Navigating the CCM and RPM Landscape

Two common types of chronic care management and monitoring are chronic condition management (CCM) and remote patient monitoring (RPM). Rachel V. Rose, Rachel V. Rose—Attorney at Law PLLC, and Pam D’Apuzzo, Managing Director, VMG Health, discuss the regulatory landscape related to CCM and RPM. They cover issues related to compliance, coding, fraud and abuse, and the Chartspan False Claims Act case. Rachel and Pam wrote an article for Health Law Weekly about this topic.

Watch this episode: https://www.youtube.com/watch?v=dR63yMTZC5M

Read Rachel and Pam’s Health Law Weekly article: https://www.americanhealthlaw.org/content-library/health-law-weekly/article/03139198-a7c2-4f3b-9ccd-6b5ac9965292/Navigating-the-CCM-and-RPM-Landscape

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Transcript

SPEAKER_00 0:04

This episode of AHLA Speaking of Health Law is brought to you by AHLA members and donors like you. For more information, visit AmericanHealthlaw.org.

SPEAKER_01 0:17

Hello, and welcome to today's podcast. My friend and colleague, Pam, who will introduce herself momentarily from VMG Health and I are presenting on a very timely topic related to CCM and RPM. And specifically, that is an area of compliance as well as services that can be rendered to patients, which really focuses on another vehicle to help control and manage chronic conditions. I'm Rachel Rose. I'm an attorney in Houston, Texas, where I have my own firm. I primarily focus on healthcare, cybersecurity, securities law, government enforcement actions. I do transactional compliance and litigation, as well as bringing False Claims Act cases. I most recently had a case intervened in by the United States Department of Justice that related to Medicare Part C up coding. And although the type of coding we're going to be talking about, or more specifically, Pam is going to be talking about today as a coding expert is very different than what goes into a Medicare Part C risk adjustment. But with that, Pam, tell us a little bit about yourself.

SPEAKER_02 1:51

Thank you, Rachel. Appreciate the opportunity, of course, to be here with my colleague Rachel and be able to have this opportunity to talk to all of you about coding and compliance. I think it's just an area folks like Rachel and I work together. I work with a lot of attorneys on these types of specific issues, and they're so much involved with the coding and compliance component of it and the documentation requirements. So certainly appreciate the opportunity to be here today. I serve currently as the managing director of the coding and compliance division at VMG Health. We are a healthcare-only consulting firm with a lot of different areas of specialty. And this area of coding and compliance is just one of them. But thank you all for having us today.

SPEAKER_01 2:39

And thank you, AHLA, for not only having us as a guest on the podcast, but also for publishing our article, which is going to be the framework of our discussion here today. So, Pam, our article really opens with, for those of you who can recall the Atari game Frogger, where the frog's trying to get from one side of the road to the other without getting hit by a car or a truck. And really, when Pam and I were discussing it, that's kind of the way healthcare compliance encoding works, especially in the RPM and CCM space. So, Pam, do you want to explain generally what RPM is and CCM is, and then how they differ from each other?

