Matthew Wetzel, Partner, Goodwin Procter, speaks with Laura Laemmle-Weidenfeld, Partner, Jones Day, about some of the key health care fraud and abuse trends from 2022 and what to expect in 2023. Laura is the author of the recent 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.
Matthew Wetzel, Partner, Goodwin Procter, speaks with Laura Laemmle-Weidenfeld, Partner, Jones Day, about some of the key health care fraud and abuse trends from 2022 and what to expect in 2023. Laura is the author of the recent 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.
This episode of A H L A speaking of health law is brought to you by a H L A members and donors like you. For more information, visit american health law.org.
Speaker 2:Good morning, good evening. Welcome to the American Health Law Association, speaking of Health Law podcast. I'm Matt Wetzel, partner with Goodwin Proctor, based in Washington DC and I'm your host for today. Um, joining us today is Laura Weidenfeld, a partner in the healthcare and life sciences practice at Jones Day in Washington, dc And Laura is the author of The Legal Issues in Healthcare Fraud and Abuse 2022 Cumulative Supplement to The Fifth Edition, which has just recently been released by A H L A. Laura is a partner, as I mentioned at Jones Day. She provides practical compliance guidance on Medicare and Medicaid fraud and abuse issues defending against investigations and litigation brought by DOJ, US attorney's offices, hhs, O I G, state Attorneys General, and other government agencies. Clients navigate challenging compliance issues, including analyzing arrangements under the Stark anti kickback statute, internal investigations and self-disclosure. Uh, earlier in her career, Laura was a trial attorney in the fraud section of the DOJs Criminal Civil Division, rather, where she conducted healthcare fraud investigations and litigation matters brought under the False Claims Act. And well, thanks so much for, uh, joining. Um, and, uh, and, and thanks also for, uh, producing the, um, 2022 supplement, um, to the legal issues in healthcare fraud abuse book. Lawrence, really a tremendous work here that you've done. And, you know, we really wanted to just chat a little bit about the new supplement and what's new. And then of course, you know, we're at the start of the new year and what do you think is sort of on the horizon for 2023, maybe some prognostications if we can convince you to do that. And then, uh, you know, sort of talk about, uh, uh, some of those hot topics, if that sounds good to you.
Speaker 3:Sure. Just go easy on me.
Speaker 2:Okay. Okay. Will do. Well, maybe we'll just get started here with, um, the new 22 supplement. Of course. Um, it's the cumulative supplement to the fifth edition of that book, which is pretty tremendous to think about, um, all the, uh, work that's gone into that. Tell us about the 2022 supplement and, uh, what are the PR sort of primary updates and what do you think folks should be really focused on?
Speaker 3:Sure. So, um, you know, it's funny, the, the, the 2022 supplement came out in the fall, and so it is the most recent thing and we're promoting it now, but, um, I'm already working on the 2023 supplement because all the work has to take place in the beginning of the year, and then there's a long editorial process. I mean, it takes a while to put it together, frankly. And then there's an editorial process and then it actually has to get published. And so it takes the majority of the calendar year to get it out. So although it just appeared, you know, and was available for, um, you know, it's used for a number of law school classes as I understand. Um, and, you know, of course generally available to a H L A members in the fall. All of the work happened in the beginning of the year. So to me it now feels like ancient history and I'm, I'm, you know, starting to, starting to pivot to, okay, I need to be putting together 2023. Um, so<laugh>, it feels like a lifetime ago that I put it together, but, um, nevertheless it, so it really was just as it is each year, just a cumulative sort of gathering of all of the main things that have that, you know, hit my radar and hit ALA's radar as, um, being worthy, you know, being significant worthy of notice something for people to sort of, you know, make sure that they, that they brush up on. Um, I, as