In this episode, hosts Brad and Michael along with guest and partner Jay Reyero, explore the critical role of compliance when adding anti-aging services like exosome therapy to your practice. They break down how legal business structures ensure the right person makes medical decisions, who can approve new treatments, and how FDA and medical board regulations shape treatment offerings. Tune in to learn the risks of non-compliance and how to protect your practice and patients.
Listen to the full episode using the player below, or by visiting one of the links below. Contact ByrdAdatto if you have any questions or would like to learn more.
Transcript
*The below transcript has been edited for readability.
Intro: [00:00:00] Welcome to Legal 123s with ByrdAdatto. Legal issues simplified through real client stories and real world experiences. Creating simplicity in 3, 2, 1.
Brad: Welcome back to another episode of the Legal 123s with ByrdAdatto. I’m your host, Brad Adatto, with my co-host, Michael Byrd.
Michael: As a business and health care law firm, we meet a lot of interesting people and learn their amazing stories. This season’s theme is Compliance Fundamentals. We’ll take real client stories and of course, scrub their names, and we’ll build these stories around navigating compliance obstacles in the business of health care.
Brad: So far, we have been talking a lot about compliance this season. But Michael, tell everyone that wants to know what does that mean?
Michael: What does that even mean? It’s a broad word used to describe kind of all the state and federal laws that govern the practice of medicine or other healthcare practices. As we’ve talked about, health care is one of the most heavily regulated industries [00:01:00] in the United States, so compliance means that you are running your practice consistent with these various laws.
Brad: Absolutely. As we always say, compliance is not stagnant. Well, Michael, for the second time this season, and for those watching us on TV land, you’ll notice our series regular and partner Jay Reyero is with us. Jay, what’s the subject for today’s story?
Jay: So today’s story, we’re going to dive into compliance fundamentals surrounding anti-aging.
Brad: The anti-aging topic kind of reminds me of an episode back in season 13. We had Dr. Jonathan Kaplan on. He joined us and discussed compounding semaglutide. On that show we were talking about how people are really pushing the boundaries of what is possible in the world of longevity, or I guess anti-aging and health and how much money you could spend on it.
Michael: Oh, yeah, I remember. Brad, I know especially the people on YouTube watching us on video know this. I’m not sure you should be here today. I mean, you’re so pro-aging. I don’t know if you are going to be [00:02:00] trustworthy to talk about this. But I will say from that episode, I remember talking about the story of Brian Johnson, the tech mogul from California. He was the subject, I remember the article was that, “How to be 18 years old again for only $2 million a year.”
Brad: Yeah. Lucky for us, we can act like 13-year-old boys most time and it doesn’t cost us anything. I mean, maybe our reputation in the street. But as an update to the Johnson story, a new Netflix documentary just came out called “Don’t Die, the Man Who Wants To Live Forever,” which is all about Johnson and his reverse aging or anti-aging quest. Have either one of y’all seen it?
Michael: I have not seen it. I have noticed him showing up in the news more and more lately and notice that he’s still going full biohacker mode, trying to fight aging with all sorts of crazy science.
Jay: I have not. I add it to [00:03:00] my list and I would say I’m dying to see it, but I know the dad jokes are reserved to Brad.
Brad: Yeah. That’s my territory, Jay. The doctor memory for those that don’t know, it’s an inside look of how he’s pushing these boundaries on science and medicine. He is not just doing one or two things to slow down the clock. He’s doing everything. We’re talking about some crazy regimens on treatments and diets and exercise and other routines, even to the point where something that sounds like it’s out of a horror movie; doing blood transfusions with “young plasma.”
Jay: Yeah. I think this whole routine and regimen has a name, it’s called the Blueprint Program. He takes over a hundred supplements in different forms a day. But the craziest part is that plasma, it’s a multi-generational plasma exchange. He got plasma from his son, he gave plasma to his dad.
Michael: I did not have on the bingo card the word multi-generational plasma exchange.
Brad: No, it was not.
Michael: Have you ever used that word before?
Brad: Never.
Michael: [00:04:00] Okay. And just to think we can watch it all unfold on Netflix if we want to. Let’s also not forget he’s not just experimenting on himself. He has a whole team of doctors and scientists under his, I guess, employee that is backing him up. It does make you wonder, “Are we at the beginning of something bigger here? Is this some sort of the real future of longevity treatments?”