SPEAKER_02 3:31

The services are different. They all kind of fall under this care management umbrella. And I think there's been a lot of interest by providers in these particular types of codes. They've been evolving. If you look at the codes, you'll see that in some of the code series, the numbers aren't even consecutive. And it's because these have been add-on and evolution of codes, and it isn't as consistent as we would have thought. I think they keep thinking about types of patients and how we can care for those patients. And with that, they've been introducing over the last couple of years these different types of codes. Now, chronic care management for a patient who has multiple chronic issues, that's part of the issue is being able to ensure that we are meeting the specific criteria for those codes. And it's about the patient. And then if the patient meets that criteria, having the appropriate type of provider who would be providing that kind of ongoing care to the patient, and then all of the associated documentation requirements along with that. So chronic care management, we've got these patients who for the month, we're providing them a lot of different services. They've got these multiple conditions that we're managing. And so we've got a care plan, we've got outreach to the patient, we're managing their all of their prescriptions. There's a lot of coordination for those particular types of patients. So all of that from a time perspective, uh both by the physician or advanced practice provider, like a nurse practitioner or PA, is all being managed, all that time is being accumulated throughout the month. And then we also have the opportunity to leverage ancillary staff who does a lot of that work as well: medical assistants, uh registered nurses, LPNs that might be working in collaboration in support of the physicians to help kind of navigate those types of patients and keep their care very well coordinated. RPM, again, coordinated with these types of services, it all makes sense, same kind of patients. But RPM is remote patient monitoring. So now we've got an FDA-approved type of equipment. Maybe we're monitoring someone's blood pressure, is probably a great example where we're monitoring that blood pressure for the patient, and there are specific requirements. Now, this is a great opportunity to stay connected with the patient, have this transmission of data coming through, reviewing that information, feeding back information to the patient about maybe some fluctuation, change in care, or maintenance. Like you're doing great, we're going to continue to do what we're doing now. But it allows us without having to bring the patient back into the office as frequently to keep track of what's going on with the patient and again, care of these conditions that they might have. But restrictions, how much time we're transmitting, how much time we're spending actually looking at this, X number of days, 16 is the number that is the prior, at least code that we were using that allows us to look at a specific number of days of data being reviewed and then recording all of that. So the foundation of all of this is this management of patients, but from a technical coding and documentation standpoint, we could be doing all of these services. But if they're not being documented properly, which is happening all the time, because I think one of the things, and I'm sure Rachel, you've seen this too, is that providers or organization, maybe practice administrators, everyone goes out to these conferences or we hear about these annual updates from CMS, and everybody gets excited about all of these great new codes and services and says, we're doing this, like we should be or we should be doing this. But I don't think as much time is spent in the appropriate coordination of what's involved with this, what is the workflow, what is the documentation, and then what are the checkpoints to make sure that everybody's doing this correctly, given the amount of information that needs to be documented.

SPEAKER_01 7:50

So, Pam, you just raised some great points and to provide a summary for our audience. The way I translate that is first, you need a physician or a nurse practitioner or advanced provider to prescribe this particular service, and it must be documented in the medical record. Along those same lines for chronic care management or CCM, there have to be two chronic conditions. And two chronic conditions that often go hand in hand are hypertension and type 2 diabetes, for example, or hypertension, yeah, and cardiovascular disease, whatever the case may be. From there, these chronic conditions have to be expected to last at least 12 months. And so that's something that, as a physician, is looking at something, and the reason I'm raising that, and Pam, your insight would be great here from the coding aspect. A woman, for example, may acquire gestational diabetes and may have pre-eclampsia. Are those two conditions necessarily going to be lasting 12 years?

SPEAKER_02 9:09

Exactly. That's the issue, right? And it certainly could be. I know many of women who unfortunately have gestational diabetes that then continue on post-baby, but most of these conditions, and I think the tie-in here to those 12 months is that when CMS and AMA created the new, which is the current 2023 EM guidelines, in these new guidelines is the first time we had some of these more definitive definitions. And one of them was specific for chronic condition, and it's something that's expected to last at least 12 months or for the lifetime of the patient. So in that specific case, like pre-clampsia, no, but certainly the diabetes could happen postpartum and continue on. But these are cases that have to be individualized. They're not something that's going to be for everyone. But your examples of hypertension, uh, diabetes, CAD for you know, heart disease, those types of conditions generally continue on to really meet the criteria for for a chronic condition that'll expect to meet that criteria.

