<v ->Greetings.</v> I'm Brian Hurley, an Addiction Psychiatrist who works for the Los Angeles County Department of Public Health, and I'm also on faculty at UCLA. This is a talk about regulatory issues and medications for opioid use disorder. I don't have any relevant financial relationships with ineligible companies to disclose. The goal of the Provider Clinical Support System is to train healthcare professionals in evidence-based practices for the prevention and treatment of opioid use disorder, and particularly prescribing medications for opioid use disorder and the prevention and treatment of substance use disorders. This is a talk about the regulatory environment regulating medications for opioid use disorder. So we'll use this time to describe the legal differences between an opioid treatment program, hospital managed medications for opioid use disorder, and office-based opioid treatment. We'll talk about X-waivered clinicians and how X-waivered clinicians can increase our caps to increase the number of patients we can treat concurrently with buprenorphine medications. We'll review the rules regulating treating opioid use disorder of buprenorphine and with methadone, we will discuss confidentiality rules governing substance use treatment records, and then demonstrate how to appropriately manage medications for opioid use disorder using telemedicine. Our outline is to review the Controlled Substances Act. We'll cover the Drug Addiction Treatment Act of 2000, or DATA 2000. We'll talk about the Comprehensive Addiction Recovery Act of 2016 and the SUPPORT Act of 2018, as well as the more recently released practice guidelines for the administration of buprenorphine for treating opioid use disorder, which is from April of 2021. We'll go through 42 CFR, Part 8, which are the opioid treatment program regulations, and then cover 42 CFR, Part 2, which is confidentiality rules. Now the Controlled Substances Act of 1972 regulates the prescribing and dispensing of controlled substances. This is the law that limits the treatment of opioid use disorder with methadone to federally registered opioid treatment programs. Now DATA 2000, CARA 2016 and SUPPORT 2018, so those three federal laws amended the Controlled Substances Act, and there have been subsequent regulatory updates that govern the treatment of opioid use disorder with methadone and with buprenorphine. This is the overview of the laws that regulate medications for opioid use disorder. So there's DATA 2000, which established a pathway for clinicians to get an X-waiver to prescribe buprenophrine for the medication of opioid use disorder. CARA 2016, which extended that authority to physician assistants and nurse practitioners, and SUPPORT 2018, which broadened other advanced practice nurses and changed who could sit at which levels, and we'll go over those in some detail. So buprenorphine that's being prescribed to a community pharmacy for ambulatory dispensing, DATA 2000, CARA 2016, and SUPPORT 2018. Those are the fundamental laws that have been amended and with subsequent regulations. Buprenorphine that's ordered in the hospital for in-hospital administration, and this is actually also true for methadone. There's no legal restrictions on the administration of buprenorphine or methadone in a hospital to treat opioid use disorder or opioid withdrawal. Extended release naltrexone injections, there's actually no legal restrictions on the use of this medication. It's not a controlled substance, and there's no particular registration step required in order to treat patients with that medication. Outside of the hospital, methadone can only be used to treat opioid use disorder in opioid treatment programs, and that's governed by 42 CFR, Part 8. And buprenorphine, which can also be used in an opioid treatment program, is also governed by 42 CFR, Part 8. So Drug Addiction Treatment Act, we'll go through these laws systematically roughly in the order in which they were passed. The Drug Addiction Treatment Act of 2000, or DATA 2000, amended the Controlled Substances Act and designated clinicians to prescribe or dispense FDA approved narcotic drugs in schedule III, IV, V, or combination of such drugs for maintenance or treatment for opioid use disorder or opioid withdrawal maintenance, that's the literal statutory language. Now to date, buprenorphine products are the only medications that meet these criteria. So DATA 2000 is sometimes called the buprenorphine law, even though the word buprenorphine actually does not appear anywhere in the regulation. That regulation also opens the possibility that future medications that are in schedule III, IV, V, or that can be used in combination in any of those schedules could also fall under DATA 2000 criteria. But to date, only buprenorphine is regulated under DATA 2000. There's no limitations on the quantities that are permitted for unsupervised administration, that is to say there's no strict quantity limits. There are some logistic quantity limits, but there's no federal quantity limits on the amount of buprenorphine that can be prescribed. There is a limit on the number of patients that buprenorphine can be prescribed to. Now the clinical requirements were initially under DATA 2000, qualifying physicians. Now, CARA 2016 and SUPPORT 2018 have since broadened this to include physicians, advanced practice nurses, and physician assistants. DATA 2000 initially required the capacity for patients to be referred appropriate counseling