Hello, everyone. Welcome to the American Academy of Physical Medicine Rehabilitation pre-conference. We are apologetic that we are not meeting live, but given the circumstances, I think we have an excellent program for you this evening in a virtual world. This is a component of the STEP program, not exactly as planned, but we have a course tonight called Advancing Clinical Skills in Spasticity Management. We have a world-renowned faculty to present to you tonight. My name is Dr. Mike Salino. I'm a physiatrist at Moss Rehab. Monica, you want to take over a little bit? Yes. Hi, I'm Dr. Monica Rodisco-Gutierrez. I am a physiatrist at UT Health in San Antonio. Again, so thankful that you're here today to do this course that had to turn virtual at the last minute, but I think it is going to be excellent today because we have these amazing faculty here with us, Alberto Eskenazi, Dr. Russ Farid, Dr. Mike Meunin, Dr. Marilyn Pacheco, Dr. Andrea Toomer, and Dr. Tom Watanabe. We are very happy to present to you today based on our objectives, and this will be the agenda. The welcome and the faculty introductions are obviously not going to take as long as we just said they were, or 10 minutes, and then this will give you kind of a timeline of what we're going to go through this evening, including a break that you will have to be able to process all the wonderful new information that you're getting. The first type of little session that we're going to have is journal club, which is what's out in the literature now for spasticity, and you'll hear from two of our faculty regarding that. Then the next three sessions are going to be point counterpoints, and these are going to be based on cases and real-life cases, and it's going to be point counterpoint on localization technique, a case with phenol versus toxin, and another case with ITB pump use versus toxin, and again, we'll hear a little bit with polls about what you do in your practice, what are some of your considerations, and then you'll hear from these world-renowned experts on spasticity on what some of their thoughts are going to be, and of course, there isn't a right answer for these cases, but it should be just really engaging. We're going to have a 20-minute break. During that time, you will have some option to also engage with some of our sponsors who are very thankful for today who are helping with this program, and usually would be in real settings providing some of their learning educational materials or be outside the room, and in the later part of the evening, we'll be having case discussions, and what we thought was really important was to bring practice development, to discuss practice development both for chemo generation and targeted drug delivery, and please, you can put questions in the chat as you go. We'll be following those, and we may not have time during the packed agenda, but we will have a debriefing with Q&A, then some other opportunities to meet with our sponsors. A few housekeeping notes. Keep your microphone unmuted to eliminate any extraneous noise. As Monica mentioned, use the chat box for questions. You can claim CME for this at the Academy's online CME portal, onlinelearning.aapmnr.org. Please provide your feedback. It's a brave new world for all of us doing these virtual courses, so anything that you would like us to do a deeper dive on, things that you think weren't important, that's very, very important for us and the continued development of the STEP program. As Monica mentioned, please, during the scheduled break and at the end of the session, stop in and see our exhibitors, and feel free to ask them questions. So without further ado, we will now switch to our first presentation, which is a Journal Club Literature Review led by the distinguished Doctors Munin and Watanabe. Very good. So, thank you very much for attending. I'm very excited to be sharing this information with you regarding a couple of journal articles that I've chosen. These are articles that I thought were current, interesting, and they highlight some specific issues related to evaluation of spasticity in general, as well as, you know, your choice of outcome measures and how to think about spasticity. So, hopefully I'll be able to provide that information. So, for background information, there are a number of studies that have been published that have looked at the efficacy of cannabinoids in managing spasticity, and this is especially true in multiple sclerosis, a number of studies. It's important to consider when you're evaluating efficacy of any intervention, what other treatments are going on that could affect results if it's early or later in the course of the disease, because there can be effects from natural recovery, and then whether other interventions are going as well. As a general comment, we do know that spasticity can impair motor ability for persons with multiple sclerosis. Can I ask you to go on presentation mode? Oh, I'm sorry. Yeah, sorry. Thanks. Is that better? Now we're seeing it as your notes, so display settings. The next one. Oh, I'm sorry about that. It's okay. Or you can go to the circle with the three dots underneath it. You see that? Oh, yes. I presented to you. No, that didn't work. We have this going. Let's see. Tom, go back to, yeah, go to slideshow. This one? Yeah, click on that one. Yeah. Go ahead from current slide. Yep. No? Is that better? No. No. Go ahead and stop sharing your screen, and then let's try to re-share it. that work? we don't now Tom if you scroll all the way to the top you'll see the double screens you remember that you had the two screens at the very top of your screen if you just kind of move your thing you'll see a little green bar that appears. Swap displays maybe? I'm sorry? Do you see something that says swap displays at the very top of your screen with the dual monitor? No. So just share share the presentation at the bottom one more time or wherever you want to share it. This is Sean. My suggestion is to stop sharing and then try to re-engage the screen share function. Okay. He tried that, didn't work. Okay, stop sharing. Yeah. Share again and then just do presentation mode. That work? Not yet. We're not seeing anything. I mean, we're seeing you and Mike, but. Jose, would it be better if you shared your screen with Tom's slides and Tom just said, next slide? Yes, I can bring those up. Give me one second. Okay. Okay, can you all see the slide? Perfect. Thank you. Okay. Sorry about that. Okay. Let's get to the slide. Next slide, please. All right. So, yeah, as a general comment, we know spasticity can impair motor ability for folks with multiple sclerosis. As a general comment, most spastical lytics have side effects. So, we really have to keep that in mind when we make our decision of medications. Marijuana or its derivatives have been the subject of much research regarding the management of spasticity in people with multiple sclerosis. Next slide. So, as an example of these studies, there was a large meta-analysis that evaluated three different products. And some of the adverse effects that were identified compared to placebo are listed. So, these are things that you would want to be considering using numiximals. So, study one is from Italy. This is a study that highlights, among other things, the importance of looking at concomitant interventions. In this case, robotics. So, robotic intervention was provided to all these patients. These patients were all already on a systemic spastical lytic, primarily baclofen. So, the numiximals was an add-on therapy. These numiximals is a THC CBD spray, and it is approved in some countries, although not in the United States. These patients all had moderate to severe spasticity. And they were evaluated by their response to the initial dose. So, those that demonstrated a greater than 20% reduction in score on the neurologic rating scale were considered responders. And they were compared with people who were matched by disease by the EDSS and the NRS who were responsive to their oral medications alone. So, they didn't need any add-on therapy. Patients were all given robotic gait training. And evaluations in gait or gait speed was altered and body weight support was altered based on how they were doing functionally. These patients also received TMS, but the goal of that was evaluating cortical excitability to try to understand why patients who were responders were responding. Results, the group, there was significant improvement in both groups on the 10-meter walk test and total FIMS scores. But the group treated with nabiximals had greater improvement in EDSS scores and depression. Regarding TMS, alterations in intracortical excitability in both the upper and lower extremities were identified, including an increase in motor evoked potential amplitude, intracortical inhibition strengthening, and a decrease in intracortical facilitation. So, here are the key points from that study. Combining interventions can lead to improvements in multiple domains, as demonstrated by the outcomes. Nabiximals did provide additional benefit on at least some aspects of the deficits in these patients. And the reasons can be multifactorial here. Symptoms may be managed better, intracortical excitability was adjusted, and there may be effects on mood as well. There are many variables to consider, so when assessing the impact of the intervention on specificity. All right, the next study is one that highlights, among other things, options for evaluating efficacy of interventions, in this case, nabiximals. So, these are patients, oh my, can you move forward on slides? Gosh, I didn't realize that it wasn't advanced. Can you move forward to the next one? And next one. All right, I lost track of which slide was up. Okay. So, 32 patients were recruited, and these were patients who did not have response to other pharmacology treatments. They're randomized to either a treatment or a control group, and assessed after the first, before the first treatment, 45 minutes after giving the nabiximals, and then four weeks later, and they were given the medication daily for those four weeks. Next slide, please. The treatment group was divided into responders and non-responders based on improvements in their NRS score. So, this was after that first dosing. The treatment group was divided into responders and non-responders primarily based on burnt-bound scale response and NRS. Next slide. So, immediate improvement in scores were noted in the treatment group compared to the control groups. This is after that first dose, again. Those improvements were stable through the four weeks of treatment. So, they didn't improve any further, but just from assessment of the first treatment, you could identify which responders are not, and that was consistent for the period of time of the study. Patients that demonstrated a minimally clinically important difference on NRS and burnt-bound scales after that first initial, continue to note that steady improvement over time. And those that did not demonstrate that improvement on the first administration did not demonstrate improvements over time either. Multiple sclerosis spasticity scale, multiple sclerosis walking scale, and a modified fatigue impact scale were also noted to have improvements only in those who had a significant response to that first dose. Next slide, please. Next slide, please. Yeah. So, an important finding here is that the response was predictable after one administration. So, you could bring a patient in, give them one dose, and be confident they would respond or not. So, that's nice as opposed to having to wait weeks to see about efficacy and change dosing. Specific improvements in gait were also identified by 3D gait analysis. So, this is nice because you can identify exactly what is going on from a functional standpoint in improving gait, and those responses are in this slide. And again, the response after that first administration was maintained for four weeks with daily administration of the medication. Okay. So, in conclusion, assessing the impact of medication spasticity can be a complex thing. The assessment may lead to identification of improvements in motor function or maybe more global measures like quality of life or depression or things like that if you look for that. Some outcome measures can also lead to a better understanding of the mechanisms by which the interventions work. In the cases I demonstrated, for instance, TMS or gait analysis. And finally, remember to be aware of concomitant interventions as they may enhance outcomes. So, thank you very much, and sorry for the technical problems. Nicely done, Tom. Okay. Well, I'm going to keep it moving here. Good evening, everyone. I'm Michael Munin from the Department of Physical Medicine and Rehabilitation at the University of Pittsburgh. I've decided to do two fairly recent studies that have practical take-home findings that might be useful for the group here. And let's see here. Hopefully, everybody can see my slides here. So, we'll start with the first online disclosures are listed here. I think there are no conflicts with the talk. So, the first paper was actually published last month from Sengal and colleagues from Izmir University in Turkey. The study is called Effective Muscle Selection in Post-stroke Elbow Flexor Spasticity, an Observational Prospective Study. And their question was as follows. They wanted to know which elbow flexor muscle should be the primary target for botulinum neurotoxin when you have elbow flexor spasticity. And that's a very relevant question. As far as the background, biceps certainly easy to locate, but it contributes to supination. And if you block it, you can worsen pronation tone. And that's important for many patients with spasticity have a pronated forearm. And that can be worsened. A Keenan in 1990 showed that the brachioradialis controls elbow flexor tone in a significant way. So, perhaps that should be the key muscle. Jeanette showed with targeted blocks that the brachialis was very important in patients with neutral or especially pronated forearms. So, the hypothesis for this study was that botulinum neurotoxin injections to elbow flexor muscles in chronic stroke patients with forearm pronation. And that's the important point. All patients had forearm pronation. May produce different outcomes depending upon the muscles injected. This is an observational prospective study done in a PM&R tertiary hospital clinic between March of 2019 and June 