This bill amends the Social Security Act to modify the treatment of certain orphan drugs under the Medicare Drug Price Negotiation Program . It specifically revises Section 1192(e) to adjust how drugs designated for rare diseases or conditions are considered within the program's framework. The legislation increases a key financial threshold from $200,000,000 to $400,000,000 for orphan drugs that have received approval solely for one or more rare disease indications. This adjustment impacts the criteria or calculations related to the drug price negotiation process for these specific medications. The amendments made by this bill are slated to take effect for initial price applicability years beginning on or after January 1, 2028 .