So, you know, Steve and Scott gave you some great caveats on what you might want to consider before you jump into this orthobiologic arena, but I think there's some pretty reasonable evidence that if you are going to use, you know, we're already using hyaluronic acid, we're using long-acting steroids. Many of us are using PRP. I think that's reasonable. I think it's reasonable to consider using BMAC and also adipose tissue to treat your patients with these conditions. So once you make the decision that you're going to do that and you do it ethically and responsibly and transparently, then I think the operational side is, you know, how are we going to bill for this and how are we going to incorporate it into our practices as a business model. So these are my disclosures, none are relevant to this discussion. So the thing that's intriguing to me about this is the size of the market, right? So Scott Bruder the other day, he's estimated the market at $4.5 billion per year, but I've read articles that say it's as high as 10, and it's going to go at a compounded annual growth rate of about 15% per year, and it's a global market. So as an unmet need, this represents, I think, not only a significant clinical opportunity for us, but also a significant business opportunity. And the reason is the market, right? Osteoarthritis is 45 million people now. It's going to more than, you know, almost double in the next 20 years. And so we're doing like a million total joints a year now. That's going to go to 4 million by 2030. So as you know, nobody necessarily wants to have a total joint replacement, and they're all looking for alternatives, non-operative alternatives to having that total joint. And I, you know, everyone could tell you stories about, oh, I've had patients go to Europe, I've had patients fly from New York to California to get $5,000 stem cell treatment. So it's an unmet need. And when you also consider what's happening with the reimbursements of our surgical tried and true methods of treating osteoarthritis, both arthroscopically and arthroplasty-wise, those have been on a 30-year decline, right? So these are things that patients are actually willing to pay for out of pocket, and I think that, once again, that represents a significant business opportunity for us. So there's some general considerations that you need to keep in mind if you're going to use this in your practice. And one is, is the patient a government payer, Medicare, Medicaid, TRICARE, or are they a commercial payer? Different rules for each one, and you have to take that into consideration. Are you going to be using this in the operating room or the office, right? So there are different rules for that, too, and you need to consider that. And if you're using it in the OR, is it going to be a standalone procedure? In other words, you're just going there to the operating room to do a bone marrow aspirate and injection in the knee, or is it in conjunction with a standard CPT surgical procedure? So for the general rules in the office, we're already using interarticular corticosteroids and hyaluronic acid, and those are the only two of these formulations that actually have J codes that you can bill for. PRP has a T code, which is a tracking code. Now, you certainly can use it, but it's got zero RVUs, so you're not going to get paid for it. The coverage for all these orthobiologics is really carrier-dependent, so you need to consult your carriers, have your offices consult your carriers for their various rules concerning the utilization of all these treatment options. And if you determine that their coverage treatment is a non-covered entity, then you can bill fee-for-service for that. In general, what you need to do is have the patient sign an Advanced Beneficiary Notification, right, an ABN, and that really codifies the fact that this is an experimental treatment and that it's not covered, and that the patient is willing to pay out of pocket for it, and also that it's a waiver from Medicare so that you don't have to worry about Medicare coming after you and saying you can't take Medicare patients for a couple of years. This is also probably a best practice for all of your commercial carriers also. They may have their own determination about this, but you need some type of ABN or waiver liability whenever you get into these self-pay methodologies for orthobiologics. And it's dynamic, right? So unfortunately, it's changing all the time, and so on a yearly basis, you probably should reconsult with your main carrier so that you don't run afoul of compliance issues. This is what an ABN looks like. This is from the CMS website. I mean, you could download these and use them, or your legal department or lawyer could determine, you know, what forms you should use here. This is sort of boilerplate stuff, but something that you need to incorporate into the medical record. In the OR, this is different, right? In the OR, for CPT roles and for CMS, injections into the surgical site are considered part of the operative procedure, so you need to consider that. Standalone procedures for Medicare could be billed fee-for-service, and you need to once again consult your individual carrier concerning their