All right, so if you're bored, I'm going to tell you how to get paid so you won't be bored anymore, okay? This is still the number one question I get asked, not how or when, but how do you get paid for this stuff? So I'll share with you our algorithm from a business perspective at Rush. And also just share with you from a clinical perspective how I use it in my practice and when and maybe also tell you a little bit about how the conversations go in an office setting. And that's something we leave for question and answer in terms of how each of us discuss these with our patients, especially given the fact that the majority of it is an uncovered benefit. So as I alluded to during the introduction, clearly we're uncertain as to who's driving the bus here. I think it's largely driven by patients. There pretty much isn't a day in my office where someone comes in and says, look, I don't want surgery. I hear you can regenerate new cartridge in my knee. You get that, right? Can you fix my rotator cup with an injection? I think most of us will have that experience on a very regular basis. And you know that it makes for a very slow beginning for a consultation when you start with that. And that's just based on patient perception. I still think the majority of what we do is a lot what Tom just talked about, and that's controlling pain, reducing inflammation, and making people feel better. And that kind of gives us a lot of latitude in terms of what we can use for our patients. It doesn't have to modify disease necessarily, even though that's the holy grail. Maybe we can use it in terms of biologic surgery to enhance the things we do. But the reality is there's just a subset of really fascinating research going on that I would say is truly regenerative. And this is one of the studies that looked at when MSCs were injected at the time of injury that looked at the relative contribution of the host versus the recipient cells that were going in. And I think Arnie's going to probably talk about that, so I don't want to steal his thunder. But it's a fascinating area of research. But the reality is we're looking at reduced inflammation and improved pain the vast majority of the time. So this is a clinic that my PAs ran not long ago, and they had everyone come in on a Friday afternoon. And I still do a fair amount of surgery, but the amount of non-surgical treatment that goes on far exceeds what happens in my operating room these days, and it becomes a management issue quite frankly. And these guys are just getting HA or cortisone most frequently, but occasionally we're using PRP in the setting of osteoarthritis. And I'll share with you what I do. But probably the best way to think about it, with really the most amount of humility, is that these are anabolic or anti-catabolic molecules that will modify the disease and or the response to treatment. So it's probably best to think of these joints as an organ, a diseased organ. So it's cartilage, synovium, MSCs, and so forth, and not just what tissue you're affecting directly. And this is really what we have. We have the concept of biologic surgery, where you can do an operation and add something to it. We have PRP. And then we have, quote, MSCs. And I would state that what you just heard might be true. We're not entirely certain where these MSCs are and if they truly are MSCs. And is that the same thing as with the traditional stem cell? And again, we're going to hear more about that. I would submit to you that there's probably very little in the amniotic world that has a single living cell. And whether or not adipose tissue functions in this capacity still remains to be seen. But that doesn't mean they can't be effective. And the same thing for bone marrow concentrate. When it comes to PRP, where are we in the office setting? I will tell you that this is a study where we looked at reduced versus enriched PRP. I'll just say leukocyte poor versus leukocyte rich versus placebo. And when you look at the best literature, sort of level one literature, level two, assuming that's the best, there is a clear differentiator that leukocyte poor dominates from a MCID difference in patient responsiveness. That doesn't mean you can't get a response with leukocyte rich, but the literature is replete with articles that suggest leukocyte poor is becoming a dominant treatment strategy based upon what we know. My algorithm, I think there's some benefit to combining PRP and HA. It's really only in the basic science realm, but it makes sense. So clinically, my algorithm in the office, if a patient's willing to do it, is I will do a standard high molecular weight HA series of three. And I will ask them if they want to, as an adjunct PRP, I tell them it's investigational to a certain extent, but we do have probably the most literature as it relates to osteoarthritis, and that it's an uncovered benefit. We charge them $2,000. That's for all three PRP injections. We space it out seven to 10 days apart. We don't charge them for the additional office visits. And we don't charge for image guidance, ultrasound, or