AHLA's Speaking of Health Law

Fraud and Abuse: What Health Lawyers Need to Know about the Final Stark and AKS Rules

December 14, 2020 AHLA Podcasts
AHLA's Speaking of Health Law
Fraud and Abuse: What Health Lawyers Need to Know about the Final Stark and AKS Rules
Show Notes Transcript

In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Associate General Counsel, Compliance Officer, GRAIL, speaks with Joe Wolfe, Hall Render Killian Heath & Lyman PC, and Kristin Carter, Baker Donelson Bearman Caldwell & Berkowitz PC, about the recently-issued Stark Law and Anti-Kickback Statute final rules. The podcast details the changes made in the final rules and discusses how the rules will encourage innovation and how the changes ease compliance with the rules. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.

To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

Speaker 1:

The following message and support for A H L A is provided by Berkeley Research Group, a global consulting firm that helps organizations advance in the areas of disputes and investigations, corporate finance and strategy and operations. BRG helps clients stay ahead of what's next. For more information, visit think brg.com.

Speaker 2:

Welcome to the latest edition of the American Health Law Associations Fraud and Abuse podcast. I'm your host and chair of ALA's Fraud and Abuse Practice Group, Matt Wetzel. Today is Wednesday, December 9th, 2020. With me today are Chris Kristen Carter, a partner at Baker Donaldson, based in Baltimore, and Joe Wolf, partner at Hall Render. Based in Milwaukee, Kristen and Joe serve as vice-chairs of educational programming for ALA's Fraud and Abuse practice group. Kristen Joe, welcome. As you know, the last few weeks have proven to be an exciting time to be a healthcare lawyer. I can't think of the last time we've seen such significant and comprehensive, uh, new and updated regulations and guidance coming out of h h s in such a short span of time. The most significant of which in the topic of our conversation today being HH S'S updates to the Stark regulations and the anti-kickback statute, safe harbors to address value-based arrangements and care coordination. The regulatory sprint, uh, has finished in this edition of the Fraud of Use podcast. We're talking about the new Stark and anti-kickback regs. What are the big ticket items? What's top of mind for healthcare lawyers? What should our members be thinking about as we digest and prepare for their implementation and, and, and, and what are, what are top of mind for our, uh, our, uh, uh, practice group leaders? So, Kristen, I might want to start with you. There's been a lot to digest these past few weeks. We'd love to hear your initial reactions, uh, on the new regs and, uh, and, and what do you think are some of the most important, uh, highlights for our members?

Speaker 3:

Sure. And I think I'll start by talking about, um, you know, the adoption of the value-based arrangement, uh, exceptions on the, the Stark side and safe harbors on the a k s side. Um, I think these have been much anticipated regulations to provide additional flexibility to parties that are considering entering into, um, value-based care coordination type arrangements to, to remove some of those regulatory barriers that they, you know, tend to butt up against when they start working on these type of arrangements under the existing regulations. Um, you know, sometimes it can be a challenge when parties are looking at these, you know, how do we squarely fit this in an exception when we're confined to fair market value, but we wanna be able to pay based on, on the value of services. How do we value that? Um, you know, also some of the restrictions on payments related to the volume or value of referrals, that they've really loosened those within these regulations to create new exceptions in safe harbors to allow for flexibility of parties working together towards value-based purposes, um, and value-based arrangements. And they've left a lot of flexibility in these, uh, safe harbors and exceptions. Um, they do require quite a bit of, um, review of definitions that, that go along with these, uh, provisions. Um, but within that, you know, they leave a lot of flexibility in terms of what can be a value-based entity that's taking advantage of these rules. Um, you know, they don't dictate a particular type of entity. Parties can work together, um, different types of value-based participants. Um, you know, one of the things that I think when we were looking at these under the proposed rule that we were hoping for, and a lot of people submitted comments on, uh, relates to the fact that the rules really are different under the, the CMS paradigm versus the OIG requirements are an anti-kickback statute. Um, both agencies, uh, within HHS responded to those comments to, to mention that, you know, while they coordinated together to develop these, and you see this with overlapping definitions and, um, common elements between the two, uh, sets of provisions, they are deliberately distinct and they couldn't fully align them. And I think actually probably have more distinctions than most parties would care for because of just the difference in the, the statute that you're addressing. So, you know, stark is a strict liability payment rule, so you have to check off every box in order to fit in an exception. Whereas the anti-kickback statute states harbors are, you know, relate to a criminal intent-based statute and really are intended to just, um, provide protection under that criminal statute when you meet all of the elements. But, you know, complying with the safe harbor is voluntary. Um, if you meet all the, all the elements you would be, you know, your, your relationships under that statute would be protected. So I was really excited that they, you know, went ahead and finalized these rules. Um, you know, there's a lot of detail involved, but, you know, as a general framework, you know, to the, the, the more risk that the parties are willing to take on from a payment perspective, the more flexibility the safe harbors and exceptions have, whereas, but there still is some opportunity under the exceptions in safe harbors to enter into an arrangements where either the value-based entity or the physician decided not to take on risk. Um, but those have a lot more limitations.

