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AHLA's Speaking of Health Law
Cosmetic Medicine: Legal and Compliance Issues
The U.S. cosmetics medical market is expected to grow from $22.64 billion in 2025 to $36.35 billion by 2034 according to a recent report by Custom Market Insights. Erin Smith Aebel, Trenam Law, and Chase Howard, Bochner PLLC, discuss the legal and compliance issues related to cosmetic medicine. They cover issues related to the corporate practice of medicine, telehealth, scope of practice, advertising and marketing, physician supervisors, and current trends.
Watch this episode: https://www.youtube.com/watch?v=c4clvVWmLFI
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SPEAKER_01:Well hello and welcome to our podcast. We're here today to discuss legal and compliance issues in cosmetic medicine. I'm Erin Abel. I'm a board-certified health lawyer out of Tampa, Florida. I've been practicing law for 29 years, and I have a wider range of clients, some physicians, hospitals, dentists, chiropractors. But a good portion of my practice is representing people who do cosmetic medicine, such as MediSpas. And so that's why I was interested in this topic. And then I've got my good friend, Chase Howard, who is another attorney who practices in this area. And I'll let him introduce his practice before we get started.
SPEAKER_03:Thanks, Erin. Yes, so I've been practicing a little bit less than 29 years. However, all of my practice experience has really been in the cosmetic alternative medicine space. In fact, my first client ever was a med spa. And so I've just kind of been in that space ever since. But I call myself a healthcare lawyer. I focus my practice on healthcare regulatory and corporate guidance to clients in the state of Florida and nationwide, depending upon the matter. I am also based out of Tampa, Florida, although we're part of separate firms, but we end up doing quite a bit of work together or opposite of each other, both moving clients forward and helping them split apart in some cases. So it's good to be here and I'm very excited to talk about this topic with you.
SPEAKER_01:Yeah, so when I was thinking about this topic, Chase was the first person I thought about because we approach it from different angles. I am more of the compliance and regulatory lawyer while he is very well aware of those issues. He is a mergers and acquisitions attorney and does a lot of deal documents. But what's funny is how we met as opposing counsel, we were on a very difficult deal where our clients couldn't stand each other and we were having to navigate healthcare and business and saw issues. And I just have a lot of respect for Chase and how he handled it. And then we became friends after that. Sometimes we'd meet for coffee and talk about business. And so, you know, it just goes to show you, you never, you know, you never know what kinds of ways you're going to build relationships, even in a very adversarial situation.
SPEAKER_03:Yeah, it's so funny. I think that's what like the beauty of being in the healthcare space is a lot of the times you can be working with clients to move something forward, to work together, and it's not really contentious. Although the way that we met obviously was, I think it really allowed us to be professionals and colleagues and build a relationship past that and outside of that, that's actually been beneficial to both us and our clients going forward because we do a lot of different things, even though we're both healthcare lawyers.
SPEAKER_01:Right. One of the, that's one of my favorite things. Well, the couple of my favorite things about being a health lawyer is the industry and how it's constantly evolving. And we're going to talk about that in a minute and also really how collegiate the legal practice is and how we all kind of try to help each other out a lot of times, because it is a very difficult and evolving area.
SPEAKER_03:It is absolutely. Yeah. And it's, you know, it's, it's, it changes every single day. So learning from, you know, competitors essentially, but I don't look at it that way. You know, everyone teaches you something. You taught me a lot over the years. And, you know, I hope that today we're able to kind of share some of our experience that'll, you know, I think just open eyes or, you know, have other healthcare lawyers look in different ways of how to approach these changing and evolving healthcare practices and clinics that we have in our country. It's not, you know, hospitals anymore only. It's not physician practices. It's a lot of, you know, concierge medicine, you know, precision medicine, elective cosmetic medicine. And with that comes a lot of changes in how you approach the client as well.
SPEAKER_01:Exactly. So I was just talking to my colleagues in my law firm and saying, you know, I'm talking about cosmetic, but they're like, Oh, yeah, that got a field like, is that a business? So that is very, very big business. I pulled the data point that I wanted to share. And then if you have anything that the US cosmetic medical market. is expected to grow from 22.64 billion in 2025 to 36.35 billion in 2034, according to a report by Custom Market Insights. So it is a huge part of our American business structure.
