BILL ANALYSIS Ó SB 1481 Page 1 Date of Hearing: August 16, 2012 ASSEMBLY COMMITTEE ON APPROPRIATIONS Mike Gatto, Chair SB 1481 (Negrete McLeod) - As Amended: August 7, 2012 Policy Committee: HealthVote:16-0 Business and Professions Vote: 9-0 Urgency: No State Mandated Local Program: No Reimbursable: No SUMMARY As proposed to be amended, this bill exempts from existing clinical laboratory requirements and regulations community pharmacies that provide simple blood glucose, hemoglobin A1c, or cholesterol tests, as specified, if the pharmacy obtains a registration from the Department of Public Health (DPH) and other requirements are met. FISCAL EFFECT 1)Assuming 20% of pharmacies register as clinical labs: a) This bill would result in additional fee-supported workload at the DPH of $50,000 annually. b) Revenue of $120,000 would be generated by existing fees. 1)Regardless of the final number of pharmacies that register as clinical laboratories, additional fee revenue will be adequate to fund additional workload. Revenues will accrue to the Clinical Laboratory Improvement Fund and be used to fund oversight of the individuals performing laboratory tests. COMMENTS 1)Rationale . This bill would allow pharmacists to perform specific over-the-counter laboratory tests, such as glucose level or cholesterol tests, without the need to hire a laboratory director. This bill would allow pharmacists to perform only specific tests that are already recognized by the law as safe to be performed with little or no oversight. The SB 1481 Page 2 author contends this bill will result in easier access to safe, simple, and economical tests, especially for low income individuals, less crowding in physicians' offices, and an improved ability of pharmacists to provide meaningful feedback to their patients when providing drug consultations required by law. The California Pharmacists Association is the sponsor of this bill. 2)CLIA-Waived Tests . Under CLIA, the federal Food and Drug Administration (FDA) categorizes laboratory tests based on the complexity of the test performed. Tests may be assigned to one of three categories: high-complexity, moderate-complexity, or waived from regulatory oversight. Waived tests are defined in federal regulation as simple laboratory examinations and procedures that are cleared by the FDA for home use, employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or pose no reasonable risk of harm to the patient if the test is performed incorrectly. This legislation would allow pharmacists to perform three types of CLIA-waived tests. Under current law, with certain exceptions, these tests can only be performed under the oversight of a qualified laboratory director. 3)Regulation of Clinical Laboratories . Under current law, an individual performing CLIA-waived clinical laboratory tests is considered a clinical laboratory. Clinical laboratories that perform only CLIA-waived tests are required to register with the Laboratory Field Services unit within CDPH, and pay a $100-per-year fee. The department's oversight workload consists of reviewing registration applications and ensuring that appropriate personnel are performing allowable types of tests. 4)Proposed amendments (a) remove the provision making an registration an biennial requirement for pharmacies (thereby conforming to existing law making registration an annual requirement), and (b) make technical, clarifying, and chaptering changes. Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081 SB 1481 Page 3