and ancillary services. The law does not say that patients have to be receiving counseling and ancillary services, and this is a distinction between 42 CFR, Part 8 and DATA 2000. That is to say the law requires the X-waivered or DATA 2000 wavered clinician to be able to refer patients for counseling, but did not require patients to actually be receiving psychosocial services as a condition of receiving buprenorphine for opioid use disorder. The initial law was that patients were capped treating, no more, or clinicians were capped at treating no more than 30 outpatients. Hospital orders do not count against this limit, but if you're writing a prescription to a pharmacy, no more than 30 patients can be treated concurrently with buprenorphine products at any one point in time during the first year. To be clear about this, we mean concurrently, not cumulatively. So it's not that you can treat 30 patients and then you're done for the year, it's no more than 30 patients at any one point in time. But with that cap, depending on how patients enter into an exit out of care, it would be feasible to treat hundreds of patients during the first year given that 30 patient cap, it's just no more than 30 concurrently. After the first year of a cap at 30, clinicians were permitted to increase their cap to 100 patients after the first year. CARA 2016 and SUPPORT 2018 have since modified these caps and modified the timing of who has access to which caps, but this was the way the law was initially constructed. In terms of who qualifies, well again, the rule for qualifying physician included a board certified addiction psychiatrist or board certified addiction physician. They could be board certified by the American Board of Psychiatry and Neurology, the American Board of Preventive Medicine, or the American Board of Osteopathy, or be an investigator in a buprenorphine clinical trial with FDA approval or have completed eight hours of training completed by a designated organization. So if you've heard of the X-waivered training, that is the infamous eight hours of training that was in DATA 2000. And there was also a a pathway for other criteria established by the Secretary of Health and Human Services. Most clinicians that prescribe buprenorphine are not board certified in addiction medicine or addiction psychiatry, so this eight hour training pathway is the dominant pathway that most clinicians that prescribe buprenorphine became eligible for DATA 2000 criteria. In order to become waivered, clinicians go online and the link is presented on the slide here to submit a waiver notification of an intent to prescribe buprenorphine. And pharmacists can also look up which clinicians are DATA 2000 waivered on the link that is underneath that top link. There is a pharmacy verification system, you need the clinician's last name and DEA number. DATA 2000 applies to buprenorphine formulations that are FDA approved for the indication of opioid use disorder. So to date, as of the time of this presentation, this includes buprenorphine with naloxone film. There's a brand name film that goes under the trade name Suboxone. There's also a generic film, and there's also a generic tablet. There's a brand name tablet called Zubsolv that is separate from the generic tablet that comes in different strengths, and then a separate brand name film called Bunavail. These five different formulations are all FDA approved for the indication of opioid use disorder, and clinicians that prescribe them for the indication of opioid use disorder have to have a DATA 2000 X-waiver to be allowed to prescribe them. There's also buprenorphine that does not have naloxone in it. There's a generic tablet that previously went by the brand name Subutex, but there's actually no more brand name Subutex to my knowledge on the market, it's just generic that comes in two strengths. And then an injectable version called Sublocade, which is also FDA approved for the indication of opioid use disorder. And clinicians that administer Sublocade have to do so under X-waiver clinician prescribing authority. There used to be a buprenorphine implant, but the company that manufactured that implant withdrew that product from the market in the year 2020. There are FDA products that are FDA approved for pain and not opioid use disorder. So there's an injectable buprenorphine product, a transdermal buprenorphine product, and a sublingual buprenorphine product. You do not have to have a DATA 2000 waiver to use those products to treat pain. So DATA 2000 only applies when buprenorphine is used to treat opioid use disorder. It does not apply when using buprenorphine to treat pain, and buprenorphine to treat pain can be done under a general DEA registration that includes schedule III. It is also possible to use these products, the buprenorphine with naloxone or buprenorphine monotherapy off label for pain. Usually it's dosed more frequently and a DATA 2000 waiver is not needed to prescribe a buprenorphine product, even if it's FDA-approved for opioid use disorder if the indication's pain. But typically that needs to be clarified at the pharmacy level, because most pharmacies do require the DATA 2000 waiver to release these products, because they're usually used for opioid use disorder, and so you would need to clarify if the indication was for pain if somebody does not have an X-waiver or if they intend to use these products off label. So opioid is not covered by DATA 2000, methadone is not covered by