Ensuring Patient Access to Critical Breakthrough Products Act of 2025

S 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, requires Medicare to cover FDA-designated "breakthrough" medical devices during a 4-year transitional period starting when the device is approved. This directly affects Medicare beneficiaries (Part A/B enrollees) and device manufacturers, ensuring coverage for these innovative products while FDA reviews their safety. The bill mandates that Medicare’s coverage decisions for these devices must be finalized within 9-12 months before the 4-year period ends, and allows coverage denial only if clinical data shows the device poses undue risk. It also allocates $10 million annually (2026-2031) to fund Medicare’s implementation of these coverage rules.