Brad: Maybe. As another update, he is no longer using his son’s plasma. He has upgraded to total plasma exchange. Here’s what total plasma exchange means; removing all of the blood from the body, which sounds like a bad thing, and then separating the plasma from the blood. They’re replacing the plasma with some type of supplement that I can’t even say – I don’t even know how to pronounce it – with basically 5% of his plasma. As such, there’s no more young blood was harmed in the making of this anti-aging man.
Michael: I have no idea what you just said, Brad. [00:05:00].
Brad: I have no idea what’s going on either.
Michael: I do feel like he is about to become a Marvel character.
Brad: Best part. I like that. Best part though is he is offering now to give away his plasma for those who want some.
Jay: Hard pass. I think I’m good over here.
Michael: I guess the theory is that his bad plasma is better than our plasma that we have. I don’t know. But I know Brad has plasma that contains 5% Tito’s vodka, which does give you your own superpower. I know, Brad, you don’t want to lose all your years of training.
Brad: That’s correct. I do not. I mean, my blood to Tito’s ratio makes me immune from most viruses, so yeah, I don’t want to give it up. Do you know what Johnson’s 2025 New Year’s Resolution is?
Jay: I’m going to assume not dying. That’s the title of the documentary.
Brad: I like that. I’m sure Vegas has some sort of pool going like a dead pool where you get to bet on how long he lives.
Michael: I did see a quote that made me laugh. It’s so not shocking, [00:06:00] that he’s always hungry. I have this picture in my brain of him breaking at some point and going on a world class bender.
Brad: In Vegas, probably, that’s all you can eat buffets. So right now he says that he is at point 0.57, meaning that his birthday happens every 21 months. He think he can get to every 24 months, but love to achieve “age escape velocity,” which again sounds like a very scientific term, meaning that every 12 months he’s the same age.
Jay: All right, Brad, I know you like sports, so this sounds like probably your dream – Science fiction, meaning the NFL combine. When I think about it, my aging speed, three daughters, one a teenager, I’m thinking more zero to 60 is probably more my aging speed, depending on the day and the hour.
Michael: That’s true. You do raise a good point because you can do all this stuff and life can get in the way and age you really fast. [00:07:00].
Brad: Yeah, no doubt. Honestly, I think we said this before, this routine sounds awful, painful and boring. So I do hope he finds some joy in his starvation and in his life.
Michael: Alright, well let’s get into today’s story, Jay. What do we have today?
Jay: Yeah, so let’s get started. So today our client is an entrepreneur. He’s the founder of a med spa here in Texas. Let’s call this med spa Blueprint Aesthetics and we’ll call our client today, Mr. Button.
Brad: Alright, excellent. Based on our pre-story on Project Blueprint, calling the client Button, I believe Jay is bringing a movie reference into Benjamin Button. For those who don’t know, it’s a movie that Brad Pitt plays Benjamin Button, who is born as an elderly man and then ages in reverse.
Michael: Okay. I’m just glad we’re keeping the streak of you guys doing movie talk every time you’re together. You’re not even tricking me this time.
Brad: Yes, I’m okay with it, Jay. Our audience all know that one of the first foundational areas of compliance is the corporate structure, [00:08:00] and here in the great state of Texas, we have to deal with CPOM or Corporate Practice of Medicine. Just to get out of the way, how do you correctly set the MSO model, Michael?
Michael: Okay. Well, you did define one acronym and then you just dropped the MSO out there without talking about it. You alluded to CPOM. Most people don’t live in your little compliance bubble, Brad, so why don’t you talk a little bit about what do these terms mean?
Brad: Yeah. So CPOM means Corporate Practice of Medicine and MSO stands for Management Service Organization. The MSO is the model that we recommend in CPOM states where you can allow non-physicians to participate in the managing and oversight of a medical practice. But I’ll keep that very brief.
Jay: So yes, Brad, to answer your question, Mr. Button had everything buttoned up with an MSO. [00:09:00].
Brad: That was well done, Jay.
Michael: Jay, I thought we had a pact, knocking egg Brad on. Okay, no more Dad jokes.
