Congress Removes X-Waiver Requirement

Physicians who want to prescribe opioids have long been able to do so with a license from the Drug Enforcement Agency (DEA). Yet if they want to treat opioid use disorder (OUD) with buprenorphine, physicians have been required to go through the additional step of receiving the so-called X-waiver.

Congress has now ended the X-waiver requirement with the passage of the Mainstreaming Addiction Treatment Act, which was included in last year’s massive omnibus spending bill. All clinicians who have DEA registration that includes Schedule III authority can now prescribe buprenorphine for OUD without any additional training.

“There are countless stories of patients who are in need of treatment for OUD and don’t have access due to the limited number of X-waivered prescribers,” said Smita Das, M.D., PH.D., M.P.H., chair of APA’s Council on Addiction. “There are also so many cases of people with OUD who start treatment and have trouble finding follow up [care]. I am hopeful that the removal of the X-waiver will reduce barriers to access, increase the number of prescribers interested in treating OUD, and reduce stigma.”

The X-waiver originated with the Drug Addiction Treatment Act of 2000, which was meant to prevent harmful practices around prescribing buprenorphine. “This is ironic, since suboptimal opioid prescribing practices may have contributed to OUD outside of buprenorphine,” Das said. Small steps have been taken in recent years to ease the access barriers that the X-waiver has presented, such as increasing prescribing limits and eliminating the waiver if treating small numbers of patients. “Removing the X-waiver entirely was probably a long time coming,” Das said.

Buprenorphine is effective for treating OUD on multiple fronts, Das explained. Patients on an effective dose reduce their use of other opioids and stay in treatment longer than patients who do not receive buprenorphine, she said. “Buprenorphine is a partial mu opioid receptor agonist and has a theoretical ceiling effect for respiratory depression, which may render it safer than full agonist opioids for pain,” she added.

“The X-waivers not only added an administrative burden for physicians, but they also added to the high level of stigma associated with substance use disorders,” Das said. “That extra bureaucracy added to unwarranted fear around buprenorphine, which is a safe, effective, and life-saving drug.”

Physicians are still required to receive a license from the DEA to prescribe any controlled substance, including buprenorphine. Further, the DEA and Substance Abuse and Mental Health Services Administration (SAMHSA) are currently working on a separate provision of the omnibus spending bill, which involves updating training requirements for all prescribers of controlled substances. The provision requires prescribers to complete a one-time training of at least eight hours on the treatment and management of patients with OUD or other substance use disorders. The new requirement will be effective in June, according to SAMHSA’s website.

Barriers to treatment for OUD still exist even with the X-waivers removal, Das pointed out. Some studies estimate that less than half of X-waivered prescribers actually prescribe buprenorphine, and they do so in small numbers.

In a viewpoint published in STAT, Beth Linas, Ph.D., M.H.S., and Benjamin Linas, M.D., emphasized the importance of spreading awareness of the X-waiver’s removal to both physicians and patients. “Removing the X-waiver is a historic step forward in treating people with opioid use disorder,” they wrote. “But it will do little good if clinicians and people who use opioids aren’t made aware of it.” Beth Linas is a research epidemiologist with RTI International. Benjamin Linas is a professor of medicine at the Boston University School of Medicine and director of the Syndemics Lab at Boston Medical Center.

“This is where continuing education and consultation with experts in addiction treatment is extremely important,” they continued. “Psychiatrists and addiction specialists must continue to participate in education and advocacy to help integrate treatment into health care.” ■