Improving Research Billing Outcomes: The Real Impact of Coverage Analysis Choices

Kylie Waller: 

Hello, everyone, and thank you for all for joining us for today’s webinar. My name is Kylie Waller, and I’m a senior marketing manager here at WCG. WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research by enabling biopharmaceutical companies, CROs, and research sites to advance the delivery of new treatments and therapies to patients. Today, our webinar is on improving clinical research billing outcomes: the real impact of coverage analysis choices. But before we begin the presentation, we have a couple housekeeping items I’d like to review.  

We will be recording today’s webinar, and you will all receive a link in your email within 24 hours of the event to the recording. If you have questions you would like to submit to our speakers, please submit them in the Q and A section on your screen. Our speakers will try to answer as many questions as we can at the end of the presentation. Now I am so excited to introduce our two speakers today for today’s webinar. Our first speaker is Derek Johnson, who is the quality manager for study startup and administration at WCG. Our second speaker is Jenny Campbell, who is senior associate director of business operations at the Jefferson Clinical Research Institute at Thomas Jefferson University. Welcome, Derek and Jenny.  

To kick off our webinar today, we are going to start with an audience polling question. A polling question will pop up on your screen in just a moment, and you can select the option that best applies to you. Our first polling question is: What type of organization do you represent? This question will help us get a better understanding of our audience breakdown today, and we’ll give you a few moments to answer the question before we share the results, all right. We will now share our results on the screen. It looks like a majority of the folks that have joined us today are from academic medical centers, around 54% Next, at community hospitals, 23% and then we also have a number of folks joining us from independent research sites, site networks, physician practices, and integrated healthcare delivery systems. So, thank you all, and I will now pass it over to Derek and Jenny to begin the presentation. 

Jenny Campbell: 

Thank you so much, Kylie. Good afternoon, everyone. Thank you so much for joining us today. We’re really excited to be here. I am going to serve as the site prospective today. I do work at an academic medical institution, so I always think it’s nice to level set so all of you have an understanding of our organization and how we’re set up and what are the kind of key facts and parameters. So I do work at Thomas Jefferson. We are located in Philadelphia, Pennsylvania, and we are Philadelphia’s second largest employer. We have an NCI designated cancer center, 10 colleges, four schools. We have approximately 18 hospitals and roughly 3800 licensed beds, over 40,000 employees, and about 172 million in sponsored research awards. So we are quite large, but I’m sure there’s some out there that are larger. Myself, I work as a senior associate director in the Jefferson Clinical Research Institute. We are a centralized office that provides both business operations and clinical operations support to all of our clinical research studies across the entire enterprise, so we serve all 18 hospitals in this function.  

I specifically work in the business operations side of things, and we have some major primary functions that we help to oversee. We’re responsible for doing all contract negotiations. We do our coverage analyzes, which we do outsource and work very closely with WCG to to perform. We do all budget negotiations as well as post award account management, including invoicing, cash reconciliation, and work closely with our study teams. Finally, we do clinical research billing review. Again, to level set, I do want to show you where we came from because I think, like so many organizations in the past couple of years, we have absolutely experienced exponential growth.  

JCRI, our clinical research institute, was implemented back in 2015. I started shortly after its inception, and we had at the time no electronic health record, no CTMS system. We had two hospitals, roughly 300 accounts, and brought in about 8 million a year. In the eight years that have almost eight years that have passed, we have just taken off. We have implemented Epic as our EHR. We have implemented Encore for our CTMS system. We’ve grown now to 18 hospitals, roughly 800 research financial accounts that we manage. We bring in about 18 million dollars in accounts receivable, and we do now research billing review for almost 850 studies. As of course, as you all know, studies are constantly opening and closing, so those numbers change day to day, week to week.  

Finally, I just wanted to give all of you a high-level overview of our process. I’m not going to get too in the details with this, but I do want to state that I’m happy to discuss this. I’m available on LinkedIn if anyone wants to talk about processes in general. I’m always happy to nerd out on this. So one of the things we’re very we do is we start with our calendar build in Encore, where we do our coverage analyzes, which we do partner with WCG to do, and incorporate that into our budget for our negotiations in parallel, doing our contract negotiations. On the back end of things, we activate our study in Encore using that Encore, excuse me, activate them in Epic using our Encore Epic integration, and our study teams are responsible for doing for associating patients to research and linking all upcoming appointments and encounters. I am extremely fortunate in that I help to oversee a specialized research-driven team. This is a team made up of certified coders and billers who are responsible for performing our research billing review at our organization. I currently have one full-time team lead as well as three full-time FTEs where we do perform 100% bill review, meaning we look at all encounters for our research patients. That that team is responsible for working with all of our partners, revenue integrity, our study teams, our post-award financial teams, accounting, to ensure that all charges are appropriately routed in accordance with our coverage analysis and our budget. Okay, so that being said, you now have an idea of what my organization, where I’m coming from. I’m going to hand it over to my friend Derek here.  

Kylie Waller: 

All right. So we have another polling question for the audience here. How often does your site perform a coverage analysis for your trials? So we’ll give you a few moments to answer, and then we will share the results with the audience. All right. So it looks like a majority of you are performing coverage analysis 100% of the time, but we do have a wide range of others who are doing, you know, about 50% or less. All right. So now I will pass it back to Derek and Jenny. 

