The U.S. Senate has taken a significant step towards modernizing healthcare through the introduction of the Health Tech Investment Act (S. 1399). This bipartisan legislation, sponsored by Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), aims to create a Medicare reimbursement pathway for medical devices that utilize artificial intelligence and machine learning.

The proposed bill seeks to amend Title XVIII of the Social Security Act to ensure appropriate payment for algorithm-based healthcare services under the Medicare program. This represents a crucial shift in how innovative medical technologies are integrated into patient care.

According to the bill, the Secretary of Health and Human Services will assign eligible AI-enabled devices to a new technology ambulatory payment classification (APC), determined based on cost data provided by the service manufacturer. This data will encompass various expenses, including invoice prices, subscription fees, clinical staff costs, and overhead.

Notably, the bill stipulates that these services must remain within the new technology APC for a minimum of five years before any reassignment is made. The adjustments to the application process and new criteria for APCs are designed to accommodate AI-driven services that are distinct yet performed concurrently with existing modalities.

This legislation is part of a broader trend in healthcare, amplifying discussions around the role of AI. Earlier this year, the House of Representatives proposed H.R.238, which would permit AI and machine learning to autonomously prescribe FDA-approved drugs, further advancing the integration of artificial intelligence in healthcare.