Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies.

Abstract

A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies. To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway. In this cross-sectional study, public databases were used to associate each techn