Derek Johnson: 

All right. So since Jenny kind of gave you all of her experience and expertise, I kind of want to tell you all how I know what I’m talking about. So I’m the quality manager at WCG. So I oversee the general quality of the coverage analysis for all of our customers across the country. So don’t have a specific site perspective, but I have a wide variety of site perspectives, and then before I start, I want to give a disclaimer. Neither of us are professional coders or billers. Just going to throw that out there and want you to know that.  

Okay, so in this presentation, we’re going to be discussing some challenging billing research billing scenarios. We’re going to provide some possible front-end solutions how we can avoid those scenarios in the first place, and we’re also going to demonstrate some considerations that need to be taken into account for these situations when they arise. And then a personal objective of mine: I would really love to get some laughs, either pity laughs or genuine, not picky whatsoever. These jokes, you know, they definitely came to me, and I didn’t have to prepare them over the course of a month, so that’s just all natural. And the best part of the webinar is I’m just going to picture that you’re all laughing. That’s just what it is. And then one more time before we move on, either of us are professional billers or coders. 

Jenny Campbell: 

You just got you getting a lot of laughs, Derek. See, that’s gratification. Love it. 

Derek Johnson: 

You didn’t even have to imagine it right there. Okay. 

Jenny Campbell: 

All right. So today, what how this is going to work is we’re gonna I’m gonna cue up a couple scenarios, maybe things that we’ve encountered as an organization, as an institution, and just some example scenarios of some challenges because we we do negotiate these coverage analysis and we think so hard about the billing determinations and what’s compliant and what’s not compliant, but sometimes there’s some additional things we need to really consider from from on the back end of things that might not always be inherently obvious at the coverage analysis budgeting time. So I’ll cue up a scenario, explain it, talk about some of those challenges, and then Derek is going to give us some possible solutions that he’s seen with some of the organizations that he’s worked with.  

So, given this first scenario, we have a coverage analysis and a budget that was just finalized for a new study. We have given in this budget we’ve negotiated on our screen here. We have a screening visit where we have items and services where some things are going to be paid for by the sponsor and some things are going to be billed to insurance, including things like radiology and lab work. Pretty straightforward, right? I’m sure we see this all the time at our sites. What is a particular challenge here? Well, you have to kind of think about what’s going to happen in actuality. Oftentimes, when we have patients who are coming in for their standard of care routine appointments, they come in to see Dr. Smith, and Dr. Smith says, “All of a sudden, you might be a great candidate for the study. Next thing you know, the patient’s signing consent, and now this standard routine visit has now changed just like that from a research from a regular routine clinical visit to a research visit. Does your site have the capacity to create some sort of bill hold? Do we have a way to notify everyone that hey, we’ve now changed this into a research visit, so now some of the billing implications may have changed. Maybe you’ve collected a copay up the front desk that may or may no longer be applicable. Do you have something in place to address that? So again, it’s not that it’s impossible, but now all of a sudden we have this challenge because now we have things going to insurance, we have things going to the sponsor. Another thing that I want to consider, and I’ll point out here, is let’s look at this tumor imaging line. So in this tumor imaging line, we have it deemed as SOC slash invoice. So this is our split billing designation. Just a level set. I’ll explain what that means so everyone’s on the same page. So the idea behind the split designation is when we’ve done our analysis, we have determined that yes, based on that disease state for that patient population and based on the timing, we’ve done our due diligence and that tumor imaging at screen up is at screening. Excuse me, is absolutely billable to insurance. But if you look at the screening window, it’s negative day 28 to day negative one. What does that mean? It means the sponsor has essentially said you have 28 days to do screening. That we will take results for that screening, those screening items to be viable, right? So let’s say your patient just had just had the imaging done as routine care 35 days ago. Sponsor isn’t going to accept the results of that scan. The sponsor is going to want a new scan, and the reality is that scan is literally only being done for research purposes, so the sponsor needs to pay for it. So in that case, in that patient, for that patient only, it is invoicable. Now think about the time it took for me to explain that to you all. You are people who are involved in clinical research and understand this. How challenging is that going to be to explain to the patient, to the clinician, to the radiologist, to the pre-cert team, to all of the teams that may have to be involved in this process, what you’re doing-it’s not impossible to do, but it is challenging. And I always think anytime you create complexities within your budget like this, you run into the risk of being non-compliant. So, Derek, given these complexities, what choices do sites have to navigate through some of these challenges? Oh, I think that question went first. Oh, sorry. 

Derek Johnson: 

We’re both controlling the same thing. All right. So, working for all these sites and so many sites across the U.S. I’ve seen quite a few strategies, and all of us at WCG have that can be taken to avoid some of these painful situations in the first place. And then for this slide, full disclaimer, another disclaimer: I was in the middle of an apartment hunt while I was looking for this, and I was kind of inspired by the creative names that the department managers gave their units, so you can see that in the names of these strategies. So the first one we have the standard. This is if your site doesn’t really have any major policies around screening. This just involves having a pretty standard coverage analysis, and then, as Jenny said, you would analyze all the items of screening, and then have SOC windows if it’s applicable. So usually for scans or any kind of procedure, biopsy, that type of thing. Next, we have the the window shatterer. So, if your institution sees SOC windows and shutters, dramatic pause, then this might be the best approach. In this approach, anything that has a potential SOC window should be paid for by the sponsor. Usually, the rationale behind this approach is that if an item can’t be guaranteed to be covered for all patients on that study, then it should be paid for by the sponsor. You want to treat all patients the same. Just eliminate that confusion right off the bat. Finally, we have the all-or-nothing. This is that everything performed at screening should be paid for by the sponsor, no matter what. This approach can be a bit of a double-edged sword if you use it. On one hand, it makes the CA my job a lot simpler, but on the other hand, it can really lead to some of those extended negotiation times since you’re having that entire visit as paid for by the sponsor, and again the rationale usually seen for this approach is that the screening visit is specifically required for that study, and the sponsor is requiring it per that protocol. Therefore, they should be the ones that paid for it.  

