New Podcast: How Does Clinical Research Billing Impact Revenue Cycle?

What do clinical research and revenue have to do with each other? A lot, it turns out.

Our latest Compliance Conversations episode, “How Does Clinical Research Billing Impact Revenue Cycle?" covers the critical topic of ensuring your behind-the-scenes billing is set up to support your clinical research goals.

Mary Veazie, a CPA who specializes in clinical research finance, sat down with CJ Wolf, MD, for an insightful conversation about the stumbling blocks many organizations don’t anticipate with clinical research billing.

Mary shared: “It’s a convergence of not only the patient, but the clinician who’s actually performing the research, clinical operations, as well as revenue cycle, the clinical research organization itself, and then compliance to really make sure that we’re following the rules and not putting the organization or the patient at risk.”

Mary and CJ discuss a range of topics, including:

• • The importance of knowing what can and can’t be billed to insurance or Medicare
  • How to navigate funding sources with multiple study sponsors
  • Fitting clinical research billing into the hospital’s revenue cycle
  • Billing considerations to set your study up for success

Interested in being a guest on the show? Email CJ directly at cj.wolf@healthicity.com.

Episode Transcript

CJ: Welcome everybody to another episode of Compliance Conversations. I am CJ Wolf with Healthicity. I’m really excited today. We’re starting a three-part series on this topic, and our guest — and I’ll tell you the topic in a moment — is a colleague and a friend of mine from many years ago: Mary Veazie. Mary, welcome.

Mary: Thank you CJ. I appreciate the opportunity.

CJ: Yes. It’s great to see you again and talk with you again. We’ve had a lot of good interactions over the years. Mary, on the podcast we like our guests to tell us a little bit about themselves: how you ended up doing what you’re doing, compliance, research, whatever your topic is. Maybe a little bit about your background professionally, we’d love to hear about that.

Mary: Sure. Well, I’m a CPA by trade, and I kind of stumbled into what I was doing at MD Anderson, because I retired from MD Anderson in March of 2022. I have always enjoyed doing audits and doing compliance and really helping and working with organizations to really improve their processes, whether it is in health care or in retail. So when I had the opportunity to work at MD Anderson and start working on the clinical research billing side, I thought it was just a great opportunity to immerse myself in all the regulations that are surrounding clinical research, because it is vast, but also trying to help our colleagues, such as the faculty members, compliance, where I met you, to really help them understand, “Here are the regulations. How do we put this into practice?” because it’s really a partnership between so many different offices, because it converges into a revenue cycle and research, and so it’s working with all those individuals to put the program together, and so that’s what I’ve been doing for the last 22 years and truly enjoyed my time doing that aspect.

CJ: Yeah. And as Mary mentioned everybody, Mary and I met when I was working at MD Anderson Cancer Center, and as you can imagine, a large, prominent cancer center like that is doing a lot of clinical research, right? They want to cure cancer. They want to break down barriers, and I love what you said Mary, because I feel the same way about compliance. I come from a clinical background, but what I want to do is take the burden off of those clinicians as much as possible, because I want them to do what they’re doing. I want them to succeed in their true mission. Their true mission is not compliance, right, their true mission is health care and medicine and in this context of clinical research is to get research done. And non-compliance can distract people from that mission. And so the more we can do to help things run smoothly — you mentioned revenue cycle to make sure things are financially viable — those are all important, sometimes they seem like background, behind the scenes type of stuff, but if they go wrong, they can’t achieve their real mission, so I really appreciate you saying that.

Mary: Yeah it’s exactly right. It’s a convergence of not only the patient but the clinician who’s actually performing the research, clinical operations, as well as revenue cycle, the clinical research organization itself, and then compliance to really make sure that we’re following the rules and not putting the organization or even the patient at risk, because there’s two types of risks there. And so really kind of balancing all that — it was a challenging position, but I truly enjoyed it because, to your point, we had 5,000 clinical trials running at one time. And so it’s huge, but it was a lot of fun and I really enjoyed my time there.

