Michelle Frazier, Chief Compliance and Privacy Officer, Advocate Health, and David Glaser, Shareholder, Fredrikson & Byron, discuss how to mitigate risk using regulatory requirements and guidance. They cover the distinction between law and guidance, the legal authority to support that distinction and how to reconcile that distinction when being proactive about mitigating risk, real world examples of where these distinctions matter, strategies for hiring compliance positions, and the overlap between compliance and legal. Sponsored by Stout.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Michelle Frazier, Chief Compliance and Privacy Officer, Advocate Health, and David Glaser, Shareholder, Fredrikson & Byron, discuss how to mitigate risk using regulatory requirements and guidance. They cover the distinction between law and guidance, the legal authority to support that distinction and how to reconcile that distinction when being proactive about mitigating risk, real world examples of where these distinctions matter, strategies for hiring compliance positions, and the overlap between compliance and legal. Sponsored by Stout.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Support for A HLA comes from Stout, a global investment bank and advisory firm , specializing in corporate finance, transaction advisory, valuation, financial disputes, claims and investigations. They serve a range of clients from public corporations to privately held companies and numerous industries. For more information, visit stout.com.
Speaker 2:Welcome to ALA's podcast, mitigating Risk, regulatory Requirements and Guidance. My name is Michelle Frazier. I'm the Chief Compliance and Privacy Officer for Advocate Health. And I am pleased today to be here with David Glaser, who is a shareholder with Frederickson outta Minneapolis. He works in its health law group and co-founded its healthcare Fraud and Compliance group. David has considerable experience in healthcare regulation and litigation, including voluntary disclosures, criminal and civil fraud investigations, overpayments and reimbursement disputes. I've worked closely with David over the past 10 years and know firsthand that part of his practice is to explain the government's enforcement position and analyze whether this position is supported by the law represents government overreaching. So , um, this is a great topic for David and I to talk about today , uh, mitigating risk, regulatory requirements and guidance. But before I get into that , um, I did want to note that David is a frequent guest on RAC Monitors Monitor Mondays, and you may even read his blog at Orthopedics today. Um, he's given speeches in 36 states and in his free time, I know among many other things, he's a storm chaser extraordinaire. So thanks for being here today, David. Um , thanks , Abel . I feel that felt so formal. I know. I, I know. And we'll have to weave in your storm chasing , uh, throughout, because , um, if anything, that's gonna be one the thing that people , uh, walk away with that that's definitely an interesting fact about you. Um, but we're talking today about mitigating risk, and we talk a lot about this issue. Um, and you've always had a , you always have a smart and creative way of working through complex regulatory issues. Um, but when these issues come up, we usually start with a discussion about language, right? Or how language really matters , um, because not everything is illegal. Um, so to that point, I thought it would make sense for just us to start with that topic. Uh , just discussing how to distinguish between the law and guidance and , um, I guess I'll, I'll start with that. What do you think the difference is between law and guidance?
Speaker 3:Well, and this is one of these things, I've learned this over time, right? Largely by making mistakes and kind of being sloppy with language. And so I had a, a , a mentor who kind of taught me the regulatory hierarchy. And so he would say, Hey, start at the Constitution. Everything starts with the Constitution. And that doesn't come up too often in the healthcare context, but it can, right? You can, especially due process will come up. Commerce Clause might, I , I think Commerce Clause is gonna have an impact on telehealth analysis at some point, but that's a , a topic for another day. After the Constitution, you've got statutes, and at the federal level, obviously that's the, you know , generally Medicare, the Social Security Act, at the state level, you'll have a bunch of state codes that's always gonna be binding unless it's unconstitutional. Then you've got the regulations at the federal level. You've got, you know, the code of federal regulations, which is gonna appear in the federal Register at the state level. It might be called regulations. It might be called an administrative code, something similar. And I will refer to all of those as law. Um, I try to use law or statutes for the law, and then regulations or rules for the regulations as a personal preference. And then so far, I haven't mentioned national coverage determinations, but those are out there and, and actually they too are effectively, at least for Medicare law, and I would compare and contrast all of those with everything else, manuals, local coverage determinations, FAQs, put out by contractors. And I would refer to all of those as guidance. And I will say I sometimes not, maybe even sometimes, I mean , I frequently goof, I was recently working on a project, it was a hard lab question, and the first thing I did was crack open the manuals. And that was a big mistake because the regulations and statute both changed fairly recently as 2014 can be recent , uh, and then 2016, but the manuals hadn't been updated to take into account those regulatory and statutory changes. And so I was looking at something that was both invalid from a regulatory hierarchy standpoint and also from a temporal standpoint.