Speaker 2:

Kristen, um, you know, uh, we heard, uh, over the past few days from, uh, deputy Secretary Hargan, uh, and another HLA podcast, and something that really struck me about that conversation with our C E O Datacade, uh, was his focus on these new, uh, um, safe harbors as a platform. Uh, what do you think that means, and how do you think, uh, uh, providers, uh, industry, uh, healthcare participants will innovate in reaction to this new platform?

Speaker 3:

Sure. I think, I think what what's intended by that is that the, the regs, while they include, um, you know, elements you have to meet, they're not overly prescriptive. They allow, you know, they, they, any arrangements you enter into have to be driving towards a value-based purpose. But those value-based purposes are pretty broad. So the, um, definition of a value-based purpose could be coordinating and managing care of a target patient population. There's a lot of flexibility on how you define that target patient, patient population, whether it's based on payer status or, um, you know, various ailments. Um, you, there's a lot of flexibility on how you define it, as long as you aren't defining it based on sort of financial reasons such as cherry picking, you know, low-cost patients or something like that. Um, these types of arrangements could be designed to improve the quality of care for the, the target pay patient population, but they're not defining, um, exactly how the value-based enterprise defines what those quality measures that it might be, um, driving towards are, um, appropriately reducing cost to, or growing expenditures of payers without reducing the quality or, you know, the value-based purpose might be something that's transitioning, uh, care from a, a volume-based, um, system to a value-based. So there's a lot of flexibility on what might fit within these various definitions. And I think, you know, what, uh, deputy Secretary Hargan was, was honing in on, is that they didn't wanna be prescriptive here. They want the industry to drive the innovation, but they have to have the safeguards in place, um, you know, that come through in these exceptions and safe harbors to ensure they're, they're allowing the industry to innovate while also, you know, maintaining the requirements that are on them from a statutory standpoint to also curb, you know, fraud and abuse within those arrangements.

Speaker 2:

Yeah, no, absolutely. I think those are good points. And you know, from my own perspective, of course, I, I've spent my career in the life sciences, so my eyes immediately drawn to the definitions in, uh, the OIGs, uh, Keck, uh, rule, uh, and specifically the various exclusions for, uh, drug drug companies, medical device companies, uh, laboratory companies and, uh, D m E suppliers and D m E makers. Um, of course, I had hoped to see changes, uh, moving from the proposed to the final regs that would allow full participation under the safe harbors for those entities. Um, uh, you know, but, but I, I did take a little bit of solace in the fact that first, um, H h s I think is trying to acknowledge, uh, that there's, that, that innovation that these value-based arrangements bring. Just like you talk about Kristen, and I think that with their, um, with their exclusion of drug device and DM e and lab companies, I did appreciate, um, their call out that this doesn't mean that these entities can't participate in the value-based arrangement. I think, uh, you know, the industry, my industry like sciences is certainly chomping at the bit to innovate, um, both in terms of technology, but, uh, but delivery of care. And so it's not that we can't participate, we just have to find protection under the, uh, under a, uh, an existing safe harbor or, um, you know, need to be engaged in such a way that it would not on its base violate the anti kickback statute. So certainly the definitions in there are really of critical importance, just like you say, Kristen, for myself included. And, you know, thinking about definitions, Joe, uh, I know you and I have talked about the big three under stark many times, uh, over the course of this podcast. And, and just in our personal conversations, fair market value, commercial reasonableness and volume and value, what did we see coming outta cms, uh, on the big three, so to speak, under Stark?

