Shannon Wiley, Attorney with Bass, Berry & Sims shares great information on being intentional about your business from a regulatory perspective. She covers billing, licensure, supervision, payor contracting, corporate structure, compliance, and mergers and acquisitions.
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Transcript: How to be Intentional About Regulatory Compliance
Amanda Brummitt: We Infuse podcast, episode number 53. Welcome to the We Infuse podcast. My name is Amanda Bromant. In every episode, we give you a seat at the table as we talk to Infusion Center owners, operators, and experts so that you can get the insight you need to run a thriving practice. In today’s episode, we talk with Shannon Wiley, attorney at Bass, Berry Sims. Shannon focuses her practice on healthcare regulatory and transactional matters in the pharma industry, including infusion centers. Shannon shares great information on billing, licensure, supervision, payer contracting, corporate structure, compliance, and even mergers and acquisitions. Shannon, thank you so much for joining us today. I’d love to kick things off with you walking our listeners through your background and how you got into the infusion industry.
Shannon Wiley: Yeah, sure. Thanks, Amanda. Happy to be here. So I am an attorney, a member of the healthcare practice group at Bassberry and Sims, and my Background was in specialty pharmacy. And so for over a decade, I had been working pretty much exclusively in the specialty pharmacy industry. And so a lot of familiarity with, programs related to drug dispensing. So, The drug acquisition side of things, the payer side of things that ecosystem was very familiar to me. And one of the things that I had seen about the specialty pharmacy industry was this kind of tidal wave growth. it started out with a bunch of mom and pop. Pharmacies, that grew, that were rolled up into bigger enterprises that were bought by private equity. And, in large part now behind themselves, within verticals in the industry. And so we’re seeing a little bit of a runnism over on the specialty pharmacy side with some new, smaller independents coming onto the market, but we had seen a big consolidation of, that. And, I had seen that tidal wave. And so I was thinking to myself, what other areas where my expertise with, understanding the dynamics of the drug distribution and patient services model, will there be growth and identified infusion. the move to alternative sites of care, the patient demand consumer driven health care. and I also saw a lot of similarities between it being a market similar to the specialty pharmacy market 10 15 years ago, smaller providers who had organically grown out of, physician practice or out of pharmacy. And so. There were some synergies there. but there were also some distinctions from a true pharmacy lawyer, the medical billing, the payer contracting related to the medical benefits, the physician practice side of things. And so I started to focus on becoming an expert in those areas. Because I thought it was a hybrid in the legal market that wasn’t well addressed, you had a lot of provider based physician practice attorneys, you had a lot of pharmacy attorneys, but not a lot of them could translate those different lines of thinking. So, I identified it and I went for it and I think that I made a good call because infusion, the infusion industry really seems to be on fire these days so I’m pleased to read the tea leaves correctly on that one.
Amanda Brummitt: Yeah, that is actually so impressive. I feel like most people accidentally end up there and I, love that it was intentional for you.
Shannon Wiley: Well, sometimes we get lucky and sometimes we, it’s, through intentionality and sometimes it’s a little bit of the two. Cause I think I have a little bit of those two on this one.
Amanda Brummitt: For sure. And then within the infusion industry, is there a certain area that you really enjoy working or that you’ve like, you have more expertise or depth?
Shannon Wiley: Yeah, so I would say and consistent with my history in the specialty pharmacy market. It’s more of an industry focus. And so, I’m not your, employment lawyer, I’m not your real estate lawyer. We certainly have amazing colleagues, at Baskerville and Sims who can handle those issues, but anything related to. The infusion practice, so whether it be the billing questions, the corporate structure questions, the compliance questions of, I have depth and expertise and all that. And then also the mergers and acquisitions, piece of things. So I would work with corporate counsel on the more corporate side of those, but I also do a lot of M& A. So I try to be as much as possible a strategic partner through the, span of the industry, rather than silo into one area of the infusion business.
Amanda Brummitt: Yeah, I bet. You must read 24 7 and just stay on top of all that. That’s so impressive.
Shannon Wiley: It’s a lot of reading and it’s a lot of, the lazy woman’s way of becoming an expert is to have a lot of friends and talk a lot. So a lot of cross pollinization of, what are you doing? What are you thinking? how does it look to you? And I’ll tell you the M& A. Is an excellent way to become better acquainted because especially on the buy side, you get visibility into the ways. that other entities do things, what’s worked for them, what’s not worked for them. sometimes it’s not an issue of right or wrong. It’s an issue of, friction, less friction, synergies. And so it really helps the more you see, the more, so I try to be as curious and inquisitive as possible.
