It takes more than five years for new medical technologies to garner Medicare coverage in the US, according to a new analysis appearing in JAMA Health Forum. Researchers from Stanford University examined 64 devices or diagnostics that received premarket approvals, de novo authorizations, or 510(k) clearance with breakthrough device designations from the US Food and Drug Administration between 2016 and 2019. Of these, 44 percent reached a Medicare coverage milestone during the study timeline — they found the median time to nominal coverage was 5.7 years. The researchers note, though, that there was variability in time to coverage by manufacturer size with larger manufacturers getting coverage faster and by product type with diagnostic assays getting coverage faster. "The time required to establish at least nominal coverage results in uneven beneficiary availability and stretches longer than the time to average FDA authorization," the researchers write in their paper. "These data highlight the need for establishment of a more efficient and timely reimbursement process for novel FDA-authorized medical devices and diagnostics."
Analysis Finds Span of Years for New Technologies to Get Medicare Coverage in US
Aug 04, 2023