SPEAKER_03:Yeah, when I had my first client, and this will tell you how long I've been practicing now, which again is not as long as Aaron, but in 2017, this data read something like, 2.2 billion, and it was expected to grow to about 12 billion three or four years later. So you can see the astronomical growth in such a short amount of time. And really, I think this data is probably focused largely on like you know, beauty cosmetics, right? The fillers, injectables, lasers, things like that. It might not even take into account all of the wellness and integrative medicine modalities that come with it, which are related, I think, to the med spa world, the feeling good world and things like that. So this market is probably even larger than that and certainly going to grow a bit more.
SPEAKER_01:Yeah, so a lot of people who are health lawyers think, oh, I'm advising on Medicare and Medicaid, and I do advise, and so do you, but that is just a fraction of the field that is regulated by all the different laws. So with that said, let's delve right into the law, because I want to make sure that we talk about some really important issues that we deal with on a regular basis in cosmetic medicine. First and foremost is the corporate practice of medicine and a lot of people will throw that out and not really explain what that means it's interesting in the state of florida because we are not a corporate practice of medicine state uh clearly at all but in other states they are and what that means is there are state laws that say that only a medical doctor can own a legal entity that bills and collects for medical services and it can even be criminal like i know um California and New York and Texas have some very strong laws. And have I explained that well enough, Chase, or do you have anything you want to add about that?
SPEAKER_03:Yeah, you know, some people might just hear California, Texas, right, New York, but really it's roughly 34 states have an explicit prohibition on it. A few others have some kind of wishy-washy statements on it, or their statute might simply say, you can't open a professional corporation unless you have a professional license. So you've got to be really, really careful. And in the world we're talking about, and it's kind of going to help us flow in our conversation here, it's very easy to go across state lines in treatment of patients, which means you're very quickly going to potentially violate corporate practice of medicine in one of these 34-plus states, right? So it's overlooked, I think, largely because it's not the hot topic like anti-kickback or Stark, right? And a lot of the owners of these clinics happen to be non-licensed professionals, right? So it's not something a traditional, I think, medical practice or even healthcare lawyer might look at all the time. But in my world, I mean, it's the number one question I'm asked is, do you have a license, right? Because if you're practicing or employing healthcare professionals, this is the biggest hurdle you have to get over.
SPEAKER_01:Right. So entrepreneurs are the kind of people that come to us, whether they have a license or not, and want to get into business because they see the profit margins. And then, you know, I always want to encourage people to start new businesses and do things as they can, but also mitigate risk. And so the first thing I ask is, what's your license? Both don't have a license. Okay, well, you need to know about this because you're going in. There might be high profit margins, but you're going into a highly regulated industry. Yes. Yeah, go ahead. One
SPEAKER_03:more big thing on that is, there's 50 states, which means there's 50 laws. So if you get it right at one state, you might get it right in a couple others, but likely you have to adjust and make sure you tweak whatever arrangement or structure you have for those other states. Because again, they all have their own laws that say what you can and can't do when you're interacting with medical care or services.
SPEAKER_01:And so for people who've heard this is a new concept, you're like, well, how do you deal with this? If it's criminal, can you not go into business? There are business structures that are put into place in various states. A common one is a management company arrangement where a licensee, which is the doctor, is the entity that builds and collects for the healthcare services, be it a MediSpa or some other cosmetic business. owns, you know, it's owned by a doctor and the doctor has a management arrangement with a management company that could be owned by investors because it's not regulated as much who can own a management company. Now there are regulations And all the states you have to look at is how can you charge the management fees? Can you do percentage fees? In Florida, that might be problematic if it's for marketing services. So even though there's no Medicare or Medicaid, you still have to look at all of those issues when you're putting together these management company arrangements, which is what you see when you have an unlicensed person getting into a medical business. Yeah,
SPEAKER_03:yeah. I mean, it's great. You know, it's great for us when this happens because it's, you know, a lot of time spent going through the analysis and educating. But I think for a lot of business owners, it's meaning non-licensed persons, entrepreneurs that want to get into the space. The worlds that they are used to typically don't have this type of regulation and oversight. And so they tend to overlook how complex it could be and frankly, what risk comes with it. So yeah, it's the number one question I think you have to get by first. And if you can get by it and live with the structures that you have to live with to do it legally and compliantly, then you kind of get into the rest of it, which isn't as, you know, isn't any easier. It's just as complex, but ownership is really, you know, the first number one issue.
