Reacting to a wave of complaints against its earlier proposed revision of rules for prescribing controlled substances via telemedicine, the DEA is changing course yet again.
The US Drug Enforcement Administration is revising proposed regulations for the prescription of controlled substances via telemedicine after receiving thousands of complaints.
A statement issued today by DEA Administrator Anne Milgram says the DEA, coordinating with the Health and Human Services Department, is submitting a draft temporary rule to the Office of Management and Budget for the "Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances."
Details of the new rule will be released when it is published in the Federal Register.
"The Drug Enforcement Administration received a record 38,000 comments on its proposed telemedicine rules," Milgram said in her statement. "We take those comments seriously and are considering them carefully. We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities while we work to find a way forward to give Americans that access with appropriate safeguards."
The use of telemedicine in prescribing controlled substances has long been stringently regulated by the federal government. 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.
The DEA had eased its rules during the pandemic to allow healthcare providers to prescribe controlled substances via telemedicine without the need to first conduct an in-person exam. With the COVID-19 public health emergency scheduled to end on May 19, the agency unveiled a proposed revision in February that would have expanded some telemedicine uses but also established a new set of guidelines.
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..
Reaction to that proposal was quick—and very much against the new rules.
"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 the Foley & Lardner law firm wrote in a blog.
Nathaniel Lacktman, a partner in the firm and chair of its national Telemedicine & Digital Health Industry Team, 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.
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.
KEY TAKEAWAYS
The US Drug Enforcement Administration strictly controls the prescription of controlled substances via telemedicine, requiring, among other things, that providers conduct an in-person exam before moving to an online platform.
The DEA relaxed those rules during the pandemic, but with the public health emergency set to expire soon, the agency proposed new rules in February that allow some telemediicne use but add new constraints.
Strong backlash to that proposal has prompted DEA Administrator Anne Milgram to unveil another proposal, which will soon be made public in the Federal Register.