Episode Transcript
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SPEAKER_00 (00:00):
This episode of
AHLA's Speaking of Health Law is
brought to you by AHLA membersand donors like you.
For more information, visitAmericanHealthLaw.org.
SPEAKER_01 (00:17):
Well hello and
welcome to our podcast.
We're here today to discusslegal and compliance issues in
cosmetic medicine.
I'm Erin Abel.
I'm a board-certified healthlawyer out of Tampa, Florida.
I've been practicing law for 29years, and I have a wider range
of clients, some physicians,hospitals, dentists,
(00:41):
chiropractors.
But a good portion of mypractice is representing people
who do cosmetic medicine, suchas MediSpas.
And so that's why I wasinterested in this topic.
And then I've got my goodfriend, Chase Howard, who is
another attorney who practicesin this area.
And I'll let him introduce hispractice before we get started.
SPEAKER_03 (01:02):
Thanks, Erin.
Yes, so I've been practicing alittle bit less than 29 years.
However, all of my practiceexperience has really been in
the cosmetic alternativemedicine space.
In fact, my first client everwas a med spa.
And so I've just kind of been inthat space ever since.
But I call myself a healthcarelawyer.
(01:23):
I focus my practice onhealthcare regulatory and
corporate guidance to clients inthe state of Florida and
nationwide, depending upon thematter.
I am also based out of Tampa,Florida, although we're part of
separate firms, but we end updoing quite a bit of work
together or opposite of eachother, both moving clients
forward and helping them splitapart in some cases.
(01:45):
So it's good to be here and I'mvery excited to talk about this
topic with you.
SPEAKER_01 (01:50):
Yeah, so when I was
thinking about this topic, Chase
was the first person I thoughtabout because we approach it
from different angles.
I am more of the compliance andregulatory lawyer while he is
very well aware of those issues.
He is a mergers and acquisitionsattorney and does a lot of deal
documents.
But what's funny is how we metas opposing counsel, we were on
(02:13):
a very difficult deal where ourclients couldn't stand each
other and we were having tonavigate healthcare and business
and saw issues.
And I just have a lot of respectfor Chase and how he handled it.
And then we became friends afterthat.
Sometimes we'd meet for coffeeand talk about business.
And so, you know, it just goesto show you, you never, you
know, you never know what kindsof ways you're going to build
(02:36):
relationships, even in a veryadversarial situation.
SPEAKER_03 (02:40):
Yeah, it's so funny.
I think that's what like thebeauty of being in the
healthcare space is a lot of thetimes you can be working with
clients to move somethingforward, to work together, and
it's not really contentious.
Although the way that we metobviously was, I think it really
allowed us to be professionalsand colleagues and build a
relationship past that andoutside of that, that's actually
(03:03):
been beneficial to both us andour clients going forward
because we do a lot of differentthings, even though we're both
healthcare lawyers.
SPEAKER_01 (03:11):
Right.
One of the, that's one of myfavorite things.
Well, the couple of my favoritethings about being a health
lawyer is the industry and howit's constantly evolving.
And we're going to talk aboutthat in a minute and also really
how collegiate the legalpractice is and how we all kind
of try to help each other out alot of times, because it is a
very difficult and evolvingarea.
SPEAKER_03 (03:29):
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 yousomething.
You taught me a lot over theyears.
And, you know, I hope that todaywe're able to kind of share some
of our experience that'll, youknow, I think just open eyes or,
(03:49):
you know, have other healthcarelawyers look in different ways
of how to approach thesechanging and evolving healthcare
practices and clinics that wehave in our country.
It's not, you know, hospitalsanymore only.
It's not physician practices.
It's a lot of, you know,concierge medicine, you know,
precision medicine, electivecosmetic medicine.
(04:11):
And with that comes a lot ofchanges in how you approach the
client as well.
SPEAKER_01 (04:15):
Exactly.
So I was just talking to mycolleagues in my law firm and
saying, you know, I'm talkingabout cosmetic, but they're
like, Oh, yeah, that got a fieldlike, is that a business?
So that is very, very bigbusiness.
I pulled the data point that Iwanted to share.
And then if you have anythingthat the US cosmetic medical
market.
is expected to grow from 22.64billion in 2025 to 36.35 billion
(04:40):
in 2034, according to a reportby Custom Market Insights.
So it is a huge part of ourAmerican business structure.
SPEAKER_03 (04:47):
Yeah, when I had my
first client, and this will tell
you how long I've beenpracticing now, which again is
not as long as Aaron, but in2017, this data read something
like, 2.2 billion, and it wasexpected to grow to about 12
billion three or four yearslater.
(05:08):
So you can see the astronomicalgrowth in such a short amount of
time.
