Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications.

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 originally effected during 2015-18 and 100 percent during 2019-22. Among the latter, when compared with noncovered indications, indications with favorable coverage decisions cited twice the number of evidence sources (median, four versus two) and more often cited studies with a mean patient age of sixty-five and older (78 percent versus 47 percent). Fewer than one-third of all studies reported race or ethnicity data. There was no significant association between indication coverage and the study design strength of cited clinical studies. Although the 21st Century Cures Act enhanced transparency, clinical evidence that better reflects the Medicare beneficiary population is needed to inform local coverage determinations.