SPEAKER_01 10:16

So in September of 2024, HHSOIG released a report. And what was fascinating about this report is that it was entitled Additional Oversight of Remote Patient Monitoring in Medicare is needed. And Pam, you and I both know as soon as one of those types of white papers or a special alert comes out, everyone in the healthcare sector's radars, and rightly so, go up because what OIG is saying is hey, this is an identified area of fraud that we are going to be focused on. So on the first page of that document in relation to RPM, they expressly state that one of the areas that they are looking at even today is where the three main components met. And the three main components of RPM are education and setup, device supply and treatment and management. And what you articulated earlier that it had to be an FDA-approved device, whether that's a glucometer, whether it's a continuous glucose monitor, whether it's a blood pressure cuff, or whether it's even someone's weight. Because if someone is gaining water, if they have a congestive heart failure, for example, edema is something that can be tracked by weight. And it's something that a physician will absolutely want to measure to see what the trend is in that, especially if they're on LASIKs or something, how that is coming into play. So that's one item from the compliance standpoint, even before you get to the coding, you want to make sure that you have those three main components the education and setup, the FDA-approved device, and then the treatment and management. The other aspects of the OIG's report that they mention was that the increase in RPM dramatically increased between 2019 and 2022. Well, in a way that's not unusual given COVID and how a lot of practices had to pivot to get people to still remain compliant so that their chronic conditions did not worsen, especially in light of people with certain chronic conditions being more susceptible for COVID. And then another part of that was that about 43% of enrollees who enrolled in RPM or who were enrolled by a provider in RPM did not receive all three of those core components. And so from an FWA standpoint, that just jumps out as not meeting medical necessity and not meeting the elements of the code and what CMS is stating. What are your thoughts on that?

SPEAKER_02 13:29

Well, you know, I think when I look at some of this with RPM, I mean, you brought up we talked about FDA, but I feel like uh the hospitals and some of these large practices, they have a lot of vendors coming in to talk to them about these different devices. And Medicare is also looking now, what is the value of that clinical data? I think that's a really important thing. We could track everything, but what value does it have in the clinical care of the patient? So I think that's part of the OIG as well, is saying, like, even if you can transmit and it meets all the other criteria, what is it, value is it bringing in the care of the patient? And so we've got a lot of different devices that are coming through, but some of them, I don't even think that it's the transmission piece too. Some of them are sitting in, like it's pending FDA approval, which again eliminates it. But you know, it's not that easy to find out, Rachel. Like, I'll tell you, we have spent for some of the clients who bring these things to us, and some of them they go directly to the providers. And so then the providers, like someone finds out at the hospital that they're actually billing for this or that they want to bill for it, and then we get brought in from a compliance perspective, and we're like on their website trying to even find out, we can't even get a clear answer about the FDA cleared versus FDA approved status. Then it's well, can you show us what the transmission looks like? Because if the transmission doesn't allow for the practitioner on the other side to really be able to evaluate and interpret that information, again, what value is it is it bringing? And then the time that's required for that provider to be able to really interpret it and then have that discussion with the patient about what that management is going to be like based on what they're seeing from the data transmission. So I think that's why, too, now the change in the codes or the add-on of the new codes for 2026, which I believe when we wrote the article probably weren't available yet, but they decreased like this new bucket of codes has less time. So the previous codes that we were using have 16 days worth of transmission required. The new codes for 2026 allow for two to 15 days worth of transmission. Because I also think they're realizing again, tied to that medical necessity standpoint, is that do we need 16 days? Maybe we are transmitting data that is valuable, but we don't need 16 days of transmission for us to be able to say this was valuable information to care for the patient. We could do it with less. So I appreciate the fact that they did make those changes as it relates to the coding requirements and the time requirements for those services.

SPEAKER_01 16:20

I agree 110%, especially when you're talking about a person's weight, right? They can go out, eat Mexican, and then swell up like a tick. And it's yet it's every four days for someone with congestive heart failure, unless they're dealing with something acute that is dramatically impacting the weight. And in that instance, the physician should be saying you need to weigh yourself every day, because we really need to monitor this closely to see how you're responding to a new medication or how this particular change is impacting your overall management of the condition. So this is not easy and it can, to your point, be a very effective tool. But if it is being done just for the sake of additional revenue versus if it's being done for significant monitoring to help the patient better manage and the physician ascertain what is going on, I think that is very helpful. And most people, as we know, even from exercise, what do they say to anyone who has trouble sticking with exercise? Get a buddy. And I think that an RPM can really be a useful tool for patients once they buy into it and actually use it.