I'm, when I'm doing it, I think of sort of two pieces of the audience. I think of folks like us who are practitioners who, you know, are dealing with healthcare fraud and abuse issues every day and have been doing so for many, many years. But sometimes we may not remember what was it that happened last year, um, you know, may just want sort of a refresh and may wanna just be able to delve into, okay, for this particular issue, what all is out there and what should I be thinking about, just making sure I'm not missing something. So, you know, trying to make sure that at least the highlights get into the book. I'm sure I, I'm sure in some people's view, I may miss a couple and I try really hard not to, but there's so much going on. It's, it's hard to keep capture absolutely everything, but I do my best. Um, but then I also think about all of the law students who are using these books as well and, you know, trying to make sure that they, as they're going through this for the first time, maybe hearing about these issues that, you know, they're getting all the historic information from the, from the Fifth Edition main book, but then also making sure that they're somewhat up to speed so that they understand how these issues are developing cuz they often have developed pretty quickly. Um, and so the, you know, the fifth edition came out okay, I don't remember the exact year, um, but, but just a few years ago, not that long ago, but in some cases the case laws has, you know, there have been significant case law developments or significant other developments. Um, you know, when it first came out, telemedicine was not much of a thing at all, at least when I was, when I was writing it. Um, and now that's big and huge. So telemedicine is definitely one of the things that we added to the book this past time. That was one of the, the big, the big topics that we added. And then, you know, really just updates on, you know, advisory opinions that have come out of hhs, o i t over the, you know, over, so for the 2022, it would be the ones that came out in 2021. So now I'm going through the ones, ones that came out in 2022 for next years. Um, so, you know, just trying to do an update of those, not a big in-depth, you know, diatribe on each one of them, but just trying to hit the main things so that, you know, some, to some extent it's always hard to strike a balance between how much detail do we put into the original book and the supplement, and then, and how much do we just reference things. So there's people who are really interested, they know where to find it and go do a deeper dive. Um, so that's the balance. There's not enough time or paper to be able to do a deep dive into absolutely everything. Um, if it were, that's all I would be doing full-time, and that's certainly could be done, but not, not by me. Um, so, so you know, advisory opinions, recent court decisions that have come out, um, you know, try to focus primarily on the circuit court decisions, but, you know, some of the district court decisions are worth getting thrown in there too. Um, and then also trying to capture significant settlements because, but as we know, many cases don't actually get litigated and it's important to, a lot of the settlements can tell us, you know, they don't, settlements are not precedent, contrary to what some people may sometimes think or try to tell us, but they're still important for practitioners like us to get a sense of, well, what's out there? What is DOJ looking at today? What do they think is important? What positions are they taking? You know, for example, the kickback statute, huge focus of lots and lots and lots and lots of settlements today. And some of those cases take, um, DOJ is taking, um, pretty aggressive positions. And so I try to work in a few of those to demonstrate, and this is, you know, this is, I think primarily for practitioners like us who are dealing with this, but to some extent the law students as well of, you know, be aware that this is an issue, this is a hot button issue, and DOJ is getting pretty aggressive and here are some of the, you know, some of the allegations that un that were underpinning some of these settlements can be useful for us just to get a sense of where they're headed and where they're going. So, um, you know, those are kind of the main things that I hit on.
