Hello, this is Laura McNicholas. We are doing a session today through the PCSS training program on the regulatory issues and medication-assisted treatment. I am an addiction psychiatrist, and have used both buprenorphine and methadone for more than 25 years in treating these patients. And have, for some reason, gotten involved in all of the legal aspects of using these medications appropriately for treating patients with substance use disorders. I have no relevant financial relationships with any commercial interest that would interfere with this program. The overarching goal of PCSS is to make available the most effective medication-assisted treatment to serve patients in a variety of settings, including primary care, psychiatric care, and pain management settings. At the conclusion of this activity, participants should be able to describe the legal differences between an opioid treatment program, commonly called an OTP and office-based practice. Demonstrate if, and when, the prescriber can increase the number of patients that they are able to treat with buprenorphine products under a waiver program. List which medical professionals may prescribe or dispense buprenorphine products, and under which conditions they may prescribe or dispense. Explain the needed confidentiality of patient records for patients in substance use treatment. And to demonstrate how to appropriately practice using telemedicine. What we're going to be discussing is something called 42 CFR, the code of federal regulations, Part 8, which is the OTP Regulations. We will also be discussing in more depth the Drug Addiction Treatment Act of 2000, called commonly called DATA 2000. Comprehensive Addiction and Recovery Act, commonly called CARA, C-A-R-A. And, again, under 42 CFR, the Part 2, which addresses confidentiality of patient records that are being used for substance use treatment. The Controlled Substances Act of 1972 is the overarching legislation covering the appropriate prescribing and dispensing of all controlled substances. It is this legislation that mandates that methadone is only to be used in OTP, and prior to 2000, it forbid doctors from prescribing opioids to patients suspected or known to have a substance use disorder. Because of this ban, physicians outside of OTPs were unable to appropriately treat substance using patients who were addicted to opioids. DATA 2000, and later CARA in 2016, amended this legislation to allow for physicians to appropriately manage patients in office-based settings outside of OTPs. Buprenorphine and office-based practice is covered under DATA 2000 and its amendments, as well as CARA, which was passed in 2016. When we think about the other medications used for treating opioid use disorder, Naltrexone has no legal restrictions. Methadone in OTPs is covered under 42 CFR, Part 8. And Buprenorphine, which can be used in OTPs in opioid treatment programs, but when it's used in OTPs, its use is also covered under 42 CFR, Part 8. The Drug Addiction Treatment Act of 2000, DATA 2000, is an amendment to the Controlled Substances Act. This amendment allows practitioners to prescribe FDA approved narcotic drugs in schedules III, IV, and V, or combinations of such drugs for the maintenance or detoxification treatment of opioid use disorders. DATA 2000 permits no limitations on the quantities of the drugs that may be provided for unsupervised use, unless the drugs have been subjected to an adverse determination. At the present time, no buprenorphine products have been subject to an adverse determination. However, both the drugs and the practitioner must meet certain requirements. Under DATA 2000, the practitioner needs to meet certain requirements. You have to have the capacity to refer patients for appropriate counseling or ancillary services. Notice that this does not say that you must provide them within your own practice, but you need to have the capacity to refer. That the practitioner could have no more than 30 patients in an individual practice for the first year. And you may request approval to treat up to 100 patients after the first year, under DATA 2000 and its amendments. A qualifying physician also needs to meet one of the following requirements, be board certified in addiction psychiatry, board certified in addiction medicine by the American Board of Addiction Medicine, certified in addiction medicine by the Osteopathic Academy, have been investigator in buprenorphine clinical trials leading to FDA approval. Or the most common route, has completed eight hours of training provided by one of the following organizations. I'm not going to read them all because you can read them as well as I can. However, the law does specifically say that one of these organizations must approve the training, or unless HHS has designated another organization to do so. Normally, the training is approved by either the AAAP, AOAAM, or ASAM. APA also does some trainings. In addition, the State Medical Licensing Boards may mandate additional training or experience. But as far as we know, no State Medical Licensing Board has done so. Likewise, criteria may be established by the Secretary of Health and Human Services, but has not occurred to the present time. Once qualifications have been met, the provider must notify the Secretary of Health and Human Services online of his or her name, their DEA registration, their category for qualification, one through seven, as noted in the previous slide, and certify their intention to comply with the law when prescribing these medications. Notifications