SB 1094: Prescription drugs.

(1)The Pharmacy Law governs the practice of pharmacy in this state, including the permissible duties of licensed pharmacists. A knowing violation of the Pharmacy Law is a misdemeanor. Existing law authorizes a pharmacist to select an alternative biological product when filling a prescription order for a prescribed biological product if the alternative biological product is interchangeable, as defined, and the prescriber does not personally indicate in a specified manner that a substitution is not to be made.

This bill would additionally authorize a pharmacist to select an alternative biological product when filling a prescription order for a prescribed biological product if the alternative biological product is biosimilar to, as defined, or interchangeable with, the prescribed reference product, and the prescriber does not personally indicate in a specified manner that a substitution is not to be made. Because a knowing violation of this provision would be a misdemeanor, the bill would create a new crime, thereby imposing a state-mandated local program.

(2)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 prohibits a health care service plan that covers prescription drug benefits from limiting or excluding coverage for a drug that was previously approved for coverage if an enrollee continues to be prescribed that drug and that drug is appropriately prescribed and considered safe and effective for treating the enrollees medical condition. Existing law specifies that these provisions do not preclude a prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee or a generic drug substitution authorized by a pharmacist, as specified.

This bill would prohibit a health insurance policy that covers prescription drug benefits from limiting or excluding coverage for a drug that was previously approved for coverage if an insured continues to be prescribed that drug and the drug is appropriately prescribed, continues to be medically necessary for the treatment of the insureds medical condition, and is considered safe and effective for treating the insureds medical condition as demonstrated by evidence-based practice, as specified. condition. With respect to both health care service plans and health insurers, the bill would specify that these provisions do not prohibit a prescribing provider from prescribing a biosimilar drug substitution authorized by a pharmacist, as described above. The bill would authorize a health care service plan, health insurer, or utilization review organization to require an enrollee or insured to try an AB-rated generic equivalent of a brand name drug, a biosimilar, a biosimilar or interchangeable biological product of a reference product that was previously approved for coverage by the plan or insurer if specified conditions are met. The bill would prohibit a pharmacy benefit manager, health care service plan, health insurer, or affiliated entity from requiring utilization of only a biosimilar product in which the entity has a direct or indirect financial interest if biosimilars not affiliated with these entities may also be available. Because a violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program.

(4)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.