SPEAKER_01:Yeah, that is. And then the other question I usually look at, and this is a nationwide presentation, so you really have to look at what licenses do I need to operate. Interestingly, and this is something not a lot of people know about, while anyone can maybe own a medical business in the state of Florida, you may need to have a special license called a healthcare clinic license if you're billing insurers. A cash-only business may be exempt from healthcare clinic licensure. So those are the types of questions. The second question is, is can I, what is my barrier to entry? Can I own a business that does this legally? And if not, how do I structure my investment or can I structure an investment to own this in a way that works out? And then secondly is what kind of licenses do I need? It's not just, sometimes it's just the providers need to have the license, but in certain states there could be facility or other types of licenses, like massage establishment license, you know, it's different things.
SPEAKER_03:Right, cosmetology, permits, right? Yeah, we have in this space, we have this overlay of so many different types of licensees, services, which means there's different boards and different potential permits, whether it's Department of Health, Board of Cognitology, that all come into play here.
SPEAKER_01:Exactly. And then the other issue. So let's say we get through the basic barriers to entry into the cosmetic medical business. Another area that you and I were when we were preparing for this, we were discussing that we see a lot of is telehealth. And it's a separate topic in and of itself, like we could do a whole course. podcast on telehealth, but basically that is providing healthcare via video or phone or something other than in-person, you know, seeing someone personally in the office. And that is very, I think patients like that a lot because they like the convenience of not having to get out of their home. Often entrepreneurs like it because maybe it's less expensive and they can, you know, get a lot more, you know, whatever the cosmetic service is. So something like Botox and fillers, you're going to have to be in person for that. Right, right, right. There
SPEAKER_03:could be more wellness-focused services. Weight
SPEAKER_01:loss, hormones, things like that. But the other thing, the big picture thing to keep in mind is this is just a regulated industry. Every state, I know Florida has its own telehealth guidelines and telemedicine guidelines are in the... the Medical Practice Act regulations and certain things you can and cannot do. So, and in fact, there's 50 state surveys on the corporate practice of medicine, but there's also on telehealth laws because every state's a little different, right?
SPEAKER_03:Yeah, COVID changed everything.
SPEAKER_01:Yeah.
SPEAKER_03:Simply because people weren't allowed to leave their homes, in essence, right? If you wanted care, unless it was super emergency, you had to do it remotely. And so, you know, that was that was bad, obviously, because it was a pretty bad time of time of life for everybody. But at the same time, it was really good for health care because it allowed providers actually forced providers, I think, to evolve and how they can provide treatments in a more efficient manner. And I think what patients learned is they really like it. They want it. And they probably want it sometimes more than they do to, you know, whether they live in a rural area and have to drive far or, I mean, I live down the street from my doctor. I'd rather just get on a video and say, hey, I've got a little sinus infection. What can we do? Instead of going to a waiting room and waiting and driving and parking. Right. So it most of the time created more efficient practices. It gave greater access to people, but what it did in the cosmetic and wellness world is it just exploded the amount of providers that could be in that space and the reach that they had on patients. that's good and bad because we, you know, saw a drop off in standard of care because a lot of providers just thought, well, sometimes I'm going to get a video or, you know, they're not thinking about what state the patient is in. They're not doing a full, you know, physical or good paid exam on the patient. They're not getting blood work. Right. So standard of care dropped off, which is important because standard of care has to remain the same as in person. But access really shot up and convenience shot up. And so, you know, I think from a, regulator's perspective, it's hard for them to balance, right? They want to protect the patient, but the patient really wants this. So as a provider, you know, and as a, you know, lawyer advising provider, I think you have to really hone in on understanding your laws for how you establish, you know, patient relationships, prescribing, you know, regulations, maintaining a high level or the appropriate standard of care, but also understanding from a business perspective, how can you do this in a way that allows you to reach more people, you know, and expand your, you know, elective cosmetic wellness business?
