The agency is once again extending a pandemic-era waiver enabling providers to prescribe controlled substances via telemedicine without first needing an in-person checkup, and is expected to propose new long-term guidelines soon.
Federal officials are extending pandemic-era flexibilities for prescribing controlled substances via telemedicine through the end of 2024.
The US Drug Enforcement Administration (DEA) and Health and Human Services Department will publish the extension in the Federal Register next week. The decision comes after two public listening sessions last month and a public comment period on proposed telemedicine rules that garnered more than 38,000 comments, many of them critical.
“We continue to carefully consider the input received and are working to promulgate a final set of telemedicine regulations by the fall of 2024, giving patients and medical practitioners time to plan for, and adapt to, the new rules once issued,” DEA officials said in a post on the agency website.
The news isn’t surprising. The agency has been under fire for not developing a special registration process for telemedicine prescriptions, and rules proposed earlier this year to help providers use telemedicine for prescribing controlled substances were roundly panned by advocates who said they were more restrictive and confusing than what had been in place before the pandemic.
Nathaniel Lacktman, a partner with the Foley & Lardner law firm and chairman of its digital health team, said during a keynote at the Northeast Telehealth Resource Center’s annual conference last month in Nashua, New Hampshire that he expects the DEA to come up with an amended version of long-term telemedicine prescribing rules by the end of the year.
Lacktman was critical of the first DEA proposal when it was released.
"The proposed rules are intended to bridge between the DEA’s current PHE waivers and a post-PHE environment," he wrote in the firm's Health Care Law Today blog last May. "In so doing, DEA proposed creating two new limited options for telemedicine prescribing of controlled substances without a prior in-person exam. The options [are] both complex and more restrictive than what has been allowed for the past three years under the PHE waivers. The DEA’s proposal will discontinue the ability for telemedicine prescribing of controlled substances where the patient never has any in-person exam (with the exception of an initial prescription period of no more than 30 days’ supply). Moreover, if the patient requires a Schedule II medication or a Schedule III-V narcotic medication (with the sole exception of buprenorphine for opioid use disorder (OUD) treatment), an initial in-person exam is required before any prescription can be issued."
The DEA has long resisted creating a registration process even though it was mandated by Congress in 2008 through the Ryan Haight Online Pharmacy Consumer Protection Act. Telehealth advocates have long argued that providers should be able to prescribe certain medications without first needing an in-person exam as a way of expanding access to and treatment for mental health and substance abuse issues. Several members of Congress and the American Hospital Association have also chimed in, urging the DEA to take action.
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.
KEY TAKEAWAYS
The DEA has been under pressure to develop a special registration process to enable providers to use telemedicine to prescribe controlled substances since the practice was strictly regulated through the Ryan Haight Online Pharmacy Consumer Protection Act of 2008.
The agency issued a waiver during the pandemic to enable providers to use telemedicine without first needing to conduct an in-person checkup with a patient, and has now extended that waiver through the end of 2024.
The DEA had proposed long-term guidelines for telemedicine prescriptions, but critics said the rules were too complex and would have been more restrictive. The agency is expected to revise its proposed rules soon.