This transcript has been auto generated
00;00;00;00 - 00;00;26;13
Jonathan Porter
Welcome to another episode of Husch Blackwell's False Claims Act Insights podcast. I'm your host, Jonathan Porter. I'm fascinated by how the healthcare industry works in our country. Around a quarter of the entire federal government's budget is on healthcare, which is just a staggering number. And you might think that if we're to spend $2 trillion on something, we'd have a well-defined system of what's okay and what's not.
00;00;26;15 - 00;00;50;23
Jonathan Porter
But we don't. There is so much gray area in healthcare, so many flexible concepts, so much conduct that is arguably okay and arguably not okay. I try really hard in my job to not get lost in the weeds, and so I force myself to zoom out every now and then and try to figure out why things are the way they are, why things are enforced, the way they are, why things are regulated, the way they are.
00;00;50;25 - 00;01;12;24
Jonathan Porter
And every time I do that in healthcare, I find myself just in disbelief that this is the system we chose, that we seem to be okay spending trillions of dollars of taxpayer money with very few clear bright line rules, but a whole lot of murky ones based on discretionary concepts. It's fascinating slash frustrating to practice in this space.
00;01;12;26 - 00;01;36;07
Jonathan Porter
So Congress tends that these murky rules and gray areas were not super helpful to the industry back about 30 years ago, and created a law as part of HIPAA that allowed HHS, OIG, which is the law enforcement arm of the Department of Health Human Services. It allowed OIG to guide the healthcare industry in written advice on several of the murky lists of healthcare laws.
00;01;36;09 - 00;01;56;24
Jonathan Porter
And so, for decades now, HHS OIG has issued advisory opinions that are intended to clear things up. But advisory opinions aren't always what they seem. And so, on today's episode of podcast, we're talking about how the healthcare industry tries to get it right and how it should view OIG advisory opinions when trying to chart a compliant course.
00;01;56;26 - 00;02;20;10
Jonathan Porter
I've asked two super smart friends to join the episode to talk these things through. First is Brett McNeal. Brett is the chief legal officer of CAN Community Health, a nonprofit healthcare organization operating in six states and providing a wide range of healthcare services with super complex regulations like a 340B pharmacy, which those who practice in that space know there's a lot of complexity there.
00;02;20;12 - 00;02;44;06
Jonathan Porter
I'm sure that occupies a lot of Brett’s time. So Brett and I worked together as vice chair of the American Health Law Association's Fraud and Abuse Practice Group, where Brett tolerated my musings on healthcare enforcement for a long time. And so I'm excited to Brett is going to join the podcast and share his thoughts on how healthcare providers can keep an organization on track when dealing with sometimes less than clear rules and regulations.
00;02;44;09 - 00;03;09;02
Jonathan Porter
And our second guest is my friend David Traskey. David is a partner in the Washington, DC office of the law firm Garfunkel Wild, where David advises clients on a range of enforcement and compliance issues. Before that, David was senior counsel in HHS OIG, where David implemented civil monetary penalties and helped OIG expand its use of data analytics. Really important stuff.
00;03;09;02 - 00;03;27;11
Jonathan Porter
And David and I, I left DOJ about the same time that David left OIG. And so we've kept in touch over the last couple of years to talk about this big shift to private practice and how healthcare enforcement works. And so I'm excited that David will give us an inside peek into the world of HHS, OIG today on the podcast.
00;03;27;11 - 00;03;39;22
Jonathan Porter
So, Brett and David, I'm excited about this episode. Thank you both for joining me to talk about the complex world of healthcare and the role that HHS OIG advisory opinions play in those efforts.
00;03;39;29 - 00;03;40;19
Brett McNeal
Thanks for having me.
00;03;40;26 - 00;03;43;07
David Traskey
Likewise. Looking forward to it.
00;03;43;09 - 00;04;01;07
Jonathan Porter
All right. So, as we said, healthcare's complicated. There's a lot of gray area, a lot more than people realize. So, Brett, why don't you get us started by telling our listeners how you go about figuring out what's okay and what's not okay, and what role OIG advisory opinions play in those efforts.
