DEA Chopping Block: DATA-Waiver Requirement | Blogs | Health Care Law Today

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.

Want To Learn More?

Telemedicine Laws for Opioids and Substance Use Disorder Treatment

COVID-19: DEA and SAMHSA Guidance for Treating Opioid Use Disorders via Telehealth

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.