Earlier this month, the Drug Enforcement Agency (DEA) and the Department Health and Human Services (HHS) published a temporary rule that further extended COVID-era telemedicine flexibilities for prescribing controlled substances through December 2024. This is the second follow-up action to a proposed rule, issued jointly by the agencies in March 2023. Had that initial proposed rule been promulgated, it would have created more stringent requirements for prescribers starting patients on buprenorphine via telehealth.
Buprenorphine, a Schedule III controlled substance, is one of three drugs approved by the FDA for treatment for opioid use disorder (OUD). Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act), a provider may only prescribe controlled substances to a patient after conducting an in-person evaluation. This requirement was temporarily lifted during the COVID-19 pandemic, but with the end of the Public Health Emergency in May 2023, this flexibility was set to expire. As discussed in Health Policy News’ March edition, the rule proposed in March would have required providers to conduct an in-person evaluation of the patient who has started buprenorphine via telehealth within 30 days in order to prescribe additional medication.
In response to the nearly 40,000 comments received during the comment period for the proposed rule, DEA and HHS issued a temporary rule in May that extended COVID-era telemedicine prescribing flexibilities through November 2023. The agencies also hosted two Telemedicine Listening Sessions on September 12th and 13th of this year, during which attendees and presenters voiced general support for permanent adoption of the COVID-era telemedicine prescribing flexibilities. Also on September 13th, several U.S. senators sent a letter to the DEA reminding the agency of its obligation under the SUPPORT for Patients and Communities Act (SUPPORT Act) to create a special registration for telemedicine, which exempts telemedicine providers from the mandatory in-person evaluation requirements, and which the senators did not feel had been honored in the DEA’s original proposed rule.
For now, DEA-registered prescribers may continue prescribing buprenorphine via telemedicine even in the absence of an in-person examination. In the temporary rule, the agencies indicate that they have extended these telemedicine flexibilities through the end of the 2024 in order to:
- Ensure continuity of, and continued access to, care for individuals benefitting from telemedicine-delivered treatment, and access to buprenorphine in particular for individuals with OUD;
- Give providers and patients ample time to prepare for issuance of final regulations governing prescribing controlled substances via telemedicine; and
- Allow DEA and HHS time to consider the public comments received in response to the proposed rule and the information shared during the listening sessions.
The agencies will also use the additional time to consider all of the regulatory options before they issue final rules, which will aim to “most effectively expand access to telemedicine encounters in a manner that is consistent with public health and safety, while also effectively mitigating against the risk of possible diversion.”
DEA and HHS plan to open another public comment period this fall prior to any final rulemaking, and stakeholders should stay tuned for further rulemaking announcements. Health Policy News will continue to follow and provide coverage of this rule as it develops and is finalized.