And really, I think this data isprobably focused largely on like
you know, beauty cosmetics,right?
The fillers, injectables,lasers, things like that.
It might not even take intoaccount all of the wellness and
integrative medicine modalitiesthat come with it, which are
(05:29):
related, I think, to the med spaworld, the feeling good world
and things like that.
So this market is probably evenlarger than that and certainly
going to grow a bit more.
SPEAKER_01 (05:39):
Yeah, so a lot of
people who are health lawyers
think, oh, I'm advising onMedicare and Medicaid, and I do
advise, and so do you, but thatis just a fraction of the field
that is regulated by all thedifferent laws.
So with that said, let's delveright into the law, because I
want to make sure that we talkabout some really important
issues that we deal with on aregular basis in cosmetic
(06:02):
medicine.
First and foremost is thecorporate practice of medicine
and a lot of people will throwthat out and not really explain
what that means it's interestingin the state of florida because
we are not a corporate practiceof medicine state uh clearly at
all but in other states they areand what that means is there are
(06:23):
state laws that say that only amedical doctor can own a legal
entity that bills and collectsfor medical services and it can
even be criminal like i know umCalifornia and New York and
Texas have some very stronglaws.
And have I explained that wellenough, Chase, or do you have
anything you want to add aboutthat?
SPEAKER_03 (06:43):
Yeah, you know, some
people might just hear
California, Texas, right, NewYork, but really it's roughly 34
states have an explicitprohibition on it.
A few others have some kind ofwishy-washy statements on it, or
their statute might simply say,you can't open a professional
corporation unless you have aprofessional license.
(07:05):
So you've got to be really,really careful.
And in the world we're talkingabout, and it's kind of going to
help us flow in our conversationhere, it's very easy to go
across state lines in treatmentof patients, which means you're
very quickly going topotentially violate corporate
practice of medicine in one ofthese 34-plus states, right?
(07:26):
So it's overlooked, I think,largely because it's not the hot
topic like anti-kickback orStark, right?
And a lot of the owners of theseclinics happen to be
non-licensed professionals,right?
So it's not something atraditional, I think, medical
practice or even healthcarelawyer might look at all the
(07:48):
time.
But in my world, I mean, it'sthe number one question I'm
asked is, do you have a license,right?
Because if you're practicing oremploying healthcare
professionals, this is thebiggest hurdle you have to get
over.
SPEAKER_01 (08:00):
Right.
So entrepreneurs are the kind ofpeople that come to us, whether
they have a license or not, andwant to get into business
because they see the profitmargins.
And then, you know, I alwayswant to encourage people to
start new businesses and dothings 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 knowabout this because you're going
(08:21):
in.
There might be high profitmargins, but you're going into a
highly regulated industry.
Yes.
Yeah, go ahead.
One
SPEAKER_03 (08:28):
more big thing on
that is, there's 50 states,
which means there's 50 laws.
So if you get it right at onestate, you might get it right in
a couple others, but likely youhave to adjust and make sure you
tweak whatever arrangement orstructure you have for those
other states.
Because again, they all havetheir own laws that say what you
can and can't do when you'reinteracting with medical care or
(08:50):
services.
SPEAKER_01 (08:51):
And so for people
who've heard this is a new
concept, you're like, well, howdo you deal with this?
If it's criminal, can you not gointo business?
There are business structuresthat are put into place in
various states.
A common one is a managementcompany arrangement where a
licensee, which is the doctor,is the entity that builds and
collects for the healthcareservices, be it a MediSpa or
(09:13):
some other cosmetic business.
owns, you know, it's owned by adoctor and the doctor has a
management arrangement with amanagement company that could be
owned by investors because it'snot regulated as much who can
own a management company.
Now there are regulations Andall the states you have to look
at is how can you charge themanagement fees?
Can you do percentage fees?
(09:34):
In Florida, that might beproblematic if it's for
marketing services.
So even though there's noMedicare or Medicaid, you still
have to look at all of thoseissues when you're putting
together these managementcompany arrangements, which is
what you see when you have anunlicensed person getting into a
medical business.
Yeah,
SPEAKER_03 (09:52):
yeah.
I mean, it's great.
You know, it's great for us whenthis happens because it's, you
know, a lot of time spent goingthrough the analysis and
educating.
But I think for a lot ofbusiness owners, it's meaning
non-licensed persons,entrepreneurs that want to get
into the space.
The worlds that they are used totypically don't have this type
of regulation and oversight.
And so they tend to overlook howcomplex it could be and frankly,
(10:16):
what risk comes with it.
So yeah, it's the number onequestion I think you have to get
by first.
And if you can get by it andlive with the structures that
you have to live with to do itlegally and compliantly, then
you kind of get into the rest ofit, which isn't as, you know,
isn't any easier.