need to be admitted online, at the present time, at the address listed below. Under DATA 2000, a narcotic drug is defined. And it should be noted that narcotic is used here in the legal sense of the Controlled Substances Act. It includes all opioid products, as well as other drugs and medications that have abuse liability, such as cocaine and illegal substances. Narcotic drug that is approved under DATA 2000 needs to be approved by the FDA for use in maintenance or detoxification treatment of opioid use disorder. It may only be listed as schedule III, IV, or V. It may be a drug or a combination of drugs. And at the present time buprenorphine is the only drug that is currently approved under these conditions, and it is in schedule III. This is a table of the buprenorphine formulations presently available. Most of the prescribing that is done is using tablets or sublingual or buccal films. And we have both buprenorphine alone, generic buprenorphine or sublingual films and tablets of buprenorphine with naloxone. The most commonly prescribed forms of buprenorphine are in combination with naloxone and that is buprenorphine naloxone film tablets or a buccal film. And what you have here are the available doses and the equivalencies. So for instance, an 8 mg dose of the buprenorphines Buprenorphine naloxone film is equal to 5.7 milligrams of the buprenorphine naloxone sublingual tablet, Zubsolv. You also do have the mono-product, as I said, you have the buprenorphine alone in both 2 and 8 mg tablets. There is also an implant that needs to be implanted once every six months in one arm and then removed and there is some. And it needs to be done under sterile conditions, Called probuphine and there is an injection that is a once monthly injection of either of 100 mg or 300 mg. The first dose should be 300 mg, and then once the patient has reached steady state after the first dose, you can go to the 100 mg dose once a month for the supplicate injection. We anticipate further formulations coming out in the not-too-distant future. And you should make sure that you keep up to date on what formulations are available and what is most appropriate for your patient. The other thing that you need to think about is what medications are not approved under DATA 2000. For instance, methadone is not approved under DATA 2000 under any circumstances. Methadone is Schedule 2 drug, not a Schedule 3, 4, or 5. In addition, buprenorphine products that are approved only for pain management such as buprenorphine immediately release injectable. The sublingual film approved for pain or the transdermal buprenorphine that is approved for pain are not approved under DATA 2000 for the treatment of opioid use disorder. Tramadol is a scheduled medication in Schedule 4 but it is not approved for the treatment of opioid use disorder for either detoxification or maintenance and thus must not be used under your waiver. Therefore, any medication not on the approved list, which is only buprenorphine and buprenorphine naloxone that carry the FDA approval for the treatment of opioid use disorder, either detoxification or maintenance, cannot be used under your waiver. DATA 2000 and CARA only apply to scheduled medications. That means that they do not apply to naltrexone, naltrexone has no schedule attached to it and can be used at physician's discretion for the appropriate patient. One of the questions that frequently comes up is what about a patient who is hospitalized and needs buprenorphine? Buprenorphine can be used in hospital setting, If the patient is in the hospital for reasons other than substance use disorder, for instance, a general medical condition, buprenorphine may be ordered by any provider for medical stabilization for the duration of the hospitalization. The provider does not need to have a waiver, it would be best if someone did have a waiver or was overseeing the management of the patient. But if no one is available, any provider may provide buprenorphine for medical stabilization. If the patient is not going to continue with opioid use disorder treatment, the patient should be tapered off of buprenorphine appropriately before discharge. It's not something, a medication that you can simply stop on the day of discharge and say I hope you're feeling better. The patient needs to be tapered off because buprenorphine will cause physiologic dependence, and so manage the patient appropriately prior to discharge. If the patient is to be continued on opioid use disorder treatment after discharge, arrangements for that treatment with an OTP or a DATA-waivered practitioner must be done prior to discharge. Again, it is not appropriate to say here's a list of physicians or practitioners, please call one of them and arrange your own treatment up. That is up to the treating provider within the hospital to make those arrangements. Buprenorphine can be used in medical emergencies. If the patient is seen for emergency care and wants treatment for opioid use disorder but no OTP or DATA-waivered practitioner is available, the emergency practitioner may invoke the 72 Hour Rule or the 3-Day Rule, it goes by either name. The 3-Day Rule is an exception to the registration requirement, according to the DEA. It allows a practitioner who is not separately registered as a narcotic treatment program or certified as a DATA-waivered practitioner to administer but not prescribe narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient's referral to treatment under the following conditions. No more than one day's