anything like that, because PRP has a tracking code, and I'll go into that in a second. And then we put the HA through insurance. That's how we do it. We have a pre-cert in Illinois now. We send them for, they get a cortisone injection often, then if they don't do well, they come back for HA, and they give them the option if they want to add PRP to it, based upon what we think we know. I have limited experience with adipose tissue and mechanical disruption. There's some interesting basic science research. I think the take-home is it may make sense intuitively, but we've got to work towards true clinical studies, and maybe even some more robust animal literature to support the contention that this has a role, either in OA or even soft tissue modification. Rachel talked about bone marrow concentrate, where you should go. I think a lot of us do it by convenience. For example, for rotator cuff surgery, I do it in a beach chair position, so it's very easy to get from the proximate humerus. There's some data that supports that that's an ample source or supply of MSCs, or at least bone marrow concentrate. Distal femur, all have been looked at. Clearly, probably the gold standard is what you're going to hear from our speakers, is the posterior of that crest. I just think that a lot of us are not as comfortable, but that's something in this course, through ultrasound guidance and just tactile techniques, you're going to figure it out and become comfortable after this course. Interesting study that was published recently from Lisa Fortier's group, looking at what's in bone marrow concentrate, and does it make sense for osteoarthritis? It actually has IL-1 receptor antagonists and platelets. Therefore, if you want to extrapolate to what we know from the orthokine world, as well as what we think we know about the role of IL-1 receptor antagonists, bone marrow concentrate may make sense. The challenge is, what you just heard, the literature doesn't necessarily support it yet for its use, say, in an office setting for osteoarthritis. Sometimes these things seem to make sense in vitro and in vivo, but you can't necessarily extrapolate in the clinic as of yet. I think that's particularly true for bone marrow concentrate, so I don't use it now routinely for osteoarthritis in an office setting. Where I do think about this is as an adjunct to surgery, and I think that's in part from the convenience factor, because at least the way my office runs, it's very hard for me to integrate this into my office general practice. PRP is super easy. Amniotic might be particularly easy as well, if that's the direction you want to go, because it's an injectable with no preparation, but when it comes to anything beyond that, I find it very difficult from an office flow point of view, so it puts me on the fence. That being said, we're looking very hard now. We're in the midst of a randomized study looking at bone marrow concentrate at the time of an osteoconialograft to see if it helps enhance integration by CT scan. Then you have to ask, well, is it really a clinical problem? Do we have trouble getting these grafts to incorporate? Sometimes we do, but the cost and the inconvenience has to justify some clinical benefit. This is probably the best model I can show you, just as an example. Basically, we're going to need cells, we're going to need growth factors, and we're going to need a scaffold. I show you this as an example, which is where we're using micronized collagen from allograft cartilage. We combine it with PRP or BMAC to hydrate it, and we use it as a scaffold at the time of marrow stimulation. This is a study we did a few years ago at Cornell, where we said, look, let's take an equine model, create a defect, perform traditional marrow stimulation, or add this as maybe a carrier for PRP and see if it makes a difference. Overall, our repair scores, our second look, arthroscopy, MRI, and type 2 collagen staining were superior in a blinded fashion against marrow stimulation alone. I like to use this just as a model to demonstrate, look, it may not just be what we're injecting, but start thinking about this like biologic surgery, where eventually we're going to be probably combining something that we want to hold on to, keep it there, and oh yeah, you might need cells on top of it. Unfortunately, it's just not that simple. Same thing for rotator cuff. I showed you an example where we might enhance marrow stimulation. There is some really interesting work, but it's just a very small amount of work looking at bone marrow concentrate as a source of potential MSCs in a poor biologic environment soft tissue healing such as rotator cuff pathology. This is really a diseased tissue state. That's why we tear spontaneously. That's why we re-tear again after we perform rotator cuff repair. So it shouldn't be a shocker, right, when that happens. PRP has been looked at ad nauseum in this setting. A couple of articles have sort of helped us understand it in terms of what its value may be. I will tell you that it might help reduce pain, might improve healing rates