Jay: Well, Brad paid me and told me to appeal to his demo. Okay, so Blueprint Aesthetics was your standard med spa. It offered a limited suite of services; injectables, microneedling, intense pulse light or IPLs to speak to Brad. There it had your typical staffing. You had estheticians, it had registered nurses, it leveraged telemedicine, which you guys spoke about a few weeks ago.
Brad: Yeah, we sure did. We had a great show with Paulina from, for those who don’t know, the CEO and founder SpaKinect, join us to talk about the utilization of telemedicine in this space.
Jay: Yeah. And so I had a call with Mr. Button because he was having a difficulty with his medical director. Let’s call the medical director Dr. Brian.
Michael: Okay. Well, it’s y’all’s movie talk meets our pre-story talk. I’m guessing Dr. Brian is Brian Johnson, I’m assuming?
Brad: [00:10:00] Oh, wow. Yeah, Michael was paying attention.
Michael: Yes. What was going on?
Jay: All right. So Mr. Button had been spending a significant amount of time researching about the revolutionary fast growing area and advancement in anti-aging and longevity treatments. He really felt that this was a new wave that he wanted to get on early, that he was going to get in early, ride this wave turn, Blueprint Aesthetics into what he thought would be the premier anti-aging longevity practice in Texas.
Brad: Yes. Sounds like a great opportunity. And from a movie talk perspective could be our next Netflix documentary that we could talk about.
Jay: Sure, it could, and Mr. Button specifically, what he wanted to capitalize on was this one particular trendy service that was just coming out, a novel treatment. and it, it was called exosomes.
Michael: Yes. An audience. I unfortunately drew the short end of the stick and they told me pre-show I was going to have to explain exosomes, [00:11:00] so I did get my trustee assistant, Siri, to help me so that I can – the audience would quickly know anyway because I don’t speak so scientifically. So exosomes according to Siri, are lipid spheres released from cells that carry genetic information and protein to other cells. And they’re involved in numerous biological processes and cell functions. So, there’s research out there that would suggest that their potential benefits in include stimulating desired responses through an exosomes stored information. Can you say that back to me, Brad?
Brad: No.
Michael: It was like science talk. So most med spas that are trying to get into the exosome market view it as a treatment for beauty enhancement. In other words, they believe it can improve things like complexion, revitalize hair and hair growth, increase collagen and elastin, [00:12:00] reduce acne breakouts, improve scar appearance, boost collagen production, sagging skin, and things like that.
Brad: Okay. Michael, that was a lot of information. Thank you, Siri. And thank you for reading, I mean, for memorizing that beforehand. I’m glad you did a good job explaining that vocabulary word. So Jay, what specific problem was Mr. Button encountering now?
Jay: Before I get to that, didn’t you just have picture him as Will Ferrell, an old school where he just goes and then he’s like, falls apart? So yeah, so the problem was Dr. Brian was not familiar just as we weren’t when we first heard about it and had no experience with this particular type of anti-aging and longevity treatment. Never heard of it.
Michael: Yeah. It’s not good if your lawyer doesn’t know what it, but he at least can research it. And it definitely is not good if you’re a doctor and you have those treatments.
Brad: Yeah, and you don’t know.
Michael: But that does make me wonder, what was Dr. Brian’s background? [00:13:00]
Jay: Yeah, so Dr. Brian was an OB-GYN. Now, absolutely trained, experience, qualified with regard to all of Blueprint’s current services. He’d been offering these for years himself through his own practice. But this was the first time he had ever heard of this particular treatment since it was so novel. And if he was like me, he was probably asking Siri how to pronounce it as well.
Brad: Yeah. And you know, I can barely speak English, so you know I’m not going to do it. Don’t make me pronounce any more of those fancy words.
Jay: And this is where Mr. Button’s frustration was coming from. He was wanting to move quickly, he wanted to move fast, he wanted to get in on this novel treatment, ride the wave before anybody else was. He had found a supplier to obtain the exosomes, the paperwork was all ready to go. He had developed the marketing, the social media blast to promote it, even had some launch events planned. He was ready to go and Dr. Brian was kind of putting the break down.
Michael: Okay. So what was your conversation like?
