Doctors, public health experts, and even Democratic members of Congress are sounding the alarm on a new Biden administration proposal to restrict access to a key addiction-treatment medication.
The proposal would curtail access via telehealth to buprenorphine, a common and highly effective drug used to treat opioid use disorder. While doctors can currently give out both new buprenorphine prescriptions and refills after telemedicine visits, the new rule would require an in-person examination for telehealth patients who want to stay on the medication for longer than 30 days.
The Drug Enforcement Administration announced the regulation with little fanfare last week, issuing a press release in which the agency’s administrator, Anne Milgram, said it was aimed “at ensuring the safety of patients.” She added: “DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”
Opponents, however, say that any reduction in buprenorphine access will have the opposite impact. While the medication is highly effective at treating opioid addiction, missing even a single daily dose can trigger debilitating withdrawal symptoms — often leading patients to return to illicit opioid use and risk overdose or death.
“I don’t want federal rules dictating to me when I have to cut somebody off a medication that, on the basis of the information available to me, is still appropriate for the patient,” said Brian Hurley, a public health official in Los Angeles and the president-elect of the American Society of Addiction Medicine.
Beyond causing a potential hit to addiction treatment access, the proposed rule represents a de facto win for the DEA over other agencies that approach addiction and drug use through a public health lens, like the National Institute on Drug Abuse and the Department of Health and Human Services. It comes as part of a broader crackdown on doctors who prescribe controlled substances via telehealth — in particular, opioids used to treat pain and stimulants used to treat ADHD, like Adderall and Ritalin.
It illustrates, also, that there is little agreement about the risks and benefits of highly effective addiction medications that have been used for decades, even within a Democratic administration that has identified addressing the opioid crisis as a top priority.
“This administration has talked about addiction and overdose as the health crisis that it is,” said Geoffrey Laredo, an addiction policy expert who served over a decade as a senior NIDA adviser. “This draft regulation seems to fly in the face of that, and will make it harder for people with a really serious health issue to get the help they need.”
Drug deaths have hovered around an all-time high in recent months. Roughly 107,000 Americans currently die of drug overdoses each year — and over 80,000 of those deaths involve opioids.
Currently, buprenorphine is one of just three drugs approved in the U.S. to treat opioid use disorder — and one of just two that doctors are allowed to prescribe directly to patients. Physicians have been allowed to issue first-time buprenorphine prescriptions via telemedicine for nearly three years, thanks to emergency rules first enacted by the Trump administration during the onset of the Covid-19 pandemic in 2020.
While the White House never explicitly pledged to let patients receive buprenorphine without an in-person evaluation forever, many advocates still saw the move to add back some restrictions as a reversal.
Expanding access to addiction medication has been a pillar of President Biden’s drug policy since he took office in early 2021. Rahul Gupta, the director of the Office of National Drug Control Policy, has urged doctors to prescribe buprenorphine more. During his State of the Union address last month, Biden touted a new law that allows doctors to prescribe buprenorphine without first obtaining a special license. A separate regulation announced earlier this year would permanently extend many of the Covid-era flexibilities for addiction medications, like telehealth prescribing and more flexible rules surrounding methadone.
In statements to STAT, multiple Democratic lawmakers voiced concerns about the proposal — a rare break between the White House and members of Biden’s own party.
Rep. Paul Tonko (D-N.Y.), the author of a new law that eliminated the requirement for doctors to obtain a special license before prescribing buprenorphine, called the move “a step in the wrong direction” that “threatens to shut the doors” on patients seeking treatment.
“Patients have been successfully receiving buprenorphine to treat substance use disorder through remote visits for years,” said Sen. Ed Markey (D-Mass.), another longtime advocate of expanding access to addiction medications. “At a time when 200 people every day are dying because of opioid overdose, we cannot roll back access to effective, evidence-based medications.”
Gupta’s statement on the DEA regulation, notably, made no mention of the requirement that new telehealth patients be evaluated in person within 30 days, and instead celebrated the move as a major step toward preserving improved patient access.
Even as they protested the 30-day limit, some doctors did acknowledge that an in-person follow-up is ideal. But Hurley cautioned that addiction treatment rarely takes place in ideal circumstances — and however well-intentioned, the DEA’s attempt to prevent buprenorphine from reaching the black market would do more harm than good.
“It’s less about what’s ideal in every case, because there are patients where there are all sorts of impracticalities” preventing an in-person visit, he said. “Right now, lack of access to buprenorphine is a bigger threat to public health than the threat of buprenorphine diversion.”
The new proposal is now undergoing a 30-day comment period, after which the DEA will consider public feedback before drafting final regulations. Even if the current draft is finalized, however, buprenorphine will remain dramatically more accessible than it was before the onset of the Covid-19 pandemic. As of early 2020, doctors could not issue new prescriptions via telemedicine — and as recently as late 2022, most prescribers had to participate in hours of additional training and receive a special license called the “X-waiver” before they could use buprenorphine as an addiction treatment.
Those emergency changes represented an unprecedented shift in addiction medicine. And according to recent data, they had few negative consequences. In particular, studies have shown that expanded buprenorphine access did not lead to a higher share of buprenorphine-involved overdoses.
In recent years, some clinics and startups have found success prescribing buprenorphine via an exclusively telehealth model. Now that the emergency policies have been proven to work, experts say, there’s no reason to add back requirements that could threaten patients’ well-being.
“We’ve been doing exclusively telehealth … since the start of the pandemic, and have been able to reach patients who previously had no access to this medication,” said Ximena Levander, an addiction doctor and professor of medicine at Oregon Health & Science University, referencing a new OHSU clinic that has prescribed buprenorphine exclusively via telehealth since the onset of Covid-19.
She added: “So at the height of a worsening opioid overdose crisis, to now say patients need to come in person — I don’t think federal regulators really understand what’s happening on the ground in asking that of patients and providers.”
Levander and Hurley, the ASAM president-elect, singled out numerous categories of patients as particularly vulnerable to the new limitations, including those who are experiencing homelessness, live in rural areas, have disabilities that limit their mobility, or those who’ve been recently admitted to long-term care facilities and are largely confined to their beds. Even patients who simply can’t take time off work for an in-person appointment, Levander said, are at risk of losing access.
The new regulation would only apply moving forward, meaning that while new patients would require an in-person examination to keep taking buprenorphine, existing patients can continue refilling the medication via telehealth appointments.
Beyond fearing the proposal’s impact, experts have also questioned the rationale. New studies show that the share of opioid overdoses caused by buprenorphine did not rise even in the wake of increased telehealth access.
Broadly speaking, doctors argue, the medication has an excellent safety profile. Buprenorphine has a “ceiling effect,” meaning that after a certain point, larger doses don’t necessarily have a greater effect.
Moreover, nearly all overdoses that did involve buprenorphine involved other drugs as well, like other opioids, alcohol, or benzodiazepines, a class of anxiety medication. In all, fewer than 1 in 600 opioid overdose deaths were caused by buprenorphine alone.
“The risk of overdosing on buprenorphine is exceedingly low,” Levander said. “There’s been no indication in the last three years during the Covid pandemic that people are overdosing or dying from telemedicine prescribing of buprenorphine. There’s been no evidence of that.”