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THE DEA And ACCESS TO TRT TELEMEDICINE
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<blockquote data-quote="madman" data-source="post: 250452" data-attributes="member: 13851"><p><h3>Telehealth and the Expiration of the COVID-19 Public Health Emergency, with Kathy Wibberly</h3><p></p><p><strong><em>An interview with Kathy Wibberly, Director of the Mid-Atlantic Telehealth Resource Center. Wibberly shares with us the impacts that the COVID-19 Public Health Emergency (PHE) has had on rural access to telehealth services and details the adjustments patients and providers can anticipate as the PHE comes to an end on May 11, 2023.</em></strong></p><p></p><p></p><p>[URL unfurl="true"]https://www.ruralhealthinfo.org/podcast/telehealth-apr-2023[/URL]</p><p></p><p><strong>Andrew Nelson:</strong> <em>Certainly. There are a lot of important changes coming up in the next couple of years as some of the allowances that were made during the PHE start to start to get rolled back as things kind of return to normal. Can you talk a little bit about this timeline and what some of the important dates are, maybe starting with May 11th?</em></p><p></p><p><strong>Kathy Wibberly:</strong></p><p></p><p><em>Let me kind of focus on those things that'll change immediately when the PHE ends. So on May 11th, the HIPAA enforcement we already talked about. <strong>The next big thing is the DEA and the Ryan Haight Act.</strong> So there were some temporary flexibilities during the PHE that allowed providers to prescribe controlled substances without an in-person visit. Under the Ryan Haight Act, which started in 2008, basically said, “If you are prescribing controlled substances, the patient has to be treated in a particular facility.” So it's a hospital or clinic, and the patient has to be treated in the physical presence of another registered practitioner. If the telemedicine consult is conducted by a registered practitioner it's allowed under Indian Health Services, but not other services. So basically the big picture is if you have not had an in-person visit with this patient, you cannot prescribe by telehealth.</em></p><p><em></em></p><p><em>So there was always this kind of registration process that was in the rules like the DEA will create a special registration process that will allow telemedicine providers to prescribe. Well, since 2008, nothing has ever been done with that registration process. Public Health Emergency was one of the provisions; you can prescribe controlled substances if there's a Public Health Emergency. So when the PHE came about, those flexibilities came about and they said, “Okay, you don't have to have an in-person visit before prescribing controlled substances.” This was a huge relief to many, many providers, obviously, and especially with psychiatric services. You know, many, many kids, with ADHD, with all sorts of medications, they didn't need to come in and have an in-person visit first. People got used to that.</em></p><p><em></em></p><p><em>There didn't seem to be a huge detriment, but as soon as that Public Health Emergency ends, you're going to have to have that in-person visit again. We're seeing a huge challenge because many, many providers, especially mental health providers, have actually moved to all-virtual in their practice. And so how are you going to have an in-person visit before prescribing? So just last month in February, the DEA announced a proposed new rule for some permanent telehealth or telemedicine flexibilities. However, they did not develop a special registry, yet again. We don't know whether the proposed new rule will become permanent prior to May 11th.</em></p><p><em></em></p><p><em>So right now we need to kind of act as if we're going to have to have an in-person visit before prescribing controlled substances. So there were three provisions in the proposed new rule. One is that you can prescribe controlled substances without an in-person visit if the patient is being referred to you by a practitioner who had an in-person visit. So that helps some. You may also prescribe a 30-day initial prescription for Schedules III, IV, and V, like non-narcotic controlled substances. But beyond 30 days, if you need a refill, you'll go back to a required in-person visit. However, prescribing Schedule II or narcotic-controlled meds will not be allowed without a prior in-person visit. So there's a lot of reaction to this right now, and we just don't know. So there's a lot of unknown with that.</em></p><p><em></em></p><p><em>So that is coming up very soon and we shall see what the impact of that is going to be. A third thing that's going to happen immediately with the end of the PHE is that the flexibility with what's called the anti-kickback statute will go away. So, the anti-kickback statute prohibits the kind of knowing willful payment, that the federal government would say you're inducing or rewarding patient referrals. So for example, for telehealth, let's say I am a huge medical center and you are a small rural clinic or small rural hospital. And I say, well, “Let me provide you with remote patient monitoring equipment for all of your COVID-19 cases or COPD cases under the Public Health Emergency.” I could do that free of charge, right? I can say, “Here, I'm giving you all this equipment.” After the PHE ends, the federal government is going to view that as inducing referrals, right?</em></p><p><em></em></p><p><em>You can't just give away stuff because then it's perceived as, “Oh, well, tit for tat,” right? “I give you lots of free equipment and then you're going to refer all your patients to us.” So that could have a significant impact on the smaller practices that don't have the funds to purchase their own equipment. Prior to the PHE, I think some workarounds around that would be like actually having a contract. So you know, “You provide this RPM equipment, we'll pay you, you know, $5 a month or you know, however, per patient.” It could be a very small amount, but it still has to be some exchange for the service. So it's not viewed as a gift for inducing referrals. We all know how difficult contracts are, right? So if you haven't started that process down a contract road by now and May 11th hits, you may be in trouble.