HHS Eliminates X-Waiver Requirement for DEA-Licensed Physicians

HHS on Thursday announced that it will publish new guidelines that will expand access to medication-assisted treatment for opioid use disorder by exempting physicians from certain certification requirements necessary for prescribing buprenorphine.

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder include an exemption from certain requirements under the Controlled Substances Act for physicians who are licensed under state law and possess DEA registration. Additional details of the exemption include:

• It only applies to physicians who may only treat patients who are located in states where they are licensed to practice.
• Physicians will be limited to treating no more than 30 patients with buprenorphine for OUD at a given time.
• The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the Controlled Substances Act, and does not apply to the prescription, dispensation or use of methadone to treat OUD.
• Physicians must place an “X” on prescriptions and clearly identify the prescription is being written for the treatment of OUD.

A working group will monitor implementation and results of the guidelines, including potential changes in medication diversion.

“The medical evidence is clear: Access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” Adm. Brett P. Giroir, MD, assistant secretary for health, said in an HHS news release. “Removing some of the certification requirements for an  X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment.”