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Pathology Under the Microscope: Fraud and Abuse Risks and What Attorneys Need to Know
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Don Crawford, Partner, HMS Valuation Partners, speaks with Lisa Re, Partner, Arnold & Porter, Danielle Tangorre, Partner, Robinson & Cole, and Elizabeth Sullivan, Member, McDonald Hopkins, about the arrangements that pathology groups rely on—hospital professional service agreements, TC/PC structures, and transactions—and why these arrangements are getting so much attention from regulators. They discuss where the pressure points are, what DOJ and OIG are zeroing in on, and how counsel can navigate these arrangements without stepping into avoidable risk. Sponsored by HMS Valuation Partners.
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SPEAKER_04Welcome to today's AHLA Speaking of Health Law podcast. I'm Don Crawford, partner with HMS Valuation Partners, and I'll be your host for today's episode. We've got a fast-moving high-impact conversation lined up for you. Today's episode is entitled Pathology Under the Microscope: Fraud and Abuse Risks, What Attorneys Need to Know. We'll be breaking down everyday arrangements pathology groups rely on hospital service arrangements, TCPC structures, acquisitions, and why these routine deals are getting so much attention from regulators. We'll talk about where the pressure points really are, what the DOJ and OIG are zeroing in on, and how council can navigate these arrangements without stepping into avoidable risk. But hey, before we get started, let's kick things off with some introductions. We've got three fantastic guests with us who live this work every day. Would each of you share a bit about your background and your focus of your practice? Lisa, let's start with you.
SPEAKER_03Hi, my name is Lisa Ray. I am a partner with Arnold and Porter. I joined the firm last fall after a 20-year career at HHS OIG, and I take that experience to help counsel clients on fraud and compliance matters. Thanks for having me with you today.
SPEAKER_04Danielle.
SPEAKER_02Thanks, Don. Hi, everyone. My name is Danielle Tangor. I'm a partner at Robinson ⁇ Cole, and I have a national pathology and clinical laboratory practice along with other healthcare providers, counseling on regulatory fraud and abuse and internal investigations. And look forward to the conversation today. Thanks to HLA for having us and HMS for inviting me.
SPEAKER_04Great. And Liz.
SPEAKER_01Thanks. Hi, I'm Liz Sullivan. I am a healthcare attorney with McDonald Hopkins. I head up our healthcare practice group. I started my career at McDonald Hopkins. I also spent a number of years, about five years in-house with a large academic medical center. And I've been back at McDonald Hopkins for about 10 years. And my practice is also focused in pathology and clinical lab. And really, you know, although it's not exclusive to that, I also am very focused on business arrangements and fraud and abuse compliance, billing issues, sort of anything that might come up for a healthcare provider, but particularly for physician groups and independent providers. So I'm very grateful to be here today and looking forward to this discussion.
SPEAKER_04Great. All right. Well, thanks everyone. Well, look, let's start with hospital professional service agreements. Every pathology group has them, and hospitals are tightening budgets. That pressure can somehow change how the agreements are negotiated and sometimes how they're even structured. So what does that mean in practice? And what's the government drawing attention to right now? Lisa, can you kick us off?
SPEAKER_03Sure. So to level set, I want to start this conversation really with a common understanding of the anti-kickback statute. The kickback statute is a criminal law that prohibits paying or receiving remuneration, which really means anything of value to induce referrals for items or services that can be paid for by federal healthcare programs like Medicare and Medicaid. It's an intent-based standard. It is very broadly written and interpreted by the federal government. And it's important to remember that arrangements raise kickback concerns if just one purpose of the reason for the agreement is to generate federal referrals. So, with that background, you know, OIG has created a lot, but given those kickback statutes, given its breadth, OIG has created regulatory safe harbors for certain situations which can protect business arrangements. You can comply with those voluntarily. If you don't satisfy each element of the safe harbor, it doesn't necessarily mean that it violates the law, but the more protection, the more you're within the safe harbor, the better protection that you have. So with that said, HHS OIG has warned about financial relationships between hospitals and doctors since at least 1991 in terms of their published guidance. And their concern is pretty straightforward. If a hospital pays a doctor more or less than fair market value, or requires the doctor to pay the hospital more or less than fair market value, then that financial imbalance can implicate the kickback statute. So trying to make sure that the relationship is, you know, that arm's length transaction. This is particularly relevant for traditional hospital-based doctors like anesthesiologists or radiologists, and of course, here, most importantly, pathologists. And that's because the concerns are different where the hospital makes the referral or where the doctor's making the referral. And in this situation with pathologists, the hospitals are often the ones that are in the position to influence the flow of business that's going to go to the doctor. So OIG looks at the relationship holistically, doesn't just focus on one piece of the arrangement, but really evaluates over the arrangement overall, including like exclusivity, exclusivity provisions and service exceptions, and that we want to make sure that it truly reflects fair market value given all the facts and circumstances and the arrangements between the parties. OIG has given a lot of guidance most recently in the general compliance program guidance, and it provides a series of questions that you can go through when you're trying to assess fair market value.