It's just as complex, butownership is really, you know,
the first number one issue.
SPEAKER_01 (10:37):
Yeah, that is.
And then the other question Iusually look at, and this is a
nationwide presentation, so youreally have to look at what
licenses do I need to operate.
Interestingly, and this issomething not a lot of people
know about, while anyone canmaybe own a medical business in
the state of Florida, you mayneed to have a special license
called a healthcare cliniclicense if you're billing
(10:59):
insurers.
A cash-only business may beexempt from healthcare clinic
licensure.
So those are the types ofquestions.
The second question is, is canI, what is my barrier to entry?
Can I own a business that doesthis legally?
And if not, how do I structuremy investment or can I structure
an investment to own this in away that works out?
(11:19):
And then secondly is what kindof licenses do I need?
It's not just, sometimes it'sjust the providers need to have
the license, but in certainstates there could be facility
or other types of licenses, likemassage establishment license,
you know, it's different things.
SPEAKER_03 (11:31):
Right, cosmetology,
permits, right?
Yeah, we have in this space, wehave this overlay of so many
different types of licensees,services, which means there's
different boards and differentpotential permits, whether it's
Department of Health, Board ofCognitology, that all come into
play here.
SPEAKER_01 (11:48):
Exactly.
And then the other issue.
So let's say we get through thebasic barriers to entry into the
cosmetic medical business.
Another area that you and I werewhen we were preparing for this,
we were discussing that we see alot of is telehealth.
And it's a separate topic in andof itself, like we could do a
whole course.
podcast on telehealth, butbasically that is providing
(12:11):
healthcare via video or phone orsomething other than in-person,
you know, seeing someonepersonally in the office.
And that is very, I thinkpatients like that a lot because
they like the convenience of nothaving to get out of their home.
Often entrepreneurs like itbecause maybe it's less
(12:32):
expensive and they can, youknow, get a lot more, you know,
whatever the cosmetic serviceis.
So something like Botox andfillers, you're going to have to
be in person for that.
Right, right, right.
There
SPEAKER_03 (12:43):
could be more
wellness-focused services.
Weight
SPEAKER_01 (12:46):
loss, hormones,
things like that.
But the other thing, the bigpicture thing to keep in mind is
this is just a regulatedindustry.
Every state, I know Florida hasits own telehealth guidelines
and telemedicine guidelines arein the...
the Medical Practice Actregulations and certain things
(13:07):
you can and cannot do.
So, and in fact, there's 50state surveys on the corporate
practice of medicine, butthere's also on telehealth laws
because every state's a littledifferent, right?
SPEAKER_03 (13:19):
Yeah, COVID changed
everything.
SPEAKER_01 (13:22):
Yeah.
SPEAKER_03 (13:23):
Simply because
people weren't allowed to leave
their homes, in essence, right?
If you wanted care, unless itwas super emergency, you had to
do it remotely.
And so, you know, that was thatwas bad, obviously, because it
was a pretty bad time of time oflife for everybody.
But at the same time, it wasreally good for health care
because it allowed providersactually forced providers, I
(13:46):
think, to evolve and how theycan provide treatments in a more
efficient manner.
And I think what patientslearned is they really like it.
They want it.
And they probably want itsometimes more than they do to,
you know, whether they live in arural area and have to drive far
or, I mean, I live down thestreet from my doctor.
I'd rather just get on a videoand say, hey, I've got a little
(14:06):
sinus infection.
What can we do?
Instead of going to a waitingroom and waiting and driving and
parking.
Right.
So it most of the time createdmore efficient practices.
It gave greater access topeople, but what it did in the
cosmetic and wellness world isit just exploded the amount of
providers that could be in thatspace and the reach that they
(14:28):
had on patients.
that's good and bad because we,you know, saw a drop off in
standard of care because a lotof providers just thought, well,
sometimes I'm going to get avideo or, you know, they're not
thinking about what state thepatient is in.
They're not doing a full, youknow, 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
(14:51):
standard of care has to remainthe same as in person.
But access really shot up andconvenience shot up.
And so, you know, I think froma, regulator's perspective, it's
hard for them to balance, right?
They want to protect thepatient, but the patient really
wants this.
So as a provider, you know, andas a, you know, lawyer advising
provider, I think you have toreally hone in on understanding
(15:13):
your laws for how you establish,you know, patient relationships,
prescribing, you know,regulations, maintaining a high
level or the appropriatestandard of care, but also
understanding from a businessperspective, how can you do this
in a way that allows you toreach more people, you know, and
expand your, you know, electivecosmetic wellness business?
SPEAKER_01 (15:34):
Yeah, exactly.
