Hello, everybody. Thank you so much for joining us today. We are going to be hosting this webinar, How Did Toxicology Become Our Most Profitable Ancillary? Just before we get started and I introduce our speaker, I'm going to just cover a couple of housekeeping notes here. Everybody is in listen-only mode, and so if you've got questions, we have the chat function and the Q&A function. I'll be monitoring those throughout the presentation, and so any time you have a question, feel free to ask those, and we'll answer those throughout the presentation. You can also chat with each other using the chat function, so just make sure you select everyone when you are chatting so that it goes to the hosts and panelists as well as other attendees. The webinar is being recorded as well. You'll be notified once the recording is available, and it will be available in the AOE Learning Center, so you'll have access to this afterwards. So, without further ado, I am excited to introduce Chris Greenman. Chris is the CEO with Vail Summit Orthopedics and Neurosurgery. So, Chris, I'm handing it off to you. Thanks so much. Great, and thank you. Thank you for this opportunity. Yeah, this is, you know, toxicology is something that I need to be clear here. We do not do this in our current group, but the group I was with previously about a year and a half ago, Tahoe Fracture and Orthopedic Medical Clinic, we did toxicology, and it was a very successful program. So, I would like to kind of go through some of those steps on, you know, how that process evolved and, you know, our experience, the things we learned, the things we did great, and the things that we kind of struggled with. But at the end of the day, I think the hope is that the participants can kind of judge for themselves whether or not this is going to be a right fit. And if the conditions are right, I think this can be a great way to help support the clinic and offset the, you know, the higher expenses, the lower reimbursement, and everything else, which most ancillaries do. So, as mentioned, I'm currently with Vail Summit Orthopedic and Neurosurgery, but my experience here at the Tahoe Fracture Clinic, it was a bit different. And we had a pretty robust pain program. And so, we had five busy pain providers. Now, in our case, they were anesthesiologists, and each anesthesiologist had one to two either nurse practitioners or PAs. Our PM&R docs didn't really get involved with this much. And what's really important through this is that they all manage patients' meds. And so, I know some PM&R and maybe anesthesiologists who do get into pain medicine, they don't manage the meds. And so, that is where this, if your group, you know, they do manage the meds for the patients, I think there could be a huge opportunity here. And this all started years ago when the opportunity to take workers' comp patients and to simply collect a sample of urine and that was all sent in. And we would get, you know, some money back for that. And over time, you know, we looked at this and then we started to ask the question, well, hey, what if we had a lab? And we were able to do it instead of sending it out. Just like everything else in healthcare and orthopedics where, you know, the orthopedists control where those patients go as far as a test, you know, from image, you know, DME and everything, you know, PT. Is this an area where we can participate? And so, we started to ask around and explore ideas. And what we basically found is we could do a screening with, you know, when we collect the urine, we could do a first pass screening. And that was kind of the start of the lab. And that was, it was relatively easy to break into financially because that first machine at the time, you know, was $30,000, $40,000. So, it wasn't a massive capital expense. We could fit it in the clinic. And there are some regulatory things that we'll talk about that we had to go through. But basically, the barrier of entry was pretty low. Now, with that, I want to also mention we included our orthopedic surgeons who were prescribing the narcotics as well. But we'll go into the percentages of that. That alone will not justify the orthopedic, just the prescriptions would not justify this program. The vast majority of it's going to be, again, on the pain management side. So, the stage, I'm going to go into a couple of stages. Stage one is the screening. Stage two is the confirmation. And then I'll be going into the process. And of course, if anybody has questions through this process, please feel free to reach out via the chat. We actually have had a question come through already. So, that's great. Thanks. So, Catherine asks, is this only for WC patients or other payers as well? Great question. Once we started the lab, it was for all patients. Okay. So, it's not just workers' comp. Now, as I'll be going into, CLIA is a federal agency, but oftentimes delegates to states. And so, it's very important to know what's going on in your state. But I do have a link that we'll reference at the end of the program where you can just click on it, click on your state, and you can see what the requirements are for that. But yeah, this is for all patients. And I need to clarify too, we use, when we first did the PERFORMA on this, we used basically Medicare rates, generally were the lowest. However, some commercial were lower than Medicare and some commercial were insanely high. So, it's really kind of