Prescription drug coverage for rare diseases.
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Majority
Fiscal committee
No
Appropriation
No
Current location
In Floor Process
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Assembly
- Passed Senate
- To Governor
- Became Law
Overview
This bill aims to improve access to prescription drugs for patients with rare diseases in California. It requires health care service plans and health insurance policies issued on or after January 1, 2027, to expedite prior authorization processes for these medications, aiming for a 30-day turnaround. The bill also prohibits ‘step therapy,’ which requires patients to try alternative treatments before receiving a rare disease drug, unless a suitable alternative is available. It clarifies the definition of ‘rare disease’ and includes an exception for Medi-Cal managed care contracts.
Key provisions
- Requires health plans to complete prior authorization within 30 days for rare disease drugs prescribed by specialists.
- Prohibits ‘step therapy’ for rare disease drugs unless biosimilar, interchangeable, or generic options are available.
- Defines ‘rare disease’ as affecting fewer than 200,000 people in the United States.
- Excludes Medi-Cal managed care contracts from the requirements.
- Establishes a 30-day timeframe for initial prior authorization requests.
- Specifies that approval occurs if a decision isn't made within 30 days or a dispute remains ongoing.
- Clarifies that a specialist’s determination of medical necessity is key for prior authorization.
- States that no reimbursement is required for local agencies or school districts due to the creation of a new crime.
Who is affected
- Patients with rare diseases
Bill text
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Sponsors
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14 on record
Primary sponsor
Cosponsors
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