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Pdf Summary

This document discusses the incorporation of artificial intelligence (AI) into Medicare coverage and payment processes. It highlights the 21st Century Cures Act, which outlines policy development procedures for Medicare Administrative Contractors (MACs) and emphasizes the requirement for services to be "reasonable and necessary" for coverage. The act also redefines the Contractor Advisory Committee and mandates the inclusion of a summary of evidence/rationale for coverage determination.<br /><br />The document also mentions the Azar vs. Allina case, where the Supreme Court ruled that the Department of Health and Human Services did not follow the proper procedures for public comment when making substantive changes to Medicare policy. The case specifically addressed changes in coverage and payment (pricing).<br /><br />The definition of AI is referenced from an executive order and an act promoting the use of trustworthy AI in the federal government. The document then explores the domains of model performance, which include clarity on intended use, datasets, generalizability to the Medicare population, analytic validity, clinical validity, and clinical utility. It also highlights the performative technology assessment program, which focuses on specific model techniques and performance metrics.<br /><br />The document briefly mentions CMS guidance documents on artificial intelligence at CMS. Overall, it provides an overview of the integration of AI into Medicare coverage and payment processes, highlighting key legislation, considerations for model performance, and the need for transparency and outcome measures.

Keywords

artificial intelligence

Medicare

21st Century Cures Act

Medicare Administrative Contractors

Azar vs. Allina

coverage determination

model performance

clinical utility

CMS guidance

policy development