for double row repairs for small and medium-sized tears, and it should be injected at the site of surgery. We don't know yet if fibromatrix or things that make it hang out longer make a difference to date. What about bone marrow concentrate and rotator cuff? We do this on occasion, and it's largely based upon some in vitro work in disease tendon modeling, but also by this single study, which is a case-controlled study, which has pretty profound results. So 45 patients had bone marrow concentrate, 45 had cuff repair only, right? So they all had cuff repair with and without bone marrow concentrate, and if you look at the healing rates, 87% versus 44% at 10 years, that's a pretty profound difference. I think Hernagel is an honest researcher. I think his results are interesting. It's not a randomized study. It's a case-controlled study, but it deserves to be repeated. So we're about two-thirds of the way through. I know I'm presenting it on Sunday at Children's Home, but I don't know if I'm presenting it here, but I'm happy to talk to you about it, maybe put it up on the podium where we're at right now. We just looked at about 60 patients in one year, but it's compelling. So that's a place clinically where I use it. Onoclidal ligament, varied opinions on this. I'm part of the biologics committee for the MLB, and there's some interesting internal data that shows that it might even be detrimental in terms of time course of healing for onoclidal ligament. There was one study that Lou Yocum published showing that a single cohort that it actually was able to get patients who had an onoclidal ligament tear at the humeral origin, right? Not an intrasubstantial, but the humeral origin was able to get these patients back at this rate of return. So it's compelling, especially in this population. Tennis Elbow, Alan's here, and I'd be really fascinated. This is the most quoted study for lateral epicondylitis. It's a very well-performed study, high leukocyte count. So people talk about now trying to stylize where you put it and what should it be, high white count, low white count, and try to really customize how we use this stuff. But this is the one study that did show a difference with leukocyte-rich in tennis elbow. But flip side is there's 50 things that might have could work with lateral epicondylitis, so we're not really sure what the dominant treatment strategy is. I'm going to give a talk on patella tendonitis, so I'm going to save this for that. PRP of muscle is also interesting. Those of us who have the opportunity to take care of high-level athletes who really can't afford to be out for even a single extra day have looked at this and utilize it not infrequently. So if they have what we call sort of a type 2 MRI signal where there's a consolidated hematoma typically for a quad or a hamstring injury, there's some literature that's supportive. What's interesting, it's been most used in the NFL for hamstrings. But the best literature does not support that there's any difference in hamstrings. All that being said, it might make sense biologically. There's individuals who are actually looking at platelet-poor plasma as well as a source of growth factors. So that's worth talking about, and we're going to have some muscle discussions as well. So I think I have four slides I'm billing, and I can drive the point home to educate you how to get it done, okay? So if you haven't been listening yet, this will sort of maybe pay for your weekend, all right? Taking time away from your work, your family, and the price to be here over the next day and a half. Okay. So these are the basic principles for billing. Corticosteroids and HA are generally reimbursed, although there are currently, to my knowledge, 15 non-covered states for HA. Illinois, as of January 1, we currently, for almost all payers except Medicare, have to get pre-certification, but as long as you provide the right ICD-10 code and do provide good medical necessity, we get approval within two weeks. This conversation I have with my patients, these biologics, specifically bone marrow concentrate, maybe PRP, amniotic tissue, by all insurance carriers are considered investigational and of unproven benefit. So third-party payers will not routinely reimburse for the procedure or the substance being injected, so that the substance usually falls under a J or a Q code. Medicare considers these as non-covered services, and the advanced beneficiary notice, that's what I'm going to show you what that is, it's not required, but it's really considered as best practice and it's something that you should use to protect yourself from a compliance point of view. The absence of FDA approval will assure pretty much no reimbursement, but if they get FDA approval, that doesn't assure reimbursement, okay? So just because it's FDA approved doesn't mean you're going to get paid. Think about this as things that are performed and utilized in the office or as an adjunct to surgery. If you use them in the office, they can actually be for any payer, fee for service, but they're considered an unreimbursed