Season 3 – Episode 1 – Coverage Analysis in Clinical Research
This episode discusses the intricate details of the coverage analysis process, including why it’s so important and the consequences if you don’t have a proper process in place.
Podcast Chapters
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To easily navigate through our podcast, simply click on the ☰ icon on the player. This will take you straight to the chapter timestamps, allowing you to jump to specific segments and enjoy the parts you’re most interested in.
- Podcast Introduction (00:00:24) Justin introduces the podcast and emphasizes its educational purpose.
- Guest Background (00:01:07) Andra Popa shares her credentials and experience in Medicare coverage analysis.
- Andra’s Entry into Coverage Analysis (00:02:21) Andra recounts how she became involved in Medicare coverage analysis during law school.
- Development of Coverage Analysis (00:03:22) Overview of the evolution of Medicare coverage analysis since 2007.
- Current Role at CITI Program (00:04:14) Andra discusses her new responsibility for healthcare compliance content at CITI Program.
- Defining Coverage Analysis (00:05:00) Andra defines coverage analysis and its role in clinical trials regarding billing.
- Process of Coverage Analysis (00:06:22) Detailed explanation of the process involved in performing a coverage analysis.
- Understanding Medicare’s Definition (00:07:49) Andra elaborates on qualifying clinical trials and Medicare’s definitions related to coverage.
- Conventional vs. Standard Care (00:08:01) Discussion on the differences between conventional care and standard of care.
- Importance of Coverage Analysis (00:09:42) Andra emphasizes the real-world implications of proper coverage analysis for patient billing.
- Interdisciplinary Nature of Coverage Analysis (00:10:15) Exploration of the various sources and guidelines used in coverage analysis.
- Role of Professionals in Coverage Analysis (00:14:52) Discussion on the diverse skill sets required for performing coverage analysis.
- Regulatory Context of Coverage Analysis (00:18:25) Andra explains the necessity and implications of conducting coverage analysis in research.
- Self-Disclosure in Compliance (00:19:26) Clarification on how self-disclosure affects compliance and the False Claims Act.
- Financial Implications of Coverage Analysis (00:20:35) Andra discusses the financial benefits of performing coverage analysis before trials.
- Understanding Core Documents (00:21:40) Discussion of the three core documents in clinical trials: budget, informed consent, and protocol.
- Importance of Document Matching (00:22:19) Emphasis on the necessity for all trial documents to align to ensure proper execution and billing.
- Reconciliation Process Overview (00:22:59) Explanation of the reconciliation process to ensure documents match and prevent billing errors.
- Multidisciplinary Nature of Coverage Analysis (00:23:49) Highlighting the various professionals involved in coverage analysis and the importance of teamwork.
- Lifecycle of Coverage Analysis (00:25:12) Overview of how coverage analysis documentation flows through billing and revenue cycle teams.
- Initiating Coverage Analysis (00:26:07) Importance of completing coverage analysis before starting trials that require it.
- Role of Revenue Cycle Team (00:27:13) Description of how the revenue cycle team uses coverage analysis to guide billing processes.
- Importance of Documentation (00:28:06) Discussion on the necessity of documentation for accurate billing and compliance.
- Challenges with EMR Systems (00:29:03) Exploration of the variability in electronic medical record systems and the need for careful management.
- Complications of Mixed Visits (00:31:40) Addressing the complexity of billing for patients seen for both clinical and research purposes.
- Consequences of Billing Errors (00:32:44) Discussion on the serious implications of improper billing, including potential audits and legal actions.
- Financial Consequences of Non-Compliance (00:35:42) Insight into the financial risks associated with false claims and the importance of compliance.
- False Claims Act Overview (00:37:27) Explanation of the triggers for the False Claims Act and potential repercussions for violations.
- Future of Coverage Analysis (00:40:00) Speculation on the evolving pressures and potential software solutions in the coverage analysis field.
- Authority in Coverage Analysis Decisions (00:42:11) Questioning who holds the authority to determine coverage analysis standards within institutions.
- Introduction to Coverage Analysis (00:42:55) Discussion on the role of consultants and the importance of judgment in coverage analysis.
- Liability in Coverage Analysis (00:43:47) Exploration of the liabilities faced by coverage analysts and the use of independent contractors.
- Decision-Making in Healthcare Entities (00:44:55) Insights on how healthcare institutions determine risk levels and decision-making processes.
- Importance of Trust in Coverage Analysis (00:45:29) Emphasis on the necessity of working with trusted individuals in high-liability environments.
- Shared Responsibility in Research (00:46:14) Discussion on the collective effort in research and its impact on health and well-being.
- Seeing Trials in Action (00:47:09) Reflection on witnessing the real-life impact of clinical trials on patient care.
- Encouragement to Shadow Clinicians (00:49:18) Advice on shadowing clinical professionals to gain insight into the patient experience.
- Conclusion and Reflections (00:50:30) Andra expresses gratitude for the opportunity to discuss coverage analysis and its significance.
Episode Transcript
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Andra Popa: That’s why you see so many coverage analysis as independent contractors, because technically there’s a lot of liability even for the coverage analyst because you’re saying bill this to Medicare to a huge hospital system. I would have professional insurance to a large amount because then the corporation won’t be liable for what you put on the coverage analysis.
