Chris Eades: Hello, and welcome to Hall Render’s Virtual Care Podcast Series. Today’s focus will be Medicare reimbursement or remote patient monitoring services. My name is Chris Eades. I’m a shareholder here at Hall Render and a member of our firm’s virtual care team. I’m joined today by my fellow shareholder, Regan Tankersley, who focuses her practice on Medicare reimbursement, both in the context of traditional in-person services, but also virtual care services or telehealth services.

Chris Eades: Regan, thanks for joining us. Before we dive in, maybe tell us a little more about your individual practice.

Regan Tankersley: Yes, thank you. I am in my 19th year of practice as a healthcare regulatory attorney focusing on Medicare and Medicaid payment issues and regulatory compliance.

Chris Eades: Great. Well, Regan, so a hot topic in the realm of virtual care has been remote patient monitoring or remote physiologic monitoring, whichever term we want to use, for a number of reasons. It’s one of those areas where we have seen some permanent change already in the way of expanded reimbursement. It’s certainly an area that seems to mesh nicely with the concept of clinical integration and value-based care. Of course with technology and the advancements we see there, there’s simply a lot out there that we can do to potentially manage patients in a more efficient manner and in a more complete manner.

Chris Eades: So, it is a big topic and really the reason we wanted to kind of level set in terms of where we’ve been in the recent past and where we are today with reimbursement, specifically Medicare reimbursement. It’s also one of those many areas that you and I have discussed where we see competing definitions and concepts, right?

Regan Tankersley: Right.

Chris Eades: So, you and I often talk about the need for healthcare providers to understand there’s kind of the reimbursement side of the coin, all of the rules that apply to telehealth and other technology-based services that are specific to whether and how you can be compensated, and then of course there’s the professional side of the coin in terms of whether you can use these technologies to begin with to render care. If so, what do you need to do?

Chris Eades: So I mention that, right, because of course there are state to state different definitions and rules in terms of remote patient monitoring. We don’t want to lose sight of the fact that those concepts are out there and that we have to pay attention to them, but of course reimbursement is huge. It’s traditionally been the largest obstacle to providing these types of services, and so we did want to drill down more specifically on, again, where we are and where we may be headed with reimbursement in this area. So, I’m going to stop there and maybe, Regan, ask you to comment on whether or not Medicare has a definition that is specific to RPM.

Regan Tankersley: So from a Medicare reimbursement standpoint, RPM services are going to be described by those certain CPT codes that Medicare developed a payment rate for a few years back. I want to say 2018, but I know it’s within the last few years, prior to COVID, prior to the public health emergency. So from my perspective, I like to make the distinction, because we’ve seen a lot with the terminology between telemedicine, telehealth, virtual care, RPM services are paid for by Medicare under Part B.

Regan Tankersley: They are not true telehealth services as defined by the statute, by the Social Security Act that has a very narrow and discreet definition. An 1834(m) of the Social Security Act as to telehealth services, which are professional services rendered by physicians, mid-levels, eligible practitioners to provide those professional telehealth visits, consults, et cetera. RPM are not telehealth in that definition, you will not see those CPT codes listed on the Medicare list of covered telehealth services, they are just fee schedule-based services.

Regan Tankersley: I have to look into it on the hospital side, but on the physician fee schedule side, they’re paid for under the fee schedule. There are certain CPT code descriptors to describe different components of RPM, whether it’s the initial setup, whether it’s the data collection, whether it’s the interaction between the healthcare provider and the patient. So, I want to make sure people kind of understand that there may be some flexibilities during the public health emergency as to how RPM services can be provided and billed, but these services have been covered and paid by Medicare prior to the public health emergency.

Chris Eades: Got it. That’s an interesting point and an important point, right, because many of the state definitions that I alluded to would capture RPM as a defined telehealth service or a defined telemedicine service, depending upon what terminology the state uses. But as you point out, even though we think of RPM in a lot of ways as telehealth or telemedicine, technically it does not fall within the definition of telehealth for purposes of Medicare.

