CMS and FDA announce RAPID pathway for faster Medicare coverage of breakthrough devices

CMS and the FDA jointly launched the RAPID Coverage Pathway, a new program designed to accelerate Medicare coverage of FDA-designated breakthrough medical devices. The initiative aims to synchronize the FDA approval and CMS national coverage determination processes to reduce the traditional lag, which can be several years, between device approval and Medicare reimbursement. For practices, this signals faster patient access to novel technologies like advanced diagnostics and implantable devices, but also introduces new coding and coverage education requirements as these products reach the market.