Telehealth Industry Pushes Back on DEA Prescribing Proposal

Telemedicine advocates are urging the Biden administration to reel in plans to reintroduce pre-pandemic restrictions on prescribing of controlled substances via telehealth.

In response to a proposed rule released in late February by the Drug Enforcement Administration, telemedicine companies and health-care providers say the reintroduction of an in-person visitation requirement would be onerous to providers and could limit access to medically necessary care for patients who rely on online providers for long term-treatments.

Their concerns come as telehealth use has exploded during the Covid-19 pandemic and, along with it, worries about potential abuses, including overprescribing of controlled substances and their diversion for unintended purposes.

The Trump administration temporarily relaxed numerous limits on telemedicine services during the Covid-19 public health emergency. The PHE provided telemedicine businesses and providers with a number of novel flexibilities, including the ability to bill Medicare regardless of where the patients or providers are located, the ability to conduct audio-only visits, and the removal of the need for in-person examinations when distributing controlled substances.

The PHE is scheduled to end May 11, and while Congress has extended some flexibilities, other pre-pandemic restrictions on telehealth are back on the table.

The DEA’s proposed rule would reinstate telehealth restrictions under the Ryan Haight Act, which forbids providers from prescribing controlled substances such as amphetamine, testosterone, or oxycodone without an in-person evaluation.

Although the PHE has allowed for a relaxation on regulations regarding how controlled substances could be dispensed online, DEA Administrator Anne Milgram said she believes the proposed rule will be instrumental in ensuring patient safety before profits as the telehealth industry continues to grow.

“DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm,” Milgram said in a statement when the proposed rule was unveiled.

Under this rule, providers would be limited to dispensing a 30-day supply of controlled substances—with an exception made for the opioid addiction drug buprenorphine and non-narcotic schedule III, IV, and V drugs like Ambien, Valium, or Xanax. All providers would be required to be DEA registered and keep detailed records of all prescriptions dispensed via telemedicine.

Any patients looking to get refills beyond a 30-day supply would need to visit a doctor in person.

The rule has drawn more than 30,000 comments from telemedicine industry advocates, critics, and stakeholders on Regulations.gov.

Risk of Alienating Patients

Audrey Davis, a health-care compliance attorney at Epstein Baker Green, pointed to health-care providers’ concerns at a recent American Health Law Association webinar.

“For three years now, providers have been able to remotely prescribe controlled substances without the in-person exam requirement,” Davis said. “Providers have also been able to do this across state lines without having to obtain a separate DEA registration in each state.

“It’s going to be really difficult to go back to the way things were.”

The American Telemedicine Association believes the proposed rule would have the unintended consequence of alienating mental health patients.

In its comment letter, the group explained that “patients with mental health conditions have historically been reticent to seek treatment due to stigma both from health care providers and from their friends, family, and communities,” and that implementing an in-person requirement would only serve to “decrease the likelihood that [a] patient will follow through on care.”

Katherine McGuire, chief advocacy officer of the American Psychological Association, said ambiguous language in the proposed rule could create roadblocks for licensed psychologists. Licensed psychologists accounted for 31% of telehealth visits in 2021.

“Without further clarification, the American Psychological Association is concerned that the broad description of [an] evaluation as ‘medical’ could be conflated with the term ‘physician’ and exclude those with doctoral-level psychology degrees with additional training in psychopharmacology,” McGuire said in an email.

“If this becomes the case, prescribing psychologists would always be in the position of referring patients—even those with whom they have a previously established relationship—to another DEA-registered practitioner, even though patients are connected to psychologists in a variety of ways that may not be through a physician or other medical professional,” she said.

Issues With Online Prescribing

The proposed reintroduction of telemedicine restrictions follows a number of high-profile incidents involving online telemedicine services. In 2022, San Francisco-based behavioral health company Cerebral made headlines after a lawsuit from a former executive asserted the company had fired him after he complained about unethical practices, including alleged plans to prescribe stimulants to 100% of ADHD patients as part of a retention strategy.

In the recent public comment period, some health-care providers have voiced concerns.

Mathew Dietz, director of virtual care, filing on behalf of Marek Hirsch, chief of emergency psychiatry at Baptist Behavioral Health, said “the PHE’s suspension of rules in place by the Ryan Haight Act created the opportunity for the emergence of Virtual Pill Mills” and that “exclusively online telehealth companies have massively expanded the number of prescriptions for benzodiazepines and stimulants under the guise of ‘patient care.’”

But the idea that online telemedicine services have resulted in dangers for patients has been challenged by some of telehealth’s biggest players. Groups like the American Psychological Association, the American Telemedicine Association, and the Association of American Medical Colleges have asked the DEA to walk back telehealth restrictions stemming from fears of widespread abuses.

Striking the Right Balance

In a public letter to the DEA, the Association of American Medical Colleges said that although it recognizes the DEA’s responsibility to safeguard the public from inappropriate and excessive prescribing, it does not believe the proposed rules strike the right balance between this objective and the acute need for patients to access effective care.

Implementing in-person requirements for telehealth would affect a vast number of mental health patients who live in areas without adequate access to behavioral health-care providers, the group said.

“Requirements for in-person visits to receive controlled substances will particularly have an impact on individuals who reside in rural areas, those with transportation barriers, and those suffering from mental health and addiction issues,” the letter said.

Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, is cautiously optimistic the DEA may change course and adjust its proposal before the PHE ends.

Zebley said in an interview he hopes “the DEA will reassess and alter the rules in a way that we believe would improve the rules such as removing the in-person requirement or at least offering up some more flexibilities in this case.”