Speaker 4:

Yeah, thanks Matt. And, um, I'm glad we're able to step through all this. Um, you know, thinking about the big three again, the fmv commercial reasonableness and the volume of value standard, CMS had a lot to say, um, in the final rule, um, in the, in the initial pre publication version of the regs, there was around a hundred pages just on these three issues. Um, ev everyone who works in the space knows that the big three are important cuz they've been at the center of all of the enforcement, um, around stark, especially in recent years. Um, most of the, um, stark exceptions, uh, focus or require these big three. So they're, they're a big part of, of any healthcare organization's compliance strategy. Uh, so the government, uh, came out now and said, uh, they've looked at the request from information back in 2018 and the responses to the proposed rule in 2019, and they're, they're trying to bring some clarity, uh, to the big three. And so they did a few things. Um, first they, they clarified, um, throughout the commentary and then some of the regulatory changes that these big three are separate and distinct concepts. So, for example, the fair market value, uh, definition previously had a, a cross reference to the volume or value standard that really conflated both definitions and created confusion. Now, in this final, uh, regulations, the government's saying these are separate and distinct concepts. Um, the second thing they did is they revised the definition of fair market value and built in a new definition of, of general market value, uh, into the regulations. And, uh, what that means is they've broken up the, the definitions, um, a bit so that you can almost choose your own path, um, within the definition of fair market value. Um, with respect to, um, whether it's a, a, a definition of, of general application or with respect to the general market value definition. If you're going to work through an asset acquisition, a compensation for services or, or rental of equipment or office space, you can, you can work through the definition and use the modifiers that pertain to your situation. Um, the third thing they did is defined commercially reasonable that had never been defined before. Um, and that, that was important because, you know, we were working again without a definition, um, for a long time, and we were relying on some old commentary, um, around commercial reasonableness. This new definition focuses on whether the arrangement is furthering a legitimate business purpose of the parties, the arrangement, and whether it's a sensible, it's sensible considering the characteristics of the parties, including their size type, scope, and specialties. So it's really getting at, you know, what are the, what is the, what are the goals of the organization and is it a legitimate business purpose? A big, big change to here as well was the clarification at the end of this definition that an arrangement would still be commercially reasonable, uh, even if it didn't result in a profit for one or more of the parties really getting at something that had been pled in several of the recent cases, that if you enter into an arrangement with, uh, the, with losses, whether they're actual or anticipated, perhaps that was a commercial reasonableness issue. Here, the government saying that that's not controlling, uh, in the analysis. Uh, fourth CMS proposed new special rules, uh, to identify more objectively when compensation would take into account, uh, the volume or value of a physician's referrals. And, and that's a big piece here. And then I think last, and, and, and I'll hit on that one more time. Um, and last, and this is the, the government used this as an opportunity to revisit and reaffirm some of its prior positions. Uh, notably in, in some recent cases there was a, some discussion around or concerns around, uh, paying physicians based on their personally productivity, if there was a correlation, uh, to, you know, facility fees or, or referrals. And the government, uh, clarified again here, just because there's corresponding hospital services that are billed out that doesn't, that you can still pay a physician, uh, a productivity bonus and that, and that's not going going to be on its face of violation of the volume or value standards. So it came right out and clarified that again here. Um, so those are the big picture items. The, in in stepping, I, I just wanna step back to that, um, test on the volume or value standard, cuz it was so significant. Um, in this final rule, the government is proposing a two-part test, and if a compensation arrangement fails this two-part test, uh, you, the, the thinking is you would have an issue under this volume or value standard. So if you have a mathematical formula that's used to calculate the amount of a physician's compensation that includes the dhs, uh, it would trigger the test. And you, you also have to have, um, a situation where the amount of compensation correlates with the number of value of the physician's referrals. So, you know, going forward, healthcare organizations are gonna have to look at how this test lines up against their compensation models. Um, in a related part of the regulations and commentary, the government also, uh, talked about, um, what are, what are often referred to as the directed referral requirements. And, and anyone who's worked in this space knows that you can put in a provision in a physician's employment agreement or a professional services agreement, a provision that that, that indicates a physician would direct, um, referrals to a particular, um, provider, practitioner or supplier as long as you build in certain car votes, um, from the regulations. The government here, um, is amending those rules to say that the existence of a compensation arran neither the existence of a compensation arrangement, nor the amount of the compensation can be contingent on the volume or value of the referrals to a pr particular practitioner, provider, practitioner or supplier. And the, but the requirement to make referrals to a particular provider, practitioner, or supplier, um, can require that the physician refers an established percentage or ratio of their referrals. And so this is going to, um, set up a situation where healthcare organization should be thinking about any directive referral provisions they have in their contracts now, and to see whether those, um, how how they're implementing those, um, is, is still workable. Uh, under these new regulations, it seems that, um, there are two issues, situations that come to mind. One is the, the government called out, uh, situations where a physicians, uh, the existence of their arrangement is somehow triggered, uh, by one of these directed referral provisions. And they mention an example of a cardiologist that's employed, and there is a, um, and, and the physician has a directive referral provision in their contract, um, with the car votes we talked about, and that when the healthcare organization is negotiating an extension, uh, there would be a problem if the hospital increased compensation, only if the targeted referrals were made or if they refused to renew employment because of the referrals. And so, um, this is a bit, this is different than where we were before. Um, so that's the contingent, the arrangement being contingent on the existence of the arrangement. The second scenario was one where the compensation is actually driven by the referral requirement. Um, the government talked about, um, a, a situation there a as well, and I'm not gonna go into it, but, um, a situation where, uh, potentially a physician's, uh, compensation, uh, could appropriately, uh, be set, uh, based on their ratio of referrals. Um, and, and that, you know, they, they emphasize that you could have a directive referral requirement based on an established percentage, um, of a physician's referrals. And so if that, um, referral requirement included a percentage, uh, even if the arrangement provided for a termination of the compensation arrangement, if they failed to meet that certain percentage, um, it would not run a follow of the special rule. I, and I'm sure Kristen would agree, this analysis is very complex. I would just say if you have directive referral provisions in your arrangements, this seems to indicate you should just have them looked at. If, if your organization is not using, uh, directed referral requirements operationally to d to make termination decisions or to, um, then, then perhaps you could live with the existence of it in a contract. Um, as long as it's not operationalized. Um, if your compensation is being driven by these directive referral requirements, I think you need to do a bit more analysis to make sure you're lining up with this new regulatory framework. So definitely lots of complexity, Matt, uh, here, but I, I think these changes are important. Um, and, and I think they do give us more of a bright line standard, uh, as we think about the Stark law.