SPEAKER_04Okay, well, great. Well, thank you for that. That's a great framework. In real-world contracting, where do pathology groups actually hit the toughest negotiation friction? Are there certain expectations for included or informal services? Danielle, Liz, can you all take that?
SPEAKER_01So I guess kind of to describe the arrangement, and this may be typical for other specialties or hospital-based specialties, but there's typically sort of two parts to the arrangement loosely. This obviously is kind of an over-generalization, but you have the professional services that the group will perform, and that's, you know, the business that is directed from the hospital, typically under an exclusive arrangement. And so the group will perform those professional interpretations, bill directly for those. Typically, the group is also going to be contracted under that professional services agreement to provide medical direction, maybe for the pathology department, if it's organized as a department, but for sure, I won't say for sure, but in most instances, also for the laboratory. They are going to be the laboratory director of record for the CLIA certified laboratory for the health system, and they're going to be responsible for the duties that go along with that. And so for the professional component, straightforward, that's typically going to be built by the group, but the hospital will often reimburse the group for the work that they're doing for the medical directorship, oversight of the lab, and maybe some other things as well. And I think with sort of the downward pressure that exists in budgeting right now, there's sort of two ways that I would say I see it playing out. And Danielle, I'm very interested to hear your perspective. But one is just on the reimbursement for those professional oversight services, medical director services, sometimes called part A services, because there is some reimbursement from Medicare Part A for the hospital's overhead, which includes that oversight piece. Those part A services, we're seeing downward pressure, whether it's reimbursement on hourly rate, reduction in sort of a larger set fee, or a cap on hours. So the hourly rate itself isn't the issue, but the hospital administration is, you know, asking for reduced hours or capping the hours somewhere that they feel is appropriate. The other thing I would say is, you know, on the other side of the coin would be increased responsibility with stagnant reimbursement or payment. So, you know, there's an explosion of tumor boards, um, laboratory testing is becoming more complex all the time with precision diagnostics. And um, some hospitals also have uh outreach laboratories that serve the community and they wish to grow those. And so some of that responsibility goes to the pathology group or the laboratory director. There's not that's not always recognized in the value of the arrangement. So those would be my thoughts there.
SPEAKER_02Liz, I would totally agree. And I think those are all common issues that we see in our pain points, right, for the downward pressure. Um, and just, you know, and to the point about the Medicare part A and those payments and what that ends up being translated into as a medical director, I think in a corollary is uh part B payments, right? Um, with or commercial payers, right? Is the hospital going to pay when you're not billing part A? You're doing those outreach services for part B or you're billing the commercial pairs. Is the pathology group going to bill for those services to commercial payers, right? For those kind of the medical oversight um and give you know disclosures to patients, or is that going to be billed to the hospital? Is the hospital hospital going to reimburse? Um, or is there this kind of expectation that it's going to be free because they're doing it, you know, and compensated under Medicare party? And I think that one becomes really sticky as a discussion point, you know, and then I think you make a good point as they branch into all of these other um issues, it's that quality and the oversight and the other expectations and what's included. And with a lot of the pathology agreements, I think they're um, I think some of them are really old, right? Like hospitals and these pathology groups just have really old contracts that were not as defined. And so when hospitals and pathology groups are now renegotiating, it's also trying to memorialize what is the expectation and really outlining what are the services, what's included, and what should be paid and how that um, you know, fair market value is determined.