Speaker 2:So one thing, you know, that comes up with , um, my team, and this is something you and I talk about a lot with developing a compliance program, and how do you , um, build a compliance program knowing that there's this distinction now because there's what the law says, and then there's guidance out there, and shouldn't we also be looking at the guidance? So I guess, I guess I'll start by saying , asking, you know, what is the legal authority to support that distinction? And then I guess more importantly, from a practical perspective , um, how do you reconcile that distinction when you're thinking about being proactive in mitigating risk?
Speaker 3:Well, I think that practical one's important, we'll come back to that. Yeah , and I'm gonna throw that one back at you, Michelle <laugh> , because I think you've got thoughts on that. But, so from a, from a legal authority standpoint, it's, I don't want to throw too many citations around because it's , it's hard in a podcast. But Social Security Act, section 18 71, 8 2, so that's 18 71, 82 , has a provision in it that if you're gonna paraphrase, it says, if it isn't a statute regulation or a national coverage determination, you can't , the , the government can't use it , um, as a means to , um, deny Medicare coverage. And so it sets statutes, regulations, and NCDs on a different platform. And that's statutory. Then the Supreme Court in the Allina decision , uh, a few years back said, Hey, manuals aren't binding. I know I've lost litiga. It's , it's interesting. I've had litigation where I told the client we can't lose and then proceeded to lose, but part of my, we can't lose was that one of two things would happen. Um, the , the , the specifics of the case were, it was an appeal to the PRRB , the provider review reimbursement board, where the manuals said that if you mailed your appeal on time, it was filing was mailing the mailbox rule. If you mail it on time, you're timely. The regulation had a receipt rule where the ma , uh, appeal had to be received , uh, by the deadline. So my client relying on the manuals had mailed it in , in just sort of the weird way of the world. Uh, it took about 180 days for them to deny an appeal for being one day late. So we're now in court arguing, Hey, look, the manual says the mailbox rule applies. Well, the eighth Circuit disagreed. And, and it, it , there's a quote in there, which is really powerful. You rely on the manuals at your own peril. And so I think one of the key things in here is if the government is willing to say we're not bound by the manuals, when there's something in there that is not favorable to the government, it's gotta be a two-way street, right? We don't have to defer to those manuals. And , and my, you can't lose with either we'd get our appeal reinstated or we would get a definitive court ruling that says, you don't have to follow the manuals for better or for worse. We got the latter . Um, then, you know, there was the brand memo that came out. I'm gonna forget the year that the brand memo came out. Rachel Brand was like the Associate Attorney General and wrote a memo that said, we, the government will not use an affirmative civil enforcement action, often referred to as ace, where the government seeks money from someone based purely on , uh, anything in the manuals. Now, Merrick Garland has since withdrawn that memo, but I don't think that changes the law because we're really focused on the, on the Supreme Court. Um, finally, you know, LCDs, people often think of LCDs as binding, but there's a bunch of reasons to know that that is not true. First, you've got the regulation in the administrative appeals portion of the rule. It's 4 0 5 , uh, 1,062 that says a LJS may disregard an LCD , and then there's the ER care case . And so ER care was a hospice in Alabama, and the question was whether or not that hospice had to defer to an LCD . There was a False Claims Act case. They said, we don't think the LCD is binding. The court agreed it went up to the 11th circuit and the 11th circuit agreed. So that's sort of where we are on the law. And of course, you know, there's the whole issues with Chevron deference and whether that's in play right now, but I think however that comes out, it's clear manuals aren't binding. So now Michelle, I wanna come back to you because how do you differ , you know, how do you get someone to understand sort of binding versus non-binding, and how do you in particular say, we wanna follow this policy even if we don't think this policy is necessarily finding ?