Speaker 2:

Always very helpful, Joe, and thanks so much for that insight and perspective. You know, um, you mentioned a couple of things that might make, uh, compliance at healthcare organiz organizations a bit easier. Uh, you know, the bright line of and clear definitions, um, always certainly help. I know, um, in my own work and thinking about, um, uh, some of the, uh, revisions both to the stark uh, regulations and to the kickback statute, safe harbors for me, I see some practical, um, use in some of the changes to the warranties safe harbor and, um, uh, the liberalization of some of the, um, requirements there, which I think really help, uh, entities, uh, who are, um, you know, trying to support, uh, innovative, um, warranties that would, you know, perhaps, um, uh, you know, allow for greater innovation and flexibility. I might ask you, Kristen, what areas in, um, the kickback statute, safe Harbors and the revisions, um, where do you see, um, uh, some of those changes making compliance easier or helping healthcare organizations comply a little bit, uh, in, in a little bit easier way?

Speaker 3:

Sure, Matt. So I think one of the, the bigger changes in my view is the, uh, flexibility that's been added to the personal services and management contracts Safe Harbor. The OIG updated that safe harbor, which previously had limited utility at times because the aggregate compensation under the current rule had to be set in advance. So you had to know the full amount that you were paying your independent contractor over the term of the agreement in order to qualify for, for the Safe harbor. And similarly, if it was a part-time arrangement, the ex, uh, safe harbor would've required that a schedule be set in advance. Um, they've updated, recognizing that that caused a lot of arrangements to fall outside of the safe harbor. They have updated it to allow, um, that the methodology similar to the Stark Law needs to be set in advance. So you need to be able to say the formula, um, that the independent contractor is gonna be paid under, but you don't necessarily need to know what the full amount of the compensation's gonna be at the outside of the arrangement. And in addition, they've eliminated that requirement, that part-time arrangements have a schedule set out in a written agreement. Another really useful, um, change in my view that they've made was related to the EHR donation Safe Harbor. Um, I would see a lot of providers get tripped up on the requirement that, um, the recipient of that EHR donation had to pay the 15% in advance or yeah, in advance. That has not been eliminated fully, but they've provided some additional flexibility as to when that the payments can be made on a regular schedule as opposed to in advance of receiving the donation. So provided some additional flexibilities there.

