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 2023. In the third episode, Martie Ross, Office Managing Principal, PYA, speaks with Jeremy Sherer, Partner, Hooper Lundy & Bookman PC, about some of the top telehealth trends to watch out for. They discuss Medicare coverage and reimbursement issues, state law and scope of practice developments, and controlled substances prescribing laws. Sponsored by PYA.
Watch the conversation here.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
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 2023. In the third episode, Martie Ross, Office Managing Principal, PYA, speaks with Jeremy Sherer, Partner, Hooper Lundy & Bookman PC, about some of the top telehealth trends to watch out for. They discuss Medicare coverage and reimbursement issues, state law and scope of practice developments, and controlled substances prescribing laws. Sponsored by PYA.
Watch the conversation here.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
A H L A is pleased to present the special series highlighting the top 10 health law issues of 2023, where we bring together thought leaders from across the health law field to discuss the major trends and developments of the year. Support for A H L A in this series is provided by P Y A, which helps clients find value in the complex challenges related to mergers and acquisitions, clinical integrations, regulatory compliance, business valuations, and fair market value assessments, and tax and assurance. For more information, visit p y a pc.com.
Speaker 2:Thank you for joining us for the third installment of the A H L A podcast series on the top 10 health law issues of 2023. I am Marty Ross with p y a, I am joined today by Jeremy Sheerer of Hooper Lundy, who was the author of the article on telehealth, uh, which certainly will be an interesting issue to follow through 2023. And Jeremy, if you'd like to introduce yourself to our, our listeners.
Speaker 3:Yeah, sure. Thanks Marty. Um, I'm Jeremy Sheer. I'm a partner at Hoop Lundy, as Marty said. Uh, I'm based in our Boston office, work with clients in, in all 50 states, um, or our firm does, I probably can't count quite all 50 at any active<laugh> any particular window in time. Um, but I, uh, I chair our digital health practice, so I primarily work with, uh, startups and scaling companies on all issues involving regulatory compliance and transactions involving digital health, and then also work with our health systems, S n f, uh, practice groups, sort of brick and mortar clients on using digital health technology in a way that, uh, doesn't get anyone in trouble. So,<laugh> looking forward to, uh, to talking telehealth today. I mean, there's a lot to sort of unpack as we had in 2023.
Speaker 2:Yeah, I was, I've been thinking if I was sitting in this chair in January of 2019, um, and, but it had the issue of telehealth. It was kind of a giant yaw. Um, we all knew the potential of telehealth, um, but the reimbursement mechanism, um, was effectively non-existent. Right. Um, and then a funny thing called covid happened, um, and c m s changed the rules significantly, most importantly, allowing the delivery of telehealth to individuals in their homes regardless of whether they resided in a rural or urban area. And it was that change in the rules, specifically good old 1834 m of the Social Security Act that allowed this to happen. All that being dependent on the public health emergency. And as you noted in the article, that was probably the big concern looking forward into 2023, is what would happen post p h e. Um, and then as is always the case, Congress got involved, um, and changed the rules. So can you summarize where we are today, at least, um, in mid-January of 2023?
