U.S. Senators Mike Rounds and Martin Heinrich have introduced the Health Tech Investment Act (S.1399) to facilitate Medicare reimbursement for FDA-approved AI tools in clinical care. The proposed legislation aims to eliminate financial barriers that hinder the adoption of artificial intelligence in healthcare by providing a temporary classification for AI-enabled medical devices under the New Technology Ambulatory Payment Classification in the Hospital Outpatient Prospective Payment System for five years.
This initiative addresses the reluctance of healthcare leaders to adopt new technologies without Medicare’s financial backing, especially in non-profits and rural hospitals operating with limited budgets. Over 600 AI-enabled devices have received FDA approval, but the Centers for Medicare & Medicaid Services (CMS) currently lack a consistent method for covering these products, leading to delayed adoption.
Supporters of the bill, including the National Health Council and the Advanced Medical Technology Association (AdvaMed), emphasize AI’s potential to improve patient care, particularly in fields like radiology. AI can expedite the analysis of medical images, leading to more accurate diagnoses and efficient healthcare resource utilization.
AdvaMed highlights the need for predictable reimbursement pathways to encourage technological advancements and broader adoption of AI in clinical settings. They note that AI-enabled devices authorized by the FDA can enhance diagnostic and therapeutic precision, thereby improving patient care.
The Health Tech Investment Act is seen as a necessary step to streamline the Medicare reimbursement process, promote innovation, and ensure healthcare providers can integrate new technologies without financial obstacles. The bill aims to create a supportive reimbursement structure to advance healthcare by embracing the critical role of AI.
