A major change in federal policy for addiction medicine—prompted in part by of soaring levels of illicit use of opioids and overdose deaths—will offer physicians more flexibility to prescribe buprenorphine, a key medication used to treat patients with opioid use disorder (OUD).
Under the new policy, physicians with a Drug Enforcement Administration registration number are no longer required to apply for a separate waiver, called the X-waiver, to prescribe buprenorphine for OUD treatment. In its January 14 announcement of the new policy, the Department of Health and Human Services (HHS) said that it would be published in new practice guidelines.
Citing recent provisional data from the Centers for Disease Control and Prevention, HHS said that more than 83 000 drug overdose deaths occurred in the United States during the year ending in June 2020, the highest number ever recorded during a 12-month period. “The increase in overdose deaths highlights the need for treatment services to be more accessible for people most at risk of overdose,” HHS said.
The agency also noted that without medication-assisted treatment, people with OUD are at significant risk of relapse, and that studies have demonstrated this approach substantially improves outcomes for such individuals.
“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,” Admiral Brett P. Giroir, then assistant secretary for HHS, said in a statement about the new policy. “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.”
Previously, physicians were required to take an 8-hour course approved by the Substance Abuse and Mental Health Services Administration (SAMHSA) to receive the waiver. Clinicians who received a waiver were allowed to treat up to 30 patients with buprenorphine concurrently, although they had the option to request increasing this number to 100 or 275.
Under the new guidelines, any physician with a Drug Enforcement Administration prescriber license will be allowed to treat up to 30 in-state patients with buprenorphine for addiction treatment at any one time. However, this cap does not apply to hospital-based physicians, such as those working in emergency departments, and other physicians can still treat up to 275 patients with buprenorphine if they receive the training and a separate waiver.
The new policy applies only to prescription of drugs or formulations that are covered under the X-waiver of the Controlled Substances Act (such as buprenorphine), and it does not apply to use of methadone. Also, the policy change does not include nurse practitioners and physician assistants, who are still required to undergo 24 hours of training and apply for separate waivers to prescribe buprenorphine.
Critics of the X-waiver requirements said it discouraged physicians from offering buprenorphine as a treatment for patients with opioid use disorder, despite evidence that the therapy is effective in preventing relapse.
Currently there are about 95 500 physicians and other prescribers (such as nurse practitioners and physician assistants) who have an X-waiver, according to SAMHSA. The majority (71%) are certified to treat only up to 30 patients at a time; another 22% are certified to treat up to 100 patients, and just 7% are certified to treat up to 275 patients. However, according to findings reported in JAMA Network Open in August 2020, “approximately half of waivered clinicians prescribed buprenorphine and most treated at levels below their patient limits, although there remains tremendous unmet demand for OUD treatment.”
Physician groups that had pressed for changes in buprenorphine prescribing, including the American Medical Association (AMA) and the American College of Emergency Physicians (ACEP), welcomed HHS’s announcement.
“With this change, 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,” Patrice Harris, MD, MA, chair of the AMA’s Opioid Task Force and the group’s immediate past president, said in a statement.
The ACEP said in a statement that the group applauds HHS’s action to alter its policy on the “X-waiver” requirement for physicians, and also that it “appreciates that the department recognized the unique nature of emergency medicine and decided not to apply this limitation to hospital-based physicians, including emergency physicians.”
“As emergency physicians, we see every day the devastating effects that the opioid crisis has had on the communities we serve—a crisis that has unfortunately only worsened during the COVID-19 pandemic,” ACEP president Mark Rosenberg, DO, noted. “The X-waiver was an outdated and cumbersome barrier to treatment, and it exacerbated stigma for those struggling with opioid use disorder.”
An interagency working group will be formed to monitor the implementation and results of the new practice guidelines as well as their effect on drug diversion, HHS said.
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Stephenson J. JAMA Health Forum.
Corresponding Author: Joan Stephenson, PhD, Consulting Editor, JAMA Health Forum (Joan.Stephenson@jamanetwork.org).
Conflict of Interest Disclosures: None reported.
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Stephenson J. New Federal Policy Expands Access to Buprenorphine for Treating Opioid Use Disorder. JAMA Health Forum. 2021;2(1):e210108. doi:10.1001/jamahealthforum.2021.0108