Speaker 3:Yeah, certainly. Um, and it's so interesting because I think we, we conventionally yeah, we always say, you know, a as usual Congress got involved, but, uh, for telehealth advocates, I think historically that's been the thing that we wanted to have happen, and that historically has not happened. Right. You know, these, uh, coverage and reimbursement standards were put into place in 1997. Um, and since then there, there hadn't really been much change until the pandemic. But I guess as to where we are now, you know, the, the way that I tend to think about this is, um, as with anything in healthcare, we're talking about a lot of complex sort of, uh, conflicting, overlapping, uh, sources of authority and, and issues, really. So there are kind of three buckets in my mind. The, the first, which you alluded to is Medicare coverage and reimbursement. Um, you know, Medicare is obviously the largest payer in the United States. Really, really important as far as sort of leading industry. And, um, that has been historically an area where there has been very little, uh, utilization of telehealth simply because it hasn't been covered or, or reimbursed for the most part. So there's what's going on with Medicare. Then there's, in terms of telehealth and pandemic, there's what's going on on the state level in terms of state law and, and scope of practice, whether folks can provide care via telehealth, um, in compliance with law and what exactly that means. And then the third bucket is the controlled substances prescribing issue, which of course is under the, uh, jurisdiction of the D E A, um, and, and is a totally separate issue. So sort of going through the, the three and kind of where we are right now, at the very end of 2022, um, heading into 23, uh, the Consolidated Appropriations Act of 2023 was signed into law, which took that first bucket of, of issues, the, uh, the modification or waiver of, of all five of the sort of core, uh, Medicare telehealth services coverage and reimbursement restrictions, uh, which involve being in a rural hipsa, uh, health professional shortage area or other, um, or, or certain other designated areas where there's a public health demonstration going on. Um, being in an approved, uh, category of originating site facility. You mentioned, you know, that the waiver of that requirement was what enabled folks to be able to get care in the home. Um, looking at the type of technology that folks are required to utilize in the, in the Social Security Act, there's this definition of a, uh, an interac, uh, interactive audiovisual communication, which means, uh, it's a fancy way of saying a synchronous, um, audio video sort of video visit, like a akin to what we are having right now. Yeah, exactly. Um, talking about the, uh, categories of practitioners who can bill for Medicare telehealth services, and then the, the list of services that can be covered, um, when they're provided via telehealth to a Medicare beneficiary, all of those requirements were either waived or, or somehow modified during the pandemic. And it wasn't clear what was gonna happen once the public health emergency ended. There was just got, and in the Consolidated Appropriations Act of 2022, there was this 151 day off ramp that was, um, not, not just proposed, but it was put in place as a congress effectively and consultation with C M s. And everyone else wound up deciding that wasn't the path forward. And the va, the majority of those Medicare specific waivers have been extended through the end of calendar year 2024. And so what that means is we now have this, this window and all along, I mean, even pre pandemic, you were saying, you know, 2019, we were, those of us, you know, who've been, who've been doing this a long time, we're talking in 20 18, 20 19, we were looking at Medicare Advantage potentially, and the flexibilities that we had there and saying, we just need the data because there, there continues to be this, this, um, frustrating hesitation from, from MedPAC and others about weather's. Telehealth actually increases quality. And then, uh, what's really coming to the forefront more lately is whether, uh, it leads to increased utilization and increased fraud and abuse. And I think the idea in industry is that hopefully with the pandemic the last couple of years, and now we have through the end of 2024 to really get a robust, uh, set of data together to really be able to show that telehealth, telehealth is a way to deliver care. It's not, uh, it's not something that that's clinically distinct. It all, and the minute that folks jump onto a a video visit, they don't suddenly become fraudsters, right.<laugh>, because they're still clinicians who are, who are delivering care to their patients. Um, so that's kind of where we are with regard to Medicare. In terms of the second bucket and where we are in terms of state law, um, during the pandemic, every state in the country, uh, made it easier to provide care via telehealth in some way. Some states went much farther than others, but in general, there were, there were waivers of licensure requirements because folks, um, were, were moving around much more. And the idea was we wanted folks to stay in the home rather than go out as a, as a way to, to, um, combat the spread of covid 19. Um, a lot of states have, have modified state law to, to keep up with the sort of trends in what's happening, um, and, and what consumers are demanding, expecting, and, and look, I mean, telehealth, again, telehealth is just a tool, but it's a really good one. And, and it's one that, that patients tend to like, and increasingly it's one that clinicians like as well. Um, you know, the payer conversation is a little bit different, but the, and so there are, there are, uh, a there's a lot that they need to unpack, but certain states during the pandemic, you look at, um, Arizona, you look at Massachusetts, you look at Kentucky, you look at others, there are, there are laws that are evolving and that are changing to try and sort of maintain to an extent the what we, what we saw, the, the landscape during the pandemic. With regard to telehealth, obviously we don't want to maintain the landscape with regard to the spread of the coronavirus in a, in a public health emergency or in a pandemic. But with regards to telehealth, there have been efforts to, to make sure that that is going to, to stay in place. And then the third bucket is this controlled substances issue where we, um, unfortunately we really don't know what it's going to look like.