</em></p><p><em></em></p><p><em>So you're going to have to stop using that equipment that was given to you by, let's say, large medical center A or big practice B. So that's going to be another issue. I think a fourth thing that's going to happen right at the end of the PHE impacts remote patient monitoring. So during the PHE, they removed the restrictions on remote patient monitoring so that the patient didn't have to be an established patient. So if I never saw you in person, but you are showing all the signs of, let's say, respiratory distress because of COVID or whatever, I can put you on a remote patient monitoring program and monitor you from home without ever having an E/M [evaluation and management] visit in the office. That will go away with the end of the PHE. And also the other flexibility that will go away with remote patient monitoring is that anti-kickback thing, right? You kind of give that patient equipment, so now they're either going to have to pay for it or the practice is going to have to pay for it somehow. So those are some fairly big changes that will be coming up.</em></p><p><em></em></p><p><em>So the Hospital Without Walls program, oftentimes known as Hospital at Home, basically waived a lot of the regulatory issues so that it said, well, if this is something that would be treated in the hospital, so an inpatient care service, if you can figure out how to provide that service without having that patient be at home. And this was in response to all the hospital beds being completely full of COVID patients, and we need to figure out how to treat these people without them having to physically be in the hospital. But Hospital at Home has actually been in existence in other countries for decades now. It's new for us in the US, but by using remote technologies, by using personnel that goes to the patient's home, they've been able to move what typically would've been an inpatient service into an outpatient setting, whether it's a home or any other facility, and provide that same kind of service and bill for that service as if it were an inpatient service. And I think that was the big piece, how do you bill for an inpatient service if the patient is sitting at home? But that's what that flexibility has allowed. And so Congress has kicked that can down the road to the end of 2024 as well.</em></p><p><em></em></p><p><em>Most of the time there was some in-person element, but a lot of the monitoring would've been done by telehealth. And so you might have one person visit the home a day a week, or two days a week and then everything else is monitored remotely. Unless there's a need — something happens, someone needs to go in.<strong> So it's a combination, it's a hybrid model, and I think that's where we're going anyway, with all of the telehealth. It's going to be a hybrid model.</strong></em></p></blockquote><p></p>
[QUOTE="madman, post: 250452, member: 13851"] [HEADING=2]Telehealth and the Expiration of the COVID-19 Public Health Emergency, with Kathy Wibberly[/HEADING] [B][I]An interview with Kathy Wibberly, Director of the Mid-Atlantic Telehealth Resource Center. Wibberly shares with us the impacts that the COVID-19 Public Health Emergency (PHE) has had on rural access to telehealth services and details the adjustments patients and providers can anticipate as the PHE comes to an end on May 11, 2023.[/I][/B] [URL unfurl="true"]https://www.ruralhealthinfo.org/podcast/telehealth-apr-2023[/URL] [B]Andrew Nelson:[/B] [I]Certainly. There are a lot of important changes coming up in the next couple of years as some of the allowances that were made during the PHE start to start to get rolled back as things kind of return to normal. Can you talk a little bit about this timeline and what some of the important dates are, maybe starting with May 11th?[/I] [B]Kathy Wibberly:[/B] [I]Let me kind of focus on those things that'll change immediately when the PHE ends. So on May 11th, the HIPAA enforcement we already talked about. [B]The next big thing is the DEA and the Ryan Haight Act.[/B] So there were some temporary flexibilities during the PHE that allowed providers to prescribe controlled substances without an in-person visit. Under the Ryan Haight Act, which started in 2008, basically said, “If you are prescribing controlled substances, the patient has to be treated in a particular facility.” So it's a hospital or clinic, and the patient has to be treated in the physical presence of another registered practitioner. If the telemedicine consult is conducted by a registered practitioner it's allowed under Indian Health Services, but not other services. So basically the big picture is if you have not had an in-person visit with this patient, you cannot prescribe by telehealth. So there was always this kind of registration process that was in the rules like the DEA will create a special registration process that will allow telemedicine providers to prescribe. Well, since 2008, nothing has ever been done with that registration process. Public Health Emergency was one of the provisions; you can prescribe controlled substances if there's a Public Health Emergency. So when the PHE came about, those flexibilities came about and they said, “Okay, you don't have to have an in-person visit before prescribing controlled substances.” This was a huge relief to many, many providers, obviously, and especially with psychiatric services. You know, many, many kids, with ADHD, with all sorts of medications, they didn't need to come in and have an in-person visit first. People got used to that. There didn't seem to be a huge detriment, but as soon as that Public Health Emergency