DEA said in a Friday announcement that the extra time will allow the agency to continue considering revisions to the February proposed rule, which said prescriptions for Schedule II substances like Vicodin, OxyContin, Adderall and Ritalin would return to requiring an in-person visit before they could be prescribed virtually. Schedule III-V substances like codeine, Xanax and Ambien—as well as buprenorphine, a narcotic used to treat opioid addiction—could only be prescribed over telehealth for an initial 30-day dose. After the 30 days, patients would need to see a doctor once to get a refill.
The agency said it received a record 38,000 comments, many of which criticized the proposed rule.
DEA said it plans to release a final rule by fall 2024, so patients and medical practitioners have time to adapt to the requirements.
In anticipation of a final rule, some telehealth companies have pushed for alternatives to the blanket restrictions outlined in the proposed regulation.
Some have pushed for a registration process specifically for telehealth providers of controlled substances, which would include guardrails such as prescription limits for individual providers and data reporting.
"We are certainly in favor of restrictions," said Robert Krayn, CEO and co-founder of Talkiatry, which was among the companies that wrote a letter to DEA administrator Anne Milgram in September outlining a potential registration process. "But [we ask] that those restrictions would still allow providers to appropriately prescribe controlled substances in a high-quality manner."
Ankit Gupta, founder and CEO of Bicycle Health, a virtual care startup providing opioid use disorder treatments, said the DEA extension will not change business in the short term. He also supports a registry for telehealth companies, along with other possible requirements such as randomized drug testing for patients.
"The DEA has gotten a variety of guidance," Gupta said. "We want to leverage the existing state licensing, credentialing and databases that already exist to allow the DEA to build their special registration on top of [those frameworks]."
On the pharmacy side, many who testified during public listening sessions expressed skepticism about the extended framework.
Kevin Duane, a Jacksonville, Florida-based pharmacy owner, was among them. He supports the increased access telehealth practitioners can provide to patients dealing with mental health and opioid use disorder conditions, but said audio-only appointments can make it difficult to verify a patient and their condition.
He said he was hoping for a shorter timeline on the final rule.
"What we have and what will be extended until the end of next year is basically a continuance of the Wild West," Duane said.