SPEAKER_01Yeah, that's such a great point. You're right. When we were talking about this, we were talking about how we've all seen those um contracts with hospitals that are maybe are decades old that you know the parties just tried their best to continue to live and operate under them, and they they have not been appropriately updated.
SPEAKER_04Okay, well, um, let's move on to TC PC arrangements. They're everywhere in pathology and getting a lot more scrutiny. What should groups and their council be watching out for when they structure these? And what's maybe a one red flag question to ask before agreeing to a purchase TC or global billing setup? Lisa, can you start us off?
SPEAKER_03Sure. So um OIG has a process for requesting advisory opinions, and you can ask OIG to opine on a proposed arrangement and whether or not it would violate the kickback statute. And I think uh advisory opinion number 2306 is really instructive here. Um, in that case, the requester, the one who went to OIG for the opinion, was a national anatomic pathology lab. And they asked AHHS OIG whether they could enter into an arrangement to purchase the technical component of a pathology service from another lab and then bill commercial payers for both the technical and the component and the uh professional component of the laboratory test. What's important is that this arrangement included a carve out, meaning it was really only limited to commercial insurance business, not Medicare or Medicaid. And the participants would be paying fair market value for the specimen from when they purchased, the lab would be paying fair market value for the technical component that they were purchasing from the referring labs. OIG here issued an unfavorable advisory opinion, and they didn't approve it for a couple different reasons that I think are instructive and things for you to think about as you're structuring these agreements. The first is that even though this arrangement was only for commercial insurance programs, OIG explained that carving out federal health care programs is not enough because payments were still tied to services from patients in a position to referral federal health care program business. And that alone can implicate the anti-kickback statute. And that's been the OIG's long-standing opinion there. The second issue is that OIG was concerned about the remuneration, and here it was a per smess per specimen payment that it could influence referrals of pathology work that may be reimbursable by federal healthcare programs despite the carve out. And finally, OIG found that the arrangement really lacked commercial reasonableness for a business purpose. And in this case, it would have actually been better and more efficient for the requester to just do both, both the professional and the technical component. And that for that reason, because it wasn't commercially reasonable in OIG's opinion, they determined that it could be designed to induce referrals. And I think, you know, the real practical takeaway here is that pathology labs and referral sources really need to be cautious with purchased purchased services or split billing arrangements. Even if it's limited to commercial payers, that doesn't get you out of the kickback realm because OIG may view them as potential kickback violations if there's any incentive tied to re to those referrals of federal health care program business.
SPEAKER_01I wonder just to jump in, um Danielle, I don't, I don't, I know that you have seen these as well. And I'm I'm not sure if you want to talk a little bit about typical TCPC arrangements because Lisa, you've kind of set the stage for us. And certainly with pathology groups that are approached by referring physician groups, you know, some of those referring physician groups will set up their own TC processing labs so that they can prepare their own specimen slides. And that is a lot of where I would say I certainly am seeing the challenge with the split bill or just TCPC arrangements in a in many different um permutations. Um, but typically we're talking with TCPC arrangements, they could be also with hospitals, but many of them, and certainly the way I read the advisory opinion, it is probably a referring group's lab and a typical more robust uh pathology lab or clinical lab that can do that work. Um, and so what you know, reading between the lines, a lot of times what will happen is if the referring group is um unable to bill for their technical component processing that they're doing in their lab, or they're getting um less favorable reimbursement, they might go to, you know, um their partner lab and say, you have better reimbursement rates. Why don't you purchase this piece from me, you know, and you could do the other piece. And so that's kind of a practical way that this is out there in the world. And oftentimes they're presented in a way that you sort of say, Well, this could make sense, um, but you really want to dig down into that and sort of see where are the drivers and where are the financial incentives.
