Capito introduces legislation to expand Medicare coverage of PDTs

U.S. Senator Shelley Moore Capito (R-WV) on Wednesday introduced a bipartisan, bicameral bill that would provide Medicare coverage of prescription digital therapeutics (PDTs) under current law.

“Prescription digital therapeutics are an excellent example of how innovative technology can address some of the health challenges providers and patients continue to face,” Sen. Capito said. “I’m proud to join my colleagues and reintroduce this important legislation.”

The Access to Prescription Digital Therapeutics Act of 2023, S. 723, aims to increase access to PDTs, which are software-based disease treatments, including products, devices, internet applications, or other technology that are designed to directly treat disease, according to the text of the bill. 

The bill is sponsored by U.S. Sen. Jeanne Shaheen (D-NH), who joined three original cosponsors, including Sen. Capito and U.S. Sen. Marsha Blackburn (R-TN), to introduce the bill on March 8. The same-named companion bill, H.R. 1458, was introduced on the same day by U.S. Reps. Kevin Hern (R-OK), Bill Johnson (R-OH), and Mike Thompson (D-CA).

“The Access to Prescription Digital Therapeutics Act would allow more patients living with a broad variety of diseases and conditions — from substance and opioid use disorders and mental and behavioral health issues to diabetes and Parkinson’s disease — to more efficiently access the care and support they need and deserve,” added Sen. Capito.

Specifically, the Access to Prescription Digital Therapeutics Act of 2023 would expand Medicare coverage to include PDTs in which patients receive cognitive therapy through software, says a bill summary provided by the lawmakers that also notes PDTs are tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration and prescribed by healthcare providers.

Additionally, the bill would require that not later than one year after the date of enactment, the government would establish a payment methodology for manufacturers of PDTs, which may consist of a one-time payment or periodic payments, as would be determined appropriate, according to the bill’s text.