ends, you're going to have to have that in-person visit again. We're seeing a huge challenge because many, many providers, especially mental health providers, have actually moved to all-virtual in their practice. And so how are you going to have an in-person visit before prescribing? So just last month in February, the DEA announced a proposed new rule for some permanent telehealth or telemedicine flexibilities. However, they did not develop a special registry, yet again. We don't know whether the proposed new rule will become permanent prior to May 11th. So right now we need to kind of act as if we're going to have to have an in-person visit before prescribing controlled substances. So there were three provisions in the proposed new rule. One is that you can prescribe controlled substances without an in-person visit if the patient is being referred to you by a practitioner who had an in-person visit. So that helps some. You may also prescribe a 30-day initial prescription for Schedules III, IV, and V, like non-narcotic controlled substances. But beyond 30 days, if you need a refill, you'll go back to a required in-person visit. However, prescribing Schedule II or narcotic-controlled meds will not be allowed without a prior in-person visit. So there's a lot of reaction to this right now, and we just don't know. So there's a lot of unknown with that. So that is coming up very soon and we shall see what the impact of that is going to be. A third thing that's going to happen immediately with the end of the PHE is that the flexibility with what's called the anti-kickback statute will go away. So, the anti-kickback statute prohibits the kind of knowing willful payment, that the federal government would say you're inducing or rewarding patient referrals. So for example, for telehealth, let's say I am a huge medical center and you are a small rural clinic or small rural hospital. And I say, well, “Let me provide you with remote patient monitoring equipment for all of your COVID-19 cases or COPD cases under the Public Health Emergency.” I could do that free of charge, right? I can say, “Here, I'm giving you all this equipment.” After the PHE ends, the federal government is going to view that as inducing referrals, right? You can't just give away stuff because then it's perceived as, “Oh, well, tit for tat,” right? “I give you lots of free equipment and then you're going to refer all your patients to us.” So that could have a significant impact on the smaller practices that don't have the funds to purchase their own equipment. Prior to the PHE, I think some workarounds around that would be like actually having a contract. So you know, “You provide this RPM equipment, we'll pay you, you know, $5 a month or you know, however, per patient.” It could be a very small amount, but it still has to be some exchange for the service. So it's not viewed as a gift for inducing referrals. We all know how difficult contracts are, right? So if you haven't started that process down a contract road by now and May 11th hits, you may be in trouble. So you're going to have to stop using that equipment that was given to you by, let's say, large medical center A or big practice B. So that's going to be another issue. I think a fourth thing that's going to happen right at the end of the PHE impacts remote patient monitoring. So during the PHE, they removed the restrictions on remote patient monitoring so that the patient didn't have to be an established patient. So if I never saw you in person, but you are showing all the signs of, let's say, respiratory distress because of COVID or whatever, I can put you on a remote patient monitoring program and monitor you from home without ever having an E/M [evaluation and management] visit in the office. That will go away with the end of the PHE. And also the other flexibility that will go away with remote patient monitoring is that anti-kickback thing, right? You kind of give that patient equipment, so now they're either going to have to pay for it or the practice is going to have to pay for it somehow. So those are some fairly big changes that will be coming up. So the Hospital Without Walls program, oftentimes known as Hospital at Home, basically waived a lot of the regulatory issues so that it said, well, if this is something that would be treated in the hospital, so an inpatient care service, if you can figure out how to provide that service without having that patient be at home. And this was in response to all the hospital beds being completely full of COVID patients, and we need to figure out how to treat these people without them having to physically be in the hospital. But Hospital at Home has actually been in existence in other countries for decades now. It's new for us in the US, but by using remote technologies, by using personnel that goes to the patient's home, they've been able to move what typically would've been an inpatient service into an outpatient setting, whether it's a home or any other facility, and provide that same kind of service and bill for that service as if it were an inpatient service. And I think that was the big piece, how do you bill for an inpatient service if the patient is sitting at home? But that's what that flexibility has allowed. And so Congress has kicked that can down the road to the end of 2024 as well. Most of the time there was some in-person element, but a lot of the monitoring would've been done by telehealth. And so you might have one person visit the home a day a week, or two days a week and then everything else is monitored remotely. Unless there's a need — something happens, someone needs to go in.[B] So it's a combination, it's a hybrid model, and I think that's where we're going anyway, with all of the telehealth. It's going to be a hybrid model.[/B][/I] [/QUOTE]
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THE DEA And ACCESS TO TRT TELEMEDICINE
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