Amanda Brummitt: Yeah, absolutely. So thinking through, tons of centers across the nation, through both M& A activity, but also in your own clients. What are the, legal and compliance traits that you see in organizations that you would say are well run, that you would want your, clients to duplicate?
Shannon Wiley: Yeah, and so, there is certainly a spectrum and kind of to your, observation about intentionality versus something organically happening. I do think a lot in the industry now, and there’s certainly exceptions to this, is organic growth. And so you’ve had, small, well intentioned, under resourced. scrappy, fighting hard, infusion providers out there that have put together really amazing businesses. What’s worked for them has worked, but it hasn’t necessarily been bumped up against, regulatory review. And so I would say, some of the things that work well. Is, those people and often it’s a luxury who have had the luxury to take a pause and think about the business from a regulatory perspective, and I say that just because even as foundational as corporate structure, what am I, an ambulatory infusion suite and that alone. do I do practice management? do I do a little bit of both? Do I have a pharmacy? Am I only buy and bill? And so there’s all these different ways in which infusion presents itself. And so having that luxury of the time and the consideration of, what do I need to do this specific model right, Maybe I’ve done that with one specific model, but I’m going to merge over. Have I been able to be thoughtful, about, what’s different about what I do. And so that’s really, one of the primary things is, just even down to the basics of corporate formation, contracting, how are your entities within your enterprise sourcing drug, contracting with your payers. And so those that have had a coherent strategy, you know, whether it’s the best or the worst. the worst, that consistency where you can explain it, you can scale it, it’s I think that’s really important and really helpful. And I’m always excited when I see that.
Amanda Brummitt: Yeah, absolutely. And so for people that are doing that for the first time that they’ve organically grown and they’ve gotten to the point that, okay, we really need to do that. Is that a conversation with their attorney and their accountant and their revenue cycle folks is, do they put them all at the table and start from scratch?
Shannon Wiley: Yeah, that’s a good question. and it’s a lot of, Yeah, it’s an all hands, consideration and you’re in some of these companies, that’s a party of two or three, just because one person might wear a lot of hats, I do think that there is, and this is, part of, running any business and being a good strategic partner to your clients is understanding That the a plus answer is not always the best answer. we’re not taking an exam here. We’re trying to run a business. And so understanding, what is your goal? You want to open three more AICs in the next six months is your goal. You want to sell the private equity in three years. is your goal, you want to get national payer contracts, what is your goal? And what do we need to do to get there? And obviously there’s, sometimes there’s going to be something that’s we uncover it, that’s a problem, it’s a legal issue, it needs to stop, we need to fix it immediately. That’s the rare though, more often, it is just a broader understanding of, What are you doing now? What do you want to be when you grow up? And how did it get between here and there?
Amanda Brummitt: That’s fantastic. I love that for any business to really put thought into that, but especially for infusion centers, that makes a lot of sense.
Shannon Wiley: Yeah.
Amanda Brummitt: What about challenges? I know you probably see a lot. what’s the biggest legal challenge infusion providers experience?
Shannon Wiley: Yeah. And this, doesn’t make me a lot of friends because it’s so unsatisfying, but it’s just, it’s a lot of gray area. what are infusion suites? what are infusion chairs in a pharmacy? what does that mean under state licensure law? Is it the corporate practice of medicine? If you think it is the corporate practice of medicine, how do you build a scalable model based on that? your laws in Oklahoma are different than your laws in Nebraska and Missouri. And so I do think for providers who want to have a regional or national platform that want certainty, it’s hard. I have clients come to me a lot and say, I just want to do everything right. I just want you to tell me what I need to do to be in compliance with all the laws. And it’s not fun to have to say, well, I don’t know what the answer is. I, here’s what the rule is. Here’s what the rule says. Here’s one way it could be interpreted. Here’s another way it could be interpreted. here’s what your competitors are doing in some cases. Here’s what your competitors are doing in other cases. Here’s what the enforcement landscape looks like. Let’s have a conversation. and that can be empowering to a client because then they have that freedom to make decisions, but it can also be very. like I said, this satisfying to them because they want to be told what’s right or wrong and it’s just, it’s an evolving industry, and it’s just not always clear.
Amanda Brummitt: Yeah. Is there a framework for essentially auditing an existing center to decide, where they fall on that compliance realm?