Speaker 2:Absolutely. Well, and Laura, I have to say, uh, you know, a couple of points in response to that. First, I, I keep the fifth edition and the 2021 supplement and now the 2022 supplement on my desk and reference them regularly for some of the very reasons you mentioned. I mean, the historical, uh, background information despite having been practicing in this area for almost 20 years now, that rereading and reabsorbing, that historical information is so informative for my guidance to my clients and just understanding that, you know, there's, well, there's now, we talked about this I think a year ago. There's, you know, now 50 years of history with the anti-kickback statute, and then of course the other fraud and abuse laws, uh, that come into play have been around for quite some time as well. And just getting a sense of that evolution can really give some good, um, context to guidance. And then, as you mentioned with the settlements and the, the directional points that they provide, again, not precedent, uh, but certainly, you know, understanding kind of where the, you know, hot zones of enforcement, so to speak, and, you know, what are some good risk mitigation tactics, et cetera, um, that can be gleaned from that. And so I, I certainly, um, you know, applaud you and commend you on pulling together this information, uh, in such a, you know, uh, uh, a really tremendous, uh, way. It's an easy reference to get through. And frankly, I really actually enjoy reading, uh, the, the supplement. But, you know, as you know, uh, you know, I'm a practitioner in this space. So much of my life revolves around this. Um, but I wonder if we could talk a little bit about, um, some of the sort of highlights from the 22 supplement that you think are, you know, say the top two or three, um, most critical updates, obviously the dive into the value-based safe harbors and some of the updates on the advisory opinions. Where would you point folks, um, if they ask, you know, what do you think are the top two or three issues from, from the supplement?
Speaker 3:Hmm. I'll confess sort of 2021 and 2022 blur together in my mind. Not just because both were done during Covid<laugh>, but also because, um, as you said, the, the, a lot of the value-based safe harbors and things were, I think that was technically in 2021, I mean, was written about in 2021, it hit in late. So those regs came out at the end of 2020. Mm-hmm.<affirmative>, um, and I'm talking here both about the Stark Law and anti kickback statute value-based, um, safe harbors and and exceptions. Um, those came out at the end of 2020. Those were included in the 2021 supplement, but the 2022 supplement is cumulative, so it in, so it rolls that information into it as well. So the, the way that these work is that the supplements are, are cumulative in the sense as of after the book was published. So the fifth edition is standalone, and then each supplement as it comes out is a standalone, and then it incorporates what was in the previous supplement. So, um, I know, I know I've even gone back to what I, to the analysis that I did and, and, um, what I'd written on some of those safe harbors and exceptions because that was such a massive change in dir not in direction necessarily, but, um, such a massive change in what we need to be aware of and what we can rely on and what exceptions are available and the, the whole value-based, um, opportunities that are there. And I think that, so I think that that's probably one of the biggest things in the supplements that's not in the book, is the focus on all of those regs that came out, um, in, at the very end of 2020 were effective in 2021 and 2022. Um, so I think that's probably maybe the most important piece, um, because we did spend a lot of time drilling down into each of them. And so hopefully that's helpful for folks. And I know, you know, I know that on the value-based care, that's something that pro various providers and others in the field are still figuring out how to make the most of, um, because there was so much there, folks are still kind of figuring that out and figuring out how that may apply and how they can take advantage of that in ways that they had long since figured out, you know, their context, you know, everybody personal services arrangement, everybody knows how to do that and has known how to do that for a long time. Now. The regs did make it a bit easier by making some changes, particularly under the, any kickback statute, um, safe harbor, you know, making it so that now you don't have to set the, you know, the aggregate compensation in advance. You can just set the methodology in advance. That was super helpful, but that wasn't, once you know that, you know, that it's not a, you don't need to sort of keep consulting where's the, um, you know, the new, the new regs on value-based care I think are, um, worth of reading and rereading and re rereading and, you know, trying to apply that to what folks wanna do and being more creative is more of a challenge. Um, I think the, I had mentioned the telemedicine, I think that's, although there's maybe not as much, maybe not as much substance there yet, um, because it's still evolving, I think that's worth a mention just because I think there's gonna be so much focus on that. I know I spent a lot of my practice in the telemedicine space now where, you know, when I, when I first, you know, about eight years ago when I first started working with telemedicine issues, I didn't even understand exactly what it was, um, right, right. And, and it's evolving and it's lots of different things of course. Um, but it's sort of a, a catchall term for lots of different things. And digital health, you know, is a little broader. And frankly, I think that's where more of us are finding ourselves. Um, think, you know, at this point, pretty much everybody's practice is crossing into digital health in some manner, but that's for, for the enforcement issues. Um, you know, we mentioned, mentioned that in the supplement, we're gonna be mentioning that we're gonna be discussing more in the 2023 supplement. Um, but I'll, I'll get to that later since you'll wanna touch on future prog a little bit. That's not really, that's sort of in between a prognostication and just what's coming in the next supplement, right, right.