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US SB3019
Bill
AI Summary
- Amends the Medicare Drug Price Negotiation Program to change how orphan drugs (drugs for rare diseases) are treated for eligibility purposes
- Removes the previous blanket exclusion that protected certain orphan drugs from Medicare price negotiations
- Raises the Medicare spending threshold for orphan drug negotiation eligibility from $200 million to $400 million, meaning orphan drugs must have higher Medicare spending before becoming subject to price negotiations
- Applies only to drugs whose sole approved indications are for rare diseases as defined under section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act
- Takes effect for initial price applicability years beginning on or after January 1, 2028
Legislative Description
No Big Blockbuster Bailouts Act
Health
Last Action
Read twice and referred to the Committee on Finance.
10/21/2025
Committee Referrals
Finance10/21/2025
Full Bill Text
No bill text available