Regan Tankersley: Correct.

Chris Eades: So, why don’t we kind of touch base briefly about where we were with RPM just prior to the pandemic, because it was one of those areas in kind of the larger area of virtual care where we had seen some expansion. Let’s just kind of touch base in terms of where we were initially pre-pandemic.

Regan Tankersley: Right. So because of the nature of those services, they’re not an in-person visit with a Medicare beneficiary. So when Medicare developed payment rates to recognize that there’s a benefit to being able to remotely monitor patients and certain physiologic parameters, weight, blood pressure, all of those things that can be monitored remotely. Because of that non-face-to-face aspect to it, there was a requirement that the patient had to be an established patient of the billing practitioner who was going to be providing and billing for the RPM services, and there had to be consent obtained prior to initiation of those services.

Regan Tankersley: Those are all beneficiary protection measures, because they’re not there face-to-face with their practitioner, so it did require established patient and consent to be in place prior to the public health emergency. There’s been some flexibility because of COVID that Medicare is allowing during the public health emergency that the patient does not have to be an established patient prior to providing RPM services, and that the consent for the RPM services can be given at the time of that initial contact with the patient.

Regan Tankersley: So, those are the flexibilities that we’ve seen during COVID. There was also a flexibility related to one of the CPT codes that required a certain number of data to be collected and reported prior to being able to bill for that code once every 30 days. There’s been then some flexibility there during the public health emergency as it relates to patients’ beneficiaries with COVID or suspected COVID.

Chris Eades: So Regan, pre-COVID, pre-pandemic, was there flexibility to use RPM for both chronic care management and acute patient care, or was it only the former?

Regan Tankersley: I believe initially it was focused on chronic conditions, but there has been some policy clarification since COVID and part of the interim final rule flexibility recognizing that RPM services can be provided for acute care. Which is how you got that flexibility related to patients with COVID. That’s an acute condition, not a chronic condition. Then there’s been some policy clarification I believe moving forward that recognizes the utility and the value in those services, not just for chronic, but also acute.

Chris Eades: Then even pretty recently during the pandemic, this is one of the areas where we’ve actually seen some permanent change, right? We had kind of the rules pre-pandemic, we had some of the flexibilities that you mentioned in response to COVID, and then we actually saw some permanent change at the very end of 2020. What did that permanent change involve in terms of RPM flexibilities?

Regan Tankersley: Yeah. So part of the interim final rule flexibility, as we noted the consent and the established patient. So moving forward, Medicare has clarified through the traditional fee schedule notice and comment rulemaking, that moving forward the permanent changes after COVID will be that that consent that had talked about before that had to be obtained prior to these services being initiated can be obtained at the time of the services being initiated.

Regan Tankersley: That is a new permanent policy change, but CMS also clarified that post-COVID-19, post-pandemic, it is going to have to be an established patient relationship to provide those RPM services. So there’s been some clarification made, but the one really permanent change that they recognized on the consent issue. I think it’s important to realize too with remote patient monitoring, patient services, there’s lots of different devices that can collect data.

Regan Tankersley: I mean, my Fitbit collects all kinds of data, heart rate and your oxygen saturation, but for purposes of these defined terms and CPT codes for Medicare coverage purposes, it has to be a type of device providing the data that meets the FDA definition of a medical device. The data has to be sent automatically, collected and sent automatically to whoever the practitioner is providing the RPM services, it can’t be self-reported.

Regan Tankersley: So, it’s not a free for all. I mean, there’s still some coverage restrictions there related to the type of devices and the interaction that has to occur between the beneficiary and the billing provider for the codes that allow for the communication part to be built.

Chris Eades: Gotcha. How many days per month does the device need to monitor and report data?

