Expert Insights on Hiring the Right Skillset [Podcast]

Don’t miss part two of our Compliance Conversations series on clinical research, financing, and compliance!

In such a specialized field, finding a great hire feels like trying to find a needle in a haystack. Our latest episode features CJ Wolf, MD and Mary Veazie, a CPA specializing in clinical research finance, as they share insights into hiring for the right skillset and ensuring your team can navigate a nuanced reimbursement and regulatory environment.

Our conversation spans a variety of topics, including:

• • The crucial importance of conducting a Medicare coverage analysis (and what can happen if you don’t do a coverage analysis)
  • What type of career experience and knowledge sets someone up for success in this field
  • The boot camp program Mary partnered to create that provides education on the financial management of a clinical research study
  • The intricacies of study guidelines, treatment frequency, and off-label use – and how it all impacts the coverage and revenue

Finding the right person for the job has far-reaching implications beyond just one role. As Mary shares, “what skillset is really needed to really optimize that process? Because it’s the foundation for so many other things downstream within that revenue cycle.”

Coverage analysis can span Medicare, Medicaid, and other various payers, so ensuring your team has the right knowledge and resources to ensure accurate coding, billing, and management throughout the research process is essential.

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, and my guest today is Mary Veazie, formerly from MD Anderson Cancer Center. Welcome, Mary.

Mary: Thank you, CJ. I’m happy to be here.

CJ: It’s so good to have you. Mary and I worked together at MD Anderson Cancer Center and she knows so much about clinical research billing. We are so grateful to have her. This is our second episode of a three-part series, so if you haven’t listened to the first episode, you might want to go back and listen to that. Mary gave us a nice overview of clinical research billing, and she has so much experience and so much knowledge in this area, so go back and listen to that one. In this podcast, the second one, we’re going to be talking a little bit more specifically about hiring staff to develop what’s known as a Medicare coverage analysis and getting that right skill set. So Mary, let’s jump right in if that’s OK, and what is this Medicare coverage analysis? Some of our listeners probably don’t even know what that is.

Mary: OK, sure. Well thank you again, CJ, for having me here. So the Medicare coverage analysis is really the transformation of a clinical research study into a financial tool. So back in 2000, Medicare realized that clinical trials and clinical research was really the way to actually advance science, whether it’s for oncology or diabetes or cardiology. They realized, “Oh, I’m seeing all these patients at our research study, but I’m not sure that they qualify for that. I’m not sure that I should be covering based on my billing coverage requirements.” So in 2000, the President of the United States issued an executive order that told Medicare that they’re going to start covering for patients who want to participate in a clinical trial, because it was oftentimes hard for them to get on the studies. So as a result, Medicare issued what is called national coverage determinations, and it is actually NCD 310.1, so national coverage determination 310.1. That actually is the billing guidelines, if you will, for Medicare coverage under a clinical trial. And so that particular NCD tells us about what is actually a covered service, the frequency associated with that and/or when that was affected. So it could be something that just took effect yesterday, so that was maybe — so it tells you all those pieces about that. So as a result of that particular issuance of the NCD back in the year 2000, there came the fact that you had to figure out, “OK, what’s covered and what’s not?” So in order to do that, Medicare says, “Well, I think we need a coverage analysis, so we need someone to actually transform that particular study requirements into something that I can see that it’s a coverage service or it’s not a coverage service.” If it’s not a coverage service, then your study sponsor — whether it’s a pharmaceutical company, the federal government — is going to be responsible for covering that charge. So that’s what the Medicare coverage analysis does, is it’s really just a tool that transforms your study into a financial document so that the billing department, or whoever is working on your claims process, understands, “This is covered by Medicare. This is not covered, and my study sponsor is going to be covering it.” It just makes that differentiation between that.

CJ: Great. And you mentioned a study protocol. Now I have an understanding of what that is; some of our listeners might not know if they’re not involved in research. Can you just briefly tell us: what is a study protocol in the context of a clinical research study?

