Phoebe Gutierrez and Dr. Leo Damasco kick off a new monthly segment recapping telemedicine news. From HIPAA marketing violations to compounding pharmacy crackdowns and Texas med spa regulations, stay informed on the latest rules and compliance tips.
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In this episode, Phoebe Gutierrez and Dr. Leo Damasco launch a new monthly segment to keep telemedicine practitioners up to date on critical news and regulations. They dive into April’s biggest updates, including HIPAA violations tied to marketing tracking tools, compounding pharmacy workarounds for weight loss drugs, corporate practice of medicine lawsuits, and new Texas med spa oversight laws. The episode also touches on federal healthcare changes, such as CMS guidance and DEA prescribing rules. Packed with actionable insights, this episode is essential for clinicians navigating the fast-evolving telemedicine landscape.
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About the Show:
Telemedicine Talks explores the evolving world of digital health, helping physicians navigate new opportunities, regulatory challenges, and career transitions in telemedicine.
About the Hosts:
Telemedicine 15
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Speaker 1: [00:00:00] Welcome back everybody to telemedicine Talks with Phoebe Gutierrez and Leo Damascus. So, , happy to have you guys back and, I'm super excited to start this new segment. you know, Phoebe brought up a great idea. We're every month we're gonna start recapping news of the month, you know, what's, new news, what we need to know to keep you guys updated.
So definitely check back at the beginning of every month to, stay up to date with telemedicine rules, compliance, and to keep yourself clean. So Phoebe, uh, take it away.
What are our monthly updates today ? Yeah, so I think today we're gonna cover like a bunch of, different topics I'm gonna be covering, just some recent updates from like the federal government in terms of just like basic reminders for people, you know, if you're in these markets, what you can consider.
also just gonna share some, Health Tech Insider kind of like information there's different things that are coming out. and then ultimately just some key regulations that, I wanna flag for people just to kind of keep. [00:01:00] Top of mind. So, I think like one of the biggest things that kind of has happened in April is, you know, I, I'm gonna jump in and kind of just talk about hipaa.
And so there are a lot of changes that are happening in hipaa, and a lot of it actually has to go with how things are effectively marketed and how things are presented. So what most doctors don't understand is like at all these companies that you're working for, there is a lot of tracking that they put into their marketing.
Processes. And, it's like pixels and they're tracking all this different stuff and it's basically considered now PHI. So like the FTC is saying like, that's PHI, you actually can't be tracking that information because, it kind of violates certain rules. And so. Effectively this month, organizations and companies are supposed to, ultimately stop tracking, at that level.
So not you using like third party tools [00:02:00] like Megapixel and Google Analytics, like they just have to be really careful if they're tracking it based on patient data. so the department, HHS has started to really, present some enforcement activities related to unauthorized tracking for patient behavior.
Um, and there's like major HIPAA violations associated with it. So one of the big things is just like. If you are a clinic or an organization and you have no idea of how you're tracking advertisements or how you're using your Facebook tracking, make sure you are not tracking these things, because it could be a big violation if you have a marketing team or a marketing person, like talk to them and they can definitely confirm it for you.
you're gonna also wanna make sure that you update your, notice of privacy practices. With this, additional caveat there. So that is a little bit on the HIPAA marketing side of things. And for people who don't know, as much [00:03:00] as. we love to talk about privacy and security and supervision and corporate practice of medicine and a bunch of other key regulations.
Marketing is extremely regulated in the healthcare space, and I think sometimes people think it's a free for all and it really is not. So that's one big thing to kind of focus on now. and so this is interesting, right? So, you know, there's tons of tracking, right? You go on Facebook, so forth and so forth, and you're continuously tracked.
And I know your marketers, If you have a marketing team, they definitely, use those tools. Now, so this is more tailored towards, those that have their own kind of telemedicine business and are using a market. is that right? Trying to understand this better.
yeah, what questions do you need to ask your marketing team then, to make sure that they are up to date with their marketing, uh, I guess activities on behalf of you. Right. Because whatever they do is. Directly linked to you, I'm assuming? Yeah, for the most part. The key questions you just wanna ask are h what [00:04:00] kind of patient level data are we tracking from an advertisement stance?
and then ultimately, are we using Facebook pixels? how are we using Google Analytics? If you're working with a big company and you go, look, I'm trying to comply with these new HIPAA rules and these new Facebook rules, you're asking the right questions and a real marketer or real marketing team will know exactly how to address those.