medication may be administered or given to the patient at one time. Treatment may not be carried out for more than 72 hours, and the 72-hour period cannot be renewed or extended. A lot of people seem to think that the 3-Day Rule means that you can prescribe a three-day supply of medication. This is not accurate, it needs to be done under 24 hour Dose regimen. And therefore, the patient for instance would have to come back to the the emergency room every day for the three days that they are being managed under the 3-Day Rule while arrangements for the patients referral for treatment are being made. CARA, the Comprehensive Addiction Treatment and Recovery Act was passed in 2016. It revises the regulation somewhat, physicians may request approval under CARA to treat up to 275 patients after having treated up to 100 patients at for one year. That's the 100 patients as allowed under DATA 2000. However, these physicians must be board certified in addiction psychiatry or addiction medicine or be practicing in a qualified practice setting. We will get to what a qualified practice setting is in just a minute. Furthermore if the patient chooses to treat up to a 275 patients, there are annual reporting requirements to the Department of Health and Human Services, HHS. And this law was signed into law on 7/22/2016 for those who want to be very specific. Furthermore, CARA 2016, expands prescribing privileges to nurse practitioners and physicians assistants for five years, and that is until October 1st of 2021. NP and PAs must complete 24 hours of training to be eligible for a waiver to prescribe and must be supervised. Even a qualified practice setting is one which provides 24-hour emergency coverage. Provides case management and related services uses Health Information Technology commonly. Meaning a health electronic record, it is registered with the state prescription monitoring program. And it accepts third-party payment for some services. This means that it cannot be a cash-only setting which unfortunately many waivered physicians provide. CARA 2016 address new standards of care and especially for the physicians who are going up to 275 patients. They need to be board certified practitioners. They need to have access to Behavioral Health Services. They need to follow evidence-based treatment guidelines. They need to have individual treatment treatment plans a diversion control plan. They need to use the state prescription drug monitoring program. And as I said, there are annual reporting requirements. The annual reporting requirements. Include reporting on the average monthly caseload of patients receiving buprenorphine based MAT. The percentage of active buprenorphine patients that receive psychosocial services either by direct provision including medical management or referral in the past year due to treatment initiation or a change in clinic status. And the percentage of patients who had a prescription drug monitoring program query within the past month. Furthermore, the number of patients at the end of each reporting year must be noted who have completed an appropriate course of treatment with buprenorphine for the patient to achieve and sustain recovery. Or are not being seen by the provider due to referral to more or less intensive level of care. The patient no longer desires to continued use of buprenorphine or are no longer receiving buprenorphine for other reasons such as simply dropped out. of treatment 42 CFR part 8 eight is the Federal Regulation that governs treatment. Aunt of opioid use disorder within OTPs, opioid treatment programs. It describes in detail both the accreditation and certification based systems of OTPs. Oversight of OTPs is a multi-disciplinary project. It is overseen by the Substance Abuse and Mental Health Administration Services Administration. The center for substance abuse treatment division of pharmacological Therapies. And the oversight is to improve treatment not just regulate. It is also overseen by the Department of Health and Human Services. SAMHSA for certification by the state for licensure and registration and by the drug enforcement agency, DEA for registration. Even under 42 CFR the initial application or a provisional certificate may be issued for one year for a new OTP recertification of existing. Otps must occur at least every three years and all otps must require compliance with State statutes and regulations as well as Federal statutes and regulations furthermore. The program sponsor must apply to samsa for adding new medical units on The OTP license or the relocation of any medical unit under that license. The program director also needs to notify samsa of major program changes for instance Samsung must be notified within three weeks of either a program sponsor or a medical director change. These include the administrative and organizational structure, quality assurance and improvement programs to version control plans, staff credentialing patient, admission criteria, required services within the OTP, record-keeping and patient confidentiality, medication dispensing and administration on supervised used commonly called take-home doses. Whether or not interim maintenance is to be used and what and the definitions of detoxification. Short-term detoxification is defined under the federal law as occurring in less than 30 days. Long-term detoxification is defined as occurring over a span of 30 to a 180 days. Maintenance treatment is defined as comprehensive treatment medical and rehabilitative services interim treatment is defined