S. 3019 — No Big Blockbuster Bailouts Act

This section revises the exclusions from the list of selected drugs under the Medicare Drug Price Negotiation Program (i.e., the program that requires the Secretary of Health and Human Services to negotiate maximum fair prices for high-cost, single-source Medicare Part D and Part B drugs). For orphan drugs (i.e., those designated by FDA for one or more rare diseases or conditions and approved only for such indications), it increases the annual Medicare spending threshold for exclusion to $400 million (from $200 million). The changes apply to initial price applicability years beginning on or after January 1, 2028.