benefit. Multiple injections, if you get them back, you say, look, I'm going to give you an office evaluation, inject you today, come back in a week, really probably shouldn't bill for the office visit, but you can bill fee for service for the stuff you're putting in, there's no predetermined rate, it's up to you, okay? If you use it as an adjunct to surgery, you got to look at the correct coding initiative and that includes taping, casting injections as part of the procedure. So if they follow CMS guidelines or it's a Medicare patient, we're really not supposed to be billing for it in the operating room if you do it in combination with another procedure. So any payer in the operating room as an adjunct to surgery, if they follow CMS or they are on CMS, meaning Medicare, you're really not supposed to bill them for the procedure. If you do it in isolation, if you're someone who takes them to the operating room and just does say a bone marrow concentrate procedure or an adipose procedure, you can actually bill a CMS patient, but that's because it's not as part of the bundle through the correct coding initiative. So if you do a surgical procedure, you inject lidocaine at the end of the case, you can't bill for it. If you put them in a cast, you do manipulation, you can't bill for it. Now some private payers don't follow these guidelines, so you got to check with your payers. So those are important concepts. So the advanced beneficiary notice, you can find this on the CMS website. I included it in my handout. I don't care if you copy it. Just check with your coding expert in-house. But we have every patient sign an advanced beneficiary notice, and we do that in an effort to be maximally compliant for Medicare purposes and even for private payers who don't necessarily follow Medicare, okay? So this basically says all the things I just said. It's like an informed consent, and it allows you, if you take a sign from Medicare, Medicare really provides that we're not allowed to pay out-of-pocket for anything that we provide. This is sort of the bypass to get you there, and it's part of an informed consent process. So that's the ABN or the advanced beneficiary notice. Everybody signs it, Medicare or not. Okay, so let's get to the final specifics on how we do it. So if it's an office-based procedure, remember anyone can be billed in the office, Medicare or not, as a cash pay, or it's an isolated surgical procedure where you're not combining it with another surgical procedure, therefore it doesn't fall to that correct coding initiative, you can bill. But you've got to check the policies and follow the coverage guidelines if they exist. If it's a non-coverage decision, what we'll do is we'll actually give the patient a copy of the policy to support the notion that it can be self-pay. So there's language in your contracts, and that's the way you can sort of protect yourself and provide maximal transparency. They'll sign the advanced beneficiary notice to allow you to do direct billing if you take Medicare, okay, or if there are other government payer like Tricare or Medicaid, or if they actually follow Medicare guidelines, which a lot of payers do these days. You can bill the patient for the procedure, the substance, the injection, and even image guidance if it's bone marrow concentrate, but you can't do it for PRP because PRP has a tracking code, and that's a whole different discussion, what the tracking code is for, but because it has a tracking code, a specific language says, look, you can't bill for ultrasound, image guidance, any of that other stuff, but you can bill for the injection. And you can even submit that tracking code for insurance, but you're never going to get it paid. There's no RVUs with it. So you can still submit it, and that was the purpose of the code, to allow CMS to sort of track how frequently these things are being performed, okay? But the ultimate goal was to get it to a level one CPT code. So for example, Arthrex has completed a formal clinical comparative trial. They're going for their IND, BLA, did I say that correctly, IND, BLA, PRP, am I right? I get it all screwed up. That's a variable alphabet. Yeah, so they're done looking at their data, and I'm not sure. There's got to be a couple. Are there any other PRP trials that have gone through that are finished right now? You guys aware? Anyone aware? Alan, Jason, anything? The undescribed Zimmer. That's a Zimmer product that has it. Okay. So there's two daring industry sponsored trials that have gone through a formal clinical trial comparison of placebo, but they're not done yet, and again, that doesn't mean reimbursement, but that's the next step towards reimbursement. Okay, so what about if you do it in surgery as an adjunct to a case? So if it's used as an adjunct, it's generally considered part of the NCCI, okay? That's the correct coding initiative. Basically, all the stuff in addition to surgery, and you can't bill it if they follow CMS guidelines. If you have a CBT code, you can use that, by the way. So the problem is that other than in the use