Justin Osborne: Welcome to On Research with CITI Program. Your favorite podcast about the research world where we dive into different aspects of the industry with top experts in our field. I’m your host, Justin Osborne, and I appreciate you joining. Before we jump in, as a reminder, this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests.
Welcome back for season three of On Research. I am very excited about the guests we have lined up for this season. I can’t wait to learn so much more about this fascinating research industry from some really great people. To kick off season three, I met with Andra Popa, who you already clipped from at the beginning. Andra is a graduate of Boston College and has a JD and LLM from Loyola. Andra was part of the first group to conduct Medicare coverage analysis, which has since become an essential element of research programs to ensure proper billing compliance. Andra owned a consulting firm for over 15 years and has published over 100 articles, written book chapters, and conducted workshops in compliance. Andra is now responsible for healthcare content at CITI Program. I had an in-depth discussion with Andra about coverage analysis. From detailing the process and requirements, to explaining the why behind coverage analysis this conversation is a great opportunity for anyone wanting to know more about this important topic. There are serious consequences tied to improper billing. So even if you’re not super familiar with what a coverage analysis is, I definitely recommend the advice and guidance Andra gives. So without further ado, I hope you enjoy my conversation with Andra. Well, Andra, it’s great to have you on the podcast. Thank you so much for joining.
Andra Popa: Thank you so much for having me.
Justin Osborne: Yeah. Of course, of course. So to get started, do you mind telling us how you got into the research industry, a little of your background and then what you’re doing now?
Andra Popa: Yes. I started working for my father who was a physician. I worked for his practice starting when I was about 14.
Justin Osborne: Oh wow.
Andra Popa: After school. And I would look at the billing and coding of the practice. That piqued my interest in healthcare, especially healthcare finance. And I studied it more in law school then my professor in my Medicare class, which was the only Medicare class at the time in the country. Was very lucky, very fortuitous. My professor asked me if I wanted to work with in this new area called Medicare coverage analysis within clinical research. And I had always been interested in the sciences and biology, so I really love the interdisciplinary aspects of research.
Justin Osborne: So you were in law school, you’re studying this stuff, and then you were asked to jump into this new world. So you’re at the beginning of this coverage analysis thing?
Andra Popa: Yes. They really started in 2007. They updated the main national coverage determination that allows routine costs in clinical trials. And that’s around the time that there was a large settlement with Rush University Medical Center with their clinical trials as well. They self-disclosed to the government. And my professor happened to be the person who conducted that settlement.
Justin Osborne: Wow. So did you help with that or was that just part of your education as you were coming up in the-
Andra Popa: No. It was right before the settlement, and then he began his startup consulting firm, and then I joined.
Justin Osborne: Okay. Okay. So then you did consulting with that group for a while?
Andra Popa: I did for over 15 … Almost 17 years.
Justin Osborne: Okay. Very nice. Very nice. So then what are you doing now?
Andra Popa: Yes. I recently joined CITI to start up their healthcare compliance content. They don’t have any content related to healthcare compliance technically. So I’ve started up that vertical for CITI.
Justin Osborne: Well, I appreciate that background. That helps because of course, our topic is coverage analysis, and this is one of those topics that a lot of us in research have … You’re vaguely familiar with it, but it is a complicated, very niche area of research. So I wanted to ask you when we start off here, if you could help us understand this, break it down and define terms. So I guess to start, what is coverage analysis?
Andra Popa: So every trial that’s a research trial has items and services provided within the trial, and those will be listed in the protocol And the coverage analysis looks at certain items and services. Not all are billable. The coverage analysis will look at certain items and services. It’ll itemize them in a spreadsheet, usually an Excel spreadsheet. And then it’ll say how they’re covered. If they’re covered by the protocol in some way, or the clinical trial agreement or the informed consent.
Justin Osborne: Okay. So when you say covered, you’re talking about who will pay for the services. Walk me through that piece. So you’re talking about coverage analysis being, there’s a document you mentioned or a spreadsheet. But this sounds like a process. It’s not necessarily just a document. Similar to informed consent. Informed more than the document, it’s the process. So coverage analysis is a process. You’re getting the information from the protocol you said, and from the contract and other documents. Is that what you’re going through the spreadsheet to identify if say for example, the sponsor in the protocol says they’ll pay for a certain procedure or something? Is that all it is or how involved is it?
Andra Popa: Yes. It’s similar to what you said before you perform the coverage analysis there’s several questions you have to ask before you start. So the coverage analysis, we perform to Medicare standards because usually the private insurance companies follow. However, each insurance company will have its own requirements, but technically we provide to Medicare. That’s also the highest risk in terms of the False Claims Act, which is when you improperly bill to the government. So you ask yourself these three questions, whether a study meets Medicare’s definition of a qualifying clinical trial that can support billing to a payer, which items and services are a routine cost. Medicare’s definition though. And then whether Medicare rules allow or limit coverage for the items and services. So then you look at these things called national coverage determinations and local coverage determinations. These are all online.
Justin Osborne: Oh, okay. So you can find these nationally in the local-
Andra Popa: National coverage determinations. You can find them online on the CMS site, the Centers for Medicare and Medicaid Services.
