This bill ensures that Medicare will cover certain breakthrough medical devices during a four-year transitional period following their FDA approval. Breakthrough devices are those that receive priority review from the FDA because they represent significant advances in treating life-threatening or irreversibly debilitating conditions. Under the legislation, Medicare must cover these devices during the transition period unless they are used outside their FDA-approved instructions or pose undue risks that outweigh their clinical benefits. The bill also requires Medicare to make final coverage decisions on breakthrough devices before their transitional period ends, as long as coverage requests are submitted at least nine to twelve months before that deadline. The legislation allocates $10 million annually for fiscal years 2025 through 2030 to the Centers for Medicare & Medicaid Services to implement these changes and requires annual reporting to Congress on breakthrough device applications and designations.
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