in spine surgery, there's no, to my knowledge, bone marrow concentrate code. So people have said, well, it's bone graft. It's not bone graft, okay? So if you talk to Marge Mailey and all the experts in coding, they really would say either use an unlisted code and see how far you get, or use, if you're doing a spine procedure with an adjunct, there is a code that uses bone marrow concentrate for that purpose, okay? What if you use it in surgery for a provider that doesn't follow CMS guidelines? You can actually bill for it, just like you do in the office. Just do the same thing you do in the office, document it, provide the patient with a pay or non-coverage policy, and have them sign that advance beneficiary notice, and you can bill your patient whatever you think is the right number. So what's the right number? I can't tell you, you know, what to do. I've heard some astounding numbers. I have a patient who lived in Denver who paid $5,000 for a $175 syringe for PRP. We charge $750 for PRP, and we charge $2,000 for three. I mean, I don't have any problem being fully transparent. I'll tell you how we do it logistically, okay? What we do, because if you work in a surgery center, the risk is if you charge the patient in the office, they say, okay, you know what? I'm going to charge you $200 for a PRP injection, and I'm going to do it in the operating room. And then the operating room also bills them, and it's not covered benefit. It makes for a really aggravated patient. So what we do, and I'll just tell you, this has worked out really well. We do it for the hospital, a legitimate hospital, two hospitals, big hospitals. We say, look, anytime we do PRP or bone marrow concentrate in the operating room, invoice our practice this amount of money, and we will pay you directly. Do not bill the patient. So we collect in the office. So how do we do it? We charge $2,500 for a bone marrow concentrate injection. About half of that is for supplies. The patient pays our practice. The hospital bills us for the supplies plus 5% handling, and the rest is kept in the practice. I don't have any problem sharing that. I mean, you guys could do that to figure out the dollar amount you want to charge. But it eliminates the hassle factor for the patient getting double billed, which is really irritating. So it's been very clean. We do it for our surgery centers. We do it for our hospitals. They're fine with it. They know as soon as they see it on the schedule. They don't go to the patient. They don't go to the insurance company. They go directly to us. Okay? And hopefully that makes sense. So a conclusion we can talk about in the panel and offline. So PRP for OA, tendonitis, muscle strange, partial ligament strange. I think there's emerging evidence, so we're going to have to go through each and every one of those through the case studies. MSCs from either adipose or bone marrow, assuming they're MSCs, my personal feeling, the data to date beyond in vitro and in vivo is not particularly convincing for any single application. I'm really compelled by the rotator cuff data, but that's only because it's one study. You'll see two studies hopefully in a year from us and from HSS that will maybe shed a little bit more light to redo that study in a truly randomized fashion with an anatomic endpoint. I think biologic surgery is what most of us in this room who are orthopedic surgeons, if that's what's dominating here, I haven't even looked, how many are non-orthopedic surgeons in the room? Okay. So suffice it to say, the majority are orthopedic surgeons, and you're thinking it's easier to do this stuff in surgery than to do it in the office. I think this is going to be an area where many of us will have interest. We just have to show that there's a value proposition there. So bone marrow concentrates soak an OA graft, put it in, does it enhance incorporation? I don't know yet, but the point is if it does, that might solve some problem with cystic formation and so forth. So figure out where we have problems in the office. We can study it and do it in the operating room in a pretty easy way using objective anatomic endpoints, and along with that, you still have to quantify and qualify what you're putting in. So anytime you guys want to study this stuff, I think a very important component is to make sure that you're looking at what you're injecting. So that could be a CBC, could be a smear, could be looking at FCUs, it could be looking at any analysis from MSC or monocyte identification, but some kind of assay to say, this is what I injected in these patients, in addition to following them clinically. And then finally, from Ken's point of view, it's a moving target, it's something you've got to keep your eyes on because they're not interested in you and me right now, but within the next 24 months, they probably will be, and they will care what you and I do every single day from a compliance perspective. So thank you very much for your time.

regenerative medicine

getting paid

clinical perspective

platelet-rich plasma

billing

compliance requirements