The Drug Enforcement Administration (DEA) appears to be leaning toward releasing a rule that would put strict limits on telehealth prescribing.
However, telehealth advocates maintain that the strictness of the yet-to-be-released rule effectively makes prescribing controlled substances via telehealth impossible. If finalized, the rule that the DEA is considering would severely limit the ability of any behavioral health operator to extend access to care via telehealth.
It would also devastate the burgeoning telehealth movement in behavioral health, the advocates believe.
For certain conditions, controlled substances are key interventions. Examples include buprenorphine for opioid use disorder or mixed amphetamine salts for ADHD. And access to care and these kinds of medication has been expanded following the loosening of telehealth regulations in response to the COVID-19 pandemic.
Advocates of the telehealth industry have argued that previous attempts by the DEA to establish post-COVID regulations would have gone too far and cut people off from care.
“If it goes into effect as is, it’s a disaster,” Robert Krayn, CEO and co-founder of the virtual psychiatry company Talkiatry, told Behavioral Health Business in an interview.
Reporting by Politico Pro suggests that the DEA is somewhat moderating its previous approach and incorporating some common concerns raised in previous comment periods. Here are the details:
— Schedule II drugs must be prescribed via in-person visit unless the prescriber is a specialist.
— No more than half of a provider’s prescriptions may be given via telehealth.
— Providers much check all 50 prescription drug monitoring programs (PDPMs).
— Drugs under the DEA’s Schedule III, IV and V may be prescribed via telehealth without an in-person visit to a provider.
As far as where the newsroom is getting its information on the DEA’s agenda, Politico Pro cites an ex-federal official that is not named in the article.
While not yet available, advocates are on the watch for the DEA to release a new proposed rule on telehealth prescribing. In June, the DEA submitted a rule to the White House’s Office of Management and Budget (OMB), which oversees the coordination and review of executive branch action. It’s often a final step before rules are made public.
The release of the Politico report hints at the arrival of a new chapter in the sojourn of the DEA trying to get its arms around the new telehealth-enabled world of health care.
In March 2023, the DEA released two interrelated rules that were roundly panned by advocates of telehealth during their respective comment periods. Large portions of the comments cited rural patients’ challenges accessing care, the potential loss of addiction treatment and access to gender affirming care. Testosterone is a Schedule III-controlled substance.
The agency has since delayed its rule and allowed telehealth flexibilities to remain in place until the end of the year.
Many feared that the DEA’s role as both health care industry regulator and law enforcement agency would lead it toward strict regulations for telehealth prescribing. This was illustrated by the DEA’s investigation and prosecution of the executives of the ADHD telehealth startup Done Global.
But the allowance of Schedule III drugs and the exemption of prescribing Schedule II drugs via a specialist may be an attempt by the DEA to accommodate concerns of commenters.
“There are things in here that I believe make sense and can be solved with tweaks,” Krayn said, adding that the specialist exemption made sense to him.
Krayn said that he believes that the DEA has shown that it is willing to listen to the industry. Already, it has backed off one rule and restarted its effort leading to the present time.
