Senator Mike Rounds, US Senator for South Dakota | Official U.S. Senate headshot
Senator Mike Rounds, US Senator for South Dakota | Official U.S. Senate headshot
U.S. Senators Mike Rounds and Martin Heinrich have introduced new legislation aimed at enhancing health outcomes for Medicare patients by encouraging the use of AI-enabled medical devices. Known as the Health Tech Investment Act, the legislation seeks to create a consistent Medicare payment system for these technologies. This system is expected to provide earlier and more accurate diagnoses for patients.
"Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer," Senator Rounds stated. He further explained that the current lack of a clear Medicare payment system results in prolonged approval times, and this legislation addresses that gap, thus fostering the adoption of such devices in clinical settings.
Senator Heinrich expressed his support by stating, "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."
Randall Rutta, CEO of the National Health Council, highlighted the existing delays in patient access due to the slow pathway to coverage. "Too often the prolonged pathway to coverage for medical devices and technology delays patient access to the critical care they need," he said. The Health Tech Investment Act aims to expedite the process, which has become a pressing issue with the rapid pace of innovation.
Jane Veerman, an oncology clinical research nurse at Sanford Health, mentioned the potential impact on cancer patients in South Dakota, saying, "Senator Rounds' legislation to create a Medicare coverage pathway for AI-enabled medical devices will be an important development for cancer patients in South Dakota."
The background for the legislation notes that while the FDA has approved over 600 AI-enabled medical devices, the Center for Medicare & Medicaid Services (CMS) has yet to establish methods for covering and paying for these products. In addressing this inconsistency, the Health Tech Investment Act proposes a New Technology Ambulatory Payment Classification (APC) within the Hospital Outpatient Prospective Payment System for a minimum of five years.
Specifically, the legislation aims to formalize a payment pathway for AI-enabled devices, ensure patient access to innovative technology, and offer certainty to manufacturers and providers investing in next-generation healthcare technologies.
The bill has received endorsement from several organizations, including AdvaMed, Alliance for Aging Research, and the National Health Council.
Read the full bill text for detailed information.
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