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

Telemedicine Flexibilities for Prescribing Controlled Medications

DEA and SAMHSA File Second Temporary Rule to Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications to December 31, 2024, While Considering Revisions and Public Comment

On October 6th, DEA and HHS filed a Second 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, 2024, from November 11, 2023.

The Second Temporary Rule is scheduled to be published on October 10, 2023, is effective November 11, 2023, and has been promulgated as the two agencies continue to consider revisions to the proposed rules set forth in their March 1, 2023 NPRMs and in light of Telemedicine Listening Sessions that DEA hosted on September 12 and 13, 2023.

The grace period provided in the First Temporary Rule is effectively subsumed by Second Temporary Rule, which continues the extension of the current flexibilities for all practitioner-patient relationships – not just those established on or before November 11, 2023 –until the end of 2024.

DEA, SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications for Six Months While Considering Public Comment (First Temporary Rule)

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.

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.

Changes to Federal Regulations Governing Methadone Treatment for Opioid Use Disorder


SAMHSA Releases Final Rule to Update Regulations Governing Opioid Treatment Programs

On January 31, 2024, SAMHSA's final rule updating federal regulations governing Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs was posted in the Federal Register.  The effective date of this final rule is April 2, 2024, and the compliance date is October 2, 2024.  To learn more, click here.

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).

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.