DEA proposes to reverse prescribing flexibility for controlled substances

Key takeaways

• The proposed rules would require patients to undergo an in-person examination before clinicians can prescribe controlled substances virtually.
• The public will be able to comment on the proposed changes until March 31.

The U.S. Drug Enforcement Administration, or DEA, has proposed permanent changes to rules on the prescribing of controlled substances through telehealth. The new rules would take effect when the COVID-19 public health emergency ends in May.

Before the COVID-19 pandemic, controlled substances could only be prescribed through telehealth if a prior in-person visit had been conducted. That protocol was waived by the DEA in March 2020 to ensure access amid the pandemic.

The proposed rules would again require an in-person examination before controlled substances could be prescribed virtually. In a press release, the DEA said that if an in-person visit is not conducted prior to a telehealth visit, providers may prescribe:

• a maximum 30-day supply of Schedule III to V non-narcotics; and
• a maximum 30-day supply of buprenorphine for opioid use disorder.

Providers may also prescribe controlled substances via telehealth without conducting an in-person visit if the patient was referred by a DEA-licensed provider who previously saw the patient in person.

The DEA said the rules will not apply to telehealth consultations that do not involve controlled substances.

Speaking to Healio, Kyle Zebley, the senior vice president of public policy at the American Telemedicine Association (ATA) and executive director of the organization’s advocacy arm called ATA Action, called the change a “fundamental alteration of how things have existed for the last 3 years.” Patients who were diagnosed with a mental health condition over telehealth would require an in-person visit to receive a prescription for a controlled substance.

“It’s going to significantly impact access to clinically appropriate medications. It’s a giant step backwards. It’s more burdensome than it needs to be, and for some of these patients dealing with psychiatric issues or issues of addiction, substance and opioid use disorder, it is not hyperbole to say it is a question of life or death,” he said.

According to Zebley, the rules will impact clinicians by “severely limiting or severing the relationship they have with those patients in a way that the physician doesn’t want.”

“The clinician wants to continue to be able to deliver this care to patients as has been allowed for the last 3 years, and now at some point in that journey of care with the patient, they’re going to have to have a physical in-person examination,” Zebley said.

This will be particularly challenging for patients who live in geographically remote areas or who live far from a provider who has prescribing authority.

Zebley noted that there had been optimism that most of the telehealth flexibilities would become permanent, allowing clinicians to use their judgement when it comes to care management for their patients.

“While it’s not the worst case, it’s not all that much better than worse case because of the inflexible, in-person requirements that we know some Americans are not prepared to pursue for a variety of purposes,” he said.

The public will be able to comment on the DEA’s proposed changes until March 31. The comments can be submitted here and here.

The rules will go into effect on May 11. However, providers will have a 180-day grace period before being required to comply.

Until the commenting period closes, Zebley said the ATA will continue to have conversations with policymakers and work through regulatory comments “to make sure that we get these rules more workable once they’re finalized.”

References:

• ATA and ATA Action call DEA’s proposed rule on controlled substances overly restrictive, fear consequences in patient care. https://www.americantelemed.org/press-releases/ata-and-ata-action-call-deas-proposed-rule-on-controlled-substances-overly-restrictive-fear-consequences-in-patient-care/. Published Feb. 25, 2023. Accessed March 1, 2023.
• DEA announces proposed rules for permanent telemedicine flexibilities. https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities. Published Feb. 24, 2023. Accessed March 1, 2023.
• Expansion of induction of buprenorphine via telemedicine encounter. https://www.federalregister.gov/documents/2023/03/01/2023-04217/expansion-of-induction-of-buprenorphine-via-telemedicine-encounter. Accessed March 1, 2023.
• Telemedicine prescribing of controlled substances when the practitioner and the patient have not had a prior in-person medical evaluation. https://www.federalregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had. Accessed March 1, 2023.