Justin Osborne: Okay. Okay. So you asked those three questions. Back to the first question. You mentioned a qualifying clinical trial. How do you know if something’s a qualified clinical trial?
Andra Popa: Right. It has to fall into certain categories. It has to be for a treatment as just one example or a type of qualifying device.
Justin Osborne: Okay.
Andra Popa: Yeah. For example, generally for preventative care, you have to be very careful with those as one example. And then we were talking the other day about what meets Medicare’s definition of a routine cost. And we were talking about what’s the difference between conventional care and standard of care. And so standard of care would be maybe one physician thinks this is how we treat the patient, or maybe a couple physicians think that, or maybe it’s an accepted practice of treating a patient. But conventional care would be something that Medicare or CMS approves of as a a national standard.
Justin Osborne: Okay. So conventional care is national standard. Yeah. Thank you for bringing that up. I always heard standard of care when I was working at a hospital, research hospital, and conventional care, you said?
Andra Popa: It’s typically provided absent a clinical trial, that would be conventional care.
Justin Osborne: Okay. So you could have standard of care because it’s best practice and whatnot. Some standard of care stuff could be conventional care, but it’s not necessarily conventional care if it’s standard care.
Andra Popa: Exactly. And when you do your coverage analysis, you have to find what is the conventional care.
Justin Osborne: Gotcha. Gotcha. That’s what you’re assessing when you’re filling out the spreadsheet and determining how charges are supposed to be billed basing it off conventional. Okay.
Andra Popa: Yeah, it’s a small aspect of it, but yes.
Justin Osborne: Okay. Yeah. Thank you for going through those differences. People throwing those terms out, if you’re not into this process and you’re not actually working on the coverage analysis, I could see where there could be confusion with that.
Andra Popa: This is where it becomes really interesting for people that like interdisciplinary work. So the items and services that are conventional care are covered as part of routine costs of a qualifying clinical trial with the caveat that all Medicare rules apply. Medicare is probably more than 500,000 pages so it’s well more than that. And they don’t edit their work. So you have a lot to apply. But this is where it gets really interesting. So where do you find this conventional care? How do you support it? There are a variety of things you can look at including the national guidelines for cancer care. There’s also a professional guidelines related to radiology for example. How often should someone get an MRI if they’re having cancer care? How often do you test if the tumor is receding or not? So it’s actually very interesting. It’s very exciting to do coverage analysis because of this.
Justin Osborne: Well, I’m very happy that there are people like you who find this exciting because it seems super complicated from where I’m sitting. So it sounds like there’s a little bit of, there’s the science and then there’s a little bit of the art to this too. Trying to figure out exactly how to … Yeah.
Andra Popa: There is. We use a variety of sources and they can be quite current as well. They’re subscription services and also the pharmacopedias. So I read those very carefully to find … So you’ll see some medications. It tells you how they’re cleared by the liver, the kidney, and that might affect the clinical trial and what types of blood tests you give. For example, if you need to test kidney function or liver function. So all of that information is … There are other sources that are more current than others, but the tried and true ones are truly the national standards or the professional standards. The professional guidelines. For example, radiology or cardiology also has excellent professional guidelines. Maybe it helps to think of a real world example would be the protocol really has a schedule of the treatments.
So it might say every week you have a chemotherapy infusion, say every week on Thursday. So your coverage analysis will have that listed. It’ll list the months and then say for six months you have … And it’ll mark a signifier to say, well, on this day, every week you have this treatment. And then resulting from the main treatments, you have a schedule of if it’s a tumor, there might be imaging, and then there’ll also be blood tests, blood work. That might be only to investigate the drug, for example, if that’s what you’re investigating. Or it might be blood work to test your health because you’re given an agent that is toxic. But that’s a case study.
Justin Osborne: So then in each one of those things, you have to determine every procedure. I’m just envisioning this document. You’re checking off how this is supposed to be essentially billed.
Andra Popa: Yeah. And I really imagine the patients, when I perform a coverage analysis. I think about them and I think about the workflow of their care. And the problem is if you do not perform a coverage analysis, then technically the charges arising from the medical center that might arise within the context of a clinical trial that aren’t related to what the sponsor’s picking up those charges, if they’re not analyzed, will end up being billed to the patient. So that’s why it’s important to perform these coverage analysis in addition to the legal liability.
Justin Osborne: Absolutely. Yes. We’ll get to the legal liability because I want to ask about that side of things. But just to back up to this process that you’re talking about … And I appreciate you saying that about putting this patience in this. This is very oriented, data driven, looking up justifications and spreadsheets and all that stuff, but there are obviously real world consequences for these things. But you were talking about the multidisciplinary aspect of this process in general. Who’s doing this typically? You were doing it as a consultant and as an attorney, but if you’re looking at a hospital doing research, who’s actually typically doing coverage analysis?
Andra Popa: There are a wide range of skills involved with coverage analysis. It’s more the characteristics of the person. It could be research coordinators who … They don’t have two jobs. Maybe they have experience as a research coordinator and then they move into coverage analysis. But not all research coordinators are comfortable with billing practices. You want someone who is comfortable with uncertainty and with also a wide range of disciplines. So they have a understanding of biology and of medical terms. Medical terminology, Some billing experience, billing and coding, although they don’t have to have that, just a sensitivity for the revenue cycle and their willingness to learn about it.