crazy what those rates are and how they differ and the margins between them. So, what we did is we ended up purchasing, it's known as a screening test analyzer. It's a Siemens Viva E. It could run 51 patient specimens per batch. And again, this was about five years ago, but it's about 37,000 at the time. Now, so I mentioned that because, you know what, maybe they could be 50 now. I don't know, and I haven't kept up on that. So, this would be considered a moderate complexity lab from CLIA. You need a lab director, which could be one of the physicians in this first stage. You need a lab manager, which was a med tech. It needs to be licensed by CLIA. And of course, they can delegate that to the states and the states can inspect on behalf of CLIA. Now, I know some people have shared concerns of the regulatory issues, everything else. We would have inspections, but we found them to go relatively smoothly. In fact, they would often go more smoothly than the radiology inspections we'd get by the state. So, you just have to have your ducks in a row and make sure that you're complying with the laws and everything else. But we did not find this to be a very problematic at all. Again, one of the physicians can act as that lab director in this first stage, but I think it's important to kind of come up, that's probably not the best long-term solution. And we'll go into that in more detail. Now, with that, when we went to, I can't remember if it was Siemens or there was a third party selling the machine, their salesperson, they're extremely helpful in getting us up and going. And we relied heavily on that. Now, there are other groups as well. I think there's a link to one of their names. I can't think of it at the moment. Now, they really were interested in helping us out. And one of the reasons, because they could be a potential person, we paid for it, mind you, this wasn't free help or any sort of kickback, but they were interested in getting the confirmations. So, the second pass. So, what the screening does, if going back to, hey, what are these labs first, you know, why are there two steps in this process? And, you know, certainly the scientists can probably do a better job describing this than I can, but basically what I gather from it and talking to them on several occasions was the first pass, the turnaround time is two to four days. So, it's a bit quicker than the confirmation. Also, with the different types of drugs, and I think, you know, I want to say like cocaine or some of the other drugs, the screening would not properly detect that drug. It might say, hey, there's something going on here, but we just don't know any of the specifics. And that's where the confirmation comes into play. It takes a bit longer, it's more complex, but they're able to narrow down more specifically of what those drugs may be. And so, the screening may be good, you know, the doctor might get the report and say, hey, no, this is good because there are no red flags saying, hey, we need to dig further into this because of, you know, certain types of drugs that were detected. And the screening test in and of itself, you know, it's okay. And what we found is the doctors, it was important and actually a requirement that the doctors have the ability to make that judgment call that, in other words, not just every test goes through the screening and then sent out in this case, because we didn't have our confirmation lab yet. So, we had to be thoughtful in this process, come up with some guidelines. And, you know, that could then be a red flag as well. If you sent everything from screening to then confirmation or doing confirmation yourself, if you have a lab, I think they would look at that as, hey, you're padding the bill, you know, you're abusing the system. Now, the codes, these were some of the codes that we use, but I really recommend you get with coders, billers to do this. Things could have changed. At the time, the Medicare reimbursement for the screening was like 62 bucks. Since then, I reached out to the lab director just yesterday to say, hey, what, you know, what's the new news? It mentioned that the Medicare reimbursement went down about 15%. Even with that, there are still very good margins with this. But this, again, the setup of the codes, how you bill it and this process, we got a lot of help from the kind of the consultants from the group that we purchased the machine from, you know, that we contracted with to set all that up. So, I would just caution if somebody is wanting to go forward with this, reach out to a consultant who can help with this and don't go specifically off this information with the codes. There could have been, you know, a change or two since then. And anyway, I think it's just important that we always are going to the true source of the people who know exactly what's going on. Now, having said that, we noticed we ended up collecting and profiting about the same amount per month as the cost of the machine. And so, at that point, we're going, wow, this is something we need to consider. And so, keep in mind through this whole time, we would send out many of those screenings for confirmation. And this was about a year and a half later. And again, the confirmation is a much, you know, much more complex lab. It's much more complex equipment and has and requires more expertise. Hey, Chris, real quick. Kathy just had a question asking if you could tell the name of