CJ: Yeah, excellent. We’re so excited to have you for this three-part series. So everybody, we’re talking about clinical research and the compliance surrounding that, specifically we’re going to get into some of the billing aspects. Let me give you a quick preview of the three podcasts we’re going to do. Today we’re going to focus on an overview of clinical research billing and its impact on the health system’s revenue cycle. Mary alluded to that already. That’ll be our first podcast. Then the second podcast we’ll do is we’re going to talk a little bit more about hiring staff and how to develop, what you’ll hear about today and next time, a Medicare coverage analysis, and we’ll describe what that is. But getting the right skillset: who do you hire? How do you develop people for that important aspect of clinical research billing? And then the third podcast, we’re going to talk about leveraging the electronic health record to bill for clinical trials with in-patient stays. So we’re going to dive deep in some of these topics, but right now, this first one, we’re going to start with an overview of clinical research billing. So Mary, just kind of a general question, a lot of our listeners are compliance folks, some coders, those sorts of folks, and some of whom might not have experience like an academic medical center or a huge research institute like MD Anderson was, so could you just give us an overview: when we say clinical research billing, what are we talking about? Why is that a topic separate from other stuff?

Mary: Yeah it’s really the act of insuring that your charges are routed to the appropriate person. So whether it’s a person and/or his or her insurance, or it’s the actual study sponsor, because, as you can imagine, there are many types of pending (investigational?) drugs and treatments that cannot be billed out to insurance. They do not meet the billing requirements for Medicare or any other insurance carriers, and so you have to really make sure that they’re routed appropriately, because you can’t send out a bill — you have to let the revenue cycle people know that this is going to be paid for by the sponsor, because you don’t want to send a claim out the door that is actually being covered by the sponsor, because now you’re getting paid from insurance and you’ve gotten paid for that same service from the study sponsor. And so as you know, and the audience knows, this is double billing, and that is a really big no-no as it relates to the billing cycle, but it’s also a huge risk for organizations involved in clinical research activities, because you want to ensure that you’re doing it right, and when Medicare comes in for their audits and their rack auditors or the insurance carrier just wants to see some sort of — do some sort of insurance claim validation process, they may see that you’ve double billed there, and so that is a huge risk met with fines and penalties, and the OIG, the Office of Inspector General, as you guys know about, really monitors that aspect of it, and so they’re always looking for ways to improve that process. And so that’s what I was over at MD Anderson, was really looking at that process and ensuring that it was compliant at all times.

CJ: Yeah. You know, you mentioned a sponsor and some of our listeners may not be familiar with research in general, where some research you may have an external sponsor, which might be a drug company, let’s say they’re doing a trial on a new drug and they grant a certain amount of money to help this trial run, and part of that money is to pay for a CT scan or a blood test or something that normally wouldn’t be done in the normal process of care, but because it’s a trial, they agree to pay for it, but now you’ve gotta think, “Oh wait, this CT scan we can bill to insurance. This one, the sponsor of the trial has already paid for. We can’t bill that,” or this lab test — same type of concept. So, is that on par with what you’re saying?

Mary: Absolutely, CJ. That’s exactly right, because what all these drugs or treatments go through are different phases. It could be a phase one, it could be a phase two study, a phase three, and then once you pass that phase three side, you usually apply for what they call a new drug development application, where the FDA may decide that they’re going to allow you to put it on the commercial market, and so therefore it is approved by FDA to actually be something that you can sell to the general public. So that’s what every single drug that is out there on the general marketplace has gone through, is all these phases, and there’s a group of individuals who really will shepherd those trials through those various phases to ensure that it’s being compliant. Because that’s the other thing that the FDA and Medicare work very closely together about, is that compliance aspect of it. And so to your point, you could have a pharmaceutical company sponsor, you can have a foundation sponsor, you can even have a federal government sponsor, because sometimes the federal government, like the National Cancer Institute, the National Institutes of Health — they all sponsor trials, and so it just depends. And so when you have federal sponsors versus a private industry sponsor like a pharmaceutical company, as you can imagine, it’s even tighter restrictions with a federal entity as opposed to those private industries. And so you really have to understand who the funding source is, first, and then the requirements for the trial, and then put all that into practice in working with clin ops and revenue cycle to make it happen.

CJ: Yeah. And I know at MD Anderson we had a lot of cancer treatments, it’s drugs, but these same principles can apply to any broader context like for medical device. So I used to be a compliance officer for an international medical device company, and same types of things. They may sponsor a trial because they want their device approved, and so it can be drugs, it can be devices, those sorts of things, so good insights.

Mary: Yeah absolutely, and just since you brought up devices, that’s a bigger realm, because Medicare wants to approve every single study for a device before you can actually bill and you can roll in patients on it, so they actually have a little bit more of requirements that need to be done before you can actually begin enrolling patients and treating patients with those devices. Medicare wants to look at that study and ensure that it meets all of their clever coverage requirements for billing and then tell you yes or no, are they going to allow you to bill for that particular study. In my tenure at Anderson, we didn’t have many device studies. Most of ours were the treatment trials where you’re looking at investigating a new drug, but we did have some devices, and we probably had maybe one or two that the federal government, Medicare, came back and said, “Nope, can’t bill for it,” so then we had to find another study sponsor and figure out what to do with that study.