<laugh>. Um, but I think that, you know, cer it, it's been interesting to watch as the American public has embraced telemedicine. Cause we had to during Covid, and then lots of people are realizing, oh, this actually is pretty darn convenient. And there are many situations where it can be very, very helpful to have it available and, you know, really benefits people. Um, versus there are always fraudsters out there who are trying to take advantage of situations and trying to, you know, find the next way to commit fraud and steal money that that doesn't belong to them. A lot of them, I think, caught onto the, the opportunities of telemedicine before the General American public did. So what we're seeing in enforcement, this is criminal enforcement almost exclusively, um, and we do address this in the supplement, is a lot of the criminal enforcement on fraudsters who are using telemedicine as a way to get money. So, you know, they, they engage in what OIG is called tele fraud. OIG has been very careful to distinguish between what they think is legitimate telemedicine and tele fraud practices. So, you know, we, we do talk about this in the supplement, um, you certainly see it in enforcement still today. And while I think, I'm sure most of, most of the folks who are reading are supplements, um, particularly practitioners aren't generally advising by and large for the most part, their, their practice doesn't involve being asked questions about this, but it's important to be aware of it so that, um, you know, being aware of the big picture is, is important for both understanding how a question that you're getting from a particular client that seems like a very narrow question. What might the context be and what additional questions might you want to ask that you wouldn't have otherwise thought the app, because it may be a different context than you appreciated. Um, and then also looking at for our other clients who, you know, don't, aren't in the Medicare space at all, or Medicare medicaid space or, you know, purely private, often even just self-paced space, but maybe are thinking of moving more broadly, what kinds of issues should they be aware of because the government is viewing things as problematic that maybe in the private pay space isn't, or nobody's thinking about it, but it's important to understand where the government's coming from and where enforcement might be coming from, especially as they're starting to pivot into, um, you know, more into gov federal, federal reimbursement. So I guess I've gotten ahead of us a little bit here, but I think that certainly is worth a, a big mention in terms of what the supplement covers. And I, I do just wanna say one thing, um, in terms of, you mentioned how helpful it's sort of look back at the history and all of that. So the, you know, the original, the, the fifth edition really builds on all the prior editions. I didn't come up with that from scratch. And so it's got this great advantage of, at the time that all these things were going on, like today with the supplement it was being written about by the experts who were putting together those earlier editions, um, you know, David Mattia started it and a bunch of folks on his team and Epstein Becker continued to add to it for years. And so a lot of the value comes out of, you know, where they started and how it has built. That was kind of the foundation. So what I really like about, about being, um, you know, having been able to do the fifth edition and now to do the, the supplements is just being able to build on that so that folks who get the book really have this wealth of knowledge that goes back from the beginning as a, which I think is much, much richer than if somebody sat, you know, if I sat down today to write it all, I wouldn't have all that to say, um, and it would take me forever to do it. So I, um, you, that wealth of information makes this a really unique product in it keeps being added to and updated
Speaker 2:And what a great representation of just the legal profession w at large, right. You know, sort of building on knowledge from the past and, uh, as the law and, and, and regulations evolve, uh, documenting that for future, uh, practitioners so that their practice is just as rich, uh, and comprehensive as yours and as mine is based on our, you know, our, our predecessor's knowledge, so to speak. Um, you know, Laura, we, we talked a little bit about Prognostications 23. Um, you know, maybe there is that little hybrid discussion we could have about, you know, sort of what are you thinking about from 2022 that were highlights that we might expect to see in the, in the, you know, the next supplement. Um, and maybe there's a, you know, one or two of those you'd like to highlight for folks.
