Andrew Ruskin, Partner, K&L Gates LLP, speaks with Mary Edmondson, Chief Compliance Officer, Inova Health, about the aftermath of last year’s Supreme Court decision in the SuperValu case and how health care organizations can prepare for potential investigations. They discuss how to ensure that stakeholders in an organization feel comfortable raising questions with compliance, how to evaluate whether a current practice is lawful, lessons learned from the Christiana case, and how to demonstrate reasonable steps related to compliance with the 60-day repayment rule.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Andrew Ruskin, Partner, K&L Gates LLP, speaks with Mary Edmondson, Chief Compliance Officer, Inova Health, about the aftermath of last year’s Supreme Court decision in the SuperValu case and how health care organizations can prepare for potential investigations. They discuss how to ensure that stakeholders in an organization feel comfortable raising questions with compliance, how to evaluate whether a current practice is lawful, lessons learned from the Christiana case, and how to demonstrate reasonable steps related to compliance with the 60-day repayment rule.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
<silence>
Speaker 2:This episode of A HLA speaking of health law is brought to you by A HLA members and donors like you. For more information, visit American health law.org.
Speaker 3:Hello , uh, and thank you for joining , uh, this , uh, episode of the HLA podcast. My name is Andy Ruskin. I'm a partner in the Washington DC office of the Law firm of k and l Gates. Uh, I specialize in Medicare, Medicaid , uh, reimbursement and compliance three 40 B , and a whole host of adjacent , uh, areas . With me today is , uh, my , uh, colleague and friend, Mary Edmondson. And Mary, why don't you tell everybody , uh, uh, a little bit about your background,
Speaker 4:Andy ? Um, I'm Mary Edmondson. I'm the Chief Compliance Officer at Inova Healthcare System. And , um, I, I should say I'm a reformed lawyer because I used to be an active participant in A-A-H-L-A , and I still follow everything you all do. It's a great organization, but now I consider myself a compliance professional, so thanks for having me.
Speaker 3:Thank you, Mary. And yes, it's nice that you wear , uh, both of those hats because some of these issues can be very thorny. The issue that we're talking about today specifically , uh, is the aftermath of the Supreme Court's super value decision from last year. The super value decision , uh, looked at whether or not a , uh, a target for , uh, FA False Claims Act investigation would be able to have the case dismissed if there was a reasonable objective explanation that could be offered for , uh, the decisions made as to how to file certain claims with the federal government , uh, where in fact there may not necessarily be evidence ahead of time , uh, that , uh, that tho those , uh, very same reasons were the reasons that the entity used as to how to decide whether to submit the claims in exactly the way they were submitted. Uh, obviously , uh, the False Claims Act is incredibly important for healthcare providers , uh, because , uh, there are many cases , uh, that , uh, start off as potential billing errors that , uh, because of any sort of , uh, circumstantial evidence, there may be , uh, some grounds for believing that there was at least , uh, uh, some form of recklessness about , uh, submitting , uh, wrong ergo false claims , uh, that , uh, triggers something more than overpayment liability and turned something into a False Claims Act case. Uh, the, the question , uh, that everyone was hoping for a different answer for , uh, from the Supreme Court was whether, if it turns out that there was reasonable justification, even if there was no documentation of that , uh, at the time of the claim submission , uh, that that justification could after the fact , uh, uh, provide some form of, of , uh, uh, immunity so to speak, from false Claims Act liability, even if it had not been , uh, thought of at the time. But now, what we're understanding from the Supreme Court is, is no, it's really critical that the , uh, that the claimant , uh, have good reason for its conduct at the time , uh, that it's submitted the claim , uh, or otherwise , uh, it faces False Claims Act liability. Uh, so that raises a whole host of, of , um, uh, challenging questions for, for providers as they try to figure out how to avoid being in situation where their only support after an investigation has been initiated is something that is post hoc. Uh , and so , uh, since , uh, uh, Mary is a Chief compliance officer, she deals with these questions every day. Uh, my own honest opinion is, is that she deals with them better than most. Uh, and so we thought it would be useful to have a podcast about this particular topic , uh, specifically, how do you set up the predicate ahead of time to make sure that those difficult questions that could end up in front of DOJ one day , uh, are all vetted ahead of time, even if it turns out you're wrong , uh, because the government sees it a different way. What more can you do as an organization to, to just prepare yourself , uh, so that , uh, if you ever do get investigated, you can say, Hey, we, we've processed this exactly the right way. So, Mary, I'm gonna ask you a a bunch of questions , uh, to get at that point. The first of which is, is how would you ensure that stakeholders in the organization feel comfortable raising questions with compliance instead of just dismissing challenging questions is , is not so important?