SPEAKER_01:Yeah, exactly. So I think like the first question when I deal with clients on this is, can you use that telehealth platform for what you want to do? Like there may be restrictions with certain type of services controlled substances. You may not be able to use it. And then the other thing that you point out that I just want to reiterate because I think it's so important is that you have to be able to provide the same standard of care as if the person were in the office. You have to be as good as that. And I still do. So I have patient consents for telehealth to make it like extra protective of my client that they can send it to it. But really, it has to be something you can do as well. And so I have a lot of physician friends and clients And someone will tell me, yes, I can do a great job via telehealth. It's very, and then other times they'll say in certain instances, I really just have to see the patient. So, you
SPEAKER_03:know. And I think too, you know, it's important that the patient understands the limitations of telehealth, right? And that's the legal liability side, right? How do you disclose to the patient that telehealth is probably not as good as in person, right? You know, if I can't physically touch you or examine you, I might miss things or I'm probably going to miss things versus on a video. One, two, there could be issues with connectivity with the platform you're using. There could be security breaches, right? So there's more risk with it, obviously. Ultimately, if the patient consents to it, I think that's important. And to your point, having some sort of consent form or disclosure that kind of lays out some of the pros and cons of it, almost like a treatment in itself, I think is a good practice to push onto your clients to say, Here's how to protect yourself if you're starting to expand your telehealth business.
SPEAKER_01:That's a great point. And you know what I've noticed, and I'm sure you've seen too, because I have clients in this area of business or doctors who want to work for a telehealth company. I just reviewed a teleradiology contract last week. Some of them, there's these national, these big companies. physician practices that have cropped up where they represent that they have physicians licensed in all 50 states and that's one of the big issues too it's like you can't can you do tell you can't do telehealth on a patient in a state where you're not licensed and so i have seen them crop up i i don't know uh i i can't say whether one's better than the other or whether it's a good practice model but i have seen that practice model so that people are like i want to have a national telehealth practice, they contract with a provider that can say, I've got all the 50 states covered. I have seen it.
SPEAKER_03:Yeah. And so, so, so here's the stack you've got to be careful of, right? You, you live in Florida, right? You comply with corporate practice and medicine laws, but now you've got a patient in Georgia and Tennessee and Texas, and you don't have a license there. Well, let me contract with somebody that does have a license there, right? Well, Now we've got to look at you're practicing medicine in those states, right? Or you own a company that's practicing medicine in those states. So are you compliant with corporate practice laws in those states? And then on top of that, are you compliant with payment arrangements, right? Are you paying that doctor or that group that provides the doctor in a way that's compliant with federal or state anti-kickback or fee-splitting laws, right? So now you're tracking, right? All of these are stacking on top of each other just to say, I want to open up a clinic that can treat patients in a couple of states on aesthetics, right? And we haven't even gotten into insurance really, right? How that comes in, I'm not going to because- I stay away from that world, you know, as much as I can, but it's just these little regulations that are state laws and scope of practice, supervision, ownership that just compound on each other and getting one wrong could obviously be, you know, detrimental to a client's, you know, business, practice, license, whatever. I
SPEAKER_01:want to build on that because I think it's an important nuance. It could be in cosmetic medicine and it could be in other areas, but definitely in the cash-based medical business space is important. oftentimes you are dealing with a client who is not licensed and who is being somewhat of a middleman in between the patient and the provider. And the question, which is not easy to answer, especially if you have multiple states, is what am I doing and can I be legally paid for it? Because it's, am I practicing medicine without a license? Am I getting fee splitting illegally for referring patients? Or am I doing legitimate management service and getting paid a fair market value management fee? Entrepreneurs are smart people out there. They see a need. They see a customer base. Customers want it or patients want it. And they're trying to put something together. And so it is challenging because a lot of the laws that we deal with as health care lawyers have not evolved to deal with what's going on in the health care industry. That's a theme that I've seen throughout my decades of practice is, you know, we're doing all this stuff with cosmetic medicine. There's developments in telehealth. Have the laws really caught up.