SPEAKER_02 17:45

Because you know someone's watching on the other side, right? It just holds you accountable. So I think that it is a great tool for some patients and saving patients from having to come in. So, like some of these elderly patients who it is a hardship to get into the office, you know, both physically or having to have someone take them. So it makes sense to be able to track and trend what's happening with the patient in this way. Um, and it allows them to really stay connected without having to go into the office. Um, part of this too is who's doing that? I think this is the confusion across these care management codes is who is permitted to do what in order for us to bill and over what time. Most of these are all like 30 days within the calendar month. So it allows us to really understand that it's like that one-time billing. But you also have to have those parameters set up appropriately too in the system so that we're not misbilling or over-billing these codes, that we're billing them when appropriate and when we've actually completed all the requirements within that time period to be able to drop a claim for that particular service that we've provided.

SPEAKER_01 18:56

Exactly. And before we delve into some more of the specifics with the coding aspects and then the fraud, waste and abuse, and in particular, the chart span medical technologies case is a false claims act case that was filed in 2021 and is still active in terms of litigation and the related potential AKS violations that are woven into that. There are some other types of remote management, including the advanced primary care management, of which the principal care management is one type. And what this does, from my understanding, and I'd love yours as a coder too, is in essence to combined a variety of different elements together related to the existing care management and technology services, which you may have already been billing your patients for, right? And then that difference there is that it focuses on high-risk chronic conditions instead of just two chronic conditions, expected to last at least three months. So here we see maybe that's where the gestational diabetes may come into play, right? And all of that. And after one year of PCM services, we also know that a new initial visit is required.

SPEAKER_02 20:30

So And see, those types of parameters need to be set up as well because people miss those requirements. The same, like even like a basic requirement, Rachel, like of just consent. Patients need to understand, you know, remember that before all of this with COVID, we have been telling from a compliance perspective, and I'm sure from a legal perspective, telling physicians and providers, we understand it takes a lot of time to call patients and give results and give advice, but it's part of the visit. There was no separate billing for any of that. So, in today's environment where so much of this is being done through telehealth and remotely for with the patients, patients need to understand this is a billable event. This is not me just picking up the phone to give you this information and kind of close the loop on something. This is a service in lieu of you coming into the office, but this is a billable service where cost sharing comes into play. So obtaining that consent from the patient, having them understand that you're billing for the service, also, it's one provider billing for this type of service per month for the patient. So they also need to understand that they're kind of agreeing that you're gonna manage their care, you're gonna bill for this service. Patients need to understand what's involved. And I think that in some of the issues that we've seen related to all of this, chronic care. Transitional care, all of these man care management services is that there's no consent on file. They or they get it once and they never go back to this again. So, I mean, we always recommend from a compliance perspective, getting that verbal consent from the patient, letting them know at each touch point this is a billable event with cost sharing involved for you. Do you agree? Yes or no? So that patients know what we're doing. And then all of these different types of services, most of this being done by medicine, you know, primary care physicians, internal medicine physicians, but we see specialists. And if you look at some of the requirements or in the guidelines of the codes, it says as long as it's a place where the patient feels it's continuity of care for them, a place where they consider their primary uh care being um addressed, we can bill those by the specialists as well. But I have to tell you, honestly, care chronic care management, transitional care management, RPM, we're seeing that all day long. The advanced uh primary care and the principal care management, less of those services, oddly enough. And I don't know if it's because providers don't think that they meet the criteria or they think it's too burdensome for them from a perspective of what's involved for them to manage it. But those two particular categories of codes, we happen to see the least amount of activity in.

SPEAKER_01 23:31

So you raise some great points. The first being that notification and consent aspect of it. And I've advised a lot of RPM companies, and even when people come to me after they're established, the best practices that I have seen are either a the patient has consented to the RPM and is appreciating the additional cost, which although for certain socioeconomic classes might be de minimis, right? Less than a Starbucks a day. For other people who are Medicare eligible, that could be a significant portion of how they manage their budget. And so I think appreciating that is critical, but the best practice is to have a form that highlights in bold less than a page, about two-thirds of a page that explains to the patient what this is, write in what their benefit is to their chronic conditions, and then have the patient sign it or their legal representative so that there is no ambiguity that this was in fact explained. Where I've seen the wheels come off, even with ambient AI or that AI scribe, is that a person has to be given the option of opting out of the utilization of an AI scribe. And so if someone has that exchange and it's been recorded, that's a lot easier to verify from a documentation standpoint versus someone just typing that in. I don't think that gives as much credence as signing that paper and just taking the snapshot and uploading it into the EMP.

