DEA Urged to Mitigate Geographic ‘Red Flag’ in Telehealth Prescriptions

A group of virtual care stakeholders has sent a letter to the United States Drug Enforcement Administration (DEA) urging the agency to provide guidance to the pharmacy community, warning against considering geography a “red flag” when prescriptions are provided during telehealth visits.

The American Telemedicine Association (ATA), its advocacy arm ATA Action, along with virtual care companies Bicycle Health, Circle Medical, DoseSpot, Ophelia, and WorkIt Health, sent the letter on February 12. The companies all offer e-prescriptions for behavioral health and substance abuse disorders.

The letter states that while there are several actions the DEA needs to take to mitigate challenges to prescribing controlled substances virtually, there is one action the agency can take that would have an immediate impact.

According to the ATA and virtual care companies, conversations with the pharmacy community and their experience as prescribers have revealed that many pharmacies and pharmacists currently consider geography, that is, the location of the prescriber in relation to the patient or the pharmacy, as a “red flag” when filling virtual prescriptions.

Thus, they are asking the DEA to provide explicit guidance to the pharmacy community that geography should not be considered a “red flag” when the prescription is written during a telehealth visit.

The letter notes that these “red flags” are not defined in statutes, regulations, or other official guidance. However, amid concerns around overprescribing and over-dispensing of controlled substances fueling the opioid epidemic, pharmacists have been directed to consider geography as a part of their due diligence to ensure that prescriptions are legitimate.

“Pharmacists need clearer green lights from the DEA to appropriately dispense critical medications to patients, not continued ‘red flags,’” the letter states.  

Though the letter urges the DEA to clarify pharmacists’ responsibilities in filling telehealth prescriptions of controlled substances, the letter also notes that the agency should not add burdensome recordkeeping, reporting, or data requirements to overload pharmacies and pharmacists.

“Telehealth providers and pharmacists need more clarity – not complexity – from DEA,” the letter states.

The letter comes as the DEA wrestles with the regulations governing virtual prescriptions of controlled substances.

In February 2023, the agency announced plans to permanently extend some pandemic-era telehealth rules, including allowing remote prescriptions of 30-day supplies of Schedule III-V non-narcotic controlled medications and buprenorphine without a prior in-person examination.

However, it stated that it would not permanently extend the same flexibility to virtual prescriptions of Schedule II controlled substances, like Adderall, Oxycodone, Vicodin, and Ritalin.

The healthcare industry pushed back, offering 38,000 comments on its proposed rule. The DEA agreed to extend the virtual prescribing flexibilities through November 2023 and conduct listening sessions in September. During the sessions, virtual care stakeholders urged the DEA to permanently allow the virtual prescription of controlled substances without requiring an in-person exam beforehand.

"The ability for these providers to prescribe controlled substances and use their medical judgment over telemedicine without a prior in-person visit allows patients to receive clinically appropriate essential care via a convenient patient-centered modality," said Helen Hughes, MD, medical director of the Office of Telemedicine at Johns Hopkins Medicine, during the sessions.

Following the listening sessions, the DEA announced that it would lift proposed restrictions on the virtual prescription of controlled substances through the end of 2024.

The ATA has also submitted recommendations to the DEA on creating a special registration process for the virtual prescribing of controlled substances. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 called for the creation of a special registration process that would allow healthcare providers to use telehealth to prescribe controlled substances without a prior in-person examination.

The ATA’s recommendations include tenets such as telehealth providers not being required to maintain local addresses in every state where they practice and special registration not being limited to any specific specialty or treatment condition.