Extending Pandemic Flexibilities for Opioid Use Disorder Treatment

Telehealth, COVID-19, and the Opioid Crisis

 


 

Extending Pandemic Flexibilities for Opioid Use Disorder Treatment Reports

These reports are authored by GW Regulatory Studies Center scholars Bridget C.E. Dooling and Laura E. Stanley with support from The Pew Charitable Trusts.

 


 

Report One Cover Photo: Extending Pandemic Flexibilities.

Telemedicine & Initiating Buprenorphine Treatment

Published February 23, 2021

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.

Extending Pandemic Flexibilities for Opioid Use Disorder: Unsupervised Use of Opioid Treatment Medications.

Unsupervised Use of Opioid Treatment Medications

Published April 22, 2021

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

 


Related Content from the GW Regulatory Studies Center

 

 

Extending Pandemic Flexibilities for Opioid Use Disorder Treatment: Authorities and Methods

Extending Pandemic Flexibilities for Opioid Use Disorder Treatment: Authorities and Methods by Bridget Dooling and Laura Stanley.

 

This Minnesota Law Review article 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.

We need smart solutions to mitigate the coronavirus’s impact. Here are 46.

Graphic depicting a person sitting down and thinking near a rendering of the coronavirus.

 

 

"The coronavirus crisis has upended American life, and fresh ideas are needed for dealing with the problems it’s creating. Here is a collection of smart solutions." - Washington Post

Laura Stanley's essay was featured as one of the Washington Post's smart ideas to reduce the impact of the coronavirus on our lives.

Read Laura's full essay: Bring back the methadone vans

 

The pandemic broke through opioid treatment red tape. Let’s keep it that way.

Image of person holding a pill bottle and pills in their open hands.

 

"People struggling with opioid use disorder deserve increased access to telemedicine treatment after the pandemic, and federal regulators have the power to make it happen. The Biden administration should act now to preserve this flexibility."

Bridget Dooling and Laura Stanley's op-ed in the Philadelphia Inquirer argues that one thing the federal government got right during the pandemic was making it easier for people to begin opioid use disorder treatment.

Read the Op-Ed.


Podcast

Laura Stanley joins GW Regulatory Studies Center communications and outreach manager Bryce Chinault to discuss related regulations at the Drug Enforcement Administration.

 


A Last-Minute Attempt to Partially X the X Waiver

GW Regulatory Studies Center logo. A Last-Minute Attempt to Partially X the X Waiver, a Commentary by Laura E. Stanley.

 

 

The Trump administration made a last-minute attempt to provide flexibilities for prescribing buprenorphine to treat opioid use disorder. The Biden administration changed course and decided not to publish the associated guidelines due to legal and policy concerns. Although HHS appears to have the legal authority to provide exemptions from buprenorphine requirements, taking time to ensure flexibilities are legally defensible will promote the uptake of the policies in the long term.

Read Laura Stanley's full Commentary: A Last-Minute Attempt to Partially X the X Waiver