ORPHAN Cures Act
Official title: A bill to amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.
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Read twice and referred to the Committee on Finance. (text: CR S3119)
Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act
This bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs.
The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The program does not apply to orphan drugs that are approved to treat only one rare disease or condition.
The bill modifies these provisions so as to exclude any period in which a drug was an orphan drug from market approval calculations. It also excludes orphan drugs that are approved to treat more than one rare disease or condition from the program.
- Introduced in Senate Formatted Text PDF Formatted XML
- EMD SERONO, INC.
- AVENUE SOLUTIONS
- INCYTE CORPORATION
- BOEHRINGER INGELHEIM USA CORPORATION, FORMERLY REPORTED AS BOEHRINGER INGELHEIM PHARMACEUTICALS, INC
- TRAVERE THERAPEUTICS
- TODD STRATEGY GROUP
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Health & Human Services, Dept of (HHS)
- Centers For Medicare and Medicaid Services (CMS)
- Executive Office of the President (EOP)
- White House Office
- Food & Drug Administration (FDA)
- Office of Management & Budget (OMB)
Cite this page
U.S. Congress. (2026). S. 1862: ORPHAN Cures Act. 119th Congress. Open America. https://openamerica.io/bill/119-S-1862/
"S. 1862: ORPHAN Cures Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-1862/.
S. 1862, 119th Cong. (2026), https://openamerica.io/bill/119-S-1862/.
[S. 1862: ORPHAN Cures Act](https://openamerica.io/bill/119-S-1862/)