Oh, that's interesting. New, PHI people. that's gonna pop up in one of the questions and do HIPAA training, right? You guys will be like, you know, when you're doing your annual thing and be like, right. Said it. It's in my Do not choose a Google Pixel choice.
Stay away from that. If it's part of all the above, the answer is not all the above. So, Yeah. So one other key thing, and this is kind of like a really good segue into some additional things, that kind of popped out in April, of course is, you know, compounding compliance and like safeguards around compounding.
So we've talked about it a lot. I think probably [00:05:00] all of our listeners think I probably hate weight loss. I don't, I just, like every other consumer have concerns with some things that I, see and, are a little troublesome. So in the ever evolving landscape of
Weight loss and the compounds. as we all know, I think we even did a podcast about this, Leo, you know, semaglutide and tirzepatide are no longer on the short list. Yeah. Which means compounded pharmacies cannot, distribute them. So. Healthcare organizations or telemedicine companies are trying to find workarounds so they can continue to use the same pharmacies.
And I think one of the interesting workarounds that is being used is this idea of personalized prescriptions, which basically means if we think that you could not, get ozempic because you're allergic or there's something else, you can still go the compounded route. What some of the companies are doing is they're actually making kind of [00:06:00] blanket statements where they're adding, vitamin B12 or, Carnegie or something like that.
I don't know the science. Okay. I know the regulations. I don't know the science, but basically the main reason that compounding isn't globally. Approved or authorized is because it's not tested by the FDA. So as you're adding a different things and compounding different things, you actually have no idea what the side effects are for those kind of downstream things and how it might interact with other things that are in your body, you know, so on and so forth.
So. It is been interesting 'cause it is approaching, the final cutoff I think was like April 22nd and it's now kind of approaching the very tail end where like they kind of need to cease the operations. and ultimately, the drug manufacturers are coming after these telemedicine companies that are refusing to listen to the FDA [00:07:00] rules.
And it's interesting what some of the allegations in some of these lawsuits are, to kind of just name a few one is deceptive marketing. So piggybacking off of kind of the talk about marketing in healthcare marketing, there are a few things that you cannot say. you can get in a lot of trouble.
one is having guarantees. So in healthcare, nothing can be guaranteed. You can't say, we will guarantee 100% or your money back. It looks like deceptive marketing because you actually, until you assess that person clinically, how can you actually know if they're gonna be a viable candidate or not? So that's one thing.
Thing. Another thing is you're actually not able to use the brand name Tirzepatide on any of your marketing materials. that is. Owned, by other companies. So a lot of companies, you're supposed to say GLP ones again, [00:08:00] because you technically can't use the specific terminology, as associated with some of the drug manufacturers.
So that's another thing. and then I think, ultimately really making sure that everything is presented as being. up to a clinician to appropriately assess you. And so if you're marketing and you're saying like, you can get this and you can get that and you can get this, and there's no mention of any sort of like clinical barrier or requiring, you know, a specific.
Speaker 1: consultation and prerequisite for the care, like really establishing that medical necessity there. again, it's just kind of deemed as like a, potentially like fraudulent marketing. And so, those are just key things that I think, you hire a marketing firm. Those are the three things.
They're gonna focus on it, right? Like guarantees and this and that. And they don't necessarily understand the full landscape of how like the compliance side in healthcare works. And so again, just really wanting to pinpoint that was one of the big kind of [00:09:00] complaints in some of the lawsuits that kind of came out.
the next big piece of it was tied to corporate practice of medicine ultimately. Alleging that CEOs were controlling the clinical decision making. So in some, they claimed that, prescriptions were like in mass, Reauthorized or adjusted. so moving somebody from semaglutide to Tirzepatide, but for all people, again, wouldn't that in theory like require another clinical visit or some sort of assessment prior to doing that, or at least a clinician approval?
So there's a lot of talks around were the clinicians making independent clinical. Decisions. was there a specific incentive for them to turn a blind eye? I have no idea.
Okay. So one key piece of it is that they're basically claiming that potentially clinicians were not [00:10:00] making independent clinical decisions, which as we know, with corporate practice of medicine, like that is the basis of corporate practice of medicine.
We don't want this company to own the clinical decision making because they're skewed because they want the business to just be successful, right? And make as much money as possible. So interestingly enough, you have patients that were, in bulk almost. I. Authorized to different prescriptions without having an additional consult without even being notified that their drugs were changing.
