January 26, 2023
With the signing of the Consolidated Appropriations Act of 2023 (the Act) on December 29, Congress eliminated the “DATA-Waiver Program,” also known as the “X-Waiver.” This means that an X-waiver is no longer required to treat patients with buprenorphine for opioid use disorder.
To begin the implementation of the “X-Waiver” repeal, the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) issued guidance on the removal of the X-waiver, on January 12.
For many years, the X-Waiver has been a significant barrier to the treatment of opioid use disorder, and its requirements contributed to the stigma that surrounded the disease. Medication for opioid use disorder is a critical tool for those fighting to overcome the disorder in that it helps to sustain recovery and prevents overdoses. The move by SAMHSA and the DEA to eliminate the X-Waiver will increase access to buprenorphine for those who would benefit from its treatment the most.
According to the SAMHSA and DEA guidance, all DEA registrants should be aware of the following:
A 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.
It is also important to note that the Act also introduced new training requirements for all prescribers. These requirements will not go into effect until June 21, 2023. The DEA and SAMHSA are actively working to provide further guidance and physicians should expect to hear from the DEA with additional information on these requirements soon.
The MMA will keep a close eye on any developments and new guidance. Stay tuned to News Now for any follow-up information.
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