My disclosures on the AOS website. So, you know, this is an exciting arena for a number of reasons. Certainly the scientific and clinical aspects are really appealing. But it's also, you know, it's also a business opportunity for us as orthopedic surgeons, because this market is huge and growing, right? So it's about $10 billion a year between eight and, you know, I've seen even 15 billion a year worldwide, growing significantly every year between study site eight to 20% compound amyloid growth rate and it's a global market. And, you know, if you look at the disease burden, especially of osteoarthritis, currently there's about 45 million people in the United States with osteoarthritis. That's gonna grow to 78 million people in the next few years. We do about 1.3 million total joints a year now. That's gonna go to 4 million in 2030. It's about $450 billion a year. So this is a real unmet need and the patient populations that are going to request and desire these treatments is gonna grow significantly. And if you also marry that with what's happening with our reimbursements for our traditional treatments of total joint arthroplasty and arthroscopic treatments of osteoarthritis and other tendinopathies, et cetera, this is a chance for us to sort of regain ground from an economic standpoint, which is really necessary for us. And so in regards to this, if you're going to use these treatments in your office, you really need to pay attention to the rules. And there's some things to consider. And the first thing is whether it's a government payer or a commercial payer, because the rules are different for each and we'll go over that. Is it in the office or the operating room? Because the rules are different for that too. And if it is in the operating room, did you do it as a standalone procedure or it was done in conjunction with another procedure such as a rotator cuff repair or other CPT code service? So the general rules in an application in the office are that only intraarticular corticosteroids and hyaluronic acid have formal GA codes for billing. So those are the only ones you can code for that. PRP and MFAT now have tracking codes, category three codes, that are used mostly to track utilization. They have zero RVUs, but you can still report them when you use these entities. And the coverage for these is really dependent on the carriers and dynamic. So some carriers cover them, some don't, and that changes over time. So you need to pay attention to whatever it is that the Aetnas, the Humanas, the UnitedHealthcares are doing in your area so that you're compliant with their rules. And if they are non-covered or experimental services, you can bill for them fee for service. If you're gonna do that in the office, you really should have them sign what's called an advanced beneficiary notification, especially if that's absolutely necessary for Medicare patients. But probably in an abundance of caution, you should use it for other patients also, or a waiver that you can construct in your office so that the patients document and understand that this is a non-covered service, that it may be considered experimental, and they're paying for it out of their pocket, and they acknowledge that. You need to consult with the individual carriers for their rules regarding this kind of documentation, and also for the need of advanced beneficiary notifications and any kind of documentation they require for the patients also. And once again, dynamic, and you need to revisit this. So this is something you can get right off the CMS website, this advanced beneficiary notification. You can do your informed consent with the patient and have them sign it. In the OR, the rules are a little different. For CMS and CPT code rules, injection of substances into these areas after a CPT code service are included in the operative service. If they're done as a standalone procedure, in other, if you took the patient to the operating room and did a bone marrow aspirate alone into the knee, or did a liposuction and injection OT as a standalone procedure, that can be billed free for service depending on coverage. Once again, you need to consult your carrier on that. And if it is deemed an experimental or non-covered service, you can bill free for service, but you need to make it clear to the patient they're gonna be paying for it, and also you need to have clear lines of payment methodologies in the center that you're working, and you don't want the patient to be billed doubly for the procedure. So, for example, Brian Cole at Rush in Chicago, what he does is their practice actually pays the center and then bills the patient, so the patient doesn't get billed twice. And you need to document this with informed consent. You need to explain the investigational nature, the reason that the entity is not covered. You need to reference that advanced beneficiary notification. And you should have a detailed procedure note. You certainly can do this in a canned fashion. So, these are ways that you can access each coverage determination by carrier on the internet. There's also a lot of good guidance in the CMS website. Actually, that's a really good place to get some information. This article that was written by the group in Rush, it's 2018 now, but it's still very relevant, and I would recommend this to you if you are going to use these in your office, because it not only goes over the science behind and the mechanisms of action, but it also goes over billing practices too. And then the Biologic Association, their website is full of all sorts of tremendous