SB 524

Bill Subjects

Abstract

(1) Existing law, the Pharmacy Law, provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. A violation of the Pharmacy Law is a crime. Existing law generally authorizes a pharmacist to dispense or furnish drugs only pursuant to a valid prescription, with prescribed exceptions. Existing law authorizes a pharmacist or a pharmacy to perform skin puncture in the course of performing routine patient assessment procedures, as defined, or in the course of performing prescribed clinical laboratory tests or examinations. Under existing law, the definition of "routine patient assessment procedures" includes clinical laboratory tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and specified regulations adopted pursuant to the CLIA. Existing law also authorizes a pharmacist to perform any aspect of a test approved or authorized by the United States Food and Drug Administration (FDA) that is classified as waived pursuant to the CLIA, under specified conditions. This bill, with respect to the conditional performance of tests approved or authorized by the FDA and classified as waived pursuant to the CLIA, would instead authorize a pharmacist to order, perform, and report those tests. The bill, until January 1, 2034, would authorize a pharmacist to furnish prescription medications pursuant to the results from a test classified as waived pursuant to the CLIA performed by the pharmacist that is used to guide diagnosis or clinical decisionmaking for SARS-CoV-2, Influenza, Streptococcal pharyngitis, or conjunctivitis, in accordance with specified requirements. The bill would require a pharmacist, in providing these patient care services, to utilize specified evidence-based clinical guidelines or other clinically recognized recommendations, and in accordance with standardized procedures or protocol designed and approved by the board and the Medical Board of California. The bill would require the pharmacist to document, to the extent possible, the testing services provided, as well as the prescription drugs, devices, or other treatments furnished, to the patient pursuant to the test result, in the patient's record in the record system maintained by the pharmacy. The bill would require a pharmacy or health care facility in which a pharmacist is furnishing treatment to provide an area designed to maintain privacy and confidentiality of the patient. Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program. (2) 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 ordering, performing, and reporting any test approved or authorized by the FDA that is classified as waived pursuant to the CLIA, as authorized by existing law, that is used to guide diagnosis or clinical decisionmaking. The bill would also expand the schedule of benefits to include furnishing prescriptions pursuant to the result from a test, as authorized by the bill's provisions, that is used to guide diagnosis or clinical decisionmaking. (3) 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.