DEA Extends Telehealth Flexibilities 6 Months in a Win for Behavioral Health Advocates

The Drug Enforcement Administration (DEA) released a temporary rule extending COVID-era telehealth flexibilities from the end of the public health emergency (PHE) on May 11 to Nov. 11, 2023.

The extension allows clinicians prescribing controlled substances over telehealth to continue to do so for another six months. Patients that initiate care on or before Nov. 11 will have a grace period extending to Nov. 11, 2024.

The temporary rule made public on May 9 comes about a week after the DEA signaled that it would hold off on finalizing two rules that, as originally proposed in February, would effectively regress telehealth and controlled substances prescribing rules to pre-COVID standards with minor exceptions.

“In the meantime, DEA is continuing to carefully evaluate the comments received on the [proposed rules] and anticipates implementation of a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion,” the rule states.

The temporary rule states its purpose is to give the DEA, patients and providers more time to transition into a post-PHE era of telehealth and controlled substances prescribing. It’s also intended to provide the DEA more time to respond to the 38,369 comments — most of which criticized the rules — received during the comment period for the two rules it originally published in anticipation of the end of the PHE.

On April 25, the DEA signaled that it was seeking White House approval for this temporary rule in place of the two proposed rules in reaction to the comments.

“We are relieved that the DEA has recognized the gravity of its proposed rules,” Zack Gray, co-founder and CEO of the virtual MAT provider Ophelia Health, said in an email. “The DEA’s original proposal will have a negative and deathly impact on the millions of Americans who are struggling with OUD.”

The move by the DEA is promising that the agency will remove barriers to addiction treatment via telehealth, Gray said.

But in the near term, the extension allows for patients to continue access to vital care, Bicycle Health CEO Akit Gupta told Behavioral Health Business.

“The main challenge with providing telemedicine care for opioid use disorder has been regulatory uncertainty,” Gupta said. “If the DEA can provide clarity and clarity that actually improves access to telemedicine SUD care, then we have a real shot of turning around the opioid epidemic in the next decade.”

Gupta said the record-setting volume of engagement on the proposed rules indicates that “we have a lot of supporters who recognize the value of telemedicine opioid use disorder treatment.”

Annual overdose deaths from opioids have increased 55% since the onset of the pandemic, according to CDC data.

A public advocacy win

Several advocates in the space previously have told BHB that the austere response of the DEA was a reaction to an unrepresentative group of “bad actors” in the telehealth space.

Today, some advocates point out that the temporary final rule states its comparatively short, six-month extension is meant to scare off new telehealth ventures “that might encourage or enable problematic prescribing practices.”

“DEA stresses that, while certain telemedicine companies may engage in problematic behavior, many telemedicine companies are engaged in good faith, patient-centered prescribing practices,” the rule states. 

Jéna Grady, health care counsel with law firm Nixon Peabody LLP, told BHB that it was the voluminous number of comments that precipitated the extension. The number of comments on the rule was remarkable, Grady said, because the DEA doesn’t often acknowledge in any detail the comment count in the text of a final rule.

“It was definitely a way that DEA hinted at that the public overwhelmingly wanted to extend these rules and figure out a more appropriate way to have telehealth prescribing based on what stakeholders are seeing [rather] than what the DEA originally thought,” Grady said. 

The federal government showed its scrutiny and skepticism of telehealth generally in several ways over the last few years. Last year, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an advisory warning health care providers to take care they don’t participate in telehealth-based kickback or false billing schemes. More recently, the OIG found that millions of Medicare dollars were inappropriately billed by mental health providers via telehealth. 

The main challenge with providing telemedicine care for opioid use disorder has been regulatory uncertainty.

Akit Gupta, CEO of Bicycle Health

On the law enforcement side, the beleaguered mental health startup Cerebral is reportedly under federal investigation for its prescribing practices of controlled substances. The company was also reportedly being scrutinized by the DEA.

Stephanie Strong, CEO of virtual addiction treatment provider Boulder Care, told BHB that the temporary rule’s acknowledgment of the importance of telehealth access came in spite of potential bad actors and in response to the public comment period.

“This is restorative of faith in the public process, that regulators can learn from the data, insights and from consumer sentiments about what more progressive rulemaking should look like,” Strong said.

Strong pointed to advocacy efforts on the part of her company, other companies and advocacy groups in mobilizing patients and other members of the public to put pressure on the DEA through the comment period and through new media. Boulder Care, among others, pushed patient stories in national media outlets.

What’s next from the DEA?

It’s unclear where the regulations will go from here. But industry stakeholders have their hopes and guesses.

“We are hopeful that during this extension period, the DEA will revise the draft rules to address unnecessarily restrictive barriers to equitable and appropriate clinical care, such as mandating in-person visits,” Kyle Zebley, the senior vice president of public policy at the American Telemedicine Association and executive director of ATA Action, said in a statement.

Strong similarly hopes that the in-person exam requirement for buprenorphine will be eliminated, pointing to federal research that the COVID-telehealth flexibility for OUD treatment was safe. She also believes that this temporary rule signals that the DEA will create ” a path for telemedicine prescribing without an in-person visit.”

We are relieved that the DEA has recognized the gravity of its proposed rules.

Zack Gray, CEO of Ophelia Health

This could be through the congressionally mandated, long-awaited special registration process that the DEA has shirked since at least 2018, Strong said. Or, the final rule could eliminate the in-person requirement for telehealth treatment via buprenorphine, she added.

Other COVID-era rules allowed otherwise properly registered clinicians to prescribe via telehealth without registration in each state where patients were located. This wasn’t addressed clearly in the DEA’s proposed rules and appears it may continue with the pending final rule. There are other hints around the use of audio-only telehealth for OUD and other parts of behavioral health, Grady said.

Gupta says the DEA has signaled that the issue of telehealth and controlled substance prescribing is more difficult to address than previously considered after the growth of telehealth during the pandemic.

“It’s a lot more complicated than it seemed to be if they want to do this right,” Gupta said. “This extra time hopefully gives them a way to reconcile all the different stakeholders in a way that increases access to telemedicine and buprenorphine treatment.”