as Medical services while awaiting referral to comprehensive treatment. And a maximum of a hundred and twenty days can be spent on interim treatment and must refer to a comprehensive treatment thereafter. Sometimes people use interim treatment when a waiting list occurs before patients can be admitted to a comprehensive program. The admission criteria for and OTP under 42 CFR are that the qualified personnel using accepted medical criteria diagnostic statistical manual of current day. Diagnosis the patient with an opioid use disorder, including current physiologic dependence or documentation or satisfaction in some degree that the patient has been dependent for at least one year. Prior to admission for comprehensive treatment and the patient voluntarily chooses maintenance treatment understands the relevant facts concerning the use of opioids clearly and adequately explained for the treatment of opioid use disorder and has provided written informed consent to treatment. There are some standard forms in the appendix of the csat right accreditation guidelines for OT peas if you need to look for those in for consent documents There are additional requirements if the patient applying for treatment within and OTP is less than 18 years old. In addition to the requirements in the previous slide, you must have two documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period. And the parent or legal guardian must consent in writing for maintenance treatment. Patience may choose buprenorphine naloxone in an OTP that offers both methadone and buprenorphine naloxone. The clinic is not restricted in the number of patients receiving buprenorphine or buprenorphine naloxone as our office based practices under data 2000. Federal guidelines for method on take-home doses are not applicable to patients receiving buprenorphine naloxone. But the labeling on the take-home doses from the OTP must meet both OTP and local standards. 42 CFR also has a part 2 which regulates confidentiality of patients who are being treated for a substance use disorder. And this law 42 CFR part 2 and the regulations contained within it were written during a time of great concern about the potential views of substance use disorder information against an individual. The purpose of 42 CFR part 2 is to ensure that a patient receiving treatment for substance use disorder in a part 2 program which we will define is not made more vulnerable than an individual with a substance use disorder who does not seek treatment. The law restricts disclosure and use of patient identifying information including reporting to PDMPs. This is under discussion at the present time, and please keep your ears and eyes open for changes in this. Patient identifying information is anything that reveals a person is receiving has received or has applied for substance use treatment disorder, disorder treatment. The program or practitioner cannot disclose participation in substance use disorder treatment, but they can disclose the identity of the patient under some circumstances. We will get to that in a few minutes too. Importantly, these restrictions include current, former and deceased patients. The background on 42 CFR part 2 applies to federally assisted alcohol and drug abuse programs. The patient consent must be obtained before sharing information from a program that is subject 42 CFR part 2, and once this information has been appropriately disclosed. No redisclosure is prevented without the patient's express consent to redisclose or unless otherwise permitted under part two. The program is considered to be federally assisted if it is conducted in whole or in part, whether directly or by contract or otherwise by any department or agency of the United States. This does not apply to the VA or DoD, that's Department of Defense. If it is being carried out under a license, certification, registration or other authorization granted by any department or agency of the United States including but not limited to. Participating provider in the Medicare program, authorization to conduct maintenance treatment or withdrawal management. Or registration to dispense a substance under the Controlled Substances Act to the extent controlled substance is used in the treatment of substance use disorders. This basically means that any provider with a data waiver is considered program under 42 CFR part 2. Currently, the definition does not apply to general medical facilities such as an overarching medical center, but it does apply to general medical psychiatric practices. Furthermore, the treating provider relationship means that regardless of whether there has been an actual in-person encounter, a person agrees to be diagnosed evaluated and or treated for any condition by an individual or entity. And the individual or entity agrees to undertake diagnosis evaluation and or treatment of the patient or consultation with the patient for any condition. What they are very concerned about under 42 CFR part 2. There are limited exceptions for disclosure without consent. In a medical emergency disclosure may be made and should be made for medical treatment purposes. Scientific research for audits and evaluations, for instance by Medicare Medicaid, CHip programs, etc. Child abuse reporting, crimes on program premises or against program personnel. What this means is that the patient may be identified. For instance, you can say that John Doe was witnessed breaking into a car. You may not say, John Doe who is a patient at blank OTP was witnessed breaking into a car. In