Jay: [00:14:00] It was a very delicate balancing act. On the one hand, didn’t want to kill Mr. Button’s excitement, enthusiasm. Clearly had a vision and didn’t want to kill that. Clearly, he was really pumped about this idea he was going for.
Michael: Okay. What about that other hand?
Jay: Well, on the other hand, I had to have that nice, delicate conversation with him about the compliance issues of wanting to bring this into Blueprint Aesthetics, a service line.
Brad: Yeah. And that kind of reminds me, we’ve talked about this in other shows, is that really when you’re trying to walk your client through something like this, you really want to try to figure out how to deal with the risk associated. And so, I know we’re probably getting more in depth, but our job is to tell you what the risk is and then you get to choose how risk averse are you. And as we said before, some people are nervous about stepping out of a shower in the morning, and some people will jump out of a perfectly good airplane, and so everyone has different risk tolerance.
Michael: Some people will partner with Brad Adatto, so we’re definitely.
Brad: Super high risk tolerance is what I just heard. So in this case, Jay, what was the compliance issues?
Jay: Yeah, so the first one was just the fundamental [00:15:00] issue of needing Dr. Brian’s comfort and approval. Now, had had this conversation with Mr. Button at the very beginning and had to remind him that the clinical related decisions and even marketing were within the purview of Dr. Brian. He needed to be comfortable and approve what was going to be happening down that road.
Michael: Yeah, I feel like, I mean, we even need to double click on that and make it even more direct and clear and strong. Clinical decision-making, including whether to offer a service line has to be left to the physician. And so, entrepreneurs cannot excerpt control over clinical decision-making. And then kind of part of that, again, to your point, is that when the doctor’s making that decision, they have to know about that service themselves. And so, the doctor has to become competent from a standard of care perspective [00:16:00] to even appropriately make the decision whether to add that service line.
Brad: Absolutely, and you also mentioned, Jay, that Dr. Brian needed to have oversight on the marketing because that’s also an issue. And for those that don’t know, medical marketing and advertisement rules are sniffly impact on how a practice actually can promote these services and or the engagement with the patients. We’ve talked about this in other shows, but there are federal and state laws which basically ensure that the marketing claims are truthful, not deceptive and are sustained. this is why physicians associated with the practice should participate in their strategic marketing choices to help protect their licenses.
Jay: And most important, let’s just go to the very fundamental issue. Dr. Brian was being asked to put his license on the line with respect to this treatment. So if there’s a compliance issue, Dr. Brian is the most at risk.
Michael: It’s going to sound like there’s an echo in here, but I mean, what gives that practice authority to be offering medical services is the license, in this case, of Dr. Brian, [00:17:00] and so that kind of highlights why he’s going to be front and center from a risk perspective if he were to offer it. But Jay, you said earlier that I’m assuming there was another compliance issue that you spoke to Mr. Button about.
Jay: Yeah. I mean, the second one is a more complex one. and that’s really the status of the treatment itself, the status of exosomes.
Michael: Okay, well, explain that.
Jay: So you see the Food and Drug Administration, Brad, that’s the FDA, regulates exosomes.
Michael: Brad, that’s what we’ve been talking about.
Brad: . Oh. I thought we were talking about movies again. Oh, okay.
Jay: He thought that was a science fiction movie. So the FDA regulates exosomes because they are classified as a drug and biological product. And according to the FDA on their website, they clearly say there are currently no FDA approved exosome products.
Brad: Okay. So I’m trying to figure out, what movie was the FDA versus Exosome? Was that an aliens movie? I mean, this does feel like [00:18:00] a good, like, conversation to be had on off-label talk versus FDA approval. I mean there’s a lot happening here.
Michael: Yeah, no, I mean, there’s a lot to get into because there’s a lot of confusion on what FDA’s place is in medical care, and I think we can kind of explore that. But let’s go to break and come back in and figure out kind of that side of compliance, the FDA side.
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Brad: Welcome back to Legal 123 with ByrdAdatto. I’m your host Brad Adatto, my co-host Michael Byrd, and Series regular, Jay Reyero. Now Michael, as we’ve talked about earlier, this season, our theme is Compliance Fundamentals.