Mary: Sure, so you’ll hear “study protocol,” you’ll hear “clinical trial,” you’ll hear it called “clinical research study.” Those are all the same — they’re synonymous for the same thing. It is an actual design of an object that they want to study, so it could be an investigational drug that showed promise in the basic science lab where the FDA looked at the data and said, “Wow, it is really working on these animal mice models. Let me see how it works on humans.” “Is it safe and effective for humans?” is what the clinical trial is trying to accomplish, and it really is a pipeline for drugs to become commercially available, so that’s how they start, is in a study protocol or a clinical trial design. The designer can be a investigator, so a faculty member who’s really interested in clinical research, or it can be a pharmaceutical company who actually will design the study and then come to academic medicine or other organizations to actually try to get the patients so they can prove the hypothesis of the safety and effectiveness, etc.

CJ: Yeah, so it’s kind of what we all did in junior high probably, or middle school, is the scientific method, right, where you propose a hypothesis, and this is what scientists do. And in medicine, you’re doing the same thing. You’re trying to control certain variables so that what you’re studying is — you want to study what you’re studying and not have all these confounding variables to be like, “Oh, there was improvement, but was it for some other reason?” You want to know it was because of this drug or because of this device, so really that protocol as I understand it, you can correct me, it’s kind of the scientific reasoning of what you’re going to be researching, but it doesn’t address what you talked about, and what we’re talking about in this series, is the finance behind that and the billing. But it says, “Look, this is what we scientifically want to study.” And then you just spoke about the Medicare coverage analysis. You take that document, and it might call for, you can correct me here, certain numbers of CT scans over the course of a year or over the course of six months or whatever it is, because you want to study the effect of that drug on a tumor size or something. I’m making stuff up, but — and so then you have to translate that. “Oh, CT scan is this CPT code and it’s for this reason.” Is that part of that coverage analysis?

Mary: Absolutely. That is definitely part of that coverage analysis, and I do want to step back a second and say that every study has to go through a regulatory review process, and so those studies have to be approved by — scientifically and for human subjects’ protection by the Institutional Review Board, or that organization’s IRB. You’ll hear “IRB,” and so that group is responsible for the safety of the patients associated with research.

CJ: Right, so that IRB is really important, and there’s a whole world of compliance around patient safety and IRBs, but correct me if I’m wrong: IRBs don’t get into the weeds on the finances, right?

Mary: No, they don’t. To answer your question around conversion of that particular study into a CPT code, yes, that’s exactly what happens. The individuals who are reading that study look and picking out those things that are going to cause or impact the patient’s bill, because that’s what you’re looking for, something that’s going to get into that claims process and get into your revenue cycle and therefore impact the patient’s bill, so it’s something that’s going to have a CPT code. It’s going to come off of your institutional charge master. Those type of things is the conversion of that science to finance.

CJ: Yeah, and before we get into the skill set and hiring people, tell me why it’s important. You probably know better, but I’m aware of some enforcement that has happened in the past. The one I remember happened many years ago, and I think it was a self-disclosure at Rush University. So I went to medical school in Chicago, and across the street — I went to the University of Illinois in Chicago — Rush was literally across the street. You had two medical schools right there, and they had some potential issues with doing or not doing a coverage analysis. Do you remember those details or any other enforcement you want to share?