They just kind of received packages of drugs. Um, so there's a lot of questions just around like how operationally that happened at some of these large companies, if they had the correct clinical protocols and oversight in place. I think the biggest thing is that I. In a lot of these telemedicine companies, and I'm sure everybody, all of our [00:11:00] listeners know this at this point, you gotta make sure that you're asking the right questions and protecting your own license.
And so if it ever appears that you are just authorizing based on some sort of company decision and you don't actually have the ability to independently make that clinical assumption, To me that does blur the line between business and clinical care. And so again, that's the basis of what the lawsuits are, alleging is that the drugs that are FDA approved went through rigorous, clinical trials for.
Basically all of the above. And they are saying that the things that are being added as these personalized prescriptions are not safe and they are giving people side effects, and companies are continuously, looking for these interesting workarounds, but where the clinicians who should be making these decisions.
Oh, Okay. So really. Now what? if [00:12:00] these workarounds are part of the clinical practice guidelines that let's say the chief medical officer says, okay, you know, of the company signs off on, right? So you have these guidelines. But I guess the issue, what you're saying too, is the issue is that, okay, they are getting this, big group of patients and just switching 'em over and not necessarily tailoring that to each specific patient.
Yeah, I think like my take from like an auditor's lens is like, if I was doing a desk audit, at a clinic, for example, and every single person deviated from the normal standard of care and required an additional personalized thing, I would wanna understand like what that criteria is that makes that person or makes that service.
medically necessary. I think, again, it's a little bit more just like optically, Now, I don't know. I have no idea [00:13:00] whatsoever if adding B12 to Tirzepatide does anything or doesn't do anything, or I have no idea. But I think when we're talking about, again, wanting to craft something that.
complies with the rules and the requirements, and you're just watering it down. And then in theory, making blanket, like medical necessity determinations. I think that's where it gets a little iffy. Yeah, totally get it right, because if they're arguing, Hey, we're individualizing this medication to each separate patient.
But you're right, you make a sweeping change in bulk of these patients and it's gonna be hard to argue yeah. That every single patient that was switched, the whole history was, readdressed again, so forth and so on. So, I, see that.
Yeah, I think it's, again, a tough thing, right? Yeah. I think that until [00:14:00] you truly dive in Yeah. From the clinical side, again, I think that's where it goes back to, if the drugs are different and you're switching prescriptions, it probably does warrant, thinking standard of care.
Yeah. And the normal prescribing requirements in telemedicine, like probably does warrant like an additional type of interaction and encounter. And it's pretty vague either way though, right? So it's gonna be interesting to see what kind of pans out. Because I'm assuming, I hope that, when the patient was switched to a medication with an additive, like we were talking about, the vitamin B or carnitine, that was done through another separate encounter.
but I guess what you're saying is some companies didn't, they just switched them in bulk and said, Hey, here's your new meds without a new encounter. That's where I guess, yeah, so I think there's some stuff again where like from a person who's done the operation side and the compliance side, and then the regulator side from an [00:15:00] operation stance, like in a startup, like you would think, oh, no, no, this is just for operations.
It totally makes sense. Oh, absolutely it does. You know what I mean? totally fine. It's super efficient operationally, right? Yeah. But I think that's where it just gets a little bit of Where's the protocol, where's the process? where's the criteria?
And I'm a big person and, in all my recommendation to physicians is always if you wanna make these decisions that, in theory, like you do wanna do personalized prescriptions, right? what is the criteria? So a person needs to be X, y, and Z. Before they would be eligible for a personalized prescription.
And then from there, here's all the other criteria that's gonna be required for it. I think to me that's what I would be looking for. So, looking back at the doctors, that are doing this weight loss, and there's a lot of us, I guess the question to ask yourselves is.
Hey, when my patients, the patients assigned to you are assigned, you are switched, right? was there, a new encounter? Was this encounter [00:16:00] individualized? And, one piece of caution is, not just signing off on a whole list of people to say, Hey, this is good. And,
I guess keep yourself squeaky clean is just Yeah. Document and have new encounters. Yeah. And I think where it even gets even a little bit more like to, make it more complicated is that in some states there's some pretty specific requirements if you are prescribing weight loss.
Yeah. What the criteria is that needs to be met and then what the actual required like. Lab testing that has to get done. So there's like some of these like really specific and really prescriptive rules that kind of almost like go around the weight loss. And so again, it's just more of anything in telemedicine is a little bit
Speaker 1 (2): harder.