DATA 2000. It's schedule II, does not meet that criteria. If methadone is used for opioid use disorder, it must be either managed by an opioid treatment program, a patient is enrolled and registered and treated in an OTP, or opioid treatment program. Or hospitals are allowed to treat patients with an opioid withdrawal with methadone in the hospital or ED setting and are permitted to provide a take home dose from the ED for up to 72 hours of treatment. And methadone can also be used for pain, as long as who's ever prescribing it has a scheduled DEA registration that includes schedule II, and that can be dispensed through a standard ambulatory pharmacy for the indication of pain and not for opioid use disorder. And then I mentioned there's an immediate release injectable version of buprenorphine sublingual film, transdermal buprenorphine. There's a bunch of other formulations, there's other opioids which I think are for pain and not opioid use disorder. Those versions of buprenorphine are not covered by DATA 2000. And there's a number of other controlled substances that are not on this approval list, DATA 2000 does not apply to them. Again, DATA 2000 and CARA and the SUPPORT Act only apply to scheduled medications. So let's talk about hospitalized patients with opioid use disorder just for a moment. Methadone and buprenorphine can be ordered and administered to patients who are registered and physically in the emergency department or inpatient unit to treat opioid withdrawal, and can be used, and can be continued throughout an admission to treat opioid use disorder. If a patient was initiated on, say, methadone in the hospital, they would need to transition to an OTP, or if they were started on buprenorphine, they would need to transition to an OTP to continue care after the hospital. If the patient was on buprenorphine, they can transition either to an opioid treatment program or to an X-waivered either office based practice or community program that has an X-waivered clinician that can continue the patient's treatment with buprenorphine. Now, you might have heard something about the three day rule. So the way the three day rule is if the patient is seen in the emergency department, or other other place in the hospital, but the typical setting's in the emergency department, and needs either buprenorphine or methadone for withdrawal management, the DEA has created the 72 hour rule or three day rule that permits clinicians working on that setting to dispense up to, well initially up to one day's worth of buprenorphine or methadone each day for up to 72 hours while the patient is arranging follow up without an X-waiver. Without an X-waiver. So the hospital does not have to have an OTP registration and the clinician does not happen to have an X-waiver in order to administer buprenorphine or methadone to patients. And then in March, 2022, the DEA created a pathway to request an exemption to limitations on dispensing medications for opioid use disorder and to literally just provide the patient a full 72 hour supply at one time. The link to the DEA instructions is in the PDF of this PowerPoint, and you can email odlp@dea.gov to request this exemption. Now keep in mind, clinicians that are X-waivered can prescribe buprenorphine for as much as is clinically appropriate. That is to say the 72 hour rule is really only applicable when the hospital has clinicians that are not X-waivered and set up a protocol to provide patients up to three days of buprenorphine or methadone while the patient is arranging aftercare. If the ER has an X-waivered clinician, the X-waivered clinician can prescribe an appropriate amount of buprenorphine with followup in the community for well beyond 72 hours. So again, the 72 hour rule really only applies in situations where the hospital doesn't have an X-waivered clinician who can prescribe buprenorphine. And because methadone for OUD cannot be prescribed out of a community pharmacy, in the case of methadone, the hospital might give somebody up to 72 hours worth of methadone while the patient is arranging admission in an opioid treatment program. All right, so we've covered DATA 2000 and the fact that the Controlled Substances Act does not limit the treatment of opioid use disorder or opioid withdrawal with buprenorphine or methadone for patients in the hospital, and there is a mechanism for hospitals to provide patients with up to three days of methadone or buprenorphine while they're arranging aftercare. But hospitals that have X-waivered clinicians can prescribe an appropriate amount of buprenorphine, which can be for way longer than three days while the patient is arranging aftercare with a clinician or a program that can prescribe buprenorphine. CARA, the Comprehensive Addiction Recovery Act of 2016 revised DATA 2000 in several important ways. First, it specified that advanced practice nurses and physician assistants can become X-waivered for between 100 and 275 patients following 24 hours of training. So there was a training pathway, unlike physicians which were 8 hours, PAs and NPs were required to do 24 hours of training. And also required the PAs or NPs in states where advanced practice nurses and physician assistants have to be supervised to be supervised or worked in collaboration with a qualified physician. That's literally all the statute says, and I know that different states have slightly different ways of interpreting what counts as a qualified physician. That is to say if