Speaker 4:Yeah. Thank you, Andy , for that question. I , I think one thing our organization has spent a lot of time working on is building a culture where it's okay to ask questions and raise your hand and, and speak up. Um, so my organization has worked very hard on psychological safety, and, you know, that is a , that's a catchphrase that's circulated often, but we're really drilling down what does that mean to people? What does that mean to somebody on the front line ? What does that mean to an executive? Um, and that's hand in hand with our core value of integrity. Um, of course, as a compliance department, we want everyone to be aware of our non-retaliation policy. Um, we openly take , uh, you know, have an open door policy for direct questions coming into compliance. And if somebody is still nervous about speaking out about something, we have a hotline and we publicize that hot hotline so that there's an anonymous venue for somebody to call or make an after hours inquiry by email if that, if that's something that , um, they'd rather do. Um, and then of course, we wanna follow up on all those questions. Um, somebody's calling the hotline or checking in with us on something to be sure it's okay. We feel so strongly about circling back. We've gotta close the loop so that , um, our team members, our colleagues don't feel like it's just a black hole , uh, that their question goes into and nobody gets back to them. So that's something we really try to focus on. But you know, what's really tricky is when you get a question or you get , um, somebody making an offhand comment in one of these avenues that's not so direct , um, it's not coming in through an email or a , or a question. It may be a hallway conversation where somebody says, Hey, I heard that so and so in this department is doing such and such . Well , um, that's a little bit trickier because then you've got to , um, number one for me, remember the comment , <laugh>, of course, I'm joking, but I take all, all those kind of comments seriously. You have to go back to your desk and say, you know what? I just heard, we need to look into this. And, and then we build , um, a way for those non-traditional ways to be logged on our , um, investigation log so that we can track it really , um, look to see if there's any there, there, and , um, and then move along to see what, what may open up.
Speaker 3:That sounds great. So, so first you have to build a , a culture of trust , uh, that people will, will not just be able to, to , uh, to voice their concerns, but that they'll be listened to. But what can you do , uh, to , to make sure that , um, that the, this , all of your stakeholders , uh, feel like it's their duty? Uh, so it's one thing to make everyone comfortable, but how do you emphasize that it's their duty to , uh, to actually , uh, provide that information proactively to compliance?
Speaker 4:Well, and that's, I'm glad you asked that, because that's really a cornerstone of our , um, core value of integrity. And that message is built in our code of conduct. It's something that we practice on a daily basis that compliance, the obligation of compliance doesn't just belong to that group of individuals in that department. Compliance belongs to all of us. Um, and, and as team members, we all believe that and own that. Um , we're only as, as good as our entire organization. And , um, we want to hold up our, our, you know, mantle of integrity, not by taking shortcuts, but by believing in all those things we do on a daily basis.
Speaker 3:That sounds great. So, so that's how we get the questions in, right? You can't do anything if you don't actually get the questions. So what's the first step, Mary ? You get the question, how do you decide, someone says, I don't think this is right. Um, but that's a person, person's view, and, you know, and not everyone is in , in ESQ or jd, and so we need to get some way to actually evaluate it. So what, what do you, what's the first step you do to evaluate whether there's a, there, there, as you said,
Speaker 4:Right? So we, you've gotta dig into the facts. And that's something that I feel like we've all also in the compliance department have taken on an additional hat of being an investigator <laugh> . So , um, or mouse detective as my, my friends like to call me. So, you know, we put on our detective hats and start to dig into the facts. Um, you know, ask the, the who, what, where, when, why questions nail down what department we rely on , um, the skillset , um, in our department, including the coders who help us look into medical records, if that's , um, a logical piece of fact finding that we need to do. Um, we also have , um, other core , uh, core compliance professionals that can help us interview witnesses if that's what we need to do. So depending on the type of , um, scenario that's been thrown at you, you you wanna look around to see what makes sense, what kind of fact , um, finding can we do here? It's not unusual for us to reach out to our internal audit partners if it's a real question of financial controls. That's , um, a situation where we might look to them to help us dig into the facts of a situation.