2021. And I applaud the authors for doing research during COVID. Good for them. And it's possible. And I'm glad to see that they were able to do that. They evaluated 55 stroke patients with a modified Aschwerth scale score of two or three for the elbow flexors, plus a score of one to three for pronators. You had to have both to be included. They excluded patients who received phenol or alcohol blocks for the musculoskeletal nerve. The other important thing is they, any degree of fixed elbow joint contracture was an exclusion. So, all of these patients had full passive range of motion to extension. Which I think is a really good point. And I was glad to see they used that in their study methodology. Outcome measures, the main one was the spasticity angle. And this is the Tardel angle. It's the angle and a slow stretch of velocity minus the angle of catch in a fast stretch. And if the fast stretch occurs quickly, that angle is large. If spasticity is not bad, then that angle is low. Of course, they also used the modified Aschwerth score. And they did baseline measurements and then measurements at week four after injections. And on the right screen, you see how they did ultrasound guided brachialis blocks here. This is a distal lateral view of the humerus. The humerus there, the biceps above it. And you see the needle, the line of going into the brachialis muscle. Distal lateral forearm, arm, excuse me. This is a, this study is what's called a real world observational perspective study. The physicians who were treating determined what muscles they wanted to inject. The studies did not demand them to do anything in particular. They use Onabot's Lamtoxin A. They use anatomic landmarks for guidance, mostly for the biceps. And some ultrasound guidance for the other muscles. This is a non-randomized study. Study researchers, again, did not mandate the muscle targets. So, I wanted to highlight one of the main data tables. You see on the top highlighted brachialis group had 14 patients. The biceps group's 21 patients. Brachialis plus brachioradialis had 11. So, those are the three groups that they had. The baseline characteristics were all about the same between the groups. I want to highlight down in the bottom here the dose used. Interestingly enough, the brachialis group used a mean of 45 units of this product. The biceps had more at 75, and the combined brachialis plus brachioradialis had 75 units. Notice also the guidance. Biceps, 90% was almost all surface guidance, whereas the brachialis about 40 or so percent was ultrasound guidance, and 55% was ultrasound guidance for the brachialis and brachioradialis groups. Now, these were the main outcomes. Looking at the change in spasticity angle over time. Let's go to the far right, probably the best way to look at this. This is the change in the spasticity angle score, which I described previously, between the baseline and the four-week score. The higher number, the better in the outcome. And what you see is the brachialis had actually a 30, almost 35-degree improvement. The biceps only had a 16.5-degree improvement. And the combination brachialis plus brachioradialis had, again, a 35-degree improvement. Now, all of these were significant relative to their baseline score, but there was no true significant differences between the groups, although the brachialis versus the biceps groups trended towards significance with a p-value of 0.059. So, it was very close to meeting significance. And lastly, this was the change of MAS and with the three groups. And what you see on the far right, the brachialis group, 64% had a great, and the elbow flexors had a great change of at least two, which is big in the modified ASH score. The biceps, 47%. The combination group, 54%. Again, not a difference between the groups, but again, it shows there might be some perhaps difference with the muscle selection. So, the summary of data presented was that the biceps was the most frequently targeted muscle in patients with elbow flexion and pronation tone. The brachioradialis was only targeted in combination with the brachialis. The magnitude of specificity change was greatest when the brachialis was targeted alone or in combination, but this did not meet statistical significance. So, how should you use this data in your practice? I think in post-stroke flexed elbow posture, I think you should consider other muscles besides the biceps, especially when the patients have pronated forearm. The brachialis is an important muscle to inject when elbow flexion and pronation tone is present, and I think it's intriguing that the brachialis received less neurotoxin dose compared to the biceps with a trend towards better outcomes. Okay, I'm now going to just go quickly to my other brief literature review. This is influence of positional changes on spasticity of upper extremity in post-stroke hemiplegic patients. This is by Huynh and colleagues published in Neuroscience Letters from the Department of Rehab Medicine, Hushan Hospital, and the Fudan University in Shanghai, China. As background, the authors note that prior studies showed that there have been changes in position that have altered quadriceps spasticity going from the supine to standing position as measured by the pendulum test. They believe this influence is due to central pattern generators on the muscle stretch reflexes. These are descending motor tracts that control automatic functions like gait, breathing, etc. And it differs from what you see in the upper motor neuron syndrome. Of course, this is the syndrome that has positive symptoms such as hypertonicity and negative findings like central paresis. But classically, upper motor neuron syndrome is believed to not change very much with changes in posture. And so today, the authors say that there is no data on the influence of body postures on upper limb spasticity in hemiplegic stroke patients. So the study aims were to explore the influence of three body positions, supine, sitting, and standing on upper limb spasticity. They assess changes using three clinical scales, the modified Ashworth, the modified TARDU, the MTS, and this triple spasticity scale, which is what the authors developed. They actually published some papers prior to this showing reliability. So it was an interesting scale for me to learn a little bit about. This is a prospective observational study. They had 84 post-stroke patients admitted from April 2017 to January 2018. Inclusion criteria, they had to have at least a modified Ashworth of one or greater in the upper limbs, a Brunstrom recovery stage three or four, and they had to be able to sit to stand for more than a minute without support, which is important to note. They had no major joint pathology, and experienced raters measured their elbow flexors, wrist flexors, and finger flexors. And really, the pictures to the right is from their paper, and it pretty much shows you the results I'm going to present in a moment here. Look at the angle of the elbow supine on the top, sitting, and then look what happens when the subject stands. Look at the change in elbow flexor posture. And that's pretty much what I'm going to show you now in the data. So to orient you, the far left graph is the MAS, the middle is the modified Trudeau, and the far right graph is the triple spasticity score, again, the thing that the authors developed. You have elbow flexors, wrist flexors, finger flexors on the x-axis of each of these graphs, and the black bars represent the standing position. And what you can see is the black bars have the greatest change in these values. These are change in values relative to baseline, and I'll just highlight that there. And so it seems that, you know, the change in posture really does influence how these instruments are scored and rated, and this was seen across instruments, whether the modified Ashworth, the modified Trudeau, or the triple spasticity score. So how should you utilize this information in your practice? Clearly, these Trudeau scores were higher in the standing position, greater than the sitting position, greater than the supine position. So there was a hierarchy of how these scores were noted. Spasticity appears to be sensitive to postural change, perhaps through the reticular spinal tract hyperexcitability that was proposed by the authors in the paper. When evaluating upper limb muscle targets for botulinum toxin or even phenoneuralysis, I think it's important to have patients stand or even walk to best assess these muscle and nerve targets. Supine evaluation only may not give you a complete picture. Even sitting was incomplete for the elbow flexion tone. Now, of course, the limitation of this is that your patient has to be able to at least stand, perhaps even walk a short distance, so only really applicable for those patients. Okay, well, we're going to now move on to the next talk here, and I'm going to bring up this slide deck here, and hopefully everyone can see this. So we're now going to move in, as Monica was saying earlier, to three debate topics, and I'm going to start the first one. I'm honored to have Alberto Espinazia of the Department of PM&R, Moss Rehab, Einstein Jefferson Health joining me. Again, I'm Michael Muinen, Department of Physical Medicine and Rehab at the University of Pittsburgh School of Medicine, and we're going to talk about, for this first debate, localization. These are our- We can not see your slides. Yeah, we're still seeing your own slides. Oh, okay. Thank you for letting me know. Let me close the other slide deck here. That might be it. How about now? No, we see you now, and me. So, hello, Mike. Hi, Alberto. Here it goes. How about now? No, it's wonderful. So I could just- All right, well, I'm going to introduce Alberto, so no need to reintroduce. I do want to start with a polling question. So how do physicians who are on the line now localize muscles for injection? So go ahead and click on what you think is the best way. Surface anatomy, EMG guidance, electrical stimulation, ultrasound guidance, or maybe no guidance is needed. Just stick the darn needle in the body and the molecules, the magic molecule, it'll find its way and do good things. So what do you think? Those who are watching at home, we'll pull up the poll results here momentarily. Get rid of this here. So do we have our poll results? So the poll results are on the screen here. So it looks like from the group, EMG guidance seemed to be the most, electrical stimulation, 19%, ultrasound guidance, 30%, and surface anatomy the least. Well, I'm really glad to see that. And actually no one put no guidance needed to stick it in the muscle or in the skin. I'm glad to see that was a 0%, so fantastic. So we're going to focus on two main ways of moving forward here. And my slide is not advancing, of course. Let me stop this, come right back in. Hopefully we can see this now. We can just, yeah, there we go. All right, so here's our case. We have a 49-year-old female. She has residual mild left hemiparesis at the right MCA territory unembarked. She reports a left great toe is stiff and she walks in the outer border of the left foot. She might drag the left foot. Her main goal is to improve walking and lessen her tightness. She's married with three children, works part-time as a music teacher. So she's highly functional. She's totally independent. She drives a car. So this is a picture of her walking. You kind of see the inverted hind foot. She'll come back towards us here in the view here. Her big toe sticks up. May not see that here. And she also has some toe flexion that may not be apparent, but that's also a part of what she has here. So the decision in this patient is to utilize botched line of toxin injections for a guanovaris and stridal toe deformity. So based on the evaluation, the following muscles were identified for injection. The EHL, the tibialis posterior, the FDL, and the medial and lateral gastrocnemius. So here's the debate question. Would you use ultrasound guidance or electrical stimulation to deliver neurotoxin injections in this highly functional patient with a guanovaris deformity? And does localization technique potentially impact the outcomes? So I'm gonna start, I'm gonna take something that most of you know me, that's near and dear to me, and that's ultrasound guidance, because in my view, ultrasound guidance is the only choice. Here we have a highly functioning patient following stroke. She needs targeted, accurate injections to improve her function. She's just not gonna continue if we're not making a substantial difference in her function. She's gonna need these every three or four months, and we need to make sure we do it in a less painful way. Ultrasound has best accuracy by using pattern recognition, contour lines, and adjacent structures to see the actual muscles to be injected. We avoid injury to nerve and vascular structures. We can keep the injectant within the targeted muscle fascial borders, which is really important. We can assess depth, fibrosis, and anatomical variations, and the technique itself is non-painful. So I know what you're saying. I can inject the gastroc without ultrasound guidance, right? Well, Schnitzler and colleagues, in a great study in 2012, looked at 121 practitioners, mostly physiatrists with cadavers. They had 30 cadavers, 60 limbs. Only 43% were successful injections. Two thirds were too deep into the soleus, went right through the gastroc, and you don't want to do that in this lady because we don't want to affect her stance-phase stability. One third of the failed injections were superficial fat, as you see on the right of it, and this is from their paper here. And so, sorry, I think you're probably likely mistaken if you think you can hit the gastroc, lateral medial heads, without ultrasound guidance. So how does ultrasound avoid injury to blood vessels and nerves? So on the far left, this is the flexor that's shown longest. I've drawn a blue line around the muscle, and everybody should see that Mickey Mouse there. Those are the two tibial veins in the tibial artery, and they're sitting right in the muscle. So if you try to inject on the far right, you need a pathway that's going to miss that vasculature. And with ultrasound, you can line things up, hit the FBL muscle, and miss that important vasculature. Now, we can also do real-time injections to make sure the injectant does not spread. So here, what you're going to see here, the soleus is to the left. We don't want to inject the