Health Affairs December 1, 2024
Abstract
Under the 21st Century Cures Act of 2016, a summary of the evidence used to support local coverage determinations, which represent the vast majority of Medicare’s coverage decisions for new technologies, must be made publicly accessible. Using reports from the Medicare Coverage Database on local coverage determinations and the medical literature, we examined the availability of these decisions and the quality of evidence cited for therapeutic drugs, biologics, and moderate- or high-risk devices during the period 2015–22 to understand whether evidence strength and generalizability differed for indications with favorable versus unfavorable coverage decisions. Evidence summaries were publicly available for 26 percent of coverage decisions...