And then at this point, I was running out of creative juices, so I had the not included in the above list, and this is not exhaustive of all the possible strategies that you can take. This is just kind of the three major ones that we’ve seen. All right. So now we have another polling question. All right. So out of the ones that I talked about, which approach to screening is your execution or site prefer? Standard Window Shatterer. all or nothing, a little bit of this that you know kind of a mix of all, or are you just in the complete wrong webinar and need to log off right now? All right, so we have a lot of lot of standard and a little bit of a little bit of that. So only only about six people are in the wrong webinar, so I think that’s pretty good. I’m impressed. All right, now we’ll just turn it back over to Jen. 

Jenny Campbell: 

All right, thanks. I’m really enjoying this the laughing faces. It’s very gratifying. So we’re going to talk about another scenario here, and again, high level because we can get into the nitty gritty. I know some of you are billing and billers and coders, and we could really talk about it for days, but in the next scenario I want to bring up is we have a newly negotiated budget and coverage analysis with a new for a new study that has outpatient chemotherapy IV infusion. There are two different drugs that are being given. One is an investigational agent, and one is a standard of care chemotherapy that is being given during that same outpatient encounter, the sponsor has agreed to provide the investigational drug at no cost, and they’re going to pay for its administration. On the other hand, we’ve done our due diligence, and the standard of care chemotherapy we’ve shown that it is in fact billable. It the chemo and its administration are going to go to insurance. Now, what are the challenges here? The challenges on the front end might not be inherently obvious, but I can guarantee you the challenges of the back end are gonna show up when the charges drop. And I can tell you this because I’ve dealt with this directly with my research billing team. On the right hand side is just a screen grab of some charges that have dropped in the system for these types of encounters, things like saline, ancillary costs such as our premedications, as well as our chemotherapy and the charges. So when you start to look at this and you start to think about this from a billing perspective, how do we determine which things are the sponsor chemotherapy costs, and which things are the standard of care? Which chemo IV charges belong to which? We have a regular code. We have add-on codes. If we try to submit some of some the add-on codes without our preliminary charge, you can believe that insurance is going to kick that out and say, “Sorry, we’re not processing this. Additionally, what about those ancillary costs? Who’s paying for the premeds? Have we spelled that out in our budget and agreed to take money? Do we need to segregate those off? And if we segregate those charges off and try to submit that claim again, are we going to have denials? It may be possible given some of the constraints of your system, some of the limitations, or some of the possibilities, depending on the charges and how they drop. But the reality is, when these charges are dropping, and you have a lot of patients and a lot of bills to review, this gets really complex, confusing, and you need to make sure that you’re doing this exactly the same for each patient, and that you’re not submitting claims that are going to result in in denials. So, Derek, given these types of scenarios, what could a site do to kind of prevent from being this kind of stuck between a rock and a hard place? 

Derek Johnson: 

So yeah, just like just like some the procedures of screening, this can be handled in several different ways, and it kind of aligns. That’s going to be a theme that you’ll see in these slides. So one, the first approach, and kind of the most common that we see, is just to analyze each infusion on its own. So in this approach, you just focus on matching the infusion to the drug designation. So if a drug is found to be standard of care, or if the drug is provided in a clinical trial, then you make that administration standard of care. Or if the drug is found to be research related, then you would want to make that infusion research. The biggest issue and the most common issue that you might have with with this is that some visits actually could have a SOC and a research infusion happening at the same time, which can be learn this from Jenny, a billing nightmare, and then yeah. So next we have make all the infusions standard of care as a whole. In this approach, you just make all the infusions billable, regardless of if the drug itself is considered SOC or not, or if it’s provided in a qualifying trial. And typically, the rationale behind this is that sites would say that they apply NCD 310.1 to justify coverage of all the infusions in a trial. Then we have them the make them pay up. So in keeping with the theme of the previous slide, if one infusion is considered research related or sponsor paid, make them all in research related or sponsor paid. This would again kind of alleviate that whole issue of having the split split billing and just kind of get rid of that as a whole. And finally, don’t forget about premedications or, as Jenny said, any ancillary costs because those are all going to pile up in there. So make sure you include that. A strategy that we like to do for those is just kind of make one bucket line item and then you can make it as an invoice amount and just try to get the sponsor to pay you for the actual cost of those items. 

Jenny Campbell: 