soleus. You see the tibia to the right. I'm going to be coming in and out of plane of view, and you see this sail-shaped muscle. That's the FDL you saw before. You'll see me coming in and out of plane view, and you'll see this blush, this hypochoic black fluid. That's the neurotoxin. And watch how it stays beautifully within the FDL muscle and does not spread to the nearby soleus. Here it comes. See that coming in beautifully? There's no spread of injectant. This can only be accomplished via ultrasound guidance. Also, in the medial gastrocnemius, these neurovascular chains, you can stab them and they cause pain. You see that dotted line shows us a nice area in the medial gastroc where if you inject it, you're not going to hit those chains. And then there's optimal needle placement, for example, for the EHL. Remembering that the EHL arises from the middle portion of the fibula on the anterior surface, and it starts on the dorsal side of the distal phalanx of the great toe, and it causes a striatal or hitchhiker toe deformity. Well, it turns out the EHL is nested between the tibialis anterior and EDL. And this paper showed various windows where EMG texts have said to needle the EHL. And if you can seal it on panels A, B, and C, you're right near the TA, and you might get with eSTEM a response on the EHL. You might get a little bit of a toe flicker via volume conduction. But when that injector comes in, it's going to spread into the TA. And you would never know that in panels A, B, and C unless you have ultrasound guidance. So why would anyone use electrical stimulation for neurotoxin injections? Hey, there's no visualization of injection spread. It's painful with multiple needle repositionings and electrical shocks. There's a high chance of needling vessels and nerves, difficult to isolate deeper overlapping structures, and there's volume conduction of stimulus, which can give contraction outside of your target muscle. So lastly, is there any evidence that ultrasound guidance has any better outcomes than electrical stimulation? Or is it just my work? Well, it turns out there is some evidence. So in this first study, spastic aquinas in cerebral palsy and RCT comparing ultrasound and eSTEM, Kwan and colleagues in the American Journal of PM&R randomized 30 children to receive ultrasound versus eSTEM guidance, class one randomized study with a blinded outcome assessor. They used 100 units divided into the medial lateral gastroc at four units per kilogram, and experienced pediatric podiatrists with the injector. Now, both groups improve with the neurotoxin. However, the ultrasound guided group did significantly better with the physician's rating scale, specifically the gait pattern and high foot position and the maximum foot to floor contact due to stance. So clearly there was a better functional outcomes with ultrasound guidance. And lastly, in a study spastic gastrocnemius and stroke and RCT comparing manual to surface guidance, electrical stimulation and ultrasonography by Alessandro Pacelli from the University of Verona and the American Journal of PM&R in 2012, class one randomized blinded outcome. They used 200 units of otobotulinum toxin A divided into the medial lateral heads of the gastrocnemius, the three groups, manual, eSTEM and ultrasound and a total of 49 patients. And what they found was ultrasound was significantly better than manual or just surface palpation for ankle MAS and ankle passive range of motion. Those are the key outcomes when you're injecting for spastic acquinus. More importantly, ultrasound was statistically better than eSTEM for the TARDU grade. And that measures resistance, catch angle and clonus at the ankle and for ankle passive range of motion. There was no difference, interestingly enough, between the manual and eSTEM groups, which isn't so good for eSTEM. All groups, of course, showed improvement. The molecule is great. You do get improvement over time, but there is a hierarchy of improvement with ultrasound guidance, yielding the best outcomes. So with that, I'm going to stop sharing my screen. I'm gonna move it on to my colleague, Dr. Espinosa, who will give us the opposing point of view here. Thank you, Dr. Munin. Yes, always very eloquent. Of course, you took all the time. So I'm gonna just say very quickly that there are a few items that you missed in your very good presentation. First of all, cost. Ultrasound is very expensive and not all of us have access to those kinds of expensive tools that only privileged universities like yours have access to. So I should say that it is important to understand that in order to use ultrasound correctly, you have to spend 30 years practicing. Is that how long you've been practicing, Dr. Munin? Maybe 25. So I think that it requires a lot of practice and it requires a lot of skill. You are correct. Ultrasound permits you to visualize, but visualization doesn't speak about precision of localization. You can only do that if you have the needle in the muscle and you stimulate the muscle. As your forebears will know clearly, electrical stimulation is the best way to be sure that you are in the muscle. You talked about the idea of really reducing pain, but not unlike with ultrasound where you need a lot of practice. If you have practice with electrical stimulation, you need very little current to stimulate and you'll be able to locate appropriately your needle. And I love you presented that pediatric study. It is a great study. Definitely the authors did a great job at showcasing the importance of putting the medication in the right placement in the muscle. But those are very small muscles. And so it's easy to go through. In an adult, you really don't need to do that. You don't need to invest in this expensive piece of equipment, all of the many months of hard work to learn how to use them and to understand the little wiggles and jiggles and try to figure out what's that dark stuff that you're seeing. It is definitely many ways to propose that there are advantages to using one over the other. What's most important, and I think I have to reiterate that, is that you use a technique in which you're comfortable. It doesn't matter if it's ultrasound, if it's EMG, if it's electrical stimulation. I think the papers you showed and certainly other publications that we have in the field clearly show that anatomical localization seems to be sensible, but it really does not rise to the level of the accuracy that you can get with either electrical stimulation, number one technique, followed by ultrasound or EMG. So with that, I want to be respectful of the time. And I hope now you clearly understand the advantages of using electrical stimulation for localization. Thank you. There is one question that I thought's important for you right now, Alvaro, and just waiting to the end. And it says, how useful is electrical stimulation in the setting of a very spastic muscle that's already activated? Yeah, very good. That's a great question. You still can stimulate the muscle. You can actually twitch the muscle. What you need to remember is that a muscle that is, and they called it here, activated, I don't know what a muscle that it's activated means, but I am going to assume that it's a muscle that it's in a contraction. So you still can overlay a synchronous stimulus, one that lets you measure within a given period of time, either one pulse per second or one pulse every other second. So you can clearly see that you can stimulate the muscle. Remember that when you're putting that big blob of gel on top of the muscle to try, or the skin, to try to apply your ultrasound, that normally is gonna raise the spasticity of the patient, not different than when you're putting a needle into the muscle. Great, thank you. We'll move on to the next case, which is gonna be Dr. Eskenazi and Dr. Watanabe. Okay, let me- You can all keep in your own head who you thought was the winner. Take it to Twitter or something. I'm gonna share my screen and hopefully you can see my screen. I'm gonna just make it project fully. Oh, this is the wrong presentation. Sorry, this is the wrong presentation. I'm gonna change presentation. I apologize for that. I had the presentation with Dr. Moonen, but I will quickly get into the presentation with Dr. Watanabe. So here we go. Let me just share my screen again. Okay. So hopefully you can see my screen. I'll put it in projection mode now. It's my privilege to have this point-counterpoint with Dr. Watanabe. He and I are gonna be talking about the advantages of phenol versus botulinum toxin to improve gait in a patient with spastic hemiparesis. Tom, you wanna present the case? You want me to do that? I can present the case, but you can present the question. I think it's a question first. Sure. These are our disclosures, just for clarity. And so here's a polling question. Which ankle muscles are not frequently involved in the equinovirus foot posture? And if you can just choose from the available answers, tibialis anterior, tibialis posterior, gastrocnemius, extensor digitorum communis, soleus, and either tibialis anterior and extensor digitorum communis. So which ankle muscles are not frequently involved? And we'll shortly see the answer to that. There it is. and so the correct answer here would have been the extensor digitorum communis. Some of you chose that and the tibialis anterior. In some cases with equinovirus, you may see the tibialis anterior being overactive, but you did a great job answering this question, so I appreciate it. So Tom, you want to present the case? Sure. I'll get us started. So you're consulted to help manage a 57-year-old female status post sprite MCA stroke with resultant left-sided spastic hemiparesis. She's four months out from the stroke, no history of any prior strokes or any other relevant past medical history. Prior to her stroke, she was very active and independent, working as a nurse, an avid hiker, and she's referred from a primary care physician who hopes that you can help with her improving her ambulatory ability, getting her back perhaps to prior recreational activities and work. She lives alone. She does not have family in the area. Medical insurance is through the hospital system, and she's currently on clopidogrel aspirin statin and a beta blocker. Next slide. On exam, and we'll see a video in a second, she does have good right-sided strength and range of motion. She seems pretty anxious overall, wondering about what you might do and if you're going to hurt her. She does have decreased range of motion in the left upper extremity and the shoulder for abduction and flexion, also for elbow extension, and she also demonstrates wrist and finger flexion, finger flexor tone. She has minus 15 degrees left ankle dorsiflexion with the knee flexed, minus 20 with it extended, and does have some sustained left ankle clonus. It's also clear from looking at her, and you'll see from the gait that there's probably some other more proximal increased tone that contributes to stiff knee gait. With that, let's take a look at the video. All right, so with that information and video, we are going to discuss which would be the better choice, botulinum toxin or phenol, and I'm going to start by advocating for botulinum toxin. There are a few reasons to consider botulinum toxin in a case like this. It's easier to perform technically. This is a nervous person. To do nice nerve blocks, you would have to be very steady, not move around much because it's harder to isolate that very tiny nerve than it is a big muscle like these. Now, I know you heard a little bit about challenges with localization, but I think in this case, it would be easier to be confident that you're in the correct muscles that you want to inject and do that. Not necessarily just dealing with the equinibarus, but in general, botulinum toxin is more selective. You can choose smaller muscles and inject into those small muscles. You can also change dilution to alter effect and things like that. Also, it's easier to obtain, so phenol, sometimes you do have to try to order through a compounding pharmacy, and that is not necessarily an easy thing to do as some people have found. Here's some other advantages of botulinum toxin. This picture of a toe, I found this, and it talks about how to cauterize a toenail, and they use phenol. I just highlight that. Phenol is not a nice substance. It's pretty caustic. We're probably not going to inject the toe, but we're going to be injecting into muscles and soft tissue. There's no question that it can cause some damage there. Phenol blocks can cause painful dysesthesias, risks quoted somewhere between 15% or sometimes even higher, so pain is definitely something to be concerned about. Another issue is determining the duration of treatment. With botulinum toxin, you can be fairly confident that it'll last somewhere between three, four, five months. With phenol, you can get a duration of action of even a year or longer, it's been reported, so in this woman, about four months out, you may not be sure how things are going to evolve, so having something that is a little shorter acting and more predictable may be the way to go. Going back to some of the challenges with phenol injections, you can get an intravascular injection. That can cause seizures, cardiac problems, and things like that. That would certainly not be good. You can't really alter the dosing and dilution in the same way that you can with botulinum toxins. If you want to have a modest effect, you can adjust your dosing as opposed to phenol, which is really more of an all-or-nothing phenomenon. For those reasons, I'm going to say botulinum toxin would be the way to go. Keep going, Tom. I apologize. That's it. It's up to you now. Thank you, Tom. I wanted to point out a few advantages of the idea of using phenol over using botulinum toxin. You talked a little bit about the duration, and certainly duration of efficacy, I think it's an important advantage. You can have a longer-lasting intervention with less injections. You pointed to the fact that your patient was quite nervous about the procedure. The idea of having these repeated injections may be a concern. You could use one injection, make it last much longer. Your patient will feel much better under that scenario. You talked about the idea of dosing and not being able to, I'm going to say, titrate. I'm going to use that word. I think that phenol allows you to do definitely a more accurate titration because you don't