Mary: You’re exactly right. It was a self-disclosure and it was Rush University, and they were not doing the coverage analysis. So the consequence of not doing that is the claims department in that revenue cycle did not realize these patients were on studies, so what they were doing was sending those claims out the door, just processing claims as normal, but the study sponsor was also covering some of those testing procedures. So the Medicare coverage, if they had done that, the Medicare coverage analysis would’ve told that revenue cycle team that, “Hey, wait, this particular CT scan is being covered by the study sponsor. Do not send that out to the patient or the patient’s insurance,” and so that was the crux of that compliance issue that occurred, and so that’s the reason why you have to have a Medicare coverage analysis, because it is used for so many different things. It is used to tell and inform the claims department that this is a clinical trial that we’re going to have patients enrolled in, we’re going to route these items to patients’ insurance or the patient, because it is something that is approved for Medicare coverage, or the study sponsor has agreed to cover it. So it’s really a document that helps that revenue cycle understand what they can and cannot bill. The other part it does is it helps the budgeting process, so it helps when you’re trying to develop a study budget and negotiate with that sponsor so that you are only sending to the actual study sponsor those things that insurance won’t cover.

CJ: Yeah. Oh you mean we have to follow a budget? (laughs)

Mary: Yes, absolutely. There’s costs associated with everything. We want to know the costs. (laughs)

CJ: We have to do it in our own personal lives, there’s no free meal in research, either, so someone’s got to pay for something, and if you don’t set out to do that, the institution ends up eating the cost, right? It’s like, “We did the CT scan, no one’s going to pay us for it now. Well, we’re out the cost,” and so being diligent upfront really helps with that. I think in the Rush example, they had a financial settlement as well.

Mary: They did. They went ahead and self-disclosed, they had a financial settlement, but they became really a shining example of the fact that we really need to do a coverage analysis at the beginning, because it sets the stage for having a compliant billing program down the line.

CJ: Exactly, and by no means am I trying to disparage Rush. They actually did the right thing. They found this themselves, I believe, where they were doing their own — that’s what a compliance program is supposed to do. It’s supposed to do monitoring and auditing, find issues and then correct them, and so kudos to them for finding the issue. And I just remembered that that kind of was a springboard for a lot of focus on this area in clinical research billing, and it’s been a focus ever since, so there’s lots of work done here, and so thanks for sharing that. Now you were probably involved in hiring people to do coverage analyses. What do you look for? How do you develop that skill set? What do you need in the skill set to do this well?

Mary: Yeah, well CJ I tried everything, because I was trying to understand exactly that question. What skill set is really needed to really optimize that process? Because it’s the foundation for so many other things downstream within that revenue cycle, and so when I first started as the director of the clinical research finance group, it was more people with a business background. So whether it was someone who had a management degree or an accounting degree, and don’t get me wrong, I’m a CPA, but I made sure that I immersed myself into understanding regulations and quickly realized that they had a difficult time converting that scientific document into something that’s actually finance, because they didn’t understand the science. So we decided, OK let’s try nurses. Let’s try nurses who don’t want to be on the floor anymore, study coordinators who actually already have exposure to that clinical research side of the umbrella, and the thing that we found that worked the best was actually MDs from foreign countries. Because they were coming into the United States as sometimes data coordinators, and so they’re sitting there crunching numbers behind the scenes with this vast amount of knowledge, and you’re going, “Wait, that’s a different — I can use you for something else.” And so we actually started using those individuals from foreign countries, because they don’t want to pursue the medical license here in the United States. They just want to contribute to research, and so once we utilized them, we quickly realized all we had to do was teach them the Medicare regulations around billing, and here’s that process. But they were able to really immerse themselves in the study, pull out those pieces that are affecting the billing of a patient, and then look it up in Medicare’s database of what covered items there are and still interpret it very well, because they understood the science. So that marrying of that person who has an MD from a foreign country with the coverage analysis process really was — wow, that was really good, because we were assured, first of all, that that interpretation from science to finance was happening and was happening in an efficient and effective manner, and then the fact that they were understanding what the Medicare regulations stated was also really helpful.

CJ: Yeah, so and then were those MDs, you also trained them a little bit in coding, were they picking the codes? Are the codes picked from somebody else? How is the coding — because in coverage analysis, don’t you list the procedure or the lab: CT scan or this pathology or whatever, and then you list a CT code, is that right?