SPEAKER_03:Yeah, there's a lot of band-aids that are placed along the way, but they don't actually encompass what's happening on the ground in clinics and how people are practicing.
SPEAKER_01:Yes, that's why I feel like we're in the grassroots of healthcare because we get our work a lot of times by what people are doing and what's going on. And then we have to react to it with the laws that we have to date.
SPEAKER_03:Right, right. I always start off with clients that want a regulatory drop on what can or can't I do. I have to tell them, disclose. you know, there's not a lot of laws that are, there's not one set of laws that says, here's what you can do, right? There's a number of sources that might apply. And that's oftentimes just the guidance that we can give is this may apply. And this is our best guess of, you know, here's what the laws might say, right? That, that apply here are your options. Here are some risks that go with it. And, you know, do with that, which you want, right? If you have a high risk tolerance, you can push it a little bit. If you don't, then I would maybe stay away from this because there's nothing to support you one way or another.
SPEAKER_01:Yeah, yeah, exactly. You don't want your client to be making the law in the area. That's it. I always say
SPEAKER_03:you don't want to be the example.
SPEAKER_01:Yeah, I mean, that's a difficult place to be. So the other issue that I think we see a lot, oh my God, I see probably... I could have made this the number one issue, but I did it because I wanted to talk about these other big picture things first, is scope of practice. Let's look at it from the patient and the business person or provider's perspective. There's so much going on there. Scope of practice is really, what does that mean? That means, what can I do with my license?
SPEAKER_02:Right.
SPEAKER_01:And does it overlap with what someone else can do with their license? And what I have seen is that sometimes business owners, you know, they don't want to, they want to have profits. And so they want to use the least expensive, lowest level of licensure to do something, but that might not be the right person to do the work. Or it may be like one of those gray areas you're talking about. Maybe it's safer with a nurse practitioner and not an LPN, you know, and nothing wrong with LPNs. And then the other area of scope of practice is there's some turf wars going on in every state there are. So whether I think a paramedic can do an IV in your home properly or not, is, and safely, or I think a medical esthetician can probably safely do radio frequency microneedling. Is that legal? Because some people, you know, one thing is, can I do it safely? Some people feel that they have the training and maybe I would argue they do. But it doesn't matter at the end of the day as a lawyer. We have to say what is within your scope of practice and what can you do? And if it's not in your scope of practice, you cannot do it unless we change the law or get a statutory statement or whatever your process is in your state discussing the scope.
SPEAKER_03:Yeah, listen, I would say this to his face. My dad is a physician, and I would never trust him to start an IV on me versus paramedic and EMT or whatever, an RN, somebody with a, quote, lower level or different level of license, because those are the people that are doing it day in and day out, sometimes in the worst and craziest conditions. And frankly, my dad probably hasn't done it since medical school, right? So, you know, when you talk about who's actually most experienced versus what their license allows them to do, very different, right? And I think patients probably want the most experience, but certainly they want to make sure that, you know, it's being done safely as well. And as a business owner, you hit it, right? What's the least expensive way, you know, for me to provide this service, right? to patients, right? Because everything costs so much. I want to make sure I make some sort of profit off this. Excuse me. So, yeah, it's really, really tricky. And, you know, you brought something up with like estheticians, you know, a lot of times in Florida, estheticians, well, an esthetician actually isn't even a license in the state of Florida.
SPEAKER_01:They're cosmetic. They're under the board of cosmetology. There's no such thing as a medical esthetician. And now a medical assistant is something and you can be a trained esthetician. esthetician that operates as a medical assistant, but the doctor has to be right there and it's very limited in what you can do.
SPEAKER_03:Yeah. And then when you think about estheticians or cosmetologists, right, and they fall into that board, that's not medical, that's professional and business, you know, completely different, you know, governmental board in the state of Florida and many other states, similar, some states have medical estheticians, but, you know, I oftentimes get the question, well, if I have a physician that supervises me, Couldn't I be a medical esthetician? Well, they're different. Having a physician doesn't change anything unless you're on site with them. And then you're a medical assistant and the doctor's in the room with you. So there's just there's so many, you know, I think groups and boards and blogs out there that there's a lot of information shared. And unfortunately, it's not always accurate. And people have this idea in their head of, oh, I read this and I can do it or everyone's doing it that way. So why can't I do it that way?