CJ: So when you say that Medicare, the government, looks at it, are you submitting a protocol to the Medicare administrative contractor for your region? Are you submitting to a national office? If you know about those things.

Mary: Yes, it used to be that it was regional, and so you would send it to your local MAC, but now since 2019, Medicare says, “I want to do it myself,” and so we were kind of, “Oh my goodness, this is going to put a large hold on our studies,” because it’s already a 30-day hold on that study. So we’re thinking, “Oh my god, this is going to really bog down our trials,” and they didn’t. They were really quickly turning those around within the same 30-day cycle timeframe, and now it’s Medicare looking at that package, so it’s really an attestation packet that you provide to them. So you send them a letter saying, “Here’s what I’m trying to do. Here’s the study documents, the coverage analysis, the IRB-approved letter, the level of risk associated with that particular device, whether it’s going to be significant or insignificant risk to the patient,” and then Medicare makes their decisions from there.

CJ: I see. Excellent, that’s great to know. So clinical research billing, it’s going to somehow integrate or fit into a health systems’ revenue cycle, so you may be doing trials, but at the same time, you’re treating patients maybe with more traditional or standard of care type of things outside of research, but the same CT scanner is being used for both, or the same infusion clinic is being used for both, so somehow you have to integrate the research activities into your normal operations. Can you talk a little bit about that?

Mary: Absolutely. So I can tell you the hardest part of that process is communication, because technology helps you do that. You have clinical trial management systems, or what the industry calls a CTMS, and so that helps manage the study, and then your electronic health record really manages the patient. So if you use integration — which I’ll talk about in one of the other podcasts, how you leverage that integration — for that, it really helps to alleviate the burden of not only the clinician but his or her study teams, because oftentimes they delegate their day-to-day functions to either a research nurse or a study coordinator, so it really helps keep people on task and really helps the charge review process and ensure you’re routing your charges correctly, because that’s the crux of everything, right? So that particular integration from the clinical trial management systems marrying the study and the patient together is where you can leverage technology. It really helps that process and really takes a lot of the risk off of the health care systems revenue cycle. And then it also usually — the electronic health care records have gotten to where they actually will flag, or they have banners that say, “This is a research patient.” So in our case, ours was a pink banner, and so when you saw a pink banner, you could click on it and you knew what study they were on. So this way the revenue cycle people, when they’re processing that claim, they see the pink banner for that particular patient. They’re going, “Wait, this is a research patient. Let me double check and make sure we’re doing this right.” That applies to the coders, that coding department, the financial clearance center can see this information, as well as the claims processing groups. That really helps a lot. And of course denials management may have to happen, and so one of the frequent questions we got was when insurance was denying it, “Is the sponsor really covering this or did we really need to send this out to insurance?” Yes you need to send to insurance. We need to go through the denial process and figure out how to mitigate that patient, if we could. So that’s how it works. Again, the biggest piece is the communication, which a lot of technology has really helped mitigate.

CJ: Yeah, so you’re somehow flagging patients and then hopefully those services get flagged and they can be processed and reviewed according to whatever the protocol or the — we’re going to talk later in the other podcast about a coverage analysis to decide, “Oh, this one’s covered, this one’s not, this one’s here, this one’s not.”

Mary: Exactly, exactly, and so oftentimes organizations have a centralized group that will look at those charges before it gets to the claims processing, so it makes a stop, if you will, within that charge review group for research purposes and making sure that it’s routing the right way. Now if you’re leveraging technology to its maximum, that group is only looking at exceptions where the charge router couldn’t make a decision or someone upstream didn’t do their job. They didn’t flag the study or the patient appropriately, and the flag router looks at it and goes, “Wait, I don’t understand what to do with this,” and it’ll route it to that queue. So we leveraged that a lot, which helped, because of course with our volumes, we needed all the technology solutions we could get, otherwise you’re throwing manpower at a lot of that stuff, and manpower really bogs down the system, because one of our biggest concerns was holding the charge too long, where you’re missing filing deadlines or you’re actually slowing down that revenue cycle, because revenue cycle has a quick turnaround. They want to get those charges out the door. They want to get those claims processed. They want clean claims. So you’re kind of balancing all that to make sure it works properly.