Speaker 3:Sure. So let me, since I was talking about telemedicine, let me just close that loop. Yeah. So, um, during this past year, well, so a couple, one point that I made earlier was a lot of, or tried to make earlier was, um, these situations where, you know, involving the, what OIG is calling the tele fraud situation. Most of those, um, the, the alleged conduct occurred before covid. So we're talking about pre covid telemedicine efforts. We're not talking about the development of, of telemedicine in its normal fashion. So, you know, those cases focus on the use of telemedicine as an easy means to prescribe as alleged by DOJ to prescribe DME that beneficiaries didn't want or need, um, you know, testing that they didn't want or need that was terribly expensive. What? But then we pivoted into, into covid and there were a lot of waivers issued so that in situations where ordinarily providers would not have been able to provide the telemedicine services and bill Medicare for them, they have been able to, um, because of a lot of waivers of the regulatory requirements, those are set to end when the PhD ends. We'll see what Congress does. It's gonna be very interesting to see what, what changes Congress makes. They've been making some to try to, to try to ease availability for, um, you know, for beneficiaries, but certainly they haven't gone as far as the waivers have gone, they haven't gone as far as people want to go. Um, but what we're gonna see I think is there's, despite the waivers and despite how easy it was to provide telemedicine services within the rules during covid, I'm sure that the people still tripped over regulatory requirements and OIG more to the point is sure that people would've tripped over regulatory requirements. And so in my conversations with, um, with folks at oig, there's, my understanding is their sense is there are going to be enforcement issues probably more in the civil realm where people just tripped over regulatory requirements even during covid, but we haven't seen those yet because it takes so much time for cases to bubble up. I think that, I don't know how much we're really gonna see from the, during the covid time, but what I think we are gonna see, um, we're gonna see it first in our counseling and then an enforcement is focusing on once the dust settles and we know what the new rules are, presumably they're gonna be new rules, um, helping clients make sure that they, they know what those are and stay within the confines. It gets complicated quickly because you have a lot of state overlays for state requirements in terms of, you know, establishing a physician patient relationship can look different in different states. Um, it can be various diff you know, some states require audio visual, um, you know, concurrent discussions and some don't for some, it depends on the kind of medicine that it is. So there, every state has different rules those layer on to, to the federal cuz Medicare expects you to be following the state rules. And then of course they're Medicaid rules as well for each state. So with all of those, there's a lot to keep track of. It's been really easy during covid because a lot of that was just waived and put on hold. But when we go back to that world of needing to be very painfully aware of your individual state requirements and any other state where you may be providing, trying, wanting to provide services, whether it's a state adjacent to you or whether you wanna have a nationwide network and you need to worry about all 50 states, um, plus DC plus Puerto Rico plus Virgin Islands, plus whoever, um, then you, there's a lot to keep track of and I think there are gonna be a lot of, um, footfalls there that hopefully, hopefully clients will be making sure that they've got the right people on the ground addressing those and keeping them in line and minimizing the, the errors. But, you know, often gross outpaces the ability, you know, folks, staff,<laugh> ability to staff up and make sure that they're staying within the line. So I think there are also gonna be issues and that's why I think OIG is thinking there's gonna be a lot more civil enforcement, not of people trying to go out and break the law, but of people, you know, acting with what they may view as reckless disregard or deliberate ignorance of what the rules are and not staying within the rules. Um, so I think that that's gonna be, we're gonna see a lot more of that in the coming coming time. And in terms of the supplement, OIG did issue a, a special advisory, what do they call it? A special fraud alert this past year that warned the tenor of it was really interesting because it took, it took the approach of warning legitimate healthcare providers about the risks of associating with purported telemedicine companies and gave them a list of, um, kind of red flags that might, might that, that they should be looking for. That standing alone may not be problematic, but should make them pay closer attention to whether in fact the telemedicine company is legitimate and is operating legitimately. So that's something we're definitely gonna be addressing in the next supplement. Um, so that's, you know, probably set enough on, on telemedicine alone now. Well,
Speaker 2:And I think, I mean, just to sort of, you know, highlight your point, Laura, I mean, you know, I think about the telehealth, uh, you know, coverage waivers, your original point or one of your second point and, and, and your comment there. And, um, you know, I mean there's been almost three years now, uh, since the public health emergency has emerged and there's been a substantial number of companies that have just come onto the marketplace that engage in and or rely upon telehealth as a, as a mode of delivering services. Uh, and you know, my concern is that, you know, there's been sort of a, you know, less focus on the telehealth coverage requirements, the state overlays as you mentioned, uh, and uh, and now it'll be time to pivot, uh, to address those, to the extent that some of those come back into, into play, to the extent that some of those don't evolve or change. Um, that could be certainly, you know, a compliance risk on the, on the horizon, so to speak.
