So, lastly, Brian Cole's got a lot of expertise and thought a lot about the cost issues, the economic issues, which are obviously very important. So, Brian, thank you. Thanks, Scott. So, all you have to do is do one lecture on business and billing, and you get asked forever to give this lecture. It's not like years ago I asked Ken Zaslav to give a talk on rehab, and this is payback, because for 10 years, he only talked about rehab and osteoarthritis, so here you go. So, I think it's already been emphasized that we have millions of young people who are looking for alternatives to arthroplasty, and then we have millions of soft tissue injuries that are often associated with a degenerative or a dystrophic phenomenon, such as rotator cuff disease that is begging for some change in biology, so clearly there's some need. I guess the question is, are we actually meeting that need? As you've heard, demand is clearly driving the supply. I think we've all had patients come to our office asking for new cartridge, or they want to fix their rotator cup with some type of magical injection, so we spend a lot of our time deemphasizing what it is and what it is not, and to that point, if we turn to what's in the public domain, language is often very imprecise, and I would argue does exploit the vulnerability of our patients, and often very desperate, because they have debilitating disease. We recently finished a study in our region, querying various clinics, both orthopedics and non-orthopedics, and it was interesting how the non-orthopedic segment, which was often PM&R, primary care, and so forth, most commonly used still the term stem cells, still offering amniotic tissue as of recent as three months ago, and pricing structure for them, which I'm not presenting that data, we'll present that soon, was about 40 to 50 percent higher than the pricing that was used by orthopedic surgeons, so there is a dichotomy, and the question, and maybe it's a question for the VA, is how do we continue to sort of police ourselves and educate people? And then I think the other issue that often gets deemphasized is are we really regenerating anything? And this is one of the most important things in that narrative you have with your patients, because that's their perception they've seen, upside-down pictures, unbeknownst to them, on airline magazines showing regeneration of joint space, and that's what they want, and I think the real issue is if you want to explain it mechanistically, I think arguably there's a lot of things we don't know, and then the things that we do know is it may be more of a paracrineal local growth factor effect, but nothing that we do today, in my opinion, is truly regenerative, and that's something that's deemphasized, and we also deemphasize the role of cells in this therapy to really explain what it isn't. This is old data, but this trend has actually continued in terms of just monitoring CMS and other areas where there still continues to be a rise in the implementation and recommendations of Medicare patients and insured patients overall, as well as the economic burden, so it's very real in terms of its utilization. How does it work? This is a great Friday clinic where people come in because, like Bill Bugbee said, I am a surgeon, but we do a ton of non-surgical treatment, so this is a joke my PAs did. They thought it was cute. That's not how my clinic runs, but at any rate, it's an anabolic or it's an anti-catabolic molecule that may modify the arthritic or healing process, and that's the joint as an organ, so to say it attacks one specific as one specific mechanism of action is probably very short-sighted. We've published a lot on trying to provide overviews and updates, and this is something that really has to be almost done yearly, but within this journal, we had an article on billing practices, which you might find useful. So where is it used, and how do we talk about it with our patients? There's three surgical areas as an adjunct to surgery. One is we and others have shown that by CT scan and even clinical results, it was alluded to that concentrated bone marrow aspirate with an OA graft, by hydrating the graft after irrigating it, has been helpful at six months and one year. We recently published in this month's AGSM, it was a randomized double-blind study using concentrated bone marrow aspirate with, well, rotator cuff repair with and without concentrated bone marrow aspirate, and we showed statistically significant improvements by MRI at about a 25% improvement in healing and actually showed some clinical outcome points in PROs that were better, which we can't really explain at this time fully. And then finally, with ACL allografts, we showed when we used the patella tendon as a surrogate for ligamentization, we showed at three months, they actually looked more similar to the patella tendon when soaking the graft in concentrated bone marrow aspirate. So is this dispositive that they work? No. I would say that it's still incumbent upon us to continue to investigate this. Like Bill Bugbee, I would say, for me, a dominant treatment strategy after cortisol and HA, it's the use of three injections of PRP with a high molecular rate HA, and we put the HA through insurance, and we put the PRP through that self-pay. And related to educating your patients about self-pay, so we have videos, and we, you know, I had this approved informally by Scott Bruder, you know, just say, Scott, where have I screwed up here? And what we've done is to really sort of, as I say, we mentioned nothing about stem cells. In fact, we tell them that this may have nothing to do with stem cells in the way we currently utilize them. There's some areas that we do use it for conditions, but the data still remains inconclusive, and we undersell it. And despite underselling it, and we de-emphasize, as I say, the word, you know, stem cells, we say, what do you think? Oh, well, I've read about stem cell therapy. I really want this. You know, in fact, they want it more than they want to pay their co-pay. So it's very, it's