SPEAKER_02Um, so Liz, I think you you hit it on the head. I mean, you know, I always ask, would this arrangement exist if other referrals were taken off the table? Right. Like, does it make sense? And I think that really goes to the commercial reasonable point, which I think people often like overlook, right? It's part of the safe harbor for personal service management under the kickback statute. Um, but I think it's the one that often gets least is least focused on, right? Everyone talks about fair market value and they think it kind of ends there. Well, if I just pay a fair market value price for this, then it's all okay. And we have a contract and it'll be fine. And it's it fails to look at that next prong of like, well, why is this arrangement existing? Is it because you're getting a favorable reimbursement or you know, you haven't gotten the in-network contract, so you're not getting paid? Like, what is the reason for it? You know, I think also you have to ask sometimes TCPCs can still be okay even with this advisory opinion, if you know there's like some esoteric or unique or right professional component where you really need that expertise from the pathologist. And maybe it does make sense for the patients um to have a global bill, right? If everyone's in network, for example, and you have those. And I think um Lisa, you hit on part of the advisory opinion that really stuck out to me in addition to the commercial reasonableness is um that it was less cost efficient and you know, inefficient to do this arrangement. And that that line in there, it just stuck while I mean, I think everyone when we saw these opinions and we're practicing in this way said, It's almost as if they were asking for a negative opinion, right? Because who would write saying it's you know less cost efficient um to do this? And I think that's part of it, right? Because that obviously goes to it it lends itself to, you know, the kind of the four principles that I think advisory opinions are written around about is it improper utilization, is there improper steering, is there unfair competition? Like what is the bigger point? Um, and so I think you really do have to dive down into those details in the arrangement and ask the hard questions about why does this make sense outside of the money flowing?
SPEAKER_03Yeah, I would agree.
SPEAKER_04Any other comments here?
SPEAKER_03I I just want to jump in and say, you know, that's what the government does when they're investigating a kickback case. Like that's the first thing is like, would what makes sense here and why are the parties doing that? And so it's really important that you're engaging, I think, in those conversations with your lawyer, because um, at some point, if there is any type of an investigation, that's you know a really common question of what is really the intent behind this? Because it's very rare that people will say out loud or in an email that they're doing it uh to induce the referral federal health care programs, though it does happen. Um, but um, but so really the government's just trying to look at like, does this make sense and why, what's the real intent behind the arrangement?
SPEAKER_04Okay, thanks. All right, well, let's um talk about transactions. Um, acquisitions and pathology are growing, and as those grow, so do the compliance risk. Um valuation decisions can start looking like remuneration if they're not grounded in FMV and commercial reasonableness. So, where's the line between valuation and inducement? And for groups that are in a roll-up, where's the risk of getting pulled into someone else's compliance problem? Liz, can you take it?
SPEAKER_01Oh, sure. Um, yeah, I mean, I I think this really builds on the commercial reasonableness discussion that Danielle and Lisa were highlighting in the last fact pattern because um, you know, but for referrals, why does an arrangement make sense or why does the pricing here, we're more talking about an acquisition, why does it make sense? And so, you know, to your question, Don, where can you kind of get sideways with these? What I would say is at least for a pathology group, I would it's most likely going to be in a situation where they're like being um added to a multi-specialty group or you know, some type of specialty group that's more of a referring, um a referring specialty, you know, if you're thinking about a GI group that needs to add a lab or some other type of specialty like that, Durham Urology. Um, because in those instances, it's super critical that you're integrating the lab services and that the compensation across the group is consistent with the Stark law. Um because if it's not, or it's um, I would say for Stark, I'm thinking about it first from the Stark perspective. Uh you know, if that compensation isn't structured appropriately for the DHS, which is, you know, the interpretation, the lab services, um, then the whole model could have an issue or could be under scrutiny. And then with respect to AKS, I would say it does come up. Um, we've certainly seen uh settlements with the government for acquisitions of referring practices that are going into a larger multi specialty or that have the ability to perform pathology services. Um, you know, if the valuation for the acquisition of That referring group really isn't based in the referring group's productivity. Then the question, you know, if that is not clearly documented, the question or the inference is sort of Lisa, what you were saying, which is why is it being purchased for X purchase price if it's not about the productivity or the footprint of that particular group? Is it about, you know, the potential for referrals? And so here we're talking about pathology, but it could be other ancillaries depending on the specialty. And so certainly there have been those settlement agreements. In one particular settlement agreement a couple of years ago, there was a roll-up in which it was self-disclosed. And the allegation was that the organization had recognized through, you know, probably internal documentation, that some of the leadership had increased or agreed to increase purchase prices for certain of the target um uh physician groups that they were acquiring. And it was likely because those physician groups were going to generate referrals. And so that was obviously problematic. And, you know, when the government worked through the settlement agreement or the self-referral process and the settlement with them, they recognized that that was problematic. So I would say, you know, those are two ways that you can see it in an acquisition. Um, but I welcome the thoughts of the other panelists.
