Jennifer Breuer, Partner, Faegre Drinker Biddle & Reath LLP, speaks with Elinor Hiller, Partner, Alston & Bird LLP, and Amy Joseph, Partner, Hooper Lundy & Bookman PC, about changes to telehealth as the Public Health Emergency ends, including Medicare coverage of telehealth, Medicare Advantage and telehealth, the DEA’s proposed rules for controlled substances prescribing, and state licensure rules. They also discuss fraud and abuse enforcement activity, billing and coding compliance, and issues related to digital health technologies. Jennifer is editor, and Elinor and Amy are co-authors, of the second edition of AHLA’s Telehealth Law Handbook.
Watch the conversation here.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Jennifer Breuer, Partner, Faegre Drinker Biddle & Reath LLP, speaks with Elinor Hiller, Partner, Alston & Bird LLP, and Amy Joseph, Partner, Hooper Lundy & Bookman PC, about changes to telehealth as the Public Health Emergency ends, including Medicare coverage of telehealth, Medicare Advantage and telehealth, the DEA’s proposed rules for controlled substances prescribing, and state licensure rules. They also discuss fraud and abuse enforcement activity, billing and coding compliance, and issues related to digital health technologies. Jennifer is editor, and Elinor and Amy are co-authors, of the second edition of AHLA’s Telehealth Law Handbook.
Watch the conversation here.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
This episode of A H L A speaking of health law is brought to you by a H L A members and donors like you. For more information, visit American health law.org.
Speaker 2:Hello, I'm Jennifer Brewer, partner and Baker Drinkers Healthcare Practice in Chicago, an editor of the newly published second edition of ALA's Telehealth Law Handbook. I'm here today with two of the authors of that handbook, Amy Joseph, a partner at Hooper Lundy in Boston, and Eleanor Hiller, a partner at Austin and Bird in Washington, DC to talk about new developments in telehealth that might be of interest. While the new Telehealth law handbook provides a pretty deep dive into telehealth law at this juncture, it's such a fast moving area that there are new developments already. Um, to begin with, I'd like to better introduce my colleagues and then we'll jump right into our discussion. Amy Joseph is a partner in the Boston office of Hooper Bookman. A particular focus of her practice is regulatory compliance, including physician self referral, Annie Kickback and other, and abuse laws. And she spends much of, most, much of her time working closely with providers across the country on these issues. Eleanor Hiller is a partner in the healthcare policy group at Austin, and her work focuses on Medicare regulatory issues for both payers and providers, and she also helps lead the firm's digital health transformation of healthcare initiative. Eleanor previously served at the Centers for Medicare and Medicaid services where both legislative and regulatory changes to c m s Telehealth policies were within her portfolio. And I'm Jennifer Brewer, vice chair of Fake drinkers health law practice and co-chair of its telehealth industry group. My practice also focuses on regulatory compliance issues, including the Stark Law, any kickback, hipaa, and other privacy matters, and Medicare billing compliance. Um, we're gonna start with what's on everybody's mind, um, today, I think, which is the end of the Pandemic Pandemic Health emergency, which is scheduled to sunset on May 11th, um, of 23. Eleanor, I'm gonna start with you. Um, as we get closer to the end of the PhD, what's gonna change in terms telehealth coverage?