CJ: Yeah, and I can imagine, like at Anderson I know the volumes were high, let’s hypothetically talk about maybe a health system or a community hospital that may be involved in a few trials, but that’s not their bread and butter, that’s not what they do day in and day out. I can imagine somebody might be on a trial for maybe cancer, but then that same hospital is where they get treated if they fall off a ladder and break their arm. The breaking of the arm, they go to the emergency room or whatever — that’s not a part of the trial, and so you may flag the patient, but not everything the patient has done is associated with that trial. Is that something that you also saw at Anderson, or not so much?

Mary: Oh absolutely. We saw that all the time, and so what our electronic health record did was divide the charges into three different buckets. It was either related to the study, billable to in-patient or insurance — meaning it’s a coverage service, it’s under that umbrella of the IRB-approved protocol, which is the Institution of Review Board’s approval of that particular study — or it’s related to the study, the sponsor had agreed to pay for it. The last bucket was not related at all, just something to medically treat the patient. So to your point, our patients came in maybe with pneumonia or neutropenic fever. Depending on what type of cancer we were treating, we routed that to that bucket, because the provider was actually trying to treat the patient so they could actually become healthier and get them back to medical stability. And so that medical necessity was met for that requirement. And so those type of charges, we would route those over to billable to the insurance but not related to the study at all, and so our claims department would realize, “Oh yeah, that’s not related to the study,” and we’d send that out the door really quickly and let insurance cover it. And so that’s the three different buckets, and most electronic health records have those three different buckets where you’re able to differentiate, because to your point, when you’re talking about a smaller community hospital or just a hospital that has a very diverse clinical research portfolio, not just oncology but say cardiology, say diabetes, you have to be able to be flexible because at the end of the day, it’s still about treating the patient and really making sure that medical necessity is in place to appropriately treat that patient. So those are the things that electronic health records are really good at. It’s just now we’re moving in clinical research into that process.

CJ: Yeah, yeah, fascinating stuff. So let’s talk a little bit about maybe some of the challenges that clinical research billing will bring and organizations face that participate in clinical research. What are some of those big challenges that you’ve seen over your career?

Mary: So the big ones I saw was a lack of understanding of the study requirements at the beginning. So oftentimes, especially in academia, faculty members are so eager to take on every single trial that comes across their desk and not realizing that operationally it doesn’t fit into their organization’s existing structure. And so really stopping to do that feasibility assessment, not only for regulatory purposes — human subjects’ protection purposes, really — also for financial purposes and to make sure that financially we can support this study, or we’re going to get enough money to support this study, and then clinical operation-wise, can we really do this? And so that was one of our bigger challenges, to really take a pause and really make sure that it integrates there, because what we were doing was — my team would get the study and prepare the coverage analysis, start developing a budget, then we’d start asking questions and realize, “Oops, this doesn’t fit into our clinical operation side. How do we fit this round peg into this square hole?” And so we’d have to put that study on pause and maybe try to redesign some of the requirements to make sure it fits into clinical operations easily, or just say, “We can’t do this study.” Then the complexity of clinical research studies, as we talk about maybe (cartesial?) infusions and that complexity around in-patient stays, which we are going to talk about in one of the later podcasts, about those requirements. That adds to the complexity, so really take a hard a look at the study and talk with the sponsor before we agree to actually do the study was one of the biggest challenges we had. As we move through that process and got past that feasibility side, the other large process issue we saw was budgeting, making sure that the study sponsor understood that billing requirements for Medicare dictate that this particular service isn’t covered. You’re going to have to cover it. That negotiation sometimes is really hard, because study sponsors had in their head that, “Oh yeah, that could be medically necessary.” Well, yes, but frequency limitations are here for the study, and so you want monthly CT scans. I can’t do monthly CT scans because insurance won’t cover monthly CT scans. And so those types of discussions we had, and that was a big challenge not only for the study sponsor to understand, but also even our faculty, because our faculty went to medical school to treat a patient. They didn’t go to school to understand insurance billing, so we had to introduce them to not only outpatient billings, so that ambulatory setting, but also the in-patient setting, because as you know, those requirements are a little bit different when it comes to in-patient billing versus outpatient billing. So balancing all that was hard for us.