And also because there’s so many nuances and coverage analysis and the medical institutions, the healthcare entities, they each have their own perspectives and their level of risk tolerance. So it can’t be someone who doesn’t have any give in their personality. You have to be willing to be accepting of other people’s opinions because there’s several layers to the coverage analysis. One of them is the conventional care, but you also look at then the Medicare portion, and that could exclude … Even if it’s conventional care, it might not be covered. So many different steps. And so it has to be someone who’s detail oriented, but easy going at the same time, which is hard.
Justin Osborne: Yes. Yeah, type A and B. Yeah. It’s a mix. No. That’s helpful actually. I think that’s helpful for folks. Either if you’re trying to figure out who’s going to do this at your institution or who should, or maybe you’re interviewing people for this kind of thing. It’s nice to hear, like you said, the qualifications. It’s not that there’s a like a specific job title that fits this role best. It’s more about the individual it sounds like.
Andra Popa: It really, it truly is. And the most fun I’ve had working in coverage analysis with people has been where they …Obviously these need to get done in a timely manner, but also where they’re comfortable asking questions about the gray areas and having a quick chat about them and seeing what they think. I always really enjoyed those conversations. I certainly don’t know everything, and I would go back and ask my colleagues, my consulting colleagues and say, “What do you think about this and what about this approach?” It was uncharted territory, and we were the first group to conduct them. They were interesting academic questions.
Justin Osborne: I bet.
Andra Popa: Yeah. So they are just a wide range of people really. You can have an accounting background or billing background or nutrition, physical therapy. Yeah. Pharmacy, law.
Justin Osborne: Interesting. Okay. So that helps. I think just starting from the top. And thank you for explaining terms and defining things and walking us through this process. This is a big process, it seems like. From the why are we doing it, why does it matter? Before we get into the potential ramifications, if something goes wrong or whatever, can you help explain, is this a regulatory requirement? Is this just best practice? Where’s the requirement coming from? Just so people understand when is this triggered? You know what I mean?
Andra Popa: Sure. It’s technically not required to do a covered analysis. But you will bill incorrectly if you don’t do a coverage analysis, especially if it involves a federally funded trial. And then also with Medicare. If there’s Medicare involved, then you have a huge compliance risk of liability related to the False Claims Act, which is a very old requirement. It’s from the Civil War. All it says is that you can’t provide inferior goods to the government and then get the federal money in return. So the inferior goods in this case are not donkeys and mules and horses, but the inferior goods are related to you’re submitting false claims to the government.
Justin Osborne: Okay. That’s so interesting. So is it your experience that the instance that you cited earlier that started this whole thing was that the first time that False Claims Act was used in this manner?
Andra Popa: They made a self-disclosure. So they were not approached by the government. They approached the government with their findings.
Justin Osborne: Okay. Okay. Help me understand that. If you self disclose, then are you saying that False Claim Act doesn’t apply?
Andra Popa: It does. It does, but it’s technically not the government coming after the entity. They stated, “We found some errors.” And you don’t get to the False Claims Act in some ways. You just say, “We found some errors and we’re willingly paying back the money.” And we have a compliance system in place now. We’re doing coverage analysis. We have consultants.
Justin Osborne: Okay. Okay. I got you.
Andra Popa: Technically don’t reach that conversation because it shows the better compliance program when you do a self-disclosure, when you don’t wait for them to find.
Justin Osborne: Yeah. No. That makes sense. That makes sense. So it sounds like from a requirement standpoint, you said it’s not technically a requirement, but it sounds more like insurance almost, right? It’s there to protect you because if you don’t have it, then your risk goes way up, it sounds like.
Andra Popa: Yeah. The charges just won’t be allocated properly without a coverage analysis. So it’ll affect not only your compliance risk, but there’s a possibility, of course, related to compliance, you can double bill, you can bill improper claims to the government. You might lose money on a clinical trial so it’s also for the financial strength of the institution. It behooves them to … Have a coverage analysis ready when you’re negotiating with the sponsor have one ready and know how much the items and services will cost you and then negotiate because you don’t want to also lose money on clinical trials either.
Justin Osborne: Right. That’s a good point, because this process that you’re talking about really, it should be done upfront. This is a front end process for starting up a trial because you really shouldn’t you’re saying finalize a contract or an agreement. It goes along with the budget. You need to be doing this in tandem when you’re negotiating a budget so you know how much to charge.
Andra Popa: That’s right. When I first started, those documents that you’re referring to, so there are three core documents, the budget is usually included in the clinical trial agreement. And so the budget refers to what the sponsor … And again, that could be a pharmaceutical company, a medical devices company or it could be something else. But whoever’s paying for the study. Yes. So there’s that agreement you have with the sponsor and the entity, and then you have an informed consent. And then you have a protocol. A protocol refers to what the clinicians will … How they execute the plan of care related to the clinical trial. How they conduct the trial. It has to be scientifically valid. You have to have a plan of care and a schedule of events. And yes. All of those documents have to match. When I first started, sometimes they couldn’t even find those documents, but all of the terms have to match. So if something says it’s free in the informed consent, it has to be properly budgeted within the budget, within the clinical trial agreement. The protocol can’t say otherwise. Usually it doesn’t have financial terms. Sometimes the protocol items and services don’t match the budget. You have to make sure everything is captured properly.