have to wait for 12 weeks in between injections to adjust your dosing if you were using botulinum toxin. Phenol, you could inject it today, and if it was insufficient, you could bring the patient tomorrow and, quote, do a touch-up to address that, where with botulinum toxin, you would be exposing that patient to another toxin injection that may end up causing a variety of adverse effects, including losing the capacity to respond to the botulinum toxin. Botulinum toxin is expensive. There is a cost to this medication, and you're very right. It is easier to access, but in fact may be easier to access because it has higher cost, and so there is an interest to make it more available, where phenol for $100, you can obtain a vial of 15 or 20 mLs. You did talk about the fact that there is the potential for adverse effects caused by phenol, but that's also true for botulinum toxins. Any substance that you inject into your body, and we've heard about injecting substances into your body in a variety of ways of late, it can produce an adverse effect, but if you do this correctly and if you're well-trained, you certainly can manage it, and if you remember what the doses are and how to avoid those potential overdoses would be also important. Finally, I think it's important to understand that botulinum toxins, yes, have many advantages. They're easier to inject. You suggested that even in a weightlifter like the gentleman you showed us, you could throw a dart from the other side of the room and inject something on those muscles. I don't think you need ultrasound, another advantage compared to the previous discussion, but there are some very nice papers, and I'll quote Weiss and Newman, who published a recent paper on the idea of central effects of botulinum neurotoxin, indicating that the toxin can get to your brain, that it really can have an effect elsewhere, not just in a muscle, where phenol doesn't do that. Phenol, if you put it around the nerve, it'll certainly be a neurolytic agent for that nerve, but it doesn't go to your brain, so I think it's a critical difference. So, the other is that, remember, you receive, you will see the response of phenol immediately after the injection, so you don't have to wait, oh, wait two to three days, to wait five days, wait seven days to see the effect of the intervention. You'll see it right there, and I think it's for larger muscles, really, the way to go, because it will allow you to use botulinum toxin, maybe for the little small muscles, the little, that you need much more selectivity, and the truth is, you know, and I've been working in the field of botulinum toxins for many years, there is not enough botulinum toxin for all the muscles that we have to do, and so being able to leverage yourself and using some phenol for the large muscles, and then using a little bit of botulinum toxin for the little tiny muscles might be a good way. So I think that with that, I will, oh, you did talk about dysesthesia, so I should talk about that, because I think it's a very important thing. Like anything else, be sure that you're well-trained, and if you're well-trained, you'll try to avoid those mixed nerves and stay to motor nerves when you're injecting phenol. The other is that if you end up with a dysesthesic response, it's easy to treat. You just put a little bit more phenol, and the nerve that was partially denervated will be now fully denervated and will get rid of the pain. So I think that that definitely puts forward my idea that phenol tends to work better. So these are the muscles, the muscles that I usually would consider, you know, the muscle groups that I would consider. I think we talked about larger muscles, so I'll stop with that, and I think we can, Tom, you want to talk about the differentiation and how to select one over the other? In a quick manner, yes. Oh, sorry for that. Tom, you want to do that, or do we cut it here, and I don't know if there are any questions we can certainly try to answer questions if there are any. I think we could cut it here and go see if there are questions. Thank you, gentlemen. Again, a very vigorous debate that I think the audience has learned points on both sides of the aisle. Our next point-counterpoint pits Dr. Rez Farid versus Dr. Monica Gutierrez in a discussion of pump versus toxin. All right, let's get this show on the road. I'm Rez Farid, University of Missouri. We have some polling questions as well, so Sean, if you can bring those up, and Alberto most appropriately brought this to point here, and that is which statement best reflects your thoughts on botulinum toxin? The five choices are botulinum toxin helps my patient make functional gains. Option two, botulinum toxin is good, but there isn't enough to go around. So, Alberto, I know you're picking that one. At least you can pick multiple choices if you wish. I'm very confident about knowing which muscles to target to maximize benefits for my patients. Botulinum toxin costs to benefit makes it a valuable tool for spasticity, or lastly, I'm not really comfortable injecting toxin. I'll just wait for that to come up. So, most everybody's confident injecting toxin. Only 20% are thinking that it's cheap, but you seem to be pretty much on the camp that functional gains are a realistic option when we're setting goals. So, the next polling question relating to intrathecal baclofen, what are your thoughts? Pumps should be used as an intervention of last resort. Pumps can be effective, but aren't worth the trouble. I'd consider expanding my use of pumps if I could get paid a little bit more for doing so. Why would I use a pump when I could just do injections? Or lastly, for the right patient at the right time, I comfortably recommend ITV. Oh, everybody. Oh, Monica, you're in such deep trouble. Everybody loves pumps in the right patient at the right time. Yeah, baby. So, I've got the pump side. Dr. Gutierrez has the toxin side. Let's get ready to rumble! Okay, so here we go. I have a 54-year-old patient who presented a year previously with a left frontal interparenchymal hemorrhage. She additionally fell. She'd been falling recently, had a femur fracture a couple months ago. So, she's transitioned to a hemi walker from her quad cane, but she complains that her toes are clenching. She can't walk on carpet. There's no way for her to walk real well. She can't really get outpatient therapy in the state of Missouri because it's not provided by Medicaid, and she does have an AFO. This is her video. I took it as quickly as I could to give you an idea of different findings on her, so spare me. I only did a one-minute-and-30-second exam. So, she has a catch in elbow flexion. She has a Hoffman's that's positive. She's going to have a pronator teres that is tight, for those that are inclined to address that. Do you always wear a crayon costume to clinic? The University of Missouri encourages casual attire three times a week. So, not only do I have a full 64-pack of crayon costumes, I also have an array of Avenger costumes and Disney princesses. Thanks for noticing. We have some clonus on reflex testing, a hamstring catch and release there. She has tightness in her rectus. We're going to show the foot here in a second. It also has clonus in plantar flexion and in posterior tib. She don't see too often. She lacks, I'd say, probably 45 degrees with her knee extended, foot dorsiflexion. She's going to walk a little bit here without her brace. I don't see much in the way of toe flexion, but that's what she was kind of primarily complaining about. I don't have a fancy runway, sorry. And then in her leg, just some catch release. And then with her knee bent, she gets at least 90 degrees. So, that's our lady. And so, because of that, I thought, you know what? This is a pump patient. This is a patient who has generalized spasticity in major muscle groups, multiple major muscle groups all around. And so, I would recommend that she consider an intrathecal baclofen pump. Now, there are a lot of reasons to do that. Oh, my disclosure slide, sorry. Medtronic Pyramol Fluonix and Saline. No toxins. Suspicious, but I would pick a pump because there's a lot of information about how to use a pump, when to use a pump, why to use a pump. A lot of other experts have already done the heavy lifting for you. Part of that is with the Best Practices Project, which was sponsored by Medtronic about seven years ago, dividing experts. Dr. Salino's there. Dr. Toomer's there. Many others into what's the best idea for selecting patients, screening patients, management of patients, troubleshooting patients, essentially making it easy. So, I like easy because I'm not smart enough to do hard stuff. And then, for those surgical implants, there's even a Best Practices for surgical techniques. That's great. So, I appreciate that. It's infinitely programmable. It's reversible. It's easy to manage. It's dependable. And it ensures compliance. So, I like all of those factors. And I even like this part, that it's cost-effective. Pretty much in every country that it's been studied, including America, it's a cost-effective intervention to improve care for those patients with severe spasticity. There's the SISTER study, which addresses spasticity and intrathecal baclofen in the stroke patients in particular, showing that ITB is associated with improvements in pain and quality of life. So, and Mike, I didn't ask you for permission. I just assumed that since you were reviewing the slides, you'd just grant it. I've modified your synergistic model of spasticity management, and I made this ITB section just a little bit bigger because I think for this patient, that's really where we ought to be focusing. Some of these other things are always going to be important for spasticity, including maybe a little neuroblockade. I made that a little bit smaller for you, Monica. But the big part here, I thought, was most important. So on that note, I'll let Monica have the floor. All right, can y'all see my slides okay? Not yet. Not yet, you said? No, we see you. I'm still seeing you and Rez. Swap display maybe? Are you on two displays? Yes, there, let me actually press share. There you go. Now we have it. There you go. We see it, okay. Yes, good, everyone. Good, good, good. Okay, so there are my disclosure slides as well. Guess it was easy to pick who chose what. But this is for those that believe in team toxins for this patient. So one thing that when we, the other thing is we didn't see our slides beforehand. So it's all kind of new on, you know, what arguments we're making for our side. So basically the thing with toxins for asbestosity, it's level one evidence for, you know, AAN guidelines for asbestosity. It's part of stroke rehab guidelines from AHA, American Heart, American Stroke Association, that, you know, this consideration of asbestosity management, first-line treatment, especially for management of asbestosity is botulinum toxin injections. So along with that, in this patient, I feel that, okay, I'm not against ITV. I think that's a wonderful option in stroke patients. I also think it takes forever and a day to get the point, to that point, to get the patient trialed and implanted and go through that whole process. And by then she could be, you know, getting worse with her asbestosity, getting worse with her gait, just learning wrong neuromuscular patterns. And so I'm a big fan of, okay, let's not, we can consider this option, but why not do something that we know is first-line therapy and do it first? And, you know, toxins have, there's a lack of systemic effect. So I know I'm putting it, I'm using my guidance techniques, which I will use EMG and ultrasound together for best guidance for me. And that I know the muscle that I'm wanting to inject, it's getting in that muscle. You know, it looked really bad when you were doing some of her physical exam, but when she was walking, I didn't see the clonus being an issue. And so I didn't have to worry about, I think pumps are sometimes really a great option for clonus. Of course, I also think phenols are really a great option for clonus, but I don't think that, in this case, that with toxins, that this can be taken care of for what she has, just focusing mostly on her plantar flexors and inverters. Like I said, it can be done early. And then there are studies that show that early management of spasticity with botulinum toxins, if you get it done early enough, then this is gonna be cost-effective long-term because they're not gonna need spasticity management for a longer time. You may have, you know, a less need for having other interventions down the line, less complications, less surgery. So especially if this can be done as early as possible, then this is gonna be cost-effective that way. There are no really drug-drug interactions when I'm doing toxin injections. There's good safety, there's good tolerability, and it works fast. Like I said, that there is, you know, ability that, okay, do the assessment, get the patient approved, get them in in a couple of weeks, get them, you know, their injections, and we know it'll start kicking in within a week or so, and then being able to put that together with other modalities that helps the patient with their outcomes. So that's my reason for saying, let's just start with her on toxins this time around. It's also easy, it also can ensure compliance, and it is the right patient at the right time. Since you said that, this is about doing, is about time and getting it done expeditiously. So what are the cons of ITB? Like I said, longer process to get it done. There's, they have to, after they get it done, they have these precautions for six weeks, so that's sometimes also limited in what therapy they can do during those six weeks, and then are they losing function during that time that they're just hanging out? And then you have to get the time to adjust it to the appropriate dose, and then sometimes that doesn't happen as quickly as you'd like it to as well. A lot of times, some team members may not understand the process or adjustments, or so that's also, you have to make sure you have a team on board that understands what ITB is about. There's definitely more risk of complications with ITB, even though they are low, and then you have to marry the patient. And so when you have an ITB patient, like you said about compliance, that also means that you have to make sure that they're right and that they're gonna come back. If I inject someone with botulinum toxin and they don't come back, it's, well, usually they do, but if they don't, then I'm not calling the police to go do a welfare check on their house because you're worried about what's gonna happen because of the risk of withdrawals. There's no withdrawing from botulinum toxin. And still, with my patients who have pumps, I often am still doing toxin with them anyways. And so just, I guess, in my real practice, I will do them both together. I did also do a few slides on the, because I'm unbiased, is that I did give some cons for toxins as well. And so, you know, it can be costly too, just depending on the type of payer that the patient has. Again, that also limits how many units you can use now that the FDA has approved on-label doses so we can't maybe use as high as much as we wanted to use before. The patients need to get it injected every three months, but then of course I have patients with pumps who need to be refilled every month. So in that case, I have some patients that, especially if they have a smaller pump and a higher dose, that I am seeing quite frequently in clinic and more frequently, and it could be more costly for them that way. The toxins can have, you know, a rollercoaster response if, you know, they start having waning effect before the three months when they can get it again. And then if you inject the wrong thing, it will take three months to wear off. So, Rez, you have anything? Of course, I need two minutes, maybe three. Let me end my sharing here. Terrific, again, oh, well, we're going to- Oh, he has a counter. I've got a counter, hold on, I got a counter here. So let's see. Okay, go ahead. This is all right. I'm going to bring out the big fist for this. So yeah, the LD50 for a mouse, for a baclofen, it's like 200 milligrams per kilogram, but botulinum toxin, you know, most lethal toxin on the planet. 