So I think like the firstquestion when I deal with
clients on this is, can you usethat telehealth platform for
what you want to do?
Like there may be restrictionswith certain type of services
controlled substances.
You may not be able to use it.
And then the other thing thatyou point out that I just want
to reiterate because I thinkit's so important is that you
(15:54):
have to be able to provide thesame 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 fortelehealth to make it like extra
protective of my client thatthey can send it to it.
But really, it has to besomething you can do as well.
And so I have a lot of physicianfriends and clients And someone
(16:17):
will tell me, yes, I can do agreat job via telehealth.
It's very, and then other timesthey'll say in certain
instances, I really just have tosee the patient.
So, you
SPEAKER_03 (16:25):
know.
And I think too, you know, it'simportant that the patient
understands the limitations oftelehealth, right?
And that's the legal liabilityside, right?
How do you disclose to thepatient that telehealth is
probably not as good as inperson, right?
You know, if I can't physicallytouch you or examine you, I
might miss things or I'mprobably going to miss things
versus on a video.
(16:46):
One, two, there could be issueswith connectivity with the
platform you're using.
There could be securitybreaches, right?
So there's more risk with it,obviously.
Ultimately, if the patientconsents to it, I think that's
important.
And to your point, having somesort of consent form or
disclosure that kind of lays outsome of the pros and cons of it,
almost like a treatment initself, I think is a good
(17:10):
practice to push onto yourclients to say, Here's how to
protect yourself if you'restarting to expand your
telehealth business.
SPEAKER_01 (17:17):
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 thisarea of business or doctors who
want to work for a telehealthcompany.
I just reviewed a teleradiologycontract last week.
Some of them, there's thesenational, these big companies.
physician practices that havecropped up where they represent
(17:38):
that they have physicianslicensed in all 50 states and
that's one of the big issues tooit's like you can't can you do
tell you can't do telehealth ona patient in a state where
you're not licensed and so ihave seen them crop up i i don't
know uh i i can't say whetherone's better than the other or
whether it's a good practicemodel but i have seen that
practice model so that peopleare like i want to have a
(18:02):
national telehealth practice,they contract with a provider
that can say, I've got all the50 states covered.
I have seen it.
SPEAKER_03 (18:08):
Yeah.
And so, so, so here's the stackyou've got to be careful of,
right?
You, you live in Florida, right?
You comply with corporatepractice and medicine laws, but
now you've got a patient inGeorgia and Tennessee and Texas,
and you don't have a licensethere.
Well, let me contract withsomebody that does have a
license there, right?
Well, Now we've got to look atyou're practicing medicine in
(18:30):
those states, right?
Or you own a company that'spracticing medicine in those
states.
So are you compliant withcorporate practice laws in those
states?
And then on top of that, are youcompliant with payment
arrangements, right?
Are you paying that doctor orthat group that provides the
doctor in a way that's compliantwith federal or state
anti-kickback or fee-splittinglaws, right?
(18:52):
So now you're tracking, right?
All of these are stacking on topof each other just to say, I
want to open up a clinic thatcan treat patients in a couple
of states on aesthetics, right?
And we haven't even gotten intoinsurance really, right?
How that comes in, I'm not goingto because- I stay away from
that world, you know, as much asI can, but it's just these
(19:13):
little regulations that arestate laws and scope of
practice, supervision, ownershipthat just compound on each other
and getting one wrong couldobviously be, you know,
detrimental to a client's, youknow, business, practice,
license, whatever.
I
SPEAKER_01 (19:27):
want to build on
that because I think it's an
important nuance.
It could be in cosmetic medicineand it could be in other areas,
but definitely in the cash-basedmedical business space is
important.
oftentimes you are dealing witha client who is not licensed and
who is being somewhat of amiddleman in between the patient
(19:48):
and the provider.
And the question, which is noteasy to answer, especially if
you have multiple states, iswhat am I doing and can I be
legally paid for it?
Because it's, am I practicingmedicine without a license?
Am I getting fee splittingillegally for referring
(20:08):
patients?
Or am I doing legitimatemanagement service and getting
paid a fair market valuemanagement fee?
Entrepreneurs are smart peopleout there.
They see a need.
They see a customer base.
Customers want it or patientswant it.
And they're trying to putsomething together.
(20:28):
And so it is challenging becausea lot of the laws that we deal
with as health care lawyers havenot evolved to deal with what's
going on in the health careindustry.
That's a theme that I've seenthroughout my decades of
practice is, you know, we'redoing all this stuff with
cosmetic medicine.
There's developments intelehealth.
Have the laws really caught up.
SPEAKER_03 (20:48):
Yeah, there's a lot
of band-aids that are placed
along the way, but they don'tactually encompass what's
happening on the ground inclinics and how people are
practicing.
