WASHINGTON — A federal proposal to impose new restrictions on a key addiction-treatment medication has caused an uproar in certain segments of the medical community. But health secretary Xavier Becerra seems to be on board.
The new Drug Enforcement Administration proposal would require that patients receive an in-person examination before obtaining refills of buprenorphine, a key drug used to treat opioid use disorder. When a public emergency was declared in response to Covid-19, patients were allowed to obtain buprenorphine via telemedicine or via an in-person visit.
In the wake of the DEA’s proposal, leading addiction doctors have warned that limiting access to the drug could make the opioid crisis even worse. Becerra, however, said the new proposal strikes an appropriate balance between safety and access.
“We’ve been able to have a good partnership with DEA to get to a place where they feel like they’re still going to be protecting the public from the spread of drugs, and we feel we’re going to be able to protect those who are trying to get the medication they might need,” Becerra said on Tuesday, speaking at a STAT event.
While the new proposal would still allow doctors to prescribe buprenorphine via telemedicine, it would require new patients to show up for an in-person examination within 30 days if they want to stay on the drug. Existing patients who were initiated via telemedicine would have a 180-day grace period before they, too, are subject to the requirement.
The proposal has garnered intense pushback from the addiction medicine community and even Democratic members of Congress. With over 80,000 Americans dying each year from opioid overdoses, they warn, any new limitation on addiction treatment access could have dire consequences.
Detractors include the American Society of Addiction Medicine, Sen. Ed Markey (D-Mass.), and Rep. Paul Tonko (D-N.Y.).
“At a time when 200 people every day are dying because of opioid overdose, we cannot roll back access to effective, evidence-based medications,” Markey told STAT in a statement last week.
In a statement accompanying the proposal, Anne Milgram, the DEA administrator, said the agency was committed to “ensuring the safety of patients,” adding that the DEA is “committed to the expansion of telemedicine with guardrails that prevent online overprescribing of controlled medications that can cause harm.”
While buprenorphine is itself an opioid, it is widely viewed as safe — both in general and especially in comparison to the drugs that people seeking addiction treatment might otherwise be using, like heroin or fentanyl.
Recent studies have shown that the dramatic increase in buprenorphine access since the onset of the Covid-19 pandemic did not result in a higher share of opioid overdoses involving buprenorphine. Roughly 2% of opioid overdoses involved buprenorphine, according to recent data, and virtually all overdoses that involved buprenorphine also involved other drugs. Overall, fewer than 1 in 600 opioid overdoses is attributable to buprenorphine alone.
Becerra, notably, took care to point out that the DEA proposal is “open for public comment” — in other words, that the new regulation could still change before it is finalized.
He also hinted at the long-simmering tension between DEA, a law enforcement agency, and the numerous public health agencies that focus on drug use and addiction treatment, including HHS.
“DEA’s mandate is very different from ours,” Becerra said. “They have to worry about protecting the public from the spread of drugs. I want to keep people alive. I want people to get off of those drugs. I want to help them. I don’t want there to be stigma.”
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