SPEAKER_01:I'll just throw out a generalization that may not apply everywhere, but I will throw it out anyway because I see it all the time. Nurse practitioners are great, and really physician assistants too, and they can do a lot. normally without a doctor on site. In Florida, we have a, there is a way for a nurse practitioner to be an independent practice, but it's only as to primary care.
SPEAKER_03:Right.
SPEAKER_01:So unless you're getting Botox. That
SPEAKER_03:definition is so poorly written that, you know. It's very hard to, yeah. What does that even
SPEAKER_01:mean, right? Yeah, if you're getting, because they'll be like, I'm an independent practice, so I need a protocol position for my money spot. And of course you do. You're not just doing Botox for migraines. You know, we... Yes. So check your state, but those higher trained licensees that are under doctors are usually very helpful in this industry and can do a lot and really do have a lot of experience with Botox fillers, other types of services and can really safely, generally speaking, Safely perform a lot. I have been involved from time to time in a process to expand a scope of practice and other people in my office have too. And it's not gonna be this, I'm gonna just generally describe in Florida what goes on, but check in your relevant state we have a declaratory statement process. It's an administrative process where you can ask the board, you know, I'm an RN and the doctor's right there and I'm trained in Botox. Can I inject patients with Botox? I think the key is the doctor has to be there in Florida, but like, you know, those are the types of scope of practice questions. And normally how we do it is we'll call the board lawyer first and say, Hey, take your temperature because we don't want to have like a negative thing. But if they're like, yeah, I think they'd be open to that. And then you do the deck action. So there are ways to ask the regulatory boards in various states about this, about expanding practice as developments occur. But just be wary of that and know that there's a process you can probably look into in your state and possibly expand. Or you can work with trade organizations to, you know, get some of these practices expanded. Or you can do it by statute. The one that I was talking about, the nurse doing Botox, it would have to arguably be under the current statutory framework. If you want to really expand practice, you would work with a lobbyist and get your state laws changed. I
SPEAKER_03:think that declaratory statements are a powerful tool to And at least in Florida, there's a lot of flexibility underneath the current statutes.
SPEAKER_01:Exactly, exactly. So the last theory I want to talk about before we talk about kind of what we're seeing is the hot topics or the hot areas. This is the area that I see all the time, and I even have a medical advertising checklist. It's advertising and marketing. Because again, I'm looking at those entrepreneurial clients that are coming in my office, wanting the high profits, the startup of the business, the low costs, and also they wanna market and get in as many patients as possible. In the cosmetic medical industry, I don't, you know, some people have the misconception that there's no Medicare or Tricare or Medicaid, so it's not regulated. That is not true at all. There are very strong, in Florida and other states, there are very strong criminal laws or laws that can get your medical director in trouble for false or misleading advertising. In Florida and in many other states, it's a felony to pay for patient brokering, which is like kickback. And so you just have to be thoughtful about how you pay marketers. You can't give someone$100 per referral. And you know who turns you in? Right, Chase? It's the competitors. They're like, well, my lawyer said I couldn't do that, but look at this letter I got from the MediSpot. I'm going to write the Board of Medicine, and guess who gets dinged for that? Maybe the licensed providers, if they're owners, or the actual medical director who's agreed to be the protocol physician. Right, who's
SPEAKER_03:probably not even been to the clinic in her life.
SPEAKER_01:Exactly. Yeah,
SPEAKER_03:competitors, and then sometimes upset employees, former employees, things like that. who don't like how their employment ended, right? So you've got to be really careful with that.
SPEAKER_01:Yeah, and the other thing that we were talking about when we were preparing for this was off-label promotion because that's another area you cannot promote off-label.
