Physicians with a Drug Enforcement Administration (DEA) registration number may no longer be required to apply for a separate waiver to prescribe buprenorphine to patients with opioid use disorder (OUD), according to new practice guidelines by the Department of Health and Human Services (HHS). This waiver is referred to as X-waiver of the Controlled Substances Act (CSA).
Physicians who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment have been required to complete additional certifications under Title 21 of the CSA.
“The Office of the Assistant Secretary for Health in HHS has determined that the need for physicians to make all of the certifications under 21 U.S.C. 823(g)(2)(b) represents a significant perceived barrier to prescribing buprenorphine in the United States, and removing the certification requirements would dramatically improve access to buprenorphine and save lives,” according to the guidelines.
The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder outlines the following changes:
- A physician who is licensed under state law and possesses a DEA registration under 21 U.S.C. 823(f) is exempt from the certification requirements under 21 U.S.C. 823(g)(2)(b) when prescribing such medications as buprenorphine. (Physicians utilizing this exemption may treat only those patients who are located in states where those physicians are authorized to practice medicine.)
- The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD.
- Physicians utilizing this exemption will be limited to treating no more than 30 patients with buprenorphine for OUD at any one time. (This cap does not apply to hospital-based physicians, such as emergency department physicians).
- Physicians utilizing this exemption must place an "X" on the prescription and clearly identify that the prescription is being written for OUD.
- An interagency working group will be established to monitor the implementation and results of these practice guidelines, as well as the impact on diversion.
“With this change,” said psychiatrist and immediate past AMA President Patrice Harris, M.D., M.A., in a statement, “office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime. Ensuring physician-led teams for treating patients with opioid use disorder is critical to ending the opioid epidemic. Removing the waiver requirement can also help lessen the stigma associated with this treatment and the persistent health disparities in treating substance use disorders.”
For related information, see the Psychiatric News article “Patients and Psychiatrists Alike Face Hurdles in Buprenorphine Prescribing.”
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