Policy Update: X-Waiver

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The Issue:

Buprenorphine, a partial opioid medication, is an effective addiction treatment. It is classified as a Schedule III controlled substance under the Controlled Substances Act, meaning that the drug is highly regulated. Under the Drug Addiction Treatment Act, clinicians can only prescribe buprenorphine, with very limited exceptions, if they are trained and have a specialized waiver known as the “X-waiver.” Buprenorphine is a powerful tool to combat the opioid crisis, particularly in communities with inadequate access to addiction specialists and treatment programs. As it stands, the X-waiver is a barrier to more clinicians prescribing buprenorphine.

Expanding access to buprenorphine is particularly important for hospital medicine because hospitalization is a “reachable moment” for patients suffering from opioid use disorder (OUD). Patients often enter the hospital from related complications and hospitalists are in a unique position to begin medical treatment. Until the X-waiver is eliminated, hospitalists will continue to miss valuable opportunities for intervention.

HHS Guidance and Subsequent Rollback:

On January 15, 2021, the Department of Health and Human Services (HHS) under the Trump Administration announced they would amend practice guidelines to exempt physicians from needing the X-waiver to treat OUD using buprenorphine. These guidelines loosened prescribing requirements for buprenorphine and would have enabled hospitalists to better respond to the opioid crisis.

Update: On January 27, 2021, HHS under the Biden Administration published a statement that indicates that they cannot move forward with the previous announcement eliminating the X-waiver. To read the official statement, please click here. To learn more, please click here.

SHM Advocacy Efforts:

SHM has consistently and vocally supported the elimination of the X-waiver. At our 2019 Hill Day, nearly 160 hospitalist advocates from 36 states advocated for the passage of the “Mainstreaming Addiction Act of 2019,” which would have eliminated the X-waiver prescribing requirement for buprenorphine. When this legislation is reintroduced in the 117th Congress, SHM will continue to push for its passage.

SHM recently joined the American College of Emergency Physicians (ACEP) and other stakeholders on a letter urging the Acting Secretary of Health and Human Services (HHS) to expand access to buprenorphine, including through the elimination of the X-waiver. To read the letter, please click here.

While SHM is disappointed in the recent developments, we will continue to advocate for expanded buprenorphine access and the elimination of the X-waiver.