Health Affairs September 5, 2023
The rapid evolution of artificial intelligence and other forms of machine learning (AI/ML) in health care has exposed the need for federal coverage and payment policies that promote innovation and protect patient interests. While the Food and Drug Administration (FDA) has moved forward to regulate software as a medical device (SaMD), and the American Medical Association (AMA) has deployed a framework for coding AI/ML in the Current Procedural Terminology (CPT), the Centers for Medicare and Medicaid Services (CMS) has yet to establish consistent methods for the coverage and payment of these technologies. The discrepancy between the FDA and CMS policy has vast implications in an era of ever-expanding digital solutions. In this piece, we examine the current situation and propose...