00;04;01;10 - 00;04;24;06
Brett McNeal
Sure, sure. I think for me, I start with the fundamentals. Then it's probably not a whole lot different from any healthcare regulatory lawyer. You know, the first two things I think about in any kind of arrangement or thing that's going to come across my desk. First question is, are federal program dollars involved? Usually that's pretty cut and dry and easy to deal with.
00;04;24;08 - 00;04;47;14
Brett McNeal
You know, the second thing I think about once that is a that's answered in the affirmative, is kind of mapping out the nature of the arrangement. And I have this. I'm I'm a bit old school, I suppose, where I have a habit of taking a piece of paper and I diagram out all of the parties, and I will arrows pointing to where the business is being generated, who's in control of the money, and the rest of it.
00;04;47;16 - 00;05;18;20
Brett McNeal
So I start with the fundamentals there, and I've been very fortunate in my career to work with a lot of really good folks who the North Star of the question always is, how do we just help people? You know, the economics matter, but the North star of the question always is how do we just help people? And once you get through the fundamentals, you kind of think through my at least analytical algorithm kind of starts with, okay, if the first two things are both, yes.
00;05;18;22 - 00;05;44;17
Brett McNeal
Then is there a safe harbor that's involved? We're talking about a stark issue or kickback issue in the rest of it, where the advisory opinion is really come into play, is it provides a number of really good goalpost for me to keep in mind. And it's somewhat of an iterative process, I would say usually as I'm acquiring facts from the client, I'm doing all sorts of different bits of analysis in my head.
00;05;44;19 - 00;06;10;17
Brett McNeal
And as this is going on, I'm also being able to consult with the advisory opinions to see what back patterns, which things are particular salient to the OIG. So those kind of things all kind of get meshed together. And the advisory opinions, or for a very long time have been a really good source of guidance that I'm able to kind of synthesize into my practice and provide my clients with.
00;06;10;19 - 00;06;17;16
Brett McNeal
Here's what the chief enforcers of these programs have in mind, and they've certainly take that into heart as well.
00;06;17;22 - 00;06;39;23
Jonathan Porter
Thanks, Brett. That's helpful background. I think there's a lot of people just like you who take a very thoughtful approach to these things, where the North Star is, how do we help people and how do we do this in a compliant way? That I think is the vast majority of people in healthcare? I think there are very few people who go into this saying, my North Star is, I want to get profits and who cares if we get investigated.
00;06;39;24 - 00;06;57;26
Jonathan Porter
That's something that I tell DOJ lawyers a lot is these are people who try and get it right. And so if you think that something bad happened here, let's talk about why you think that and whether that's an intentional thing or are we just assuming some bad motive. That's not proper. But I love that you said that you break out arrows.
00;06;57;29 - 00;07;16;28
Jonathan Porter
So I do that all the time. I think about where business is coming from, where referrals are coming from. And I try to figure out are there dollars going back? Is there an opposite arrow going back with a dollar sign that is rewarding those referrals? I think that's something that we should be teaching younger healthcare lawyers when they're thinking about kickbacks.
00;07;16;28 - 00;07;40;28
Jonathan Porter
And stark is you have arrows pointing opposite ways referrals coming one way, dollars going the other. So really good points Brett. All right David, Brett mentioned OIG advisor opinions how he uses those. David, you want to tell us what OIG advisory opinions really are? And what does OIG put in these advisory opinions? Tell us the backstory of the process that OIG takes to issue these opinions.
00;07;41;01 - 00;08;06;21
David Traskey
Yeah, sure. I will tell you. I'll start by saying I am encouraged that there are other fellow artists out there. When I joined OIG many, many years ago, that was actually one of the first skills that I learned was to do the diagram to break out the legal pad and draw the boxes and draw the parties and draw the arrows and see what was going on, to make sure or to see whether or not there was any sort of an impermissible kickback or other type of beneficiary inducement.