Speaker 2:Well, it's a great question, and I mean, as you know, in working together, it's one that we talk about a lot because again, our, our goal as a compliance program is to run offense, to, to be preventive and to design things in a way, so we don't always have to get to an appeal to get the right answer. Um, but oftentimes that is making decisions where we set something up based on things that are maybe guidance rather than regulation. And, and making the determination of when to do that is the trickiest part. And so really it comes down to the level of risk associated with it, the should we do this versus can we do this discussion? Um, and , um, getting consensus around that. But I don't have a perfect answer to your question because it's one we struggle with quite often. Um, but we do use guidance a lot in developing and designing our program with the thought being that we're trying to avoid these types of arguments. But if there's a practical reason that the impact of setting something up in a way based on guidance could impact the business doesn't make sense, then, you know, we have more flexibility. And, and so that's a good thing. But , um, I, I struggle with this one a lot and, and hence why we, we talk a lot about this.
Speaker 3:Well, and to , to me, Michelle , one of the big things I have seen people who , you know, Gary, Lars , there's a Gary Larson cartoon about the monster or uh , uh, the monster in the basement, right? And pe and like parents will use tricks to scare their children. That's many a fairytale is doing that. And I think compliance people sometimes will say, don't tell, you know, the doctors about the actual law, because if they know that this isn't illegal, they won't listen. And I, I wanna fight back against that a little bit and say, Hey, I think we should be really honest in what is legal and what's not. And you don't have to use the law to scare someone into compliance. You can tell 'em it's not illegal. It's a matter of corporate policy, right ? And I think there are all sorts of things, you know, if I started swearing at my clients, that's not illegal, but the firm can fire me. And, and , and I think it's, it's important to not to, to invent gin up fake laws as a mechanism for compliance, but to say, Hey, look, this might not be illegal, but we're choosing not to do it. And I think that very direct approach can, can get you there in a way that at least someone isn't going to use your conservative language against you.
Speaker 2:I completely agree. I mean, it goes to your credibility as a program and believe you me, your your clients, those who you are working with on a day-to-day basis are very smart. And so even if you do build a program around this idea that this is what the law says, you will be called out on that , um, <laugh> because people understand and can, and can make that determination. And so , um, you have to be prepared to explain why. And , um, and be be very honest that this, this may not be binding law, but it is something that we believe strongly for whatever reason it may be to be our corporate policy. So I, I heartedly agree, practical ,
Speaker 3:You know, a practical example of that that you and I have both dealt with is e and m coding. And EM coding is less important I think in the new, in the new coding criteria today. But technically Medicare doesn't require documentation , uh, to build for a service and saying , and I think people get really worried, Hey, what if the doctors know that no one's gonna actually try to code to the guidelines, but I think it would be foolish for an organization to tell its doctors, Hey, you don't legally have to follow the guidelines. So we're not going to, I would expect an organization to say, these aren't legally required, but we as an organization expect you to follow them. Because if you don't, we're gonna have to go pay some outside counsel or use our inside lawyers a bunch unnecessarily. So that's a real world example to me where I would both explain something isn't binding and expect people to follow it nonetheless.
Speaker 2:Right. You know, and, and typically , uh, at least my experience has been that those on compliance teams, so you know, who are doing these types of auditing using e and m and maybe , uh, as an example, they're not attorneys and they work in a world of, you know, they need to understand black and white. And so those nuances are hard. And so really trying to build up your team with this understanding , um, can be a challenge, but really will benefit your program in the end. But somewhat related to that , um, we often have our team trying to figure out these nuances of regulations and use the old Google machine <laugh> to do this and wanted to get your thoughts on the perils of Googling regulations.