Speaker 3:So thank you so much, Jen. I think that Medicare policies related to telehealth are, are, have been a big focus and a lot of the messaging around telehealth, uh, p h e waivers, um, was really affected by action that Congress took to extend these beyond the end of the p e. So for telehealth policies that were included in the Consolidated Appropriations Act of 2023, that May 11th date won't have a big impact. Um, there are some others where it will have an impact, uh, but this, the, the policies that have been extended through the end of 2024 include the waiver of originating site requirements and geographic location requirements. And those ha have been the waivers that I, I think have really led to some of the most significant increases in telehealth access during the pandemic for the Medicare population. So under the statutory rules, those sort of underlying rules without the waivers, Medicare beneficiaries would typically have to be physically at a healthcare facility and in a rural area in order to connect with a provider at a distant site via telehealth and the ability to receive telehealth from home. Um, that has been one of the big changes during the P H E. So that's going to continue through the end of 2024 based on that congressional action. Other p h e error policies that won't change immediately include the ability to provide certain services using audio only communications as opposed to video as well. Um, and a broader set of providers who can provide telehealth services. Um, so despite those really significant policies that are remaining in in place, there are some changes that are coming on a shorter timeframe. Um, some of the changes, um, that, that we have in place now during the P H E will last through the end of this year. So through the end of 2023. Um, some of those policies that remain in place are payment parody for telehealth provided in, in non facility distance site settings. Um, uh, that was a policy that wasn't affected by Congress when they acted at the end of last year. Um, another category is the ability to provide direct supervision using realtime audio visual communication technology that will be allowed, but only through the end of 2023. Um, there are a few things in the telehealth space that will change immediately at the end of the PhD. So despite a lot of messaging talking about a longer tail, um, there are a few things that, um, people need to be paying attention to. Uh, one is just as an example, when Medicare will pay for e-visit. So these aren't technically telehealth, but they, um, are are very much in that space. Um, and after May 11th, these services can only be provided to established patients rather than new patients as well. So I'm not trying to tick off every single change. And c m s has some very helpful guidance, um, and fact sheets that are a really good, uh, resource on this, but it's an area where there are multiple different timeframes, um, for when the rules will change or snap back into place. And as we get to the end of 2024, I think we'll be looking to see whether policy makers take additional action so that we don't see a cliff there either.
Speaker 2:What about Medicare Advantage, um, and telehealth? Are there differences in what's gonna be required?
Speaker 3:So, uh, the Medicare Advantage space has received a lot of attention, um, in the Medicare world as, as these programs, uh, as it becomes sort of the same size as the fee for service program. In terms of enrollment, um, there are some differences. Uh, Medicare Advantage plans have to cover everything that's covered in fee for service, but they have, uh, flexibility to provide what are known as additional telehealth benefits. Um, those are Medicare benefits that can't be provided via telehealth and fee for service, but they, but ma plans can choose to provide them that way, um, and that those are separate from MA plan's ability to offer other types of benefits as supplemental benefits using telehealth. Um, 2020 was the first year for the additional telehealth benefits flexibility, and that sort of got merged with the timing of the public health emergency when Medicare telehealth access, uh, was expanded across the board. But, but the, uh, that authority is permanent and, and will continue regardless of, of what happens in in other spaces. Um, but I think one, one thing that's interesting is, is, um, that C M S is partnering with MA plans on telehealth really to assess and help improve seniors digital health literacy. So, uh, this is an effort where for starting in 2024 MA plans will have to have processes to help find enrolls that have low digital health literacy, and then offer some education to help make sure that their members, um, can take advantage of some of the, uh, telehealth and other digital te uh, type tools that are available, um, in the healthcare space.
Speaker 2:That's great. Um, I think we've learned that seniors aren't as technology phobic, um, as I think people thought before the pandemic. Right. I think they're, they're doing pretty well.
Speaker 3:Yep. Yep.
Speaker 2:Um, another area that's sort of still up in the air, um, is the dea. Can you tell us a little bit about, uh, the proposed rules for controlled substances prescribing?
Speaker 3:Absolutely. So this is another area where I think there, there has been some effort to thread the needle and preserve the type of access that we have seen during the pandemic, but it's an area where there is some nu nuance. So after the public health emergency expires enforcement of, um, Ryan Height Act provisions that require in-person medical examination before controlled substances can be prescribed, uh, these, you know, enforcement will return for these rules. Um, but the, the Drug Enforcement Administration Department of Justice and H H s have come together to propose rules to preserve some of the telehealth access that, uh, I think, uh, providers and patients alike have become familiar with. Um, and, and these rules that are proposed as we're speaking, may be final by the end of the public health emergency. In order to, uh, sort of bridge a gap, um, the rules will provide limited, uh, ability to prescribe non-narcotic schedule three through five controlled medicines via telehealth for, for a short period of time before patients would have to be seen in person. Um, there's a separate rule that that seeks to expand access to, uh, substance use disorder, uh, medications via telehealth. Um, so again, these rules are trying to thread the needle, uh, but I do think that there, there will be instances where it will be harder after the end of the PhD, even with these rules in place to prescribe certain narcotics using telehealth for a patient who hasn't been seen in person before.