Speaker 3:Okay . So you, you look at the facts. Do you ever come across circumstances where these facts are hinky, but you're not really quite sure? Did anything really wrong? Go on. What what do you do under circumstances like that?
Speaker 4:Well, that's, that's where we want to look to see what is the, what is our responsibility? What's the policy, what's the regulation, what's the law that's applicable here? And , um, you know, if that's not always clear, and sometimes it can be ambiguous. Um, there , there , every now and then we have to call our, our lawyer friends. Um, so Andy might be getting a call from me occasionally , uh, when these kinds of things come up, particularly where there's not an on point manual provision or we don't have a CMS letter on point that helps us understand what do they mean by this? Um , or this seems kind of vague, what are we supposed to do in this situation? I'm not finding any clear guidance here. Uh, what are we supposed to do?
Speaker 3:So this is interesting. You mentioned both policies as well as manual. And so what you're, you're saying is that sometimes, even if it's not necessarily against the law, compliance is of course also responsible for, for , uh, actually , uh, making sure that the policies of the organization are, are , are adhered to. So in other words, it could be that the outcome of a compliance review is, is a warning to a particular employee as opposed to necessarily a , a, a repayment and that both of these fall within the compliance department's purview.
Speaker 4:It sure can. Andy, and, and thanks for raising that point. Um, I would say one of our most, you know, active policies is our policy on the 60 day payment rule, though <laugh> . So , um, it's, it , uh, comes in handy because it provides us as a compliance department, a bright line rule on what are we supposed to do next? If we find X, then we do y and that really helps us , um, with scoping and, you know, making sure there's not scope creep that we're really staying within the confines of our question , um, and drilling down on those important details.
Speaker 3:Yeah, and , and I, I, I would echo that having a good , uh, six city , uh, repayment , uh, rule , uh, policy is really helpful because the , the guidance from CMS, while detail does not answer every question and not every answer from CMS that they give is practical. And so organizations , uh, should try to figure out for themselves what are they willing to live with, and having some level of detail to be able to distinguish between the real issues versus the, yeah, there's just some noise there. It's not really a repeat issue. Could be very , uh, very helpful. So , um, so you mentioned that, that , uh, compliance couldn't possibly do this all on their own. Uh , and we certainly expect that everyone within the organization understands that in , in some, in some fashion, they're all wearing two hats. Everyone is a deputy in the compliance , uh, department in some, in some form or another. Um, but are there certain , uh, other departments you rely on specifically , um, as you are trying to, to figure out whether or not , uh, an issue is, is truly an issue, or if it's just something where , uh, there might have been a misunderstanding , uh, by an individual or two within the organization?
Speaker 4:Absolutely. Um, there , it would be impossible to do this job on our fire cells and in a silo. We have a very close relationship and a working group that meets regularly with our revenue integrity colleagues, as well as our coding operations colleagues, so that we are all on the same page when there are questions that arise on just day-to-day operations. Um, how can we align and make sure that we're doing the right thing as we, as we move along? Um, and of course, there, there are times when , um, there may be a real discreet part of the regulations that I don't come across every day , um, where I rely on , uh, the clinicians that work here in the organization to help us understand what, you know, what is our operational practice, how does, how does this work practically? Uh , and sometimes that's just as important , um, not more important than, than the law, but we need to understand those things in order to have an appreciation for potential corrective measures and, and , um, what are our peer organizations doing? Um, and when you're working with, let's say we're drilling down on a particular investigation, and , um, it looks like we're thinking through potential corrective measures, and we want to , um, work hand in hand with our operational teams to be sure that whatever we are recommending makes sense practically, you know, it's gotta be able to, to have a functional workflow in order for it to be effective. And , um, we don't wanna recommend things that are just going to sit in an inbox and not , um, be practical and workable. Um, so that's, that's really important to involve all those folks. And, you know, sometimes somebody who may raise this, I mentioned a hallway conversation, Hey, I heard this is going on over there, and you guys may wanna look into it eventually, we wanna get back to that person too. You know, we wanna be sure and say, Hey, I'm so glad you said something to me because we looked into it and here's what we found. And I want you to be aware that , um, we do things more formally too. We have compliance billing alerts we share with our colleagues , um, and we of course try to get on meeting agendas for our service line leaders to speak about recent investigations and outcomes , um, when that happens, so that everybody's aligned and on the same page and hearing this message from compliance department.
