Telehealth Industry Pushes DEA on ‘Red Flags’ for Prescriptions

Telehealth industry leaders are putting pressure on the Drug Enforcement Administration to guide pharmacists on how to safely dispense controlled substances without limiting access for the drugs to patients who need them.

In a letter to the DEA released Wednesday, a consortium of online health-care companies, trade groups, and policy organizations urged the agency to provide explicit guidance informing pharmacies that the “geography of a prescriber in relation to the patient or the pharmacy should not be a ‘red flag’ when a prescription is a result of a telehealth visit.”

Currently, pharmacists who notice prescriptions filed by out-of-state telehealth providers have the discretion under the Controlled Substances Act to block treatments they deem too risky to fulfill.

While red flags are not explicitly outlined in statute or regulations, in the aftermath of the widespread over-dispensing that contributed to the opioid crisis, pharmacists have been directed to identify red flags as part of their due diligence to ensure that prescriptions are legitimate, the letter said.

These red flags often include behaviors such as writing significantly more prescriptions than other practitioners in a particular area, returning too frequently for refills, or presenting prescriptions in the name of other people.

“If pharmacists are reticent to fulfill these prescriptions of controlled substances because the provider isn’t physically geographically proximate to the patient, the patient is out in the cold,” Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, said in an interview.

The organizations’ letter comes as they anticipate the first-quarter release of the agency’s controlled substance special registration pathway—a licensure program that would allow vetted providers to prescribe controlled substances without worrying about running afoul of the Controlled Substances Act.

Libby Baney, an attorney at Faegre Drinker who supported drafting of the letter, said the proposed rule will be the perfect opportunity to clear up any ambiguity over what constitutes “proper dispensing” for pharmacists.

“Right now, the red flags tell a pharmacist, ‘Yikes, I’m nervous, and the DEA’s guidance says I should be nervous, and the DEA hasn’t told me how to stop being nervous,’” Baney said.

“The DEA has a unique opportunity in this rulemaking to clarify that we do want you to dispense pursuant to legitimate prescriptions, and legitimate prescriptions can be issued via telemedicine when a doctor is at a distance,” she said.