Quick Note and Good News re: Pandemic Flexibilities

October 6, 2023

DEA Extends Certain Pandemic Era Flexibilities Through 2024

Today, October 6, the Drug Enforcement Agency (DEA) announced that they would once again extend pandemic era rules for prescribing controlled substances via telemedicine. The temporary rule would extend these telemedicine flexibilities for prescribing controlled substances until the end of 2024. The extension allows patients to be prescribed controlled substances via telehealth without the requirement of first seeing a provider in-person.

From Behavioral Health Business, 10/6:

The federal government will extend COVID-era telehealth flexibilities until December 2024, dramatically extending the runway for the Drug Enforcement Administration (DEA) to establish new rules for using telehealth and controlled substances. 

The DEA and U.S. Department of Health and Human Services released a new temporary rule on Oct. 6 after conducting two days of listening sessions about how best to regulate telehealth and controlled substances in the post-COVID era. The DEA expects to release a new rule regulating telehealth and controlled substances in about a year. 

During the pandemic, the federal government extended temporary flexibilities that allowed for telehealth services of many types — but especially medication-assisted treatment providers — to thrive. These COVID-era rules demonstrated that telehealth treatment for addiction and other forms of behavioral health was effective and had few downsides

“The purpose of this second temporary rule, like the one before it, is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards,” the rule states. “DEA is working to promulgate new standards or safeguards by the fall of 2024.”

Though released publicly on Oct. 6, the rule will be published officially in the Federal Register on Oct. 10. 

On March 1, the DEA published two interrelated rules that re-established rules that require controlled substances categorized under the DEA’s Schedule II through V to be prescribed only after an in-person examination, among other regs. 

The rules unleashed a torrent of negative feedback. The DEA released tens of thousands of comments, most opposing and criticizing the rule. In May, DEA delayed the implementation of its rule, announcing it would put off the implementation of the rule until November. 

In Sept. the DEA hosted a two-day-long listening session. That agency also disclosed that it was open to considering a special registration process allowing certain providers to prescribe controlled substances via telehealth without a prior in-person exam. Despite several legislative actions directing the agency to develop the process, this is a reversal of historic inaction by the DEA on the topic. 

The listening session featured dozens of commenters who made in-person or virtual appearances. During the listening sessions, DEA leaders Administrator Anne Milgram, Deputy Assistant Administrators Tom Prevoznik and Matthew Strait heard about 11 hours of presentations and asked only a few questions of the presenters

The DEA states in the rule that the purpose of the extension, in part, is to consider the feedback generated by the comment period and listening sessions, allowing providers time to prepare for combining into compliance with in-person exam rules and all patients and provider flexibility. 

Another stated purpose of the extension is to “avoid incentivizing the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices by limiting the second extension of flexibilities to a short, time-limited period.”

Alleged misdeeds by some telehealth providers were seen as the impetus for what was seen as an austere snap-back to pre-COVID telehealth regulations. Companies such as Cerebral and Done Global faced significant public and regulatory scrutiny over allegations of inappropriate prescribing practices.