Speaker 2:

Thanks so much, Kristin. I, and and I, I agree with you on the personal services Safe Harbor as well. Um, you know, in addition to the changes for, um, you know, periodic or sporadic services, part-time services, there was also the addition of the outcomes-based payment, um, uh, uh, new Subpart, uh, to that safe harbor. Of course, uh, you know, the Life sciences industries, drug device, et cetera, are, um, not, uh, are technically excluded from that, but I do believe it demonstrates that OIG is, is taking a little bit more of a forward thinking approach towards, uh, its safe harbors and for those entities who, um, are eligible for, for the safe harbor, uh, to, uh, help them comply a little bit more easily. And, and, and, and practically, um, Joe, y you mentioned a couple of these areas, but I wonder if there's any, um, particular spots in the Stark, uh, uh, regulations, uh, the revisions to the Stark regulations, I should say, uh, that would help healthcare organizations compliance, uh, and, and, and make it a little bit easier, a little bit more practical?

Speaker 4:

Yeah, man, I think there are, um, I mentioned earlier that the government went back here, CMS went back here and gave some examples. I think that the examples they gave are gonna be really helpful for, for organizations as they think about complying with, uh, the fair market value and commercial reasonableness and volume of value standards. So I would encourage organizations to look at those examples, uh, when they do their analysis. Uh, there for there, there was one that, that jumps out at me. It's, uh, the government talked about this in the proposed and the final rules about this rockstar orthopedic surgeon that justifies higher levels of compensation above the, the normal salary survey percent not percentiles. And used that in as, as an example to say, Hey, look, the percentiles in the industry don't govern or don't control the analysis when we start thinking about fair market value. And so I think that that commentary, uh, can be helpful, especially if an organization is looking to, uh, recruit, um, and, and, and bring in a physician that, uh, in an area of, of high need, there may be, um, considerations that could be built into the record to justify higher levels of compensation. So I think that's gonna be important for organizations. Then I think you have, um, in, in the commercial reasonableness, uh, commentary, there's discussion of, you know, overlapping or, or duplicative medical director arrangements being problematic. And I, I think we all know that, um, and the volume or value standard for testing compensation arrangements, there were several examples of, of, of situations where that volume or value standard may be tripped. Um, so I, I think I would look to those examples, but then I'd also look to the technical, uh, cleanups that we saw, um, being built in and the new exceptions being built into Stark. I think it's just gonna make things easier for compliance professionals. Um, we're gonna have a new limited position remuneration exception that is gonna cover situations where, um, physicians are paid less than$5,000. So if you, uh, need a stand-in medical director, um, and it's on short notice and you're, you're just gonna pay them, you know, a a few hundred dollars per hour during that medical director shift, um, the, you know, that physician could come in and do the work. And as long as those terms are said in advance, and it's consistent with fair market value and it's commercially reasonable, the fact that you don't, don't have a writing in place and no and without a signature is not going to be problematic. So that's gonna be a big deal, uh, for those unique one-off situations. As long as you're under that$5,000 threshold, you're gonna be okay. Um, the government is giving us, um, new language around reconciling compensation. Um, if there are discrepancies in payments under the arrangement that can occur within 90 days of the end of that, uh, calendar days after the end of that arrangement, that's going to help, um, protect and insulate arrangements that may have glitch issues, uh, during their term and they can be cleaned up afterwards. Um, the government's giving us new writing and signature requirements, we've, we, we've, at least since 2016, have had a clear path to 90 days to get the signature in place. Now we have 90 days to also get the writing in place, uh, for an arrangement after it starts. Um, you know, the, the, the financial terms still need to be said in advance. And, and, and as you can see in the commentary, that can be achieved through, uh, uh, several ways now. And there's even discussion about text messages, uh, in the commentary. But the idea here is that you can get that writing and signature in place within 90 days, that's gonna give a little bit of breathing room, um, in, in case the contracting process doesn't quite catch up with, with a new service arrangement. Um, in the office space lease exception, uh, the, the government is revising the exclusive use requirement to allow multiple lessees to use the spacer equipment as long as it's to the exclusion of the lessor. I think that's, that's gonna be helpful because organizations will be able to look to the lease exception more, you know, previously if they had shared usage among the lesses, they were probably looking to the timeshare exception. Um, but now I think you can look to the lease exception itself if you have, um, multiple lessees in that space, uh, at, at, at once. The, the government also is, um, allowing for, uh, the usage of the fair market value exception with respect to leases. And so that, that was, uh, good to see as well. Um, on the physician recruitment exception right now practices if, if the, if the dollars are just a flow through to the recruited physician just as a pass through, then the practices no longer need to sign that recruitment agreement. Um, so those are just a, a few of the, the technical, uh, changes and there, and there are several more. And, and so I think CMS really did come through on, on making, uh, relieving some of the burdens related to technical compliance. And I think that was partly due to them taking a look back at the RFI responses and also some of the self disclosures they were, they were getting in that they didn't feel rose to program abuse. So those are some thoughts.