Shannon Wiley: Yeah. Yeah, there is. And, there’s a couple of different ways to think about this. one is corporate structure, your scalability. Feasibility. And that tends to be a question of who’s asking for the audit. is it a self audit? Is it a buyer and a transaction? And in that case, it becomes the big conversation. Now, what do you want to do with the asset? Because, what they’re doing, as far as how it becomes integrated into your current enterprise or, what you’re going to do with it. So there, that can be a complicated conversation. there are a lot of. Other parts of the infusion business that can be confusing and challenging as well. nurse practitioner supervision, whether they can build independently or practice independently or whether they need to be under a supervision agreement. Medicare Part B billing incident to billing, what does it take to establish a patient with the infusion center? And so those are the types of things while still a continuum of risk, things you can do to be ironclad, you’re going to survive audit versus others where, you likely could survive audit. Versus others where if people ask questions, you’d be having trouble. And so on those types of things, I think there are somewhat more clear cut answers. And so to your question, about, like, what can someone be doing internally to deal with that? I would say having an internal compliance department, a compliance program, that can mean a lot of different things as well. but, at its. At its foundation, it is a considered plan by the client that identifies the unique risks that entity faces. So, for an infusion provider, that would be things like, pedigree and security around your drugs, particularly if you’re dealing with security, I’m sorry, controlled substances, it would be consideration about relationships with your Referral sources, are you paying your medical directors? Are they referring business in? Do you have a sales force that’s going out there and talking to and, having dinners with or playing golf with these referral sources, having policies in place to govern those activities and having audits? That could ensure compliance with those processes, on the nurse practitioner front or any, infusing practitioner front, what does that look like for the administration? How are you establishing the patient, plan of care or the relationship with the patient? What is your billing look like? What is your nursing notes look like? Going back and auditing, not just want to pay or ask for the audit. But consistently throughout the year to make sure that you’re tracking whatever those expectations are. And then, of course, being open to revisiting those expectations, just because you thought that was best practice in 2019 doesn’t mean that it’s best practice today. So, making sure that program is always evolving as well.
Amanda Brummitt: Yeah, absolutely. And that you utilize it. I, see beautifully written compliance programs and they’re only as good as they are when they’re used. If it just sits around, it doesn’t do as much good. so I love that you’re talking about having a cadence that you review and update and look at your processes. That’s really important.
Shannon Wiley: It really is. And one of the things that I always have clients say is, what’s the rule? Do I have to have a compliance department? What happens if I don’t? And so, I have these pretty silly maxims, but one of them is it only matters when it matters. And then it really matters. And so a compliance department is exactly that. if there is a problem and you could have caught it, if you had a compliance program and you didn’t, and you could have mitigated or remediated the risk and you didn’t, because you didn’t even know that it happened. And then a regulator comes in and, if your penalty was going to be X, maybe now it’s X times Y because you have nothing to show for it. Whereas if you had processes in place. And this was just a true deviation. You caught it yourself because you did an internal audit. You immediately put remediation in place. You have a internal compliance plan that shows your CAPA and what you’ve done. And then a regulator finds out and you say, Oh, let me give you this package. And here’s the policy we have. And yes, we violated, and that was bad on us. And here’s what we’ve done to make sure it didn’t happen again. And in fact, we audited last week and look at us, we’re squeaky clean now, instead of X times Y you’re X minus Y,
Amanda Brummitt: Yes, I actually wish more people realize that I do not wish more people had to go through the process, but you know that was more common knowledge that the regulators are human beings and when they look at your intent, and how you’ve handled things, it makes a difference in what your punishment ultimately is.
Shannon Wiley: Yeah, it’s absolutely the case, and you know for those who are listening that do have an acquisition on the horizon. Thank you. It is such a comfort to a buyer to see, to your point, okay, you’ve got the compliance plan, is it dusty or show me what internal audits have you done? the, biggest thing, it always makes me laugh when you’re doing diligence and someone says, well, how many HIPAA breaches have you had? It’s saying no, like, okay, well, that means you’re not paying attention. That doesn’t mean you’re perfect. That means you’re not paying attention. We all are human. Yeah, exactly. We’re all human. You’re gonna have problems. The question is not, do you have problems? The question is, what problems do you have? And what are you doing to make sure you have different problems in the future instead of those?
Amanda Brummitt: Yeah, exactly. Well, speaking of problems, are there ones that repeatedly come up? that you wish infusion center operators knew about and really have more legal guidance on that they didn’t navigate on their own.
