US Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), co-chairs of the Senate Artificial Intelligence Caucus have introduced draft legislation titled the Health Tech Investment Act, which is aimed at improving health outcomes for Medicare patients by encouraging the use of cutting-edge, AI-enabled medical devices. The bill will assign all US Food and Drug Administration (FDA) approved AI-enabled medical devices to a New Technology Ambulatory Payment Classification (APC) in the Hospital Outpatient Prospective Payment System (OPPS) a minimum of 5 years so that adequate data regarding delivery and service costs is acquired before assignment of a permanent payment code. Specifically, the bill would: (1) develop a formalized payment pathway for ABHS FDA-cleared medical devices; (2) provide patients with access to innovative, AI-enabled clinical technology; (3) provide manufacturers and providers with the certainty they need to invest in developing next-generation healthcare technologies and bringing them to market, and (4) improve patient outcomes, providing resources for providers to meet ABHS standards of care.
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