Speaker 2:So the, the d e a at the beginning of the PhD exercised its statutory authority, correct? Yes. And said you can, you can prescribe a controlled substance based on a telehealth visit as opposed to the traditional face-to-face, correct.
Speaker 3:Yeah. So, so the, the, the Rhine Hate Act provisions of the Controlled Substances Act say that a, uh, a valid prescription is one that is issued by a practitioner who's acting in the usual course of professional practice. It's for a legitimate medical purpose, and it's prescribed by a clinician who has performed one, at least one in-person exam of the patient, unless, uh, there there's a covering, practitioner exception. And then there are these practice of telemedicine exceptions, and they were introduced back in 2008 and haven't really kept pace with much of the way the telehealth is, is provided these days. Um, but when you go through the, the practice of telemedicine exceptions, one of them is that there's been a declared public health emergency. So it was pursuant to that authority that this in-person examination requirement, which is usually required at the federal level to prescribe controlled substances, was waived for the duration of the public health emergency, as well as the D E A also requires, in addition to being registered in with the d e A to get a, a controlled substances prescribing, um, basically authorization a registration in the state where the practitioner is located, you also need to get that registration in any state where a patient to whom you're prescribing is located. And that requirement was waived in, uh, March, 2020 for the duration of the pandemic as well.
Speaker 2:But unlike the telehealth Medicare coverage rules, the door is going to come slamming down the day the PhD ends controlled substances. Right.
Speaker 3:As far as we know at this point, yeah, I, you know, I, I mean, I think there's, the, the conventional wi, I mean, the conventional wisdom is that there's going to have to be some sort of transition, some sort of off ramp just from a continuity of care perspective. When you're talking about controlled substances, you're talking about folks who are getting care that, that they really need. And the reason why these drugs are so heavily regulated is that they're really powerful and just in the way that they can really help folks address really, really, you know, difficult, uh, conditions, whether it be, you know, substance use disorder or, or, um, you know, the A D H ADHD is getting a lot of, a lot of attention right now. These are also things where if you just pull the rug out from under people, you can have really adverse, uh, events and consequences in terms of withdrawal and that sort of thing. So from a clinical perspective, I'd have to imagine there will be some sort of off ramp. But the only indication that we've had from the d e A so far, and this is what they've been pointing back to when they've been asked about it, is this March, 2022 statement where they made clear that they are committed to maintaining access to medication assisted treatment, um, that's delivered via telehealth post pandemic. And so there's, there's some, you know, sort of reading tea leaves, there's some expectation that in creating, in, in the Rhine Hay Act, there was this special telemedicine registration that was supposed to be created back in 2008, was called for by Congress. It's been called on by, uh, several presidents, and it hasn't happened. We're now 14, 15 years later and hasn't happened. Um, there, we understand that there is a proposed rule at the O M B at the Office of Management budget. Um, it's been there for a year, uh, if not more at this point. Um, but the, the, again, we don't know this, it's, it's, you know, conjecture, but it looks like that registration may be specific to treatment, very important treatment mind you for first substance use disorder involving medication assisted treatment. But it, that doesn't cover all of the ways that, um, the care has evolved during the pandemic thanks to these flexibilities. So it really, if that is what ends up happening, it leaves, um, a a lot of providers in, a lot of patients in in, uh, limbo, frankly.
Speaker 2:Yeah. Uh, let's go back to the state law regulation of telehealth. Um, can you explain, I, I've heard these terms bantered about, but I'm not quite sure what the, what the, the legislation looks like. What, what's coverage parody? What's payment parody? What are these state laws attempting to accomplish?