SPEAKER_03:Right, yeah, so from the standpoint of advertising services or products, especially in this space, you've got to be really, really careful with how you promote weight loss drugs or, you know, regenerative medicine, you know, treatments, right? The FDA has purview over, you know, obviously food, drugs, right? Cosmetics, right? So if something either isn't FDA approved or, you know, explicitly prohibited by the FDA, or you're using it off label from an FDA use, right? you have to be really, really careful with how you advertise that treatment or service, how you disclaim that to the patient, right? Patient education consent is obviously, you know, first and foremost, and you don't want to be misleading about it. You don't want to, you know, make, you know, statements that are untrue or misrepresent, you know, exactly what could happen. And so, you know, you overlook it, but look at how you're marketing, look at what you're you know, Instagram says about this treatment or whatever it is, and find out if you have to say something specifically to, you know, what the FDA says, you know, you've got to be really careful with it, because not only will the board come down on you, but the FDA, you know, could could inquire or send a letter, right, make a statement as well. And that could really crush not only your business, but your license, if you have one or your provider's licenses.
SPEAKER_01:I try to be very proactive about it because I think many business owners who are entering into a cosmetic medical business may not even be aware that their advertising is regulated. And just by way of example, in the state of Florida alone, there is a regulation under the Medical Practice Act that says that you cannot have false or misleading advertising. The medical director's name has to be in your ad for medical
SPEAKER_02:services.
SPEAKER_01:There is like a very detailed disclaimer that you have to have in your ad if you offer free or discounted services. Like I said, kickbacks, referral fees, those are actually... felonies. And that's just in the off-label promotion. That's just some state and federal laws that we'd be looking at for every business. So I try to be proactive. And I know I have a new client in this area. That's why I created the medical advertising checklist. And I'm like, here, look at this, and then let's talk about your advertising. And also how you pay marketers. It is very commonplace to want to pay people based on their production in... in this field. And so, you know, we have to have a conversation about the risks in that and how you can structure pay for marketing people. But, you know, it may be different if they're employees versus independent contractors in Florida.
SPEAKER_03:Yeah. Listen, if you don't want to get in trouble, then you're not going to be public facing, right? You're not going to have patients. You're not going to market. You're not going to advertise. But obviously, every clinic is going to want to do that. And once you put yourself on the map, that's where you are gonna start to see scrutiny from the three-letter agencies that are out there. So have that done correctly, because that's the first thing they're gonna see, and that's gonna lead them to you further. And unfortunately, a lot of these agencies and people that work there are not familiar with these types of clinics. So if they see something that they don't like, they're gonna kind of shoot first and ask questions later, and that's gonna... now you're behind the eight ball and trying to defend yourself versus, Hey, I had everything correct. And they didn't even look at me or they didn't even inquire any further. So, you know, protect yourself on, on the front end, build a, you know, big shield out there with how you market by doing it compliantly. And I think you'll really avoid, you know, a lot of unnecessary inquiries.
SPEAKER_01:Exactly. The other thing I wanted to mention is the, is medical directors. And this is really for the doctors from their perspective. Doctors are going to be not, whether you're a business owner or not, the physicians are going to play an important part in this cosmetic medical industry, whether they're the owner or the direct provider or just the supervisor. Um, It is a, you know, it is a good field to get into. They certainly can supervise and train people. They just need to know what they're getting into and they can't just dial it in or phone it in. You know, they really, because they do have legitimate liability for supervising these providers.
SPEAKER_03:The biggest misconception I see when I talk to a doctor that says, Hey, I've got this agreement to supervise or be a medical director is they think I've got no risk, no liability and no responsibility. Right. Um, And that's couldn't be further from the truth. You are the name, you are the license, you are responsible for the people that are touching patients, right. Treating patients. And if you're out to lunch and not paying attention, if you're not experienced, if you don't know what's going on or have any involvement, whether there's, you know, just general protocols or there's, you know, adverse events and you're not involved, uh, you're going to get hit pretty hard. You know, when someone files a lawsuit or a border agency comes in and says, who are we going after because who's doing the most wrong here? So, you know, for a thousand bucks a month, right? You better really make sure you know exactly what your responsibilities are, what everyone's doing and be protected if something goes wrong. Cause you know, that, that amount of money is not worth it for your license or for a lawsuit. So, you know, I see a lot of, you know, really low cost, uh, you know, engagements. And unfortunately, you know, with that, I think people think this means I don't have to do much or worry about anything. But really, it's a lot of responsibility and liability.