you're a PA that requires, that operates under supervision from a physician, if you have an X-waiver, does your physician need to be X-waivered? The law doesn't say explicitly whether a qualified physician counts as somebody who's an X-waiver or not, and I know that that's been the subject of, what I would do is say refer to local counsel because there's been a couple different interpretations of what counts as qualified physician. Clinicians can request approval to treat up to 275 patients after one year at a 100 patients. And the 275 cap was available to physicians, advanced practice nurses, and physician assistants working in a qualified practice setting. So it wasn't available to everybody, you had to be in a qualified practice setting or be board certified in addiction psychiatry or addiction medicine, which are board certifications currently specific to physicians. Clinicians with a 275 limit are required to report, there's annual reporting requirements of the amount of buprenorphine that they're prescribing. Now CARA 2016 defined qualified practice settings. What are qualified practice settings? Our one qualification for physicians, advanced practice nurses and PAs to get their limit up to 275. So first, is that there's 24 hour emergency coverage. That doesn't mean you have to be a hospital, but there has to be a system, an on-call process in case somebody has an after hours question or problem for a 24-hour coverage. If you're a health system that has hospitals in it, and that hospital has people in it who are X-waivered, that can count as long as there's a protocol for that hospital to to provide information or services to patients served in the ambulatory part of the network. The practice setting has to provide case management and related services. So that usually means case management, care coordination, and does not necessarily mean that you're providing counseling, but has to have a pathway of connecting patients to counseling when the patients are ready for it. You have to use health information technology, that pretty much means EHR, you have to have electronic health record, can't be paper charts, paper notes, paper prescription pads. And at this point, and I live in California, the state of California has very much narrowed the ability of clinicians to continue to write prescriptions and document on paper at this point. The practice setting has to be registered with the state prescription monitoring program. For practical purposes, that means that the clinicians in that program have to be registered with the state PDMP, and you have to accept third party payments. So it can't be a cash only practice, there has to be third party payment accepted, and all of these have to be in place for the practice setting to count as a qualified practice setting. The reporting requirements require clinicians that have the up to 275 patient concurrent limit to report their average monthly caseloads, including the percentage of patients that receive psychosocial services, the percentage of patients where the PDMP was queried, the percentage of patients who completed treatment with buprenorphine that were started on treatment then stopped treatment with buprenorphine. The percentage of patients who are not being seen by the provider because the patient had been referred to a different level of care such as residential or IOP. The percentage who no longer desired to continue with buprenorphine, and the percentage who are no longer receiving buprenorphine for other reasons. So that's CARA 2016. And then two years later, the SUPPORT Act, which further modified a DATA 2000 and then CARA 2016 to elaborate the clinicians that can get an X-waiver include physicians, nurse practitioners, physician assistants, clinical nurse specialists, CRNAs, and certified nurse midwives. Any of these clinicians who can get X-waivered to prescribe buprenorphine for the indication of opioid use disorder who work in a qualified practice setting can now start with a limit of 100 patients concurrently treated with buprenorphine rather than 30 during their first year, and can increase their limit to 275 after having one year at 100. So, and just to be clear about the caps, the caps are the clinicians are supposed to keep track of how many patients you're treating with buprenorphine in one point in time, and you're capped no more than 100 concurrently the first year in a qualified practice setting. And if you apply to increase your limit to 275. And that's an important point because the limits are not automatically increased, you have to submit an application, and SAMHSA reissues or sort of issues a new, I forget what the right term is, but sort of cap increase. That is to say, each time you go through the same waiver application process, but you have to apply to increase your limit. And then the latest change, again, at the time of this presentation is the 2021 Practice Guidelines for the administration of buprenorphine for treating opioid use disorder. So the Biden Administration in April of 2021 changed the regulations governed under DATA 2000, CARA 2016, and SUPPORT 2018 that allows qualified clinicians to become waivered to treat up to 30 patients concurrently. So the kind of lower waiver limit that was created in the initial DATA 2000 law, without completing the 8 or 24 hour requirement. So physicians, advanced practice nurses, and physician assistants can register to get an X-waiver without completing the training and without requiring