STAT+: Medicare eliminates key pathways used by ‘breakthrough’ devices for extra payments

Medicare has announced the elimination of specific regulatory pathways that previously allowed medical devices designated as “breakthroughs” by the Food and Drug Administration to bypass standard qualification requirements for supplemental payments. This policy shift removes the flexibilities that enabled these devices to secure additional reimbursement from the federal program more easily than traditional medical technologies.

The change marks a significant adjustment in how Medicare manages the financial incentives for innovative medical equipment. By tightening the criteria for extra payments, the agency is effectively ending a process that allowed authorized breakthrough devices to leapfrog established administrative hurdles, potentially impacting the speed and ease with which new medical technologies are integrated into the Medicare payment structure.