HIV: preexposure and postexposure prophylaxis.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy and makes a violation of these requirements a crime. Existing law generally authorizes a pharmacist to dispense or furnish drugs only pursuant to a valid prescription, except as provided, such as furnishing emergency contraceptives, hormonal contraceptives, and naloxone hydrochloride, pursuant to standardized procedures. This bill would authorize a pharmacist to furnish preexposure prophylaxis and postexposure prophylaxis in specified amounts and would require a pharmacist to furnish those drugs if certain conditions are met, including that the pharmacist determines the patient meets the clinical criteria for preexposure prophylaxis or postexposure prophylaxis consistent with federal guidelines. The bill would require a pharmacist, before furnishing preexposure prophylaxis or postexposure prophylaxis, to complete a training program approved by the board. Because a violation of these requirements would be a crime, this bill would impose a state-mandated local program. Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services pursuant to a schedule of benefits, including pharmacist services, which are subject to approval by the federal Centers for Medicare and Medicaid Services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. This bill would expand the Medi-Cal schedule of benefits to include preexposure prophylaxis and postexposure prophylaxis as pharmacist services, as specified. 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 Department of Insurance. Existing law authorizes health care service plans and health insurers that cover prescription drugs to utilize reasonable medical management practices, including prior authorization and step therapy, consistent with applicable law. For combination antiretroviral drug treatments medically necessary for the prevention of AIDS/HIV, existing law prohibits plans and insurers, until January 1, 2023, from having utilization management policies or procedures that rely on a multitablet drug regimen instead of a single-tablet drug regimen, except as specified. This bill would additionally prohibit plans and insurers from subjecting antiretroviral drugs, including preexposure prophylaxis or postexposure prophylaxis, to prior authorization or step therapy, except that if the United States Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the prevention of AIDS/HIV, the bill would instead require the plan or insurer to cover at least one of the therapeutically equivalent versions without prior authorization or step therapy. The bill would also prohibit plans and insurers from prohibiting, or allowing a pharmacy benefit manager to prohibit, a pharmacy provider from providing preexposure prophylaxis or postexposure prophylaxis, except as specified. The bill would prohibit plans and insurers from covering preexposure prophylaxis that has been furnished by a pharmacist in excess of specified amounts. Because a willful violation of these provisions by a health care service plan would be 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.