Speaker 2:There was a lot of discussion about this and how the telehealth providers who have been, um, pretty active in this space and, you know, have set up good protocols for, for security and making sure that patients really need the medications that they're, you know, they've sort of done all the right things are feeling very pressured, um, by these rules or proposed rules. But, so we'll see what happens with the, with the changes.
Speaker 3:Yeah. And there's, there's also a 180 day period, so there's a sort of a six month runoff for existing telehealth patients to continue to have access. But for, for a new patient, um, who needs access to certain drugs, I do think there'll be some change.
Speaker 2:Yep. Um, what other rules factor into when telehealth can be offered?
Speaker 3:So I think the, the area we haven't spoken about yet, um, that that is covered in, in the h l a book, our, our state licensure rules. Um, the requirements that are imposed at the state level, uh, do make operationalizing access to telehealth trickier, uh, geographical location. Uh, as, as, as I said, really doesn't matter at this point in terms of whether Medicare will pay for a service, but it really may matter in terms of whether, um, a patient can, can be seen by a certain, uh, physician. Um, it depends on that physician's licensure and physically where the patient is sitting during that interaction. Um, so state waivers of licensure requirements that we saw during the pandemic are mostly gone, but some state laws now permanently allow out-of-state physicians to practice telehealth and at least in certain circumstances. Um, and another trend is state participation in licensure compacts that streamline applications or make it easier for physicians who are licensed in one state to to practice in another state or to see patients in another state via telehealth at at least. Uh, so this is, I think, an area that will continue to evolve, but that there's an effort to, uh, for states to work together to facilitate access. And
Speaker 2:We've seen a lot of traction on those, um, interstate compacts that sort of, you know, had been around for a long time but weren't, weren't utilized so much, but I think now they're, they're really coming into their own. Um, one of the reasons we understand that Congress has been hesitant to fully commit to telehealth is the fear of widespread fraud, um, resulting from the proliferation of virtual services. Amy, I'm gonna turn things over to you. Where have you seen a lot of fraud enforcement, um, involving telehealth in recent years?
Speaker 4:Yeah, so for years now, we've been seeing significant enforcement activity by DOJ with fraud schemes involving telehealth. There was a flurry of activity in 2018, 2019, and we're still seeing it today. You know, if you're like me and you check, um, the press releases by DOJ just as a hobby for, you know, kickback enforcement actions, they, they're still popping up from time to time. And all of these activities were really focused on activities where it was, you know, marketing to Medicare beneficiaries, often by a TV ad or social media where you'd call to a call center. Maybe you'd get connected to a physician, maybe you'd have a short visit, maybe not, and then there'd be ordering often of D M E or pain creams, and there was often payments between the various players, which appeared to be kickback. So that's kind of the classic tele fraud scheme that we have seen for years, and we've seen a lot of enforcement activity around it, and I think that's why we've seen a lot of hesitation around telehealth. But I think, you know, I'm sure that we're all aligned here. It's important to recognize that there's nothing inherently problematic with telehealth. This is tele fraud. It's a completely different thing, you know, by, you know, a certain small group of bad actors, which should not color the use of telehealth, which is just the new mo modality for kind of old fraud schemes. Right. Um, this past summer we did see a special fraud alert out of oig, and that is not every day that we get a fraud alert. It's a pretty big deal, and it is advising healthcare providers to exercise caution when entering into arrangements with telemedicine companies. And it's really focused on this tele fraud type scheme, but it's not limited to that. It's not limited to certain types of providers or suppliers. And it does mention suspect characteristics that people should be aware of. And many of those are focused, again, on marketing. How are you finding these patients? How are they coming in the virtual door? And also on freedom of physicians to really practice the way that they feel like they need to practice? So are they able to have meaningful interactions with the patients? Can they follow up if they need to? Are they limited to certain things that they can recommend or can they recommend next steps as they see fit? Um, and it's something to keep an eye on, although I think TelePro is very different from telehealth. You know, when we're, um, advising clients or working with a telehealth company or helping to vet a telehealth company for someone who's looking to contract with them to be aware of these developments and to make sure we're very much, uh, on the right side of things.
