WASHINGTON — U.S. Senators Martin Heinrich (D-N.M.) and Mike Rounds (R-S.D.), co-chairs of the Senate Artificial Intelligence Caucus, introduced the Health Tech Investment Act, legislation aimed at improving health outcomes for Medicare patients by encouraging the use of cutting-edge, artificial intelligence (AI)-enabled medical devices. The bill establishes a consistent and predictable Medicare payment pathway for these technologies, providing patients with earlier and more accurate diagnoses.
“I’m proud to cosponsor legislation that expands Medicare coverage of new technologies and helps New Mexicans get the best, most affordable high-quality care they need when they need it,” said Heinrich.
“Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer,” said Rounds. “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. This legislation would create that system, improving diagnoses and encouraging the adoption of AI devices in clinical settings.”
The use of AI in healthcare is quickly becoming the standard of care, with practitioners using algorithm-based healthcare services (ABHS) to detect and diagnose diseases sooner and advance better patient outcomes. The FDA has over 600 AI-enabled medical devices, but the Center for Medicare & Medicaid Services (CMS) lacks standard or consistent methods for covering and paying for these products. This inconsistency will, in the long run, impact the adoption and patient access to medically appropriate AI technologies across the country.
The Health Tech Investment Act will assign all U.S. 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) for 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 Health Tech Investment Act:
Develops a formalized payment pathway for ABHS FDA-cleared medical devices;
Provides patients with access to innovative, AI-enabled clinical technology;
Provides manufacturers and providers with the certainty they need to invest in developing next-generation healthcare technologies and bringing them to market; and
Improves patient outcomes, providing resources for providers to meet ABHS standards of care.
This legislation is endorsed by AdvaMed, Alliance for Aging Research, Brem Foundation to Defeat Breast Cancer, Focused Ultrasound Foundation, National Health Council, National Psoriasis Foundation, Patients Rising, and Right Scan Right Time.
The text of the bill is here.