Michael: Yeah. So quick recap. The test, annual test that I get every time we have an episode or the test I get every time we have an episode; we have Mr. Button who is wanting to expand into this anti-aging longevity world through a product we’ve talked about called Exosomes. Exosomes are not FDA approved for any purpose. He has a medical director, Dr. Brian, owed to our hero and our banter talk. And so, we were working through kind of the risk of trying to add this service to the practice. And where we left off was, what is the FDA’s role in all this and what are the different ways the FDA can impact compliance on a medical practice? [00:20:00] Jay, before the break, you had made that point that exosomes are not FDA approved.
Jay: Yeah. So at a high level, when a product has been approved by the FDA, basically that means they’ve evaluated it use in a very specific way; that use has been supported by strong scientific data and that the FDA has approved some labeling on whatever that use was. So they’ve gone through some clinical trials to see how it works, whether it’s safe for human use, and they’ve kind of given it stamp of approval – so that’s FDA approved. When something’s not FDA approved, none of that has happened. There’s no scientific evidence supporting whatever it is, the product itself. And so, to the FDA, there’s no means to market it for human use or to produce them for human use because the FDA hasn’t given them that stamp of approval.
Brad: And that’s to your point for context, that that stamp’s pretty important [00:21:00] because that means the FDA has really gone through a process of making sure that they assess the product and they believe that, obviously there’s always risk associated with it, but it supported that this particular product or drug will meet certain substantial scientific data on this particular procedure or this particular utilization. And the approval, then they have the guidelines and that are safe and effective ways in which they can then use it related to labeling this particular product.
Michael: Yeah. And so this can be a source of confusion as it relates to the FDA, and Jay, I’d love for you to talk about how we have on the one hand something like exosomes that’s not FDA approved for any purpose and a term that most people have heard before, and that is off-label use.
Jay: Yeah. So it really easily to think about it – off-label, on-label, both involve FDA approved products. So first off, we’re dealing with something that’s been approved. When you’re using something that is [00:22:00] off-label, that means the FDA has said, we have looked at this product for this particular use and deemed it safe. Well, I’m going to use that product, but I’m going to use it for a different use. That’s off-label. So the easiest example that we see this really common is the weight loss area where semaglutide, Tirzepatide, they were approved for a very specific use; diabetes, obesity. And when you’re prescribing that for just a normal person without those, you’re prescribing that off-label. That’s being prescribed for a use that has not been otherwise officially approved by the FDA. If you’re using it for obesity or you’re prescribing it for diabetes, that’s on label.
Brad: Yeah. On/off, on/off label – gosh, a lot’s happening here, but I think Michael or Jay, one of y’all can, both of y’all can address this, but understanding that’s just the FDA’s view about how to utilize that, that doesn’t exactly directly [00:23:00] impact Mr. Button and Dr. Brian, so they should not necessarily just focus on that FDA issue.
Michael: Yeah, it gets really confusing. So if that wasn’t confusing enough, trying to figure out where the FDA comes in as it relates to this non-approved on-label, off-label business, then figuring out FDA’s place inside a medical practice is really confusing because this is going to throw everybody off, but an FDA doesn’t regulate the practice of medicine.
Brad: What? This is new.
Michael: And so yes, it is not new, Brad, and you’re baiting me. I can tell. No, the FDA does not regulate the practice of medicine. And so if for example, Dr. Brian were to offer exosomes, the decision clinically in of itself to do that is not going to be under the purview of the FDA. That doesn’t mean you don’t have to worry about any of this because [00:24:00] this is where the medical boards come in. And that varies on a state by state basis as to how the medical boards view things. But remember, the medical board’s purpose is to protect the patients. And so they’re looking at things through a standard of care perspective. And so when you have a product that has not been approved for any purpose by the FDA to touch a human, then they may come out very directly and regulate clearly you can’t do this, or they may do so indirectly, and there may be some possibilities to do it through a study that’s its own animal, but you really have to understand where the medical board stands on something like this before you go forward.
Brad: And just following that thread, just pretend in this particular case, the medical board said we think it’s within [00:25:00] the standard of care. That’s just a piece of the element. You still need to make sure you’re informing the patients correctly, that they are using something that is off-label, and that they may have other choices associated with it. Because not only you have the medical board issues, but if you’re using something off-label and a patient has a very negative reaction to it, you have the board issues, but you also have malpractice issues of course. So again, there’s a lot of different pieces that come together with that. But Jay, love to hear your thoughts.
