New Buprenorphine Laws

In addition, recent practice guidelines have created two different memoranda of understanding on the prescribing of buprenorphine. To obtain an exemption to administer, dispense and prescribe buprenorphine, physicians must inform SAMHSA`s Centre for Addiction Treatment (CSAT), Division of Pharmacological Therapies (DPT), of their intention to perform this form of drug-assisted therapy (TMA). The Notice of Intent must be submitted to SAMHSA prior to the first dispensing or prescription of medication for the treatment of OUD. Trish Mashburn works at two independent clinics in western North Carolina. When a nearby pharmacy stopped dispensing buprenorphine, it received five calls a day from potential customers trying to fill its prescriptions, she said. Although both employers have buprenorphine in stock, they only order a certain amount, so Mashburn often has to turn away patients. But research suggests that buprenorphine abuse has decreased in recent years, even though prescribing has increased, and that most people who use diverted buprenorphine do so to avoid withdrawal symptoms and because they can`t get a prescription. Many pharmacists worry that ordering too much buprenorphine could trigger a DEA investigation, according to research in Kentucky and North Carolina. This creates a “prescription cliff,” says Bayla Ostrach, who researches substance use disorder treatment and health policy. Doctors could prescribe more, but if pharmacies don`t fill the prescription, patients won`t be able to get their medication. Ainsley Bryce / KHN Hide subtitles Practitioners who avail themselves of this exemption cannot treat more than 30 patients at a time (the time practiced under this exemption does not qualify the physician for a higher patient limit). This exemption applies only to the prescription of Schedule III, IV and V drugs or combinations of such drugs covered by the CSA, such as buprenorphine. The training requirement has long been seen by some providers and policymakers as a barrier to building a UOT processing infrastructure.

Unlike methadone, which is also prescribed to treat OUD, buprenorphine can be provided in primary care, where OUD can be treated alongside other chronic diseases. The relaxation of buprenorphine prescribing requirements supports ongoing efforts to integrate behavioral health into primary care. It also signals a normalization of this treatment approach, which can serve to reduce the stigma of OUD. Across the country, when a pharmacy stops supplying buprenorphine, the impact can be significant. Are there any questions about customer privacy when prescribing buprenorphine? On 27 April 2021, the Federal Ministry of Health and Social Care (HHS) announced new practice guidelines for service providers prescribing buprenorphine, a medicine used to treat opioid use disorder (OUD). These guidelines create an exception to long-standing federal training requirements for providers, including physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthesiologists, and certified nurse midwives. The rules also exempt providers from the obligation to certify their ability to provide advisory services. Learn more about buprenorphine exemption training or SAMHSA training and resources.

Under certain conditions, the attached Practice Guidelines exempt eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthesiologists, and certified nurse midwives (collectively, “practitioners”) from certification requirements related to training, counseling, and other ancillary services (i.e., psychosocial services) under 21 U.S.C. 823(g)(2)(b)(i)-(ii). This is necessary to expand access to buprenorphine for the treatment of opioid use disorder. In particular, the exemption allows these practitioners to treat up to 30 OUD patients with buprenorphine without having to undergo specific training-related certifications. This exemption also allows physicians to treat patients with buprenorphine without certifying their ability to provide advice and ancillary services. This exemption specifically addresses identified barriers to the training requirement. Providers must always submit an application, called a letter of intent, to prescribe buprenorphine for the treatment of opioid use disorder. Do providers still need an AED registration to prescribe buprenorphine? Like many other prescription drugs, buprenorphine can be found illegally on the street. There are unscrupulous doctors who dispense prescriptions and pharmacists who fill them. Subutex, which consists solely of buprenorphine, is easier to abuse and generally has a higher resale value than Suboxone, a combination of buprenorphine and naloxone, an overdose reversal drug. 6. This exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of those Schedule 21 U.S.C.

823(g)(2)(C) drugs, such as buprenorphine. It does not apply to the prescription, dispensing or use of Schedule II medications, such as methadone, to treat opioid use disorder. Yes, these guidelines exempt eligible physicians from certification requirements for training and delivery of mental health services that were previously required when dispensing or prescribing buprenorphine to treat opioid use disorder (OUD) to 30 or fewer patients. The filing and approval of a Letter of Intent (NOI) remains legally required to use buprenorphine in the treatment of patients with OUD. In order to indicate exemptions from qualified training when applying on the Notice of Intent website, applicants must choose a source of training or the system will eliminate them. To apply, mid-level practitioners (APRN and MA) must review SAMHSA`s Provider Clinical Support System (SSCP) under “CERTIFICATION OF ELIGIBILITY CRITERIA” and then enter “Practice Guidelines” in the date text box. Do these new practice guidelines remove the requirement to obtain a CSA waiver or to file a letter of intent to use buprenorphine in the treatment of patients with OUD? Can I start prescribing buprenorphine immediately without training? Many doctors in general practice institutions do not meet these criteria. Therefore, Part 2 generally does not apply to their medical records and they do not have to follow Part 2 even if they have obtained a DATA 2000 exemption and prescribe buprenorphine. HIPAA protections remain in place. Learn more about record retention requirements. No, these guidelines do not eliminate the CSA`s exemption or notice of intent requirements. Providers must also file a letter of intent before using buprenorphine to treat OUD patients and receive a DEA waiver number.

The Letter of Intent requires a simple online application, submission of documentation of a valid DEA registration and state license, and subsequent approval. To learn more about this process, click here. 1. With respect to prescribing 21 U.S.C. 823(g)(2)(C) drugs, such as buprenorphine, state-licensed practitioners who have a valid DEA registration under 21 U.S.C. 823(f) may be exempt from training certification requirements, counseling and other ancillary services (i.e., psychosocial services) under 21 U.S.C. 823(g)(2)(B)(i)-(ii). In accordance with applicable law, practitioners who meet the above conditions must file a notice of intention in accordance with the applicable procedures to qualify for this exemption and obtain an exemption. However, if a physician chooses a limit of 30 patients in the Notice of Intent, the physician is not required to certify beyond the training, consultation, or other ancillary service requirements listed in 21 U.S.C. 823(g)(2)(B)(i)-(ii).

The law allows qualified physicians to obtain an exemption from the separate registration requirements of the Narcotics Treatment of Addicts Act – 1974 to treat opioid dependence with Schedule III, IV and V drugs or combinations of these drugs approved by the FDA for that indication. Find out more about buprenorphine for substance use disorders. This creates a “prescription cliff,” said Bayla Ostrach, lead author of a paper examining the issue in North Carolina. Doctors can prescribe buprenorphine to more patients, but pharmacies order enough for a number of customers. Since many people stay on buprenorphine for years, once the pharmacy reaches its self-imposed quota, it can rarely have openings for new patients. To apply for exemption under the practice guidelines, practitioners must still submit a letter of intent to SAMHSA and wait for SAMHSA approval. Do practitioners also need to obtain the DEA X number and use it to prescribe buprenorphine? In 2016, after flooding displaced people in neighboring counties, Njoku began distributing the pharmacy in his hometown of Oak Hill in Fayette County to local customers. 42 CFR Part 2 Privacy Regulations apply to government-sponsored programs, which are providers of substance use disorders impersonating and providing providers of SUD services and substance use disorder treatment facilities.

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