Regan Tankersley: It’s at least 16 out of 30 under normal conditions. Again, there’s that limited exception during the public health emergency for patients with or suspected COVID that you can collect data less than 16 days and still report that CPT code that represents the data collection part of the service.

Chris Eades: Okay, so it sounds like then post-date of emergency, even with the permanent changes we’ve seen, that the two areas that will revert back, so to speak, would be, one, that RPM must involve an established patient. Then two, the exception that you just mentioned related to COVID treatment obviously would not apply at that point.

Regan Tankersley: Correct.

Chris Eades: So do we have any indication, Regan, in terms of where we’re headed next with RPM? Do we expect that we will see more permanent change or maybe additional flexibility? Is there any intel on that piece?

Regan Tankersley: I think as CMS continues to provide coverage and pay for these services, they’ll continue to monitor and collect data as to the utility. I mean, obviously I think the benefit of this type of data is that to be able to track patients for chronic and some acute conditions to hopefully provide for better health outcomes and to be able to treat patients sooner based on collecting that data that can be transmitted remotely, it’ll be interesting to see if there are permanent statutory changes made under the telehealth statute.

Regan Tankersley: For example, if going back to the original coverage for RPM services after the public health emergency, there has to be an established patient relationship. Well, can we establish that patient relationship through an initial telehealth visit? Part of that will go to are we going to have some flexibility following the public health emergency [inaudible 00:12:16] to the geographic limitation. That would really expand the ability to have that initial visit and establish a patient prior to establishing an RPM service for the program for those patients. Again, that’ll depend on whether we see a statutory change to the telehealth provisions.

Regan Tankersley: We’re already seeing sort of these RPM companies pop up, because part of the policy clarification with remote patient monitoring is that you can have auxiliary staff performing these services, but under the Medicare Incident-to regulation of services of auxiliary staff have to be directly supervised. RPM is a general supervision standard and CMS has clarified that you can contract with auxiliary personnel to provide the services.

Regan Tankersley: So, we’re already seeing RPM companies coming to physician practices with an RPM program to provide all of the technological support, all of the monitoring, and then providing the support then for the practitioner or their staff to be able to do the interactive communication parts of those services described by that codes. So you might start seeing more of [inaudible 00:13:24] industry pop-up to be able to support it to think about, one, for a data center entity.

Regan Tankersley: If we have some of these contract provision for auxiliary personnel and if we’re not limited by a supervision standard, considering what we do in different locations, different states. I mean, there’s still some of those things to consider, but I can see that happening more as kind of coming to a physician practice with here contract with us, we can provide the services for you so you can provide them to your patient population.

Chris Eades: Interesting. Yeah, we’ve obviously seen a lot of activity legislatively and we continue to see a high number of bills being introduced, most of them focused on reimbursement in the realm of virtual care. We’ve also seen some legislation that’s more specific to increased funding, and worth noting, I think, that we’ve seen some of that legislation be specific to remote patient monitoring.

Chris Eades: I know very recently there was some legislation introduced called the rural remote monitoring patient app, which intended to or is intended to establish a pilot grant program to support RPM in rural areas. So I think in addition to some of the rules themselves potentially changing, there’s certainly the possibility for some increased funding in this area as well that healthcare providers should be mindful of. You had mentioned, but just to emphasize. In terms of the actual technology, Regan, that can be used, what’s the threshold requirement there?

Regan Tankersley: So there has to be, one, depending on the CPT code we’re talking about, but for the data collection devices, there has to meet that definition of a medical device and it has to be able to capture and collect data and send it automatically. But as far as the codes that capture the interaction between the patient and the billing practitioner, that’s described. Then interactive communication, it has to be conversation in real-time. It’s synchronous, it’s a two-way communication.

Regan Tankersley: I believe a lot of that can be done … I mean, there aren’t the restrictions you see under telehealth regarding video, but you can use video enhancements. I think there’s another CPT code that can reflect some other type of services, but the data collection CPT codes have certain requirements, and then the communication-based codes with that interactive, that’ll have a set of requirements, and that’s going to be defined by those CPT code descriptors.