00;08;06;23 - 00;08;29;18
David Traskey
And it's a skill that I still use today. It sounds like much like you guys. The advisory opinions are funny beasts, right? I think they're both the cause of and the solution to sometimes the headaches that we experience as healthcare regulatory attorneys. But as you mentioned, Jonathan, the issuance of these advisory opinions is mandated through HIPAA and through the Social Security Act.
00;08;29;20 - 00;09;04;07
David Traskey
And really, the whole purpose of these advisory opinions was to provide guidance to, at least initially, the parties that were requesting the guidance. Right. And so the focus of these advisory opinions typically is on the applicability of the federal any kickback statute, any safe harbor provisions, and certain other administrative sanction authorities under the civil monetary penalties Law as it relates to either actual or proposed arrangements that various parties want to enter into.
00;09;04;09 - 00;09;30;13
David Traskey
That's the box that these advisory opinions fit in in terms of what is their focus. The advisory opinions themselves, though, are legally binding on HHS and also the parties that are requesting the opinions. You know, OIG publishes a redacted form of these opinions and post them on their website. And, you know, interestingly enough, they're always sort of rife with disclaimers saying that the opinions are for informational purposes only.
00;09;30;16 - 00;09;54;26
David Traskey
No third parties are bound by these opinions or may legally rely on these advisory opinions. And I think that kind of puts the provider community in a tough spot, right? Because on one hand, the advisory opinions are very helpful, as Brett mentioned, in sort of providing rules of the road or goalposts or Guideposts for you as you're thinking about how to fashion certain arrangements.
00;09;54;28 - 00;10;20;02
David Traskey
On the other hand, their reliance only goes so far because the government would say, unless you are the requester of the opinion, the same protections that the requester might enjoy don't extend to other folks. So I think that's sort of interesting. And also what I would say is in the last few years, OIG has sort of revised its regulations to remove some hurdles and to kind of promote transparency.
00;10;20;02 - 00;10;54;09
David Traskey
It used to be that OIG would not issue advisory opinions on the same or substantially the same actions that were under investigation by different government entities in 2022. They removed that hurdle again, sort of in the interest of promoting flexibility and transparency. So they're sort of making some adjustments, I think, to the process. And I do think, like Brett said, that they're still really valuable pieces of the puzzle to help you figure out how to stay on the straight and narrow when it comes to fashioning these types of arrangements.
00;10;54;14 - 00;11;07;08
David Traskey
I think it's also worth noting that advisory opinions are totally voluntary in the failure to not get an advisory opinion cannot be introduced into evidence to prove that a particular party violated the law.
00;11;07;10 - 00;11;33;17
Jonathan Porter
Yeah. Thanks, David. They are voluntary, but I can't tell you how many times I've been in a DOJ office talking about something and explaining how complicated it is, and the DOJ lawyer to say, well, you could have got an advisory opinion. You're legally correct. That does not stop DOJ attorneys from playing that card. And I think, you know, Dave, what's interesting is you mentioned how advisory opinions really only bind OIG and HHS and the party that requested it.
00;11;33;17 - 00;11;50;27
Jonathan Porter
So other people really can't rely on these advisory opinions, even though they're publicly available. They're published so that people can know about them. And I think everyone knows people look at these advisory things and try to figure out, what do we do? We're dealing with some sort of hard area. Is there an apples to apples situation out there?
00;11;50;27 - 00;12;10;07
Jonathan Porter
Were OIG has spoken on something. And of course people rely on that. People are making educated decisions. And in my book, X is still a willfulness statute that you can only violate if you have a bad mindset, a mindset to break the law. And if you're doing something that OIG has said is okay in a different spot, I think that's meaningful.
00;12;10;07 - 00;12;38;06
Jonathan Porter
But other people disagree with me. But also, you know, what a lot of people may not realize is there's gamesmanship that happens with OIG advisory opinions. You can seek an advisory opinion, find out the high level answer, and then pull your request back so that you don't actually get the answer. I think that's really interesting. And people also may not know that it's not uncommon for someone to call out wrongdoers by submitting advisory opinion requests on what their competitor is doing.
