Doubts surround pending DEA telemedicine rule

Experts are warning that a Drug Enforcement Agency rule expected out in October will leave doctors confused about whether they can use telemedicine to provide medication assisted treatment for opioid disorders.

Last year’s big congressional opioid bill gave the DEA a deadline for guidance that it promised years ago to clarify when physicians can get exemptions from a federal ban on prescribing controlled substances — including medications that treat opioid addiction — without in-person exams.

The 2008 Ryan Haight Act, named for an 18-year-old who overdosed on drugs he was prescribed online, gave DEA its marching orders to create a special registration for doctors.

HHS leadership, eager to promote telemedicine as a solution to the opioid crisis, has published its own suggestions of how clinicians can use the technology.

But until the DEA promulgates its rule, most doctors can’t legally prescribe substances such as buprenorphine to patients unless they’ve seen them in person first. The opioid bill gave the attorney general, in consultation with HHS, a year to clarify when DEA can issue physicians a special registration enabling them to treat for the first time with telemedicine.

A spokesperson confirmed that DEA is working on the rule but declined to share details on its content. The agency’s lack of clarity has raised questions about how specific DEA’s guidance will be, and whether clinicians will feel comfortable prescribing virtually once it’s out, explained Nate Lacktman, chair of Foley & Lardner’s telemedicine team.

For example, DEA hasn’t clarified whether it will restrict registration to certain specialties or limit the type and purpose of drugs that can be prescribed.

Once DEA announces the process for obtaining special registrations, doctors would still need to analyze their own state laws and abide by the more restrictive of the two, Lacktman said.

Patients in states that prohibit telemedicine prescription still won’t have access to these services, he said. Some states are preemptively relaxing their own laws in anticipation of the federal rule, however. Last year Connecticut passed a law allowing doctors to prescribe controlled substances via telemedicine.

Groups including the American Telemedicine Association, the American Psychiatric Association, and the National Rural Health Association have urged DEA to publish a draft before the October deadline for promulgating final rules, leaving time for public comment. The telemedicine association urged DEA not to limit the special registration to certain specialties, and said prescribers should be able to apply for DEA registration in multiple states.

Doctors can’t prepare for the changes until they know how the DEA plans to set up special registration, the association’s CEO Ann Mond Johnson told POLITICO. The Ryan Haight Act cracks down on “pill mills,” she wrote, but “also inadvertently limits the valid and clinically-appropriate prescribing of controlled substances.”

“None of us want to get in trouble,” John Dutton, a doctor and medical director at telemedicine company CirrusMD, told POLITICO. “We want to do the right thing for the patient, but we also want to make sure we can continue to practice medicine.”

Dutton said complying with the upcoming special registration rules — and shoring up technology to meet other rules surrounding electronic prescription — could take physicians several months. CirrusMD is considering offering telemedicine for opioid treatment, but expects significant legal compliance checks.

Some doctors are already virtually prescribing controlled substances for addiction treatment. The Ryan Haight Act makes a few other exemptions — doctors can prescribe to patients they’ve never met if the patient is at a DEA-registered clinic, or as part of the Indian Health Service, for instance.

Eric Weintraub, a Maryland doctor who has been virtually prescribing controlled substances for years at DEA-registered clinics, said the special registration provision could open medication assisted treatment up to more patients.

“We’re missing patients that still need this,” he said. If DEA’s rule clarifies how to prescribe to patients at home, it would enable him to reach people who can’t access clinics.

But home treatment brings challenges, he said. Staff at clinics he works with send him patient records, urine toxicology results and other documents before he prescribes. “If somebody’s in their home, where are they going to get a urine toxicology screening?” Weintraub asked. And in large rural states, “are they even going to have access to a pharmacy?”

Despite lingering questions, Weintraub is drafting a guide for doctors new to telemedicine, including advice about how to safely observe patients taking buprenorphine. (The drug can sometimes be harmful if a patient has other opioids in their system.)

Some addiction specialists are skeptical. Marvin Seppala, chief medical officer at Hazelden Betty Ford, said the treatment center will be cautious in adopting telemedicine-based prescription because their evidence suggests medication assisted treatment is most effective in conjunction with other interventions, such as behavioral therapy.

“If the medicines are made available, then absolutely we’ll use them,” Seppala said, but likely not as a standalone treatment.

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