S 1862 119th Congress
ORPHAN Cures Act
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.
Official Title as Introduced Congress.gov
Open official Congress.gov recordSource-linked procedural record
Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
Open bill recordOfficial action Congress.gov
Read twice and referred to the Committee on Finance. (text: CR S3119)
Open bill recordOfficial action Congress.gov
Introduced in Senate
Open bill recordText version Congress.gov
Introduced in Senate
A dated text-version record is available.
Open text record
View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Finance. (text: CR S3119) | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov |
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Congressional Research Service
CRS summary
Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures ActThis 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.
Official documents
Text versions
- Introduced in SenateMay 22, 2025