00;12;38;06 - 00;12;55;14
Jonathan Porter
I think that's super, super interesting. So, David, start us off by telling a little bit about this gamesmanship with OIG advisory opinions. And then, Brett, I want to know whether you think that there are better ways for the healthcare industry to get some more certainty on what's okay and what's not.
00;12;55;16 - 00;13;29;15
David Traskey
Yeah. So it is really interesting, right? I think that typically if we just take a step back for a minute and just say, how do you even go about requesting the opinion? Right. So requests for advisory opinions, they have to be submitted in PDF format, special email address that OIG requires that you use. And in an effort to try to simplify the process, OIG is also created this advisory opinion template to try to get folks who are requesting these opinions to provide information that they're going to want upfront to kind of cut back on any delays.
00;13;29;18 - 00;13;54;16
David Traskey
And, you know, as part of this process, you've got to identify who the requesting party is, who's involved. You may have to provide different documents if they exist. If it's a proposed arrangement, you might have draft documents or some sort of a detailed narrative description. And understandably, OIG is not going to issue advisory opinions to anonymous requesters. So you've got to designate a contact person, you know, when you submit your request.
00;13;54;23 - 00;14;29;00
David Traskey
And also there's a cost associated with it. Right. And so you can request sort of an estimate from OIG about how much it will cost you to do this. But to your point about the gamesmanship aspect of it, I think you're correct, right? It is that sometimes people want to go far enough in the process to get an answer, and if they don't like that answer at a very high level, they may find that it would be beneficial to their interests to withdraw the opinion or withdraw their request, which can be done at any point in time before the formal opinion is issued.
00;14;29;02 - 00;14;51;28
David Traskey
So that does happen. Of course. I think it bears noting that just because you get an unfavorable advisory opinion doesn't necessarily mean that's the end of the world. It just means that OIG is not able to bless this particular set of facts. But you could still theoretically proceed with the arrangement, albeit cautiously, because, as you mentioned, Jonathan, the key element to all of this is intent, right?
00;14;51;28 - 00;15;15;15
David Traskey
And if you don't have the right intent, even if you're arrangement doesn't sort of stack up the way OIG would like it, to see it doesn't necessarily mean that it's inherently wrong. And then, you know, kind of with respect to competitors using the advisory opinion process to either undercut their rivals or or to gain insight. I'm aware, at least anecdotally, that that occurs when you submit these advisory opinions.
00;15;15;15 - 00;15;41;19
David Traskey
You have to make certain certifications or attestations about who you are and what you're doing and why you're making the request. So I suppose that you could submit these types of requests for opinions, but probably doing so with nefarious intent would require you to probably make some certifications or attestations that may not be 100% correct. I do know that that does happen from time to time, from what I understand.
00;15;41;21 - 00;15;50;17
David Traskey
But yeah. Oh, I guess the whole goal in doing these advisory opinions is, as they say, to provide meaningful guidance. Right? I think they're trying to sort of stick to that goal.
00;15;50;22 - 00;16;17;27
Brett McNeal
So what I would say in terms of how the healthcare industry could get more certainty, I take it from the perspective of having done the in-house thing for the majority of my legal career. The OIG advisory opinions, the average 15 year, sometimes low, sometimes it's high. But those things are precedential in my world, where they come out and everyone.
00;16;17;27 - 00;16;34;25
Brett McNeal
If anyone has a bad habit that I have, I'm always checking OIG website daily. Just kind of see what's new. You see the advisory opinion and you kind of make a note in your head, okay, I need to read that today and kind of see where they're going, because I tend to look at it. I imagine the same way a lot of practitioners do.
00;16;34;25 - 00;17;19;02
Brett McNeal
As the OIG is warning the healthcare industry to act in certain ways and not act in certain ways. And it communicates that in large part through its advisory opinions and or the regulated community to act in kind. Well, more advisory opinions would be better. And maybe David, maybe you can speak a little bit to how many requests you get in versus how many opinions actually are generated, either favorable or not, but another one for folks like me is being able to take one of these opinions, because very, very rarely in my career is there an arrangement that is on all fours with any advisory opinion.
