Change of Law: Hospital Action Required
To: Chief Executive Officers, Chief Medical Officers, Chief Nursing Officers,
Legal Counsel, and Government Affairs Staff
Please forward to clinic managers.
Staff Contact: David Streeter, MPA, WSHA Government Affairs
DavidS@wsha.org | (206) 216-2508
Subject: Waiver Removed for Buprenorphine Prescribing
Purpose
The purpose of this bulletin is to inform hospitals and health systems that the federal government has eliminated the DATA-waiver/X-waiver for the prescribing of buprenorphine to treat opioid use disorder (OUD). This is an important federal change that will increase the availability of buprenorphine to treat OUD because it removes a key barrier for prescribing a potentially lifesaving medication. WSHA participated in the advocacy campaign to Washington’s congressional delegation in support of this change, and we are pleased Congress included the waiver elimination in the Consolidated Appropriations Act, 2023.
Applicability/Scope
According to the Substance Abuse and Mental Health Services Administration (SAMHSA), this change applies to “all practitioners who have a current DEA registration that includes Schedule III authority.” These prescribers are now eligible to prescribe buprenorphine for OUD without seeking the DATA-waiver/X-waiver from SAMHSA and the Drug Enforcement Agency (DEA).
Recommendations
- Review this bulletin, section 1262 of the Consolidated Appropriations Act, 2023, and the notices from SAMHSA and the DEA to understand the change.
- Forward this bulletin to eligible prescribers in your hospital so they are aware the DATA-waiver/X-waiver is no longer required to prescribe buprenorphine to treat OUD.
Overview
Prior to the passage of the Consolidated Appropriations Act, 2023, practitioners who wanted to prescribe buprenorphine for OUD were required to submit a notice of intent to SAMHSA. Once approved by SAMHSA, the DEA would issue an X-Waiver identification number to the practitioner, who then became eligible to treat patients with buprenorphine.
However, the Consolidated Appropriations Act, 2023 eliminated the waiver process. According to SAMHSA:
“Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill), removes the federal requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe medications, like buprenorphine, for the treatment of opioid use disorder (OUD). With this provision, and effective immediately, SAMHSA will no longer be accepting NOIs (waiver applications). All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law and SAMHSA encourages them to do so.”
The DEA notes, “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.”
Next Steps
- Hospitals should forward this information to all prescribers who are now eligible to prescribe buprenorphine for OUD without seeking a waiver.
WSHA’s 2022 New Law Implementation Guide
Please visit WSHA’s new law implementation guide online. The Government Affairs team is hard at work preparing resources and information on the high priority bills that passed in 2022 to help members implement the new laws, as well as links to resources such as this bulletin. In addition, you will find the Government Affairs team’s schedule for release of upcoming resources on other laws and additional resources for implementation.
References
H.R.2617 – Consolidated Appropriations Act, 2023
SAMHSA. “Removal of DATA Waiver (X-Waiver) Requirement.”
DEA. “ DEA announces important change to registration requirement.”
PQAC. “News- January 18, 2023.”