Speaker 2:Um, the has engaged in a number of studies on telehealth in the context of the pandemic, um, and telehealth is in the OIG work plan. Um, so I guess we can expect to see increased scrutiny on billing and coding compliance moving forward. What do you think about that?
Speaker 4:Yeah, I, I agree. I, I think we probably all again, are aligned on this. I mean, we've seen the use of telehealth as a modality just expand exponentially, um, in the past few years. Uh, it was doing so anyway before the pandemic, but that really, you know, kicked things off in a significant way. And we've seen a lot more reimbursement. And where there's more reimbursement, there is going to be more scrutiny. And so the OIG g undertook a number of studies during the pandemic, um, to study the use of telehealth. And a lot of these reports are very positive. You know, I think everyone recognizes the value of, particularly to promoting access to underserved populations and, you know, ways to reach more patients in the right setting at the right time. But there was a report this past fall, uh, in September and o I g reviewed claims of 742,000 providers. Now, the vast majority of these claims, there was no issue. They were completely fine. It was a very small percentage. It was something like 0.2%, you know, some very small percentage where they did find there was some high risk of billing issues. And for some of these, it was physicians who were, um, billing more claims for visits than it was really humanly possible to do in a single day. I mean, there's always gonna be, again, a few bad actors out there, right? But so out of that report, although I think the vast majority was a very strong report, OIG G did put recommendations for c M S to implement more monitoring and oversight, uh, with a particular focus on individuals who are providing these services via telemedicine companies as opposed to part of their larger practice. And then this past January, just, just a couple months ago, there was a new addition to the work plan where OIG is going to issue a toolkit, and that toolkit is going to help provide a roadmap. I expect to analyze claims data from a program integrity perspective. And it says that it's putting it out, um, for use by its public and private sector partners, which tells me, um, that we will expect to see continued scrutiny in a toolkit given to folks to do so to, to keep like taking a look at billing and coding compliance here.
Speaker 2:Makes a lot of sense to me. Um, frankly, it's not so different from the rest of the world that we live in frequently, um, right where, you know, sort of whenever there's a new code, people aren't quite sure how to use it or, you know, there are some compliance issues and they get studied for a while. Um, but hopefully this'll just become part of the normal armamentarium going forward. Um, there are a variety of other new issues coming to the forefront with the use of digital health, um, technologies. And some of these are covered in the, um, A H L A telehealth law handbook that we all contributed to. Um, I think one of the most interesting areas that we're hearing about right now isn't li limited to virtual health itself, but instead it's related to the technologies that hospitals, health systems and other healthcare providers, um, and frankly other website, uh, service providers use to track visits to their sites and learn how individuals engage with those sites. Um, many of these tools were developed by third parties like Facebook and Google, um, and they're embedded in the website's browser to track a user's movement through the sites. Um, there's now a host of findings that show that the information contained in these, uh, tracking tools may be available not only to the site's owner, like a hospital or health system or physician physician group, um, but also with third party developers for marketing and analytics purposes. Um, we've seen recently the FTC has taken action against several sites. Um, there was one on menstruation and OB ovulation tractor, um, two site allegedly shared sensitive information, um, with marketing and ANA analytics firms like Google and Facebook, um, in violation of the website privacy policy. Um, we've seen the same kind of action, um, from hospitals and health on the hospital and health system side as well. Um, but as opposed to being, um, regulated by F T C, um, by O C R with, with HIPAA violations, a very large Midwestern health system, um, reported, uh, a violation, a HIPAA breach, um, of I think almost 3 million users of their site, um, for sharing, uh, again, similar information that was contained in their, uh, patient portal, uh, with the developers of those technologies, again, in violation of hipaa. Um, and so now we're seeing a variety of class action lawsuits, um, and, and other suits underway. So we're likely to hear more about these types of transactions in the future. Um, but that's really all we were gonna talk about today. Um, there's lots and lots more to learn about, uh, telehealth. Um, and we thank you for joining us. We hope you enjoyed our chat. Um, if you need any additional information on telehealth laws or other regulatory requirements, please feel free to reach out to any one of us, um, or check out the new edition, um, the new second edition of the A H L A Telehealth Law Handbook. Thank you.
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.