Justin Osborne: Yeah. No. That makes sense. I’ve worked with institutions myself where they have a reconciliation process. It’s done by somebody different than the person doing the coverage analysis. But their job, essentially, part of their job was to make sure, to your point that all these documents match. Sometimes the protocol will have a sponsor that says, for subject injury, the sponsor will say they’ll pay for it, and then the consent says that the patient’s responsible for it. And so that reconciliation process is vital, it sounds like. And you’re saying, again, just to think about the fact that coverage analysis is so tied into the entire research process and the study process, all that stuff goes together. You can’t do an adequate coverage analysis if you are not ensuring that all these documents are matching.
Andra Popa: No. You truly can’t complete the analysis without all of those documents. And it really highlights the multidisciplinary nature of the field because you have people in finance involved, negotiations. You have the pharmaceutical clinicians who are creating the protocols or the clinicians that are creating these protocols. Informed consent. It’s more legal. Even just by those documents you can see right away that the analyst is very multidisciplinary. And a great way to approach it is think of it as a team. So not everyone has to have the answers in all the areas. If you can’t hire someone without that expertise, maybe people in different departments can help in coding and someone in legal maybe or someone in finance.
Justin Osborne: Yeah. That’s really helpful. So then you have this … Okay. I want to follow this through. So you have this document, this analysis of the coverage analysis. It’s the spreadsheet or whatever. And say you’ve completed that analysis. The study has started. In terms of documentation, there’s some documentation of this. I assume that that follows through. Can you walk us through the lifecycle of this? How does this follow and find its way to billing and revenue cycle and all those teams?
Andra Popa: And as you mentioned, there should be a process where the study doesn’t start. Some studies don’t require a coverage analysis. For example, maybe no participants are enrolled at that entity.
Justin Osborne: And there’s no bills involved with those kinds of studies right.
Andra Popa: Right. And I’ve been a PI, for example, on a study where I study the efficacy of compliance materials because I’m analyzing that. It was considered exempt. But that’s an example of I look at how are the materials designed, does that help the compliance aspects? But that’s still technically a trial. But yeah. I’m not billing Medicare or-
Justin Osborne: Yes. Yes. And to your point, you would identify whether or not something needs a coverage analysis going back to those three questions you talked about at the beginning. Is this a qualifying clinical trial and all those other things right.
Andra Popa: Exactly. Exactly. Correct.
Justin Osborne: Okay.
Andra Popa: So you would have to have some type of system to capture that. Which ones would need one, which ones wouldn’t? And then in the ones that did need them … I know this is a little bit tough to say, but you should never start the trial without the coverage analysis if it’s needed. So that will be review … Should technically be held. I always suggest that because it’s a nice incentive to start the trial to get a coverage analysis first.
Justin Osborne: Sure. Sure.
Andra Popa: It’ll go there first. It also has to go to all the other departments. So if radiation is involved, it has to go to radiation, all the different committees. So it’s part of the process of IRB approval. And then it’ll go to … So the coverage analysis will go to the revenue cycle team for review after it’s completed before the trial starts hopefully. The revenue cycle team means … There are the people, they do the coding and they also the billing is what goes out. And technically that’s in your electronic medical record system. And they reference the coverage analysis to guide them how to direct the charges so they can place edits within the patient. They’ll trace it to the actual patients enrolled or the participants enrolled in the trials on their record. The third MRI is covered by the sponsor, so we’re not going to bill Medicare, but the fourth MRI goes to Medicare.
Justin Osborne: Gotcha. And so that source of truth, that’s why thinking through this as a process, that’s why that documentation of the analysis is so important. So revenue cycle has that, and so they can check against that anytime a bill goes out or goes through the system for patients. Because you would have to have some source of truth to go back to.
Andra Popa: Exactly. And any patient that is in a clinical trial should be flagged within the system, and then they’ll have this pathway that’s specific to them as related to the coverage analysis.
Justin Osborne: Yeah. Again, when we’re talking about pathways, I’m just thinking there are a handful of EMRs out there, electronic medical record systems and whatnot. And not to go through the differences, but there are differences in them. And I know just through experience and talking to other folks in the industry, there’s preferences. Some people like one over another. But it doesn’t sound to me that the EMRs themselves necessarily have a solution for this. It really is every single institution or hospital has to manage this process in a way that fits within their revenue cycle team and how they bill and how they use the EMR. I know in certain EMRs they have research modules and those kinds of things. They’re not all the same, I guess is my point. So you really have to figure out your process individually.
Andra Popa: Yes. absolutely. And you bring up a great point that in my consulting work I did find you have to be very careful with the EMRs and always audit the EMRs and not rely too heavily on them in the sense of calculations of coding in particular. I noticed in my consulting practice, there was one instance where the EMR was up coding things accidentally. It was mainly because the EMR is again built by an interdisciplinary team. You have computer programmers who code, and then you have compliance. It has to be compliant with rules and regulations. Coding is also highly specialized. In this sense, coding and medical coding is very specialized. So you have these three disciplines.
