AHLA's Speaking of Health Law

Top Ten 2025: Telehealth—Uncertainty Ahead

• American Health Law Association

Share episode

Based on AHLA's annual Health Law Connections article, this special series brings together thought leaders from across the health law field to discuss the top ten issues of 2025. In the second episode, Jennifer Kreick, Partner, Haynes Boone, speaks with Jeremy Sherer, Partner, Orrick Herrington & Sutcliffe LLP, about the various telehealth legal issues coming down the pike in 2025. They discuss the future of Medicare telehealth flexibilities, government scrutiny of telehealth and current enforcement initiatives, and requirements around controlled substance prescribing and in-person visits. From AHLA's Health Information and Technology Practice Group.

Watch the conversation here. Learn more about AHLA's upcoming conference, "Telemedicine: Legal and Compliance Issues," here.

AHLA's Health Law Daily Podcast Is Here!

AHLA's popular Health Law Daily email newsletter is now a daily podcast, exclusively for AHLA Premium members. Get all your health law news from the major media outlets on this new podcast! To subscribe and add this private podcast feed to your podcast app, go to americanhealthlaw.org/dailypodcast.

Speaker 1:

<silence>

Speaker 2:

A HLA is pleased to present this special series highlighting the top 10 health law issues of 2025, where we bring together thought leaders from across the health law field to discuss the major trends and developments of the year. To stay updated on all the major health law news, subscribe to ALA's New Health Law Daily podcast, available exclusively for premium members@americanhealthlaw.org slash daily podcast .

Speaker 3:

Hi , um, thank you for joining us today. Uh , my name is Jennifer. I'm a partner with Hanes and Boone , um, located here in Dallas, Texas. Um, I'm in the healthcare practice group, and I have Jeremy Scherer here with me , um, joining us today for a podcast about his recently published article , um, on the top 10 issues for A HLA Telehealth Uncertainty Ahead. So, thank you for joining us today, Jeremy. Um, can you maybe start by just giving me a little bit of background on your work in telehealth and, and what you do?

Speaker 4:

Yeah, absolutely. Um, thanks so much for that and, and thanks to a HLA for having me today. Um, I'm Jeremy Sheer . I'm a partner at ORIC based in Boston. I'm a partner in the firm's FDA and healthcare regulatory practice and part of the life sciences and health tech sector here. Uh, I have really focused on telehealth My , um, entire career, which isn't all that long. I'm not that old, but it , uh, does mean that I've been focusing on this one narrow area as long as just about anybody. Um, I historically have done a lot of work with, I, I sort of grew up as a, as a brick and mortar healthcare lawyer , uh, focused on telehealth, so whether it was health systems, sns , medical groups, sort of the, the whole , um, continuum of care as it were. Over time, I focused more on , uh, emerging companies and startups. Uh, so I'm doing a lot more in , uh, the direct to consumer space these days than I used to. But I still work with plenty of, of health systems on , um, virtual care issues, Medicare reimbursement , uh, and , and all the rest of it, but also add to that , um, corporate practice medicine issues and , uh, really everything that comes into play when standing up a a 50 state virtual practice.

Speaker 3:

Fantastic. That is great. We are so glad you could join us. Um, so, you know, one of the things that , um, stuck out to me in your article, I thought that it was so aptly titled, you know, uncertainties in Telehealth, and we have all these different , um, issues coming, coming down the pipes. Uh, from a legal perspective, I think one of the big ones that folks are focused on is what is happening with the Medicare telehealth flexibilities. Um, so I think at the time the article was published, those were set to expire at the end of the year, and now it looks like they, they have at least been extended until March 31st of , of 2025. Can you give me any thoughts about , um, you know, maybe a little bit of background. What, what are the telehealth flexibilities for Medicare purposes that we're talking about? Why do they matter so much to providers and, and what can folks really do , um, to get ahead of this and prepare?