clinicians to attest to their capacity to refer patients for counseling or psychosocial services. The cap stays at 30 until a clinician has completed the training and can attest to the capacity for patients for counseling. So it is now any clinician that has a DEA registration and is licensed to practice medicine, advanced practice nursing or being a physician assistant can apply to get an X-waiver without a training requirement. But to go over the cap of 30 does require following all of the standard training requirements and all of the standard attestations. That's the laws governing buprenorphine for opioid use disorder in a nutshell. We're going to go on to opioid treatment programs, 42 CFR, Part 8. This is a separate code of federal regulations that govern the accreditation and certification of opioid treatment programs. Opioid treatment programs are regulated by the Substance Abuse and Mental Health Services Administration, particularly the Center for Substance Abuse Treatment Division on Pharmacologic Therapies. The oversight by SAMHSA is not just to regulate, it's also to help improve treatment. And there's what's called tripartite oversight. So there's SAMHSA, which does certification. The state which separately licenses and registers OTPs. In California we usually use the term NTP, it's the equivalent to an OTP, but there's a state NTP registration process. And then the DEA also has a separate opioid treatment program registration process. So that's the tripartite oversight of opioid treatment programs. OTPs that apply are offered an initial application with professional certification for a year with re-certification at three year intervals. It requires OTP compliance with all federal and state statutes and regulations. You apply to SAMHSA to establish an OTP to then add new units to an OTP or to relocate an OTP. And if the program sponsor or medical director changes, notifications are required within three weeks of any program sponsor change or any medical director change. The definition, and this is again in the code of federal regulations, is there's short-term detox, which is opioid treatment program maintenance treatment with methadone or buprenorphine for 30 days or less. Long-term detox is defined by the use of methadone or buprenorphine for between 30 and 180 days. And maintenance treatment is defined as comprehensive that includes both medication and rehabilitative. That typically means counseling services but also care coordination services. So medical and counseling services. And interim treatment is defined as medical services while somebody's awaiting referral or connection to comprehensive treatment. Patients cannot stay on medication treatment for longer than 128 days without receiving comprehensive treatment. So whereas with the DATA 2000 and the X-waiver, clinicians have to have the capacity to refer. For patients enrolled in OTPs, patients have to be receiving, actually be receiving comprehensive treatment as a condition of being enrolled in an OTP. To be admitted to an OTP, a patient has to have a physiologic opioid dependency that's different than opioid use disorder, although the patient has to have opioid disorder. So opioid use disorder with physiologic dependency. So opioid tolerance and withdrawal if they were to stop using. And have been, had opioid use disorder with physiologic dependency for at least one year prior to admission. So patients that don't meet that criteria are technically do not meet for 42 CFR, Part 8 rules to be admitted to an OTP. And in addition to opioid use disorder with physiologic dependency for at least a year, the patient has to choose maintenance treatment, so that the patient cannot be forced on maintenance treatment. Have been explained opioid, what opioids are, and the facts concerning the use of opioids, clearly and adequately explained and have a written informed consent. And there are example informed consent forms in the CSAT Accreditation Guidelines. So those are the admission criteria. For patients who are less than 18 years old, the codified regulations requires that patients have to have had two unsuccessful short-term withdrawal management, so 30 day or less withdrawal management attempts, or drug free treatment, that is to say non-medication treatments for opioid use disorder within a 12 month period to be eligible. So patients who are 18 years or younger, unless they haven't had these two documented unsuccessful short-term withdrawal management or drug-free treatment attempts are not eligible to be admitted to an opioid treatment program for maintenance treatment services. Parents or guardians have to consent to treatment in writing. It would be worth consulting with a pediatric addiction experts if there's questions regarding eligibility of patients under 18. Because there's instances of emancipated minors and questions around, OTPs can serve people under 18 years old, there's a clear pathway to do that. To consider consulting with a pediatric addiction specialist about whether opioid treatment program treatment is going to be best for each patient. This is where getting a child addiction specialist can be very helpful. Patients in an OTP can be treated with either buprenorphine or with methadone. OTPs are not restricted to the number of patients receiving buprenorphine at any given point in time. So X-waivered clinicians have limits of 30, 100, or 275, depending on how they've progressed in their duration and completed X-waivered