In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Associate General Counsel, Compliance Officer, GRAIL, speaks with Dan Murphy, Bradley Arant Boult Cummings LLP, about his recent AHLA Fraud and Abuse Practice Group Briefing, Compliance Tips for Integrated Health Care Organizations: Coordinated Care and the Shift to Value-Based Reimbursement. The podcast discusses the conflict between the fraud and abuse risks that arise out of a fee-for-service payment model vs. those arising under value-based care models in light of the recently-issued Stark Law and AKS final rules, and gives practical compliance tips for organizations. 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.
In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Associate General Counsel, Compliance Officer, GRAIL, speaks with Dan Murphy, Bradley Arant Boult Cummings LLP, about his recent AHLA Fraud and Abuse Practice Group Briefing, Compliance Tips for Integrated Health Care Organizations: Coordinated Care and the Shift to Value-Based Reimbursement. The podcast discusses the conflict between the fraud and abuse risks that arise out of a fee-for-service payment model vs. those arising under value-based care models in light of the recently-issued Stark Law and AKS final rules, and gives practical compliance tips for organizations. 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.
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 American Health Law Associations Fraud Abuse Podcast. I'm your host, Matt Wetzel. Today is Friday, December 18th, 2020. Joining us today is Dan Murphy, a partner in Bradley Errands, Birmingham office. Dan recently wrote and published an A H L A briefing entitled Compliance Tips for Integrated Healthcare Organizations, coordinated Care, and the Shift to Value-Based Reimbursement, the topic of Today's Discussion. Dan, welcome.
Speaker 3:Thank you, Matt. Glad to be here.
Speaker 2:Glad to have you. And you know, Dan, I think, uh, we'll just jump right into it. And before we start with, uh, some of the compliance tips, I think it might be helpful to set the stage for our listeners. Can you define for us rather what it is we're talking about when we say integrated healthcare organization?
Speaker 3:Yeah, I'd be happy to. So I use the term integrated healthcare organization in this briefing, um, and struggle with that term because it's really not a term of art. Um, you know, you won't find that anywhere in the Kickback statute or the Stark Law, um, as such or really anywhere. Um, and, you know, it could be a lot of things, but what I, what I've meant here was really any, uh, collection of entities or providers who are, um, coordinating care, delivering care in a coordinated manner. Um, I would say it's not unlike the term of art that, um, CMS and the OIG just adopted in the final, um, regulatory sprint rules for the value-based enterprise. Um, but I didn't want to use that term because I, I think it could be broader than something that just meets that definition. Um, just to give a couple of examples, I think you know what I mean here by integrated health, um, organization could be, um, could be an aco, could be a clinically integrated network, could just be a, um, a, a hospital system that has different types of providers, or it could even just be a, a large company that has different, um, providers or even, um, you know, manufacturers in their, in their system that coordinate care.
Speaker 2:Great. No, I think that's very helpful, Dan, and I appreciate the distinction between, uh, your term, uh, which I, I understand to be, you know, much more of an umbrella type, uh, uh, term versus value-based enterprise, which is quickly becoming a term of art in our, in our world, uh, with a very specific meaning. Uh, you know, uh, given all of the updates and enhancements we've seen over the past few weeks with the new a k s, uh, rules, with the new stark rules coming out, I found it interesting in your briefing, Dan, you talk about the conflict between the fraud and abuse risks that give rise under a, a fee for service, uh, payment model versus those that arise out of the context of a value-based for care coordination arrangement. Could you set this dilemma up for us? What exactly is the conflict between those risks and how is is it particularly evident at Integrated healthcare organization?
Speaker 3:One, one of the things that I found working with, um, larger clients particularly is that, you know, what they want to do is they want to take care of their patients. They want to do well, um, business wise as well, of course. Um, but they can find it pretty confusing that in some settings, uh, payer settings like fee for service, um, the big fraud and abuse concern, or one of the big ones can be over utilization or lack of medical necessity for services. Um, but for, you know, within the same setting of care, um, the same client, uh, or company also has patients who are, um, who are pay, who are getting paid for through value-based care models or, or risk models. And there, one of the big concerns is, um, stinting on care or not providing medically necessary services. Um, so one of the, one of the real things that I wanted to try to think through in this briefing was how to, how do you guide your clients when maybe they're not quite as attuned to, um, to the very, to the nuances that are in the fraud and abuse laws. And what they're trying to do is just run their business and take care of patients. So I would say the big, the big tension is this overutilization in the fraud in the, um, fee for service world versus stinting on care in the, in the value-based world. Um, and then another big tension, I think is on the, the patient inducement front. Um, you know, in the fee for service world, uh, it, it's pretty tightly constrained, um, under the kickback statute, um, and the CMP beneficiary anti inducement law, um, what type of remuneration someone can provide to a patient gets to be, um, a little bit more flexible in the value-based world, um, especially when patients are being aligned to the provider or the organization. And so they're not, you know, they haven't even really been, um, they're not really fully selecting their provider. They may be a aligned by the payer. Um, so I think that's another big area of tension is just what can you really do in terms of patient, um, engagement in the fee for service versus value-based world.