SPEAKER_02 25:25

One time one and done. It's not a one and done. It really isn't. And I think that's where most of these practices go wrong. And we'll we ask all the time when we're auditing these, like, can we have all of that documentation? I would say more than half do not include this as part of their each visit requirement. Our recommendation is the same as like have a smart phrase that you have to fill in the blank. Part of that is the consent so that there's never an opportunity where you are interacting with the patient and don't have that opportunity to obtain consent.

SPEAKER_01 25:58

Right, exactly. And the safest consent is written consent. And so that's from my perspective, on the legal side, you're never gonna go wrong having that one page with the signature right there and having it explained. But that I think is a great point.

SPEAKER_02 26:15

Now, do I think you oh I'm so sorry, you brought up one point that I don't want to forget about because we talked about the setup for RPM. Uh, you mentioned how that's like the number one requirement. And so we see on a couple of these, and I think this is just a good call out, is that on a couple of these that we've been asked to vet, there is no setup. They're like, oh no, the patient gets it from Amazon. It's like, but you're not meeting the criteria. Like, this is part of the criteria. And I don't know how to ex how best to like convey that that these are the big flags that clients really need to be aware of because these are the things that already should be a big flag for anybody on the other side saying, like, we're just not gonna be able to bill this as RPM. I mean, if the patient has to go buy it themselves on Amazon and they have it at home and we don't instruct them and we don't go over all the setup with them, and we're not billing that initial setup code because there's a separate code for the setup piece, this is not gonna meet the checkpoints for RPM.

SPEAKER_01 27:22

No, that's an excellent point. And in my experience, the companies that have come to me do provide the blood blood pressure or the scale that has some type of connectivity so that it interacts with an app or whatever the case may be.

SPEAKER_02 27:42

We're providing it as the provider's office or the organization. We're providing it to the patient, we're walking them through, and that setup could be ancillary staff, right? It could be a nursing team that spends that time with the patient, but we are providing the equipment and we're teaching them how they're going to use it so that they can and how they're gonna trip transmit and how often they're gonna transmit.

SPEAKER_01 28:04

And that can dovetail too, as you know, into how often Medicare will cover a glucometer or how often it will cover a blood pressure cuff, which on average is every three years. I believe so. Um, and the other point related to that is a glucometer can only be used by one person. That's not something that can be returned to the RPM company, which makes sense why, because there are biohazards that are on that. Uh your blood pressure cuffs, maybe, maybe not. But then again, factoring that in and having a system as part of the education with the doctors annually to say, you know what, this person's been doing RPM for three years, they are also allowed to get a new device, which makes sense because the readings start to go, and then you could get uh unreliable patients. Yeah. So those are all factors that the patient, the provider, and the RPM company need to appreciate. But your point is very well taken on just ordering something off of Amazon that the provider doesn't necessarily know how to share it.

SPEAKER_02 29:17

Sure. And we don't even see it, right? Because the patient's just getting delivered to the patient's home, and unless the patient brings it into office. But again, this kind of just circumvents the whole idea of what RPM is supposed to be and how we're supposed to use it from a provider perspective.

SPEAKER_01 29:31

Right. So in our article, and I'm just gonna mention this for the audience, for those who haven't read our article, which came out in March of 2026. We did a chart of do's and don'ts. And we have different tables after each section that say do this, don't do this. So from a compliance roadmap vantage point, this is a great resource for anyone who's listening to this podcast to go back and review. Now, Pam, I want to pick up on something on the coding side that you mentioned earlier. And as we know, there's been a lot in flux across telehealth, right? Since COVID, the ending of COVID, and then how different types of telehealth could still be utilized? Then to your point, you brought up the number of days for RPM that needed to be recorded. And for a period of time, some providers were struggling with patient compliance to get those 16 days. What benefits do you see, and what advice would you give generally as a best practice for someone who is utilizing RPM in their practice?

