Under pressure from the White House, Congress and trade and patient groups nationwide, the Drug Enforcement Administration submitted a proposed rule regarding flexibilities on telemedicine prescribing of controlled substances on Oct. 10.
“Specifics of the proposed rule are not yet available, but we anticipate the rule will extend the current D.E.A. telemedicine prescribing flexibilities for at least one more year, possibly two,” Marika Miller and Nathaniel M. Lacktman wrote in a post on the website of the law firm Foley & Lardner LP. “The proposed rule is expected to be released and available for public review before the end of the year and should extend both the in-person exam waiver and the state-by-state D.E.A. registration waiver.”
The proposed rule is filed on the reginfo.com website, marked as “pending review.” It is titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.”
When the pandemic struck, telehealth quickly became the norm, after years of pushback from the healthcare system. Now everybody has gotten used to virtual care — doctor visits and telehealth prescribing of medications — and the in-the-breach setting of regulations seemed to work pretty well. But the pandemic-induced telehealth guidelines, referred to as flexibilities, were modified only by temporary extensions, and they are set to expire later this year.
The Centers for Medicare and Medicaid Services recommended in July that many telehealth flexibilities be extended through the end of calendar year 2025. The recommendations are detailed in this post from the Baker and Donelson law firm, primarily covering Medicare beneficiaries, providing “some level of certainty regarding the regulatory landscape while we await legislative changes that would be necessary to permanently remove certain statutory constraints” on telehealth services such as the originating site requirements,” the law firm wrote.
“In late August 2024, POLITICO broke news on the D.E.A.’s internal plans to release an unworkable regulation that would render telemedicine prescribing of controlled substances functionally impractical,” Miller and Lacktman wrote. “Although the draft rule was not publicly released, reporters uncovered how the U.S. Department of Health and Human Services strongly opposed the D.E.A.’s draft, having formally objected to its release at least three times and lodging approximately 400 line-item concerns regarding it. After the news broke, stakeholders were stunned and disappointed. Soon after, patients, clinicians, and leading advocacy associations such as the American Telemedicine Association, A.T.A. Action, and the Alliance for Connected Care, took action through online petitions, and a series of scathing letters from Senators and other members of Congress urged the D.E.A. to honor its prior promises to issue a set of telemedicine regulations before the end of 2024.
“Now, with insufficient time before the end of the year to enact a special registration rule, the only path forward to avoid the Telehealth Cliff is to extend the flexibilities further. This will allow time for the D.E.A. to draft a new proposed rule (ideally doing so in collaboration with a taskforce comprised of practicing clinicians and industry stakeholders).”
Without an extension, the flexibilities will end on Dec. 31, 2024.
Early chaos
Telemedicine practices during the pandemic started out being somewhat chaotic, partly because the healthcare system had long insisted that a doctor and a patient need to be in the same place at the same time physically for good medicine to take place. When Covid made that impractical and even undesirable, doctors, hospitals, urgent cares and others scrambled to come up with a workable system.
In some cases the payment system was the problem. In other cases, licensing across state lines was the problem — but many systems and doctors got credentials in other states, to make it work. Regulations of who had to be credentialed where seemed to work pretty well, for a time. Some states issued waivers, which lasted for a while; others made streamlined licensing processes.
Then one by one, starting as early as 2021, both legislatures and medical boards began rolling back telehealth access, reverting to pre-pandemic rules.
The Drug Enforcement Administration, which is in charge of telehealth regulations at the federal level, extended the telehealth flexibilities last October.