Mary: That’s correct, absolutely. Yes and so the actual CPT code pieces of it, we did teach them some. We had an individual who has a CPC certification, and so we actually had her teach them, “Here are some of the CPT codes. Here’s how you merge themselves,” so everybody’s desk reference was the CPT code manual. We refresh those every year, but we had that as a new reference for them, so they could actually interpret that and make sure that the CPT code they were typing in and putting down was the actual right one. So that was, it’s a little bit of a manual process, so you always want to have a Q&A process at the end, but those individuals really helped that and changed that process. I have to say that it does take a little time to train them, though, because that conversion just — first of all, introducing the concept, because most people don’t understand. So you have to introduce the concept, and then that revenue cycle, having them understand the revenue cycle is also important, and then how we’re laying that coverage analysis, so to speak, on top of that revenue cycle, was also a process that we did with them and walked them through that process. So that entire time from the time we actually on-boarded them the first day until the time they were actually able to make an effective impact on our actual production cycle was anywhere from six to nine months, depending on the actual knowledge of that person, the experience they came in with, or the speed of their learning. But it was an average of six to nine months, and so that is a long time to have someone in a training program, so we decided that we needed bench players, too, so we we would also cross-train other individuals within our department so that way we always had someone sitting there that knew the coverage analysis enough to truly pick it up and run with it, should we have a person that decided they were going to do another career path or go onto another department.

CJ: Fascinating. And I know you’re doing some work to try to educate folks through a university and a boot camp. Can you tell us a little bit about those works and will those boot camps focus on medical coverage analyses and this type of stuff as well?

Mary: Yes, absolutely. So I partnered with the University of Houston’s executive development program to create a three-day boot camp designed specifically to teach individuals about the financial management of a clinical research study or to help educate individuals who are interested in a career in research finance, so that three-day boot camp takes you in-depth through the Medicare coverage analysis: why is it necessary? How do you create one? How do you read Medicare’s actual database of coverage? And then it goes into the budgeting process, the billing process, kind of teaches them beginning to end — so study concept down to the termination of that study — what that financial management looks like. And so those three-day boot camps will start in September of 2022 and they will be offered in-person as well as virtual. Throughout the next year or so, I’ve only pushed out for a year right now, and so I have dates planned starting in September and monthly through there, so if you go to University of Houston’s executive development website, you’ll see those particular classes offered.

CJ: Great. And, you know, because I worked at MD Anderson, Mary, I know that medical center in Houston, it’s like a mecca for research and health care, and so there’s probably a lot of people that’ll be interested there throughout Texas and throughout the whole country. Thanks for sharing that.

Mary: Yeah, and we decided to offer it in-person as well as virtual just for that purpose, because some people may not be comfortable coming in-person still, but also because it is such a needed area. There is very few training classes. If you go out and Google “clinical research finance,” there’s very few training classes for that particular financial management side, and so really trying to get the knowledge and the education out there to not only the Texas medical center but to the population at large that’s actually doing clinical research.

CJ: Yeah. So we’ve talked a lot about Medicare coverage analysis. Do you have to do a similar process for other payers, or do you have much information on Medicaid? What do you do for Medicaid? What do you do for commercial? My guess is with commercial, I can’t imagine they get too in the weeds with that, but you tell me a little bit about those other payers.

Mary: Yeah, so we leveraged — that’s a really good question — Medicaid when it came to some of our patient populations. So we had our pediatric ward, where we were looking at that actual Medicaid side of it. So we kind of blended the two together, but the other thing that we had was a very informed managed care contracting group with MD Anderson, and they realized that a lot of the managed care contracts that we had in place with our various payers — Blue Cross Blue Shield, United, Aetna to name a few — were very similar to what we did with Medicare. So that Medicare coverage analysis was a broad brush for the rest of the actual insurance populations, because that was one of the big questions when we first started proliferating the clinical research billing program throughout MD Anderson, was, “Do we need to do a coverage analysis for all the various major payers that we see in our portfolio?” And at first we thought, “You got to do that,” but then we did an analysis, and we determined that, so that would be my recommendation to anyone listening who's asking the same question of their organization — really look at your managed care contracts, and what have you negotiated with those managed care contracts? Is it similar to what we already have covered as it relates to Medicare? Do you have some of the same coverage that’s there? So if that’s the case, that Medicare coverage analysis should be sufficient by itself. If not, then you might want to work with your compliance department to understand, “OK, what’s my risk of doing that?”