Speaker 4:

Yeah, absolutely. So , um, I guess just to , to quickly bring anybody not , um, well versed in this space up to speed, Medicare has covered telehealth services since the late nineties. At that point, they were more thought about as a way to expand access for folks in rural areas than anything else. And so the statutory coverage standards that are set forth in the Social Security Act , uh, which importantly therefore require an act of Congress to modify , um, really think about that, right? Think about telestroke, think about expanding access to folks who are in areas where they otherwise wouldn't have access to specialists. And so there are standards for these Medicare telehealth services to be covered , um, separate and apart from state law, which addresses whether address , uh, services can be delivered via telehealth by those practitioners. But for Medicare beneficiaries and for providers treating Medicare beneficiaries, it's important for the services they provide to be paid for. Um, so the, the sort of core restrictions that we think about , uh, first , uh, is that the, for these services to be covered and paid for, historically, they've had to be provided to a beneficiary who is in a rural health professional shortage area, a rural hipsa. Um, and that's designed to, to get at the rural access issue, right? To, to limit coverage in of these services to scenarios where you have somebody who wouldn't be able to access that care. But for telehealth , um, it's not, it also has historically not been enough to be in the rural hipsa . You have to be in a specific type of qualifying healthcare , uh, facility in that rural hipsa. So think about , uh, a hospital, a , uh, skilled nursing facility, a brick and mortar practice, sort of traditional healthcare provider facilities, and importantly , uh, that does not include the patient's home, which in certain ways kind of negates the miracle of telehealth, which is the ability to meet the patient where they are with certain exceptions. Right? So in 2018, for instance, under the support act , uh, there was a carveout put in place for , uh, treatment provided to, to folks , um, uh, receiving substance use disorder services. But for the most part , uh, there is that requirement that you're in the rural hipsa and that you're in , uh, uh, what's called an , an approved originating site facility. After that , um, the, the services at issue, and again, remember we're talking about initially the late nineties. So the , the term of art is a , a , a , a covered interactive telecommunications device. Um, I think I have that right. That

Speaker 3:

Is a long Yeah, <laugh>,

Speaker 4:

Right ? It would be, we get, it's a lot of words that mean more or less the same thing typically. But , um, with that, typically with that has meant historically a synchronous audio video, meaning a video visit , uh, similar to what we're doing now. And that does not include, not

Speaker 3:

Audio only is what you're

Speaker 4:

Talking not audio. Exactly. And certainly Well, there are certain and , and not stor forward , right? Which is , which refers to, in, in, historically in clinical disciplines like , um, dermatology, for instance, where it's consistent with the standard of care because the clinician's getting access to more or less the same information, they would get an in-person visit. You can take a picture of a section of, you know, my forehead if they're , if I have a , a skin lesion of some sort, that can be sent to a clinician to review , uh, on their own time asynchronously, so not live. Um, and they can then report back with a diagnosis and a, and a proposed plan of treatment. But historically , uh, the, the standard under Medicare has been that it does have to be that synchronous audio video. Uh, beyond that, there are only certain types of providers who can , uh, provide services via telehealth, and it does cover most of the usual suspects, sort of physicians, nurse practitioners, physician assistants . But when you get into services that are provided by allied practitioners, think about , um, complimentary services like occupational therapy speak and speech and language pathology , um, behavioral health services provided by social workers, things like that. They were , and certainly not health coaching. And some of the stuff that's happening in sort of the, the direct to consumer verticals , um, uh, services were limited to those provided by those types of , uh, providers. Um, and then, let's see , uh, rural hipsa, and then there's the Medicare telehealth services list. So once you've gotten through all of those requirements, then you also need to confirm that , um, it's very elegant, very advanced tech that CMS uses . They literally post an Excel spreadsheet once a year after <laugh> fee schedule process. Um, but you have to confirm that , uh, CMS has determined that the , uh, that the service , that issue could be provided in a competent manner , uh, via telehealth. So once we've gone through all of those , uh, all of those requirements that would determine, and again, these are in the Social Security Act , um, whether , uh, whether a, a service can be , uh, provided and paid for via telehealth, fast forward ,

Speaker 3:

That's so restrictive. Yeah.