SPEAKER_02 30:53

So I I still see that physicians from a going back to telehealth, I think as a whole, there's been a lot of confusion. I think when Medicare proposed kind of a rollback last year, I think people started realizing that maybe this wasn't going to be kind of the forever um work stream that they had already set up in their practices. And so a few people kind of retracted, others kind of decided to just forge ahead. And luckily, with all of the Congress weigh-in, we did get the extension through the end of 2027. So it gives everybody a lot of time to be able to really navigate this properly. In the telehealth world, the majority of stuff that we see is the evaluation management services. We're seeing those patients, whether they're doing it through audio video or audio only, they are providing those services, but they're using that opportunity to provide telehealth instead of bringing the patient back into the office all the time. All of these services that can be permitted to be performed through telehealth that we can do as part of all of the care management services, I think folks forget that you need to look at that list. There is a list, and they did a great job, I think, from a CMS perspective, of providing us with a list of all of the codes and then whether or not those services can be performed through audio video only, or could they also be performed through audio as well? So just double checking those at the beginning of every year and sometimes throughout the year because there's changes that won't be now through next year, but it's always great to refer to that list, double check that the codes that you're using are on that list and permitted for you to be able to provide this way. So a lot of these services, like the RPM, that is not the intention of the service that you're putting a modifier that this was telehealth. You're transmitting the data, you're reviewing the data. But when the physician is contacting the patient to go over that information or using a specific code, you want to ensure that the documentation is clear about what is the modality. Was this audio video where you were speaking to the patient and going over all these results and giving them that advice? And then, of course, what was discussed with the patient. But I think folks get a little lax in this world and as it relates to these particular codes, thinking that they don't have to kind of check all the boxes. Everybody's worried about evaluation and management. But these services are under scrutiny as well. In fact, obviously, based on OIG, anytime OIG looks at something, it kind of sets the stage for everybody else reviewing them as well from an audit perspective. So here I would say they want to ensure that their documentation is very clear, especially when we're billing for the provider time for these services, that they're not only are they just documenting what was discussed and the time spent doing it, but all of those other components. How did you deliver the service? Were you on video with the patient? Was it audio only? All of that should be well documented in the note.

SPEAKER_01 34:06

So you raised an excellent point in terms of the provider calling. Oftentimes, as we know, once the provider does the initial establishment, then a medical assistant can in fact review that data. Yet the medical assistant's touch pointer call cannot be built at a telehealth, whether it's a phone or an audio visual. Also, one important item is text message can be effective as well. And some people respond better to text messages or an app. Going back to the app as the legal side, I look at that is is the app FDA approved? And as you know, yeah, we're communicating. Yeah, there are a lot of factors that one has to deal with there, including artificial intelligence and what the output is related to that. But again, if your app is part of the RPM, if you're the company, you absolutely need to make sure that it's FDA approved as part of that process. Yes.

SPEAKER_02 35:19

And I think, you know, when you touch about a touch on who can provide the services, the codes are very clear about what is auxiliary personnel, like your medical assistants and your nurses, and others that are very specific that it has to be a provider who can bill for an evaluation and management code. So those are your physicians, your non-physician practitioners that are qualified. And that's the other part, too, is that sometimes some of these services, folks will say, but Medicare considers this individual a qualified provider. It depends on the service, but could that individual provide an EM? Because that's part of the definition. It's not just qualified healthcare provider, but it's qualified healthcare provider who can bill, who is qualified to bill for an evaluation and management service. So the most common, you know, PA or an MP are the two most common that we do see. But you have to also recognize that when you've got this care team and you've got certain services that allow you to really leverage your ancillary staff, great. But then you have to have very clear distinction and parameters set in place for those services that are restricted to physicians and the advanced practice providers so that we're not missbilling the service. And I we see that a lot. That happens to be a big issue related to all of the care management services.