CJ: Right. And I know in oncology and cancer care, a lot of patients — it’s almost the, you can maybe talk about percentages, but it’s almost the norm for patients to be on some sort of trial, which may be a variation of the drugs originally approved to use or something, but really those are the ways that most people are treated. Is that accurate, or am I off base on that?

Mary: No, that is accurate. So that off label use is something that we see a lot of. So they take a commercially available agent and decide they want to combine it with another commercially available agent to see its effectiveness on lymphomas or leukemia, depending on what disease they’re actually researching. And so that combination is considered investigational, those studies have to go through that regulatory review by the Institution of Review Boards as well.

CJ: So Mary, if my memory is serving me right, I recall that when it comes to some drugs and things, when you’re actually determining if something’s covered, I recall a compendia or a collection of various compendia that you could reference to determine some coverage that Medicare allowed you to use some of those things. Is that accurate, and if so, could you shed a little bit of light on that?

Mary: That is very accurate. So for oncology it’s the NCCN guidelines, and it’s the National Cancer Compendia — and I forget what the other one stands for, but it’s actually that particular bit of evidence, if you will, that says that this is being, this is really effective for this particular treatment of disease that they’re studying, and so they would use — we could leverage that compendia as long as it was sitting in the right category. So the right category is when you open that compendia, this is Category A, this is Category B, as long as it was sitting in Category A we could certainly do that, because that meant that Medicare was really looking closely at that, and they were more than likely going to issue a coverage for that particular treatment.

CJ: I see. Yeah and so I think that probably also lends to what you were talking  before about MDs doing some of that work that they may be more comfortable with. One of the things I wanted to ask about a coverage analysis is, you’re looking at things from a frequency perspective, like a CT scan, maybe it’s normal to do a CT scan for a certain disease once a year or once every six months, but the study may require it multiple times, like maybe every month. So part of that analysis is frequency. The other part is maybe diagnosis and reason for doing the CT scan. Is that a part of the analysis, and could you talk a little bit about that?

Mary: Yes, it’s actually, that is the beginning of the analysis. Once you determine that it’s actually something that’s going to impact a patient’s bill, we have to determine coverage, so is it in the Medicare coverage database? If it is, then we’re going to be looking at the frequency at which it is actually in that particular study, and so that coverage analysis will have the frequency information based on that study requirement, and so you’re going to be looking at that. And then one of the other things we look at also is the disease, so what type of disease are we studying, and is that particular indication covered for that disease?

CJ: Gotcha. So you mentioned during the year the NCD 310.1, I think you said. So are you also relying on other NCDs or LCDs, because I know there’s LCDs for CT scans. So are you looking at some of those to help determine coverage, or do you stick mainly with that 310.1?

Mary: So we are looking not only at the NCD but also the LCD, so those local coverage determinations that are issued by the regional MAC. So for Texas, our regional MAC is Novitas, so we’re looking at Novetas’ guidelines as it relates to their coverage of a CT scan or whatever procedure we’re looking at. Thankfully, 95% of what our local MAC has as a covered item is also covered by our NCD, and so we have very few adjustments to make there. I know some other regions have more adjustments because their MAC has issued a more restrictive LCD, and so that is going to be region by region depending on who your LCD is issued by.

CJ: That’s such good information, because you mentioned this NCD for clinical research 310.1, which is national, but it doesn’t get into the weeds about every type of service. It I think probably talks more generally about what’s a qualifying trial and those sorts of things, right?