Speaker 4:

Yeah. Um, and, and it's very restrictive. And , and, and I think it's not from, there's no , there was no, there was no bad intent here. It's just that the practice of medicine evolves, changes, and I think a lot of states are actually learning from this experience and deliberately creating definitions of, of telehealth and virtual care and different things that are, that are meant to, to be able to withstand the evolution of digital health technology. Unfortunately, that's not the case here in terms of section 1834 M . So , um, as a result of that , uh, these standards really just didn't keep pace with, with the evolution of healthcare technology. And so then fast forward , and we have the, the, you know, once in a lifetime event of the COVID-19 pandemic and the result of public health emergency, and all of those standards that, that I just listed were either , uh, completely waived or rolled back in some manner because you had a scenario where for public health reasons, Congress and everybody else at Department of Health and Services, so on and so forth, wanted to ensure that folks were able to stay home and not, not leave home. Uh, certainly when you think about they

Speaker 3:

Couldn't be in the hospital essentially re receiving

Speaker 4:

These Yeah. And or if they were, it was dangerous and we didn't want them there. Yeah . Particularly when you think about Medicare population, you're talking about folks who are 65 plus with certain limited exceptions, but you , you're , you're talking about the folks who were in a lot of ways , um, the most at risk Yeah. Uh, to, for contracting COVID-19 . And, and we saw what happened. So , um, it, it create , and you also had, I mean, at the state level, all states were waiving licensure laws and all the rest of it. But that's sort of the, the framework that we're , that we're working with. And when that happened , and all of these standards were, were either relaxed or , or rolled back , um, a lot of folks were forced to utilize telehealth for the first time. I mean, before the public health emergency, it was something like one quarter of 1% of Medicare fee for service beneficiaries. 'cause there have been more , um, there have been more flexibilities historically for Medicare Advantage than there have for fee for service , but one quarter of 1% of Medicare fee for service beneficiaries had utilized telehealth. That changed very quickly, as you can imagine. And folks liked it. Uh , it's not to say hard to

Speaker 3:

Go backwards. Yeah, yeah.

Speaker 4:

The number of times I can't put the toothpaste back in the tube and all the , but now that's sort of what we're talking about. Um, and so I , I think, you know, concerns about telehealth replacing in person , I , I don't think that's reasonable, but I do think that it is at this point a part of the clinical toolkit and something that folks need to, to be able to utilize. So throughout the pandemic, we sort of ebbed and flowed, and , um, we didn't, Congress didn't know how long it was it was going to last. And so , um, neither did the Secretary of Health and Human Services. And so , um, these, these waivers were incrementally extended over time. And it's become a big issue figuring out post pandemic, how it , it's pretty clear that we are going to need to modify these standards, but it's not clear , um, exactly what that's gonna look like. And there are , there have historically been concerns about , uh, over utilization that if you provide folks the ability to receive treatment via telehealth, that they're suddenly going to use a much greater volume of healthcare services generally. Um, there, there are concerns about fraud, right? Um, sometimes it seems to be the idea that like when a clinician turns on a a video camera, suddenly they become a fraudster. I, I don't, I don't really endorse that theory. Um, but there are some legitimate concerns there, right? When you're providing care in a virtual setting, particularly, and we'll talk about it later in service lines like RPM or me patient monitoring and elsewhere, they are somewhat more susceptible to fraud. Um, and then , um, there have been sort of similar to the utilization concerns, cost concerns , um, and this is something that, that , uh, MedPAC and Congress have gone back and forth on over time and, and sort of trying to find what that, what that next step is going to look like. I don't think there that we're particularly close, frankly, I think the most likely outcome to the, the most recent extension, which, which pushed us forward into March, is a further extension so that folks like MedPAC and, and others advising Congress can have a more robust data set to be able to, to sort of analyze these trends. But , um, we'll see.

Speaker 3:

So more uncertainty, basically <laugh>,

Speaker 4:

There's more uncertainty. I mean, if I, if I were a betting person, I mean, at this point , I think it , it is safe to, I , I I think it, it is of course, possible, right? As a, as a matter of law where lawyers here, the standards are in sta are set forth in statute. If Congress does not act and there are not further extensions, we will go back to where we were for the most part, with certain minor modifications in terms of behavioral health and some other things that were done outside of the context of the Social Security Act. So Congress did do some stuff, it's just elsewhere. So it doesn't impact these core coverage restrictions. Um, there's gonna need to be a middle ground. Um, I , I think that the, just when you look at what telehealth can do from an access perspective, it's, it's, it would be very silly to , uh, deny the American public and Medicare Medicare beneficiaries of those benefits. We just have to see exactly what it's gonna look like.

