Drug Enforcement Administration sends second attempt at a telehealth prescribing rule to executive budget office

The Drug Enforcement Administration’s long-awaited second attempt at a telemedicine prescribing rule has been handed off to the Office of Management and Budget (OMB) for review.  

The rule is a major issue for telehealth companies that allow for the prescription of controlled substances, such as Adderall for ADHD, testosterone for transgender men, and buprenorphine for opioid use disorder. There is not yet a separate rule for buprenorphine prescribing like there was last March when the DEA attempted its first set of telehealth prescribing rules. 

The pandemic-era flexibilities for telehealth prescribing will end in December 2024. The administration’s clock is ticking on the release of the rule for there to be enough time for the public to comment, the agency to review the comments, and promulgate a final rule before the end of the year.

Organizations will likely also need a considerable amount of time to comply with the final rule. 

DEA's last version of the telehealth Rx rule was proposed in March 2023. The agency received over 38,000 comments from the public, the overwhelming number of which said the proposal was too restrictive, as it required an in-person visit within 30 days of a controlled substance being prescribed via telehealth. 

The DEA held two days' worth of public listening sessions in September 2023 to discuss a special telemedicine registration system for keeping tabs on providers prescribing controlled substances via telehealth. The special registration system has been required by law since the passage of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Still, the DEA has not followed through on the rulemaking to the consternation of stakeholders. 

There have long been concerns about fraudulent online prescribing if the DEA makes permanent the relaxed, pandemic-era rules for telehealth prescribing of controlled substances. The DOJ yesterday arrested two digital health company executives for alleged fraudulent prescribing of Adderall and other stimulants.

Once the Office of Management and Budget reviews the costs and benefits of the proposed rule, it will be published for public comment in the Federal Register.