roles. How do they consider injections of this type in regards to using in conjunction with surgical procedure? And if it's deemed, once again, experimental and non-covered, then, you know, you can bill them fee-for-service, but you need to be very transparent with the patient and let them know exactly what's going on, get an ABN, and then you need to also arrange with the surgery center or the hospital to make sure that the patient doesn't get doubly billed for these components, because they're already paying out-of-pocket once for the injection of the BMAC or the adipose tissue or the PRP. You don't want them paying again through the hospital billing system, so it rushed what they do, which is, I think, considered a best practice. They make sure that the hospital bills the practice for any kind of equipment that's used during the injection, and that way the patient doesn't get double-billed, because there's nothing that's going to frost a patient more than getting billed twice for, you know, a few thousand dollars. You need to find out exactly what documentation is necessary. It's a need to inform consent, explanation of the investigative nature of the procedure, caution for non-coverage, reference the ABN in your documentation, and then also a detailed procedural note, and this is, I think, going to keep you in compliance with these non-covered entities. There's great information on the web. All the main big carriers have coverage determinations pretty much on the website. This is where your office staff can get this stuff most of the time. There's also great information, believe it or not, on the CMS website on this, and you should be accessing this also. There's also some pretty good articles. This is one out of rush. It's already three years old, but I would refer this to you in the Arthroscopy Journal 2018. There's all sorts of good information in this article, not only in the efficacy of these treatment options, but also, I think, best practice billing arrangements, and they still hold up right now. And lastly, the Biologic Association is a consortium of ANNA, AOSSM, ICRS, and several other organizations, and if you're a member of ANNA or AOSSM, you're already a member of the Biologic Association through your affiliation with those organizations. Access this website, and there's all sorts of great information, not only on the, once again, the efficacy and safety of these treatments, but also the economics of it. So the thing that intrigues me about this is the potential of using cell therapy. Once again, we're going to use certain nomenclature and terminology. We're not going to call ourselves a stem cell clinic, but it's a cell therapy line, right? And a lot of practices are creating these as a separate business entity or a separate service line, much like you have MRI, PT, or an ASC, and basically, you can track it as an ancillary. You can track not only the economics of it, but I would suggest that you also check, track the clinical outcomes of it also, right, and become part of the data collection that we need to justify the utilization of these things. And then you can market it, and once again, you need to market this responsibly. It's not stem cell therapy, it's cell therapy. It's not regenerative medicine in any way, shape, or form, as you learned today. It's really a paracrine function of cell signaling, but there is significant anti-inflammatory and other good stuff that's going on in here. Some practices have a separate room. They have different, you know, a different setup with special chairs where patients can lie back, sort of like a bark lounger, and patient monitoring also. So what about specifics? Let's get into the specifics. So VSCO is sort of an orthobiologic, perhaps. It's covered by CMS, carrier-dependent otherwise, and may require pre-certification, obviously. For the billing, you actually use the injection code, the large joint injection code, or the musculoskeletal injection code, which includes the injection with the ultrasound, and then you amend a 25 modifier to your E&M code. That's for the first injection of HA. For subsequent injections, then you don't bill the E&M code. And then there's J codes for the VSCO too, and for each different VSCO product, there's a different J code. And obviously, this is something that your billing office has got to know. What about PRP? Not covered by CMS, so you can bill CMS patients with an ABN, right? Some are covered by some carriers, but not all of them, and usually, usually this is a non-covered service. I did an informal survey of people who are doing this throughout the United States, and they're charging anywhere between $400 and $1,000 to do PRP injections. If you use the T code for PRP, it's inclusive of everything, the harvesting, the injection, the preparation, everything. So you can't bill for other things aside that if you use that T code. And obviously, if you're doing this in the office and you do a significant E&M code, then you bill that also. And this is Codex, where all the CPT codes are, and you can see that this tracking code is specific to PRP. I've heard some people get up and say, well, you know, I bill the 0232 T code for BMAC. Well, it's not for