All right, thanks, Derek. All great solutions. We’re going to move on to our next scenario, and this is the dreaded inpatient admission. And I know there’s a lot of different scenarios, but I think as Derek and I are talking to it, there’s really only so many solutions you can come up with. So, in this example, and this was one that did come up at our site, and we navigated through successfully. But we had a new study where it was designed so that the eligibility criteria of the study requires that a patient is already scheduled to undergo a procedure that requires an inpatient admission. So the inpatient admission, because that’s part of the eligibility criteria, the patient would be having it having this procedure in the admission, regardless of the participation in the trial, that has been deemed billable to insurance in both the coverage analysis and the budget. However, during that inpatient admission, the sponsor says, “Wait, wait. We want you to do another research only procedure and we’re going to pay for it and then we want to pay for the two days after that for the procedure for observation same admission but we’ll pay for some of it so the reality is under DRGs and under inpatient rules and regulations there are a lot of there are a lot of rules and regulations that have to be adhered to, things that go well above and beyond my expertise. But the reality is, if I start to peel off things like overnight visits or procedural codes, I you better believe I’m going to be getting a call from my revenue cycle team saying, “Hey, wait a second, we got a problem here. There are going to be restrictions around billing that that claim, there may be an option to do split billing at your organization for inpatient admissions. They’re possible, but they’re not easy, and there are always challenges with that. My own site, we are not able to do that given our size and our systems. We know that there’s always a ripple effect. So any changes you make for for split billing, there’s a ripple effect upstream, downstream that impacts registration, maybe order sets. There’s a lot of things that can happen. So just doing split billing is not. It’s not that it’s impossible, but there are a lot of challenges there. And then the last thing is we want to be really careful because if we are saying that we’re going to be billing an admission to to an admission to insurance and having them pay, we have to be careful. We’re not taking money from that sponsor for something that we absolutely can’t pull off that claim without it being denied. And you better believe that in the time and these times at our hospitals, not being able to bring in revenue is not an option. So in this case, Derek, we’ve really kind of put ourselves in a corner where we potentially have agreed to something that we can’t necessarily. If we follow our billing compliance standards here and don’t bill to insurance, we are going to result in a denial for the inpatient admission. So what could a site do to not get painted into this corner? 

Derek Johnson: 

Yes. So that actually, you know, poses a really Shakespearean question on SOC or not to SOC. It’s like Hamlet. So there’s one all-encompassing approach to research-related hospitalizations that I would really recommend and kind of just. Standard that we do at WCG, and then that is that everything during that hospitalization should also be researched and need to be paid for by the sponsor.  

Research hospitalization has quite a few potential billing implications, as Jenny said, especially since inpatient billing is so complex. And this is where that double disclaimer comes in again, where neither of us are professional or coders or builders, so these complexities should be directed to people to actually do that for a living. Which again, not us. Some some workarounds around this might exist, but really aren’t recommended. It all just comes down to your institution’s preferences, policies, and risk tolerance. And then with the with making that entire hospitalization research and sponsor paid, this is the one time where that extra budget negotiation time is actually worth it. Often, the sponsor is still going to try to push for SOC procedures during a research hospitalization, and this should be shut down immediately in negotiations in order to prevent those future billing issues from even happening.  

And then on the flip side, what happens if the sponsor is offering payment for the procedure during SOC hospitalization? And SOC, I’m sure you all know, standard of care. So this typically occurs whenever our patients are scheduled for a specific type of surgery, or if they’re already admitted to an inpatient stay prior to enrolling in that study. And the standard approach for this is to include that sponsor payment, at least that we take include the sponsor payments for the procedure. Again, this might not work for every site or every institution. And if you can and you do accept this sponsor payment, you really need to review the billing implications with your billing team to see if it’s possible to even do that in the first place. And then, if this gets too complicated, you consider either you can consider either declining sponsor payment for that procedure, or just requesting that they pay for the entire hospitalization and just kind of keep it one-sided there. And again, as a running theme, is the all-or-nothing is the ideal strategy for this to avoid those billing issues down the line, but might not always be possible.  

Jenny Campbell: 

All right, so we’re going to do our last polling question here before we hit our final scenario. So, does your institution run into capitation issues? Simple yes, simple no, kind of. Hey Siri, what’s capitation? Or I still think I’m in the wrong webinar. Any ideas here? Don’t worry, I will give you the answer if you don’t know. All right, our polling results. We we have a a high percent, which I’m surprised of. Hey Siri, what’s capitation at 56% So this is you know the learning continues. I love that. So this scenario is is near and dear to my heart. I will say that as a former, I did work in in a in a former life as a research coordinator, and so this one really gets into logistics, which I think is always something that people don’t always aren’t always aware of when we talk about coverage analysis development. So let’s talk about this. So we have a new study that has been negotiated where some of the lab work has been determined to be billed to the sponsor, and some of the lab work is going to be deemed billable to insurance as standard of care. So you might say, okay, that seems reasonable. This is shouldn’t be an issue. It seems simple. Some goes here, some goes there. What’s the big deal? Well, if you have capitation to navigate, it might be. So capitation is the idea that depending on your patient population and your insurance payer mark makeup, some insurance companies do require that their patient population get capitated out to a third-party lab to have the lab work done to be paid for by their company. So in those cases, if your patient population gets capitated, they may not be able to stay at your organization to have lab work done. They have to go out to like a lab court or a quest to have that done, and this is not uncommon. The same could be true for imaging or some other services.  

