On April 9, 2025, U.S. Sens. Mike Rounds, Republican of South Dakota, and Martin Heinrich, Democrat of New Mexico, launched a invoice titled the Well being Tech Funding Act (S 1399). The proposed invoice would amend Title XVIII of the Social Safety Act to create a Medicare fee system for algorithm-based healthcare companies (AHBS), outlined within the proposed laws as companies delivered via FDA-cleared or -approved units that use synthetic intelligence (AI), machine studying, or related software program to yield medical outcomes to be used by healthcare professionals to diagnose and deal with ailments.
Using AHBS in healthcare has change into more and more widespread throughout medical specialties. In radiology, for instance, AI-enabled units are incessantly used to investigate imaging sooner and extra precisely, resulting in improved well being outcomes for sufferers. In line with the press releases of the 2 invoice sponsors, FDA has permitted over 600 AI-enabled units. However, there nonetheless isn’t any constant and predictable fee pathway for using these units in healthcare supply below Medicare.
The Healthcare Tech Funding Act seeks to handle this concern by assigning AHBS to a brand new know-how ambulatory fee classification (APC). This may create stability and certainty within the reimbursement course of, which might spur innovation and enhance entry by sufferers to health-improving and life-saving applied sciences. Beneath the laws, the brand new know-how APC is designed as a transitional reimbursement mechanism that might be assigned to a tool for a minimum of 5 years. This strategy would offer the Facilities for Medicare & Medicaid Providers with the time wanted to gather sufficient knowledge on supply and repair prices to adequately decide a everlasting APC for the know-how.
Final session, publications issued by the Bipartisan Senate AI Working Group (AI Coverage Roadmap, Could 2024) and the Bipartisan Home AI Activity Pressure (Report on AI, December 2024) included suggestions to determine a steady pathway for reimbursing AI-enabled units below Medicare. The Well being Tech Funding Act, which builds on these earlier efforts, has not progressed because it was launched and referred to the Committee on Finance in early April. If enacted, nevertheless, the invoice would have important implications for well being tech innovation and affected person entry to those units.
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