Virtual prescribing of controlled substances is in limbo as PHE winds down

The coming end of the COVID-19 public health emergency and pandemic-era telehealth flexibilities could rattle an already besieged behavioral health system and force providers to make ethical decisions. 

The public health emergency, which President Biden will end May 11, allowed clinicians to prescribe controlled substance medications via telehealth without an office visit. The 2008 Ryan Haight Act, which temporarily waived the office visit requirement, allowed providers to treat a larger population of behavioral health patients more efficiently because they could prescribe and see patients remotely. 

Unlike other pandemic-era telehealth flexibilities, the rules around the prescription of controlled substances are still tied to the May 11 date.

Related: What the end of the federal COVID-19 emergency means for healthcare

“We estimate that we will not be able to see new patients for six to nine months as we catch up with having to see patients who we've never seen face to face,” said Dr. Joel Young, medical director of the Rochester Center for Behavioral Medicine in Rochester, Michigan. “This is going to be devastating and the cost will be significant, particularly for adolescent mental health.”

Young said his outpatient behavioral clinic was able to expand its patient base beyond Rochester into more rural areas because of telehealth. The technology and relaxed rules also allowed clinicians to work more flexible hours without the need to see someone in person, which will go away without those flexibilities.

“I feel like we’re going to lose 20% of our workforce who can’t go into an office,” Young said. “Whatever progress we’ve made moving into underserved areas will be reversed overnight.”

The end of the flexibilities will affect patients beyond behavioral health, said Jeremy Sherer, digital health co-chair at law firm Hooper, Lundy & Bookman, who represents providers and telehealth companies. He said it would also affect people undergoing obesity and hormonal treatments, as well as those getting treated for opioid use disorder. 

“It’s going to leave a lot of folks in limbo,” Sherer said. “This has become quite widespread.”

The Drug Enforcement Agency could help providers by issuing a rule outlining how they can register to waive the in-person requirement. The agency is required to release the registration process as a provision of the Ryan Haight Act. The DEA’s requirement to make the process available was later reinforced in the SUPPORT Act of 2018.

But the DEA's proposal has been stuck in regulatory review since March 2022, according to the Office of Management and Budget. A DEA spokesperson said the agency is working on proposed regulations to address the issues.

“This is the moment for the DEA to show that they can complete this next step,” said Libby Baney, a partner in health IT law at Faegre Drinker Biddle & Reath. “We have a hard deadline.”

Various industry groups, including the American Hospital Association and American Telemedicine Association, have called on the DEA to release the proposed rules as soon as possible and map out an interim plan for the period between the expiration of the public health emergency and implementation of the telemedicine registration process.

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Baney said she’s advising provider clients to start making backup plans immediately.

“You don’t want to cut people off from these medications cold turkey,” Baney said. “You might have to start weaning them off sooner than later [if you can’t see them in person]. You can’t just say on May 10, ‘Sorry I didn’t think about it.’”

The DEA could also lightly enforce the in-person requirement, Sherer said, which would make prescribers less likely to get in trouble for prescribing controlled substances virtually without seeing the patient in person. There is also the possibility that the agency could vary its rulings on different classes of controlled substances, experts said. Class II substances like oxycodone, which have a higher likelihood of getting abused, could still require an in-person visit while Class III drugs may be available for virtual flexibilities. 

Meanwhile, telehealth and traditional providers affected by the measure are figuring out their contingency plans.

Ophelia Health treats opioid use disorder virtually and its clinicians prescribe buprenorphine without ever seeing patients in person. Zack Gray, CEO and co-founder, said the company believes the government will make the waiver permanent beyond the public health emergency for buprenorphine, which is a Class III substance used for opioid use disorder. It could also tie the waiver to the open-ended opioid public health emergency rather than the COVID one that expires in May, Gray said. 

“We are taking the approach that any contingency plan is unlikely to be necessary based on guidance that we're getting from the government,” Gray said.

The company has an office in Philadelphia that Ophelia can use in-person visits, Gray said. It also can work with affiliated licensed clinicians to assess patients in person before handing the patients off to the company for virtual care.

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Bicycle Health, a virtual care startup providing opioid use disorder treatments, was founded in 2017 with a single clinic in Redwood City, California.  After COVID, the company went exclusively virtual. While  founder and CEO Ankit Gupta said he is optimistic the waivers will be granted, they’ve had internal discussions about how to shift delivery of care in the event of a stringent enforcement decision. 

“It obviously increases risk [for providers],” Gupta said. “Every provider with a DEA license that is hired by Bicycle Health and any other company has to make that decision for themselves.”

Gupta said he expects some providers will stop prescribing the medications. Last year, the company sent providers to self-created pop-up clinics to satisfy in-person visit requirements in Alabama.

“I can’t give you a firm plan now but it will essentially be a scaled-up version of what we did in Alabama,” Gupta said. “It will probably significantly decrease the number of patients we can serve.”

Virtual providers operating in adjacent spaces to addiction treatment have similar worries.

Talkiatry, a virtual mental healthcare company, employs more than 400 psychiatrists and 60 therapists serving patients in 48 states and the District of Columbia. CEO Robert Krayn said individuals living in rural areas without mental health professionals would be the most acutely affected by the end of this flexibility.

“There are certain medications that we're not going to be able to prescribe, even if it's the best medication for the patient,” Karyn said. “That's really unfortunate because there's nobody else who can prescribe it to them because there's no psychiatrist [where] most of these people live.”

Krayn said Talkiatry was able to expand access “significantly faster” without the burdens and costs associated with in-person clinics. He said the company has no capacity to see patients in-person.

“We do not have any infrastructure to be able to continue to see these patients,” Krayn said. “89% of our patients don’t live in the same city as their doctor.”

Krayn said approximately 18% or about 10,000 of Talkiatry’s total patients are prescribed medication that would require an in-person visit.

“It's almost like doctors are going to be forced to make an ethical decision or a legal decision,” Krayn said.

This story first appeared in Digital Health Business & Technology.