SPEAKER_02Yeah, I mean, I think that, you know, um acquisitions can be tricky. I mean, at some point, right, all the valuation of an acquisition is, you know, is based on the business that that entity is bringing in, right? So it is based on referrals kind of at the heart of it anytime you're purchasing it. But the question is, um just where does that become an issue, right? And I think it's some of times it's that post-acquisition when the owner stays on, right? And um whether it's um incentivized or whether it's um if there's some other manner in which, you know, uh as they're aligning into kind of the practice groups like you talked about, Liz, that um that alignment has an increased expectation, right, of cer referrals being directed a certain way. And I think that goes back to those um, you know, kind of those themes that I think OIG looks at if, you know, as laid out in the um advisory opinions often is whether, you know, is there inappropriate steering? You know, are we thinking about where referrals are going based on the best interest of the patient or uh most cost efficient or things of that nature, or is it increasing utilization? And if those post-acquisition expectations, right, and being compensated for that is to improperly steer that or influence that, then I think that can be um can you know highlight some concerns. Uh, you know, and I thought I I do think this um decision was interesting in that there was some sort of documentation about essentially purchase price manipulation, um, you know, and how that how that played out.
SPEAKER_01Yeah, that's actually a really good point, Danielle. I was kind of focused on the purchase price piece, but you're so right that you know it's kind of post-close and it's like what are the compensation incentives for you know the former owners or the former physicians as they come in to the group? Like what's driving that? It's a really good point.
SPEAKER_04Lisa, do you have anything on this too?
SPEAKER_03I was just gonna talk about self-disclosure. So if you want to jump into that piece of it.
SPEAKER_04Yeah, absolutely.
SPEAKER_03Um I mean, I just I just wanted to highlight really quickly, you know, because you mentioned that um one of those cases was a self-disclosure. And um, you know, I think, you know, now that I sit on on this side, I realize, you know, how many this is a complicated analysis, right? On whether you've discovered a billing error, so now what? Right. And sometimes the right answer is that you just need to repay an overpayment. Sometimes the answer is you need to do a self-disclosure. Then who do you self-disclose to? Do you go to OIG? Do you go to the Department of Justice? And there's a lot of factors I think that go into this, but I guess the point I want to make is that there are a lot of self-benefits to self-disclosure when it makes sense. Um, you know, for putting on my government hat, you know, the government knows that no provider is going to be perfect. And so the question is, when you have a problem, what do you do with it? Right. And I think that the perfect, at least from OIG's perspective, in my experience, they use a lower multiplier, they don't have compliance obligations in part to encourage people to take the time to do the self-auditing and to identify problems and to be a good corporate citizen once they decide determine that there is an issue, and then bring it to the government's attention. And like I said, it gets really complicated. You know, is the rule clear? Should the payment go back? You know, there's a lot of things that go into it. But I just want to say that um, you know, you really interface with the government one in two ways. And one is when the government knocks on your door, and the other is when you knock on their. In my experience, um, it's always best to be doing the person who's doing the knocking. So um, that's my pitch for self-disclosure when it's appropriate.
SPEAKER_02I think, you know, that's a really good point, Lisa. And I do think, you know, you definitely get more favorable um, you know, cooperation, you know, if you're being fully transparent and cooperative, I think that's always part of it, right? And it's always a hard analysis when we walk clients through whether to do whether, you know, this is a self-disclosure or whether it's just an overpayment or what that is. Um, you know, I did think there was um a case a few years ago uh that was also a self-disclosure, um, and it was after the TCPC um advisory opinion. And a pathology group went in and did a self-disclosure because they had these TCPC agreements and they did an internal investigation. And um, you know, they had to pay a significant amount of money back because of um, you know, their conduct. Uh, you know, but in the press release, it really highlighted that um the self-disclosure and the full cooperation that the you know pathology laboratory presented the government with really reduced and saved them hundreds of thousands of dollars, I think was what the quote was, um, you know, because they had gone through the self-disclosure. So I think that just really highlights um, you know, regardless of the um type of scenario we're talking here, it's important to discuss that because no one's perfect, you may not realize. Um, and it's important to have those conversations and go through that analysis that you just talked about.
