U.S. Senators Mike Rounds and Martin Heinrich have introduced new legislation intended to establish a standardized Medicare reimbursement pathway for AI-enabled medical devices.

The Health Tech Investment Act seeks to reduce delays in coverage and promote broader access to technologies that support earlier disease detection and diagnosis.

According to the bill’s sponsors, the current lack of a consistent Medicare payment mechanism for FDA-cleared AI-enabled devices can delay patient access by years. The proposed legislation would place these devices into a new technology ambulatory payment classification (APC) under the Hospital Outpatient Prospective Payment System for at least five years. This window is intended to allow the Centers for Medicare & Medicaid Services to collect data before assigning a permanent payment code.
“Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer,” Rounds said. “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.”

The act aims to provide clarity to manufacturers and providers investing in algorithm-based healthcare services. While over 600 AI-enabled devices have been cleared by the FDA, inconsistent reimbursement practices have posed challenges to implementation.

“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, which has endorsed the bill.

Supporters say the bill could improve access to advanced technologies in rural areas where hospitals often lack resources to adopt innovations. Backers include AdvaMed, Alliance for Aging Research, Patients Rising, and several disease-focused advocacy groups.

If enacted, the legislation would formalize reimbursement for FDA-cleared AI medical tools, with the goal of aligning Medicare policy with rapid developments in digital health.

The proposal now awaits review by the Senate committee to which it was referred.

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