On January 12, 2023, the Drug Enforcement Administration (DEA) confirmed in a letter to registrants that the Consolidated Appropriations Act of 2023 (P.L. 117-328) (the Act), which was signed into law on December 29, 2022, eliminated the “DATA-Waiver Program”. The removal of the DATA-Waiver (or X-waiver) will increase the pool of practitioners eligible to prescribe buprenorphine, a clinically-proven medication used to treat patients with opioid use disorder (OUD).

The Substance Abuse and Mental Health Services Administration (SAMHSA) also issued a statement on its website on the removal of the DATA-Waiver.

What this Means

DEA’s letter warned all registrants of the following changes:

• A DATA-Waiver registration is no longer required to treat patients with buprenorphine for OUD.

• 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 OUD with buprenorphine.

• The Act does not impact existing state laws or regulations that may be applicable.

The DATA-Waiver Requirement

The DATA-Waiver (also known as the X-waiver) was created under the Drug Addiction Treatment Act of 2000 (DATA 2000), to allow certain qualified practitioners to treat patients with buprenorphine outside of an opioid treatment program (OTP), often referred to as a “methadone clinic”. To obtain an X-Waiver, practitioners were required to submit a Notice of Intent to the DEA and SAMHSA, attesting to the completion of certain specialized training requirements. When approved, the letter “X” was appended to the practitioner’s DEA license number. 

Further limiting access to buprenorphine, practitioners with an X-waiver were subject to patient caps (30, 100, or 275, depending on certain factors) – limiting the number of patients an X-waivered practitioner could treat with buprenorphine at any given time.

Studies have shown that buprenorphine, in combination with counseling and behavioral therapies (known as medication-assisted treatment or MAT), is a leading tool to combat the ongoing opioid epidemic.

Changes for All DEA-Registered Practitioners

The DEA also noted that another section of the Act (Medication Access and Training Expansion or MATE Act), also introduced new training requirements for all prescribers of controlled substances, which include an eight hour training in identifying and treating addiction when a practitioner applies for or renews their DEA registration to prescribe controlled substances. This requirement will go into effect on June 21, 2023.

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