Eliminates X-Waiver Requirement for DEA-Registered Physicians

Today, the U.S. Department of Health and Human Services is announcing it will publish Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder*, to expand access to medication-assisted treatment (MAT) by exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder (OUD) treatment.

More than 83,000 drug overdose deaths occurred in the United States in the 12 months ending in June 2020, the highest number of overdose deaths ever recorded in a 12-month period, and an increase of over 21% compared to the previous year, according to recent provisional data from the Centers for Disease Control and Prevention (CDC).

The increase in overdose deaths highlights the need for treatment services to be more accessible for people most at risk of overdose and today's action will expand access to and availability of treatment for opioid use disorder.

"The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder," said Adm. Brett P. Giroir, MD, assistant secretary for health. "Removing some of the certification requirements for an  X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment."

Without MAT, the chances of relapse for a person who suffers from OUD are significant; studies have shown that outcomes for people with OUD are much better with MAT.

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder issues an exemption from certain certification requirements under 21 U.S.C. § 823(g)(2) of the Controlled Substances Act (CSA) for physicians licensed under State law and who possess a DEA registration. Accordingly:

• The exemption only applies to physicians who may only treat patients who are located in the states in which they are authorized to practice medicine.
• Physicians utilizing this exemption will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time (note: the 30 patient cap does not apply to hospital-based physicians, such as Emergency Department physicians).
• The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD.
• Physicians utilizing this exemption shall place an "X" on the prescription and clearly identify that the prescription is being written for opioid use disorders (along with the separate maintaining of charts for patients being treated for OUD).
• An interagency working group will be established to monitor the implementation and results of these practice guidelines, as well as the impact on diversion.

* This content is in the process of Section 508 review. If you need immediate assistance accessing this content, please submit a request to digital@hhs.gov. Content will be updated pending the outcome of the Section 508 review.