Well, it's great to see you all here this morning, and we thought that we'd probably have about five or six people here, so this is great. I'd like to thank Nick and Kevin and Steve and Brett for putting on a wonderful program. I mean, I don't know about you, but this has really been more of a celebration than a medical meeting. So, orthobiologics are fascinating on a number of levels. You know, certainly clinically, as a way to help our patients heal, but also as a business opportunity, and that's what I've been asked to talk about. My disclosures are available on the web, and none are pertinent for this talk. So the market here has been estimated to be between $4.5 and $10 billion, and growing at a compounded annual growth rate of about 15 to 23 percent, depending on who you read. I mean, that's amazing, right? It's a global market, too, because what's happening is, as you know, is the incidence of osteoarthritis is doubling, almost doubling over the next few years, and we're doing like a million total joints now. It's going up to four million in the next few years, and, you know, we take care of these patients, and many are reluctant, very reluctant, to get a total joint, and they'll do just about anything to try to not have one, so these therapies are in great demand. And if you think about what's happening in our surgical treatments for osteoarthritis, both the arthroscopic and arthroplasty versions, they're on a 40-year trend of decreasing reimbursement, right? So we have this problem here where we're being squeezed, and this is obviously a business opportunity for us, because many of these modalities and treatments are cash pay, and people are really using them as an ancillary service. So there's a couple of considerations to keep in mind if you're going to use orthobiologics. One is the patient a government or commercial payer patient? Are you going to be doing this in the office of the OR? And if you're doing it in the OR, is this an adjunct to a surgical CPT procedure? In other words, are you doing a rotator cuff repair and using BMAC in addition to that? Because there are some rules that guide that. In general, in the office, we certainly only have codes for intraarticular steroid injections and hyaluronic acid. PRP has a T-code, which is a tracking code, has zero RVUs attached to it, so you certainly can report this, but you won't get any reimbursement for it. Coverage for orthobiologics is really carrier-specific, and we need to be on top of this, and it's obviously changing rapidly, too, so it's something you have to revisit every once in a while to find out exactly what your carrier's policy is regarding these treatment modalities. If it's determined by your surge that these are non-covered services, then you certainly can bill fee-for-service for that. You basically need to have the patient sign what's called an advanced beneficiary notification, which alerts you and them to the fact that you're performing an experimental treatment that is not covered by insurance, and that the patient understands this. You can use an ABN for CMS patients. There are other waivers that you can use for your private pay patients, but some practices, as a rush, they get an ABN on everybody, I believe, and I think that would probably be considered best practice. Once again, you need to consult your individual carrier regarding their policy in this regard. This is what an ABN looks like. This is off the CMS website. It's pretty much boilerplate-type legalese, but something that protects the relationship here because, obviously, you don't want to affect your relationship with being able to take care of Medicare patients because you're billing outside of the Medicare system. In the operating room, CPT and CMS rules say that injections at the time of a surgical procedure are inclusive, so you need to remember that. So standalone procedures for CMS could be billed as a fee-for-service, but you might want to consider not doing that for a CMS patient if you're doing an adjunct surgical procedure. Once again, you need to consult the individual carrier regarding their policies, but most of the time, these carriers are not going to cover this, and it's considered a non-covered procedure, so even as an adjunct to surgical procedures, you can charge fee-for-service for it. You need to make it very clear to the patient that it's experimental and it's not covered, and you also have to have a good policy with your hospital so that the patients don't get double-billed. In other words, make sure that the hospital doesn't bill the patients for any of the equipment that you use in doing this. Some practices who do this have the hospital bill their practice because the practice is billing the patient for the procedure. You need to document this. You need to reference your policies, once again, from your carriers individually, but it's good to have all these different parameters in here just to make sure that you've explained to the patient the ramifications of these types of treatments and that they understand that it's outside of the realm of their insurance coverage. There's all sorts of good information on the web. This is the Aetna website in regards to their policy for the coverage of orthobiologics, and CMS website's actually pretty good, too. They have some good information there. Then there's articles. This article came out of rush. It's actually three years old now, but it's still very germane and up-to-date, and I would recommend it to you in the Orthoracic Journal of 2018. Another great source of information here is the Biologic Association, which is a consortium of specialty societies, including AOSSM and ANA, and if you're a member of either of those associations, you're automatically a member of the BA, so I suggest you get onto the website here. There is an amazing amount of great information regarding not only the efficacy of these treatments, but also the economics. So I'm intrigued by this because I would consider this a service line, and we're going to use the proper nomenclature here. It's a cell therapy service line, and to Donny's point, he has a lab here, so he has a hematology analyzer. It's actually a setup, right, and this is what a room might look like for your orthobiologics. Some people have these specialized independent rooms for this, and you basically treat it as an ancillary. You track your outcomes. You track your economics, and you market it. You can market it, and if you market it in a responsible fashion, and you don't claim that you're regenerating tissue, but rather that you're just trying to help the patient heal, and you say that these are experimental treatments, then I think it's certainly ethically okay to do that. So how about some recommendations on coding? So we all treat VSCO patients. It's covered by CMS. It's carrier-dependent. It may require pre-certification, and use your injection codes there. If you use musculoskeletal ultrasound, use the 20611 code. You append your E&M code with a 25 modifier, and don't report E&M codes after the first injection. All the VSCOs have a J code. That's how you get paid for the substance itself. What about PRP? It's not covered by CMS, covered by some carriers, but not many. Most carriers do not cover this, and my informal survey of people who do this throughout the country put these price points here between $400 and $1,000 for this treatment. The T code is 0232T. It's an inclusive code, so if you charge this, you're basically charging for all the things you do with the PRP, including image guidance. And if you do significant work, I think you could still code an E&M code. But once again, since it's a non-covered service, even if you charge the 0232T, you're still going to have to bill the patient outside of their insurance coverage for that procedure. Here's the CPT code book codex, and as you can see here, the 0232T code is specific to PRP only. I've seen some people recommend that you charge these codes for BMAC and adipose tissue too, but that's not correct. This is only for PRP. And this is a really interesting article. The Rush Group put this out. They basically took all the randomized clinical trials on PRP. They converted the outcomes to utility scores, and they came up with a price point of almost $1,200 for PRP. I thought that was an interesting way to look at this issue. So PRP in the office, you code the 0232T, you use an advanced beneficiary notification, and you make sure the hospital won't double bill the patients. BMAC, between $2,200 and $5,000. There's no codes here that are specific. Basically it's a 20999 code, ABN, and once again, the same thing. And with adipose tissue, it's the same. This is what they're charging throughout the country. There are no codes, and you charge the 20999 code. So in summary, orthopedologics are in demand. They represent a clinical and economic opportunity. Know the regs, right? Know what FDA is saying, and be transparent, and document, and follow outcomes. Thanks very much.

orthobiologics market

therapies in high demand

coding guidelines

coverage and reimbursement

documenting outcomes