00;17;19;02 - 00;17;49;08
Brett McNeal
Usually there's a fact that's off and sometimes you can't conform. The fact on my side with something that's in the opinion. So I would very much like, to the extent it would be feasible for the OIG in writing these opinions to make them and to draft them so that they are almost inherently you can extrapolate out against other similar or back patters that would be immeasurably helpful for the industry, I think, as a whole.
00;17;49;10 - 00;17;52;20
Jonathan Porter
Yeah, that sounds like it would be tremendously helpful. David, what do you think?
00;17;52;22 - 00;18;17;21
David Traskey
Yeah, I would agree. I mean, every time it's, you know, top of mind for me, every time I see an OG opinion come out, it's one of the first things I do in the morning is I'm looking at that opinion like Brad, I'm checking the IDs website every day, and typically within a day or two I've drafted some sort of a client alert that gets posted on our website that says, hey, provider community, just say, you know, here's another new OIG opinion and here's how it might affect you.
00;18;17;23 - 00;18;44;22
David Traskey
I think you're right, Brett. That rarely is a particular arrangement that I review. I'm going to hit on all cylinders with an advisory opinion. But again, sort of as I was mentioning, I think the healthcare attorneys in particular rely heavily on those opinions as a guidepost to help them fashion these types of arrangements in a way that even if you can't get it squarely within the advisory opinions fact pattern, you can try to get as close as you can.
00;18;44;22 - 00;19;01;11
David Traskey
Right? Because that helps the client make an assessment as to whether or not, you know, like what's their risk tolerance and what's the likelihood of OIG kind of kicking over the hornet's nest on something like this, depending on the facts of the case? You know, they, like you said, they issue, I don't know, anywhere from 15 to 20 a year.
00;19;01;11 - 00;19;27;29
David Traskey
Typically by regulation, they're supposed to issue advisory opinions within 60 days, and they're supposed to at least have some sort of an initial assessment done within ten days of receiving a formal request. Those calendars change depending on if IG asks for more information and things like that. But I think the advisory opinion function and what it serves is instrumental to healthcare attorneys being able to advise their clients.
00;19;28;01 - 00;19;53;04
Jonathan Porter
Yeah, I totally agree, David. And by the way, 60 days is also what Congress allows DOJ for making an intervention decision in key terms. So sometimes 60 days means more. I'm with you there, David. And I think what we're all saying here is it'd be nice if things were just a little bit clearer for the industry, because I think the industry is full of people who think exactly like what Brett does, which is how do I help patients and how do I do that in a compliant way?
00;19;53;06 - 00;20;17;15
Jonathan Porter
And so, yeah, I'm hoping that what people can realize listening in this episode is there should be more clarity on just a lot of things. And it is a bit frustrating when you've got these advisory opinions that technically you can't rely on, and yet are super helpful to people who are trying to find the right way forward. So let's shift gears a little bit and tell our listeners where we think healthcare is heading, both from a regulatory perspective and an enforcement one.
00;20;17;17 - 00;20;41;23
Jonathan Porter
Brett, when we were actually vice chairs together, we spent a bunch of time talking about the next big fraud and abuse issues coming. And so I'm hoping you can tell our listeners where you see the healthcare industry going in that respect, and then we'll let David close by telling us whether he can tell what's coming next from a legal, advisor, opinions or guidance and where he thinks healthcare enforcement is going.
00;20;41;23 - 00;20;42;24
Jonathan Porter
But we'll start with Brett.
00;20;42;26 - 00;21;12;09
Brett McNeal
So I say, without an ounce of shame, that I am a healthcare regulatory error. That's kind of the stuff that that's always kind of been in the center of the fairway for me, something that I am very interested to see how it's going to continue to play out is the erosion might be too strong of a word, but the fundamental reshaping of the administrative state with respect to healthcare regulation post Loper, break post even a line of decision for a firm even before that.
00;21;12;11 - 00;21;35;28
Brett McNeal
Is that going to cause the Jedis sitting up a lot of kind of the bulwark or regulatory environment that practitioners like myself, both of you and the overall community have kind of, if accepted as established practice, maybe that doesn't end up being the case. Then how does that connective tissue connect with false claims like enforcement and things like that?
