Ensuring Patient Access to Critical Breakthrough Products Act of 2024

This bill creates a 4-year transitional coverage period for Medicare to automatically cover "breakthrough medical devices" - new FDA-prioritized devices approved after March 2021 - as "reasonable and necessary" for treatment. During this period, these devices qualify for additional payments under Medicare's hospital and outpatient payment systems without requiring separate approval. After the 4-year period, Medicare must develop regular coverage based on additional data, with automatic coverage for all approved uses if no action is taken within two years. The bill requires Medicare to assign unique codes for these devices within three months of FDA approval and to update payment systems regularly. It also includes special provisions for "specified breakthrough devices" that lack existing Medicare benefit categories, requiring reports on their impact and cost to Congress.