Shannon Wiley: Yeah. And this is one where, it’s a biggie. but, and I, see it just from well intentioned people and it’s the basic, it’s Medicare part B incident to billing and really just having a basic understanding of, who’s NPI can use. What level of supervision is needed? What does it take to have The billing be incident to, and, what level of care has to be done and what kind of documentation do you need to justify those codes, whether they’re, regular infusion codes or highly complex drug infusion codes, what are you doing to support, that billing. And I think, it can be all over the place. And the reason it’s so important is because with a federal program, if you’re getting it wrong, the intent really doesn’t matter as much. It’s you submitted the claim and you intended to submit the claim. You might have been mistaken about the fact that it was accurate or inaccurate, but your intent to submit was there. And then you have recruitment issues. Thank you. Or, overpayment issues where you have to pay the money back and, let Medicare know, and it can just be can be such a, it’s just a hard conversation to have, and it’s such a difficult place to be in because. it’s so fundamental to the operation of the infusion center that if they’ve got it wrong, it’s almost in the DNA. And so extracting that and hit reset can be very difficult. so that would be, was the fairy godmother with my magic wand. I would imbue everyone with a great understanding of instinct to billing.
Amanda Brummitt: Good to know. and then in that same vein of thinking, but even broader, are there particular resources, either state or national that you recommend for infusion center operators on billing and any other topics?
Shannon Wiley: Yeah. So, I love we infuse, obviously, I think you guys do a great job, in, in giving, providers that Guidance and insight. I love NICA. I think they’re great as well. an excellent community, and there’s resources for their members. their push, newsletter that comes out is great. tons of specific actionable information for infusion providers. Oftentimes I’m reading it. I didn’t even know that was thing to be thinking about. so very educational for me. I think when in doubt from a legal standpoint, getting on the CMS website and googling, you don’t want to be an armchair doctor or lawyer. So you definitely want to consult your legal counsel, but see what you can find out there. Look to see. what others are doing, back to my MO of how I learn, ask questions and go to these conferences, talk to your competitors, to the extent that they’re willing to talk to you learn, from anybody you can get, to talk with you, not necessarily because they’re going to know and you’re not going to know. But because it just gives you a reference point, I don’t want to do it that way, or, oh, interesting that they have that perspective. I know that’s wrong. Here’s, maybe how they got there. so certainly all the water cooler talks that you can absorb as well.
Amanda Brummitt: That’s great advice. Well, wrapping up here. what are you most excited about right now in the infusion industry?
Shannon Wiley: The whole skin thing. I’m just having so much fun with this. It’s just, it’s great to see the growth. It’s great to see the enthusiasm. it’s really nice to see the cash coming in from investors so that these smaller organizations that have worked so hard to grow. create that, vibrant DNA now have the resources to scale, have the resources to, to pause and think about and put the infrastructures in. So I’m, really excited about seeing this next wave where we start to see, sophistication and maturation of the industry. and so I’m just really pleased to be in at this level and looking forward to seeing what comes next.
Amanda Brummitt: Absolutely. And then is there one last piece of advice that you’d leave our listeners with?
Shannon Wiley: In addition to make sure to call your friendly legal counsel early and often. I think it would be just to, take stock in the fact that you’re in this industry that really is dynamic. And when it feels as though the footing is not sure it’s, because that’s right. It really is a changing and dynamic industry and to not question that, but rather just find the things that you can hold fast to that you can take comfort in kind of. deal with creating that shore footing, in the areas where you can, but just to have that enthusiasm for being part of the growing industry as well.
Amanda Brummitt: That’s fantastic. Well, Shannon, thank you for your time. Thank you for all of the awesome advice and resources and for everything that you do for the infusion industry.
Shannon Wiley: Well, thank you so much
Amanda Brummitt: for having
Shannon Wiley: me. This has
Amanda Brummitt: been fun. Wow. Shannon had such great information on being intentional about your business from a regulatory perspective. Be sure to check out her resource recommendations with CMS, NICA, and of course, WeInfuse. Speaking of WeInfuse, if you aren’t familiar with the WeInfuse software platform, I encourage you to schedule a test drive to see how they can save you time and money in your practice. My name is Amanda Brummett, and we’ll catch you in the next episode.
Guest Speaker:
Shannon Wiley, Member at Bass, Berry & Sims, specializes in healthcare regulatory and transactional law. She focuses on the pharmaceutical industry matters involving pharmacy management and collaborations; infusion providers; specialty pharmaceuticals; and healthcare contracting, regulatory, and operational matters. Shannon is a member of multiple healthcare associations, including the National Infusion Center Association and American Health Law Association.