So let’s think about that logistically. If we have a patient, we’ve determined some go to insurance, some go to to your organization or to the study sponsor rather, if you have a patient enrolled in your study who’s capitated, what that now means is you have two options. You’re always going to have to send them out to have that standard of care lab work done at the third-party lab. You may also require them then to come back to your site to have the research lab work done. That helps because you can control the billing for that. But the problem is you’re now asking the patient to put in yet one more visit into an already maybe very busy tight protocol schedule. You’re asking the patient potentially to have another stick to have a venipuncture done, and you’re really creating a lot of additional logistical work for your study team, they have to go around making sure that they’re getting the results that they need from that outside lab, that the patient got there in time, that they’re on on schedule to be able to come in for maybe their infusion that now has to be eight hours. So you can see it’s a lot of consideration. The other side, the other option, what you could do is you could say, okay, well, rather than have this additional visit for the patient. Let’s partner with that third-party lab. Let’s work with them, and that way the patient goes there for one one lab visit and has all their lab work done. Well, of course, there’s considerations there. If the patient goes out to that third-party lab, you have to have some sort of contractual agreement as an organization with that lab to make sure that you have a clear business set up with them. That there also is some sort of prices negotiated because oftentimes they’re more expensive than your local app. And additionally, you have to make sure. And this is definitely the the key point. You have to make sure that they are billing in accordance with your coverage analysis. That the things that they’re billing for aren’t going out to things that we’re paying for aren’t going out to insurance, and we already know how hard that can be at our own organization. Now imagine have relying on yet another party to do that, and again, it’s administrative burden and it’s more work. So again, there’s it may seem pretty straightforward, but the reality is if you navigate capitation, this can actually be really challenging for our study teams to to manage. So, Derek, what could we do to avoid this situation? 

Derek Johnson: 

So, if your institution frequently sends patients to an outside facility for these protocol-related tests, you should really just try to develop and implement a policy around these tests to ensure consistency across all studies. Just getting that policy down so it’s actually consistent is huge. So there’s no differences there. And then I would also strongly suggest that this policy is put on one of the best possible things that you can have during negotiations, and that’s documentation on official letterhead with the signature of someone who has a at least important sounding title. And then as Jenny said, it’s your site’s responsibility to share your coverage determinations with the outside facility. Due to this, you might want to try keeping the CA designations as simple as possible in order to avoid any downstream billing errors, because the more complex it gets, the more chance that the outside facility is not going to bill it in accordance with this coverage analysis, and then bringing it back to the common theme that I’ve had multiple times here: simple, I have a whole process. You could even consider if one of these protocol required labs can’t be filled at your site, just consider making them all research, so you can avoid sending the patient to the outside facility in the first place, and I do want to make this clear that this is a very common problem across sites. Many sites do struggle with this and have to develop policies around the lab billing. And I’ve heard from quite a sites that think they’re the only ones having the issues with this, or they think that there’s not many places. So it’s important to realize that there are plenty of others who’ve gone through this and have actually come up with solutions that work for them.  

Then, finally, if you do have to use an outside facility for any research-related protocol test or procedure, make sure that you’re getting and using the pricing from that facility while you’re building and negotiating the budget, because as Jenny said, 95% of the time the outside disability is going to be much more expensive than what your charge master cost.  

Okay, so now we’re going to get into some considerations that you can take ahead of time. So, so the consideration of your site risk tolerance is a big one. It’s how far is how far are you and your institution willing to go? Are you going to be willing to extend negotiations, possibly you know, an additional month in order to get the sponsor to pay for everything, or are you willing to take on that risk of more complex billing? The risk of the complex billing also can lead into your trust in your staff. It’s not just the study team working on the billing of the trial. There are so many other parties that are involved that had little or nothing to do with the study prior to the billing cycle, and some of them might not even know what research is or what coverage analysis is in the first place. Imagine not knowing what a coverage analysis is.  

Then the next one you have to take into consideration is your ability to negotiate. Sponsors, as we all know, are going to push to bill things to insurance. They don’t want to pay for other things, so you’re going to need to be able to discuss with them and get them to pay for items that they don’t necessarily want to pay for. You know, this is the case for every budget negotiation, but to a greater extent for some of what we talked about, like inpatient days. And then negotiators should also have some knowledge in the billing in billing conditions. Having the knowledge to know why things are, why they’re not considered standard of care is immensely valuable during negotiations, especially while you’re talking to those sponsors. 

Jenny Campbell: 

Yeah, I can speak to this directly. Prior to us in having a research billing coding team and having our transparency and Epic, we really didn’t have a leg to stand on. But once we gain some of that, we found we have people we can say, hey, let’s talk through what are the issues here, what are the concerns, and and you’ll you would be amazed when I can go back to a sponsor and say, I’m sorry, I’ve talked to our our coding team, and you start to you know you speak the language. It’s amazing how well that comes across. Because the reality is, sometimes you get lucky and you get a sponsor who really does know their stuff? And I have had those instances, but oftentimes they’re also not knowledgeable on the topic. And the reality is, you you might most likely know more than they do. So don’t be afraid to have them say, you know, if they push back, say sorry. I know. I talk to my people. No way. We got to do this, and otherwise, this isn’t going to happen, so just you know, get some confidence. If you’re not sure, find that person at your organization who knows billing, who knows coding. Get them in your corner, call them up, and you will be as surprised how far that goes with your negotiations. 

Derek Johnson: 

And I can’t tell you how many times when I negotiated, I had to send pictures of the NCCN guidelines to sponsors to prove that I was right. So next, again, you’re going to want to have some documentation. The more documentation that you have on that Purdy signed letterhead, the better. It’s it’s really just a small investment of time ahead of time, just to draft that up and get it signed. But it’s going to save you so many hours in the long run. And again, coming back full circle, it’s all about your risk tolerance. 