40 grams kills out all of us. So, and there's this, you know, it's a lack of, like, Monica, I was listening to what you said, lack of systemic effect, good safety and tolerability. And yet there's this, this is not a video that doesn't work. This is a black box warning. It's a black box warning because of adverse effects that are well-known and need to be very carefully considered. Additionally, when patients, I love this study. This is a study of a patient who on one gastrocnemius had botulinum toxin single injection. On the other side had saline injection. And there's this high signal intensity pattern a year after MRI, after a single injection. And that's nothing compared to the atrophy and fat deposition that occurs here in this case, in this study, six months after one, two or three injections of botulinum toxin. Or in this study, not just on one side, but also on the contralateral side, a rabbit injected on the one side showing atrophy even six months after on the contralateral side. So, you know, I know exercise is medicine and we talk about muscle building and strengthening, et cetera. I know Botox, botulinum toxins, excuse me, have a role in an R-spasticity management and I inject toxins too, of course. But I wanna be cautious about whether or not I'm really doing what I think I'm doing. I haven't seen that it's preventing contractures and things of that nature. So I have a list of references here. And of course I found probably the best reference, the most awesome reference, the most important reference that I could cite in this particular talk is this one. Inquiring minds wanna know, and that's even my opponent knows that stroke and ITB patients and stroke and TBI patients need ITB. So better for everyone. And thanks for your time and attention. Yes, thank you. Remember, there's no one right answer unless it's mine. All right, we'll do our next. Yeah. Actually, I think we're- Oh, it's a break. Yeah, we're up to a break. We are five minutes past the time. First of all, thanks to all the presenters on the first half of this session. I thought it was a very vigorous and academically appropriate debates. And I certainly learned a lot from all the discussions. Why don't we trim five minutes off the break so that we could try to get back on schedule. So we will reconvene at half past the hour, whatever time zone you're in, that'll be different. So that gives us about 15 minutes to go into the breakout sessions and meet with the sponsors. So thanks to everyone. And we'll see each other in about 15 minutes. As we head into the break now, we would like to once again thank our session exhibitors. You can visit their exhibit breakout rooms to speak with them about their products and services. When you enter the rooms, please look for the reps with the company names next to their own name. Here are some instructions on how to enter the exhibit rooms and move from one to another or return back to this main room. A message will be sent to all rooms when they're about to close before the session resumes. Attendees still in exhibit rooms when they close will automatically be brought back to this main room. The session will resume at 7.30 Central Time, 8.30 Eastern Time. The exhibit rooms will open once again at the end of the sessions. Thank you. I think we're just about at half past the hour, so I am now going to turn over the virtual podium to my colleague from New Orleans, Dr. Andrea Toomer, who's going to start off the second part of our session with a case discussion on troubleshooting intrathecal delivery systems. Good to see you, Andrea. Good to see you, too. Let's see, I'm sharing my screen. Okay. Do you guys see this? Yes. Yes, okay, great. So I'm Andrea Toomer from New Orleans. I'm going to be going over troubleshooting and presenting a case that I had fairly recently on troubleshooting. So my disclosures, I am a speaker and advisor for a number of different pharmaceutical and device organizations. So we'll go through the signs and symptoms of backliff and withdrawal, review that medical conditions that can mimic the signs of backliff and withdrawal, discuss troubleshooting procedures that we can go through, and then really focus the time today on the case discussion. So symptoms of backliff and withdrawal, we're seeing the patient return to their baseline level of spasticity or sometimes worse. They have itching, hypotension, paresthesias. They can develop a high fever, altered mental status, exaggerated rebound spasticity, worse than they ever had at baseline, and muscle rigidity. This is a very serious condition that obviously we need to recognize and work up and treat rapidly. So backliff and withdrawal can be mimicked by other noxious stimulation causing increased spasticity in the body. Things like bowel and bladder retention, things like autonomic dysreflexia, sepsis. So we need to, when we think of patients potentially having backliff and withdrawal, we need to consider that other medical things could be going on with the patient and it may not just be the pump. It's very common to focus on the pump when the patient has a pump, but we have to look at the patient as a whole. So when we're troubleshooting a patient that could potentially have backliff and withdrawal, first and foremost, most important is history and physical. And in that examination and in that history, we need to investigate for other causes of increased spasticity. And then we need to look at the device itself. So we need to evaluate the pump function and we need to evaluate the integrity of the catheter. So of course, in our physical exam and our history, we're looking for other things that could be going on, other causes of noxious stimulation that could be increasing spasticity. The bowel and the bladder are number one and number two always. So we're looking for things like a urinary tract infection or urine retention, constipation, ileus, other noxious stimulation, things like pressure wound, things like fractures, things like ingrown toenails, other things that could be causing discomfort, things like kidney stones, all those other things that we need to be looking for in our patients. When we're actually troubleshooting the device itself, we need to be looking at the pump. So interrogating the pump, looking to see if there's been any programming errors on putting in the wrong dose of medication or putting in the wrong concentration or not performing a bridge bolus when we change concentration. All of those things can cause withdrawal symptoms because the patient's not actually getting the correct dose of the medication. We want to make sure that there aren't any alarms going on in the pump, such as low reservoir, that the pump wasn't filled, that we've had an unintended motor stall, or if we've reached end of service, knowing that that battery was going to end, but the patient didn't follow up, was lost to follow up, didn't have their pump replaced when they need to. When we're interrogating the pump, we can also access the pump and verify the reservoir volume. So we know how much medication is supposed to be in there if the pump is working properly. So we can access the pump and verify that volume. Then moving on to evaluate the catheter, we can do catheter X-rays to look at the integrity of the catheter. If we can see it all the way through, we can see that there were no fractures. We can aspirate the catheter to make sure that there is good flow of CSF through the catheter. That lets us know that our catheter is patent. If we can aspirate, we can then move forward and do a dye study. So if we can't aspirate out of the catheter through the catheter access port, we can't push anything in because then we're potentially pushing a catheter's full of drug in at one time. So we don't want to do that. But if we can aspirate and we can fully clear that catheter, we can then push dye through. We can look at that under fluoro and see that the dye is flowing into the intrathecal space. And then we can follow it up with a CT scan so that we can further see where that dye is and make sure that it is in the intrathecal space. We can also give a test dose of intrathecal and we can do that a couple of different ways. One way is programming it through the pump itself, or we can completely bypass the pumping catheter system and give it through a lumbar puncture. So all of these different methods are ways to try and figure out where is the issue? Where is the breakdown? Where are we no longer getting the intrathecal back within delivered the way that we want to? So I just have a few slides of images. So this is the same image on both sides of the screen, but I just highlighted with a little bit of yellow. This is where we wanna see what we're looking at. So what we can see here is that the catheter is actually fractured and these two yellow points should be touching each other. That's where the catheter has fractured and that distal end is now slipped down. So we're no longer in the intrathecal space. We're no longer delivering medication there where that catheter is completely broken off and it's out of the spinal canal. And that other piece of catheter has just drifted downwards because it's no longer connected where it should be. Here's a view of dye studies and the CT following an intrathecal dye study. So we can see here on the left. So this is a normal dye study where we see a normal level meniscus in the subarachnoid space. So this is exactly where we want to be. Here we see on the right that the contrast is in the subdural space. So it's tracking up the sides of the canal. So that's showing us that our catheter is not in the subarachnoid space. And even though on a actual dye study, we see that the intrathecal dye pushed through on fluoro. When we look at this on CT, we can see that that catheter has migrated and it's not where it should be. And therefore we're not getting the effect that we should be with the intrathecal baclofen. So this is a case that actually happened a couple of years ago in my clinic. So I'll give just a small background on my clinic to understand how all of these pieces went together. So I'm in a multi-specialty private practice clinic where we have neurosurgery, neurology, and PM&R. We're in a community hospital, but we're affiliated with the academic center. We're in the same healthcare system. The neurosurgery residency is based at our hospital. And one of my partners is the chair of the neurosurgery department. So we have academic and private practice physicians working together, treating patients and working with that neurosurgery residency. So in this clinic, when I joined 13 years ago is when I started this spasticity clinic. So there wasn't any intrathecal baclofen happening there before. So neurosurgery is there to implant the pump, but PM&R, we do everything else. We do all the management, we do all the troubleshooting. So we basically turn to our neurosurgical colleagues when we need a pump implanted or a pump replaced, or when we've completely figured out what the issue is with the pump and we need this sort of revision because we've determined we've done all the troubleshooting already. So this is a 24-year-old female. She has cerebral palsy. She's got existing intrathecal baclofen therapy treatment for her spasticity. Her pump battery is running low. So we know that we need to do an elective replacement. So at the time that her pump was replaced, because her dose was high and because there can be some pump-to-pump variability, and what I don't wanna do is give someone with a high dose already too much medication at the same time that they're getting general anesthesia, I opted to lower her dose by 15%. So her surgery was performed at a surgery center by one of my neurosurgery partners, a private practice partner, not an academic partner. He operates at an office that's 40 minutes away from us, and he did this surgery at a surgery center, not at a hospital. At the time of surgery, no catheter revision was performed. The pump was just replaced. New medication was refilled, and she was started at her dose of 15% less than her previous dosing. So the trouble starts the next day when the mom calls me and she says she's not doing well, she's been having spasms overnight. So I thought that 15% decrease that I performed was probably the cause of that, and I wanted her to come into the office. So she had some spontaneous spasms noted. She didn't look terrible. She didn't look incredibly different or worse than her baseline. There was some difference there. I increased her back to that 15%, so brought her back to her baseline dose, and I also programmed a 25-microgram