SPEAKER_01 (21:00):
Yes, that's why I
feel like we're in the
grassroots of healthcare becausewe get our work a lot of times
by what people are doing andwhat's going on.
And then we have to react to itwith the laws that we have to
date.
SPEAKER_03 (21:12):
Right, right.
I always start off with clientsthat 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 oflaws that are, there's not one
set of laws that says, here'swhat you can do, right?
There's a number of sources thatmight apply.
And that's oftentimes just theguidance that we can give is
(21:34):
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 youroptions.
Here are some risks that go withit.
And, you know, do with that,which you want, right?
If you have a high risktolerance, you can push it a
little bit.
If you don't, then I would maybestay away from this because
there's nothing to support youone way or another.
SPEAKER_01 (21:53):
Yeah, yeah, exactly.
You don't want your client to bemaking the law in the area.
That's it.
I always say
SPEAKER_03 (22:01):
you don't want to be
the example.
SPEAKER_01 (22:03):
Yeah, I mean, that's
a difficult place to be.
So the other issue that I thinkwe see a lot, oh my God, I see
probably...
I could have made this thenumber one issue, but I did it
because I wanted to talk aboutthese other big picture things
first, is scope of practice.
Let's look at it from thepatient and the business person
(22:28):
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 withmy license?
SPEAKER_02 (22:38):
Right.
SPEAKER_01 (22:39):
And does it overlap
with what someone else can do
with their license?
And what I have seen is thatsometimes business owners, you
know, they don't want to, theywant to have profits.
And so they want to use theleast expensive, lowest level of
licensure to do something, butthat might not be the right
person to do the work.
Or it may be like one of thosegray areas you're talking about.
(23:00):
Maybe it's safer with a nursepractitioner and not an LPN, you
know, and nothing wrong withLPNs.
And then the other area of scopeof practice is there's some turf
wars going on in every statethere are.
So whether I think a paramediccan do an IV in your home
properly or not, is, and safely,or I think a medical esthetician
(23:23):
can probably safely do radiofrequency microneedling.
Is that legal?
Because some people, you know,one thing is, can I do it
safely?
Some people feel that they havethe training and maybe I would
argue they do.
But it doesn't matter at the endof the day as a lawyer.
We have to say what is withinyour scope of practice and what
can you do?
And if it's not in your scope ofpractice, you cannot do it
(23:45):
unless we change the law or geta statutory statement or
whatever your process is in yourstate discussing the scope.
SPEAKER_03 (23:54):
Yeah, listen, I
would say this to his face.
My dad is a physician, and Iwould never trust him to start
an IV on me versus paramedic andEMT or whatever, an RN, somebody
with a, quote, lower level ordifferent level of license,
because those are the peoplethat are doing it day in and day
out, sometimes in the worst andcraziest conditions.
(24:17):
And frankly, my dad probablyhasn't done it since medical
school, right?
So, you know, when you talkabout who's actually most
experienced versus what theirlicense allows them to do, very
different, right?
And I think patients probablywant the most experience, but
certainly they want to make surethat, you know, it's being done
safely as well.
And as a business owner, you hitit, right?
(24:38):
What's the least expensive way,you know, for me to provide this
service, right?
to patients, right?
Because everything costs somuch.
I want to make sure I make somesort of profit off this.
Excuse me.
So, yeah, it's really, reallytricky.
And, you know, you broughtsomething up with like
estheticians, you know, a lot oftimes in Florida, estheticians,
(24:59):
well, an esthetician actuallyisn't even a license in the
state of Florida.
SPEAKER_01 (25:02):
They're cosmetic.
They're under the board ofcosmetology.
There's no such thing as amedical esthetician.
And now a medical assistant issomething and you can be a
trained esthetician.
esthetician that operates as amedical assistant, but the
doctor has to be right there andit's very limited in what you
can do.
SPEAKER_03 (25:19):
Yeah.
And then when you think aboutestheticians or cosmetologists,
right, and they fall into thatboard, that's not medical,
that's professional andbusiness, you know, completely
different, you know,governmental board in the state
of Florida and many otherstates, similar, some states
have medical estheticians, but,you know, I oftentimes get the
question, well, if I have aphysician that supervises me,
Couldn't I be a medicalesthetician?
(25:40):
Well, they're different.
Having a physician doesn'tchange anything unless you're on
site with them.
And then you're a medicalassistant 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 thatthere's a lot of information
shared.
And unfortunately, it's notalways accurate.
And people have this idea intheir head of, oh, I read this
(26:02):
and I can do it or everyone'sdoing it that way.
So why can't I do it that way?