00;21;36;00 - 00;21;52;07
Brett McNeal
Regulations that have been on the books for quite some time, that perhaps aren't the best reading of the underlying federal statute. How does that play out? I'm very, very curious to see. That's probably the biggest thing on my bingo card, I'd say going into the rest of this year at beyond.
00;21;52;10 - 00;21;53;15
Jonathan Porter
David, what do you think?
00;21;53;17 - 00;22;21;24
David Traskey
Yeah, I mean, I think on a more nuts and bolts level, what I would say is there's a huge uptick recently in CMS and DOJ looking at providers who are using skin substitute products. It is a big issue right now, the subject a lot of audits and investigations, the consequences for providers operating in that space are huge, with clawbacks of millions of dollars for not that many patients in not that many dates of service.
00;22;21;26 - 00;22;43;23
David Traskey
So I would envision that to continue to be on point for the rest of this year and into next year or two, just, you know, sort of in my personal practice, we're seeing lots of providers coming to us looking for help to appeal these decisions. And so that's been keeping us rather busy these days. And then I think to your question, Jonathan, about what is the future hold?
00;22;43;23 - 00;23;02;00
David Traskey
I mean, one of the questions that I get all the time as a former OIG attorney of recent vintage is, hey, what are they going to do next? And I don't have a crystal ball. I don't have one any more than you or Brett do. But what I can tell you is, is that the IG is actually really transparent about what they're doing and where they're going.
00;23;02;02 - 00;23;36;23
David Traskey
And so I know you guys are both consumers of OIG content. So it may not be a surprise to you to say that in addition to the advisory opinions, one of the things that I spend a lot of time looking at is the information that they put on their public facing website. So whether it's the summaries of the self disclosures that have been settled, whether it's settlement agreements under a couple or one of the DOJ settlements OIG puts on their website all the time, the audit reports, their audit work plans, the annual and semiannual reports.
00;23;36;23 - 00;24;01;13
David Traskey
Right. All of these things indirectly should guide practitioners and providers in terms of what OIG is thinking, what's their sort of their thing of the moment, and also kind of where they may be going next. So that's what I always say is it's about as good of a crystal ball as you'll get. But there is a lot of great content on OIG's website that I think informs sort of their next steps.
00;24;01;15 - 00;24;16;19
Jonathan Porter
Yeah. So great insights from both of you. Thank you both so much for joining the podcast and telling our listeners about OIG advisory opinions and this murky road that the healthcare industry has to walk down and so, Brett, David, thank you so much for joining the podcast. I think this has been great.
00;24;16;21 - 00;24;17;23
David Traskey
My pleasure. Thank you so much.
00;24;17;23 - 00;24;19;02
Brett McNeal
Thanks for having me.
00;24;19;05 - 00;24;43;25
Jonathan Porter
To close, David’s right. So skin substitutes is the next big thing coming. And that's not even a secret at this point. I would expect uptake done on that. I think CMS announced earlier that they spent $10 billion on skin substitutes in 2024. That's almost ten x for recent years. And so it's stuff like that where we're going to continue to bring you information on this podcast about the future of healthcare enforcement and the future of false claims action.
00;24;43;25 - 00;25;04;18
Jonathan Porter
Foresman, so continue to listen to us. You know, I also think a lot about how these advisory opinions interact with willfulness. We talked a little bit about that on this episode, and we'll continue to do that on the podcast. Because, you know, when OIG says, look, this thing that someone is describing is technically a kickback, but it has minimal risk of fraud and abuse.
00;25;04;21 - 00;25;25;17
Jonathan Porter
I think people should be able to rely on that and demonstrate good faith through that. And so I think it's important now that you have lawyers who understand what willfulness means, who have talked to a jury about what willfulness means. And so if you don't have that, folks like David at Garfunkel Wilder are good options. And we've got some good ones here at Husch Blackwell as well.
00;25;25;22 - 00;25;41;17
Jonathan Porter
But I'm grateful for our listeners to paying attention to this episode. I think was a good one. So thanks to David and Brett and we'll see you next time.