Speaker 2:Absolutely. No, I appreciate that, Dan. That's, um, it's an interesting observation. And on your latter point, the patient inducement point, you know, this might be, um, this might be even more apparent given some of the, um, changes to the safe harbors that we've seen over the past two weeks, especially when it comes to care coordination and that, and the new care coordination safe harbor. Tell me, um, you know, is there an example that you could provide for us at an integrated healthcare organization that you've seen where this particular issue is kind of come to light, um, you know, something a little bit more, uh, uh, concrete for our listeners to better get a sense of what, what it is we're talking about today?
Speaker 3:Right. So, I mean, I think that, um, technology is a big one. Um, so if we're talking about something like, um, remote patient monitoring, um, for whatever condition they the patient has, whether it's, um, it's a heart condition, whether they need to be monitored for lab values, whatever, or, you know, vital signs, whatever it is, um, under the fee in the fee for service context, it can be, it could be tricky to give a patient something that has independent value, um, because, you know, outside of this new patient engagement, um, safe harbor, there's, uh, you know, there's a de minimus value, um, exception, or it's not even really an exception, but interpretation, um, for, for the value of, um, items or services you can give to patients that's very low. Um, I think$15 per item,$75 per year. Um, so you may have providers who want to give a patient some sort of device, um, maybe, you know, maybe they can even use it, um, for some other purpose. So, you know, arguably has independent value harder to do that in the fee for service context. I think in the, in the value-based care context, it, it's clear that once you're in that, um, you know, especially if you're in this value-based enterprise framework, one of the purposes as you know, has to be, um, engaging the patient to coordinate their care, to improve quality, um, reduce cost. And if you're doing that, um, the, the, the agencies become more comfortable that you don't have a prohibited intent for, um, inducing the patient to choose a provider. What you're doing is trying to meet one of your value-based purposes. And so, um, especially under this new, um, patient engagement safe harbor, the value limit is, is much higher. It's up to$500, um, per year for a patient. So, um, that's an example where I think we're gonna see our clients, um, our clients feeling a lot more comfortable doing what they think really is in the best interest of the patient to take care of them. Um, and they don't have to be quite as worried as they were before about tripping over, uh, a really low value threshold.
Speaker 2:Absolutely. Although I will say, you know, just in that, um, very, um, uh, concrete example that you provided, it seems to me that at an integrated healthcare organization, they have to thread that needle carefully, especially if there are, um, you know, elements of, uh, fee for service, uh, payment and value-based payment at the same organization. So, you know, and that kind of brings us to the title of your briefing today, the top Compliance Tips for Integrated Healthcare Organizations. Um, you know, given that example, given this conflict between risks, given the changes that we've seen recently, what are your top compliance tips for integrated healthcare organization stand?
Speaker 3:Sure. And, and, and Matt, you said it really well threading the needle between those two, um, you know, types of patient populations. Um, you know, one of, one of the good things about, one of the good things about these new Stark and Kickback rules is that if you can get in that framework, it does give, um, providers the option of taking a uniform approach to all their patients, um, and not have to always worry about threading the needle between patient who's sitting on the left side of the, you know, of the office, and one who's sitting on the right side and figuring out who the payer is in each case. But if, if you're not in a situation where you, where you can avoid threading that ne threading that needle, um, that's what I was trying to cover in the, um, in the briefing. And one of the, one of the tips I have is pretty simple, which is get the facts and circumstances of whatever the proposal is that your, um, you know, that your organization has. So whether it's providing a patient with, um, with an iPad or whether it's, um, you know, a hospital providing a primary care practice with a care coordinator, my, my tip there is understand why we're trying to do that. Um, and, and it, it sounds simple and it is, but, um, really understanding from the business and the clinical folks why they're doing something I think, you know, will help you ferre it out. Whether, um, as the lawyer who knows all the nuances, um, of the different safe harbors helps you ferret out, okay, are these, are these motivations proper? Are they gonna fit in a safe harbor or are they gonna meet a stark exception? Um, and, and getting the facts and circumstances. What I've, what I've always found really helpful is, um, the oig the OIG list of preliminary questions when you're asking the OIG for an advisory opinion. Um, and I find it really helpful because the, their questions really hit on both the, the both sides of the, um, of this tension on the value-based side and the fee for service side. So they, they ask questions related to over utilization, but they also, um, ask questions about adverse, um, impacts on quality of care. So I think if you can gather all that information from, you know, the business and the clinical team, it really helps you start piecing together as a lawyer, um, or a compliance professional, whether there's gonna be a pathway under, um, under the fraud and abuse laws to make it work.