Speaker 3:Sure. So, um, parody laws at their core intend to require practi, well require payers really, um, to treat services delivered via telehealth, just like services that are provided in person and, and coverage and payment parody, laws address parody of different types. Uh, when you're talking about coverage parody, the, the principle is that when a service is covered, when it is provided in person take, let's say talk therapy, if, if talk therapy is covered when you're sitting in a psychiatrist or social worker psychologist's office, and that clinician determines that they can provide that talk therapy service in a clinically competent manner through, again, a synchronous audio video interaction, typically, although there's some other types of technology in store forward and things that we could, you know, uh, we could talk about as well. But the, the idea generally is that if that talk therapy service is covered in person and it can be provided in a clinically competent way via telehealth, then it is also covered when it is provided via telehealth. So that's sort of step one. And, uh, most states have coverage parody laws in, in place at this point. Payment parody is, uh, uh, sort of the thornier issue and, and what payment parody stands for is the proposition that in addition to covering that talk therapy service, when it's provided via telehealth, the payment parody laws require payers to pay the same amount for that service that's delivered via telehealth as they would if the service was delivered in person. Um, and fewer states have, uh, payment parody laws on the books. Um, and it's, uh, it's a contentious issue, and it's one way, I mean, we're seeing more and more states have payment parity laws in place, in addition coverage parity laws, um, as, as telehealth becomes sort of part of that, that clinical toolkit as it were. Um, but there are real debates that go on, um, even in states that are, that are perceived as historically quite progressive with regard to, to health policy and, and coverage of things like telehealth benefits where, um, you know, payers often wanna be in a position where they're free to negotiate rates and not, and not sort of bound by what, uh, state law
Speaker 2:And, and again, they're state laws. So these parody requirements don't reach ERISA regulated plans. Correct. So again, that wonder of, of the, the regulation plans we end up with, yeah. We end up with two sets of rules, ERISA rules and state law rules.
Speaker 3:Right. And I'm, that's about, that's about as far as I go. I'm not a nurse, a lawyer, but, you know, insurance is regulated state by state, and then you've got the ERISA preemption issue. And, um, yeah. It's, it's complicated something, right? And we, and we, you know, it, it is something that on a state by state basis, we need to continue, um, we need to continue monitoring.
Speaker 2:Um, I'm not, I apologize for jumping around. Let's go back to Medicare for a minute because Sure. At the same time that Congress provided that 151 day off amp, they also, I think I may be confusing my loss and I apologize, but they also created a permanent, um, coverage for what they termed mental health services in the statute. Um, so they eliminated the geographic and location restrictions for those services, but they imposed this requirement that prior to initiating services via telehealth, the practitioner had to see the individual in person within six months prior. Now, how does that square up with the now extension of telehealth through December of 2024? How to, if I, if I'm a practitioner, do I need to make sure before I start telehealth services that I've seen that patient within the last six months face-to-face?
Speaker 3:Not yet. So that, that rule will not take place until, uh, until after at the, at the very late. Well, it is, it has been extended, that waiver's been extended through the end of calendar year 2024. Okay. So that's not something that, that you need to worry about yet.
Speaker 2:Okay. So that's, that's one of those looking past the 2025 and who knows what's gonna happen. And, and I guess that's along those lines. Um, as I understand it, the reason Congress has not eliminated the 1834 M restrictions as when the congressional budget office places such a high, um, cost high price tag on these telehealth services because they consider telehealth additive as opposed to subs substituting for a face-to-face visit, any chance that CBO is gonna change their mind, is that gonna be part of this research we hope we're seeing, um, with the extension?
