American Society of Addiciton Medicine

Select Federal Policies Governing Methadone and Buprenorphine for Opioid Use Disorder

Practice Management

Select Federal Policies Governing Methadone and Buprenorphine for Opioid Use Disorder

Home Advocacy Practice Management Select Federal Policies Governing Methadone and Buprenorphine for Opioid Use Disorder

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

On March 16, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued an exemption to Opioid Treatment Programs (OTPs) whereby a state could request “a blanket exception for all stable patients in an OTP to receive up to 28 days of Take-Home doses of the patient’s medication for opioid use disorder.  SAMHSA published a Methadone Take-Home Flexibilities Extension Guidance in November 2021.   SAMHSA has now updated that November 2021 Guidance in full by revising the standards applicable to OTP provision of methadone for unsupervised use. The newly revised April 2023 Guidance can be found here and will be effective upon the expiration of the COVID-19 Public Health Emergency, and will remain in effect for the period of one year from the end of the COVID-19 Public Health Emergency, or until such time that the U.S. Department of Health and Human Services publishes final rules revising 42 C.F.R part 8, whichever occurs sooner. A notice of proposed rulemaking has been published that proposes revisions to 42 C.F.R. part 8 entitled ‘Medications for the Treatment of Opioid Use Disorder’ (87 FR 77330), which SAMHSA is working to finalize.  ASAM’s related comment letter to SAMHSA can be found here.

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. 

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.