And what I noticed was that the EMR was up coding, because there’s a term called bundling where some services are considered just one. So an example is a complete blood count medical lab tests a variety of things like your red blood cells, white blood cells, platelets. But this program was separating all of those out. So it was saying each one of the components is an individual test, which is logical by the standards of a computer programmer. Because I spoke with them, they’re like, “We don’t understand. It’s one test one.” Which makes sense, but in billing and in coding it’s considered one test. It’s all together as a complete blood count test. So by separating them, they were increasing the charge of the visits because it was saying that, well, we ran all these tests. It was very complicated.
Justin Osborne: Yeah. That’s interesting.
Andra Popa: Your visits are billed according to the complexity, so it was increasing complexity. So that’s a great example where, as you say, you can’t quite rely entirely on your EMR. They are very different. You have to see what works for you.
Justin Osborne: Yeah. That’s good. That’s good advice. I know another example that I always ran up against in terms of complicating this more was mixed visits where you had people and patients coming in and how to manage the EMR so that the patient that was seen for a clinical purpose and a research purpose in the same visit, that becomes complicated to make sure that everything is split out the way it should.
Andra Popa: Yeah. And that’s a great point. And technically what should happen is any item in service, not on the coverage analysis should be then sent back into the main healthcare entities, non-clinical research billing flow. But again, as we talked about, sometimes the coverage analysis doesn’t have all the items and services. So if that doesn’t capture everything within, it might accidentally then be built improperly. But technically they should know right away because it’s not in the coverage analysis. They should know right away that it’s for a different purpose.
Justin Osborne: Yeah. Yeah. Again, assuming that it’s done properly and all that stuff is there. So, all right, so that’s a good segue. So talk about the downer side of this. What happens, I guess? Say you have a coverage analysis, but at some point the process failed and bills are sent out incorrectly. You either over bill, double bill, whatever. Say that happens at your institution. Why does it matter? Can you just, oh, we caught it and we’ll give the money back to the sponsor or to Medicare insurance or to the patient and move on? What does that trigger?
Andra Popa: Yes. It’s very serious if that is found. And it depends again on the fact pattern. But if you find that you’ve improperly billed Medicare on a trial, the best thing to do is to just take a breather and for that trial to stop billing just until you can get everything proper again to see what happened and make a record of any education, any corrective action plans, any root cause analysis and any contact at all you have with the government entity. And it’s better if it’s all under privilege of your general counsel and your outside counsel. You can hire outside counsel consultants, get your audit team involved to see what happened. Sometimes you have to consult a variety of people. It’s very important to not assume that someone is guilty of something. So you have to be extremely careful to make sure that it’s not an innocent person that you’re blaming or that …
Justin Osborne: Sure. It sounds like from what you’ve described and explained in this process, as complicated as it is, it doesn’t sound that hard to make a mistake. It sounds like it’s reasonable that a bill could go out to the wrong party if you’re not hyper focused on this.
Andra Popa: That’s right. And the most important thing to do is to make sure that there are controls in place where you can find these instances where perhaps the compliance program breaks down. And just to try, I think is the biggest … If the government sees that you’re trying and that you do have a coverage analysis and that you caught errors in the system and can speak with your council, speak with outside counsel if needed about whether you need to self-disclose. It depends on the fact pattern. But the most important you can do … And the timeline of reporting that and things like that. But most important thing that you can do is document attempts at compliance and try to have policies and procedures, true education, auditing and monitoring.
Justin Osborne: Yeah. Yeah. No. That’s great. That’s great. This all makes perfect sense. Obviously the consequences of the overpayment, double billing, all that stuff is all over the map. But I guess just to dig a little bit deeper in the consequences area, I guess in your experience, what have you seen? But can you help people that aren’t really familiar with how dire the consequences could be with this? Walk us through that side.
Andra Popa: Yes. It’s very serious financial consequences. We’ve talked before about not losing money with clinical trials, and that’s actually important for maintaining … It’s surprising, but it’s actually important for maintaining the not-for-profit status. If you’re not making money, you’re giving things away for free, and that plays into your not-for-profit status. So there are a lot of areas of expertise that are touched by these clinical trials. And the biggest one, of course, is the financial consequences of the False Claims Act. Trebles damages, which means it multiplies times three. If you can imagine an oncology trial, for example, if you can think of all the items and services that they consume during their treatment, all of that, imagine that multiplied times three, for example. The penalties can range to millions, to hundreds of millions to close to a billion, and they have consequences on the staff of the hospital on the eligibility for Medicare. Depending on what happened. The hospital might have to sell assets. So it’s extremely important for the financial health of the institution and to keep financially healthy. So this is not a cost center.
Justin Osborne: Yeah. No.
Andra Popa: Quickly say compliance is a cost center, but it truly saves millions, hundreds of millions of dollars.
Justin Osborne: Yeah. That was a great sales pitch. Gosh, I think you just scared everybody listening to this. But to your point … And if you’re interested in this stuff, anybody can Google past instances of this and see what happened.