a difficult narrative to have with patients, but spend a lot of time, at least face-to-face, de-emphasizing it, and I'm not going to play this, but we use patient education videos and things like that as well. So when you get through the process of speaking to your patients in the office and telling them what you think it is and what it is not, how do you actually build this? What's the business of orthobiologics? So corticosteroids and HA are generally reimbursed, but there still is about 15 states that have non-coverage decisions for HA. We actually go through the pre-certification process for HA for most payers right now, and within two weeks, patients have to inconveniently come back to get the injections. PRP, bone marrow, aspirate, and adipose are considered investigational and unproven benefit, and third-party payers will not reimburse for the procedure using a CPT code or the substance injected. So that's the first takeaway that's important. Medicare considers these as non-covered services, and the advanced beneficiary notice, which you can get from the Medicare website, I'll show what that is, it's not required, but it's considered as best practice. And keep in mind that just because new technologies that you're seeing come on the horizon are approved by the FDA, it doesn't guarantee reimbursement. So there's two places you would consider billing patients or the insurance carrier for these procedures. One is office-based, the other one's an adjunct to surgery. And as an office-based, it could be free for service for all payers. In the surgical setting, if it's a government payer, then in general, it follows the NCCI. That's the National Correct Coding Initiative. And those patients, really, that's a procedure that's inclusive of the surgical procedure. Non-government payers, you can treat as office-based care. So the ABN, this is just our example of the ABN. We combine it as a consent, a financial obligation, and acknowledgment. And basically, if you take Medicare assignment, you've agreed not to charge the patient out of network from Medicare or a government payer. So this is basically a workaround that involves informed consent, so patients understand that this is not a pocket expense that is not being covered, and it's within the rules and guidelines. Again, like Scott, I'm not an attorney, I'm not a coding expert, but that's what best practices recommends. And then, as proper documentation, again, that monograph on PRP, we included this article, and this is still completely consistent today. Informed consent, explain to the patient in the electronic health record the terms of government programs, reference a advanced beneficiary notice with a non-coverage language as a non-covered benefit. And then, we do a step-by-step procedure note. In the office or in surgery, just check the policies, follow the coverage guidelines. If there's no coverage for an offer or policy to the patient, that helps to support the notion that it can actually be self-paid. Again, we have them find best practices, advanced beneficiary notice. That can be gotten, you can obtain that in the Medicare website. And then, you can bill the patient for the procedure, the substance, and the injection, and the guidance, all in one CPT code or a non-CPT code. But when it comes to PRP, everything's included, because that is a tracking code. So, the purpose of the tracking code is actually a surveillance code that, in theory, ultimately would be converted to a level one CPT code, but it's probably never going to happen. But the objective was for Medicare to actually sort of evaluate the utilization of PRP with the tracking code. So, what about as a surgical adjunct? CMS and those that follow CMS policies, if it uses an adjunct, the injection is generally considered inclusive of the surgery by the NCCI, and you should not be billing it. Now, there are some of these things that have identified CPT codes, like you see here, but most of these don't fall into play for the things that this audience is probably likely to be doing. If it's a contracted provider and a surgical adjunct, they may not be following CMS and NCCI guidelines, so you can actually treat this group financially, just like you treat the office-based patients who are either CMS or private care. So, there is a distinct difference when you're billing in surgery versus in the office. All right, what about pricing? So, I mentioned to you that we just recently completed a study on pricing and how the forward-facing narrative goes for surgeons and non-surgeons in our region. We also looked at the pricing of PRP as a utility analysis and basically showed, based upon the utility of these substances, the fair market price for HA would be about 500 bucks, and the fair market price for PRP would be about 11 or nearly 1,200 bucks. So, in the surgical setting, what we do is we will bill the patient in the office, and then we have the surgical facility bill our office. So, it's a nuance, but patients get overwhelmed by numbers of bills, very confusing, and often the hospitals and surgery centers don't really know how to handle it, and you get a lot of frustration. So, what we do is we say, hey, this is the fee up front, and then we have the surgery center invoice us for just the capital equipment, if that makes sense, and that's made it really clean. So, in conclusion, you can see how we use it both in the office and non-office. There is some data for concentrated bone maraspirate supporting in osteoconagrafts, rotator cuff repair, and even ACL surgery now. Adipose has some data in OA and RCR, but I think we're still working our way through it, as we are with these other agents. I do think that biologic surgery is probably going to dominate, at least in this setting in this room, the clinical adoption curve, and as has been said time and time again, really got to follow what's happening in the FDA, a la amniotic allograft tissue today. Thank you very much. Thank you.

orthobiologics

regenerative medicine

stem cells

patient education

billing challenges