Legislative record
Prescription drug coverage for rare diseases.
Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and makes a willful violation of the act a crime. Existing law provides for the regulation of health insurers by the Department of Insurance. Existing law sets forth specified prior authorization and step therapy limitations for health care service plans and health insurers. This bill would require a health care service plan contract or health insurance policy issued, amended, or renewed on or after January 1, 2027, to require a health care service plan or health insurer to complete prior authorization within 30 days upon initial request, as specified, for a drug approved by the United States Food and Drug Administration (FDA) for the treatment of a rare disease if the drug is prescribed by a specialist with expertise in the condition or disease being treated, the specialist has determined the drug is medically necessary, and the drug is the only FDA-approved treatment for the rare disease. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.