Speaker 3:So , uh, so much of my talks are based on times I've stuck the finger in the socket. So I was talking to someone specifically about the , uh, uh, diagnostic test supervision rule, and I know the rule number , so I googled it, I'm looking at it, I'm reading it, I'm talking to the client as I address their question. And then something in the back of my head said, something here seems wrong. This isn't sounding right to me. And I then realized that when I had Googled dysregulation, it had taken me to the , uh, 2003 version of the regulation. It was like the 2003 code of federal regulations. So that regulation is like old enough to vote at this point, right? Like it, and it was the number one hit. And then I wondered if this was something that happened all the time. So I replicated it and I learned the key lesson, which is Googling regulations is super dangerous. Now I think there's an easy fix to this, which is using the ECFR site, which I believe the e is for electronic, and it's a governmental site. And so if you, instead of Googling, you know, CFR, if you just put an ECFR and then the citation, it almost always takes you to the ECFR, which you can then look at the date and see that what it's current as of. So one of the things I tell people is everyone is going to Google stuff that is fine. Googling is all right , but you gotta be really careful and know what you're getting so you don't wind up like me.
Speaker 2:Yes, very good advice. Um, thinking back, so back to the NCD um, discussion we were just having , uh, I'm just thinking of real life examples, and this is front of mind for me because this is something my team has been looking at and trying to distinguish from prioritizing our audits , um, between audits based on NCDs audits, based on LCDs making, you know, having the discussion that we're having now on , um, where's the risk lie , uh, when it comes to these , um, these guidelines. Um, but just wondering if you could share some real life examples of where these distinctions really matter and have come into play.
Speaker 3:So my colleague Katie Oton taught me something back when we were working on the , uh, implantable cardiac defibrillator case. And so this I think is not widely understood. Once I learned it, it was easy and obvious, but until I learned it, it was not. So most NCDs are written with like an with four parts, A, B , C , and DA is almost always general B is almost always covered services, c non-covered services, and then D is other stuff. Now, not every NCD is set up this way. Many are, there are exceptions to this principle, but if you use the ICD example, there are a lot of covered services listed under B covered services. If you look at non-covered services, there's an NA for non-applicable. And what that means is that NCD operates like a safe harbor. Everything that's listed in covered services is always covered. Everything else is just a general service. Like every other service in Medicare, you determine it based on medical necessity. I think. I know, I thought, and I think most people think if you've got a whole list of covered services , um, and let's say it says it's covered on Monday, Tuesday, Wednesday, people would think that if it was the service was on a Thursday or a Friday, it's uncovered. That is not how an NCD works, unless Part C, non-covered services said services are not covered on Thursday or Friday. And that's super confusing and it makes the audit a big thing because if you, if you're doing an audit of an NCD and something doesn't fall into the covered services bucket, you shouldn't, you know, you might fail it in terms of the NCD , but that doesn't mean it's uncovered or that we it payment should be denied. Um, how, I mean, I know Michelle , how have you, how have you done this with folks?
Speaker 2:Yeah, I mean, it's a great point and I, I think that is a mistake that is easy to make. And so we have designed our audit program around NCDs with that, you know, with knowing this , um, point. But , um, it's, it's something that I, I feel like we revisit on a regular basis. And , um, it's , uh, it is something you've talked to my team about , uh, recently as, as we've brought practices together. So I think it , um, really comes down to the devil being in the details , uh, which you have driven home before when we've talked about this issue. Um, and , uh, I, I guess I just say it's, it hasn't been easy and it continues to be something that , um, is top of mind in designing our proactive auditing.
Speaker 3:Well, and I now almost think in some ways the devil, it's whatever is in the details, it's almost our friend, right? I I love those details. Um , and 'cause the details can , can get you out of so much trouble. Uh , you know , the two midnight rule, which is a favorite of mine, because the manuals for the longest time didn't come close to accurately de describing the two midnight rule. They were not updated for a long time, but when they were updated, you had this crazy situation where the manual was issued in March of 2017, but purported to be effective in January of 2016, like, you know, 14 months before it happened. And as , as we've discussed, manuals aren't binding, so you shouldn't be deferring to a manual anyway. But to the extent you think a manual has any relevance at all, it can't travel retroactively through time, right? <laugh> . And so that's really a big part of this, is that detailed analysis
Speaker 2:When we've talked about this for some reason, I have Fruit Loops in my mind. Remind me why I think about cereal with this issue.
Speaker 3:Well, do you remember who these spokesperson , uh, these spokes animal for Fruit Loops was
Speaker 2:The Toucan Sam.
