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Improved Access to Rare Disease Drugs: New Insurance Rules.

This act aims to improve access to medications for individuals with rare diseases, defined as conditions affecting 200,000 or fewer people in the U.S. It modifies drug coverage rules for Medicare and Medicaid programs and introduces an expedited appeal process for private health insurance denials. These changes are designed to help patients more easily obtain necessary treatments that might not have been covered previously.
Key points
Expanded Drug Coverage: Medicare and Medicaid will now cover drugs for rare diseases, even if their use isn't standardly approved, provided it's supported by medical literature.
Expedited Appeals: Private health insurance plans must implement a faster appeal process for denials of coverage for rare disease drugs.
Support for Patients: The changes aim to ensure individuals with rare diseases have a realistic opportunity to access medically supported treatments.
Effective Date: Most changes will take effect on January 1, 2027.
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Status:
Introduced
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Additional Information
PROTECT for Rare Act
Print number: S 3551
Sponsor: Sen. Tillis, Thomas [R-NC]
Process start date: 2025-12-17