SPEAKER_00Yeah.
SPEAKER_04Well, yeah, it sounds like what you're saying is um self-disclosure could actually be part of a strategy, right, for counsel. Like think about it as another avenue to make sure everyone's safe.
SPEAKER_02Yeah, I mean, I Don, I think, you know, I think all of us, you know, as we advise clients, we have to sit there and say, both what is what do we have to do about looking back, right? When a client comes and we say, oh, there might be a problem here, it's not only about fixing it for the future, but is there anything we have to do in the back? And that can look like a potential self-disclosure or an overpayment, or maybe nothing, right? Depending on what you know it is and where they come to us at the the time.
SPEAKER_01Yeah. And I I guess I think this is such a valuable discussion uh because so often it is a tough conversation, like you said, Danielle. And I don't think I don't think providers always realize, you know, that the government understands that everything's not always perfect. I think that, you know, there is a lot of hesitation and fear around the idea of a self-disclosure. Um, but you know, as you guys said, there's there can be such significant value to it. It's really important to be a strategy as you approach, you know, issues when they're uncovered.
SPEAKER_04Okay. Well, um, we've covered quite a bit today. We've talked about service agreements, TCPC structures, transactions, valuation, inducement risk, and self-disclosure. And even though these arrangements look very different on the surface, the compliance themes running through them are remarkably consistent. So before we close, how about one final question for everyone? Um, if pathology counsel listening today could walk away with just one structural principle to apply across all of their arrangements, what should it be? Somebody want to just start that off for us.
SPEAKER_02Sure. I mean, I think you have to not look at things in a silo, right? Like you really need to evaluate the entirety of um the strategy, not just one deal, one arrangement. Um, and you know, it's risk isn't just what about you pay pay. I think, you know, Lisa started off really well saying, you know, it's the antiquity break statute has breath, right? And I think as Liz and Lisa and I've talked about it through the day, you can hear hear that in all of the different ways. And so, you know, it's not just what is the payment, but what can you expect in return and really looking and asking the hard questions about the overall arrangement.
SPEAKER_03I think my advice would be invest in your compliance program. Um, I mean, it is the front line, it is your first defense against fraud and abuse risks. And in my experience, we, you know, um, we talked a little bit earlier about some of these really old agreements, you know, that pathologists have with hospitals. And sometimes, you know, a relationship, uh, an agreement is perfectly fine when it's originally structured with the intent of the parties and the way that it's set up, but things change and evolve over time. And so I think it's important to just be doing that quick check on does this still make sense? Or or has, you know, have have in practice um or intent have things changed such that we need to take a closer look at this? Because, you know, um, I think a lot of people, and you know, through my career, I've had a lot of people say that um, you know, they didn't commit fraud because they didn't know, right? It wasn't knowing, it wasn't on purpose, it wasn't, it wasn't this intentional thing that was done without recognizing that that's not what the law requires, right? I mean, the the standard, it's more than negligence, but it's newer should have known, right? And so the government's gonna take this perspective of you, we expect you to be taking a look at things. Um, it's not, it's not that actual, that that actual knowledge. And so I just really think that um investing in compliance and doing a quick um compliance review and just making sure that everything is on track, having really good internal auditing just serves you really well.
SPEAKER_01Yeah, I couldn't agree more. I would say my thoughts are you guys have expressed them. Like you it every arrangement should be thoughtfully, you know, it doesn't have to be sort of turn it inside out and upside down, but it should be thoughtfully considered. Like what are the financial drivers? Where is the where is the business flowing from? Who are the parties? It really is that holistic approach that Danielle said or talked about. And Lisa, absolutely, you know, a culture of compliance. We're gonna look at these. We're not just gonna throw them in a drawer and let them collect dust.
SPEAKER_04So okay, great. Well, I think that's gonna be a wrap for today's episode. Um, a huge thank you to everyone on the panel here, Liz, Danielle, Lisa, thank you so much for bringing such sharp practical insight to the conversation from deal dynamics to valuation pitfalls, compliance tracks, anything that can sneak up on pathology groups. And thanks to our AHLA listeners. Thanks for spending part of your day with us. And we hope this episode gave you a clearer, more actionable view of the issues shaping pathology arrangements right now. Thanks for tuning in and have a great rest of your day.
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