response to a court order, not a subpoena. This is something that always comes up. Because if records are subpoenaed, you must refer to a lawyer and get a court order so that the records may be properly managed by the judge overseeing the case. And communications with a qualified service organization of information needed by the organization to provide services to the program. And for that reason, there needs to be a qualified service organization contract in place. Breach of privacy of the information protected by part 2 can lead to civil and criminal consequences for patients. There can be loss of employment, loss of housing, loss of child custody. Discrimination by medical professionals and insurers, and there can also be arrest prosecution and incarceration. There are efforts underway at the present time to modernize these regulations and make them more understandable and less burdensome. So please keep an eye out for those hopefully new regulations to be promulgated in the not-too-distant future. One of the areas that is coming into play right now is telemedicine. And a lot of physicians are being approached to provide buprenorphine management by telemedicine in conjunction with a program that does not have a wavered physician. The term practice of telemedicine means for purposes of this subchapter. The practice of medicine in accordance With applicable Federal and State laws by a practitioner, other than a pharmacist, who is at a location remote from the patient and is communicating with the patient or health care professional who is treating the patient. Using a communication system referred to in section 1395m of title 42, which practice is being conducted while the patient is being treated by or physically located in a hospital or clinic registered under section 823 of this title. And by a practitioner acting in the usual course of professional practice, acting in accordance with applicable state law and registered under section 823(f) of this title in the State in which the patient is located. That is how the DEA defines telemedicine. The DEA statement use of telemedicine while providing MAT emphasizes that all conditions of the definition of telemedicine must be met. Therefore the physician providing telemedicine must be licensed in the state in which the patient is seen. For instance, if you are licensed in the state of Illinois, and you are seeing a patient in the state of Ohio, by telemedicine you must also be licensed in the state of Ohio. You must have all appropriate state licenses including, if needed, a state DEA license. Some states require, in addition to the federal license, a state DEA license, some do not. It is the responsibility of the physician to be aware of the state laws where they will be providing telemedicine. And you should have a practice agreement with the clinic or practice in which the patient is seen. And for your own protection that should be a written practice agreement. If all of the above are met then the physician does not have to do the initial or follow-up interviews face-to-face. But the physician should ensure that the person doing the evaluation is qualified to adequately assess the patient and to determine if the patient needs and qualifies for prescribe buprenorphine. In summary, there are 42 CFR part 8 governing OTPs, primarily methadone is very rigid and restrictive. The reason that we go into it for general practice physicians is if you are going to be referring a patient who, for instance, is not doing well on buprenorphine. You do need understand the way in which a patient is admitted and the definitions under which they are admitted to an OTP. DATA 2000 and CARA 2016 allow for the prescribing of schedules III, IV and V medications for the treatment of opioid use disorder. The medications used under these laws and regulations must be FDA-approved for treating opioid use disorder. Confidentiality of patients and their records in substance use treatment is more stringent than normal and governed under 42 CFR, Part 2, revised in 2017. And as I said, more revision is probable. And telemedicine is allowed under the Ryan White Exemption. References are provided if you wish to go into the laws in detail. And the PCSS Mentor Program is something that you should be aware of. This is designed to offer general information to clinicians about evidence-based clinical practices in prescribing medications for opioid addiction. PCSS mentors are in national network of providers with expertise in addictions, pain, evidence-based treatment, including medication-assisted treatment. And there's 3-tiered approach allows every mentor and mentee relationship to be unique and cater to the specific needs of the mentee. There is no cost for this program, and for more information you should visit the website that is listed here on the slide. Furthermore, there is a PCSS discussion forum. This offers a PCSS Forum which is comprised of mentors and other experts in the field who offer prompt responses to clinical cases or questions. We have a mentor on call each month, it is available to address any submitted questions through the discussion forum. And you can create a new login account by simply clicking on the image on this page to access the registration page. This is information on the PCSS itself and list the lead partner organizations that are part of the PCSS project. As well as the contact information, Twitter and Facebook handles to find out more about what we offer. Thank you very much for your attention during this presentation.