single bolus just to kind of get it started and get her a little bit more medication right away. I asked them to hang out in the clinic for a little bit so I could just watch her. Her mom felt like she was getting better, and they felt comfortable, and they wanted to go home, and again, they do live a little bit away from me, so I let them get on the road and get home, and of course, this was a Friday. So she's actually not better. So then the mom calls me on Saturday, and she says, overnight, she seemed to be doing okay for a little bit when she left the office, but overnight, she really did bad. She's having a lot of spasms, her whole body's shaking. Her mom's really concerned. So I said, you guys just need to go into the ER. So they decided to go to the ER closest to them. She couldn't go back. She had her surgery done at the surgery center, so there's no hospital to go back to where she had her surgery. So they went to the nearest ER to their home. Of course, that hospital doesn't have any physicians who are familiar with intrathecal baclofen in any way. So the ER doctor called me. So I updated him on everything that had happened up to that point, and I told him I thought we needed to be looking for other causes of increased vascosity. So, and he didn't say, when I interrogated her pump, there was nothing wrong. There were no alarms. Everything was programmed the way it should. So I felt like I had really checked that pump, and there weren't any issues there, so there must be something else going on that's causing her to have this increased vascosity. So I advised him we need to look at her bowel. They did a KUB. She did have some stool there. She had had a bowel movement the day prior to her surgery. So surgery was Thursday. She'd had a bowel movement on Wednesday, and today is Saturday. And her mom said it's kind of her normal bowel pattern to have a bowel movement every couple of days. This wasn't anything outside of that ordinary. So then I said, we really need to look at her bladder. So they did a UA looking for infection, but the UA was normal, but they did put a Foley in and a catheter for 850 cc's of urine. So I thought, well, here we go. She had a distended bladder. This was a very noxious stimulation. This is why she had her increase in spasticity. So I told the ER doctor I felt pretty good about this. We found out what was going on. She'll be better. Everything looks good, but she's getting worse. So he calls me back and he says, how long should it take after we emptied her bladder for her to get better? And that's not a good sign because she's clearly not better and she should have been better pretty rapidly after we removed that noxious stimulation. He said, I'm really worried about her. She's having these continuous whole body spasms. She's febrile. She's tachycardic. She's really not looking good. She needs to be admitted, but none of the doctors here at our hospital are familiar with intrathecal baclofen and would really want her transferred to your hospital, to my hospital. So of course I agreed that she needed to be admitted and she needed to be under my care. So she was transferred over to my facility. And this is a 45 minute transit time. Plus we have to set up transportation and everything and I have to get a bed set for her. So there's a little bit of time before she actually arrives at my hospital. So in that time, I figured, let me cover all of my bases. So I called her implanting surgeon and he told him everything that was going on with her. And I asked him just to confirm that they did aspirate that catheter when they implanted that new pump. And they absolutely did. He said they had beautiful, easy flow after they implanted the pump. Once the pump was down in the pocket, they aspirated, everything looked great. So I also confirmed that they put the right drug in. So we confirmed the lot number. It was the correct concentration. She had the drug in there that she was supposed to. They had good flow in the OR. The programming was what it was supposed to be. So I'm just kind of, before the patient arrives, covering all my bases, trying to make sure that I've got everything intact to figure out what's going on with this patient. So the patient is then admitted to my hospital and she's admitted to the critical care unit. So she comes into ICU. She's under the care of PM&R Neurosurgery. Of course, the neurosurgeon on call has no familiarity with pumps. He doesn't implant pumps at all. But the neurosurgery residents are the same residents that work with my partners who implant pumps all the time. So they're very familiar with the implanting of the backfill and pumps and the backfill and pump patients. So looking at the patient now clinically, she's really decompensating. She's having severe whole body clonus. She's tachycardic, she's tachypneic, she's febrile. Something is very, very wrong with her and we need to figure it out and take care of her. So we decided that we really wanted to thoroughly evaluate the pump and the catheter. And we wanted to do a catheter system again. So normally this would be the kind of thing that you would do, a catheter aspiration under fluoro. My neurosurgeon who was there decided, let's just bring her to the OR. Those neurosurgeons are more comfortable. They'd much rather be in the OR than be at the bedside with a C-arm. She was really clinically to the point that she needed to be intubated so that we could manage her airway. And we did that with her under general anesthesia. So brought her to the OR, interrogated her pump again, which I had done on Thursday, interrogated again now on Saturday, no motor stalls, everything looks fine. We accessed the catheter access port. We could easily aspirate. We sent that CSFL for culture. We did a dye study then in the OR and we have free beautiful flow into the CSF. We did the pump reservoir. The volume now, of course, the volume, it was full. It had just been put in a couple of days ago, but access the reservoir. It had the correct volume that it was supposed to. I got a new set of drug from the pharmacy and we filled it with new drug just in case that was anything. But at this point, we've come up with nothing. There's nothing that I can identify in the pump or the catheter. No problems here to cause withdrawal yet the patient is having severe back off and withdrawal. But at this point, there's no reason, there's nothing to fix. There's nothing to do a surgical exploration for. So we're at this point where something's wrong with the patient, but I can't figure out what it is, but I don't think we're making anything any better by surgically exploring something that we've thoroughly worked up and we can't identify any problems with. So at this point is when we realized that it wasn't actually the pump at all. So as we're prepping the patient for transfer off of the OR table, back to the stretcher so we can bring her back to the ICU, she had passed after going under general anesthesia, her balls had evacuated and she had passed an extremely large, extremely hard, solid mass of stool. And it being very delicate when I'm saying how large it was. So this noxious stimulation was causing the patient to be so severely ill that she appeared to be in acute critical back off and withdrawal. She completely returned to her baseline when she recovered from her anesthesia. So in summary, intrathecal back off and withdrawal can be dangerous and life-threatening. And this patient was very, very critical looking and certainly needed critical care and was in a life-threatening situation with as tachypneic and tachycardic as she was and needing respiratory support. But it's really important to remember that other medical conditions can mimic symptoms of withdrawal and a thorough history and physical exam is necessary when we're working on potential back up and withdrawal. So other than questions. There is one question that we just have a minute for before we move on. Is there saying who takes the call, but I guess. So I take the call for for all of my pump patients and I have a partner. So between she and I, we manage the call for all of our pump patients. So we're the ones that do the troubleshooting issues, but we do have that neurosurgery residency. So if someone needs to be admitted, those residents are in house 24 hours and can admit our patients and we can kind of talk through the workup with them until it's, you know, hours that we can get into the hospital and help them. Okay, thank you. Kind of goes to my point counterpoint. So next, we're going to go into our practice development sessions and we'll have Dr. Pacheco. Okay, veering off the very interesting case that turns out to be the bowel. So this is about practice management of spasticity clinic, chemo denervation. And I'm Dr. Marilyn Pacheco and I'm from Heinz VA used to be everywhere else. The objective of this study is at the end of this presentations, you'll be able to identify challenges in preparing for the practice of spasticity, learn to or how to organize your operations, identify the software and supply needs and create a plan promoting your specificity practice. So like in any challenges for initial practice, if you're just opening a practice, you know, the initial challenges would be what type of practice setting are you in the insurance payers checking your account, your loans, you have money, your tax identity number, your employee identity number, your business planning, right, the business plan entity setup and office setup and location, you have to make sure you have malpractice insurance, your fee schedule, your credentials with Medicare and Medicaid, with your provider application, your private insurances, medical credentialing and hospital privileging, your NPI number, your state medical license and hospital privileges. You want to look at what software and supplies you need. You know, we all work within the EHR templates. At one point in my previous world, I was working with four different EHR, what's very difficult, billing, medical equipment and tools would be what equipment they need, the exam table, the sheets, the supplies like gloves, needles, syringes, gauze, alcohol wipe gel, what services, which particularly means like your staff, do you have a scheduler, you have a nurse that would be helping you, do you have other providers that will be helping you? Or are you going to be if you're in a group that other providers are doing specificity clinic, the clothing, like the patient gowns, you want shorts and things like that. Furnishing would be the table chairs, waiting room, the computers. An important part, of course, for specificity is what kind of guidance would you want EMG guidance, ultrasound guidance, you have a simulator. Other things are your fax and computer, especially if you want to do your approvals and things. And the most important if you're working with toxins is the refrigeration. So for most toxins, like you wanted like two, like a couple of them, like two to eight degrees Celsius, or 36 to 46 degrees Fahrenheit, make sure you have a temp check for your refrigerator. Staff flows, you know, work with your human resources if you're in a hospital setting for your scheduler, healthcare tech nurse, delineate your employee roles, personal benefits, security risk assessment, do your admin setup, and then your compliance with all these letters. Additional vendors will be your utility maintenance, your office supply, janitorial services, medical waste, credit card processing, and then promote your practice. Network with your colleagues and then be in the list of providers for treating specificity. So this part, we're going to go into more detail about the payer landscape. There's two payers, like the government plans and the commercial plans. With Medicare and Medicaid, and then VA, which I'm in right now, and then active military and state health insurance exchanges. And then there's managed care organizations and pharmacy benefit managers and employers. For most Medicare carriers and Medicaid, you know, medical policy specific. There's a medical policy specific to botulinum toxin. And then in your notes, you must write like botulinum toxin to be medically necessary. That's the number one thing that needs to be done. And there's different verification processes, prior authorization requirements. So whether the treatment or the drug needs to be pre-approved, botulinum toxin acquisition guidelines for your SPP, which I'll talk about later. And then treatment limits, like how many dosing they're eligible to receive. Also, you know, talk to the patient about their financial responsibility. Talk about, are they on a deductible? Which means that they need to pay a certain amount before the payer begins to share their expenses. And then copayment would be a method of cost sharing used by payers. And then coinsurance, a method for cost sharing used by payers that requires the patient to pay a percentage of your cost. And this can get expensive. So Medicare, this is one question, you know, even though it's first-line treatment, does Medicare require prior authorization? Then the answer is yes, require prior authorization. Some insurance companies have a separate form to complete. And then, of course, most insurance companies would want to see more affordable options were attempted and failed, even though we know that it is first-line now treatment for specificity. Then you need your letter of medical necessity. Then you have to document what the medical service would be, detail the impact of the diagnosis, inclusion, appropriate medical literature of the diagnosis, explain, sometimes they want the physician's experience and training on botulinum toxin, and explain the toxin procedure and anticipated outcome and document the patient history. For documentation that's necessary, of course, there's the ICD-10 CM code, you know, not just like don't use muscle spasms there. It's not going to get approved. You have to use like spastic hemiplegia, the terms that would be useful for the ICD-10 code, and then use the CPT code and then describe injection areas provider intends to treat the botulinum toxins. So these are your 64642 until 64647 codes, and you could look it up. And if you need it, I could send it to you and then or to Jose, and then we'll print it out for you guys. And then you have a list of traditional therapies have been tried, PT, OT, and all those things. And then injection treatment, and then other therapies would be, of course, they want us to look at oral medication, hopefully not as much these days because it's like first line treatment, and it would be easier for approval. And then Medicare cover botulinum toxin for spasticity, the Part B does cover it. And then it's in the outpatient setting and doctor's office. And so how to get Medicare coverage for botulinum toxin, of course, Medicare would pay for 80%, and then 20% is an out-of-pocket cost. But think of it like if you're treating the patient every 12 weeks, that 20% can become a financial burden. So maybe advise your patient to have Medicare with a supplement plan. This is a better way to cover costs for the procedures. FDA has approved four different toxins out there. The numbers here are their ENCODES. So I'll talk about ENCODES later. So different ENCODES that you will need if you are thinking about opening your own practice. But the ones for spasticity is only like this three, ABO, ENCO, and onobotulinum. And then for upper and lower are just ABO and onobotulinum that has been approved. I do, the reason why I name it chemo denervation too, because I do blepharospasm, cervical dystonia, chronic migraines, hyperhidrosis, spasticity, and scialorrhea in my practice. Toxin drug acquisition options. You could do a buy and build if you're in an outpatient setting. This means your practice will buy, then build a health plan when the vial is used, but you have to keep an inventory, carries a financial. Your practice will be carrying the financial responsibility. This is SPP, the special pharmacy provider. Then there's certain pharmacies that you go to and the cost of the drug is built by the special pharmacy. And then the special pharmacy carries the financial responsibility for the toxin. And then this varies by commercial plans. Inventory management. You have to check your ordering. You have to implement an ordering system, monitor your shipments. Of course, these are expensive medications, right? With proper storage, your refrigeration again, again, 36 to 46 degree Fahrenheit. 