Advocates are renewing a push this year for federal legislation that would ease the path to reimbursement for prescription digital therapeutics in behavioral health.

The legislation – reintroduced in March – enjoys bipartisan support. Nonetheless, it could face an uphill battle in Congress. That’s because the legislation would add costs to Medicare at a time when lawmakers are sensitive about saddling the program with more spending. The bill covers prescription digital therapeutics for both physical and behavioral health.

An industry-backed study three years ago pegged the cost at $500 million over a 10-year period, said Andy Molnar, CEO of the Digital Therapeutics Alliance, an industry trade association based in Arlington, Virginia.

However, advocates argue that prescription digital therapeutics ultimately could save costs while expanding access to critical behavioral healthcare. 

“The promise of digital is, over time, we’ll be able to provide care to patients at a much lower cost than what we’re probably paying now,” said Joe Perekupka, CEO of Kirkland, Washington-based Freespira, which makes an FDA-cleared digital therapeutic used by people with panic disorders and post-traumatic stress disorder. Available by prescription only, the company’s 28-day treatment uses an app and a handheld tablet to help people better regulate their breathing.

The Centers for Medicare & Medicaid Services took a step forward last year, in the industry’s eyes, when it introduced what is known as a Level II Healthcare Common Procedure Coding System code for “prescription digital behavioral therapy.”

The code helps pave the way for commercial payers to offer reimbursement, Perekupka said. But companies seeking reimbursement still have to go payer by payer, making it a slow-moving process.

The proposed legislation, called the Access to Prescription Digital Therapeutics Act, would require the Centers for Medicare & Medicaid Services to create reimbursement codes for prescription digital therapeutics. That would offer a better-defined pathway for commercial payers, potentially accelerating the reimbursement process.

“Providing alternative ways to access care is essential in the increasingly modern times in which we live,” U.S. Rep. Mike Thompson, a Democrat who represents portions of the San Francisco Bay area, said in a statement emailed by a spokesperson. “Prescription digital therapeutics have been shown to improve outcomes for people struggling with mental health issues, making clear the importance of alternative treatment methods.”

Thompson’s co-sponsors come from both parties and both chambers of Congress: Rep. Kevin Hern, an Oklahoma Republican; Sen. Jeanne Shaheen, a New Hampshire Democrat; and Sen. Shelley Moore Capito, a West Virginia Republican.

Lawmakers introduced similar legislation in March 2022 but it did not move. Advocates hope this year will be different and are working toward an important first step for the legislation: Having its costs estimated, or scored, by the Congressional Budget Office.

“It takes time to get a score, but we’re really hoping with all the pressure that we’re applying right now that we end up getting a score sooner rather than later,” said Sara Elalamy, director of U.S. government affairs for the Digital Therapeutics Alliance.

Perekupka said he is optimistic the legislation will move this year.

“There’s a lot of focus on mental health and substance-use disorder,” he said. “And there are some incredible technologies, not just Freespira, but some really great technologies and products out there that can actually help patients.”

Pittsburgh-based health insurer Highmark studied the impact of Freespira on more than 1,500 of its health plan members. Highmark members in the study used Freespira for one month. A year later, the health plan saw a 35% reduction in medical costs and a 65% reduction in emergency department costs for those members. More than two-thirds, or 68%, saw a remission of their panic symptoms.

However, the Congressional Budget Office is unlikely to take savings into account when it scores the new legislation, Molnar added. Nonetheless, he said of prescription digital therapeutics, “We do see this as a way to make healthcare more effective and more efficient.”

Photo: MikeyLPT, Getty Images