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Bill Introduced to Expedite AI Medical Devices

by The O&P EDGE
April 11, 2025
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US Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM), cochairs of the Senate Artificial Intelligence Caucus, introduced legislation to improve health outcomes for Medicare patients by encouraging the use of artificial intelligence (AI)-enabled medical devices. The Health Tech Investment Act (S. 1399) would establish a consistent and predictable Medicare payment pathway for these technologies, providing patients with earlier and more accurate diagnoses, the legislators said.

“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.”

“Too often the prolonged pathway to coverage for medical devices and technology delays patient access to the critical care they need,” said Randall Rutta, CEO of the National Health Council. “This issue has intensified as the pace of innovation has increased. The National Health Council is pleased to support the Health Tech Investment Act to help patients gain timely access innovative health solutions.”

The use of AI in healthcare is quickly becoming the standard of care, with practitioners using algorithm-based healthcare services to detect and diagnose diseases sooner and advance better patient outcomes. The US Food and Drug Administration has over 600 AI-enabled medical devices, but the Centers for Medicare & Medicaid Services lacks standard or consistent methods for covering and paying for these products. The Senators believe the inconsistency will, in the long run, impact the adoption and patient access to medically appropriate AI technologies across the country.

Read the Health Tech Investment Act here.

 

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