Speaker 3:It was Toucan Sam, of course. All right . Yeah . So, yeah. Uh , and I had , I always, I always fond Toucan Sam , even if I didn't like Fruit Loops, I, this is another place where I've made a lot of mistakes, which is someone will ask, can we do this? And I often think , um, well Medicare won't pay for it. And so I will say, no, you can't do this. And it emphasized in my mind that I always have to think of two cans. Can we do it and can we bill for it? And I will sometimes focus on the, can we bill for it? And mistakenly say you can't do it. And there's lots of stuff you can do for free. I mean, you may not, it may not be the best business decision, but sometimes you do it anyway 'cause it's good for the patient. And so I, I use two cans, Sam, as my new , as my pneumonic for remembering that one. So , uh, I don't know , are you focused ,
Speaker 2:Sam ? I , no , now I remember. No, I don't eat fruit loops on a regular basis, but I will remember two cans now, so that's great. But it does, it does lead to that distinction. Makes me think about a conversation we have on my team quite often. Is this a violation or a potential violation of a condition of participation or a condition of payment? So speak to that a little bit bit because I think that goes right to, you know, the Toucan example,
Speaker 3:It doesn't. So first I don't know how we managed to come up with two, two expressions that are both abbreviated COP , and can you make things more confusing? So <laugh> , you know, a condition of payment, as the name suggests, is what it takes in order to get money. A condition of participation is a requirement that if you fail to meet Medicare can throw you out of the Medicare program. And a great example is that one of the conditions of participation is that physicians have to be properly , uh, uh, credentialed. Like in a hospital, your bylaws have to permit a physician to do whatever procedure they choose to do. And if they don't, you can be out of compliance with the conditions of participation. So if I'm a hand surgeon and I, for whatever reason, am not licensed to operate on fingers or no , sorry, not licensed , uh, I don't , I'm not credentialed within the hospital to do that, and I do it anyway, the hospital can face some sort of citation. And the question is, does that mean we the hospital have to refund the money for all of the surgeries I did when I didn't have the proper credentials? And the answer to that is no, because it's only a condition of participation. Payment isn't dependent on whether the hospital has credentialed you properly or not. It might be conditioned on licensure, but generally there isn't a payment rule that says only procedures for which the hospital has properly credentialed someone are eligible for reimbursement under Medicare. And so in the absence of such a requirement, there's no condition of payment. And so you can be in a situation where you kind of, in quote , just have a violation of the conditions of participation. And I don't wanna minimize that getting thrown out of the Medicare program is a big deal, but there is language in the manuals that specifically instructs contractors not to look for or to assess an overpayment merely because they found a violation of the conditions of participation.
Speaker 2:Very helpful. I mean, this is an issue that has come up , um, with our organization and something that we've now built that analysis into how we , um, address it. So extremely helpful guidance. But what about something as seemingly insignificant as a signature missing? And so that comes up too, where if we're not meeting every letter of, you know, whatever the rule may be or guidance may be, I think I should be clear on that. Um, you know, that's something that our auditors catch through an audit. And is , is that enough to trigger a repayment?