BMAC. It's only for PRP. So if you use it to track your utilization of PRP, that's great. But it's specific for PRP, and it's inclusive. This is a pretty interesting study, once again, out of rush. They took all the randomized clinical trials of comparison studies between PRP, hyaluronic acid, et cetera, and then they converted those outcomes to utility scores. And then based upon the economics in the articles, they found out what they thought was the recommended price point for PRP injection, and it was almost $1,200. Pretty interesting little study, and sort of comports, I think, with what some of the pricing is. So for PRP in the office, you use the tracking code with an advanced beneficiary notification. In the operating room, you make sure that, once again, if you're using it with Medicare, I think best practice would be that you're not going to bill for it, right? Because you might get into trouble. But for private carriers, you use an advanced beneficiary notification or a liability waiver, and you make sure that the hospital's not going to double bill them, right? For BMAC, not covered by most commercial carriers or Medicare. The average charge in the United States is between $2,200 and $5,000 for a BMAC injection. And all these codes I've seen on the right have been suggested for utilization in this procedure, and none of these codes, none of them are apropos for what we're considering when we're using a BMAC aspiration and an injection into a joint. So that's really going to be an unlisted code, the 20999 code, with an advanced beneficiary notification. And similar to a PRP, once again, you just make sure that the hospital's not going to double bill them for that equipment. Similarly, for adipose, not covered by CMS or commercial carriers, and this is the average price in the United States, $3,000 to $4,500. The code that some people were using is 20926. That was in, it was also inappropriate, but they got rid of that code, I think, two or three years ago. And they instituted these five or four new codes, and you can see the RVU values that are associated with them. None of these codes listed here, and none of them is appropriate for what we're considering using adipose for in regards to treating osteoarthritis. So since that's the case, it's also an unlisted code, once again, with the ABN, and similar protocol as per BMAC or PRP. So in summary, orthobiologists are, they're in demand, and it's an unmet need. Patients are demanding these treatments, and I think it's part of our job to educate them as to the potentials of these treatment modalities, and also the fact that we're not really regenerating anything, but we're helping, we're just creating maybe a better environment in the joint for symptom modification. Know the rules and regs, especially with the FDA. You know, when I first did this talk, I made the talk about three or four months ago, I had amnion in here, right, because some guys were using it, and it was sort of really off the radar, but now the FDA has really come down hard on that. So I really just took it off, because that's something I don't think we really can be talking about in a compliant fashion right now. And be transparent, and treat this as a service line, and also as something that we need to follow scientifically with some outcome data collection. And thank you very much, and if anyone has any questions, I'd certainly be willing to answer any right now, and try to give you the best information. Yes? Yeah, I think it's, you can get a boilerplate template, I mean, I don't have one, so I have, since last year, I've sort of not doing clinical medicine anymore, but you know, when I was, we just had a boilerplate template, and it listed, you know, risks and benefits just like a surgical procedure. The fact that it's an uncovered experimental treatment, right, patient recognizes that, recognizes that it's not covered by the insurance company, and that they're going to pay out of pocket, and that, and it's just, you know, if you're really concerned about it, I could, just I would go to your legal, and see what they, you know, how should we, how should we craft this document to, you know, to best protect ourselves. Yes? Well, if it's a Medicare patient, I wouldn't, but obviously this is not going to be a Medicare patient, right? If it's a private pay patient, I would reference the policy of that specific carrier for utilization of injection therapies like this in conjunction with surgical procedures. If it's determined that it's a non-covered service, then you can bill self-pay for it, but you need, once again, I would still protect yourself with some kind of advanced beneficiary notification. And yet, so yes, you could. Yeah, go through that same, those same steps, and that way you'll be above board. What you, most of the time, what's going to happen is that it's going to be a non-covered experimental service, and yes, then you can bill fee for service for it. All right, well, I hope you guys have enjoyed the meeting as much as I have. It's really great to be back, and I hope that the rest of today and tomorrow are beneficial for you. Thank you.

orthobiologics

osteoarthritis

billing

clinical outcomes

cell therapy