Matt Wetzel, and we'll return next month with another episode. Thank you.
Speaker 4:Thank you for listening. If you enjoy this episode, be sure to subscribe to a H L a speaking of health law, wherever you get your podcasts to learn more about ALA and the educational resources available to the health law community, visit American health law.org.