Healthcare
Prescription drug coverage for rare diseases
Starting in 2027, plans and insurers must act within 30 days on prior authorization for certain sole FDA-approved rare-disease drugs.
Patients with rare diseases may receive automatic approval when a plan or insurer delays a decision or an authorization dispute remains unresolved after 30 days.
What the law does
- Applies to health plan contracts and insurance policies issued, amended, or renewed on or after January 1, 2027.
- Requires prior-authorization decisions within 30 days of the initial request for an FDA-approved drug that is the only FDA-approved treatment for a rare disease.
- Limits the protection to drugs prescribed by a specialist with relevant expertise who determines the drug is medically necessary.
- Requires immediate approval if no decision is made within 30 days or a dispute remains ongoing at that deadline.
- Defines a rare disease as one affecting fewer than 200,000 people in the United States.
- Excludes Medi-Cal managed care contracts.
Who it affects
- Patients with qualifying rare diseases.
- Specialists and their staff submitting prior-authorization requests.
- Health care service plans and health insurers.
Context
Existing faster prior-authorization timelines remain unchanged.