Speaker 1: Yeah. Um, mainly just because the rules are again. So nuanced, and it is tough. It is tough when you have clinicians, physicians working in this space, [00:17:00] especially, in the startup space where it's a company that's, growing and figuring things out, which unfortunately, the healthcare industry, healthcare regulators like that is just not a good enough excuse for us.
when something does come up like this. Yeah, and you know, we talk about operations and efficiency, so forth and so on, but, I just personally wanna stress, it also just boils down to patient safety, right. And it's what's good for the patient, right? Yeah. For the most part, these additives may not cause any problems, but who knows, right?
So, yeah, I could see the rub there. awesome. Yeah, well, and now, jumping over to a different kind of like adjacent space. and I think that, the med spa space is also making some changes a little bit. So I talked a little bit about this last month, but especially in Texas.
One thing about regulations is usually one big state needs to pass some sort of legislation and [00:18:00] other states will follow. So like when I was a California regulator, that was something that like, we kind of took pride in. nobody else is doing these crazy rules, let's go try to do them.
Let's see if other states pick up. and half the time that's what happens. So in Texas there's a house, bill. HB 37 49, also known as Jennifer's Law. So there was a woman named Jennifer, who passed away due to IV hydration in Texas. And so this bill basically proposes to require more physician oversight, and more physician presence, and puts a lot more.
Risk on the physician and basically just accountability on the physician for clinical decision making, responding to emergencies, so on, so forth. So for physicians that are either like supervising med spas in Texas, it, ultimately. [00:19:00] Some of the key requirements that were originally in the bill, about like almost requiring a physician to be on site.
daily those things have been stuck out and now it's a little bit more on some of the, less. trained staff. So like EMTs, RNs, those are still on the table, where they're discussing exactly what limitations they're gonna put in terms of who can do IV hydration in Texas.
Speaker 1: the other big thing in Texas is just that Texas is starting to enforce. In telemedicine, and by that they mean that they are really digging into people's, like business structure. They're really digging into, collaborations and medical directorships and all these different things.
And they're really actually starting to enforce, mainly due to. What I like to call, like the rubber stamp physician where sure, I'll do these things and I'll help you [00:20:00] comply, but I'm not really actually doing my part on the operational side. I'm just like there for the piece of paper.
And so Texas is putting out a lot more effort to encourage and actually require, clinics and practitioners to tell patients how to submit. A Texas Medical Board claim, if anything happens. So Texas, actually now it is required for anything that is patient facing a consent form, a marketing landing page, a website, anything in Texas now has to have a really good instruction set and kind of guidance on.
If they have a grievance they need , they can report that to the Texas Medical Board. And that is a brand new rule, that just, came out. No, that's totally interesting, right? I like the accountability piece, it's definitely front forward. but yeah, no, that, that is super [00:21:00] interesting.
and really like you said, that's pretty low hanging fruit on people's end, right? It's just putting it out there, um, it's just needing to know about the requirement, right? I think most often we are all, you're a business owner. You're, just trying to maintain the normal day to day.
You're not gonna go, oh, I need to update all my consent
Speaker 1 (2): forms.
Speaker 1: I need to update my website. I need to add these little things so I don't get in trouble. and so to me it's just, again, like as long as you know that those are now things that you need to publicly share with your patients or who's being served, you should be fine as long as you actually implement on the requirements.
Yeah.
And then I think, just some other kind of just key things that are happening in the background and just like basic reminders. So as we all know, there's a lot of stuff happening at the federal government level Yeah. At the moment. budget savings and funding cuts, Medicaid is [00:22:00] really under the spotlight.
so I'm, I am personally like tracking that very closely. in terms of just where everything is shaking out, CMS did issue some guidance saying that physicians are responsible to report through Picos. Anyone who is supervising anybody at an organization. And again, I think this is a little bit more geared towards like the telemedicine side of business, but they did come out stating that and they did direct it at physicians.
So just a end of a month call out, like make sure you log into your picos if you're doing anything in the Medicare space. Work with an organization. If you're working with an organization. ask them if they have, Help or they can support you. But that's one big, kind of like call out.
we all know, health and Human Services is going through a reorg. and they, now have an administration for Healthy America. my friends in CMS, they say they call it [00:23:00] Maha.
Very catchy name there. There, are looking at cutting around 20,000, employees. Through this reorganization. and I think we're all a little kind of on the edge of our seat, at least us, policy junkies over here. how does that gonna affect policy and like the implementation of it, like.
