The US Centers for Medicare and Medicaid Services (CMS) codified an alternative new technology add-on payment (NTAP) pathway for Food and Drug Administration-approved breakthrough devices, while updating “substantial clinical improvement” NTAP review policies, in a new Inpatient Prospective Payment System (IPPS) rule.
The changes were made to incentivize creation of new technologies to treat Medicare beneficiaries, and better help device and diagnostic sponsors understand how the agency evaluates new technology applications for...