The Drug Enforcement Administration on Wednesday issued an announcement 16 years in the making: it will create a special registration process for prescribers wishing to provide controlled substances, like opioids or stimulants used to treat ADHD, via telemedicine.
The move finally fulfills a mandate that DEA had largely ignored since Congress first issued it in 2008. But the new special registration system is merely a proposal, meaning the incoming Trump administration could nix it.
It also carries a number of restrictions that prompted instant pushback. Among other rules, providers seeking to prescribe Schedule II medications, which include Ritalin and Adderall, would need to be physically located in the same state as their patients. They would also be required to issue at least 50% of their prescriptions after in-person appointments, a potential threat to providers whose core business is telehealth.
The Alliance for Connected Care, a trade organization representing telehealth providers, wrote in a statement that it was “very concerned to see language in the proposed rulemaking mandating what portion of patient care can be offered through telemedicine, as this is not an appropriate guardrail for a telehealth service. Similarly, restricting the geography in which telemedicine can be offered undermines the value of creating virtual access for those patients who need it most.”
The DEA’s new regulations, issued with just days remaining in President Biden’s term, represent the latest chapter in a saga that dates back to the 2008 passage of a law regulating online pharmacies. The law included a requirement that the DEA create a special registration process for practitioners who wished to prescribe controlled substances remotely.
DEA will delay telemedicine restrictions for buprenorphine, Adderall, and other drugs
Emergency rules enacted at the beginning of the Covid-19 pandemic allowed for significantly increased flexibility in telehealth prescribing of controlled substances. The DEA’s efforts to enact new, post-pandemic regulations, however, have faced significant resistance — especially when it comes to buprenorphine, a Schedule III medication commonly used to treat opioid addiction.
In a separate rule, the DEA moved to allow prescribers to continue providing six months’ worth of buprenorphine without an in-person visit. The buprenorphine-specific rule, which is set to take effect in mid-February, was issued in final form, meaning it would be far more difficult for the Trump administration to reverse.
After six months, patients could re-up their prescriptions either via an in-person visit or, if the DEA’s broader telehealth proposal is finalized, receive a refill remotely if their prescriber is specially registered under the new system. Under the new system, pharmacists would be charged with verifying patients’ identification on pickup.
Pharmacies, however, pose a substantial roadblock for many patients seeking buprenorphine: even beyond the discrimination that many people with addiction can face in retail stores, many big-box drug retailers simply do not stock the medication.
The DEA’s new rules draw a number of other distinctions between buprenorphine, commonly known by the brand name Suboxone, and other controlled substances, amid growing recognition that the medication is highly unlikely to cause overdose. In October, two Democratic lawmakers introduced a bill effectively instructing the DEA to back off monitoring buprenorphine entirely until the opioid crisis is over.
Medications like buprenorphine and methadone, a Schedule II drug that doctors cannot prescribe directly to patients to treat addiction, are seen as key weapons in the U.S. response to the opioid crisis, but remain highly stigmatized.
Buprenorphine prescribers, for instance, will be required only to check a prescription drug monitoring database in the state where the patient is located. By contrast, if the broader proposal is finalized, prescribers seeking a special registration to provide other controlled substances via telehealth would be required to check every existing monitoring system across the 50 states and U.S. territories, though the provision would not take effect until three years after the regulation was finalized.
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“The DEA published these rules, not because they were fully ready for implementation, but to ensure they were not abandoned by the incoming Trump administration,” said Marika Miller, an attorney with Foley & Lardner, a law firm seen as an authority on telemedicine issues. “The long-awaited special registration process falls flat with stakeholders, and it is anticipated that the associated rule will undergo yet another round of notice-and-comment rulemaking. Among other concerns, a key issue for stakeholders with both rules is the nationwide prescription drug monitoring program check requirement, a burden the DEA still appears to underestimate.”
Currently, providers are relying on the DEA’s repeated extension of Covid-era telehealth flexibilities, which the agency recently re-upped through the end of 2025. Timelines for finalizing regulations are typically long, however, and even if the rule moves forward, it is unclear whether the DEA could finalize it by year’s end. Barring another extension, the new rules risk creating another “telehealth cliff” for patients who rely on medications prescribed via telemedicine.
The DEA’s future also remains in flux: President-elect Donald Trump has not announced a nominee to lead the agency after his initial choice Chad Chronister, the sheriff of Hillsborough County, Fla., dropped out amid criticism over his enforcement of Covid-19 lockdown measures in 2020.
Mario Aguilar contributed reporting.
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.
