Biological products.

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 also provides for the regulation of health insurers by the Insurance Commissioner. Existing law requires a health care service plan contract or a health insurance policy that provides coverage for outpatient prescription drugs to cover medically necessary prescription drugs, including nonformulary drugs determined to be medically necessary, and authorizes a health care service plan or health insurer to utilize formulary, prior authorization, step therapy, or other reasonable medical management practices in the provision of outpatient prescription drug coverage. With respect to a health care service plan contract or health insurance policy issued, amended, or renewed on or after January 1, 2021, that provides coverage for biological products or their respective biosimilars, as defined, this bill would prohibit a health care service plan or health insurer from determining which manufacturer's biological products or their respective biosimilars are to be used when medically necessary biological products or their respective biosimilars are prescribed. The bill would prohibit a health care service plan or health insurer that is subject to this provision from requiring prior authorization or step therapy to limit which manufacturer's biological products or their respective biosimilars are to be administered by a physician or clinician to an enrollee or insured. By imposing new requirements on a health care service plan, the willful violation of which is a crime, this 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.