Speaker 2:

Absolutely. No, thank you Joe. I think that's great. And you know, I might conclude our discussion today by asking each of you, you know, are there any parts of the rule that, uh, or the proposed rules that the government didn't act on and you wish they had? Was there a wishlist that you had hoped to see but didn't? Where do you want the government to go moving forward? I can tell you from my own perspective, I do hope that the government continues to reexamine, uh, its approach to, uh, the device drug and laboratory industries. I think there's a lot of opportunity for collaboration and innovation that might be chilled, um, due to, uh, the OIGs and CM S'S language. Uh, but that having been said, I do appreciate the flexibility and innovative, um, platform that they've developed with the new value-based rules, and I hope that we can see some further evolution. But Kristen, what about you? Any, any, any parts of the wishlist that you didn't get and, and, uh, and where would you like to see the government go with this?

Speaker 3:

Uh, I would say the big one on the value base is just that the, the rules are, um, very distinct in pieces. So I think there's gonna be arrangements that parties, um, for example, DHS entities and physicians can fit within a stark exception, but not, might not fit cleanly into a, um, a k s safe harbor. So I think it'll be, you know, I I, I was hoping for more alignment there. Um, it'll be interesting to see how this evolves over time if, you know, these things become tested and people are, you know, driving that inter innovation through these value-based arrangements, if, you know, we might see tweaks and changes to those in the future to further align them.

Speaker 4:

Yeah, Matt, and I'll, I'll just jump in with some thoughts from my end. Um, I, I echo, um, Kristen's comments on trying to see the stark and anti-kickback, um, regs synced up. You know, perhaps, uh, the next go round we'll be able to react to actual value-based arrangements, um, and see more, um, more uniformity between the two approaches. Um, along those lines too, the government CMS did not react to situations where there may be a dual, uh, financial arrangement going on, like physicians under employment, but then also another layer under a value-based enterprise. And I think their reaction from c M s and, and it probably, it was likely the right reaction that, um, organizations should, may need to rely on, um, multiple exceptions or different exceptions based on where those dollars are coming from. Perhaps after we have a chance to look at these value-based arrangements and react, we also will get some clarity around those, those dual situations. Um, but I, I think that this is definitely a step forward. Um, one other thought too, you know, per maybe next go around, we, we might see, um, some discussion around virtual care and telehealth specifically, um, under the Stark regulations. I'm not sure if we need that at this point, because I think CMS has said that quality, um, and other types of, of, uh, arrangements, um, could fit into other exceptions. But, um, it would be interesting to see if, if the government finds a way to specifically address telehealth and and compensation for virtual care within these stark um, regulations.

Speaker 2:

Absolutely. Absolutely. Well, Kristen, Joe, thank you so much for the time today, and thank you to our listeners for tuning in to the A H L A Fraud Abuse podcast. I'm your host, Matt Wetzel, and we look forward to bringing you our next episode soon. Thanks so much.