the company that you used. I, my recollection, it was through the vendor. And I mean, I could look that up. I want to say Lighthouse or something. I think there's a link down here, we can we can do it. But these when you when you purchase these from the vendors, they're very much aware and generally set up to help out through this process, to work, you know, through it, because it can be a bit complex. But I want to say, I do remember, and as we go through the slides, I can point out one of the website, actually, it's the website that you are able to pinpoint each state to see what the requirements are. That is one of the groups we used at one point. And you use Siemens as the vendor the first time? You know what, it was a third party because the vendor sold different machines. Pardon me, I believe we bought the Shimatsu, the confirmation through the same vendor. So I'd have to, I'd have to look that up. But basically, they're all set up to help manage it and get you get you, you know, set up with the proper, you know, to meet to meet the guidelines. Okay, for your state, because each state can be a little bit different. So you're welcome. So about a year and a half later, we realized, hey, we're sending now, pardon me, a lot of these first screenings for confirmation is that, pardon me, is that something that we could be a part of? And so we looked into it, and we ended up purchasing a Shimatsu LCMS. And I want to say this machine was probably about $250,000, thereabouts. And what is needed, so suddenly, so what you need in this is a lab information management system. So you have to kind of, it's almost like the lab EMR, so to speak, how do you collect the data? How do you organize it? As far as the lab results and all that, then suddenly, the lab goes to high complexity via CLIA, as far as their definition, and the lab director, I don't think really one of your doctors, even though it says MD, they're generally a PhD slash MD, they're more strenuous requirements. And they are trained in certain aspects that generally a pain medicine doctor or obviously an orthopedic surgeon would not be. Technical supervisor needs certain amount of years experience with the equipment, you need a lab manager, again, who's a med tech, and needs to be licensed by CLIA. And again, they can delegate that to the states. Now, this confirmation was obviously a bit more complex. And that so there's, there's the staff or two assistants to the lab manager, and then we outsource the director, and the director would come on site maybe once a month per state mandate, you know, with the CLIA, and they'd have to go through the different settings and whatnot, the machine and the readouts and, you know, the testing and whatnot. And the Medicare reimbursement was a bit higher. But again, please, the Medicare reimbursement has been reduced. Again, I'm told about 15%. Please verify that on your own. And again, reach out to, you know, if you're using a consultant for this. So some of the problems that we ran into is that we tried to expand this in the clinic and just kind of make a bit bigger lab space to fit this machine. And so we had built out space. And we ran into some problems. And the problems were that it requires its own HVAC system cooling process, it's loud. And so after we built out space, we basically had to scrap it and get new space for a lab. Because of the noise because of the heat. And it really made no sense for that lab to be in the clinic, because clinics typically are higher cost real estate. And we were actually within in the same building. You don't have to be because our lab basically took samples from we had, you know, three, four offices. And so it really does not have to be on site. There really doesn't have to be a whole lot of build out aside from the HVAC, it could just be an open space, which is, again, a very good reason not to try to convert exam rooms and everything else. So that is kind of, as in it later on, we'll go into some of those lessons that were learned. But what basically our process was, like, who do you take a sample from? You know, what triggers this? And so what we did is we worked with a local psychologist. Who happened to actually be in our, he rented time in our clinic, and he had come up with a opioid risk assessment tool as a part of our electronic intake. And anybody who, you know, with scores four or higher in a preoperative or post-op refill must provide a urine sample. And that would be the trigger. And again, we'd have this as a part of our intake. And then we also had an MSQS assessment tool, which helped determine the patient's need of behavioral health referral. So in other words, it was basically kind of testing out the patient's, I guess, risk or tendency to become addicted. And so we're able to pull out these patients and to kind of isolate them of, hey, they're going to be higher risk, and these are the people that we need to do. Also, this was built in, the pain doctors had this built into the patient-doctor pain medicine contract. So as the doctors manage the meds, typically, and it should be the case, that a doctor has a contract with the patient to say, hey, you're not going to abuse drugs, you're not going to do this, you're only going to take what's needed. And if the patient did not follow that contract, that could be termed for termination of the patient from the pain clinic. So we didn't just kind of come up with this all