Read Bridget Dooling and Laura Stanley's related reports.
This Essay evaluates two specific flexibilities granted during the COVID-19 pandemic that made it easier for patients to access buprenorphine and methadone. First, the Drug Enforcement Administration (DEA) allowed practitioners to prescribe buprenorphine using telemedicine without first conducting an in-person medical exam. Second, the Substance Abuse and Mental Health Services Administration (SAMHSA) made it easier for patients to have a take-home supply of methadone, reducing many patients’ need to make a daily trip to an opioid treatment program. The White House Office of National Drug Control Policy indicated that extending pandemic flexibilities for treating opioid use disorder is a priority for the Biden Administration, and this Essay provides a roadmap for the executive branch to do so.
While Congress could certainly make the changes permanent through legislation, this Essay provides an independent assessment of whether DEA and SAMHSA have the statutory authority to extend these flexibilities after the COVID-19 public health emergency ends by making changes to their regulations using the notice-and-comment rulemaking process under the Administrative Procedure Act (APA). The main finding is that DEA and SAMHSA have regulatory mechanisms available to extend the flexibilities described above. In addition, the U.S. HHS Secretary’s opioid-specific public health emergency declaration could offer a longer term, but still impermanent, legal pathway to extend these flexibilities beyond the current pandemic.
Bridget Dooling and Laura Stanley published these two reports with support from The Pew Charitable Trusts.
Do federal regulatory agencies have the authority to extend flexibilities for the treatment of opioid use disorder beyond the COVID-19 pandemic?
Bridget C.E. Dooling and Laura E. Stanley provide details on the rulemaking background for medical practitioners and policy makers, and layout their findings on what the Drug Enforcement Administration and Substance Abuse & Mental Health Services Administration can do going forward.
In response to the COVID-19 public health emergency, the Substance Abuse and Mental Health Services Agency (SAMHSA) made it easier for patients to receive take-home supplies of methadone and buprenorphine. This report explores the effects of this policy change, and explains why SAMHSA has the legal authority to extend this flexibility beyond the pandemic to help treat opioid use disorder.