information on this topic. And also, it's fairly current too. So, all of the talks from various courses are uploaded on a regular basis. So, what if we considered doing this in our office? A lot of people that I know have done it, considered as a sort of an ancillary service. And they have a separate cell therapy business, right? We don't call it stem cells, but rather cell therapy, which they track it as a business. They establish a biologic laboratory, because as we've heard from both Steve and Jason, we need to actually characterize these substances that we're treating patients with. We need to know the platelet concentration and other things so that we can properly characterize it. And we should probably collect some kind of data in that regards, and also outcomes data so that we can track how patients are doing. You can have a specially designed room with special chairs that can recline and be used for different procedures. And then you can certainly market it, but if you do, you need to be very careful and pay attention to all the things that Steve talked about in regards to the FDA and using certain buzzwords. And you can't really claim that this is regenerative therapy. You can't really claim that they're stem cells, and you really need to watch out with patient testimonials. So what about some specific recommendations? So we're gonna include viscose supplementation here in the biologics. I use this extensively in my office. It's covered by CMS, and it's carrier dependent for other insurance companies. It may require a pre-certification, so you need to know that. If you bill it, you bill a standard injection code, a 20610 code, that's a major joint injection code. If you use ultrasound guidance, you use the 20611 code. You report an E&M service if you did real work prior to the injection, but don't report that E&M service for subsequent injections because there's already work in that CPT code, in 20601, that has some pre-service and post-service time. And then you bill the J code from out of your office. And these are the various J codes for all these hyaluronic acids. And you know, stocking will be practice dependent for your buy and billing procedures. PRP, it's not covered by CMS, covered by some insurance carriers, but very rare. A very, a survey that I did last year on what various orthopedic surgeons were charging for this was between $400 and $1,000 for a PRP injection for fee-for-service. The tracking code is 0232T. The code is inclusive of the harvesting, image guidance, and the preparation. So if you use that code, you don't bill any other codes. And you, once again, bill an E&M service if you performed a significant evaluation and management service prior to the injection. I've seen some folks recommend that you use 0232T for other types of injections. It's really specific to PRP alone. This is from the codex. And you can see that 0232T is really for PRP only. This is sort of an interesting study that the Rush Group did. They took randomized clinical trials and converted the outcomes to the utility scores. And then based on those, what the various treatments should cost. And they found that the price point for PRP should be about $1,200. And thought this was a really interesting way to look at this. So sort of if you're charging in this, there's some justification for this in the literature. So in the office, 0232T, an advanced beneficiary notification. In the OR, the same, but make sure the hospital or ASC will not double bill the patient. If it's a CMS patient, do not bill them, right? Because that's included in this CMS service for Medicare patients. How about microfragmented fat? It's not covered by CMS or commercial carriers. The price point throughout the United States is between $3,000, $4,500. There is a new T code for this, 0565T. It's inclusive, once again, of all the harvesting and preparation. So there's a separate code, 0566T, for ultrasound-guided microfragmented fat. And once again, if you do a significant E&M service, you can bill for that also. So in the office, 0565T or 0566T, and an advanced beneficiary notification, or in the operating room, the same. And once again, make sure the hospital is not gonna double bill, or the ASC is not gonna bill. Do not bill CMS patients for that. BMAC, not a covered service, charged between $2,200 and $5,000 across the United States. I've seen all these codes on the right, recommended for BMAC, and none of them really describe what we're doing. So I would not recommend using any of these codes on the right, but rather an unlisted code, 20999, with an advanced beneficiary notification. And once again, in the operating room, the same thing, but make sure the patient doesn't get a double bill, and don't do it for CMS patients. So in summary, orthobiologics are really going to be increasing demand as we get more granular and more specific about what we're treating in regards to arthritis. I mean, that talk by Jason is great. I mean, all arthritic patients are not the same, all cuff patients are not the same. We're really gonna be able to get down into specific treatments for patients, which is really one of the very exciting aspects of this. So the need's gonna go up. It's really an opportunity for us, both clinically and economic, but really you need to know the rules because you can get into trouble, not only with the billing of these things, but also with the FDA. And so be transparent, document, and follow your outcomes. Thank you very much.

orthobiologics

orthopedic surgery

business opportunities

osteaoarthritis

regulations