at once. We had to kind of go through these steps and kind of learn and pick things out as to create things that were going to work in this scenario to help ensure that we weren't just selecting everybody. And I have to say, even though there's potential, obviously, profitability and an upside, even though this can't be a lot of work, not all the doctors felt the same way about this. So it was important that the physicians got together, and there was an agreement from the start of what was going to be expected. And it is, I would say, just about impossible to manage if you set it up where each doc kind of just wants to say, hey, we're going If you set it up where each doc kind of just wants to do their own thing, and they have different opinions and this and that, and then suddenly it's unmanageable. And you're not following any sort of best practice. And if one were to come in and take a look at what's being done, and Dr. A is doing something totally different from Dr. B, it's pretty hard to say that, yeah, we're following best practices and following this true science to this. So the number of tests, the average was about 363 per month. 82% were from the five pain management providers. And then the balance was from the surgeons on the preoperative and post-op, if they had. Again, if they had a score for higher on the test, and they're asking for refills and everything else, and that was a way to select those patients. Now, the question too, is what are the providers going to do with the information? The test will come out and might show, hey, they're taking this or taking that. It even gets down to the point of, are they taking the prescribed amount? Or are they taking other drugs that could adversely affect the outcomes? And also seeing kind of the overall compliance of a patient. And look, you're going to have, I remember a doctor who was saying he didn't believe the test because this sweet 80-year-old woman tested positive for meth. I think at the end of the day, the doctors are going to be probably a bit surprised, the providers, of what's going on. And these issues are out there. I know we had situations where the patients weren't taking the meds, but we're asking for refills. So what does that tell you? Are they selling it? Or oftentimes, someone working at the prison, there's this high propensity or probability, if they're not taking their meds, are they giving it to someone else, selling at the prison? Now, sometimes the recreational drugs, the docs just said, hey, we're not touching that. The pain docs would, but the orthopedist might not, because they didn't feel it was important. The pain docs would say, hey, you know, the pain docs, obviously, there could be issues with the addiction and everything else that they were more concerned about. Now, I'm not saying it's good one way or another. That's something that I think each group needs to kind of figure out of what they're going to look for. You know, for example, marijuana or other things that, you know, in many states, it's legal. So are they even going to spend any time on it unless it's interfering in their care and their healing? So some things that we did learn, and I did briefly touch on this, you know, some things that we got right, we didn't want to spend the money on a LIMS, the lab information management system. So our IT guy was able to put, you know, basically make one, and that was helpful because it could then communicate with our EMR. So we saved a fair amount of money there, but we had someone on staff who had that ability. And again, I think seeking the help from the experts, you know, when we bought the first machine, you know, we got the help to kind of get started. When we bought the second machine, we got additional help. Our billing company at the time, because we had billing outsourced, they had a lot of experience in lab and billing, and they were extremely helpful in this area. In fact, it really helped out to kind of get a sense of, hey, what, you know, what are the rules out there? For example, you know, how many times could you even run this test? And they were able to, the billing company was able to come back and provide a lot of insight, much more than I ever thought, because they were actually billing for national labs, and so they were probably billing out, you know, 300,000 lab claims a month or something. So they really had this dialed in. And we, you know, we would have, for example, our pain doctors in their, basically their contracts with the patients, they might say, hey, we're going to test you two times a year, unless something comes up, you know, behavior, or you do test positive, we're going to test more frequently to follow up on something that, you know, maybe they shouldn't or the behavior or whatever else. And so we felt, you know, once talking to the lab, or I'm sorry, to the, you know, the billing company, you know, some of these systems are set up, you know, like Medicare has, they'll only pay for so much PT or chiropractic or whatever else. And I don't know those specifics, but a lot of them was like, you know, we're like, oh, yeah, you know, you can, in theory, test it, like every other month, for example. So we were not going anywhere near that. And we just felt for our situation, it wasn't needed. You know, it's costing the system more, it's padding the bill, it's, you know, it's kind of abusing, you know, abusing that. So what gave us some