Dive Brief:
The Drug Enforcement Administration released a long-awaited regulation on Wednesday that would create a process for prescribing controlled substances via telehealth, just days before President Joe Biden’s term ends.
The proposed rule would create special registrations authorizing providers and telehealth companies to prescribe Schedule II to V drugs, like Adderall or Xanax, without first conducting an in-person evaluation. The agency also finalized a regulation that allows registered practitioners to virtually dispense buprenorphine, a medication for opioid use disorder.
Although telehealth proponents have urged regulators to enshrine pandemic-era virtual prescribing flexibilities, some industry groups said the proposed rule included restrictions that were too onerous for providers. “We implore President Trump to make it his urgent priority to withdraw this proposal immediately following his inauguration on January 20,” Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, said in a statement.
Dive Insight:
Before the COVID-19 pandemic, clinicians typically couldn’t prescribe controlled substances without an in-person visit. But those rules were relaxed in an attempt to preserve access to care during the public health emergency.
The temporary flexibilities have been extended multiple times, most recently through a November rulemaking that preserved the changes through the end of 2025. Before the extension, telehealth groups and some lawmakers were worried regulators could miss a year-end deadline to continue the flexibilities or promulgate more restrictive prescribing rules.
Now, the DEA has released a potential permanent framework for managing telehealth prescriptions for a range of controlled medications.
The proposal would create multiple special registrations for providers offering controlled substance prescriptions over telehealth: one allows clinicians to prescribe Schedule III to V controlled substances, while a second would authorize specialized providers, like psychiatrists and hospice care physicians, to dispense Schedule II to V medications. A third process allows online telehealth platforms to prescribe Schedule II to V controlled substances.
Providers would also have to maintain a state telemedicine registration for each state they practice in, according to the proposal.
The rule includes some prescribing restrictions too. Clinicians would eventually have to check prescribing drug monitoring databases in all 50 states before issuing a prescription, though that provision wouldn’t go into effect for three years.
Additionally, providers could only dispense Schedule II medications, like Adderall or OxyContin, to patients located in the same state. The proposal would also require clinicians’ telehealth Schedule II prescriptions to make up on average less than 50% of their total Schedule II prescriptions each month.
Overall, the DEA said the rule aims to protect access to care while preventing drugs from being dispensed improperly. Some telehealth companies have faced fines or legal action for allegedly attempting to boost prescriptions or prescribe the drugs even if patients don’t qualify.
But telehealth groups say say the proposed rule isn’t entirely feasible, and the restrictions could limit access. The ATA said the regulation would be a “major setback” for virtual care if finalized.
The Alliance for Connected Care, an industry group, said it was pleased the DEA proposed a special registration process, but raised concerns about geographic restrictions and others that outline what proportion of prescriptions could be delivered virtually.
“Restricting access to telemedicine will lead to harsh consequences for many Americans relying on telehealth for mental health, substance use disorder, sleep disorders, terminal illness, and many other medical issues,” the group said in a statement.
The proposal wasn’t the only telehealth prescribing regulation released by the DEA on Wednesday. The agency also finalized a rule that allows registered providers to dispense an initial six-month supply of buprenorphine via telehealth, which the agency argues will prevent lapses in care for patients seeking treatment for opioid use disorder.
The regulation goes into effect 30 days after the rule is published in the federal register on Friday.