applications to increase that limit. Opioid treatment programs are not subject to these same limits. And the federal guidelines around methadone take home doses, that is, there's a strict limit on how quickly you can advance patients to take home doses from methadone are not applicable to patients receiving buprenorphine. But the labeling of buprenorphine has to meet the same opioid treatment program and local standards that applies to methadone treatment. So labeling is the same, but patients could be advanced to take on doses with buprenorphine faster than with methadone in OTPs. On March 16th, 2020, SAMHSA began issuing exemptions. So states began to, I mentioned the strict limits on when patients could be advanced to take home doses. March 16th, SAMHSA said States can request an exemption for stable patients receiving care in OTP to receive 28 days of take home doses. And then for unstable patients, states are allowed to request that they're registered certified OTPs can request up to 14 days of take home medications for patients who are less stable, but whom the OTPs can safely handle this level of medication. So created more flexibilities with regarding take home dosing for medications receiving OTP services. States had to request it, so it wasn't automatic to every federally registered OTP, but SAMHSA created the flexibility for states to request this exemption to give their OTPs more flexibility in doing take home dosing with methadone or buprenorphine. Now with buprenorphine, buprenorphine already had that flexibility. So really, this flexibility that SAMHSA provided is ultimately mostly applicable to methadone. This exemption remains in effect, but is currently slotted to expire one year following the end of the COVID-19 public health emergency. And then in June of 2021, OTPs were permitted to add a mobile component to their existing registration. A mobile component could be a satellite clinic, or mobile component could actually be a true mobile service, but you didn't have to sort of entirely register in a totally different site, you could add a mobile component to your existing registration without completing an entirely separate registration on an additional site. So there's now more flexibility, and during the COVID public health emergency over giving patients take home doses of methadone from an OTP and in establishing mobile components. So that's to date the most current regulation, both law and regulatory framework affecting opioid treatment program services. Confidentiality, 42 CFR, Part 2 is a confidentiality law. And it was written during a time of great concern that information gleaned from somebody's substance use disorder treatment records could be used against them. So 42 CFR Part 2 establishes that patients receiving treatment for an substance use disorder in a program that's encumbered by 42 CFR Part 2 should not be made more vulnerable than an individual with a substance use disorder who does not seek treatment, that was the goal of 42 CFR Part 2. So you get counted as a 42 CFR Part 2 program if you hold yourself out as providing substance use disorder treatment and you provide substance use disorder treatment to patients, and you have to be federally assisted. There's a lot of questions around what counts as a federally assisted alcohol and drug abuse programs. So like the SAMHSA frequently asked questions, for example, says, if I'm a primary care doctor treating opioid use disorder in my primary care practice, am I covered under 42 CFR Part 2? And SAMHSA's guidelines is generally no, unless you advertise, you hold yourself out as providing SUD treatment and you provide that treatment to patients, and you're federally assisted, that is you take Medicare, Medi-Cal or other. And federally assisted could also mean that you're X-waivered. There's a lot of different definitions of what it means to be federally assisted. And most of us that work in healthcare at some point have a DEA registration, sort of count as federally assisted in some respect. The law restricts disclosure on using patient identifying information. So I work for a specialty SUD treatment setting. I can release aggregate information around the types of patients we see, I can release aggregate information about the levels of care we offer and our volume, but I can't release any protected health information or patient identifying information. So that would be patient identifying information as anything that reveals that a person is receiving or has received or is applied to receive substance use disorder treatment. And it limits who I can disclose patient identifying information to in only narrow circumstances. And this includes current patients, former patients, and patients who have died. Now there are some exceptions to 42 CFR Part 2's rule requiring patient consent for sharing protected health information. One of those are medical emergencies, that is in a medical emergency, information from an alcohol or drug abuse treatment program can be disclosed without the patient's consent. IRB scientific research is another instance. Medicare, Medicaid, and the Children's Health Improvement Program can conduct audits or evaluations. That's another instances where 42 CFR Part 2, where there can be disclosure of protected health information without the patient's consent. Child abuse reporting, information related to crimes committed on the program premises or against program personnel can also be disclosed without the