Jenny Campbell: 

Yeah, and the last thing I think to consider is logistics, and I think it is important. It’s talking to your study teams, understanding, you know, what are the needs of that particular study. Are they having staffing issues? Are there resourcing issues? You know, we want to make sure things are as as simple as possible in this very complex world. Knowing your patient payer makeup. Do you need to address capitation? That’s really important for you to know. Is this something that my study team is constantly encountering that I need to be working on their behalf? Also, just knowing where your patients coming from. Are there patients in network, out of network? What are considerations there? What are your physical locations? We’re all from different places across the the globe, and so the considerations we may have here in Center City, Philadelphia, are very different than what’s happening in Oklahoma. So we just need to be very aware of what your needs are as a site, as an institution, and then also, you know, what about the study specifics? Different studies have much rigorous; some are much more rigorous than others. So, if the sponsor is asking for rigorous turnaround times, long PK days, it’s really demanding. Don’t be afraid to push for them to pay for more and more and more, because the reality is, if they want things to happen without deviations, they need to pay for it. Otherwise, it’s going to you know really be so challenging for not just our our patient, for not just our study team, but more important for our patient population. If we can get them to come to one place, have everything done, and and now and and reduce their payment out of pocket, everybody wins. 

Derek Johnson: 

And then, so the biggest thing that Jenny and I wanted you to take away from this is that there’s not going to be a single solution that really works for you know every study, study by study, or even sponsor by sponsor, especially given the large difference in the industry between industry and cooperative or government-funded studies. So, big takeaway we wanted to give you all.  

Kylie Waller: 

All right. Well, thank you so much, Derek and Jenny. We had a ton of questions and some great audience reactions. So thank you to everyone who has participated so far. Now we have some time for some audience questions. Our first question: How can you determine when a coverage analysis is needed or not? 

Jenny Campbell: 

Yes, that’s a great question, and it’s not always straightforward. So I think the the key is you know you’re really trying to identify are there potentially billable clinical items and services. And for some of our studies, that’s really not too bad. That’s not too hard to figure out. But for some of them, it’s very nuanced. And I see this a lot with especially with some cooperative group studies, but also mostly with our investigator-written protocols, they always try to write things in a way that oh no no it’s standard of care and we’re collecting data and it’s like but is it mandated by the protocol at a certain time point and so it’s it’s really knowing how to to really read between the fine lines of is this going to drop a charge in the system that I need to be concerned about? Does it require codes and modifiers? So I think that what my takeaway would be, you know, at our organization, what we do is our team who who works on the coverage analysis budget side, they make that initial run through to say yes, it needs a coverage analysis, no, it doesn’t. If there is any uncertainty, they kick it up to me, and I am absolutely not afraid to go to a PI and say, “But this is going to drop a charge. We need to do a coverage analysis. Sorry. So when in doubt, if we’re not sure, we’re going to do one. But I think it’s just making sure that you know you have someone who can kind of read between the lines a little bit, because again, I find that it’s most common. It’s not so much on our industry side, but it does happen. And it’s really understanding: is this going to drop a charge? So if you’re not sure, go to that clinical department, find that biller, find that coder there who might be able to say, yeah, absolutely. If this happens, this would drop a charge. And if that’s going to happen, and you’re going to have to do something with that charge in terms of making sure it either gets built to the study or it needs codes and modifiers, you need to have a coverage analysis done. 

Derek Johnson: 

And I know, just in in my experience, I’ve kind of seen this several ways. We have some sites only send us CAs that they determined are necessary. Some sites will send us every single study that they have that want they want to get a C on everything, so they have that documented, and then we actually have some that would send us a study. And if we found that you know coverage analysis wasn’t needed given the limitations of what they wanted, we would fill out a form for them, and they would go out and actually give it to the PI to get them to sign, so that they have that documented. And typically, the only time that we would really even consider that is if it’s a totally data collection study. Basically, as soon as there’s a CPT coded item or any item that needs to be analyzed, you should get a coverage analysis. 

Kylie Waller: 

All right. Next question: What if a PI or clinician disagrees with the determination made in a coverage analysis? 

Jenny Campbell: 

That would never happen, Kylie. Never. I kid. It does happen, right? So I think one of the things that we we do as an organization and what we have found to be successful is we developed a policy. We have a clinical research billing compliance committee. We help to draft a policy where essentially, if you disagree, you can disagree, but you must provide us with some level of you know LCD NCD disease guidelines or peer-reviewed literature, and if you cannot provide that, we cannot move forward. And the other thing that we absolutely do is, I would recommend is get a clinician in your corner and in in for for this. So someone who can be a champion for research who’s a clinician. So if you get a PI who is you know really fighting you, you do want somebody in your background. I’m very fortunate that we have our deputy provost for research who’s a clinician and a researcher. I can go to him if I hit hit a wall with a PI, and he can speak clinician to clinician, and then they can can duke it out, but ultimately we won’t flip the designation. And if they’re saying yes, this is billable, yes, this is billable, they can’t provide us with the appropriate documentation. We cannot deem it as billable and won’t move forward with it that way. 

Kylie Waller: 

Great. All right. Okay. So next question: Is it up to each site or the sponsor to document whether or not a trial meets the qualifying criteria for Medicare coverage. 

Derek Johnson: 

Yeah, that’s that’s up to the site. Don’t let the sponsor make that decision for you. So you know, a lot of sites have more specific requirements as to this. An example: some sites, when they look at the therapeutic intent portion of the final trial qualifying. Some sites will only use the primary objective, whereas I’ve seen others that use the secondary or even exploratory to make that therapeutic. And for this one, ultimately, it’s just your site’s it’s your site’s retractability. So it depends again on your risk tolerance, especially the risk tolerance of your compliance department, as to whether you’re more willing to kind of stretch it to make it qualifying, or if you want to be very stringent and if this thing is not not included or not making it qualifying. 