2 to 8 degrees centigrade for the rest of the world. Perform a monthly reconciliation of inventory and a logbook to help reconcile amount purchased versus the amount used, billed, and paid for by the insurance and your patient. Okay. When to collect. It's better to collect their co-payments or whatever payment that they need before you inject because after you inject, it's harder to collect. Which is true. Like out-of-pocket expenses is harder to collect after a visit. And that's speaking from personal experience. Practices can choose to call the patient prior to the office visit to do the out-of-pocket costs of botulinum toxin so that they know what to pay for. And then document, document, document. So document the date of service, frequency of the injection. The wastage should be documented. Your clinical effectiveness of the toxin. So your exam before and after is important. What guidance do you use? Although only one guidance is paid for. So just pick one. Muscle injected. I vote for, I'm not going to say, muscle injected sites per muscle and dosing per site. And then again, the ICD-10 code, the CPT code, the J code, the MDC code, which I mentioned in the table before this. And then the modifiers that you need for the drugs. So these are the different J codes that you could build by drug. Like, you know, ANA is 585. ABLE is 586. RIMA is 587. And INCO is 588. And then when you build the unavoidable wastage, because each vial is for single patient use. But you have to record the wastage and then record the exact amount of toxin that is injected that in any unavoidable wastage discarded. This should be discarded. Collection of accurate patient coinsurance amount based on the amounts received. Identify the claims that has been denied so that you know how much you're losing. Or you need to like, keep asking for the payment. Understanding the changing payer requirements for appropriate billing is needed. Understand the required documents. Track the length of appeals window. And then you have to maintain the file of denials and why. And learn from that. And then, you know, complete the letter of medical necessity. If you have a template of this, it's easier to do it. In my previous practice, a nurse has a template. And then we just send it to Medicare or whatever insurance. And then they would just come in and pay. And then we get paid. And then the patient pays. And then it's all for the good. We carry about, you know, sometimes on the refrigeration, we have about 200 Botox vials in our refrigerator at a time. There's a couple of us in that practice. Follow up documentation protocols. Your appointment to evaluate and assess treatment results. Document the treatment results to meet your payer criteria. And educate your patients on expectations. So leveraging your treatment team. You have your front desk and checkout staff. And they're the potential responsibility. For time's sake, I'm just gonna run down to like clinical staff for the documentation. Inventory management. Educate the patient providers for, you know, the proper coding. The writing of your letter of medical necessity. Your admin department should help you with your claims. Insurance verification. Prior authorization. Patient collection process. And then your toxin patient navigator can help you out too. And then, so again, going back, we have to identify the patient first. Secure your treatment approval. Order your toxin. Maintain inventory. Collect patient responsibility that day. Procedure documentation. Claim submission. Receipt of the payment from the insurance. Receipt of the... Reconcile your claims. Follow up documentation. And then collect outstanding patient balance so you don't go out of business. Clinic day scheduling. Grouping a specific type of patients. Usually we have migraines, you know, and then I have my hemifasm on one day, cervical dystonia on one day. It's easier that way. It's more efficient because your mindset on how you're injecting is in that mindset. And then I have spasticity. Of course, spasticity takes longer than the other injections that I've done for other like, you know, migraines really fast. Evaluate current volume of patients to determine viability of grouping. Assess average time per injection. And then how many limbs are you injecting? Sometimes I have four limb patients because they're not agreeing to the pumps. That's one thing too for Botox. It's very hard sometimes to convince patient to go for the pumps because they're so scared about the surgery. Consider the days and time works best for the provider and staff. Consider how staff will assist on your clinic date. Conduct regular training on your staff and assess and modify clinic schedules. So check-in, patient intake, informed consents, toxin reconstitution, room prep, set up and turnover, and then patient checkout. So these are my references. I think I got in in 15 minutes, Mike. So, Mike, I'll turn over to you for intertical baclofen or intertical baclofen business practice management. I will un-share. Thank you, Dr. Pacheco. That was excellent. I will now share my screen. Let me get that up. Can you guys see that okay. Now it looks like your press, you need to. You're on a double screen Mike go at the top there. Yeah, that's right. Gotcha. Thank you again Dr Pacheco our presentations will parallel, one another. Very nicely. My name is Mike Salino again I'm a physiatrist at Moss Rehab, and also my academic appointment is at Jefferson. These are my disclosures. device and pharmaceutical companies involved in spasticity and pain management. I will do my best if there are any off label discussions to bring that to the forefront. My objectives for the next couple of minutes are to talk about the phases of intrathecal drug delivery and then identify the practice needs within each phase. This is the algorithm that individuals go through in utilizing this therapy, some initial evaluation, then going on to the trial, if the trial is successful going on to pump implantation. Rehabilitation and lastly long term pump management so we'll just walk down this ladder and touch upon the practice management issues that touch base in each one of these boxes. So, the initial evaluation can be done, either as an inpatient or an outpatient. Not really anything unique about these initial evaluations. They are the traditional E&M codes that we would utilize either in an inpatient or outpatient setting, but you should begin to consider the payer coverage for the further steps. As mentioned by Dr Pacheco you want to look at this in a global perspective, and make sure that you have coverage for all the different steps. There are a number of different potential referral sources from this, particularly the physical and occupational therapy groups within your organization and actually external to your organization. Other physiatrists who might not be utilizing this therapy, neurology, neurosurgery, orthopedics, as well as disease specific support groups such as MS and cerebral palsy often have very vigorous support groups in the community. You can also elicit aid from your industry partners that can be highly effective in your marketing approach. Trialing. Trialing can be done in a number of different settings and I list them there for you. You always want to consider how you're going to manage any prolonged effect of the intrathecal baclofen as well as how would you manage any adverse effects. For example, if you inject someone and they have an excessively long reduction in their spasticity, what do you do at the end of the day if they're not in the hospital? Those are things you need to consider. The injection code for a single bolus trial is there for you, 62326. This is the same code that individuals utilize for a lumbar epidural. You can also bill a guidance code, including fluoroscopy, CT, and ultrasound, and the codes are associated for you. You could also bill an E&M code for interpretation of the trial results. Sometimes during the trial, one individual may be actually doing the injection and a second individual might be interpreting the results and, therefore, the codes can be separated out. Implant. Again, this is more the domain of our neurosurgery colleagues. Perhaps individuals who have done some specialized training might be involved with this. I'm not going to touch on that too deeply. There are two separate codes, one for the actual implant of the pump and one that can be done, and a separate one for the catheter placement. This is typically done either as a short hospital stay or conceivably a same-day procedure. You want to have some discussion with your implanter if you're not an implanter, if you are going to initiate drug at the time of implant or you're going to initiate it at some point later. It's conceivable, depending on your payer group, that you may just get one lump sum payment for implant and all the associated costs. So, putting drug in at the time of implant will actually potentially have an impact on your bottom line. It also may be beneficial just from a post-implantation rehabilitation perspective to initiate drug at some point later. The implant itself can be done in a number of different places, such as a stroke procedure or in a hospital, but then you also need to consider what are the post-implantation strategies, whether that's an acute rehab, a subacute rehab, a skilled nursing facility, day hospital, or traditional outpatient. So, you have to consider that and have a dialogue with your implanter as how you strategize your post-implant rehab strategies. Post-implantation rehabilitation, similarly, you can bill both a traditional E&M code as well as your dosing adjustment. If you do bill an E&M and a procedure on the same day, your billing system has to add a 25 modifier. The code for the adjustment itself is 623625. I'm sorry, 62368, excuse me. And the definition with the 25 modifier is a significant and separately identifiable evaluation and management by the same physician or other qualified personnel on the same day as the procedure. I think you need to consider that as you document and you bill your E&M, a good little sort of litmus test for the 25 modifier. If you took the procedure portion of your note away, what would your E&M coding look like? I think that's a good way to consider it. Long-term management, most often this is done in an outpatient setting, but potentially could be done in some other settings. Similarly, you can bill E&M codes based on your evaluation and management with the 25 modifier, again, keeping that separately identifiable service attached to it. The refill code is 62370. If you do use guidance other than your hands and eyes, there are associated guidance code, one for fluoroscopy, one for CT, and one for ultrasound. Of note, ultrasound localization for pump refills is an off-label situation. Not so much that ultrasound will harm the system, it is just not going through the rigors of an FDA approval process. Recognize that refills require a drug acquisition that we'll discuss more in a moment and be very similar to Dr. Pacheco's discussion. Another component to think about is if you use guidance that may change your site of service. For example, if you go into a fluoroscopy suite, that actually might be a different site of service than your outpatient. You want to pay close attention to sites of service because coverage for drug codes may be different based on site of service. Remember that adjustments require a brand-specific programmer. There are more than one brand of intrathecal drug delivery systems in the United States now, and you need to have the appropriate programmer for that. Following completion of the either adjustment or the refill, there will be a telemetry report. Sometimes this can be printed out as a PDF document and can be scanned directly into your EMR. There is the potential for the programmers to have a direct interface with the electronic medical record, but that can provide a challenging interface. Many IT support groups within hospitals don't like external devices to directly interact with their EMR. It is a little bit of a paradox that you have one electronic device that requires to be printed out into paper just to put it back into a different electronic device. Hopefully, that will improve as time will move forward. Similar to what Dr. Pacheco said about medical necessity, I think it's a very good idea in your documentation to add some discussion