Andra Popa: Yeah. And they’re ongoing. You can really go to the Office of Inspector General, it’s called the OIG, and they have press releases. The Department of Justice has press releases and you can see. So there are different things that trigger the False Claims Act that your listeners might want to be aware of. It’s not only improper billing, but there was a recent case where, in a settlement for … It also occurs if there’s a scientific misconduct and there’s federal funds involved. There was one recent one that the CEO of a startup pharmaceutical company, they misrepresented their thesis and their findings and their graphs. But their foundation of their company was based on this thesis. And they were billing the government and that nullifies the … Things also have to be medically necessary. So something isn’t efficacious, it’s not medically necessary if it doesn’t do anything. So that triggered the False Claims Act as well. There could also be security violations if you have a contract with NASA or a government entity where you don’t have proper security to secure the records that you’re conducting the research on. So all of these things you have to be aware of, not Just the coverage analysis part.
Justin Osborne: Yeah. No. that’s really helpful actually. That’s a really nice list of things to make sure you’re covered against.
Andra Popa: Yeah. And also it’s extremely important because you want to have a viable clinical trial program. Unfortunately, viability does require proper accounting and proper financial maintenance. So you need to make sure that you’re … As we stated, you’re making money on these trials because otherwise it’s not a viable program. So for all these reasons, it’s definitely a good practice.
Justin Osborne: Absolutely. No. That is super helpful. I really appreciate you going through that side of it. So it’s interesting. You talked at the beginning about your experience in this coverage analysis. It’s an industry, right? There’s a lot of options out there, a lot of consultants, a lot of companies that are able and willing to help out institutions with this process. You’ve seen this almost from its birth, right? Where do you see this industry going? Is this going to get more complicated, less complicated? Where do you see this thing going?
Andra Popa: There is a lot of pressure in the industry currently to minimize the time spent on coverage analysis. Almost to a point where it’s hard to complete a coverage analysis that’s accurate. It’s going in that direction definitely. However, at the same time, it’s such a complex field that it’s difficult to cut corners. So there are things that will stay the same, and there’re all things that will change. Even at the early stages, people were trying to create computer programs to create coverage analysis. Not AI but a program to … Software to create that.
Justin Osborne: Do you think that’s where this is going? Do you think that there’s going to be eventually a software solution that could do this or is there too much nuance? And I’m just thinking about how could a software system dig through recent oncology trials to provide us justification to get something approved for Medicare? These people are smarter than me, but do you see that going in this direction or how do you see it?
Andra Popa: It’s possible that portions of the coverage analysis could be analyzed separately. And you had a guest on the show who talked about just creating the grids for coverage analysis. You still need someone who understands the computer and who understands coverage analysis to review it. But it’s possible that different aspects could be then put together and overseen by a human. That’s possible. But no. There is just pressure in the industry to make the time spent on these much smaller.
Justin Osborne: That is interesting. And again, I understand from the industry side why there’s pressure to make the coverage analysis shorter, like everything else. But it’ll be interesting, I guess, to see how either technology, AI in some fashion can help with this or … Yeah. To your point, it seems like when it comes down to whether or not it’s covered how you get there, there’s an art to it, but at the end of the day, there is an answer. Can you disagree on a coverage analysis I guess?
Andra Popa: Oh, very much. Yes. Very much so. That’s why my favorite parts of my consulting work were where we do have true discussions like academic discussions about the coverage and also the entity will have its own interpretation. The clinician might have their own outlook as well as to the conventional care. Because again, we’re not the clinician, we’re just suggesting these materials to them. But yes, absolutely. The entities can say we disagree, we need-
Justin Osborne: Yeah, sorry. That brings me to who is authorized or I guess at an institution, is there an individual that has the authority to say, “This is how I want the coverage analysis to be.”?
Andra Popa: Because I worked in consulting, usually it’s the lead consultant or the attorney working with the entity or maybe their counsel or the compliance officer or everyone together with someone with knowledge of the government standards and the legal risk. So you have to make a judgment call on some of the coverage analyses.
Justin Osborne: Gotcha.
Andra Popa: That’s why you see so many coverage analysis as independent contractors, because technically there’s a lot of liability even for the coverage analyst because you’re saying bill this to Medicare to a huge hospital system. I would have professional insurance to a large amount, it won’t cover a billion dollars, but it has to be a large amount of professional insurance as all auditors have. But that’s why you see independent contractors. Because then the corporation won’t be liable for what you put on the coverage analysis.
Justin Osborne: That makes sense.
Andra Popa: You’re setting their electronic medical billing software to bill a certain intervals that you’re telling them to.
Justin Osborne: Right. Right.
Andra Popa: Them the wrong answer you become liable. It’s very important to work with people you trust when you’re a coverage analyst. But the entity has to decide on its own what risk they’ll accept. There are different levels. So there isn’t really one person. And the clinician might also have an opinion as well as to the coverage analysis.
Justin Osborne: That makes sense. I guess what I’m thinking is because every institution is different and they to decide, to your point, their risk level that they’re comfortable with, it’s not set up in a way that a clinician could come in after you do a coverage analysis and say, “I disagree. Change it to this.”, and then that settles it. There should be either a committee, a group, or somebody that is the final say to say, “No, no. I hear you, but based on everything else, this is what we should go with.”