Mary: Well yeah it does actually have the weeds, so to speak, but it does — Medicare is actually done really good. I think in the last two years they’ve kind of blended the LCD and the NCD, so you can actually put in the — let’s say we want to look at an echocardiogram and how often I can do that, so you put that information into their database. When you pull it up, it actually will ask you, “Are you looking to look at the one in North Carolina or in Montana or in Texas?” and so you can actually click into those full coverage determinations pretty quickly in addition to looking at Medicare’s coverage of that particular echocardiogram.

CJ: Gotcha. Yeah that is helpful. We have listeners all over, and so that’s important, folks. As you’re doing these types of things, make sure you’re also doing what Mary said and using their database to find those coverage requirements.

Mary: It is so helpful.

CJ: Yeah. Well awesome, so we’re getting a little bit toward the end of this second podcast. I want to make sure I’ve asked you all the right questions as it relates to coverage analysis. Any last-minute thoughts or things that I may have left out that are important?

Mary: Yes. Communication, again, is really key. I know I said it in the first podcast. I will emphasize that again. But truly understanding in this particular case, the Medicare coverage analysis, truly understanding your study requirements and being able to take those and translate that in from the actual study document itself, so that scientific piece, to the actual financial side is so important here, and not missing testing procedures that you should be picking up when you’re doing that Medicare coverage analysis. So really understanding your study requirements and moving and translating that into a financial management document — that coverage analysis is really key.

CJ: Yeah, and I guess I should’ve asked this, too, as far as where in the timeline you do this coverage analysis. I’m assuming you’re doing it before you sign an agreement with a sponsor, so they know what’s covered. I mean you have to do that earlier in the process, not later, right?

Mary: Absolutely. So it is recommended that as soon as that study is submitted into the regulatory pipeline for scientific and a human subject safety review, you want to start that coverage analysis. You want to start that financial management cycle as well, and so you start the coverage analysis. It proceeds into the budget pieces, and then of course once the budget is approved and negotiated, then once you start enrolling patients that Medicare coverage analysis becomes a billing grid with an electronic health record to drive those charges to the appropriate places and let the claims department know that this is actually something that’s going to be paid for by the study sponsor, or it’s a routine care approved by Medicare to be billed out to patient or the patient’s insurance.

CJ: Gotcha. And is that, so is this kind of financial work that we’ve been talking about done in a parallel path as the IRB approving for safety, patient safety and appropriateness, or does it happen in a linear fashion, one before the other?

Mary: No, it is parallel. That’s a very good question. It is recommended that it’s done parallel to that regulatory review. So you have the financial process going down the same pathway as the regulatory, and hopefully by the time that study is approved, your finding is finished, your study is negotiated with the sponsor, contract signed and you’re ready to begin enrolling patients as soon as that study is IRB-approved.

CJ: And is this general process a 30-day process, 60-day, one week? I know it would probably vary, depending on the complexity, but when does a red flag go up when it’s taking more than X number of days?

Mary: Well yeah, when it’s taking anything more than 100 days is the norm in the industry now. We’re trying to truly get these studies activated in 90 days or less, because if you think about it, our ultimate goal is to truly treat the patient with these novel compounds, and you really want to impact that patient’s treatment, and that’s what ultimately determines how effective and safe this drug is, is our ability to get it to the bedside as quickly as possible. So it's usually shooting for anywhere under 100 days is what we’re shooting for.

CJ: OK, good ballpark. I wasn’t exactly sure how long this is taking nowadays. Mary, this has been really great information and so I’m just so grateful for you to be here and to share your expertise, and we have one more podcast. We’re going to do a third podcast in this three-part series, so we hope you all will listen to that. Thank you so much, Mary.

Mary: You’re welcome, CJ. Thanks for having me. I truly enjoy sharing my knowledge and informing others about the financial management and clinical research.

CJ: Thank you. And thank you all for listening. Listen again to our last podcast on this clinical research topic. Thanks everyone.