Senators seek to fast-track payments for AI-enabled medical devices 

WASHINGTON – U.S. Sens. Mike Rounds, R-S.D., and Martin Heinrich, D-N.M., have introduced legislation aimed at improving health outcomes for Medicare patients by encouraging the use of cutting-edge, artificial intelligence-enabled medical devices. 

The Health Tech Investment Act would establish a consistent and predictable Medicare payment pathway for these technologies, providing patients with earlier and more accurate diagnoses, the senators say. 

“Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer,” said Rounds. “There is currently no clear Medicare payment system for these devices, meaning that it can take years to be approved and paid out by Medicare accurately. This legislation would create that system, improving diagnoses and encouraging the adoption of AI devices in clinical settings.” 

Rounds and Heinrich are co-chairs of the Senate Artificial Intelligence Caucus. 

The Health Tech Investment Act would assign all U.S. Food and Drug Administration approved AI-enabled medical devices to a New Technology Ambulatory Payment Classification (APC) in the Hospital Outpatient Prospective Payment System (OPPS) for a minimum of five years so that adequate data regarding delivery and service costs is acquired before assignment of a permanent payment code. 

Specifically, the act would: 

• Develop a formalized payment pathway for ABHS FDA-cleared medical devices. 
• Provide patients with access to innovative, AI-enabled clinical technology. 
• Provide manufacturers and providers with the certainty they need to invest in developing next-generation health care technologies and bringing them to market. 
• Improve patient outcomes, providing resources for providers to meet ABHS standards of care. 

The legislation is endorsed by AdvaMed, Alliance for Aging Research, Brem Foundation to Defeat Breast Cancer, Focused Ultrasound Foundation, National Health Council, National Psoriasis Foundation, Patients Rising and Right Scan Right Time. 

Click here to read full bill text.