Bipartisan Health Tech Investment Act Will Enhance Patient Access to AI-Enabled Medical Devices
- Bill Will Establish a Stable Reimbursement Pathway for AI-Enabled, FDA-Cleared Medical Devices
- AdvaMed Urges Swift Passage of Legislation to Improve Care Pathways
WASHINGTON – AdvaMed, the Medtech Association, today commended Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM) for introducing the Health Tech Investment Act (S. 1399). This landmark bipartisan legislation will establish a stable reimbursement pathway for medical devices authorized by the U.S. Food & Drug Administration (FDA) that rely on artificial intelligence (AI) and machine learning (ML), also known as Algorithm-Based Healthcare Services (ABHS).
AI’s role in improving patient care is already evident and increasing, particularly in radiology, where AI can help doctors and other healthcare professionals swiftly analyze medical images, detect illness and abnormalities, and make a more informed diagnosis. Moreover, FDA authorized AI-enabled medical devices are poised to save the health care system resources due to enhanced diagnostic and therapeutic precision that can help drive efficient and effective care.
Scott Whitaker, President & CEO of AdvaMed, said: “With AI-enabled medical technologies already making remarkable strides in patient care, and with even more incredible strides ahead of us, now is the time to establish a predictable reimbursement pathway. We thank Senators Rounds and Heinrich for their leadership and strongly urge Congress to pass this bipartisan legislation. It is critical to advancing the medical progress upon which patients depend and which is being driven by medtech.”
Peter J. Arduini, President & CEO of GE HealthCare, and Chair of AdvaMed’s Board of Directors, said: “Senator Rounds and Senator Heinrich have shown their deep knowledge of how AI is used in health care, and we greatly appreciate their leadership. The Health Tech Investment Act would help bring beneficial medical innovation to patient care by ensuring a clear payment pathway for algorithm-based health care services. We look forward to working with members of Congress to pass this important legislation and help bring these latest technologies to patients.”
Dave Pacitti, President, Siemens Medical Solutions USA, Head of the Americas, Siemens Healthineers, and Chair of the AdvaMed Medical Imaging Division Board of Directors, said: “I applaud Senator Rounds and Senator Heinrich for their leadership in establishing improved payment pathways for innovative AI software and devices, such as Algorithm-Based Healthcare Services, to increase adoption and expand access for all patients. Introduction of the Health Tech Investment Act is an important step towards expanding patient access to AI solutions in screening, diagnosing, and treating cancer, neurovascular, cardiovascular, and other diseases.”
Limited reimbursement for AI-enabled medical devices creates challenges for physicians and health systems looking to integrate FDA-authorized AI technologies into the care continuum. By establishing a consistent and stable payment pathway for ABHS, the Health Tech Investment Act will help expand opportunities for patients and physicians to benefit from AI-enabled medical devices.
In the previous Congress, the Senate and House Appropriations Committee and bipartisan Senate and House AI Task Forces each addressed the importance of establishing a payment pathway for AI-enabled medical devices in policy reports and roadmaps.
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