The Drug Enforcement Administration on Wednesday made an announcement that has been in the works for 16 years: It will create a special registration process for prescribers who want to dispense controlled substances, such as 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 just a proposal, meaning the new Trump administration could ignore it.
It also comes with a number of limitations that have led to immediate backlash. Among other rules, providers who want to prescribe Schedule II drugs, including Ritalin and Adderall, must be in the same physical condition as their patients. They would also be required to fill 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 group representing telehealth providers, wrote in a statement that it was “very concerned about the language in the proposed regulations that determines what portion of patient care can be provided via telemedicine, as this is not an appropriate guardrail for a telehealth service. Likewise, limiting the geography in which telemedicine can be offered undermines the value of creating virtual access for patients who need it most.”
The DEA’s new regulations, issued with just days left in President Biden’s term, represent the latest chapter in a saga dating 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 seeking to prescribe controlled substances remotely.
The emergency rules introduced at the start of the Covid-19 pandemic significantly increased flexibility in remote prescribing of controlled substances. However, the DEA’s efforts to issue new, post-pandemic regulations have been met with significant resistance — especially when it comes to buprenorphine, a Schedule III drug often used to treat opioid addiction.
In a separate rule, the DEA decided to allow prescribers to continue dispensing buprenorphine for six months without an in-person visit. The buprenorphine-specific rule, which takes effect in mid-February, was issued in final form, meaning it would be much harder for the Trump administration to undo it.
After six months, patients can refill their prescriptions through an in-person visit or, if the DEA’s broader telehealth proposal is finalized, get a refill remotely if their prescriber is specifically registered under the new system. Under the new system, pharmacists would be tasked with verifying patient identification upon collection.
However, pharmacies pose a significant obstacle for many patients seeking buprenorphine: even leaving aside the discrimination that many people with addiction may face in retail, many big-box drug retailers are simply have no stock the medication.
The DEA’s new rules make a number of other distinctions between buprenorphine, commonly known by the brand name Suboxone, and other controlled substances, amid growing recognition that the drug is highly unlikely to cause an overdose. In October, two Democratic lawmakers introduced a bill that would effectively direct the DEA to completely halt oversight of buprenorphine until the opioid crisis is over.
Drugs 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.
For example, prescribers of buprenorphine need only consult a prescription drug monitoring database in the state where the patient is located. In contrast, if the broader proposal is finalized, prescribers seeking special registration to dispense other controlled substances via telehealth would be required to check every existing monitoring system in the 50 states and U.S. territories, although the provision would not take effect until three years later become. the arrangement has been completed.
“The DEA published these rules not because they were fully ready for implementation, but to ensure they were not abandoned by the new Trump administration,” said Marika Miller, an attorney at Foley & Lardner, a law firm that is considered an authority in the field of telemedicine. problems. “The long-awaited special registration process has not gone down well with stakeholders, and the accompanying rule is expected to undergo yet another round of notice and comment rules. Among other concerns, a major issue for stakeholders with both rules is the audit requirement for the national drug monitoring program, a burden that the DEA continues to appear to underestimate.
Currently, providers are relying on the DEA’s repeated expansion of Covid-era telehealth flexibility, which the agency recently reinstated through the end of 2025. However, timelines for finalizing regulations are typically long, and even as the rule continues to evolve, that is still the case. unclear whether the DEA could complete it by the end of the year. Unless there is another extension, the new rules risk creating a new “telehealth cliff” for patients who rely on medications prescribed via telemedicine.
The future of the DEA also remains in flux: President-elect Donald Trump has not announced a candidate to lead the agency after his initial choice Chad Chronister, the sheriff of Hillsborough County, Florida, quit amid criticism of his Covid-19 enforcement -lockdown measures in 2020.
Mario Aguilar contributed reporting.
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