Chris Eades: Right.

Regan Tankersley: I would comment too as we’re talking about payment, my sense, and we know this from some of the committee hearings that have been going on in D.C., that if we do see some increased flexibility under telehealth, I mean, it could be a domino effect, like I just mentioned, that they end up changing the statute and moving the geographic restriction. Well, now you can provide more of these initial patient contacts via telehealth that open up the door to some of these other services like chronic care management and RPM. Will the fee-for-service system continue on or will there be some other methodology or mechanism to pay for some of these services?

Regan Tankersley: I feel like the Medicare fee-for-service system was meant to be reactionary. You’re paying for medically necessary treatment for diagnosis or treatment for people who are already sick, and I think part of these initiatives with virtual care is trying to capture this patient population and data to help provide for healthier outcomes before they get to the point that they’re really sick. Does the fee-for-service mechanism payment methodology really support that type of care? So, I think that still remains to be seen.

Chris Eades: Yeah, and going back to the earlier point that you made regarding the technology actually constituting a medical device. As simple as that sounds, we’ve certainly encountered concerns or issues in the employment setting or hospital setting where individual providers are seeking to use technology that kind of looks and feels like it’s a medical device, but in reality is not a medical device. So even though fundamental, I think it’s important to be mindful of that, that there are millions of applications out there and technology as well and wearable devices, et cetera, that do not rise to the level of medical device.

Regan Tankersley: That’s right.

Chris Eades: I also wanted to mention, you had pointed out one of the permanent changes involving the ability to obtain patient consent at the time of service, which provides some helpful flexibility. You and I field a lot of questions more generally about consent in the realm of virtual care, and so I think it’s also important with consent to keep two additional pieces in mind. One is, again, any state law specific requirements, right? So we’re talking about consent, again, for purposes of Medicare reimbursement, but RPM may be captured by a state telemedicine act, which itself has particular requirements for documented consent. So, need to remain mindful of those state law specific provisions.

Chris Eades: Then two, in a more healthcare provider specific context, quite often RPM is not the only service that you are providing electronically, right? You may be, as you pointed out earlier, providing RPM in conjunction with other types of virtual care services. So, approaching the consent process more strategically and proactively in a way to check all boxes, and also in a way for the healthcare provider to obtain a meaningful and helpful consent ahead of the time is probably a good idea and something that our providers should be mindful of.

Regan Tankersley: Well, and you raise a really good point between consent as required by state law, whether it’s in regard to telehealth telemedicine or just consent to treat, versus some of the specific Medicare coverage requirements for consent related to your ability to have coverage in both of those services, such as the RPM. So those are two those questions, but which one trumps, the federal or the state? We’ve got to comply with both.

Regan Tankersley: I mean, I think that’s just the important thing to remember is that if these certain services from a Medicare payment standpoint require a certain type of consent, we still have to comply with everything related to your state law. But I think too moving forward, I just read this article kind of on security and cyber-attacks attacking medical devices. Something kind of out there as far as whether or not what data devices you’re using to collect data, but how are we ensuring from a cyber standpoint the security of the data, making sure there isn’t any way to hack into patient accounts. So all of that, the more we do virtually, it’s going to just raise that compliance and risk level of how we’re making sure all this type of data and patient contact and information that’s being done virtually is going to be protected.

Chris Eades: Absolutely. Well, Regan, hey, thank you very much for your insight. To our audience, thanks for joining us. If you or your organization have any questions or topics that you would like to share with us, please contact us via our website at hallrender.com. Certainly feel free to reach out to me at ceades@hallrender.com, or Regan, particularly if you have questions specific to reimbursement in this arena. Regan can be reached at rtankersley@hallrender.com.

Chris Eades: As always, please remember that the views expressed in this podcast are those of the participants only and do not constitute legal advice. Thanks so much for joining us.