patient's consent. Court orders can be used to compel release of information without the patient's consent. Subpoenas don't count, court orders do, but not a subpoena. And then communications with qualified service organizations that might need information related to facilitate the service through the program can also be disclosed without the patient's consent. Now, breach of privacy, information protected by 42 CFR Part 2 can lead to civil and criminal consequences. So if a patient was to be learned to be getting SUD treatment, it could risk their employment, their housing, or child custody. Medical professors and insurers, although it is unethical to do this, can discriminate against patients who've received SUD treatment. And depending on the circumstance of someone's life, it can contribute to arrest or prosecution or incarceration. Now the CARES Act of 2020 directed SAMHSA to make substantial revisions to 42 CFR Part 2 regulations. But as of this presentation, the revised regulations remain pending. Moving on from 42 CFR Part 2 to telemedicine. Telemedicine or the practice of telemedicine really means practicing medicine, seeing patients, prescribing medications or other treatments in accordance with federal and state laws by clinicians communicating or treating the patient using audio and visual equipment that's two way, realtime and interactive. So telephone medicine is different than telemedicine. Telemedicine means audio and visual, realtime two-way communication, that's telemedicine. It is possible to call patients on the phone and talk to them, but that's not the definition of telemedicine according to the federal government definition of telemedicine. So using multimedia communications equipment, audio visual, two-way realtime communication, that is telemedicine. Now, in April of 2019, the DEA published the implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 that amended the DEA regulations that were intended to prevent illegal distribution and dispensing controlled substances through the internet. That requires in-person medical evaluations if a clinician's going to prescribe a controlled substance. So it's not enough to, according to Ryan Haight, it's not enough if that regulation, under that regulation to have had a telemedicine visit or a telephone visit, you have to have seen the patient to prescribe a controlled substance. Now, pre-COVID-19, there was the use of telemedicine while prescribing medications for opioid use disorder because we don't have enough X-waivered clinicians in the United States to prescribe buprenorphine. If I'm X-waivered, but I can't physically be in the same room with somebody, I can't do an in-person evaluation, what's a way that I can use my X-waiver while treating patients remotely? And so DEA clarified a pathway for that. This is again, pre-COVID, which is the clinician providing the telemedicine must be licensed in the patient where the patient is seen. And as a general rule, if you're treating a patient remotely, it's where the patient is that counts as the location of care, not where the clinician is. So the clinician has to be licensed in the state where the patient is seen, must have all appropriate state license, including a state DA license if that's where the patient is, should have a practice agreement with the clinician or the practice in which the patient is seen because the patient has to be in person in the presence of a DEA-registered clinician or in a DEA-registered location for it to count as an in person visit. So if I'm the X-waivered clinician prescribing buprenorphine, I have to send the patient to a DEA-registered clinician or site and then see, and then I could use telemedicine to evaluate the patient remotely. And I have to be licensed and have a practice agreement with the location with where the patient is. So that was the pre-COVID mechanism to treat opioid use disorder with buprenorphine remotely. If all of the above are met, the clinician prescribing through telemedicine, and again, telemedicine meaning audio/visual, does not have to do the initial interview in person, and does not have to do the follow up interviews in person. Now, after the in person evaluation is conducted to initiate treatment, subsequent refills can be done through telemedicine. So it's the initial visit, the establishing of care that had to be in person, follow up assessments were allowed to be done through telemedicine, that is through audio/visual evaluation. And the prescribing clinician had to ensure that the clinician conducting the in-person evaluation was qualified to assess the patient initially and to also concur with the determination that the patient would need buprenorphine for opioid use disorder. So they had to make sure that whoever was there was qualified to adequately assess the patient and render a determination. With COVID-19, as of March 2020, there was a 1135 waiver that now authorizes telehealth services in our telemedicine services in any healthcare facility and broadened a much more extensive array of telemedicine platforms that were allowed. So that means that under COVID-19, we can now use controlled substances to treat patients including buprenorphine for opioid use disorder, for which there has not been an in-person medical evaluation, that is Ryan Haight effectively suspended particularly around buprenorphine for opioid use disorder during COVID-19. I'm allowed to establish care using a telemedicine platform. And SAMHSA further