Speaker 3:Yeah. So what , what one of several things that I heard there. One is that , um, it's important that you have allies, and that even though everyone theoretically has their own mandate as to what they're supposed to do on their, in their day to day , that , um, that there's always going to be some overlap. And it's important that people don't , uh, uh, put fences around their turf that essentially everyone needs , uh, to , to work together. Um, uh, and that secondly , um, compliance is not , uh, compliance's goal is not to be , uh, uh, the , uh, the traffic cop. They're not supposed to be there just to say, Hey, you can't do that and tell someone stop or No, your goal is just to come up with a practical solution that will allow something to actually move forward , uh, in a, in a sensible fashion. Um, and that to do so, you have to see it from their perspective before , uh, before you're able to tell them, well, this could work for you and it would be compliant. So , um, so it is , it is really important that it be a give and take as opposed to , uh, compliance , uh, sitting up from , uh, from up high and , uh, and , and make passing judgment. So , um, um, so that's , uh, I , that those are all very , um, uh, helpful , um, uh, helpful ways for, for people to be thinking about , uh, that particular role. And they also will all go towards helping to avoid being in a situation where you're in a super value . If you are , uh, if if communications from compliance are one way and they're all driven, pushing out, then it's hard for compliance to get that information , uh, uh, in , uh, taken , uh, from the other business , uh, units. And as a result, then , uh, you will, you will be surprised when , uh, when you , you're settling investigated for , uh, for reasons that you never knew about because no one shared it with you. So , um, okay. So Mary , uh, you and I are both aware that there was this recent Christiana case , uh, where , uh, there were accusations that , uh, Christiana allowed , um, uh, its apps , uh, to be , uh, used by , uh, clinicians who were then billing for , uh, the services of the apps as if it was incident two, even though the apps were employed by the provider and could not actually be , uh, billed as incident two under under Medicare rules. Um, it looks from, from public reporting that , um, that the compliance office may very well have raised a couple of issues, but those issues had not necessarily been thoroughly vetted by compliance until , uh, DOJ uh , came in on the backend. We know that split shared billing is an incredibly complicated area, and for all we know, Christiana may very well have had a number of, of defenses that they had tried to put out there based upon some of these split shared billing rules or what have you. Um , but it ended up being a very sizable settlement, all the same. Um, do you , uh, see any lessons learned , uh, with respect to Christiana , uh, you know, taking into account some of the super value , uh, decision factors that you think other organizations should say, Hey, I really should do X, so , so I'm not in a , in a similar situation where I have , uh, an eight figure or retainment , uh, to the government,
Speaker 4:Right? Well, I certainly wanna avoid that at all, <laugh> . Um, the Christiana case , uh, was certainly troubling. And the , you know, I've dug into some of those media releases as well, and it was the chief compliance officer who was the whistleblower there, which is fascinating. And some of the reports make it look like that some of the work had been done, but that it was, there was inability to roll it out. So what do you do if you come up with recommendations, you see the problem, you have a recommended solution, and your counterparts or the leaders in your organization , um, are troubled by this and not willing to , to move? Well, you know, I knock on wood, that never happens to me or any of my , uh, the potential listeners out there, because that is very scary indeed. Um, I think that several things come to mind when thinking about that one. Um, if you feel like , uh, you've escalated to the extent that you can, you've, you've gone up through all the ranks, you've , um, discussed what due diligence you've done, what fact finding you've done, you've proposed the solution, the , the law, maybe ambiguous may be clear. What if they're not acting, then , um, that's where you really want a good relationship with your board. Um, I'm, I'm really thankful that I've got that , um, dotted line to the, the chair or somebody on the board and meet with them regularly. I think you might even wanna talk to , um, your committee chair, your board chair about potentially meeting every now and then so that it doesn't see , seem so unusual if you go into executive session with them. Um , make it look like this is a regular thing and it should be happening, that you have those kind of closed door discussions so that you can escalate to that board member when you're not getting the kind of traction that you want. Um, uh, that, that I think, has gotta be critical, critical to go into that executive session and ask for that reinforcement and the support. Um, fortunately for me , um, here, I, anytime I've said , um, you know, we have to hold claims right now , uh, for these federal payers because of this, I have never gotten pushback, and I think I'm lucky. I hope that my colleagues out there have that same kind of cooperation where you get to take a pause and have that opportunity to do some really important digging to make sure you're getting it right. Um, because we don't want a claim to drop if it's not right. And , um, I, I feel really lucky to work for an organization that takes those requests so seriously and doesn't hesitate.
