Dive Brief:
The Drug Enforcement Administration and the HHS extended flexibilities allowing providers to prescribe controlled substances via telehealth for the fourth time last Tuesday, about a day before the policies were set to expire.
The extension lets clinicians prescribe Schedule II to Schedule V drugs, like Adderall or Xanax, without first conducting an in-person evaluation through the end of 2026.
The rule gives the DEA and HHS more time to hash out permanent regulations, the agencies said. A proposal that would create a process for virtual controlled substance prescribing inked nearly a year ago under the Biden administration was panned by industry groups and has yet to be finalized.
Dive Insight:
During the COVID-19 pandemic, regulators relaxed rules that typically prevented providers from prescribing controlled substances through telehealth without an in-person visit, in an attempt to preserve access to care during the public health emergency.
Those flexibilities have since been extended multiple times, including at the end of 2024 to preserve the policies through the following year.
Regulators say they’re attempting to balance protecting patient access to critical medications while preventing drugs from being distributed illegally and ending up on the illicit drug market.
The potential harm from allowing the flexibilities to expire was significant, regulators said. More than 7 million controlled substance prescriptions, or about 16%, were issued via telehealth without an in-person visit in 2024, according to data cited by the DEA and HHS in the regulation.
Plus, the agencies noted a sudden drop-off in telehealth visits after Medicare telehealth flexibilities expired for weeks amid the historically long government shutdown last year.
“Telehealth prescribing flexibilities have become a lifeline for millions of Americans,” HHS Deputy Secretary Jim O’Neill said in a Friday statement. “Extending them ensures continuity of care while we finish the work of putting permanent, commonsense policies in place.”
Regulators have moved forward on some controlled substance policies. At the end of the year, two finalized rules went into effect that governed telehealth prescriptions of opioid use disorder medication buprenorphine as well as virtual controlled substance prescriptions at the Department of Veterans Affairs.
A proposed regulation released at the tail-end of then-President Joe Biden’s term that would have created a special registration process for clinicians and telehealth firms still hasn’t been finalized. Telehealth and provider groups argued the regulation would have been too onerous, potentially preventing patients from receiving needed medications.
Still, stakeholders have urged the Trump administration to put a plan in place for telehealth prescriptions of controlled substances for months.
The latest extension, which was released on Dec. 30, was cheered by telehealth groups, but the “critical federal action came down to the wire,” Alexis Apple, vice president of federal affairs at the American Telemedicine Association, said in a statement last week.
“We applaud DEA for acting to continue access to care for the millions of patients who depend on telehealth for essential medications,” Chris Adamec, executive director of the Alliance for Connected Care, said in a statement. “However, this should be the last time these Americans come within days of losing access to treatments they need.”