Speaker 2:No, that's great, Dan. I think that's really helpful. And, and you know, when we were talking before, uh, prior to this podcast, you mentioned following a set of core principles and then working with clients to kind of follow through. And it seems to me that this is what we're talking about, this core, the core principles can essentially be found, um, in the OIGs own guidance documents, uh, that are, you know, frankly, you know, a couple decades old at this point.
Speaker 3:That's right. They a couple decade gold and you know, as we've seen recently, um, with the new rules, there can be a lot of changes in this fraud and abuse world, and we have a lot to digest right now. But I, my, you know, my, my opinion, these types of principles that the OIG has in those questions, they're not, they're not going anywhere. Um, you know, they, first of all, they, they're gonna be the same for the fee for service setting, but even if you look at in this value-based context, um, you know, in these new, um, safe harbors and, um, even the stark exceptions, um, these same concepts are embedded in, in the definitions and the elements of those, um, you know, those new protections. So it's, it's good to really understand, um, those risk areas when you're trying to, to vet a new, a new proposal.
Speaker 2:Yeah. And you know, for me, as someone who's been practicing in this area, uh, for quite some time, uh, as I know you have as well, Dan, you know, over utilization, increased cost to federal healthcare programs, adverse, you know, diminish patient choice in increase or diminish competition, rather, you know, all of those are just the foundational bedrock of, uh, you know, the fraud and abuse analysis. And, and I, you know, it seems to me that they don't change. I agree with you.
Speaker 3:Exactly. Um, you know, another, another thing that, um, I think is important is, um, this, and, and, you know, this is something that the OIG and CMS covered in their rulemaking, um, OIG particularly, um, in an, in an integrated healthcare or organization, however loosely we define that you really have to pay attention to, um, separate legal entities. Um, o one thing I found Matt in talking to clients is that if you have a successfully integrated organization, you know, you may have one common owner, or you may have several wholly owned subsidiaries. And, um, the decision makers think of it as just one, it's just one organization. Um, you know, it's, it's, uh, this health system or it's this company. But, um, you have to be a little bit careful there because the, you know, the OIG has taken the position that, um, it's at least possible, you know, you can have a kickback between two separate legal entities, um, that have a common owner. And they, they, fortunately in the rulemaking, they did not, um, end up, uh, prohibiting protection under the safe harbors for entities under common ownership, but they did consider it. Um, and the, the fraud and abuse reason they used, um, you know, why they were considering it was, um, a term, I think they used a couple of formulations, but basically they have this idea of abusive cycling of patients between care settings. Mm-hmm.<affirmative>, so, you know, what, what they're worried about is, okay, we may have a common owner at the top, but if you've got, um, someone at the top who can control a hospital discharge to a home health agency, for example, and they're discharging to their own home health agency in an abusive way that, you know, limits patient choice, or maybe it's not the best quality or whatever, they, that's why the OIG has some concern even in this common ownership context. So Matt, I, I've just found that it's, it's hard. It's, it's not intuitive and it's hard to, you know, explain why a company that really is integrated and thinks of itself as providing, you know, seamless care transitions, why they ought to think of themselves as two different, you know, organizations in this case. But I think it's important
Speaker 2:Absolutely, Dan and very well said, and I think really kind of, you know, hits home a couple of points perhaps as to why many of us are practitioners in this area. First, I think some of us really like playing in the gray space. Uh, it's, uh, it can be a, you know, a a really, um, a really interesting area. But, you know, I think what your bulletin and, uh, or your briefing rather and what the podcast today is really emphasizing is that despite that gray space, there is a fundamental set of principles that the OIG will apply. And, uh, and, and, and those, you know, that that gray, uh, becomes different shades, especially now that we're dealing in an environment that's both fee for service and value based in nature.
Speaker 3:Right, right.
Speaker 2:Well, Dan, thanks so much for joining us today and for your insights on this important and evolving topic. Uh, for our listeners, Dan's Briefing Compliance Tips for Integrated Health Systems is available on the H l A website as an exclusive benefit of a H L A membership in the Fraud Abuse Practice Group. Please consider joining the group to access Dan's briefing and other expert content shared only with our members. Thank you. As usual, to our Fraud Abuse podcast sponsor, the B r G group. And thanks to our listeners for tuning in. I'm your host Matt Wetzel, and we'll be back in the new year with another edition of the A H L A Fraud Abuse Podcast.