The Drug Enforcement Administration (DEA) said Friday it will extend telehealth flexibilities that enable clinicians to virtually prescribe controlled medications to their patients through 2024 as it mulls permanent policy changes.
The agency recently held two-day listening sessions to inform the agency's regulations on prescribing controlled substances via telemedicine.
Telehealth leaders and doctors urged the DEA to allow prescribing via virtual care, arguing that mandates that require in-person doctor visits for patients to get prescriptions for controlled drugs, such as Adderall or buprenorphine used to treat opioid use disorder, severely restrict access to care and could increase patient harm.
"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," the DEA said in a statement on its website.
In a notice (PDF) published to the Federal Register, the DEA and the Department of Health and Human Services said they are working to develop regulations "providing access to the practice of telemedicine when consistent with public health and safety, and that also effectively mitigate the risk of possible diversion."
DEA officials also said the agency was limiting the second extension to a "short, time-limited period" to work on more permanent policy changes and avoid incentivizing new telehealth companies to pop up that might "encourage or enable problematic prescribing practices."
During the COVID-19 pandemic public health emergency, the DEA granted flexibilities for prescribing controlled substances remotely and waived a requirement, as mandated by the 2008 Ryan Haight Act, that an in-person visit occur prior to prescribing controlled drugs via telehealth.
In February, the DEA issued proposed rules that pulled back some of those flexibilities and reinstated strict limitations on the virtual prescribing of controlled substances. Under the proposed rule, Schedule 2 medications or narcotics would require (PDF) an in-person prescription. Schedule 3 or higher medications, including buprenorphine, can be prescribed for 30 days via telehealth but would require an in-person visit before a refill.
The Biden administration said at the time that the new rule seeks to provide safeguards to prevent online over-prescribing of controlled medications.
The DEA faced immediate and major backlash from doctors and telehealth groups. Many providers voiced concerns about patients' ability to obtain in-person appointments within 30 days. The DEA received a record 38,000 comments on its proposed telemedicine rules.
The agency then extended telehealth flexibilities for another six months, until Nov. 11.
This second temporary rule extends "the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID–19 PHE, through December 31, 2024. This extension authorizes all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023," DEA officials wrote in the notice.
The American Telemedicine Association (ATA) cheered the news that telehealth flexibilities were extended through 2024.
"We are thrilled that the DEA is taking such a thoughtful and thorough approach to creating the right rules around the prescription of controlled substances. This is a critical issue for millions of individuals and their families, as well as clinicians wanting to provide care to their patients, wherever and whenever they need it,” said Kyle Zebley, ATA senior vice president for public policy and executive director of ATA Action, in a statement.
He added, "What this means is that next year is shaping up to be the Super Bowl for telehealth, with many of the telehealth flexibilities enacted during the public health emergency set to expire at the end of 2024, including the High Deductible Health Plan (HDHP) and Health Savings Account (HSA) telehealth tax provision, geographic and originating sites flexibilities, forestalling implementation of Medicare’s telemental health in-person requirements, Medicare face-to-face telehealth requirements for hospice care and the Acute Hospital Care at Home Program. It is time to quadruple down on our efforts leading into 2024. This is a historic opportunity to make crucial changes to our healthcare system that will appropriately expand access to urgently needed care to some of our most challenged and underserved patient populations. This is not rhetoric, it’s real opportunity that we must not squander.”
The Health Innovation Alliance signaled that it was disappointed that the DEA did not go further to enact permanent rules.
"While this extension will help millions of Americans access much-needed medications, an extension is not a permanent rule. The DEA needs to stop dragging its feet, admit that tele-prescribing is a success, and trust in the medical professionals who are treating patients," the organization said in a statement. "Instead of waiting another year and keeping doctors in limbo, the DEA should act with urgency and make tele-prescribing for controlled substances permanent."
DEA's notice did not indicate whether the agency would set up a "special registration" pathway to enable practitioners to prescribe controlled substances via telemedicine without a prior, in-person medical evaluation, something the DEA was mandated to do 15 year ago.