Speaker 3:

Yeah, that's really helpful. Um, and appreciate the, the prediction. I , I tend to agree with you on, I think we're gonna see, we have to see at this point, another extension and March is approaching quickly. So , um, I know you mentioned Jeremy, the kind of government scrutiny and the fraud and abuse aspect. Can you tell us maybe a little bit about current enforcement initiatives and what the telehealth industry should kind of look out for?

Speaker 4:

Yeah, absolutely. And I mean, and there are different, I think when we, when we think about, when we think about telehealth and, and scrutiny and enforcement agencies and so forth, we're often talking about H-H-S-O-I-G, sort of in terms of the, the traditional healthcare industry stakeholders at this point. The telehealth industry is quite a bit broader though, than the, the brick and mortar facilities that are providing services to Medicare beneficiaries and are therefore under the scrutiny of H-H-S-O-I-G. So we also have to think about state medical boards, we have to think about the FTC increasingly , um, there's, there's fortunately a lot to worry about. Um, so

Speaker 3:

Consumer protection Yeah. State

Speaker 4:

Exactly as sort of, you have traditional healthcare services and with sort of the consumerization of healthcare delivery, you have wellness and, and traditional healthcare services sort of melding together more and more, and that creates different concerns when it comes to influencers and things like that. Yeah . Um, but starting with sort of the, the , um, most traditional, I guess , uh, enforcers here and thinking about the OIG, I mean the, the, the latest , um, and there are always , the first thing I'll say is that for particularly pre pandemic, I mean, there was this whole idea through the Department of Justice about a, a tele fraud takedown, and , and industry was unhappy about that and, and understanding , I

Speaker 3:

Remember Operation Brace yourself and , and those ,

Speaker 4:

Yeah . Yeah. And , and like, no , nobody is, is supportive of , uh, like fraud starts just utilizing another way to , uh, commit fraud, which is a lot of what this was, right? It was the , there was a new method of care delivery. Yes. But a lot of the stuff actually didn't even involve synchronous audio video communication. It was anything involving any sort of telecommunication device, literally telephones, call centers and things like that, that was suddenly being labeled as telehealth and sort of dragged the industry through the mud. So nobody was happy about that. Um, but more, I think, and , and there are, right, there are folks who are utilizing this new method of care delivery to perpetuate fraud schemes that are unfortunately tried and true. Think about DME and, and taking advantage of Medicare beneficiaries, and you find, you know, folks with, with 14 medically unnecessary wheelchairs or whatever, it's like there are vulnerable populations who are taking advantage of here, and that's it's important work that justice and the OIG are doing. Um, there are continued concerns about remote patient monitoring, which even though it, it sort of by definition provides for 24 7 monitoring, it is for the, for the most part, the , there's only limited synchronous interaction required. And there are a lot of , um, first of all, during the pandemic, there were real concerns because , uh, again, in order to encourage folks to shelter in place , stay home, not go to facilities and, and potentially spread covid , um, it was permissible to waive copays for RP M services. And so you , when you waive copays are sort of altering the fundamental equation of an insurance arrangement. Um, and you had a lot of folks advertising just free services. Let , let me send you this blood pressure cuff, it's not gonna cost you anything. Yes, I am gonna charge the Medicare program and indirectly to the American taxpayer . Um, so, so anytime you have folks waving copays, card blanc, that raises concern. And so there's been an ongoing concern at OEG with regard to RPM , and that hasn't gone away. The , the most recent report was in September or October of 24, where they identified RPM as an area of concern, and then we saw in the , uh, OIG work plan for the next, the next year that they were planning to, to , uh, perform audits in this, in this area. So that's something to look out for. Um, I think more generally, the, the consumer protection point that you made, Jennifer, is a really good one. And I think there's ongoing concern about , um, transparency and, and folks understanding who is delivering their medical care. And the entities that are, that are enforcing those standards are coming after folks who maybe aren't being as transparent as they should be, aren't the traditional healthcare enforcement agencies. Right. You're talking about the FTC getting involved, you're talking about potentially state attorneys general, you're talking about the state medical boards. Um, and, and that is all increasingly important in virtual care context. Um, there were a couple of very high profile , uh, investigations during the pandemic involving , uh, uh, virtual care , uh, and prescribing controlled substances for the treatment of , uh, A DHD. Um, you know, I , I think those are, those are well known and there were lessons learned there. Um, so of course, anybody , uh, prescribing controlled substances virtually, and we'll get to that in a minute. Sure. Um, that's an area of concern. There's also just across the industry, and this isn't specific to virtual care, but I think in some ways we are , we are particularly , um, I don't wanna say susceptible, but when you're talking about 50 state virtual practices, there can be concerns from a corporate practice and medicine angle because you are talking about the laws of all 50 states. Not that they all prohibit the corporate practice of medicine, only about half of them do. Um, but there are concerns about the involvement of venture capital and private equity in healthcare. Right? Um, and that is , and in terms of , uh, protecting the autonomy of clinical decision making , when you have a , uh, a management services organization or an MSO, which sort of takes care of all of the business side of things to allow an affiliated medical practice to focus on delivering clinical care , um, that is a tried and true structure that has existed for a very long time. But where state boards get and others get concerned is when that, that MSO entity maybe exerts too much influence and starts trying to, to exert influence over clinical decision making and things like that. Um, that's an area that, again, this isn't anything new, but , um, sort of annually, there are different states where these issues come up in legislation. Typically, California is one of the, the stricter states. And , um, oftentimes it'll be a very intense , uh, sort of battle, and then the industry will sort of breathe a sigh of relief because whatever bill it was that we were so concerned about wasn't passed in that form. But these are , these themes are not going away. Um, so I'll pause there. Does that answer the question?