comfort was, hey, look, we could be billing a whole lot more, we don't feel that we should. And so we are well, and I'm not saying there's like a safe harbor there, but we are well less than what maybe the maximum what they would pay. And so that really through this whole process, getting the feedback from the experts, you know, learning as we go. You know, one of the things also that that billing company helped us with was coming up with a policy of, okay, how do we deal with, we've got, you know, we have the first pass, we did the first, like scan, and what is going to determine if it goes on to the confirmation. And they were able to help us out and then also give us, hey, these are where the red flags are. If you just send everybody for that second pass and that confirmation, that's not good. What is required is the doctors have to have a say. Now the doctors, what they can do is they can say, hey, they can set up a protocol. And so the doctor doesn't have to come in every single time and make a judgment. They can always say, hey, if they test positive for these four things, because the first test might not be as in depth, and I don't know the particulars that are really important here, I want them to get the confirmation. And so we are able to set those protocols up from the start, which made it a whole lot easier. Some things we did wrong. I mentioned this, we tried to build a lab in the clinic space. The heat and the noise became problematic. Here's the second point here was a real struggle. We had to get the providers out of the decision-making process to collect a sample. I found more often than not, because of the relationship the provider has with the patient, it is extremely difficult. I don't know about you, my take is most providers do not like confrontation and they would essentially chicken out and just kind of say, no, they're a good person, they don't need it. And it was terrible. We would collect a quarter of the samples that were truly needed. And so the process, we quickly learned that providers cannot be a part of that process. Now they can make up, like, hey, set up the protocol, but never have them asking the patient or being a part of any interaction with the patient about this. We had someone else come in, a staff member, it was predetermined because of the scores on their test or whatever it may be. And the employee came in and basically the provider had no say to override that. It was just, this is part of our protocol and this is part of our process. And then we also talked about letting the provider select which drugs to test for confirmation post-screening. Okay. So I left this blank. I did this presentation at AOE, it was a couple of years back. And it was one of those things that I wanted to be mindful of and frankly, I didn't necessarily want to put in print. Look, I mean, I know there are a huge amount of profits to be made in many areas, but with the screening and then with a highly complexity lab with adding the confirmation, we just experienced high profitability. And of course we had to stay on top of it. We had to follow CLIA, we had to make sure that we were ready for their audits and when they come and visit and everything else. But I honestly felt it was a great thing. Now a question could be asked, hey, why aren't I doing it? Why aren't we doing it now at the new clinic? Well, the main thing is that our pain docs do not follow, they do not manage meds. And as I mentioned before, if you don't have that responsibility and that requirement, well, it's not a requirement, I'm sorry. It's more of a, hey, that's a service that we provide. A lot of docs don't like to go there. I get it. But for those that do, and I personally feel someone's got to help manage, work this out with people. This I think is a very viable solution, but you're going to have to put time into it. You're going to have to figure out, work with the right people to make it happen. Now as some additional information, we had our positions and these were people that were required, CLIA required these positions. And I would say this would fall under the, by and large, the high complexity. So if you've got the confirmation machine, again, a lab director, this person was contracted for monthly on-site visits, available for phone, email support. When CLIA would come visit, they definitely need to be a part of it. There's a lot of work behind the scenes of calibrating the labs, which the machines themselves. And so this is where the lab director would come in and help out. We would typically we would typically fly this person out once a month. And, you know, in our case might pay them, you know, three, $4,000 a month. You have a clinical consultant. This can be filled by the lab director. Again, providing that clinical guidance and the lab related questions. You have a technical supervisor, local chemist contracted for LCMS technical support and troubleshooting. This is the position that needed to have experience on the machine. And so, you know, real quick, I'll interject here. You know, some of you might be going, oh gee, what, where do you find these people? Well, you have to remember these people already exist in hospital labs and, you know, any sort of I want to call I think it's called a resource lab. Right. And to be clear, we did not have a resource lab. A resource lab is when you can take outside samples. Right. We could not we could not take outside