Andra Popa: Well, yes. Especially if the physician is an employee of the hospital, which more and more are now. An employee, can’t decide the risk level of a healthcare entity because if you do have fraud on their decision, then they’re putting the whole institution at risk. No. They can’t make that independent decision. It is a very interesting field, but it is a very high liability as well just to perform the coverage analysis.
Justin Osborne: Yeah. Yeah. No. That’s helpful. That’s actually really helpful to think through. Again, just there’s so many pieces to this process. Well, this is fantastic. I really appreciate you walking me through this complicated process and talking to us about this.
Andra Popa: Thank you so much for having me. It was a joy to speak with you. Thank you.
Justin Osborne: Well, we’re back. I’m still sitting here with Andra, and we’re going to start our same team segment. So I know we all get bogged down in our day-to-day job responsibilities, but I believe that those of us that stay in this research industry do so because we really believe in making a difference and that our individual efforts have a larger impact on the health and wellbeing of others. So can you give an example or an experience from your career that ties back to this idea that we’re all on the same team?
Andra Popa: Yes. I became really interested in children’s care, children’s healthcare, and I volunteered extensively at a local children’s hospital in Chicago. The Lurie Children’s Hospital. And because I was in this industry for so long in research for so long, I really saw the life cycle of chemotherapy products, of different types of treatments that they provide children. So it was interesting to see that trials that I worked on as a coverage analyst or within an IRB setting then were used on the children that I helped. I just helped create art activities for them but it was very interesting to see it in fruition to see that treatments can help them.
Justin Osborne: Yeah. So you got to see the other side. A lot of us on research get to see the science and the business and all these details to run a trial, but it’s difficult because those people or administrative operations folks typically don’t see the patient side of it. How does this play out in real life? So you got to see these trials in action, so to speak?
Andra Popa: Yes. Once the items were approved, I saw once the approval came through. One of the benefits of sticking with something for a long time is you do see hopefully an improvement in the care. So from 2007, 2008 to 2020, for example, you do see changes and then medicines being approved. I saw that as well. And I was able to shadow an oncology physician also at a university where I helped with their program. There you see it as well. The pharmacy there was embedded within the clinical unit, so I could hear conversations about the medicines that they were using. I didn’t tell them, but I knew I had worked on some aspect of the trial.
Justin Osborne: Oh, that’s cool.
Andra Popa: Before it was approved for use. Really it changed my life as well. I was diagnosed with something as well in my arm. It was called a sarcoma. And it’s usually for pediatric patients and say 30 years ago the treatment was amputation. Amputation of your arm. But through clinical trials, it was one of the first clinical trials that they used was just they learned that if you just remove the issue, then you get better. It depends what stage you are. So in my whole life, it affected me greatly, so it was really incredible having all these experiences where you see … I’d recommend to anyone working within … If possible. Especially if you’re around an IRB, you know clinicians. I asked an IRB member, do you mind if I shadow you? And I ended up shadowing him for two years.
Justin Osborne: Oh my goodness. That’s awesome.
Andra Popa: Yeah. With an oncology clinic. I published a paper with him. I attended the radiation oncology board meetings. It was extremely enriching. I’d really recommend for anyone, even for a few hours, if you have time, if you’re in the IRB setting or in the coverage setting, and anywhere within research, just to go out and be in a clinical setting for a few hours or a few days. Whatever you can.
Justin Osborne: That’s great advice. And thank you so much for sharing. That is an awesome experience that you’ve had to see how this industry has impacted. Obviously you personally, which is amazing.
Andra Popa: Now I can pick up my children and things like that. It changes your life really too.
Justin Osborne: Absolutely.
Andra Popa: You do see progress. I know there’s so much negativity and there’s so much going on in the world with the fires recently, but you do have some positivity. You do have progress in science, and it changes people’s lives.
Justin Osborne: That’s awesome. That is awesome. Well, Andra, this has been wonderful. Thank you so much for sharing all this and part of your story and for educating us. This has been extremely enlightening on this coverage analysis process.
Andra Popa: Okay. Thank you again for having me. It’s just been a real joy and I love speaking about coverage analysis, so thank you.
Justin Osborne: Be sure to follow, like, and subscribe to On Research with CITI Program. If you enjoyed this episode, you may be interested in other podcasts in the CITI Program universe, including On Campus and On Tech Ethics. You can listen to all our podcasts on Apple Podcasts, Spotify, and other streaming services. You should also review our content offerings regularly as we continually add new courses, subscriptions, and webinars. Thanks for listening.
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Meet the Guest
Andra Popa, JD, LLM – CITI Program
Andra is responsible for healthcare content at CITI Program and was part of the first group to conduct Medicare Coverage Analyses. She has worked with a wide range of healthcare entities. A graduate of Boston College, she also has JD and LLM degrees from Loyola University Chicago School of Law.
Meet the Host
Justin Osborne, Host, On Research Podcast – HRP Consulting Group
Justin is the host of CITI Program’s On Research Podcast. He has over 16 years of experience in the human subject research field. Justin began his career working for a local IRB and then a commercial IRB. After spending time on the industry side doing business development, he transitioned to research operations as the Director of Clinical Research at an Academic Medical Center and later a community hospital.