Practice Management
Select Federal Policies Governing Methadone and Buprenorphine for Opioid Use Disorder
Telemedicine Flexibilities for Prescribing Controlled Medications
DEA and SAMHSA Issue Third Temporary Rule Extending COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications to December 31, 2025
On November 19, DEA and HHS filed a Third Temporary Rule further extending certain exceptions granted in March 2020 as a result of the COVID–19 Public Health Emergency (COVID–19 PHE) to existing DEA regulations for new practitioner-patient relationships through December 31, 2025. This includes allowing clinicians to initiate, via telemedicine, controlled medications for opioid use disorder (OUD), such as buprenorphine.
The extension grants the two agencies further time to review feedback from public comments and listening sessions as they develop a final rule; it also gives providers additional time to come into compliance with potential new standards.
On February 24, 2023, the DEA previously proposed rules for prescribing controlled substances via telemedicine after the COVID-19 PHE expires. ASAM’s related comment letter to the DEA, which includes recommended revisions, can be found here.
Changes to Federal Regulations Governing Methadone Treatment for Opioid Use Disorder
SAMHSA Releases Final Rule to Update Regulations Governing Opioid Treatment Programs
SAMHSA's final rule updating federal regulations governing Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of OUD with Medications for Opioid Use Disorder (MOUD) went into effect April 2, 2024, with a compliance date of October 2, 2024.
Learn more about the rule here. Find a new SAMHSA manual outlining federal guidelines for OTPs here.
Dispensing of Methadone To Relieve Acute Withdrawal Symptoms of Opioid Use Disorder
On August 8, 2023, the DEA revised regulations to expand access to methadone for the treatment of OUD pursuant to the Easy Medication Access and Treatment for Opioid Addiction Act (the Act). The Act directed the DEA to revise its regulation to allow practitioners to dispense not more than a three-day supply of narcotic drugs to one person or for one person's use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both). As a result, a request for an exception to administer or dispense (but not prescribe) up to a three-day supply of methadone for treatment of OUD is no longer necessary after the publishing of the final rule. Click here to read the new rule found at 21 CFR 1306.07(b).
Removal of the 'X-Waiver' and New Education Requirements Under the MATE Act for DEA-Registered Prescribers
Consolidated Appropriations Act, 2023
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “CAA 2023”) into law. Section 1262 of the CAA 2023 eliminates the requirement that a healthcare practitioner apply for a separate waiver through the Drug Enforcement Administration (DEA) to dispense controlled medications in Schedule III, IV and V of the Controlled Substances Act (e.g., buprenorphine) for substance use disorder treatment. There are no longer any federal limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine. The Substance Abuse and Mental Health Services Administration has posted this notice on its website, and the DEA has released this letter.
Under Section 1263 of the CAA 2023, the one-time SUD education requirement becomes a condition on a controlled medication prescriber's DEA registration beginning with the first applicable registration. The "first applicable registration" is defined as the first DEA registration or renewal of the DEA registration by a controlled medication prescriber that occurs on or after the date that is 180 days after the law’s enactment. The DEA is to provide an electronic notification of the new SUD education requirement to DEA prescribers within 90 days after the law's enactment. Of note, a physician who holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties, a board certification from the American Board of Addiction Medicine, or a board certification in addiction medicine from the American Osteopathic Association meets the training requirement set forth in Section 1263 of the CAA 2023.
The DEA has issued guidance on this education requirement, which can be found here. Related ASAM educational resources can be found here.
Healthcare practitioners should also be aware of applicable state laws or regulations that may still be in effect regarding the prescribing and dispensing of buprenorphine for SUD treatment and will need to seek further guidance from their state officials considering the impact of this federal reform in their state.