clarified that buprenorphine for opioid use disorder can be initiated by a telephone evaluation without an in person or video evaluation. The letter on this is actually worthwhile. It says, although telephone only care we think is antithetical to the, to treatment that the access through telephone only evaluations, the benefits that outweighed the risks of inadequate evaluations that might come with not being able to see somebody either in person or through video. So during the public health emergency, the 1135 waiver allows us to initiate buprenorphine treatment for opioid use disorder with a telephone evaluation and initiate controlled substance treatments for patients with a telehealth or audio/visual presentation. And as of May 2022, these telemedicine flexibilities are not permanent and are set to expire at the end of the COVID-19 public health emergency. Now I've gone through a lot of different regulations, so I'll just sort of highlight like organizations, particularly, am I a 42 CFR Part 2 program? Do my advanced practice nurses and physician assistants that if I'm in a state that requires supervision of those clinicians by physicians, does that physician have to be X-waivered for the clinicians to be X-waivered? Organizations and clinicians with operational questions like that. particularly in regards to the regulatory landscape around the treatment of opioid use disorder with medications like buprenorphine or methadone might consider consulting counsel. Because I'll just say that I get asked these questions a lot and am aware of different organizations coming up with different answers to those questions in consultation with counsel looking at the same law. And so what I presented is the law, the statutes again as they've been adopted and the language that includes, but they do beg other questions that I will be straightforward, have not fully been resolved. Okay, so 42 CFR, Part 8 regulates opioid treatment programs. Opioid treatment programs offer methadone and buprenorphine, which are controlled substances directly to patients, they're dispensed to patients and they are subject to a whole set of federal regulations. Methadone for opioid use disorder can be administered to patients in the hospital without, they don't have to have an OTP in order to treat opioid use disorder with methadone. But when the patient's discharged, methadone treatment for opioid use disorder would have to be through an OTP. Buprenorphine can also be ordered in the hospital, buprenorphine can also be continued through an OTP or through an office based opioid treatment program with an X-waivered clinician. DATA 2000 and then subsequently CARA 2016 and SUPPORT 2018 allowed for the prescribing and administration of buprenorphine for OUD from non-OTP settings from clinicians who obtain an X-waiver. And again, as of mid 2022, that means X-waivered clinicians that have not received 8 or 24 hours of training who have essentially registered under the practice pathway or the practice exemption can become X-waivered without a training requirement, treating no more than 30 patients concurrently. And then to treat 100 or 275, you have to have done the training and or work in a qualified practice setting or meet the other qualifications for those higher caps. Hospitals are not restricted from administering methadone or buprenorphine to treat opioid withdrawal or initiate either buprenorphine or methadone for opioid withdrawal or treat opioid use disorder because the medications do both treat opioid withdrawal syndrome and treat opioid use disorder. 42 CFR, Part 8 governs OTPs, but the confidentiality of patients is governed under 42 CFR, Part 2. The most recent revisions to that were in 2020 to elaborate language around electronic transmission of protected health information, but there's additional revisions forthcoming. And prescribing buprenorphine through telemedicine and actually through telephone is allowed through a temporary exemption to the Ryan Haight Act associated with the public health emergency. And that exemption is set to expire at the end of the COVID-19 public health emergency. So that concludes the regulatory environment. Here are some references, so you can actually look up on if you're like, hey, I want to, what is the, what are the actual rules regarding this? And you want to actually go to the source, I've listed each of the regulations and some informational resources about the regulations in the references, so I encourage you to check them out. The Provider Clinical Support System has a mentoring program. If mentoring is of interest to you, please come to the pcssNOW.org/mentoring site. PCSS mentors have a network of providers that have expertise in addictions, pain, and other evidence-based treatment, including medications for opioid use disorder at no cost. There's also a discussion forum, so if posting questions and getting answers on a discussion forum is your thing, the PCSS discussion forum is open for posting. And PCSS is a collaboration between, is led by the American Academy of Addiction Psychiatry, but in collaboration with a whole number of national partners across the country. The Provider Clinical Support System, here's the Twitter, Facebook, website, and email address. Thank you so much for your time and attention. Take care.

Addiction Psychiatrist

regulatory issues

medications

opioid use disorder

Provider Clinical Support System

evidence-based practices

treatment

confidentiality regulations