Several groups have issued critical reviews of the DEA's proposed revision of rules regarding telemedicine prescriptions of controlled substances. Some say the revision will imperil thousands of patients.
Telehealth and digital health advocates aren't pleased with the US Drug Enforcement Agency's proposed rules for prescribing controlled substances via telemedicine after the expiration of the COVID-19 Public Health Emergency.
The long-awaited proposal, unveiled in February, had been expected to ease the pathway for healthcare providers to use telemedicine to prescribe medications like buprenorphine without needing an in-person examination. But with the agency's 30-day window for public comments expiring, the vast majority of the 20,000+ comments submitted have been negative.
"Leading professional associations, respected think tanks, and experienced clinicians submitted compelling and noteworthy comment letters explaining how the proposed rule will result in limitations on access to care, harm patients in rural and urban areas alike, and likely result in otherwise avoidable overdoses and deaths when patients are denied access to their medically-important medications," several lawyers from Foley & Lardner wrote in the firm's Health Care Law Today blog.
Nathaniel Lacktman, a partner in the firm and chair of its national Telemedicine & Digital Health Industry Team, was among the earliest commenters on the proposed rules.
"The proposed rules are intended to bridge between the DEA’s current PHE waivers and a post-PHE environment," he wrote in a February 27 blog. "In so doing, DEA proposed creating two new limited options for telemedicine prescribing of controlled substances without a prior in-person exam. The options [are] both complex and more restrictive than what has been allowed for the past three years under the PHE waivers. The DEA’s proposal will discontinue the ability for telemedicine prescribing of controlled substances where the patient never has any in-person exam (with the exception of an initial prescription period of no more than 30 days’ supply). Moreover, if the patient requires a Schedule II medication or a Schedule III-V narcotic medication (with the sole exception of buprenorphine for opioid use disorder (OUD) treatment), an initial in-person exam is required before any prescription can be issued."
Lacktman and his colleagues produced a legal guidebook shortly after the proposed rules were unveiled, and submitted a 15-page letter picking apart various aspects of the rules on March 30. Others submitting critical comments (the Foley & Lardner team called it a "tsunami of criticism") include the American Telemedicine Association, the Alliance for Connected Care, and a group composed of members of the Brookings Institution, Harvard Medical School, David Geffen School of Medicine at UCLA, and Harvard T.H. Chan School of Public Health.
Krista Drobac, executive director of the Alliance for Connected Care, said the proposed DEA rules would lead to "immense patient harm," particularly to patients seeking treatment for behavioral health issues. According to the alliance, 65% of all patients living with a substance abuse disorder or overdose diagnosis in 2021 also had a pre-existing mental health condition.
"DEA must find a path to allow the continuation of comprehensive mental health (and substance use disorder--which is often overlapping) treatment to patients through telehealth," she wrote. "While we believe there are many appropriate use-cases for telehealth involving controlled substances, such as palliative care, the vast majority of patients who would be harmed by the rule are relying on telehealth for access to mental healthcare."
The FDA's proposed rules would allow providers to use telemedicine to prescribe 30-day supplies of Schedule III-V non-narcotic controlled medications and buprenorphine, the latter specifically for the treatment of opioid abuse disorder, for new patients and without the need for an in-person evaluation. They redefine guidelines that had originally been included in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which severely restricts the prescription of controlled substances, and requires an in-person exam by a qualified provider before those drugs can be prescribed via telemedicine. Enforcement is handled by the DEA.
Dozens of federal and state waivers were enacted during the COVID-19 PHE to improve access to and coverage of telehealth services. Many of those waivers were extended to the end of 2024 by Congress, but others—including the DEA waiver on using telemedicine without an in-person visit—will end with the PHE on May 11.
With that deadline looming, the DEA proposed to amend its rules to allow for more telemedicine use. The response was anything but positive.
While many complained that the 30-day comment period was too short, commenters like Foley & Lardner cited several issues with the proposed rules. Foley & Lardner Partner Nathan Beaver, the author of the letter to the DEA, listed 14 changes that the firm feels should be made, including removing requirements for an in-person exam, creating a special registration process for telemedicine providers as directed by the Ryan Haight Act, grandfathering patients being treated via telemedicine during the PHE, and revising the rules to allow providers to refer patients to medical groups, health systems, and other collaborating practices.
"We believe the proposed rules as written will limit access to legitimate healthcare while not promoting the public health and safety goals of DEA," Beaver wrote. "In this comment letter, we provide reasonable suggestions and solutions that will allow DEA to appropriately address diversion concerns while safeguarding patient access to essential telemedicine services including for the treatment of mental health and substance use disorder."
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, Telehealth, Supply Chain and Pharma for HealthLeaders.
In February, the US Drug Enforcement Agency proposed new rules regarding the use of telemedicine to prescribe controlled substances, timed to take effect at the end of thr COVID-19 Public Health Emergency in May.
The new rules set certain instances when providers can use telemedicine to prescribe controlled substances without an in-person examination.
Telehealth and digital health advocates have strongly criticized the new rules, saying they're too complex and would put many patients dealing with substance abuse and mental health issues at peril.