Speaker 3:Well, and that's such a good question. I think you did a really nice job there of that sort of distinguishing between the regulation and the guidance. And this is a place where it's really important because there is a lot of manual language that suggests signatures are necessary. Um, and some of it is inconsistent internally. And then most importantly, it's inconsistent with regulations. So there is manual provision that says when a signature is missing from an evaluation and management note, think office visit there, the manual says you should contact the physician for a validation or authentication of their signature, but not deny it. The manual says that their signature is missing from an order, you should deny care. Now, first key thing, as we've kind of talked about, manuals aren't binding. And so my advice is that if you find something that's inconsistent with a manual, I would tell you, you do not need to refund. A manual isn't enough to owe money back to the government. And that's kinda hearkening back to our hierarchy, the brand memo and things like that. But this is where things get even more interesting, because there is language in the federal register from Halloween of 1997. Um, I don't remember all of my Halloweens, but I remember this one because the IDTF rules came out in the fee schedule October 31st, 1997. And when I think it might have actually then still been hifa , the Healthcare Financing Administration, I don't think it was CMS yet. So when, then hifa , now CMS created independent diagnostic testing facilities, I DTFs they said, we think these things are bastions of fraud. These are my words, not its words. And because fraud is so common in IDFs, we're going to impose requirements on IDFs that don't exist in other settings. And amongst them, we're gonna require written orders for a , a diagnostic test done in an IDTF. So reading between the lines , actually, it wasn't even reading between lines, it was very clear in a physician office, you don't need a written order to do a diagnostic test. So here's a crazy thing in a situation where you don't need a written order, there's manual language that says you need a signature that can't be right. Like if it doesn't have to be in writing, it doesn't have to be signed. Whoever wrote that manual provision hadn't really thought about kinda the full, the full context of the regulatory framework. So I just wanna reemphasize, I wouldn't refund money ever off of a manual provision. If someone's only bringing me manuals, I'm gonna come back to them and say, Hey, show me the rule. Um, and then here on the rule, you gotta kinda , well , I guess we gotta think about what is the rule applying to the right place? Because if there's a rule that says you need a written order for an IDTF, the absence of that in any other setting is very compelling evidence that you don't need a signature. Right,
Speaker 2:Right. You know what, what I'm thinking about too , um, is with our , uh, audit team, we often hear we shouldn't do this because that is what our industry association is telling us . And so there's that type of guidance out there as well. Um, have you had experience with that? And what are your thoughts on that?
Speaker 3:I have had, I've had very memorable experience. I had a poor doctor who suffered through a search warrant because a trade group , um, was , or a physician. So it's a specialty, I would call this a specialty society even really, right? So it's a physician specialty society was talking specifically about the coding for a test, or I'm sorry, not for a test, for a surgical procedure. And so the coding question was a , a corpectomy code, if you really wanna follow along at home, it's a 6 3 0 8 1 . And the instructors at seminars would say that if you don't remove a third of the vertebrae, you don't get to bill with this code. And they've viewed that as a black and light . You don't remove a third. If you did 28%, it's fraud. So this physician didn't believe that was true and was at times removing 15% of the vertebral body and billing the code and his coder , uh, you know, called the government. And like I said, a search warrant was executed. And it took us a while before we got the government to recognize, hey, the definition of the code is partial removal of the vertebral body. And that a fact that a specialty society has come up and articulated a particular different standard is irrelevant. When we're in the world of Medicare, we really can limit our consideration to statutes and regulations and NCDs. And if it's not in one of those things, it, it doesn't matter. I should put a caveat on there because I believe CPT is incorporated. I will admit the last time I tried to find the regulation incorporating it, I struggled. There used to be one, it wasn't where it used to be, but I'm gonna say CPT guidance and I would even include CPT assistant as something I'm gonna defer to. But if it's a trade group , um, if it's something by , uh, help me out, Michelle . The , um, the coding trade group , uh, that I am , uh, totally blanking on the name of right now , um,
Speaker 2:I am too. Okay . Don't come to me . The coding trade group, for those of you listening, you all are screaming, screaming out the, the letters to us right now.
Speaker 3:It , it'll come to me in a second and I will, I will interrupt myself with it. Um, but they, what they say isn't binding. It can be helpful, but not binding.
Speaker 2:Well, what about LCDs then? I mean that, that's kind of similar and that's something that comes up. I referenced this earlier. Um, what are your thoughts on LCDs?
Speaker 3:So LCDs in my mind are as unbinding as anything. Well, I I'm not going to refund on them, right? I might, I might choose to follow one if I'm an organization because life is short and I don't wanna pick that battle. But I , I have discovered that we are in violation of an LCT . I'm gonna ask a key question of the medical team. Do you think this care was medically appropriate? Did the patient need this care? And if their answer is yes, I am not gonna refund the money, I'm gonna say that the LCD isn't binding and we haven't committed fraud by providing care that the patient needs. So I might tell the pa tell the team, Hey, look, going forward, we don't wanna do this anymore. And I think that is really one of the big challenges. And I would look to you there for, do you have any wisdom on language you've used in the situation where you, you know, in essence have decided something isn't, if something is legal right, but we're gonna change it going forward. Is there anything you'd like to say on that?
