The Drug Enforcement Administration (DEA) has openly signaled a reversal in its stance towards a long-mandated special registration process that would allow telehealth prescribing of certain controlled substances.
In a newly published meeting notice, the DEA says the voluminous and negative feedback on its proposed rule for post-public health emergency telehealth regulations inspired its new consideration of a special registration process.
The meeting notice calls for two public comment listening sessions on Sept. 12 and 13. These listening sessions are intended to inform the DEA on preventing and detecting the diversion of controlled substances prescribed via telehealth.
“DEA is open to considering — for some controlled substances — implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all,” the meeting notice states.
The DEA has ignored congressional mandates to create a special registration process for providers to be able to prescribe controlled substances without an in-person exam — first in 2008 as part of the Ryan Haight Act and again in the SUPPORT for Patients and Communities Act (SUPPORT Act) of 2018.
The American Hospital Association recently called out this behavior in an open letter to federal lawmakers.
“To date, the DEA has continued to ignore congressional intent on this process, and it is clear more congressional action is needed in the reauthorization of the SUPPORT Act,” the letter stated.
The DEA states that it is also open to making some of the COVID-era telehealth flexibilities permanent. But it also states that it believes a new era of telehealth-supported health care requires additional compliance mandates on providers.
Specifically, it says cementing in place flexibilities to controlled substances prescribing would “potentially create a new framework for medicine that fundamentally expands access to controlled substances in a way that warrants a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time,” according to the notice.
The DEA published questions it has a specific interest in addressing. This, in part, includes questions about diversion prevention for drugs in Schedules III through V; if Schedule II drugs should be allowed to be prescribed without an in-person exam; and what data should be collected to ensure compliance and safety by practitioners and pharmacies.
On Feb. 24, the DEA published two proposed rules that would effectively end telehealth-only health care where controlled substances — like those used in medication-assisted treatment (MAT) for addition — are involved. This move put several behavioral health companies, especially startups that flourished during the public health emergency, into a state of crisis.
The DEA announced it would delay the implementation of its proposed rules for six months, until November, after being inundated with 38,000 largely oppositional comments from the public.
While it’s not guaranteed, federal agencies tend to tweak proposed rules based on feedback from the public. It’s unclear what will happen once November arrives, considering another round of public input from the DEA.
Still, advocates in the behavioral health space told Behavioral Health Business that the DEA’s delayed implementation was a win for public advocacy and a good omen for things to come.
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