samples. We could only do samples from within our group, you know, like LabCorp or something you could they can take samples, you know, from the outside. So these people are out there sometimes. Yeah, they can be hard to find. But just to maybe put, you know, put someone at ease, they're likely in your community now, you know, just that they're probably at a resource lab or a hospital or, you know, wherever it may be. So then we had, you know, general supervision. That would be a med tech with minimum years of experience. It varies by state, testing personnel, med tech or med. I think MLT is limited tech or chemists with credentials. Eleven states require lab personnel to be licensed. So, again, it depends. A licensed laboratory assistant able to perform moderate complexity testing, screening test instruments only, supervision. And of course, this was a Nevada state requirement. Could be with other states as well. And then a laboratory manager role is useful to add to the med tech's duties as a lab has many facets. Yeah, budgeting, staffing, protocols, etc. And again, they're helping as kind of the bigger picture, you know, of that process. Now, the references. Here's some of the references. Data information. This right here, Lighthouse Lab Services. This link will take you to a site that has every state, you know, has the map of the United States. You can click on the state and see what the requirements are. Again, I want to say, I think we use Lighthouse for some consulting as well. And then you have, so they could be someone to reach out to specifically. And of course, you know, you're going to pay them, but they're typically more than happy to help out. Sometimes they want, you know, if you're doing the first phase, if you're doing the first phase, they might want to do the confirmation as well. You know, with that, we have the CMS government, you know, basically information on the CLIA labs. And then more that third link is additional CMS regulations. For CLIA. So that is pretty much what we have. I also have a list of the different accredited organizations under CLIA. If you needed to reach out and to contact them. Again, it's important to, you know, be closely aware of what the requirements on, and obviously to be on people's good side. And this is just continuation, but, you know, some people to have asked, well, you know, is this even legal and everything else we got with our health attorney and don't, don't take our word, contact your health attorney. But this is something that had had a green light and you know, was, was just fine to do. So with that, I have my contact information, but so if any of you have questions, you can always reach out and I can try to answer them the best that I can. Or if you have any questions now, I'm happy to answer any of those questions. So I'll give it a moment to see if any questions come in. I want to mention that I dropped the links that were in Chris's presentation in the chat, as well as his contact information. This PowerPoint slides will be available in the AOE Learning Center, too. So if you want to use the, go through yourself or go to that list of contact information for the different societies involved in the process, that'll be available within that. I'm not seeing any questions yet. We'll give it just another moment here. But while we do, I just want to say thank you so much to you, Chris, for putting this together and putting it together so quickly. This was something that came out of a discussion in the AOE Collaborate. If you aren't, you know, active in there, not signed up for emails, that's another great resource for different things that people have going on. You know, if you've got a question come up, people are super responsive in there. So make sure you're utilizing that as a member benefit, because it is super helpful. And everyone who's a member has access to that. And then, you know, like Chris mentioned, this is a presentation he did at the annual conference. Obviously, that's another great place for resources and connection with other members too. So just keep that in mind as you are going through the course of the year. I'm not seeing any other questions come up. Chris, do you have any other closing words? I just have one little thing. I just received the text from the lab director I used to work with. And recent change in the regulations, and frankly, I wasn't even aware of this to begin with, but I thought I'd just pass it on, is that nurses are no longer considered qualified personnel to perform laboratory testing under CLIA. And so I wasn't even aware that they were allowed, but apparently they are no longer allowed. So just a slight update. Yeah, well, thank you. Thank you so much. Thanks, everyone, for attending. The rest of our webinars for 2024 are open for registration on aoe.net slash events. We have a couple other events coming up. And I do want to mention we have a flash sale going on right now for our AI Summit coming up in August, which is virtual, as well as our Women in Practice Management coming up in October. So if you use the code FLASHSALE in all caps, you get 50% off of those. Just looking forward to seeing everyone on the next time around. Thanks so much.

toxicology testing

medical field

ancillary service

clinic implementation

patient care

regulatory requirements

protocols

resources

toxicology

profitability

clinics

CLIA regulations

billing

staffing

operations