SPEAKER_01:Exactly. Well, I think we've covered like the main big issues that we see a lot. And before we end our podcast, I wanted to go into what some of the trends are. Like I said, we're the grassroots lawyers. We see what's going on. Yeah.
SPEAKER_02:You
SPEAKER_01:know, What are you seeing? What's out there, Chase, in the grassroots?
SPEAKER_03:If I could pick four topics or five topics, it's the GLP-1s, compound medications, weight loss drugs, IV therapy is continuing to evolve and develop, and then the biohacking and what I call the precision medicine world. A lot of that is focused on wellness. There's physical aesthetics that go into that as well. But I think those treatments and those areas are so young in this space and people want more and more to look young, feel young, live forever, reverse their age, and know exactly what's going on with their body. That area is going to continue to expand. And right now, there's not a lot of regulation, excuse me, on those areas. So, you know, GLP-1s, weight loss drugs, the FDA, you know, has been very involved with those recently because a lot of the drugs were on the FDA shortage list. They recently came off the FDA shortage list. And now the drug manufacturers, the Eli Lilly's, Novo Nordisk, et cetera, You know, they now get to, you know, recontrol this weight loss world and journey that people are on rather than compound pharmacies. And so now you've got a lot of people who are like battling with, you know, do I use compound drugs? Do I use the FDA approved drugs? There's marketing issues there, all of this stuff. But that space is going to continue to grow. It's so young, but it's constantly developing. And I think a lot of people really, really are interested in it.
SPEAKER_01:And then the other thing that you and I were saying that we, I wrote an article on it because it was so popular. It's IV therapy.
SPEAKER_02:Yeah.
SPEAKER_01:People want the convenience of, I have the flu. I have a hangover. I just want to feel better. And give me an IV therapy. And then, What's interesting in that, like we're dealing with it in Florida, but it's, it's, you know, it's a nationally popular issue is who can do it, what level of licensure. And then if you go into someone's home, are you a home health agency? What are you, do you need other licenses to go into people's homes? What if you do it in a van outside of someone's home? What if you have a brick and mortar practice? So who can
SPEAKER_03:actually, who can actually perform it and supervision who needs to be there, right? Exactly. There's a lot that goes into IV therapy. More complex, you know, compounded bags, right? Who's compounding it, right? What type of requirements for compounding do you need to have before you can actually create a bag and then deliver it to a patient? Yeah, that's growing. And, you know, the instant delivery of it, you know, I think is the big aspect where you've got telehealth that's going to overlay on it. You've got licensure, like you said. It's going to be interesting to see how that continues to develop, you know, across the country.
SPEAKER_01:I feel like we could do a podcast about like so many of the topics that we just discussed.
SPEAKER_03:Yeah. Each of these areas. Yeah. And then the last one is that, you know, precision medicine, right. Which is really, you know, an approach to healthcare that has, you know, custom treatments, right. You're looking at people's genetics, their lifestyle and environment, right. And you're, it's preventative medicine, but like on steroids for lack of a better term, it's, it's a way in which you're like, not only just looking six months in advance, right. But years in advance and saying, how can I prevent things from happening, diseases, et cetera, or even reverse things that are happening to me. And, and those clinics are, are super, super, I think, elite right now. But there's a lot of online ones that are popping up, blood tests at home, that go further than what you get at Quest and LabCorp, right? So being able to understand and advise clients on all the nuanced regulations that come with a treatment like that or a product or service like that, I think over the next five, 10 years and more is gonna be really, really important.
SPEAKER_01:Exactly. No, thank you for that. So big picture... Can you even do this business? If so, how does it have to be structured? What licenses do you need? What level of licensure do your providers need? And how can you bring in business and how can you advertise? So those are the big ones. So thank you for your time today, Chase. I thought we had a good time and a good discussion. We have so much to talk about. Hopefully we'll get to do this again at some point, but I really enjoyed this. And thank you to the American Health Lawyers Association for giving us this platform. And that's it. Thanks, everyone.
SPEAKER_03:Thanks.
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