The Drug Enforcement Administration appears to have filed for a temporary extension of telehealth flexibilities beyond the public health emergency.
This reflects an apparent reaction on the part of the DEA to the major backlash it faced during the public comment period for two rules it release that would reestablish austere restrictions on accessing treatment via telehealth that includes a controlled substance such as buprenorphine for opioid use disorder (OUD) or Adderall for ADHD. It also gives an additional cushion as the federal public health emergency (PHE) ends and pre-COVID regulations come back into play.
On April 25, DEA filed a final rule with the Office of Management and Budget (OMB) titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” The final rule uses the same identification number as one of the two proposed rules it previously released on telehealth and the prescribing of controlled substances after the end of the PHE.
The OMB is a part of the Office of the President. It oversees the coordination and review of all major executive branch regulations and acts as a final stop before federal rules are released.
However, the DEA did not release the text of this final rule, nor has the DEA responded to a request for comment. This story may be updated.
Several behavioral health insiders and regulatory experts tell Behavioral Health Business that DEA is seeking additional time to assess the response to the two proposed rules it released on Feb. 24. Near the end of the official comment period for the rule, a wide range of health care providers, advocacy groups and patients submitted over 21,000 comments, the bulk of those comments opposed the proposed rule. Today, the two rules have received 37,400 comments.
In effect, the proposed rules would severely limit care provided to patients whose care includes controlled substances without first seeing a provider in person. Behavioral health insiders argue the greatest impact of this rule falls on vulnerable patients for whom status quo care models fall short, especially in addiction treatment. It is also a threat to the existence of a burgeoning segment of the behavioral health industry.
“[The PHE] allowed providers to prescribe to live audio video telehealth — so it’s not the Wild West like some people characterize it,” Michael Petegorsky, general counsel and head of public affairs for the virtual mental health and ketamine therapy provider Mindbloom, told BHB. “It’s still a face-to-face, live audio-video telehealth consultation.”
The DEA appears to be seeking to preserve the flexibilities that were provided during the federal COVID-19 PHE, which ends soon. The PHE has allowed for looser federal regulations in several settings to better account for the onset and duration of the pandemic. The PHE will end on May 11, when the flexibilities afforded by the PHE will end and regulations will revert to the status quo.
Petegorsky said the final rule will be released when OMB has completed its review and will be effective according to the timeframe the DEA set for the final rule.
The Ryan Haight Act of 2008 required a prior in-person examination of a patient to get a controlled substance prescription. The law provides a handful of narrow exemptions, none of which allow for care outside of health care facilities. One of the exemptions to the Ryan Haight Act is a federal PHE.
Since the Trump administration declared the PHE, the behavioral health industry has taken up and continued to use telehealth more than any other segment of health care. Analysis by Trilliant Health shows less than 1% of behavioral health visits were conducted via telehealth pre-pandemic. That number spiked during the onset of the pandemic and settled at about 33% as of the second quarter of 2022.
The same analysis finds that 64% of all telehealth visits are for behavioral health reasons.
Members of the DEA have told behavioral health industry advocates and providers that their original goal with the proposed rules was to prevent controlled substance diversion via identity fraud. This could be prevented by reverting prescribing controlled substances back to the Ryan Haight Act standard of an in-person visit before prescribing, several sources told BHB.
Other industry sources tell BHB that the DEA has made an internal commitment to avoid interrupting care. At the same time, it will work on a final telehealth prescribing rule that accounts for the industry response.
“They were pretty forthright about the fact that what they were trying to solve for with the initial first pass of the regulation,” one industry expert who spoke with members of the DEA said. “It was really trying to target bad actors … It wasn’t about safety and prescribing from a medical standpoint or medical judgment or standard of care.”
While the public comment period reflected a severe negative reaction from the public, Petegorsky said that it was a good sign that the DEA proposed rules before the end of the PHE and that the DEA is seeking to preserve flexibility while it works through a final rule.
“On the one hand, I think [the proposed rules] reflect that they do understand how vital telehealth is to ensuring Americans have access to care,” Petegorsky said. “I think it’s a really great sign that not only did the DEA issue a proposed rule back in February but they’ve now issued this new rule to extend the time to consider all these comments and try to get this right.”
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