Recently, the Substance Abuse and Mental Health Services Administration (SAMHSA) published frequently asked questions about the removal of the DATA Waiver (X-Waiver) requirement, as included in the Omnibus bill of 2023. Previously, for practitioners to prescribe medications like buprenorphine for the treatment of the opioid use disorder, they had to submit a Notice of Intent (also known as a waiver application). However, SAMHSA is no longer accepting waiver applications and practitioners who have a current Drug Enforcement Administration (DEA) registration that includes Schedule III authority may prescribe buprenorphine for Opioid Use Disorder in their practice, if it is permitted by state law.
SAMHSA notes that the DATA-Waiver registration number is no longer required for opioid use disorder prescriptions, only a standard DEA registration number. This means that effective immediately, providers can prescribe buprenorphine for the treatment of Opioid Use Disorder under federal law (state law may be different) with just a standard DEA registration number.
The repeal of the X-waiver also removed patient caps, meaning a practitioner may treat as many patients as they are able to support with buprenorphine.
Prescribers who are currently registered as a DATA-Waived prescriber should have received (or will be receiving shortly) an updated DEA registration certificate to reflect the elimination of the DATA-Waiver registration number. It’s important to be aware that state laws may still be in effect, and an individual practitioner’s state requirements may differ from federal law. In that case, state laws that are applicable may need to be followed.
SAMHSA also notes that while buprenorphine can be prescribed via telemedicine, the practitioner must be cautious to follow all relevant federal, state, and local laws, regulations, and other related requirements. While telemedicine was expanded during the COVID-19 public health emergency (PHE), it is possible that changes to telemedicine permissions will changes as the PHE ends on May 11, 2023.
Further, any federal reporting requirements under the DATA-Waiver are no longer applicable. However, detailed records must always be kept in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and 42 C.F.R. Part 2, as well as any applicable state laws.
A key point in the FAQs is that the Act does not override any state laws, and it is important for practitioners to be aware of state and local laws. If additional clarification is needed from a state law perspective, SAMHSA recommends contacting state departments of health regarding specific state regulations. A list of State Opioid Treatment Authorities (SOTA) can be found here.
SAMHSA and the DEA are working together toward implementing a separate provision on training requirements for DEA registration, and our article on that can be found here.
Information on pharmacist verification of buprenorphine providers can be found here. The SAMHSA notes that pharmacists can use the Buprenorphine Pharmacy Lookup to verify a practitioner’s certification to prescribe and dispense buprenorphine for the treatment of Opioid Use Disorder. This may be helpful in instances where a state still requires a practitioner to be certified by SAMHSA.