Experts Express ‘Grave Concerns’ Over DEA’s Proposed Telemedicine Rule

After the Biden administration announced they were planning to end the public health emergency in May, the Drug Enforcement Administration (DEA) released a proposed rule for the prescribing of controlled substances with the use of telemedicine, making some pandemic-era telehealth flexibilities permanent, while also establishing certain guardrails.

However, some medical organizations and stakeholders concerned about disruptions in access to critically needed medications argue that the new rule could do more harm than good.

Pandemic Flexibilities

Early in the pandemic, the Trump administration waived the in-person requirement for the prescription of controlled substances, which was passed by Congress in 2008, explained Kyle Zebley, senior vice president of public policy for the American Telemedicine Association.

“The idea was, let’s make sure people have every tool at their disposal, within reason, to stay at home and have ease of access to the healthcare system,” he told MedPage Today.

As a result of these flexibilities, huge numbers of patients benefited from clinically appropriate care, ranging from mental health services and substance use disorder treatment, to gender-affirming care through testosterone replacement therapy, Zebley said.

The draft rule specifically calls for patients who are being treated for opioid use disorder to have an in-person visit within 30 days of receiving an initial buprenorphine (Suboxone) prescription in order to obtain refills.

With this new rule, his organization is most concerned about what it views as “mandatory, inflexible clinically unnecessary in-person requirements,” he said. “We are opposed, across the board, in every circumstance … either at the federal level or state level. They’re not clinically necessary and what they are, are barriers to care that will limit the full potential of telehealth.”

“This could be truly life or death emergencies for folks who will have their continuity of care interrupted,” he added.

Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine (ASAM), has called for the DEA to eliminate this in-person requirement.

“As a clinician myself, there are many instances where I might start somebody on buprenorphine through a telehealth encounter and then require that they come into my office to provide a urine toxicology sample or so that I can do an in- person examination,” Hurley told MedPage Today during an interview in which a press representative was present.

“The decision of when to bring the patient in for in-person care really is a clinical decision that should be made by the clinician, not a regulatory decision that would make it, essentially, a de facto federal crime to continue buprenorphine, even when it’s clinically appropriate, if that happens to be more than 30 days” after a prescription was issued, he said.

There are also many instances in which bringing a patient into the office isn’t practical; for example, when the time and effort it can take for patients who have mobility issues or who may be homeless isn’t feasible and serves as a barrier to care, he added. “That’s also true for people in rural areas where the closest clinic might be hours of travel away.”

“We’re in the biggest overdose crisis in American history,” and less than 20% of people with opioid use disorder have access to medication to treat their disorder, Hurley noted. “So, from our perspective, inappropriate regulation restricting prescribing buprenorphine is a bigger threat to the health and safety of the American public than continuing buprenorphine after 30 days without an in-person visit.”

In a March 27 letter to DEA Administrator Anne Milgram, the ASAM asked the agency to consider whether certain “record-keeping proposals” are really in the interest of public health and whether there may be “less complex mechanisms” that would not require providers to change their workflows.

‘Grave Concerns’

In a March 31 letter to Milgram, James Madara, MD, CEO and executive vice president of the American Medical Association, thanked the agency for continuing to allow “buprenorphine induction based on telemedicine encounters” even after the public health emergency ends.

However, like other stakeholders, Madara expressed concern about the 30-day requirement and urged the DEA to extend that window to at least 6 months.

“We have grave concerns that requirements for an in-person visit within 30 days would cause many patients who were started on buprenorphine to have their prescriptions lapse, leading to more overdose deaths instead of closing the treatment gap,” he wrote.

He also cited a 2021 study from the Journal of Substance Use and Addiction Treatment, which found that the average wait time for an in-person visit for a patient with opioid use disorder in upstate New York was 12 weeks.

Zebley highlighted another population that would be affected by the proposed rule: those seeking testosterone therapy for the purpose of gender-affirming care.

“These are obviously underserved, left-behind … very vulnerable communities, and they might not be able to replicate the care they’re receiving now virtually in various parts of the country — both because of provider shortages and other issues,” he said.

“Hopefully, the president, who has said explicitly and implicitly that he is friends and allies and wants to support these communities, will use his executive authority to influence as best as he’s able, within the law, obviously, the DEA to get these rules right, because they’re not final. They’re drafts,” Zebley added.

The DEA has until May 11 — the end of the public health emergency — to finalize the rules.