CMS Ends Automatic Medicare Add-On Payments for Breakthrough Devices

CMS has finalized removal of the pathway that let FDA "breakthrough"-designated devices automatically qualify for supplemental Medicare payments, including new technology add-on payments and transitional pass-through payments, without demonstrating substantial clinical improvement or novelty. Device manufacturers are affected most directly, since new breakthrough-designated products will need to meet standard evidentiary requirements to secure extra payment starting in October. The change follows an August CMS rule finalizing the policy shift. While this is a Medicare payment policy change, Medicaid stakeholders should track it because device coverage and payment precedents set in Medicare often influence state Medicaid fee schedules and managed care benefit design for the same technologies.