Uh, I mean, I don't necessarily think it's gonna be the implementation of the policy. I think you're going to have a significant gap in knowledge. Yeah. I think my biggest concern is, I joke about this, I can go to my government. I can go to DHCS, my old, stomping grounds and I speak their language.
I understand this stuff. I know the historical background of how things came about. you're cutting a lot of people who have that background. Yeah. If things aren't documented well, if there isn't a good handoff, you're just gonna lose a lot of that information, which is going to. Unfortunately kill a lot of
Speaker 1 (2): momentum.
Speaker 1: Yeah. So [00:24:00] interestingly enough, CMS has released a bunch of new like final rule regulations. So at least there's that, which is gonna give states, a good 12 to 18 months to start thinking about how they're gonna operationalize and, build their operations to comply with some of those new rules.
but I'd like to say some major policy changes will probably go a little bit slower. you're probably looking at some things that might have been in the very early days, probably dead,
Speaker 1 (2): unfortunately.
Speaker 1: Yeah. Um, if you don't have somebody who's gonna pick up the torch and carry it across the finish line, and I just know that personally 'cause that happened to some of my stuff too when I left.
but ultimately I think there's gonna be some things, in that space a little bit. Yeah. Yeah. We'll Wait and see. It's a huge reorg and huge reconstruction.
looking into some rules and regulations. I think one other thing that. Is going to be interesting and I'm really excited to actually see where the new DEA prescribing rules and regulations are gonna land.
and I know that there's a lot of doctors out there and clinics that are like, oh, everything's gonna get [00:25:00] extended and everything's gonna be great. And I am going to dissent and I'm gonna say I wanna see some tighter regulations around healthcare companies that are doing controlled prescribing.
and, have some more, maybe like certifications imposed on telemedicine companies. that's just a mixed bag. 'cause I'm in the camp where it just makes sense to extend it out. It's just, good for the patient, so forth and so on.
But man, things are recently have just been a crapshoot. So, you know, it's gonna be interesting to see where that kind of finally plays out. I think like you have to understand like my thought process a little bit is so in California before a health plan wants to actually serve.
A single person in California, they would go through 18 months of what's called readiness. Yeah. And we would review 500 policies and procedures and we would go audit their systems and we would have one-on-one interviews and we would really, we would do secret shopper surveys and call their clinics and see what the experience, I mean, [00:26:00] we would do end to end to make sure that the second they saw one person, we had blessed it and that.
At the very end of it, we could at least say they're
Speaker 1 (2): ready.
Speaker 1: Yeah. And I think all I'm asking for in this space is that there's a little bit more checks and balances before a company can go. I set up my agreement and I now have a, PC MSO structure. and I have $3 million from a VC company.
I'm gonna go start clinically treating patients like, I think a little friction there to require a submission or an interview or an approval process. I view that as just being a baseline for keeping people safe. Yeah. and yeah, if anybody wants to, start that state agency, I'd be
Happy to join.
Maybe it'll be part of Maha. Right,Well shoot. thanks Phoebe. Thanks for that great rundown. and hey, I definitely [00:27:00] expect this to be a regular thing. I think this is super useful. You know, keeping up to date with what's going on is super important for those that practice in telemedicine, especially since it's such a moving target.
so yeah, definitely check it out. Check us out every month. Also, if you have any specific questions, Phoebe is a treasure trove of knowledge. Yes, I said it trove. email her separately, phoebe@telemedicinetax.com. and definitely tap into all that knowledge. closing thoughts. Phoebe, closing thoughts are, you know, this is the tip of the iceberg.
Like these are the big things that I found were important or interesting and like some of my research, but I. don't forget that for your specific, you know, the companies you're working for, the patients you're serving, the scope of services you provide, like there's a thousand other rules that probably changed this month alone.
And so, just making sure that, you're building in internal [00:28:00] processes to do some checks and balances. especially if you're in the Medicare and Medicaid space. But looking at some of the stuff with Eli Lilly like. If you're cash pay too, like you really just wanna stay informed.
and if you ever have any questions or you want us to dive into a topic, shoot us an email. I would love to, expand this to, build in other topics that y'all wanna hear about. Yeah, no, I would definitely love to hear from y'all. and so we could tailor this so it's, it makes more useful for everybody.
Awesome. Well, hey, thank you guys so much for joining us and can't wait to see y'all later