SPEAKER_01 (26:06):
I'll just throw out
a generalization that may not
apply everywhere, but I willthrow 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 onsite.
In Florida, we have a, there isa way for a nurse practitioner
to be an independent practice,but it's only as to primary
(26:29):
care.
SPEAKER_03 (26:30):
Right.
SPEAKER_01 (26:31):
So unless you're
getting Botox.
That
SPEAKER_03 (26:32):
definition is so
poorly written that, you know.
It's very hard to, yeah.
What does that even
SPEAKER_01 (26:37):
mean, right?
Yeah, if you're getting, becausethey'll be like, I'm an
independent practice, so I needa protocol position for my money
spot.
And of course you do.
You're not just doing Botox formigraines.
You know, we...
Yes.
So check your state, but thosehigher trained licensees that
are under doctors are usuallyvery helpful in this industry
(27:00):
and can do a lot and really dohave a lot of experience with
Botox fillers, other types ofservices and can really safely,
generally speaking, Safelyperform a lot.
I have been involved from timeto time in a process to expand a
scope of practice and otherpeople in my office have too.
(27:21):
And it's not gonna be this, I'mgonna just generally describe in
Florida what goes on, but checkin your relevant state we have a
declaratory statement process.
It's an administrative processwhere you can ask the board, you
know, I'm an RN and the doctor'sright there and I'm trained in
Botox.
(27:43):
Can I inject patients withBotox?
I think the key is the doctorhas to be there in Florida, but
like, you know, those are thetypes of scope of practice
questions.
And normally how we do it iswe'll call the board lawyer
first and say, Hey, take yourtemperature because we don't
want to have like a negativething.
But if they're like, yeah, Ithink they'd be open to that.
(28:03):
And then you do the deck action.
So there are ways to ask theregulatory boards in various
states about this, aboutexpanding practice as
developments occur.
But just be wary of that andknow that there's a process you
can probably look into in yourstate and possibly expand.
Or you can work with tradeorganizations to, you know, get
(28:25):
some of these practicesexpanded.
Or you can do it by statute.
The one that I was talkingabout, the nurse doing Botox, it
would have to arguably be underthe current statutory framework.
If you want to really expandpractice, you would work with a
lobbyist and get your state lawschanged.
(28:46):
I
SPEAKER_03 (28:47):
think that
declaratory statements are a
powerful tool to And at least inFlorida, there's a lot of
flexibility underneath thecurrent statutes.
SPEAKER_01 (28:59):
Exactly, exactly.
So the last theory I want totalk about before we talk about
kind of what we're seeing is thehot topics or the hot areas.
This is the area that I see allthe time, and I even have a
medical advertising checklist.
It's advertising and marketing.
Because again, I'm looking atthose entrepreneurial clients
(29:21):
that are coming in my office,wanting the high profits, the
startup of the business, the lowcosts, and also they wanna
market and get in as manypatients as possible.
In the cosmetic medicalindustry, I don't, you know,
some people have themisconception that there's no
Medicare or Tricare or Medicaid,so it's not regulated.
That is not true at all.
(29:43):
There are very strong, inFlorida and other states, there
are very strong criminal laws orlaws that can get your medical
director in trouble for false ormisleading advertising.
In Florida and in many otherstates, it's a felony to pay for
patient brokering, which is likekickback.
And so you just have to bethoughtful about how you pay
(30:06):
marketers.
You can't give someone$100 perreferral.
And you know who turns you in?
Right, Chase?
It's the competitors.
They're like, well, my lawyersaid I couldn't do that, but
look at this letter I got fromthe MediSpot.
I'm going to write the Board ofMedicine, and guess who gets
dinged for that?
Maybe the licensed providers, ifthey're owners, or the actual
(30:29):
medical director who's agreed tobe the protocol physician.
Right, who's
SPEAKER_03 (30:32):
probably not even
been to the clinic in her life.
SPEAKER_01 (30:35):
Exactly.
Yeah,
SPEAKER_03 (30:37):
competitors, and
then sometimes upset employees,
former employees, things likethat.
who don't like how theiremployment ended, right?
So you've got to be reallycareful with that.
SPEAKER_01 (30:51):
Yeah, and the other
thing that we were talking about
when we were preparing for thiswas off-label promotion because
that's another area you cannotpromote off-label.
SPEAKER_03 (31:03):
Right, yeah, so from
the standpoint of advertising
services or products, especiallyin this space, you've got to be
really, really careful with howyou promote weight loss drugs
or, you know, regenerativemedicine, you know, treatments,
right?
The FDA has purview over, youknow, obviously food, drugs,
(31:25):
right?
Cosmetics, right?