about medical necessity of what you're doing, including the risk of harm if the patient does not receive therapy. I think that has a very nice language to add to your note. When you're considering how your E&M coding gets looked at, there are a number of different criteria. One of the things that is often overlooked in the E&M coding of managing intrathecal drug delivery systems as well as toxin injections and alcohol and phenol injections is any time that you are managing a non-oral medication, by definition, that can raise your level of medical decision-making. That's an important nugget to have. Sometimes, the billers and coders don't recognize that when you're refilling a pump or adjusting a pump that you're actually dealing with a non-oral medication. That is an important component to bring up. Long-term management. Management of patients is absolutely crucial, making sure when the patient has their next appointment. I make it a point that every patient leaves their appointment with a specific date, time, and location as to when they are to come back. Some clinics actually will put a buffer in their scheduling to account for the potential urgent or emergent appointments. Dr. Toomer talked about a case where she needed to see someone perhaps initially urgently and then emergently. How you budget that into your system is something you need to consider. As mentioned by colleagues earlier this evening, a no-show or a canceled appointment has different implications. The sun never sets on a pump patient unless you know where they are and what's going on. There are different options for managing patients. Some clinics use a spreadsheet function. Other folks use a calendar function. Some have systems built in within their electronic medical record to help manage patients. I would also like to put forth that there is a possibility of utilizing home care and home infusion services so that your pump patients do not have to come into clinic. I think it's a reasonable thing to say at this point that it's a somewhat controversial practice. I think that's appropriate in two realms. One is the clinical realm, meaning that you are not putting your hands and eyes on the patient to make those decisions. I will also tell you that there are a number of lawsuits across the country for home infusion companies and home care companies for what is being considered fraudulent billing. If you are using home infusion companies, I think you need to do your due diligence and make sure that you know what you're getting yourself involved with. Let's finish up with a little bit of the drug acquisition costs. As mentioned by Dr. Pacheco, a J-code is a code that is specifically designated for a drug or a biologic. It cannot be self-administered. The other criteria are listed there for you. Intrathecal baclofen fits that bill. Recognize that there are two codes for intrathecal baclofen, one for the trial, that's J0476, and one for the refill in the clinic. That J0475 is billed for every 10 milligrams of baclofen used during the refill process. So, for example, if you're filling someone with a 20 cc pump that has 2,000 micrograms per cc, that's 20 cc times 2 milligrams, and that results in a 40 milligram amount being placed in the reservoir. Bless you, Bill. Four units of the J0475. I have known clinics who have made that mistake, and obviously that will affect your bottom line. As mentioned by Dr. Pacheco, there is a buy-in bill option. Typically can only be used in a physician office setting, cannot be used typically in a hospital outpatient. As mentioned, you need to check for prior authorization and quantity limits. Recognize that J-code billing can be challenging for some departments. As mentioned by Dr. Pacheco, the practice buys the product that bills the health plan for the material used. This puts the onus of profit and loss directly on the practice, which can be beneficial if there's a profit and not so beneficial if there's a loss. Similarly, as mentioned by Dr. Pacheco, you want to keep an inventory of what you're using and what's coming in and what's going out. A little bit of a discussion about branded and compounded products we'll do in a moment. Hospital pharmacy. Again, this is typically done in a hospital outpatient setting and not a physician office. The pharmacy buys and bills the health plan when the material user does. They take the financial responsibility. The practice procures drug from the pharmacy, and that sometimes creates a delay in getting product to the clinic. There is the possibility of the 340B program, and we'll talk about that in just a moment, and this typically only involves branded products. The 340B program is an entity in which federal resources can be utilized to provide services to patients on a more comprehensive scale. Some of the eligible organizations are listed there for you. You have to find out if your hospital is a participant either in a disproportionate share hospital, a children's hospital, and other safety net providers. This can only be provided in a hospital outpatient setting. The pharmacy can procure the drug at a lower cost and thus has a potential benefit on bottom line. As mentioned by Dr. Pechera, there is the possibility of utilizing a specialty pharmacy. This is where the drug comes external to your clinic or to your hospital and is delivered to you. The specialty pharmacy bears the financial responsibility, including some commercial plans and managed care Medicare and Medicaid programs. Recognize that specialty pharmacies can often change at a moment's notice. You may be managing a patient for many years, and they can be using the same specialty pharmacy, and they come in for the next appointment, and they now have a different specialty pharmacy. This takes office time to coordinate the delivery with the appointment. This takes any potential profit out of the drug directly. Drug inventory management. The key thing is making sure that you have the drug available at the time when refill is needed. You need to implement an ordering system based on your practice needs. If you're using a lot of specialty pharmacies, you need to have that specialty pharmacy notified ahead of time. Sometimes the specialty pharmacy requires consent of the patient to deliver the drug to your office. You might even wind up managing multiple inventories, one for buy and bill, one for specialty pharmacy, one for 340B. Let me talk just very briefly about compounded products. Compounded products are products created by specialty pharmacies, usually at a lower cost. This may be appropriate if an individual has lost insurance coverage or have difficulties meeting financial obligations. Different practices have different approaches to compounding pharmacies as well as different insurance coverage. Similar to what Dr. Pacheco said, you want to keep a log of how much you used, what your costs were coming out, and what your costs were coming in. Long-term management, as mentioned by Dr. Toomer. Who handles patient contact for one problem? You don't contact your neurosurgeon if you need a minor dosing adjustment. You don't leave a message on a voicemail after hours if you're in a life-threatening situation. Who handles those off-hours coverage, as mentioned before? Very nicely, it's appropriate to develop overdose and withdrawal protocols to make sure everything is being done. Dr. Toomer did a terrific job in describing all the potential workup options. And lastly, just some operational issues, as mentioned before. Dr. Pacheco mentioned that you want to make sure that you have the appropriate malpractice coverage for all the different steps. It may require credentialing with individual payers to execute these things. I have heard some rumblings from different parts of the country that only individuals who are fellowship-trained may be the only individuals who can do certain procedures. I would check with your local insurers. Hospital privileging can be an issue. Dr. Toomer talked about that her patient was in another hospital. And how do you manage that? It can be a discussion all to itself. And this therapy, as well as botulinum toxin injections, are a continuous quality improvement opportunity to continue to refine your protocols in your systems. So that was a whirlwind tour through practice management issues of intrathecal drug delivery. I think at this point we now open things up for questions. Dr. Pacheco brought out the idea of do not use compounded products for botulinum toxin. I agree wholeheartedly that is not an appropriate intervention. There was a while back like I don't know 20 years ago, I'm aging myself, somebody did a compounded botulinum toxin and end up in the ICU intubated. I think this happened in Florida. Florida, I'm sure. I've never heard of compounded botulinum toxin, that's scary. I have heard of a person's mixing instead of their botulinum toxin with saline with lidocaine and in that case there has been a reported patient death. I think they used the industrial botulinum toxin that, you know, World War II type and that ended up in ICU. So that was 20 years ago and hopefully that person learned. It's more for, you know, cosmetic issues. Just a reminder that potency is very important and it varies by toxin. That's why there are differences in the dosing schemes for each one of them. We welcome anyone, you know, put any questions that they have in the chat for any of us. I actually have a question if I may, since we're waiting for the chat box to occur. But I was wondering if Dr. Pacheco, Dr. Solino could talk about the complications of billing. Do you find yourself that sometimes you've done all the right things but still your medication or your actual charge for the procedure gets denied and what do you do at that point? Appeal. Appeal, very good. Yeah, we do appeals and then, you know, there's like the important thing to learn is how to appeal and how to write a very good letter of medical necessity. Dr. Solino did mention like the risk of not receiving the therapy is equal to, I actually have a patient that I kind of like inherited that actually ended up in amputation because of a pressure injury. So after that, everything got approved, right? But before that, prior to me taking over, it was very hard to get approved, especially those days when it's not the first line dose yet, like the first line for treatment for botulinum toxin. Dr. Solino, like for intrathecobaclofen, denials, anything? So I think I agree completely with what you said. Both the medical necessity and the benefit of the patient and receiving the therapy as well as the risk of not receiving the therapy. I also think it's important that you have a very close relationship and a good feedback loop with your billing individuals. You don't want to find out that you had a pump in an individual and that you've been refilling them dutifully every three months for five years and find out that you haven't gotten paid for the last five years and there's a big bill. So you need to be proactive in creating that feedback loop. I actually now have taken it upon myself that every note on every patient says something like, this therapy is medically necessary. The patient would suffer severe and potentially life-threatening harm if therapy was not maintained or some standard verbiage that I've templated into every note. Thank you for that. We got a question. Do you often increase baclofen concentration to get longer refill intervals? Terrific question. That is a possibility. Recognize that when you increase concentration, there is the potential to change the distribution of drug in CSF, and that is probably the biggest black box of the therapy. The relationship between concentration, flow rate, delivered dose, the way you deliver the dose is still a little bit of an unknown in this therapy. The simple answer to your question is, yes, I will, but if I notice that a patient seems to have less of a positive effect at the higher concentration, I talk to the patient about the idea of going back to the lower concentration to get return of therapy, even though that may require them to come in more often. So, Monica, I think we have hit the allotted hour. We have one quick question. How soon do you consider initiating botulinum toxin after pump implantation? And I guess my answer to that would be, if you think that the botulinum toxin injection is going to interfere with your dosing decisions of pump therapy, I would hold off. If you don't think it's going to interfere with those dosing decisions, there's no reason to wait. I don't think that there's any postoperative infection risk or anything like that. I think as long as you can parse out who's doing what, I think you're fine to initiate it at any point. It depends on where you're doing it. So, you know the pump's going to have most of the effect on the lower limb. And if the patient, you want to address their upper limb spasticity, then go ahead and do it right away. So, we have reached the bottom of the hour. I want to thank all the faculty and all the participants for taking time out of their busy day. Again, hopefully at some point in the not too distant future, we could do this live and share all the expert techniques as well as the expert knowledge that we did today. I believe we can now move for a few minutes at least into breakout sessions. Monica, you want to do the final wrap up? Just really want to thank today all our presenters and for people who are still not all zoomed out and are willing to come to the Academy meeting and to come to our spasticity section. So, just thanks for our presenters and for those that were here. Again, we are always happy to be reached out to for any kind of questions in the future. And we do have our spasticity step course. That is, you know, we'll be going live and we'll eventually have a in-person hands-on certification program to learn all these techniques that we've talked about in person. So, don't forget about that. And also, 10 more minutes where you can go to the breakout rooms as well. Have a good evening, everyone. Thanks. Thanks, everyone. Well, have a good evening. Thank you all. Have a nice evening.

spasticity management

intrathecal baclofen pumps

guidelines for spasticity

cost-effectiveness

systemic effects

early management

botulinum toxin injections

level one evidence

compliance

individualized approach

drug-drug interactions

fast results

spasticity clinic management

proper documentation

billing procedures