On April 9, 2025, U.S. Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM) introduced the Health Tech Investment Act (S 1399), a bipartisan bill designed to create a Medicare payment system for algorithm-based healthcare services (AHBS). These services, delivered through FDA-cleared devices using artificial intelligence or machine learning, are increasingly common across medical specialties. For instance, AI-enabled devices in radiology analyze imaging faster and more accurately, improving patient outcomes. Despite over 600 FDA-approved AI-enabled devices, a consistent Medicare payment pathway remains absent. The proposed legislation seeks to address this by assigning AHBS to a new technology ambulatory payment classification (APC), providing stability in reimbursement and potentially spurring innovation. The new technology APC would serve as a transitional mechanism for at least five years, allowing the Centers for Medicare & Medicaid Services to collect data for a permanent APC. This bill builds on recommendations from the Bipartisan Senate AI Working Group and the Bipartisan House AI Task Force. While the bill has not progressed since its introduction, its enactment could significantly impact health tech innovation and patient access. Stakeholders should monitor this legislation for future developments.
By techgeekwire