Speaker 2:Well, I mean, back to our initial point on language matters, that's where, I mean, this is, this is an active conversation we're having right now in developing , um, as you know, our system just went through a combination. And so we're integrating our processes. And so looking at all of this through fresh eyes and , um, where LCDs are informative, where we believe that it is something we should audit for the reasons that you just mentioned. Um, we, we build that into our work plan. However, we have to be really careful on how we word things so that it doesn't somehow look to be triggering a retroactive or repayment situation. And so that's where just how we word things in our reports , um, and making sure it's clear that this is guidance best practice, but not based on law. So I don't have specific wording, but that's the spirit of how we're designing things right now.
Speaker 3:You've got Spirit, yes, you do. <laugh> got , I think that's exactly the right way to do it. And hey, I did, it's a, A PC , the American , uh, association of Professional Coders. It did eventually come to me. Great. Um , and I will note if you Google is undercoating fraud, A A PC says that it is , and I could disagree more, right? A undercoating it may be foolish, but it is not fraud.
Speaker 2:Yeah. And that's something we, I mean that, that's, that's definitely a , a perception for those that belong to that group. Not all, of course. But , um, it's definitely something that, again, back to having open discussions around these things, making sure your team , um, understands what these nuances are. When we've talked about this issue before, we've talked about a , what , what we've called the endoscopy capsule conundrum. But remind me exactly , um, what that means and how this relates to what we're talking about now.
Speaker 3:Yeah, so this is one where a client calls me up and they said, Hey, David, we've been crediting our physicians in our compensation formula when they do capsule endoscopy. So capsule endoscopy, as you know, Michelle , you swallow a pill, this is science fiction stuff. You swallow a pill with a camera and it takes pictures of your gut, basically all the way down very , uh, Ms . Frizzly , uh, from the Magic School bus, right? And so they were crediting physicians and they said, we're in a, in a deal with private equity right now, and we have been told that capsule endoscopy is a designated health service. And so I said, no, it's not. Um, and they said, well, the other side says it is, and they actually, they, they can point to language in the federal register. And I'm like, oh, geez , I've missed something. And it is true, I had missed something. This is one of the stories I like because I am both right and wrong, or both wrong and right, depending on which way you wanna go with it. So if you look up the list of designated health services in the Federal Register capsule , endoscopy is on it. So that would suggest it's A DHS, but the law says the applicable provision of the law would be radiology services , including MRI , CT and ultrasound. That's kind of the, the mechanism that would be the gateway in if it were covered. And is capsule endoscopy a radiology service that is Mr . CT and ultrasound? Well including those? And I would say absolutely not. And part of how I would point to that is I would say that the other way you do endoscopy is you have a tube and you stick the whole tube down the esophagus. Everyone agrees that's not a radiology service. So why does it become a radiology service if the same thing is being done with a capsule instead of a tube? And my answer is, it doesn't change anything. And so, to me, this is a great illustration of a regulation that exists, but it's invalid because it's inconsistent with the statute. And so I really think, you know, this may be is our , will be our last concrete example, is that it's a perfect one for thinking about the hierarchy and how just because you find a regulation that says something is covered or , uh, or not covered, that you don't, you don't stop there. You have to think about statutes, right? So if you find something is in the manual that tells us nothing, we gotta go look at a regulation. If we find something in the regulation that tells us something, but we still have to consider the statutes in the constitution before we can put it to bed. So Michelle , I got a question for you, which is one of the challenges in compliance world, I think is hiring. Um, do you have any tips for strategies to get people who are gonna think about this in a way, you know, who, who will be good team members, right? Who will, who will be able to think about this in the right way?
Speaker 2:Well, that's a great question. Um, and you know, my philosophy in hiring, I mean, first, first off , uh, making sure that I have a diverse team both from , you know, diverse in many regards, but from backgrounds and experience. So thinking about our revenue cycle compliance team, certainly you want people who have strong coding experience , um, who can use that to be efficient and effective in how we do our ongoing auditing and monitoring. But you also wanna bring in people who have kind of a different way of looking th at things. So I love bringing in people from operations into compliance because they understand the practical implications of a policy, an auditing process, you know, various components of a compliance program. Um, uh, and uh, I will say that although we don't have a lot of attorneys on our team , um, I do think that it's really important for a compliance team to understand the connection to legal and the relationship between compliance and legal. Um, and I and I, I'm an attorney myself, I , but I do feel like there is that difference. And when there are questions around is this legally binding, what is the impact of this guidance? Having that close relationship with legal, having a team that you've hired that is open to these discussions is extremely important. And looking to legal to help with the interpretation and not just , uh, trying to Google to figure it out. And so that's kind of how we've built things up. Um, and um, and , and what I look for when I'm hiring people that openness and understanding of the role of compliance.