Jay: Yeah, I mean, to just piggyback off of that, we see this with stem cells, a lot in the regenerative medicine, and now the anti-aging, these novel treatments, these new novel things that are coming out, a lot of times process doesn’t catch up with the clinical decision-making. And so you have these providers that are put in a really tough spot to know, wow, stem cells, exosomes, it can really benefit because I’ve seen it, but from a legal compliance perspective, the rules haven’t caught up to give enough comfort to say, you should be fine. But then you can also [00:26:00] dismiss the advertising and marketing angle. I mean, one of the potential issues when you’re promoting these types of products is the scrutiny not only the FDA, but also the Federal Trade Commission, the FTC, both can take action. We saw this during Covid when they were going after med spas and clinics for promoting certain IV hydrations as the cure for Covid, or the promotions of the weight loss semaglutide and Tirzepatide. So they can come after or send warning letters to providers from that level. They don’t regulate the practice of medicine, but they can do it from an advertising or marketing standpoint if you are promoting something that is essentially false, deceptive or misleading because you’re categorizing in a way that that isn’t supported by their rules.
Michael: Yeah. And on the marketing piece, as you said, they do; both of these governmental bodies have authority over that, and the medical board is going to have authority over the marketing, and they’re all going to be under this theme of truth in advertising so that patients aren’t misled. [00:27:00] And so, there’s a lot of different angles that you could carry risk on depending on how you’re marketing it.
Brad: Yeah. And to your point is because it’s the federal government, there are huge and significant fines that you can be hit. Now, it’s all civil, so maybe the doctor keeps their license, but you’re paying 50, 30, $60,000 a day for each fine they find on you. So again, it can be very financially negative for you. Okay, so let’s keep moving. Jay. What ended up happening? Did Dr. Brian get comfortable with offering exosomes or any other fancy word like that?
Jay: Well, Blueprint Anesthetics did not venture into the exosome territory, but it wasn’t because of Dr. Brian. Ultimately, once we walked through all these issues and had this long conversation with Mr. Button, he just felt like the risk associated with didn’t justify the upside potential, so he ended up just kind of scrapping that, and moving on to the weight loss area, which was at the same time starting to get going. [00:28:00].
Brad: Good little risk assessment there was too high of a risk for them, so he was basically jumping out of airplane without a parachute. And for our audience members that’s trying to keep up, obviously this is a very complicated area of law practice. It really does need weigh several rules and regulations when they’re entering these types of new ventures, with the FDA approvals of a medical device or drug, is it on label or off label? And then once you figure out, go through all of those gymnastics and logistics trying to figure it out, you finally have to confirm, are you providing these services consistent with the standard of care that’s Wiley accepted in your medical community? So going back to the doctor didn’t know how to do it, so that’s not going to be consistent, or you can do it, but the medical community in your area does not believe it’s a good practice of medicine. I would think those venturing these new areas of medicine really need to be cautious as they approach these different things. But Michael, I’m going to give you the final thoughts.
Michael: Well, if a practice [00:29:00] offering longevity wants to have longevity, they’re going to need to lean into these compliance issues to make sure they navigate these cutting edge treatments.
Brad: Jay, thanks again for stopping by. Glad you could make it by this week. But next Wednesday, we’re back with special guest Patrick Blake, co-founder and CMO at Portrait to discuss how Portrait helps aesthetic and wellness clients with compliance. Thanks again for joining us today. And remember, if you like this episode, please subscribe, make sure to give us a five star rating and share with your friends.
Michael: You can also sign up for the ByrdAdatto newsletter by going to our website at byrdadatto.com.
Outro: ByrdAdatto is providing this podcast as a public service. This podcast is for educational purposes only. This podcast does not constitute legal advice, nor does it establish an attorney-client relationship. Reference to any specific product or entity does not constitute an endorsement or recommendation by ByrdAdatto. The views expressed by guests are their own, and their appearance on the program does not imply an endorsement of them or [00:30:00] any entity they represent. Please consult with an attorney on your legal issues.
