WASHINGTON — The Biden administration Wednesday finalized a long-awaited rule laying out how some health care providers can prescribe gold-standard opioid use disorder treatments through telehealth.

The final rule from the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration within the Department of Health and Human Services allows providers who have not had an in-person visit with a patient to prescribe six months’ worth of buprenorphine through telehealth, including through audio-only visits.

Afterward, to continue prescribing buprenorphine through telehealth, providers can conduct an in-person medical evaluation or continue treating the patient “via another form of telemedicine.”

The final changes means a patient “will not necessarily need to be seen in-person by the prescribing practitioner at any point.”

The federal government initially eased restrictions on prescribing controlled substances via telemedicine during the COVID-19 pandemic, and telehealth has since boomed in popularity.

Advocates have said the flexibilities, which allowed providers to prescribe buprenorphine to patients they haven’t seen in person, were necessary to expand access to drugs that treat opioid use disorder.

The DEA began rule-making in March 2023, ahead of the end of the public health emergency, to find a path forward after the pandemic.

When the public health emergency ended in May 2023, the DEA temporarily extended those flexibilities. The agency most recently extended the flexibility for the third time in November, with them now set to expire Dec. 31, 2025.

The final rule charts a path forward to allow providers to prescribe buprenorphine to patients they haven’t seen in person.

A previous version of the rule proposed limiting telehealth prescriptions for buprenorphine to a 30-day supply until the patient could be seen in person by a physician. That proposed rule sparked backlash from health care providers, patient advocacy groups and telehealth advocates who have argued telehealth has expanded access to treatment for people who may not have a provider they can see in person.

“A review of the comments persuaded DEA and HHS that the requirements … would be overly burdensome for the majority of patients,” the final rule stated.

The rule notes that these new prescription limits would not apply to existing provider-patient relationships where the provider has already conducted an in-person patient exam.

Still, the rule issues new requirements the DEA said are necessary to prevent diversion of buprenorphine, including that providers review the state’s database of controlled substances prescriptions to ensure patients hadn’t already received the drug from another doctor.

Pharmacists would also be required to verify the identity of the patient before filling the prescription.

Wednesday’s final rule will provide a permanent solution to the temporary extensions, and is set to take effect 30 days after it is published in the Federal Register.

The DEA and SAMHSA also issued a separate final rule Wednesday that would extend these flexibilities to Department of Veterans Affairs providers and a proposed rule to create a “special registration” process for providers to be able to prescribe controlled substances, such as stimulants used to treat attention-deficit/hyperactivity disorder through telehealth to patients they haven’t seen in person.

Congress first directed the DEA to create the special registration program in 2008. That law prevented providers from prescribing controlled substances through telehealth unless they received such a special registration. But the DEA did not implement that part of the law, preventing providers from prescribing controlled substances through telehealth until such restrictions were waived during the COVID-19 pandemic.

Providers must prove they need special registrations to prescribed controlled substances, like evidence that patients live in remote or distance areas, are “vulnerable,” have a communicable disease or other conditions.

Special registrations for providers who want to prescribe Schedule II drugs, which include stimulants, in addition to schedules III and V drugs, would only be intended for specialists like psychiatrists, pediatricians or neurologists.

The proposed rule would also allow for registration for telehealth platforms.

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