Select Federal Policies Governing Methadone and Buprenorphine for Opioid Use Disorder
Dispensing of Methadone To Relieve Acute Withdrawal Symptoms of Opioid Use Disorder
On August 8, 2023, DEA revised regulations to expand access to methadone for the treatment of opioid use disorder pursuant to the Easy Medication Access and Treatment for Opioid Addiction Act (the Act). The Act directed 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 3-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).
DEA, SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications for Six Months While Considering Public Comment
On May 9th, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Administration (SAMHSA), issued a temporary rule that will take effect on May 11, 2023: "Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications." The temporary rule extends the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE) for six months, until November 11, 2023. For patient-practitioner relationships that have been or will be established up to November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications established during the COVID-19 PHE will be extended for one year, or through November 11, 2024.
Read the full announcement here.
SAMHSA Announces April 2023 Methadone Take-Home Flexibilities Extension Guidance
DEA Announces Proposed Telemedicine Rules for Buprenorphine
On February 24, 2023, the Drug Enforcement Administration (DEA) released proposed rules for prescribing controlled substances, including buprenorphine via telemedicine after the COVID-19 Public Health Emergency (PHE) expires. ASAM’s related comment letter to the DEA can be found here.
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.