A New Era for AI in Healthcare
A new bill introduced in the U.S. Congress aims to establish a steady reimbursement pathway for medical devices authorized by the U.S. Food and Drug Administration (FDA) that utilize artificial intelligence (AI) and machine learning, with a particular focus on radiology.
Understanding the Health Tech Investment Act
The Health Tech Investment Act, designated as S. 1399, was introduced by Senator Mike Rounds (R-SD) on April 9, 2025. The bipartisan legislation seeks to amend Title XVIII of the Social Security Act, facilitating appropriate payment for certain algorithm-based healthcare services under the Medicare program.
“Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer,” said Rounds in a prepared statement.
Currently, there is no clear Medicare payment system for these devices, which Rounds noted can lead to delays in approval and payment. This legislation aims to establish a robust framework that would enhance diagnostic capabilities and promote the integration of AI devices in clinical environments.
The Role of the FDA and CMS in AI Adoption
The FDA has been actively evaluating emerging AI technologies, particularly in radiology, where it has issued the most clearances compared to other healthcare specialties. Despite this, the U.S. Center for Medicare & Medicaid Services (CMS) lacks standardized methods for the coverage and payment of these innovative products.
According to Rounds, this variability could hinder AI’s implementation in clinical settings, subsequently affecting patient access. The proposed legislation would categorize all FDA-approved AI-enabled medical devices into a new technology ambulatory payment classification under the Hospital Outpatient Prospective Payment System (OPPS) for a minimum of five years, allowing for comprehensive data collection on delivery and service costs prior to assigning permanent payment codes.
Support from Industry Leaders
The Advanced Medical Technology Association (AdvaMed) expressed support for the introduction of the act, highlighting its potential to open new avenues for patients and physicians to benefit from AI technologies.
“Now is the time to establish a predictable reimbursement pathway,” stated Scott Whitaker, AdvaMed president and CEO.
Additionally, David Pacitti, chair of the AdvaMed Medical Imaging Division Board of Directors, commended the bill’s sponsors for their leadership and commitment to enhancing payment pathways for groundbreaking AI solutions, thereby increasing patient accessibility.
“Introduction of the Health Tech Investment Act is an important step towards expanding patient access to AI solutions in screening, diagnosing, and treating diseases,” Pacitti noted.
The act has bipartisan support, co-sponsored by Senators Martin Heinrich (D-NM) and Marsha Blackburn (R-TN). The complete text of the bill is available for those seeking further details.
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