So if something either isn't FDAapproved or, you know,
explicitly prohibited by theFDA, or you're using it off
label from an FDA use, right?
you have to be really, reallycareful with how you advertise
that treatment or service, howyou disclaim that to the
patient, right?
Patient education consent isobviously, you know, first and
(31:49):
foremost, and you don't want tobe misleading about it.
You don't want to, you know,make, you know, statements that
are untrue or misrepresent, youknow, exactly what could happen.
And so, you know, you overlookit, but look at how you're
marketing, look at what you'reyou know, Instagram says about
this treatment or whatever itis, and find out if you have to
(32:10):
say something specifically to,you know, what the FDA says, you
know, you've got to be reallycareful with it, because not
only will the board come down onyou, but the FDA, you know,
could could inquire or send aletter, right, make a statement
as well.
And that could really crush notonly your business, but your
license, if you have one or yourprovider's licenses.
SPEAKER_01 (32:29):
I try to be very
proactive about it because I
think many business owners whoare entering into a cosmetic
medical business may not even beaware that their advertising is
regulated.
And just by way of example, inthe state of Florida alone,
there is a regulation under theMedical Practice Act that says
that you cannot have false ormisleading advertising.
(32:52):
The medical director's name hasto be in your ad for medical
SPEAKER_02 (32:55):
services.
SPEAKER_01 (32:55):
There is like a very
detailed disclaimer that you
have to have in your ad if youoffer free or discounted
services.
Like I said, kickbacks, referralfees, those are actually...
felonies.
And that's just in the off-labelpromotion.
That's just some state andfederal laws that we'd be
(33:15):
looking at for every business.
So I try to be proactive.
And I know I have a new clientin this area.
That's why I created the medicaladvertising checklist.
And I'm like, here, look atthis, and then let's talk about
your advertising.
And also how you pay marketers.
It is very commonplace to wantto pay people based on their
production in...
in this field.
(33:36):
And so, you know, we have tohave a conversation about the
risks in that and how you canstructure pay for marketing
people.
But, you know, it may bedifferent if they're employees
versus independent contractorsin Florida.
SPEAKER_03 (33:49):
Yeah.
Listen, if you don't want to getin trouble, then you're not
going to be public facing,right?
You're not going to havepatients.
You're not going to market.
You're not going to advertise.
But obviously, every clinic isgoing to want to do that.
And once you put yourself on themap, that's where you are gonna
start to see scrutiny from thethree-letter agencies that are
out there.
So have that done correctly,because that's the first thing
(34:12):
they're gonna see, and that'sgonna lead them to you further.
And unfortunately, a lot ofthese agencies and people that
work there are not familiar withthese types of clinics.
So if they see something thatthey don't like, they're gonna
kind of shoot first and askquestions later, and that's
gonna...
now you're behind the eight balland trying to defend yourself
(34:33):
versus, Hey, I had everythingcorrect.
And they didn't even look at meor they didn't even inquire any
further.
So, you know, protect yourselfon, on the front end, build a,
you know, big shield out therewith how you market by doing it
compliantly.
And I think you'll really avoid,you know, a lot of unnecessary
inquiries.
SPEAKER_01 (34:49):
Exactly.
The other thing I wanted tomention is the, is medical
directors.
And this is really for thedoctors from their perspective.
Doctors are going to be not,whether you're a business owner
or not, the physicians are goingto play an important part in
this cosmetic medical industry,whether they're the owner or the
(35:10):
direct provider or just thesupervisor.
Um, It is a, you know, it is agood field to get into.
They certainly can supervise andtrain people.
They just need to know whatthey're getting into and they
can't just dial it in or phoneit in.
You know, they really, becausethey do have legitimate
liability for supervising theseproviders.
SPEAKER_03 (35:29):
The biggest
misconception I see when I talk
to a doctor that says, Hey, I'vegot this agreement to supervise
or be a medical director is theythink I've got no risk, no
liability and no responsibility.
Right.
Um, And that's couldn't befurther from the truth.
You are the name, you are thelicense, you are responsible for
the people that are touchingpatients, right.
(35:49):
Treating patients.
And if you're out to lunch andnot paying attention, if you're
not experienced, if you don'tknow what's going on or have any
involvement, whether there's,you know, just general protocols
or there's, you know, adverseevents and you're not involved,
uh, you're going to get hitpretty hard.
You know, when someone files alawsuit or a border agency comes
in and says, who are we goingafter because who's doing the
(36:12):
most wrong here?
So, you know, for a thousandbucks a month, right?
You better really make sure youknow exactly what your
responsibilities are, whateveryone's doing and be
protected if something goeswrong.
Cause you know, that, thatamount of money is not worth it
for your license or for alawsuit.
So, you know, I see a lot of,you know, really low cost, uh,
you know, engagements.
