A bipartisan group of U.S. senators has introduced the Health Tech Investment Act (S. 1399), aimed at establishing a Medicare reimbursement pathway for FDA-cleared medical devices that use artificial intelligence and machine learning. Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.) are leading the initiative, which seeks to amend Title XVIII of the Social Security Act to ensure appropriate Medicare payment for algorithm-based healthcare services. The legislation proposes assigning eligible AI-enabled devices to a new technology ambulatory payment classification (APC), with cost-based data submitted by the manufacturer to determine the classification.
The proposed law mandates that services placed within the new APC remain there for at least five years, allowing time for comprehensive data collection before reassignment. The Secretary of Health and Human Services would also be responsible for adjusting the application process and eligibility criteria to accommodate AI-based services with a clearly defined structure and distinct resource requirements. Additionally, the U.S. House of Representatives is considering a separate bill, H.R. 238, which would permit FDA-authorized AI technologies to autonomously prescribe approved medications under certain state regulations. If enacted, the bill would amend the Federal Food, Drug, and Cosmetic Act to formally recognize AI as a licensed prescribing practitioner.
