Backtracking from an earlier proposal that drew heavy criticism, the agency is extending pandemic waivers for the use of telemedicine to prescribe controlled substances until November 11.
Federal officials have extended for six months pandemic waivers designed to enable healthcare providers to prescribe controlled substances via telemedicine.
The announcement, posted this week in the Federal Register, follows a busy few months in which the US Drug Enforcement Administration proposed new rules around telemedicine prescriptions, set to take place when the public health emergency (PHE) ends on May 11, then backtracked after received thousands of comments criticizing those rules.
“The DEA received a record 38,000 comments on its proposed telemedicine rules. We take those comments seriously and are considering them carefully,” DEA Administrator Anne Milgram said in a press release issued on May 9. “We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities for six months while we work to find a way forward to give Americans that access with appropriate safeguards.”
“Access to evidence-based treatment is a pillar of the HHS Overdose Prevention Strategy,” added Miriam E. Delphin-Rittmon, the Health and Human Services Department's Assistant Secretary for Mental Health and Substance Use and the leader of the Substance Abuse and Mental Health Services Administration (SAMHSA), which is assisting the DEA. “We strongly support policies that promote access to effective and safe treatment for opioid use disorder, including through telemedicine platforms, and ensuring continued access to necessary controlled medications past the COVID-PHE.”
The temporary rule taking effect on May 11 will extend the full set of telemedicine waivers adopted in January 2020 to expand telehealth access during the COVID-19 pandemic through November 11, 2023. For providers who have set up a telehealth relationship with a patient for the prescription of controlled substances, the waivers will be extended through November 11, 2024.
The proposed revisions to the telemedicine prescription guidelines unveiled in February drew strong comments from a wide range of stakeholders, including the American Telemedicine Association (ATA), 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.
Also weighing in were members of Foley & Lardner's Telemedicine & Digital Health Industry Team.
"The proposed rules are intended to bridge between the DEA’s current PHE waivers and a post-PHE environment," Nathaniel Lacktman, a partner with Foley & Lardner and the digital health team's chair, wrote in the firm's Health Care Law Today 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."
News that the DEA was changing course was met with positive comments from the ATA.
“The ATA and ATA Action strongly commend the actions that the DEA has taken, jointly with SAMHSA, in temporarily extending flexibilities for the remote prescribing of clinically appropriate controlled substances," Kyle Zebley, the organization's senior vice president of public policy and executive director of its ATA Action lobbying group, said in a press release. “It is especially important and encouraging that these actions cover access to clinically appropriate prescriptions of controlled substances that patients need for a wide variety of medical circumstances, including for mental health and substance use disorders."
“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," he added. "The ATA and ATA Action are committed to continuing our work with the agency and others to help create the most effective and appropriate rules that ensure access to needed treatments."
Passed into law in 2008, the Ryan Haight Online Pharmacy Consumer Protection Act 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.
Writing in their Health Care Law Today blog earlier this year, Thomas Ferrante and Rachel Goodman, partners with Foley & Lardner and members of the Telemedicine & Digital Health Industry Team, said the waiver of the in-person exam during the PHE ensured that "millions of both established and new patients were able to receive medically necessary prescriptions via telemedicine."
They also pointed out that the DEA's actions this year don’t address a key element of the Ryan Haight Act.
"There have been efforts to amend the Ryan Haight Act and encourage the DEA to activate the telemedicine special registration rule before the PHE expires, including pending federal legislation," they wrote. "However, to date, the Ryan Haight Act has not been changed and the DEA has not activated the telemedicine special registration rule."
"The DEA’s proposed rules are not the special registration process that Congress mandated and could gravely disrupt millions of patients’ treatments and care regimens," Robert Krayn, co-founder and CEO of telepsychiatry company Talkiatry, said in an e-mail to HealthLeaders. "Instead of taking inspiration from more modern state-level prescribing policy already introduced in Connecticut and Florida, the rules reinstate obsolete and counterproductive in-person requirements under the guise of novelty. There is nothing novel about sending vulnerable patients back into the dark ages of care delivery."
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.
Prescribing controlled substances via telemedicine is heavily restricted through the Ryan Haight Act, with the DEA handling enforcement.
Due to the COVID-19 pandemic, the DEA issued waivers in 2020 to expand telemedicine use, with those waivers set to expire with the end of the federal public health emergency on May 11.
The agency had proposed new guidelines for telemedicine use, but that proposal drew thousands of negative comments, forcing federal officials to backtrack and keep the current waivers in place for six months.