(36:34):
And unfortunately, you know,with that, I think people think
this means I don't have to domuch or worry about anything.
But really, it's a lot ofresponsibility and liability.
SPEAKER_01 (36:43):
Exactly.
Well, I think we've covered likethe main big issues that we see
a lot.
And before we end our podcast, Iwanted to go into what some of
the trends are.
Like I said, we're thegrassroots lawyers.
We see what's going on.
Yeah.
SPEAKER_02 (36:59):
You
SPEAKER_01 (37:00):
know, What are you
seeing?
What's out there, Chase, in thegrassroots?
SPEAKER_03 (37:06):
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 anddevelop, and then the biohacking
and what I call the precisionmedicine world.
(37:26):
A lot of that is focused onwellness.
There's physical aesthetics thatgo into that as well.
But I think those treatments andthose areas are so young in this
space and people want more andmore to look young, feel young,
live forever, reverse their age,and know exactly what's going on
(37:50):
with their body.
That area is going to continueto expand.
And right now, there's not a lotof regulation, excuse me, on
those areas.
So, you know, GLP-1s, weightloss drugs, the FDA, you know,
has been very involved withthose recently because a lot of
(38:12):
the drugs were on the FDAshortage list.
They recently came off the FDAshortage list.
And now the drug manufacturers,the Eli Lilly's, Novo Nordisk,
et cetera, You know, they nowget to, you know, recontrol this
weight loss world and journeythat people are on rather than
compound pharmacies.
And so now you've got a lot ofpeople who are like battling
(38:34):
with, you know, do I usecompound drugs?
Do I use the FDA approved drugs?
There's marketing issues there,all of this stuff.
But that space is going tocontinue to grow.
It's so young, but it'sconstantly developing.
And I think a lot of peoplereally, really are interested in
it.
SPEAKER_01 (38:49):
And then the other
thing that you and I were saying
that we, I wrote an article onit because it was so popular.
It's IV therapy.
SPEAKER_02 (38:56):
Yeah.
SPEAKER_01 (38:57):
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 inthat, like we're dealing with it
in Florida, but it's, it's, youknow, it's a nationally popular
issue is who can do it, whatlevel of licensure.
(39:18):
And then if you go intosomeone's home, are you a home
health agency?
What are you, do you need otherlicenses to go into people's
homes?
What if you do it in a vanoutside of someone's home?
What if you have a brick andmortar practice?
So who can
SPEAKER_03 (39:29):
actually, who can
actually perform it and
supervision who needs to bethere, right?
Exactly.
There's a lot that goes into IVtherapy.
More complex, you know,compounded bags, right?
Who's compounding it, right?
What type of requirements forcompounding do you need to have
before you can actually create abag and then deliver it to a
(39:51):
patient?
Yeah, that's growing.
And, you know, the instantdelivery of it, you know, I
think is the big aspect whereyou've got telehealth that's
going to overlay on it.
You've got licensure, like yousaid.
It's going to be interesting tosee how that continues to
develop, you know, across thecountry.
SPEAKER_01 (40:06):
I feel like we could
do a podcast about like so many
of the topics that we justdiscussed.
SPEAKER_03 (40:13):
Yeah.
Each of these areas.
Yeah.
And then the last one is that,you know, precision medicine,
right.
Which is really, you know, anapproach to healthcare that has,
you know, custom treatments,right.
You're looking at people'sgenetics, their lifestyle and
environment, right.
And you're, it's preventativemedicine, but like on steroids
(40:34):
for lack of a better term, it's,it's a way in which you're like,
not only just looking six monthsin 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, aresuper, super, I think, elite
right now.
(40:54):
But there's a lot of online onesthat are popping up, blood tests
at home, that go further thanwhat you get at Quest and
LabCorp, right?
So being able to understand andadvise clients on all the
nuanced regulations that comewith a treatment like that or a
product or service like that, Ithink over the next five, 10
years and more is gonna bereally, really important.
SPEAKER_01 (41:16):
Exactly.
No, thank you for that.
So big picture...
Can you even do this business?
If so, how does it have to bestructured?
What licenses do you need?
What level of licensure do yourproviders need?
And how can you bring inbusiness and how can you
advertise?
So those are the big ones.
(41:37):
So thank you for your timetoday, Chase.
I thought we had a good time anda good discussion.
We have so much to talk about.
Hopefully we'll get to do thisagain at some point, but I
really enjoyed this.
And thank you to the AmericanHealth Lawyers Association for
giving us this platform.
And that's it.
Thanks, everyone.
SPEAKER_03 (41:55):
Thanks.
SPEAKER_00 (42:01):
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this private podcast feed to
your podcast app, go toAmericanHealthLaw.org
(42:30):
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