Jenny Campbell: 

Yeah, the reality is your site’s the one doing the billing. You’re taking on the risk. So regardless, the sponsors like to tell us what’s qualifying. They like to tell us what’s what’s billable, what isn’t. The reality is, you’re doing the billing. So if something goes wrong, you’re going to be the one that gets fined. So don’t let them tell you what needs to happen. That is, you’re totally in the driver’s seat for that. 

Kylie Waller: 

All right. Okay. Next question: How does creating a budget and creating a coverage analysis overlap, and how do you ensure alignment between the two? 

Derek Johnson: 

 So, so the biggest thing is you definitely want to complete your coverage analysis prior to working on building an internal budget because they they work together. They’re necessary for each other. They work hand in hand. Once you complete that CA, you should really take those designations and determinations that you figured out while doing the analysis, and make sure it’s consistent in that internal budget. So that kind of creates that layer of accountability where you have those determinations figured out, and then right after that, that’s when you’re going in and you’re actually inputting that into your budget, so there’s kind of no going back and forth there. And in terms of document alignment, basically just kind of comparing the documents. Just look for the the big things that would cause any issues, and that’s going to be your billing designations. Make sure that things that are SOC in your VA are marked as SOC and your internal and sponsor budget. Same with research, and then you’re also going to want to check for any sort of hidden language. Big one: if you look in the invoiceable section, always look for something that says invoiceable if not performed for routine care or something like that, because that can really get you. You need to look for all that language and make sure that all the those definitions match up. 

Jenny Campbell: 

Yeah, at our organization, from an alignment perspective, you know it is challenging because sometimes we’re negotiating budgets and contracts for months and months and months, and by the time it finally gets done, your head is spinning. But that that that alignment is key. That you’re putting in front of you the final consent, the contract, the budget, the con, and the the coverage analysis to make sure everything lines up. And I would definitely suggest more than one set of eyes. We have someone from our contracts team reviewing the contract and the ICF, someone from our post award team reviewing the payment terms and and or the payment section and the ICF as well as the contract. And then we have our research billing team who’s checking out that that coverage analysis as well. So I think you know getting more eyes on it and making sure they align, and then also you know if you find something, if something is out of is not concordant, and you find an error, even if it’s on the first patient, ring the alarms, right? Let somebody know. Get those things fixed. If it’s if it’s an amendment, it’s an amendment. But get that fixed on that first patient so that you know it happens. We’re all doing a lot of different things. Sometimes we miss something. It happens. But make sure you go back to the sponsor and say, “Hey, we have to get this switched. It’s not right in the contract, so that everything lines up. 

Kylie Waller: 

Great, thank you. All right, so our next question: Our institution has hospitals that fall under two different jurisdictions. Do you have any advice as to how to deal with conflicting LCDs? 

Derek Johnson: 

Yeah, so we work with quite a few institutions that handle this in a couple ways. You know, institutions that again have sites and locations throughout different states that just happen to be in different math jurisdictions. So one of the approaches that we see is, you know, you look at those LCDs, and if it changes coverage for one site, you know, if it changes it from research to billable, or it changes the item from billable to research, you need to make sure it’s consistent for all. So that means if you have an LCD in one of your jurisdictions that takes an item that would be SOC and makes it research, you should make it research for every institution, even in that one CA and that one budget. And then you know vice versa, if a if an LCD makes an item that would usually be research billable, you wouldn’t really apply it if it’s not applicable to all of your map jurisdictions. Then the other approach that we see, and this one’s much less common, is to have an actual separate CA and budget for each jurisdiction. So these can, you know, align for a lot of the items, but there’s going to be some items that have LCDs that are applicable only for a couple states and not others, and this will also lead to additional coverage analysis and additional budgets and budget negotiations. So again, the more common approach is to just have it all inclusive in one CA, and it’s really important. Do not ignore LCDs if they’re only applicable to a portion of your site. Don’t ignore it. You still need to take those into account because if you ignore that and the patient goes to that site in that jurisdiction, it might not be covered, and they could have to pay for that out of pocket. So please don’t ignore them.  

Kylie Waller: 

All right. Okay. So we have another question. What are some best practices to capture all the services when only the protocol schedule of events is as of events is used as the billing grid? 

Jenny Campbell: 

It’s a great question. And as we all know, these protocols are long, and there’s lots of information, right? You can always start with that schedule of events as your basis, but I think the reality is you have to be able to navigate your way through a protocol a little bit. So start to familiarize yourself with the protocol, understand it. Footnotes are key. So a lot of those schedule of events, there are footnotes that go on for days. They matter. The other thing I would definitely point out is start to know some of your sections of the protocol. Maybe you don’t need to look at the scientific rationale, but you should be looking at the breakdown of things like radiology lab work. Very often, your schedule of events will say something like chemistry panel. Don’t assume that’s just a CMP. That’s most likely going to be a laundry list of labs, amylase, lipase, LDH. The list could go on and on. So make sure you’re really looking and you’re looking at that in detail. Don’t be afraid to ask questions to the study team, the PIs. They’re the ones who are going to be running the study, so they should be able to recognize if things are missing. And then last, lastly, don’t be afraid to push back and ask questions to the sponsor. I’ve been on multiple times where I’m reading through a protocol, I’m looking at it, I go to the study team. We’re all confused. You better believe we’re getting on the phone call with the sponsor to say you got to explain this to me. You have two things in here that directly conflict one another. What’s the deal when it comes to our to our billing conditions, so just know that the schedule of events is a start, but there’s certainly so much more in that protocol. Things to consider if you have a procedure, maybe there’s pre, you know, pre-admission testing that needs to be addressed. You know, ancillary premeds. There’s always additional costs that might not be inherently obvious that you need to consider when you’re when you’re looking at a protocol. 