Speaker 3:In short, yes. I mean, that is what we are hoping to, to see. And, and, you know, historically, I mean, the data hasn't really shown to date that these, these concerns around cost and and fraud have really come to, um, come to fruition. Uh, you know, everyone has anecdotally the, um, the Medicare beneficiary in their life, uh, who, you know, you think about, I, I have a, a grandmother who's 94, and she's incredible with her iPad. I mean, she, and she and my three-year-old almost, they, they FaceTime independently of, of my wife and I, and, and the, the thought is, you know, well now that, you know, Jeremy's 94 year old Bob has her iPad there and she can just, you know, press a button and see her doctor, she's gonna wanna see her doctor four or 5, 6, 7 times a day. That's part of the concern. I don't think we've seen, I think that's an, is sort of an anecdotal concern. Although unfortunately, as, as you know, folks in the space know that oftentimes does drive policy, sort of anecdotal experiences from key lawmakers and, and their staff. Um, we haven't seen that happen yet. And in turn, the the point that you made about whether telehealth is additive or can stand in place of those, uh, those, those physician services that folks are, are receiving is a really important one. And I think what we've, again, the data to date hasn't, hasn't shown that folks are going to the doctor twice as much and deciding to do their in-person visits and then, you know, a, a a separate bucket of telehealth visits in addition to those in-person visits. But that's part of what we need to see in, um, in the next couple of years.
Speaker 2:Um, in your article, you referenced an OIG report that came out, what, last summer? Summer of 2022. Yeah. Um, you know, kind of looking for fraud where fraud may be. Is that, that of concern? Should our compliance folks be worried about the potential of audits in the telehealth space? What's, what's the potential issue there?
Speaker 3:Yeah, I mean, so the, that particular alert focused on what that really was was less, you know, we're talking about brick and mortar facilities and, and, um, folks that are, that are, uh, providing care via or, or greatly expanded the care that they were providing via telehealth during the pandemic. But the, who have those, uh, practitioner patient relationships with, with these folks that are, that are long standing involving person care. The, the OIG special fraud alert was actually targeted more at, uh, historically direct to consumer telehealth platforms and, and practices that for a long time have been, uh, quite common in the cash pay space where you're not subject to, uh, federal fraud and abuse laws like the federal anti kickback statute. You're not, Medicare rules also don't apply. But for a long time, a lot of telehealth companies said, we don't want to deal with this really complex, uh, reimbursement landscape. We certainly don't wanna get anywhere near federal fraud and abuse loss. We wanna stay, uh, outside of the HIPAA landscape if we can. And so we're just gonna provide care direct to direct to consumer. As the telehealth industry has grown, a lot of those really successful companies, some of them are now publicly traded in, they, they've sort of scaled and at a certain point, they, they realized that the, the Medicare market is really substantial and, and started wanting to provide services, uh, to, to Medicare beneficiaries. And so you've seen more and more of these, uh, telehealth first platforms that are providing care to Medicare beneficiaries. And in the process, some of these practices that have been common in the cash pay space where you're not subject to all of those rules have started to, to creep in to the Medicare landscape and, and when a special fraud alert is issued, that's a, it's a noteworthy event. I mean, this was the, this was the first time in, in something like a decade that the special fraud alert had been issued. And basically what it says is, we OIG see that there are things going on in the industry that we don't like, and we want folks to, to stop them. Um, that being said, I, I think that most of the, in, in that special fraud alert, most of the things that were highlighted are not, are not, uh, likely to be the case, uh, with brick and mortar facilities and, and larger sort of medical practice groups and folks that are, that are treating their patients via telehealth because it's things like, um, limiting a, a practitioner to only only be able to, uh, utilize certain modalities to, to provide care. So you think about certain platforms that maybe, you know, only do remote patient monitoring or, or only do, um, another, another specific type of care. And, and really what OIG G was talking about there is if you have a situation where a practitioner can't make a referral or rec or see that there is a, you know, a patient comes in thinking that they need an R P M service and the practitioner says, wow, there's a, there's a cardiac issue here. I need to get you to a cardiologist. If you, if they don't have the ability to make that referral, that's something that O I g, they didn't say that it was illegal, but they said that they view that as suspect. Um, the, the, uh, advertising, uh, waiver of copays, uh, indefinitely, that was something that, again, OIG labeled as suspect. Um, these things aren't illegal, but the, for the most part, when