Last January, the federal government declared a public health emergency in response to the accelerating spread of COVID-19. As state and local governments issued stay-at-home orders, wider use of telehealth became critical to preventing potential virus exposure in medical offices. In response, the U.S. Department of Justice and U.S. Department for Health and Human Services (HHS) enhanced flexibility for practitioners so they could prescribe buprenorphine—a key medication to treat opioid use disorder (OUD)—for patients after consultations by telephone or video conference.
Practitioners and public health experts are now expressing concern that if these flexibilities end as the public emergency eases, access to treatment could drop significantly. Congress could act to extend these policies, but a new report by researchers at the George Washington University (GWU) Regulatory Studies Center finds that the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration (SAMHSA) have the legal authority to do so themselves. The Pew Charitable Trusts funded the research, which was published Feb. 23.
Under the emergency designation, practitioners approved to prescribe buprenorphine are no longer prohibited from doing so without first conducting an examination of the patient in person. Instead, providers can prescribe this drug for new patients they have consulted with over the telephone or through video conference. This flexibility also applies to new patients receiving buprenorphine through opioid treatment programs (OTPs)—federally regulated facilities where patients take medications for OUD under the supervision of medical staff. They also receive counseling and other care services.
The GWU report describes the potential pathways that the DEA and SAMHSA could take to expand access to lifesaving care with medications that have proved effective.
Under the existing regulations, health care providers must conduct an in-person evaluation before prescribing or dispensing buprenorphine and cannot rely on telemedicine. This requirement applies to practitioners who have undergone specialized training and received the federal “X-waiver” to prescribe buprenorphine for OUD, as well as to OTPs. These rules have been eased temporarily during the pandemic to ensure that people can access or continue treatment.
What could change
The DEA and SAMHSA currently permit practitioners to initiate buprenorphine treatment for new patients with OUD over the telephone or using an audio-visual connection—without requiring an initial in-person evaluation. However, these flexibilities are set to lapse if the emergency declaration expires or is revoked.
In their report, GWU researchers describe three potential approaches that the agencies could take to extend the flexibilities for buprenorphine without legislative action:
- They could issue joint regulations allowing practitioners to prescribe buprenorphine without first conducting an in-person medical evaluation.
The DEA and SAMHSA have the authority to extend the telemedicine flexibilities by issuing joint regulations under a statutory exception in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. This provision gives them broad discretion to advance regulations that allow practitioners to prescribe controlled substances using telemedicine without an in-person evaluation. These regulations, however, would apply only to practitioners with an X-waiver, so SAMHSA would need to issue a companion policy to exempt providers at OTPs from the requirement to conduct an in-person medical evaluation before treating people with OUD with buprenorphine.
- The DEA could establish a special registration for a telemedicine program. SAMHSA would need to issue a companion policy to apply the telemedicine flexibilities to OTPs.
Under another exception included in the Ryan Haight Act, the DEA has the authority to create a registration program for providers to prescribe controlled substances (including buprenorphine) via telemedicine, without first conducting an in-person evaluation. In fact, the SUPPORT for Patients and Communities Act of 2018 directed the DEA to advance regulations to create such a program by October 2019. However, the DEA has not done so. As with the previous approach, this program would not be relevant to OTPs, so SAMHSA would need to issue a companion policy to exempt providers at those programs from the requirement to conduct an in-person medical evaluation before prescribing buprenorphine for OUD.
- The agencies could rely on the separate, opioid-specific public health emergency declaration to offer a longer term—but not permanent—option to extend these flexibilities.
If the COVID-19 public health emergency declaration expires or is revoked, SAMHSA and the DEA could choose to grant flexibilities that match those under the current opioid-specific public health emergency declaration. HHS first declared the opioid crisis a national public health emergency in October 2017 and has renewed that declaration 11 times, most recently in January 2021.
The report shows that the DEA and SAMHSA have the legal authority to broaden treatment access for people with OUD without relying on the COVID-19 public health emergency. Although more research is needed to understand the precise impact of telemedicine on treatment, policymakers should encourage these federal agencies to extend the flexible rules that have the power to save lives.
Beth Connolly is a director and Ian Reynolds is a senior manager for Pew’s substance use prevention and treatment initiative.