Medicare’s coverage rules serve as the gateway for the adoption and use of new medical devices. Thus, the Centers for Medicare and Medicaid Services’ (CMS’) new proposed regulation to streamline the coverage pathway for medical devices has important implications, not only for patient access to new technology, but for evidentiary standards, Medicare spending and the incentives for product manufacturers as they invest in further advances. Medicare officials have touted the degree to which the reforms would speed patient access to new devices, enhance the predictability of the process, and even improve health outcomes. However, the proposal raises questions and concerns, and risks eroding decades of progress made to bolster the scientific evidence underlying coverage decisions for medical technology.