CJ: Yeah it seems like you have to set the stage with all the players even before you get into all the details. Maybe technology is — because I deal a lot with docs that may be doing a medical necessity review outside of research and say, “Well, you can’t do that CT scan for this diagnosis,”and they’ll say, “What do you mean I can’t do it?” You can do it, but Medicare might not pay for it, because they’ll say, "Medicare can’t tell me what I can and can’t do. I’m practicing medicine.” You’re right, you can do it, but you might not get paid for it, and so if you got deep pockets and you have a willingness to pay for these things yourself … ”Oh wait, wait, I don’t want to pay for it,” you know, so you’ve gotta differentiate the difference between what you are allowed to do as a physician in taking care of patients, and that’s appropriate, and Medicare — nobody can really tell you what you can and can’t do. That’s the state licensure who tells you what you can order, but the state doesn’t promise you that Medicare is going to pay for it. The state doesn’t promise that a payer is going to pay for it. So to your point, you have to look at all that stuff upfront, because this might be a great academic exercise or a great research idea, but if no one’s going to pay for it, is the institution willing to pay for it? Are you, doctor, willing to pay for it yourself? And then, “Oh wait, maybe it’s not as important as I thought if no one’s willing to pay for it.”

Mary: Yes, and I’m glad you brought that up, because that is another big challenge that every organization who is trying to blend finance and clinical research and clinical ops together is that disconnect between language. So from our perspective, routine care, we’re following what Medicare says. And then they often try to surmise that, “What's the standard of care?" And a provider’s standard of care is very different sometimes from routine care as covered by Medicare and any other insurance carrier. And so making sure that we differentiate between those two for the provider — so to your point, CJ, telling them, “Yes, you can order this test. We just won’t get paid for it, so how do we plan to cover for it? Because I’m not trying to tell you and dictate how you’re going to medically treat that patient. I’m not dictating medical practice. I’m just telling you, financially, we won’t get paid.” And so that’s the difference between those two, and so once we were able to make the faculty understand the difference between standard of care and routine care, it was a lot easier conversation to have, versus, “You can’t tell me how to treat a patient.”

CJ: Exactly. It’s that approach, and I can imagine that you probably had some proactive training and education, because you’ve got all sorts of rotating physicians and residents, fellowships, all this sort of stuff, and just some general research training to say, “Look, here’s scientific research, here’s keeping the patient safe and then here’s the finance piece, and nobody has a blank check that’s been signed that you can just do everything without worrying about money.” Money may not be the most important thing, but it’s pretty important, or otherwise you can’t do any of this.

Mary: Exactly. Right before I retired, I actually introduced the concept of educating the faculty on the revenue cycle, and then weighing clinical research on top of that, because if they understand the revenue cycle, then they can understand some of the challenges we’re facing when the finance team says, “I can’t bill it. I get reimbursed. I’m not telling you we can’t do it. I just can’t get reimbursed, so who’s going to cover that?” And so when they see those differentiations on that Medicare coverage analysis, they understand, “Oh, this is a billing issue.” Frequency limitations, coverage limitations, whatever the case may be.

CJ: Well great. This has been a really good introductory podcast. Any last-minute thoughts on this introduction topic of clinical research billing? We’re going to do a couple more, and so I want our listeners to be prepared for that. Any last-minute thoughts on this particular topic?

Mary: I just want to emphasize again the need for communication. Despite the fact that you may have cutting-edge technology sitting out there, you still have to have effective communication between the faculty, his or her study teams, the central finance team that’s working on it, revenue cycle and clinical operations, because these folks are going to see the downstream impacts, and so they need to be prepared to receive either that study requirement, that patient treatment plan or the clients. They need to understand what they’re seeing when that does happen, so communication is really key.

CJ: Yeah, and maybe one last question, Mary. I noticed on professional social media that you’re going to be doing a boot camp to this topic. Could you just briefly tell us a little bit about that: when that is, how people can learn about it, what it’s about, why you decided to do that?

Mary: Absolutely, and I can explain in our next podcast around Medicare courage analysis and that skillset. There’s a three-day boot camp offered through the University of Houston, and it’s going to be in-person as well as virtual class sessions, so there’s going to be several different sessions offered, starting in September, and the three-day boot camp is this time for individuals who are interested in a clinical research finance career, but also make the individuals who are interested in the financial management of a clinical research study. And so that boot camp is designed to help them understand that, because there is a big knowledge gap around financial management.

CJ: Great. So for those who may be listening to our podcast months later, that’s September 2022, but my guess is it’ll be a success and my guess is you’ll probably do more of them, so I think University of Houston is a good place to look, and in the podcast notes we’ll include Mary’s contact information if she’s comfortable with that so that people can reach out to her anytime when you’re listening to this. So thanks for telling us a little bit about that, and we’ll learn more, probably, about the details in our next podcast. So everybody, thank you so much for listening to this episode of Compliance Conversations with Mary Veazie, and we will talk to you next time. Keep in mind we’ve got two more podcasts in this series. Thanks everyone.

Mary: Thank you.