Speaker 3:Yep, yep. I agree. And then pivoting from, from telemedicine to, um, you know, sort of a hard, a hard, a hard 90 degree turn to something else that I think is gonna be very interesting to watch is going to be the, the evolution of the case law relating to the false claims acts requirement. So there are so many years ago, I think it was, I wanna say around 89, I might be wrong on the, uh, no, maybe it was two, 2007 or so, um, in a completely non-fat Claims Act related case, a case that related to the Fair Credit Reporting Act, um, safe co-insurance company versus of America versus Burr, the Supreme Court analyzed the Fair Credit Reporting Act requirements and, and their intent requirements or, or cito requirements, which are, which are similar to the False Claims Act. And in that context said that if a defendant didn't act, that a defendant couldn't act with the requisites under that statute, if it was acting consistently with an objectively reasonable interpretation of its obligations under the law. And a number of cases have tried to argue, tried to expand that Safeco argument into the False Claims Act context. And, um, I was even involved in one of those many, many years ago, and initially the courts were pretty skeptical about it, but the courts have become a lot more have come to embrace that a lot more. And so currently there are two Supreme Court to two cases that have been, uh, the, um, where they've sought CERT from the Supreme Court. And I think those two cases are gonna be very interesting to watch both. So the first one, the seventh Circuit, I mean, at this point I think they're, I should say I think they're like maybe five-ish circuits that have adopted this Safeco approach under the False Claims Act. Um, so one of those is the Seventh Circuit, um, US Xra shooting versus super value. Um, it's a, a case involving Medicaid drug pricing. So the Medicaid reg defined the term usual and customary price as the price that's charged to the general public by a pharmacy. Um, and in this case, the defendant had reported to Medicaid its retail cash prices, but it didn't report lower amounts that it charged under its discount program, um, as the usual and customary. And so, so the, you know, the initial fight was over, well, what should they have been reporting that super discounted price or the normal retail, um, retail pricing. And the district court held that the discounted prices were what they should have been reporting, um, and the seventh Circuit agreed to that, that they were actually reporting the incorrect prices and therefore the claims were false. But when they got to the piece, they said that the company didn't act knowingly as defined by the False Claims Act because its conduct fell within, but was an objectively reasonable understanding of the law. And that understanding did not conflict with any authoritative guidance that was out there. So, um, and then there was the, the other case that, so that was outta the Seventh Circuit. There's a fourth Circuit case that is also where they've also sought review by the Supreme Court. And um, this case also relates to Medicaid drug pricing, but the signs of Medicaid drug rebate statute, um, and about reporting best price. And this related to, um, how the manufacturer, um, this case was US X Rail Sheldon versus Allergon, um, how they aggregated customer discounts when they were reporting best price to cms. And in this case, the, um, the district court granted the defendant's motion to dismiss the district court held that the quote, plain natural meaning reading, sorry, of the statute didn't require aggregating the discounts and said that c m s had not explicitly said anywhere that, that they could find that the manufacturers had to aggregate the discounts in the way that the relator was arguing that they had to. Um, it then went up to the fourth circuit. Um, and then, then there was a fourth circuit, um, rehearing. And on the rehearing, I'll skip over what the fourth Circuit has said, cuz on rehearing, they just vacated, uh, fourth circuit's prior opinions and simply affirmed the district court's dismissal. So that's where we stand right now. So both of those cases gonna be tremendously interesting to see, and I think very potentially powerful for the Defense bar to see what the Supreme Court does. Now, doj, um, you