Speaker 3:So , so we've talked previously about everyone is, is, is to some extent a deputy of the compliance department. What I'm hearing you say is, is that goes all the way up to the, to CC the c-suite, as well as to the board itself. Uh, and that , um, whatever someone in your role can do to , to foster those, those , um, uh, relationships that is going to pay off in spades in terms of avoiding a situation where compliance is , um, is not just vetoed, but vetoed without potentially any alternative explanation, having been thought through and documented , um, and potentially li lying out there as a, as a, you know, as a grenade that's just waiting to go off. Uh , so , uh, so , so leadership
Speaker 4:Question for you , Andy , if you don't , if this is a good time,
Speaker 3:Go for it .
Speaker 4:Okay. So as you know, we have the 60 day payment rule policy that we work on , um, that requires us to do a lot of due diligence, and , um, sometimes we start to get close to that 180 days or , um, you know, the, the , the long period of time that you get for the due diligence. We're getting very close to that mark and may even surpass that. Mark, what, what should somebody in our position do to demonstrate to the government , um, if they come to investigate that you have been taking reasonable steps , uh, related to the 60 day repayment rule?
Speaker 3:Yeah , uh, excellent question, Mary. This comes up all the time because , uh, even if you dedicate a ton of resources to fixing a problem, sometimes those problems are really intractable and will require quite a bit more time than the six months the government gives you to, to try to , uh, uh, figure out all of your due diligence and then take the additional 68 to make the payment. So the, the , this , the most important thing is, is that you don't let something just fester you. Uh, you should routinely check in and make sure that activity has occurred with respect to a particular issue, so that it's very clear that , uh, that there's no stalling , um, uh, because the, not to get too hyper-technical here, but if you don't, if you don't actually make a repayment of an amount that is due , uh, under the six day repayment rule, then that becomes a , what's called a quote unquote obligation under the False Claims Act. And , uh, and knowingly , uh, an improperly concealing an obligation is one of the triggers for , uh, for the false, for false Claims Act liability. So if you can say, well, we are not , we haven't done anything knowingly and improperly because even though we're outside of the, you know, the six , the six months in , in 60 days , uh, IE eight months, we still are working this in a reasonable fashion. Uh , then it's not knowing an improper , uh, concealment of, of , of a particular or retention of a , of a particular obligation. And so the goal is, is always to demonstrate reasonableness , uh, and steadfastness in terms of the approach that you're taking , uh, to, to handling an issue. My suggestion as well is always to document every instance in which , uh, the issue has been touched, as well as the next step and, and , uh, some sort of timeframe to make it very clear that this isn't just supposed to happen organically. That in fact , uh, the organization is taking all reasonable measures to bring an issue to a close in whatever is the most reasonably expeditious fashion possible. Uh , so by doing so, it would be very hard for the government to say that even if it took a year or two years, that it necessarily was due to in , uh, inattention by the, the entity , um, and that ultimately this got taken care of in the minimum reasonable amount of time , uh, necessary , uh, to, to be able to handle that particular issue. So, yeah ,
Speaker 4:Um , I could agree more. Andy and I, I think it's also great if you can document and keep those notes under privilege , um, to protect yourself and keep , keep track, you know, it's not only a great , um, documentation practice, but it helps you with your next steps and to-dos, and it's constant , you know, constantly there and being monitored. So, great tips . Yeah .
Speaker 3:Yeah. So it so much complexity in , in a lot of, a lot of the stuff too , um, especially in areas like research , uh, which is just so, it's a whole world unto itself. So , um, well , uh, with that , uh, we will close this out. Um, I just wanna say thank you to all the listeners for giving us an opportunity , uh, to present our experiences on this particular topic. And if everyone looked at super value last year and said, shucks, I really had hoped that , uh, that I was going to be able to , uh, limit my responsibilities for, for doing due diligence on the front end. Uh, hopefully Mary and I have convinced you it's really not so terrible. It really does , uh, come down to , uh, creating a culture where compliance is, is respected , um, and is an , uh, a good business partner. Um, and , uh, when that happens, then it all happens organically, even if there's still, still a still a lot of hard work that that occurs. Uh, so , uh, Mary, thank you so much for sharing your wisdom today. Uh, and with that, we will , uh, we will conclude.
Speaker 2:Thank you for listening. If you enjoy this episode, be sure to subscribe to a HLA 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 .