Speaker 3:

It does, and I think you highlighted some really good areas for people to kind of , um, you know, just review and, and make sure they have all their ducks in a row. Um, particularly the remote patient monitoring, I know you meant , and , and corporate practice of medicine kind of investment in healthcare and , and what making sure you've got the right guardrails in place , um, that you have the, the medical practice and, and I would say, you know, documenting those , um, which decisions , uh, are made by the medical practice and, and making sure you've got good policies and procedures in place and that sort of thing. Um, and then as well, the , the transparency issue, I think we've seen that come up so much with , um, some of the recent FTC enforcement actions, and some of them have involved , um, kind of tangentially telehealth or, or to some aspect, at least healthcare providers. Um, and so just making sure folks are, and , and a lot of that oftentimes focuses on transparency and , and , um, especially when you're dealing direct to consumer. So definitely some good areas to highlight for folks. Uh , and you had mentioned , um, controlled substance prescribing. Um, can you give us an update on what is going on with the requirements around controlled substance prescribing, and particularly in-person visits? I, I know it's kind of constantly, we're hearing things and, and things are in flux, but what, what's the current status and then where do you think, what do you think 2025 will bring us

Speaker 4:

With the qualification that we are recording this on January 16th? We and folks will know that on January 15th, we, we received a 160 page notice of proposed notes of proposed rulemaking. Um, what we don't know what, yeah , 2025 is going to hold. We do know that there was a lot of work done over the last nine months or so at DEA to come up with a further modified proposal , um, with regard to , uh, prescribing controlled substances. Virtually , um, the most recent proposal does envision a , um, a special telemedicine registration process, which is progress, given that this was something that was , uh, actually expressly called out and required. And when the Controlled Substances Act was, was amended by the Brian Heet Act 2008, 2009, but had never been done until this point. So that, that is, is progress. Now what was proposed is , um, is extremely restrictive in some ways , uh,

Speaker 3:

Not surprising <laugh>, I think from what we saw with the DEA before, it's just, yeah, it's there . It's hard to meet everybody's needs. I think

Speaker 4:

This right , and, and there are legitimate concerns about diversion, right? Um, as proposed, and, and folks can , uh, read about this , um, elsewhere, but the , particularly with regard to schedule two drugs, the, the one that folks will be most familiar with, I think is , um, is Adderall and other stimulants that are used to treat A DHD as proposed. This rule would effectively eliminate the possibility of a multi-state virtual psychiatry practice that treats patients , um, via telehealth. And, and in certain scenarios, it's, it's easy to understand the desire to, and, and all of this comes back to wanting to establish a situation where a patient can receive treatment in person if they, if they want it or need it. Right? And so the , the requirements that were proposed included that the physician treating the patient would need to be not just licensed in the state where the patient is located, but physically in the state where that patient is located , um, in order to be able to provide that , uh, in-person treatment to the extent that it's needed. Now, the obvious follow up question there is, okay, well, what about folks in rural states where don't have a sufficient volume of behavioral health providers? Um, but there were also steps taken that were, I mean, one thing that's really notable, for instance, is that this was the first time that the DEA has proposed to have telemedicine platforms rather than just the medical group groups delivering clinical services. So we talked about the, the PC MSO structure, sometimes called the friendly PC structure. Um, historically, DEA has basically played a game of whack-a-mole focused on individual practitioners who are maybe prescribing in a way that the DEA hasn't been happy with. This would actually require the, the MSO entity , uh, where a d is supporting practices that are providing care virtually involving controlled substances , um, to register. And, and the idea there is to give the DEAA much better idea of who it is out there that that's providing these services that would be , uh, that were requirements in there that also relate to annual reporting and tracking of the volume of prescriptions being issued. And so, really, this all just, I, I think, goes back to the DEA wanting much more oversight of what is going on in terms of , uh, controlled substances prescribing. Um, and look, we, we, the , the big, the, the elephant in the room as it were, is that we are about to undergo a change in administration. And with that, it is possible that there will be a change in leadership at the DEA . And a lot of folks are now pivoting and turning to President-elect Trump and, and hoping that a potential change at the DEA could , um, those folks are not obligated to finalize this proposed rule that just came down. And so it's a long road ahead. And I think part of what we're seeing in industry, I think as many of us as counsel to, to folks impacted or companies impacted , um, by these rules, is a little bit of a , um, boy who cried wolf situation. I mean, throughout the pandemic, it was sort of every 12 months we said, well, th this , these waivers are set to expire. And if that happens, this entire business that you have built around the idea of virtually prescribing these medications is going to need to fundamentally change. And the can has been kicked time and time again. We eventually that will stop. Um, but we really don't know. The , the huge , the , the very unpredictable element that has just been introduced is that change in administration. And so , um, it's something for folks to track carefully. There are also separate rules that were introduced with regard to buprenorphine , um, which is a little bit different. I mentioned before how treatment of substance use disorder can is oftentimes treated differently. I don't know that we have time here. I think I spent too much time rambling about other things. But , um, <laugh> , that's all that via a HLA and the many , uh, resources that a avail that are available, folks can find more detail about that. But the bottom line is, like a lot of other things with telehealth, I think we saw massive expansion in terms of access and , um, and , and the delivery of these services nationwide in areas. And it's not just behavioral health, right? It , it also relates to , um, gender affirming care, for instance. Mm-hmm <affirmative> . It was really important, another area where we saw a , a lot of advances. And so , um, folks need to continue working with advocacy organizations like the American Telemedicine Association, the Consumer Technology Association, and otherwise to make their voices heard, to make sure that we don't lose the progress from a sort of virtual care , um, even e evangelism perspective , um, so that we don't lose the, the progress that we made during the pandemic when we were able to see what telehealth can actually do , um, really from a public health perspective in terms of expanding access to, to high quality care.

Speaker 3:

Well, that is so helpful, Jeremy, and thank you. I'm sure you are , um, probably up all night reading that notice of proposed rule making so you could be ready for today. So thank you for doing that. Um, and , uh, I think it's great advice, you know, to , um, keep checking with the industry groups and, and making your voice heard, because that's really how I think the telehealth industry is going to be able to survive this period of uncertainty and , and that sort of thing. Um, so if folks are looking for more information, I know we've got our , um, virtual telemedicine conference coming up March 11th and 12th, so that would be a great opportunity to check in and see what's new , um, and, and kind of what, where things stand again. Um, and then also ALA's , uh, health Information Technology Practice Group has a lot of very helpful resources , um, that, that people can reference. And , um, if anybody is ever looking to , uh, get involved , um, that is a , a fantastic group to work with. So , um, thank you again, Jeremy, so much for joining us and for all of the really helpful insights that you've provided.

Speaker 4:

Thank you, Jennifer. Really appreciate it.

Speaker 2:

Thank you for listening. If you enjoyed this episode, be sure to subscribe to ALA's speaking of health Law, wherever you get your podcasts. To learn more about a HLA and the educational resources available to the health law community, visit American health law.org.