know, they're saying at least publicly, oh, you know, sort of, you sort of get the sense the sky is falling or they think the sky is falling because, you know, they say, well, all that these defendants need to do is to bring in some lawyer today who can manufacture some reasonable interpretation that the company didn't have at the time, and can just make that up and on on the basis of that can, even if the company knew that they were doing something terrible and were trying to commit fraud and you know, based on this, they can just get the case thrown out. I just, to me that's just not realistic<laugh>. Um, we're dealing both of those cases deal with really complicated regulations and I just don't, I think the DOJ often just does not appreciate how difficult it is for industry to figure out what that is they're supposed to be doing and to do it. Um, and DOJ folks, a couple on a couple panels that I've both spoken on and listened to, they've seemed to be taking the position that, and, and I know this sounds overstated, but this is kind of what I feel like I'm hearing from them, that if there are two interpretations, both of which are reasonable, that the defendant has an obligation to take the one that's the least favorable to it and to take the one that's favorable to the government. And to me that just doesn't make any sense at all. There,<laugh> there is no rule that if there are two, if there, if there are two interpretations, thou shall take the one that is the least favorable to you that that's crazy. Um, and, and just doesn't make, just doesn't make any sense when, you know, particularly when you recognize every, I mean this is, this is, this is business, yes, it is healthcare, but, um, you know, all healthcare entities have to remain operational<laugh> Now, you know, if they're, if their real issue is, and sometimes I think both of these cases are Medicaid drug pricing cases, and I'm, I don't know to how ex you know, how expensive these particular drugs are, but I do get the sense that, um, part of do J'S concern may also be, although it, it wouldn't, I'm sure they wouldn't say this publicly and may not even admit this to themselves, but it seems like part of the issue is that drugs have gotten so expensive that they feel like any way that any drug company or anybody else would is typically gonna drug companies that are taking advantage of that and causing so much expense to the Medicare program and Medicaid programs that that's gotta be stopped. Um, and I can certainly appreciate the fact that drug pricing has gotten very expensive and there's some drugs that are terribly expensive, but I don't think this is the way to do it.<laugh>, I don't think this is the, the approach to take,
Speaker 2:Maybe to add onto that, I mean, you know, I, I think it, I think it was in the, the, the super value, um, decision where the judge said that the Medicaid drug rebate statute is the most incomprehensible text in human history or something to that effect. I think I'm paraphrasing it, you know, not exactly correctly, but, um, you know, the point remains the same, that this is a very dense and complicated area, you know, of course subject to informal guidance, program releases, manufacturer releases, you know, CMS direction that may not find authority in, um, you know, notice of proposed in, uh, rulemaking, um, authority, et cetera. Um, you know, I think that speaks to something we might see in 2023 more broadly, which is the government's authority with respect to drug pricing, both on the Medicaid side and of course on the Medicare side with the new inflation reduction act provisions, um, that will give CMS significant authority in that area. I think that's gonna be another hot topic for 2023 as well,
Speaker 3:For sure. Absolutely. Absolutely.
Speaker 2:Well, Laura, thank you so much for joining us for the podcast today. This has been really tremendous. The 22 supplement, as I said, is really, um, you know, quite effective and quite helpful, and I look forward to the 2020 supplement at the end of the year, uh, and, uh, look forward to chatting with you again soon. Thanks again for joining.
Speaker 3:Thanks, Matt, it's a pleasure.
Speaker 1: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 a H L A and the educational resources available to the HK community, visit American health law.org.