Speaker 3:Michelle , I know there are definitely organizations that think compliance and legal should have a a wall between them, right? Um, and that they're different critters and that if anything, they may be even in competition. What's your take on that?
Speaker 2:Uh, I, well, I mean, I, we work extremely closely with legal. I think there we are different. I I always equate it to offense and defense or, you know, compliance is the primary care physician. We're trying to be preventive. Um, and legal are the specialists that come in to help with , um, complex matters. But I mean, in reality, we are working with legal every day to make sure that we're designing a compliance program that is effectively being preventive and proactive. Um, without that relationship, I think it would be really hard. Um, so I, I'm, I'm not in the club of , um, looking at the teams as in competition. I do think we have different focus areas , um, but certainly the overlap , um, is more important.
Speaker 3:Well, it's interesting. I, like I talk with you a lot. I have clients that I've literally never talked to a compliance person. Yeah. And I think it's an interesting difference and I, I'm constantly impressed with the way you guys pull operations in , right? 'cause operations is such a big part of this. There's no mere legal without the it , um, without the, the practical part. But that integration I think, works better. And I think I've been impressed by what I I've seen.
Speaker 2:Thanks. I mean, if you think about building, I mean, at the end of the day, complies about is about building a culture that keeps us within the lines and keeps our focus on our patients. And if we don't have operations buying into that , um, we'll never meet that goal. So that , that , that is really important. So take us home , uh, David, I know you kind of summarized the , um, you know, what you want people to walk away from this with, but , uh, if you could summarize the message from this podcast quickly, how would you do that?
Speaker 3:Yeah, I think, I think it's really just a few specific things. So the first one, I would posit that us lawyers are paid primarily to read carefully. And often the answer is in there. You just, it's, it's just, it's, it's got too many here, two fours and therefores and here under , and people stop reading 'cause it's hard. And so the first thing, read carefully and figure out if what the thing , the thing says what everyone says. It says the next thing. If someone shows you something, like when someone tells you something is illegal, the first question I always ask is, show me the rule, right? Because I wanna figure out what they're looking at. Uh, and so as they show me the rule, I'm gonna ask, well, is this thing valid? And that validity really is then a multi-pronged question. So part of it is in our hierarchy, is it valid, right? So that's our constitution statutes, regulations, NC D versus manuals LCD and FAQ . But validity gets more complicated than just that because you've also got , um, to check the dates and, you know, maybe the rule was issued after the event . The behavior you were doing , uh, happened a place, gosh, I struggle a lot these days with incident two. And what level of supervision do you need? And it's so easy to forget that during the pandemic, you didn't need anyone in the office suite. Like I grew up virtually. If you shook me at two o'clock in the morning and said, what does it take to do incident two? I'd be like, you need a physician in the office suite. Well, during the pandemic that was suspended and then it was gonna continue through the end of 20 20, 20, 23. Now the new fee schedule extends that for another year, right? And so now if someone comes up and asks, do you need a physician? My answer today would be, you do not need a physician in the suite. They just have to be available remotely. I'm rambling on on this one a long time, but just to say it will be important now to remember there was a time in the past where this wasn't the rule, right? And so you have to check the dates and then you have to climb that regulatory hierarchy. And I think I, I'm at the top of that ladder right now and it is starting to fall because I went on too long on that one. Michelle .
Speaker 2:No, it was great, A great summary. I hate to think the people waking you up at 2:00 AM asking you about incident two. Hopefully that really doesn't happen in real life. But , uh, a great example, the dogs <laugh>. Well, thanks David. As always, I've enjoyed talking to you today, and thanks to everyone who's listening to this A HLA podcast. It's been a pleasure.
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