SPEAKER_01 36:48

That's an excellent point. So, with that, let's transition into the fraud, waste, and abuse arena. And as most people who have been in healthcare for a while know, HHSOIG has identified five core fraud, waste, and abuse laws that they say every physician needs to know. I would also add the Eliminating Kickback and Recovery Act of 2018 to that because it's so similar to the federal anti-kickback statute. But those five laws are the False Claims Act, the physician self-referral law, also known as the STARK Law, the federal anti-kickback statute, we have civil monetary penalties, and then we have the exclusion authorities. So those are all great points to start. Now, if we're thinking about the False Claims Act, what are we looking for? A false or fraudulent claim that is being submitted, either for services that were never provided or for services that have requirements, but not all of the requirements have been met. Or lastly, implied certification, which was the Escobar case, which, Pam, to your point, we could completely see. If a medical assistant is billing for an MP, then that's what was at issue in the Escobar case. You had non-qualified providers, meaning that they were acting outside of the scope of their license, utilizing someone else's number in order for that claim to be submitted. And that's where the implied came in, because you shouldn't have to say you need to be qualified in this area of medicine in order to submit the claim, right? But that's what happens.

SPEAKER_02 38:37

And we see this all the time. And there are very specific parameters. A lot of people also outsourcing some of these services to vendors, like chronic care management is probably the most common where we see this. And you have to be really careful to have checkpoints where you're looking at that documentation to validate that the documentation is being well captured. If you think about how much time in a compliance atmosphere we spend educating physicians and advanced practice providers, like that's my life all day, every day. This is what we're doing we're providing information, we're educating them from a documentation standpoint. We don't get that kind of FaceTime with ancillary staff. So ancillary staff is certainly more than a custom of documenting in the EMR. But if you think about the intricacy of the level of documentation that is required for a service like chronic care management, and then you're tasking that to individuals who don't necessarily get this kind of education of how much their documentation and each entry that's the requirement for chronic care management, is that at the end of the day, I've got all of these entries that equal or exceed the time requirements that I need for that service, and that I can validate all of this. You spent a minute doing this, you spent two minutes doing this, everything is entered and detailed with not only just two minutes, but like the descriptor of what you did that then makes sense because we've seen things where it'll say, like, we fax something to the pharmacy five minutes. It doesn't take five. Five minutes for those of us that speak for a living, five minutes is a really long time, and five minutes it does not take to fax something over. So those entries have to be valid and appropriate for what they're doing. But again, we we're talking about a grouping of people who are more than accustomed to spending time with patients and documenting in the chart, but not to that level of granular detail that we're now holding them responsible for. And there are also restrictions, like those folks can't be offshore, and you know, there has to be appropriate documentation if it's a vendor that you're using. We've seen some of the tools. Sometimes it's not outsourced to a vendor to actually perform the service, but rather outsource is the software that we're purchasing. We're using a software that's allowing us to do this, maybe outside of the EMR, because the EMR isn't necessarily driven to account for like all of these individual line items. So they're using an outside uh software to allow them to capture this well. But the software, if you look at it, sometimes you know, like I'll I'll be asked to review it and I'll say, like, wow, like this looks great. Like it's really helping and prompting. And then we'll get to like the last part, and it'll say, I'll say, like, show me the time for the month that drives the coding. And sometimes we've gotten folks say, like, oh, we've built this so sophisticated that if you at the are getting close to the end of the month and you're short time, you get a message in your inbox saying you're short three minutes. From a compliance perspective, I feel like now you're leading me to like go out and try to have three minutes. So I think this is why there's so much scrutiny, and everybody has to really do their due diligence before they engage with a software vendor or an outside vendor to provide these services. There's plenty of great companies out there that are providing wonderful, legitimate work. But there are others that maybe that software sounds great, but I think that that could put a practice in jeopardy if you constantly have this prompt and you respond to the prompt by spending more time calling the patient or doing another activity that all of a sudden, you know, miraculously gets you to the 20 minutes you need.