Derek Johnson: 

And then on top of that, even in the items that are in the protocol, like chemistry, you’ll want to look a little more in depth. Big thing, look at the central or local lab because that’s going to affect a whole lot of analysis and a whole lot of billing as well. And then on top of that, don’t be afraid to use other documents. I know when we do coverage analysis, we look heavily at the sponsor budget, and it’s one of my kind of in my process personally. I always will after I finish looking at the coverage analysis, I’ll skim through that sponsor budget to see if there’s anything in there that is not in the CAA. And I’ll you know first I’ll question you know am I blind? Did I miss something? Is it bad? And then once you look into it, 50% of the time the sponsor is including a cost that’s not actually necessary. And then when we negotiate, we just ask them, “Is this needed for the study? And then the other half of the time, it was missed. It just could be, you know, hidden in the deep section of one of the scientific breakdowns on a page, or anything like that. So definitely look at the different documents, and then also the ICF, since that’s written in you know more plain English for us people. But for me, that’s not scientific minds like that. I can actually I can actually comprehend that a little better than a lot of people can. So if something’s a little confusing in the protocol and you’re not fully sure. ICF won’t always help, but it can, and it has the opportunity to be helpful as well. 

Jenny Campbell: 

And even to add to that, you know, if something happens on the back end, like you get your first patient on, and all of a sudden there’s charges that you don’t know what to do with, and the study team saying, “Yeah, no, this is part of the study. Don’t be afraid to to go back to the sponsor, have those discussions, do amendments. A lot of times, things pop up, so I think it’s important to just constantly be referring back and forth. Just because you did your coverage analysis, it’s not just done. It’s it’s kind of it is a living, breathing document. Amendments happen, new charges drop. Like you always have to be going and modifying. So don’t be afraid to address those things as the study goes on and your patients are on. 

Kylie Waller: 

Thank you both. All right, we’re getting close to time, so we have time for just a couple more questions. Next one here is: When a study population is varied, for example, solid tumors, under what guideline, if any, should the CA designations be determined? 

Derek Johnson: 

Yeah, so at WCG, how we handle this really depends on a couple things, and it’s going to be how detailed the inclusion and exclusion criteria is, and then how many disease types are actually allowed to enroll. So the limit that we usually set is if it’s less than five indications, we’ll actually find guidelines for each individual disease indication, and if it’s not supported by all these guidelines, so if there’s a scan that’s billable from three guidelines but not the other one, we will make it research for all patients so that they’re all treated the same, and the only thing that can really go above that is if you have drug side effects or any sort of side effects that can justify that, of course. And then if we get five or more indications, or if it’s truly just a general solid tumor studies where the inclusion criteria doesn’t go more in depth or provide any actual localities or anything, then we don’t use any guidelines at all. It has to be all from the drug side effects. So, if you have a solid tumor first in human study, odds are everything is going to be researched, and the sponsor is going to have to pay for it because with solid tumor you cannot really, you can’t really assume that something’s going to be standard of care for every single possible indication on that study. And again, with the five plus indication or solid tumor, the only thing that you would really use are going to be drug side effects, or you know maybe the immunotherapy guidelines if it’s an immunotherapy drug trial.  

Kylie Waller: 

All right, thanks, Derek. Okay, so last question here: Is it appropriate for an institution to waive subjects copay slash deductible coinsurance for clinical trial SOC assessments? 

Jenny Campbell: 

Great question. It is something that I think I address at least once a month across my organization. The blanket answer is for for clinical trial patients for a study. We cannot waive copays, deductibles, or coinsurances, nor can we pay them. This is seen by CMS as a fraud and abuse problem. Additionally, paying for those things or waiving them can be seen as an inducement issue, which is an ethical issue from an IRB standpoint. You know the the reality is you can there is a way to waive copays on a on a per patient basis. So there are your you can talk to your hospital. There are charitable care or indigent policies available for patients who have financial needs. So there is there your your hospital should have an entire group that’s dedicated to this, or at least a person who can speak to this. So at the patient level, yes, if one of your patients has a financial need, that could be assessed and it might be possible. But across the study, we absolutely 100% cannot waive copays and deductibles. We want to, right? We want to do what’s best for our patients. We want to reduce those out-of-pocket costs, but it is a fraud and abuse problem, so we cannot do it. And I have this conversation with our study teams all the time, our physicians. You know, we want to do everything to remove barriers to participating in research, but the reality is that is one thing we absolutely can’t do across a clinical trial or for clinical trial patients. 

Kylie Waller: 

Thanks so much Jenny. All right, so I know we’re coming up on time. I think those are all the questions that we have time for today. Before we wrap up the presentation, we have a final poll question for the audience. If you’d like to learn more about WCG’s coverage analysis solutions and how we can support you site, please answer the question here. Last year alone, our coverage analysis experts performed over 3,600 coverage analysis on behalf of institutions across the country. We’re always willing to chat about the complex world of coverage analysis. As you can see today, we have a ton of questions that came in and our experts are always willing to discuss. Thank you so much to Derek and Jenny for joining us today and sharing your expertise. And thank you to the audience for joining us. We will be sending out the recording via email within the next 24 hours. So you’ll be able to watch that again if you’d like or send it to any of your colleagues. And thank you all for joining us again, and have a great rest of the day.