talking with clients about this, the, the challenge right now is, um, is really avoiding being perceived as a bad guy as it were, because what they're, I mean, in this special fraud alert, what OIG G is going after for going after is, is pretty problematic conduct. And, and so generally when you're working with companies who are, who are engaging outside council and trying to go about things the right way, you know, we're, we're not really concerned that if, if OIG G were to look under the hood, that they would, you know, suddenly discover that this is a, a massive fraud scheme. But the problem is in lifting up the hood and paying lawyers to stand next to the OIG G as they look under the hood, you, you know, that's a, that's an expensive and disruptive process. So we're trying to make sure that folks don't, um, don't get caught up in that mistakenly where there is likely, uh, to be enforcement. That's going to impact, um, really everyone in the healthcare industry who, who, uh, is providing care via telehealth, uh, to any beneficiaries of public programs, whether it be Medicare, Medicaid, TRICARE or otherwise, um, is, is audits. Um, we've seen an unprecedented number of audits initiated by, um, largely the OIG g uh, but also, uh, state Medicaid fraud control units. The, the state mafu Gus, you know, I, um, they have a, an annual training. Um, and I spoke on a panel there just talking about telehealth law because it's an area that is so new to those investigators, and it's something that I think there's a bit of a blind spot, um, concerning. And so they're getting up to speed and they are, you know, these are the way that one bills for telehealth services is different than other services in that you need to have both the, at least, you know, when you're talking about hub and spoke models, the, the originating and distant site, uh, claims that are, that are submitted. And so it's those sort of nuts and bolts things like making sure that you have both claims that line up to, to avoid, uh, any sort of appearance of impropriety that are, that are really important. But I do think that a lot of, uh, a lot of provider facilities are going to be audited, not because they've done anything wrong, but simply because as we, as we look at this data and try and figure out what telehealth is gonna look like going forward, you know, the conversation we had before about the cbo, it, it, they're gonna want to know what's going on in terms of the spending and, and make sure that, um, that there isn't anything untoward going on.
Speaker 2:Yeah. On the topic of billing for telehealth, um, you know, the 2023 Medicare physician fee schedule, final rule, um, set up the rules on what the post pandemic world would look like, um, and c m s announcing that it would require the use of the appropriate place of service code to indicate telehealth and most concerning that they would discontinue, um, paying at the facility rate, I mean, excuse me, at the non facility rate, always get it backwards at the non facility rate. And then instead, now for telehealth services, even if provided an independent position practice, the reimbursement would be at the lower facility rate. Of course, CMS made those rules up before for consolidated appropriation act of 2023. Do you expect c m s come out and say, we'll keep our rules the same that we created for purposes of the PhD e we're gonna keep those rules the same through December of 24, or do you expect we're gonna have sort of a patchwork of, well, this rule will apply, but that rule won't apply, having outta cms, and how do you think, c have we heard anything from CMS on any of these topics yet?
Speaker 3:I have to imagine, I mean, just thinking about it, looking at the sort of the, the arc of the pandemic and what C m s has done, I think that they've done a, an unusually good job here trying to look at the experience of industry and, and figuring, I mean, we had all of those town halls early in the pandemic where they were saying, wow, we didn't realize that folks were gonna use audio only in the way that they were and, and so on and so forth. And making corresponding changes to reimbursement policy. I'd have to imagine that they're going to, um, that they're going to try and, and reconcile what they're doing with the approach that's being implemented, um, at, you know, under Congress leadership. But that, you know, is really, at least I have not, uh, I've not heard anything that being said, Marty, you're probably more in the leads than I am with regard to, uh, you know, Medicare, Medicare payment rules and, and specific policy in that regard. So to the extent you've heard anything, please say so.
Speaker 2:No, I'm just the nerd that checks the website every day and nothing yet. So, Jeremy, I could talk telehealth with you all day. Um, fascinating talk. We don't wanna put anyone through that. I know we don't. Your insights are just great. Um, the article really highlighted these key issues, and thank you for going in greater depth. So everyone, thank you for joining us and stay on the lookout for part four of the series.
Speaker 3:Thanks so much, Marty.
Speaker 1:Thank you for listening. If you enjoy this episode, be sure to subscribe to a H L A speaking of health law wherever you get your podcasts. To learn more about a H L A and the educational resources available to the health law community, visit American health law.org.