US SB3551

Expands Medicare, Medicaid, and Medicare Part D coverage to include drugs used for treating rare diseases or conditions affecting 200,000 or fewer individuals in the United States, effective January 1, 2027

Allows coverage for off-label drug uses when supported by peer-reviewed medical literature or clinical guidelines, provided the use is not listed as contraindicated in FDA-approved labeling or drug compendia

Requires private health insurers (group and individual plans) to establish expedited appeals processes for patients denied coverage of FDA-approved drugs used to treat rare diseases

Amends the Social Security Act, Public Health Service Act, ERISA, and Internal Revenue Code to implement these coverage requirements across public and private insurance systems

Introduced December 17, 2025 by Senators Tillis (R-NC) and Heinrich (D-NM) and referred to the Senate Committee on Finance