The fate of reimbursement flexibilities for telehealth may very well be decided in 2024.
Multiple COVID-19-era temporary policies and regulations are set to expire in the coming year. Stakeholders across healthcare are gearing up for policy and rule changes that could alter everything from artificial intelligence and telehealth reimbursement to remote prescribing.
Read more: Telehealth companies lobby on prescribing as DEA mulls rule change
“It's the telehealth Super Bowl [in 2024],” said Kyle Zebley, executive director of ATA Action, a lobbying arm of the American Telemedicine Association.
Zebley and other experts say certain issues will require action from Congress while others can be largely addressed by agency rulemaking.
Remote prescribing rules could come early in 2024
Experts predict the most imminent permanent policy change may involve the remote prescribing of some controlled substances.
In May, the DEA extended flexibilities that allowed telehealth companies to remotely prescribe certain controlled substances without an in-person visit until November 2023. That temporary order was subsequently extended again in October until Dec. 31, 2024. The DEA's original proposed rule in February would have allowed Schedule III-V substances like codeine, Xanax and Ambien to be prescribed over telehealth for only an initial 30-day dose. After the 30 days, patients would need to see a doctor once to get a refill. Schedule II substances like Vicodin, OxyContin, Adderall and Ritalin would have gone back to fully requiring an in-person visit before getting prescribed virtually.
Jeremy Sherer, a partner and co-chair of the digital health practice at law firm Hooper, Lundy & Bookman, said the federal government is attempting to balance access to care with its diversion efforts around controlled substances.
“We [need] to figure out how to appropriately balance valid and important concerns about diversion of, in some cases, very powerful and potentially harmful medications with an obligation to pass laws and establish a framework that is going to enable folks to get the care they need," Sherer said.
The potential middle ground could be a special registration process for large telehealth providers, which is supported by various industry groups.
“I think you can just fully expect that there will be a special registration,” said Eric Triana, a former DEA official and chief compliance officer at Talkiatry, a telehealth company that prescribes certain Schedule III and Schedule IV controlled substances via telehealth. “Within that question is what are the details of the special registration? [Will] Schedule II [drugs be part] of this special registration or are they excluded? Then the next thing is what are the safeguards?”
For this special registration process, Triana said providers may be tasked with identifying where patients are physically located during a telehealth appointment and ensuring they're able to provide care with the proper licenses in that state. He said the DEA would likely collect some type of prescribing data including the types and strengths of drug, the percentage of a provider's patients that were prescribed a controlled substance and the dose of that prescription.
Tensions between pharmacists and telehealth companies surfaced as the two groups attempted to sway federal regulators during public listening sessions in September. Some pharmacists have been hesitant to fill prescriptions from out-of-state, virtual providers who are unfamiliar to them. Triana said a special registration would likely appease many of those concerns.
Telehealth reimbursement is on the clock
While remote prescribing's fate can be decided by federal agencies, telehealth reimbursement requires an act of Congress.
Waivers that extended telehealth reimbursement flexibilities until Dec. 31, 2024 were signed into law by President Joe Biden in December 2022. These telehealth reimbursement provisions will expire without congressional action.
These provisions include not requiring providers be licensed in the same state as the patient receiving care, allowing more types of practitioners to provide telehealth services, permitting audio-only telehealth services and delaying the in-person requirement for mental health patients seeking treatment through telehealth.
The December 2022 omnibus bill also extended telehealth services through 2024 for federally qualified health clinics and rural health clinics. The two-year extension also instructed the secretary of Health and Human Services to study how telehealth has affected Medicare beneficiaries’ overall health outcomes and whether there are geographic differences in use. This information, along with a review of medical claims data related to telehealth, is due by Oct. 1, 2024.
“We've got to get Congress to act on these Medicare flexibilities because they will lapse if Congress doesn't,” Zebley said. “That's just clear as day in black and white.”
Zebley and most experts agreed passing legislation in a presidential election year will be difficult. René Quashie, vice president of digital health at the Consumer Technology Association, said some reason for optimism exists.
“I think there's enough bipartisan enthusiasm for making sure that we're able to extend the delivery of care in a way that makes sense,” Quashie said. “We're going to have to rely on technology to extend the access of the clinical workforce, particularly in light of [workforce] shortages.”
Zebley said the flexibilites were supported across two presidential administrations, as they were initiated by former President Donald Trump and maintained by Biden.
What about AI?
Despite the industry's enthusiasm for AI, few are optimist that major legislation regulating the technology will become law in 2024.
While Biden’s sweeping executive order signed in October established the first set of standards on the use of AI in healthcare and other industries, most industry insiders said it will take time to understand its true scope. Individual federal agencies are responsible for enacting and following through on many of its provisions.
Quashie said CTA believes the current regulatory framework is adequate for healthcare AI.
“Because 2024 is an election year, and for a number of other reasons, I don't think we're going to have any major legislation passed in this space," Quashi said. “But I do think 2024 is a runway to 2025 when the new Congress is sworn in.”
