Telehealth industry and mental health groups are scrambling amid fears the Drug Enforcement Administration is poised to place strict limits on remote prescribing of controlled substances such as Adderall and Vicodin.
The legal authority for clinicians to prescribe DEA-regulated medications through platforms such as Talkiatry expires in less than four months, and the law enforcement agency has moved slowly to issue a final rule after the draft version released last year triggered protests from providers and telehealth companies.
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Anxiety among telehealth stakeholders soared last Wednesday, when Politico Pro reported the DEA intends to produce a regulation that would narrow the list of drugs that remote providers can prescribe and require them to verify that patients aren't seeking medicines to misuse them. That report is unconfirmed and was attributed to an unnamed former DEA official.
According to Politico Pro, the DEA is planning to impose tighter restrictions on providers who remotely prescribe Schedule II drugs such as Vicodin, OxyContin, Adderall and Ritalin and end remote prescribing of Schedule III-V drugs such as codeine, Xanax and Ambien. The agency would also limit providers to remotely prescribing only 50% of their total prescriptions, the publication reported.
The DEA did not respond to a request for comment.
The American Telemedicine Association and allied organizations are now calling on the White House to pressure the DEA to extend the current remote prescribing flexibilities, which emerged during the COVID-19 pandemic, for another two years and are asking Congress to step in.
The Alliance for Connected Care is seeking signatories to letters endorsing a two-year extension, which it intends to deliver to White House Domestic Policy Council Director Neera Tanden, House Speaker Mike Johnson (R-La.), House Minority Leader Hakeem Jeffries (D-N.Y.), Senate Majority Leader Chuck Schumer (D-N.Y.) and Senate Minority Leader Mitch McConnell (R-Ky.).
"Millions of Americans will lose access to critically important mental health care treatment on December 31, 2024, unless the administration acts. We need your leadership to ensure that the Drug Enforcement Agency (DEA) [sic] preserves this access," the letter to Tanden says. The letter to the legislative leaders says, "We urge you to include, in the end-of-year legislative package, a two-year extension of prescribing flexibilities."
Sen. Mark Warner (D-Va.), a former information technology executive, pounced on the Politico Pro report to criticize the DEA.
“We don’t need an arbitrary new set of regulations — we just need DEA to set up the minimum training requirements for providers and a special registration that allows the DEA to do its job to monitor telemedicine prescribing of these medications and catch bad actors,” Warner said in a news release last Wednesday.
The DEA's mission is to stem the proliferation of drugs of abuse, which can be at odds with the needs of healthcare providers, patients and telehealth vendors. The agency has a mandate to limit access to controlled substances but was also tasked with updating its rules to facilitate convenient access to medicines to treat mental health conditions, pain and other ailments, especially for people who live in areas with few providers.
Moreover, some in the telehealth space have lent credence to a restrictive approach to remote prescribing.
For instance, the Justice Department is prosecuting two top executives from the digital behavioral health company Done on charges that the company knowingly prescribed Adderall to patients who did not have attention-deficit/hyperactivity disorder. According to an indictment issued in June, Done founder and CEO Ruthia He and Clinical President Dr. David Brody oversaw a $100 million Adderall distribution and healthcare fraud scheme. ADHD medications such as Adderall and Ritalin are often used recreationally.
But Dr. Shabana Khan, chair of the American Psychiatric Association’s committee on telepsychiatry, said telemedicine prescribing flexibilities have benefited patients without access to nearby mental health providers. The potential for a restrictive rule raises massive concerns for care, she said.
Eric Triana, chief compliance officer at Talkiatry and a former DEA official, said such a rule could force providers into hybrid business models. Aspects of the rule, as described by Politico Pro, also would be unreasonably burdensome, he said.
"I have no idea why anyone would enact such a 50% rule. That's arbitrary, capricious, and not based on any evidence of diversion," Triana said.
While interested parties await word from the DEA itself, they are preparing as though a restrictive regulation is coming.
For starters, providers and telemedicine companies should assess whether they meet exceptions under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which would allow them to continue remotely prescribing controlled substances, said Nathaniel Lacktman, a partner and chair of the law firm Foley & Lardner’s telemedicine and digital health industry practice.
Under the Ryan Haight Act, providers may remotely prescribe in certain circumstances, such as when patients are in hospital or clinics or Veterans Health Administration or Indian Health Service facilities, during a public health emergency declaration or as permitted by other laws and regulations, Lacktman said.
Providers that don't quality under the Ryan Haight Act should start thinking about continuity of care for their patients, Lacktman said. Most state medical boards require providers to give at least 30 days’ notice if they can’t maintain treatment, he said. That means notices will have to start going out soon since the current policy lapses at the end of the year.
Telemedicine providers without physical locations should also consider ways to offer prescriptions in person, such as through house calls or at health fairs, Lacktman said. Providers should also start the DEA registration process, he said.
The proximity to Election Day is another complication because the DEA may seek to delay issuing a rule until campaign season is over, or even wait until a new president takes office in January, said Kyle Zebley, senior vice president of public policy for the American Telemedicine Association. That makes it even more urgent for President Joe Biden to act before the calendar turns, he said.
“This White House would argue, understandably, that they're out there fighting and advocating for these communities, day in, day out. Well, they have a major area to act upon here in order to continue to advocate for them, because they're going to sever the continuity of care if we don't have a permanent, workable framework in place, come Jan. 1.”
