Bill seeks Medicare category for digital therapeutics

Lawmakers in the US have reintroduced legislation that aims to encourage the adoption of prescription digital therapeutics (DTx) by creating a dedicated benefit category for these products in Medicare and Medicaid.

This Access to Prescription Digital Therapeutics Act would introduce a framework that will allow Medicare and Medicaid to cover and create product-specific codes for DTx, setting up a payment system that according to commentators could greatly increase the availability of prescription DTx in the US.

Industry group the Digital Therapeutics Alliance (DTA) said the bipartisan legislation is “a critical step toward expanded patient access and appropriate reimbursement” as, if it comes into law, it will allow more healthcare professionals to prescribe DTx products – and ensure the health of the category, as developers will find it easier to get a return on their investment.

The reintroduction of the act comes amid growing evidence that DTx can complement other therapies for a wide range of health conditions – potentially reducing costs and improving patient engagement – but also as the sector runs the risk of being held back by a lack of clinical, regulatory, and reimbursement standards around the world.

It is the second attempt to get the bill through after it was first introduced in March 2022, with versions under consideration in both the House of Representatives (HR 1458) and Senate (S 723), that have identical wording to the earlier version other than implementation dates.

Backers of the bill suggest that getting the Centres for Medicare and Medicaid Services (CMS) to introduce a reimbursement framework will also encourage private payers to cover DTx.

It has been introduced by Senators Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV), and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA), who say that it reflects the growing recognition of the clinical and health economic value that DTx products provide to patients, caregivers, and clinicians.

“Prescription digital therapeutics are tested and regulated like traditional prescription medication, so it’s common sense that we remove barriers to care for those who respond positively to this kind of treatment,” said Shaheen.

Capito, meanwhile, said the act would “allow more patients living with a broad variety of diseases and conditions – from substance and opioid use disorders, and mental and behavioural health issues, to diabetes and Parkinson’s disease – to more efficiently access the care and support they need and deserve.”

The legislation defines a prescription DTx as “a product that uses software to achieve its intended result, is cleared or approved by the […] FDA for the prevention, management, or treatment of a medical condition, and is authorised by a qualified, licensed clinician.”

It has been applauded by the Academy of Managed Care Pharmacy (ACMP), which said that prescription DTx are “an impressive example of harnessing technological innovation to treat and manage illnesses for millions of Americans.”