SPEAKER_01 42:46

Yeah, one thing before I delve into the family clinic of Albany versus the chart span medical technologies case is having read a variety of these contracts, so from the legal side, another area that I would caution any provider and or lawyer who's reviewing those contracts is is there a fee sharing, which isn't completely impermissible if you construct it within Stark and AKS, that may be permissible. But when I see a shift in fees twice during a one-year annual period, I mean the flares go off. Why? Because CMS does not change their reimbursement rates multiple times within a year, right? We look for the uh physician codes every October or so, and then the physician fee schedule is where they're set out, as you know, Pam. And then typically those become effective January 1st. So if you're viewing a contract and there are shifting in fees or percentages within a fiscal year, to me, that raises a significant area of potential fraud. The chart span case is fascinating because it's still going on. I actually pulled the docket this morning, but the one item that I wanted to focus on was the motion to dismiss, in which the court rendered its opinion in August of 2025. And what the court said was okay, relater, first this is a decline case by the DOJ, meaning the government declined to intervene at this point, but they said to the whistleblower and their counsel, go forth and conquer. We think there's enough here, but we may not have the person resources to go and pursue this by ourselves. Also, if you think about 2021, that was a very new period for RPM. So I think that could have been a factor here. Having said that, there are really three things that stood out to me about the judge's opinion in the motion to dismiss. First, he did allow for the individual owner of the chart span company to be removed as a defendant. He left intact the liability with the LLC chart span itself. Secondly, there was the allegation of unclean claims to CMS for reimbursement, meaning, as you led with Pam, they weren't meeting those core three criteria. And then lastly, they they offered direct or indirect remuneration in violation of the federal anti-kickback statute. So the AKS remuneration can be direct or indirect in cash or in kind, and influences either the utilization of a service or a product or the referrals of a service of a product for any government program, with the exception of the federal employee health benefits program. So what the judge said was that relators, you can proceed on the claim that charge chart span personnel, and this goes to your last point, did not meet the Medicare standard for CCM services to patients by routinely failing to make any actual communication. And it's important to note, communication again, can be via text message, it can be through your EMR, it can be via phone or audio visual, but there has to be some form, as well as routinely failing to provide management of patients' chronic conditions, having little to no health information to actually manage, and also the numeric portion, like you were saying, how did these people get to 20 minutes a month when there is no way that it would take that long?

SPEAKER_02 47:16

And I think you hit on something there too, that you know, the comprehensive care plan, it's not again one time, and you're you never have to look at this again. I mean, if these patients have these types of chronic, complex conditions that we're trying to manage and keep them out of the hospital, like that's part of all of this, is we're trying to keep these patients healthier and out of the hospital in their own homes if possible, right? Or keeping them just away from having to be admitted to the hospital, go to the emergency room. So the whole intent is that we are constantly managing. So it can't be one time that you provide this comprehensive care plan and you never have to go back to modify that. But these services, uh, when you were talking about this and and some of the responses to this case, is that I think it's sold many times. You know, we have physicians and providers who are, I think we can all agree, very overburdened. They're seeing high volumes of patients. And in addition to that, there's a lot being put on them as it relates to documenting in the EMR. So we've tried to streamline the guidelines, we've tried so much that you know to make it easier. But imagine when you're posing these services as this doesn't really involve you, doctor, right? We're going to leverage your ancillary staff. We don't need you to do these things. It kind of removes them from the workflow. But they are, although they're leveraging others to be able, both in the RPM and the CCM and in these other services, we can leverage our team. It does not exclude the provider who's the ultimately the billing provider from the involvement and the interaction, and in many cases, the time and the documentation themselves for parts and some of those services that they'd be billing for.

SPEAKER_01 49:14

So with that, and since we're near the end of our time, Pam, I will just wrap up with our core takeaways. First and foremost, when creating a compliance program, I know your go-to, my go-to is 42 CFR 483.85. And that provides seven broad elements, including a compliance officer, including policies and procedures, training, all of those fun items that go along with that. Using that in relation to what CMS says is required is a great first step in meeting your RPM requirements and mitigating fraud, waste, and abuse. And then if we bring it all home with charts band, providers need to be mindful of A, getting that initial consent and informing the patients about what their financial obligations may be, especially under Medicare. Secondly, making sure that depending on the type of chronic care management that they're utilizing, that they're meeting that specific criteria and then annually going through a full review to see if that patient needs it. And then lastly, making sure that the three elements are met, Pam, that you mentioned from the outset. And it's the education and setup, it's utilizing that FDA approved device, and it's having the management and making sure that it's documented appropriately in the medical record. Do you have anything else to add or does that? No, that was a great wrap-up.

SPEAKER_02 51:00

Thank you. Thanks for having us.

SPEAKER_01 51:03

Absolutely. Thank you, AHLA, and thank you, listeners.

SPEAKER_00 51:12

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