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January 26, 2023 (Cleveland, OH)

Congress Eliminates the X-Waiver, Providing Easier Access to Opioid Treatment

With the passage of the end-of-year omnibus legislation, Congress formally ended the DATA-Waiver program, commonly known as the X-waiver program. Federal officials, lawmakers and public health experts believe this change will improve access to buprenorphine, a drug known for treating opioid dependence and considered by advocates as a vital tool for preventing fatal opioid overdoses.

The Mainstreaming Addiction Treatment (MAT) Act — which called for elimination of the X-waiver — was first introduced in Congress in 2019 and co-sponsored by Ohio Senator Sherrod Brown. Gaining bipartisan support in Congress and endorsed by hundreds of organizations, it was added to the Consolidated Appropriations Act of 2023, which passed on Dec. 29.

Previously, any doctor wanting to prescribe buprenorphine would be required to undergo additional training and receive permission from the federal government. The process of getting an X-waiver was seen as time-consuming and ultimately discouraged doctors from prescribing the drug — adding to the negative stigma around the medication. The MAT Act’s elimination of the X-waiver removes these requirements and will allow easier access to this treatment.

Practitioners who want to prescribe buprenorphine to their patients will still be required to get a license from the U.S. Drug Enforcement Administration (DEA), but they won’t face the lengthy administrative requirements. In a letter to prescribers, the DEA expressed support for this policy reform and said registrants should be aware of the following:

  • The DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
  • Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
  • There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
  • The Act does not impact existing state laws or regulations that may be applicable.

As deaths from opioid overdoses reached record numbers, access to buprenorphine remained a challenge. During the COVID-19 Public Health Emergency, federal rule changes allowed qualified clinicians to remotely prescribe buprenorphine, removing a requirement for in-person evaluations. That change will remain in place until the public health emergency is ended by the federal government. 

“Our bipartisan efforts to expand access to lifesaving buprenorphine will help ensure that more patients can access this critical treatment to enter recovery and rebuild their lives,” said Senator Maggie Hassan (D-NH). “I am glad that lawmakers on both sides of the aisle could come together, listen to the voices of our constituents, and get this important law over the finish line.”

While critics voiced concern on the potential abuse of the drug, a new study from researchers at the National Institute on Drug Abuse and the Centers for Disease Control and Prevention indicates the proportion of opioid overdose deaths involving buprenorphine did not increase in the months after prescribing flexibilities were put in place during the COVID-19 pandemic.