BILL ANALYSIS Ó AB 761 Page 1 Date of Hearing: January 19, 2012 ASSEMBLY COMMITTEE ON APPROPRIATIONS Felipe Fuentes, Chair AB 761 (Roger Hernández) - As Amended: January 12, 2012 Policy Committee: Health Vote: 17-0 Business and Professions Vote: 8-0 Urgency: No State Mandated Local Program: No Reimbursable: No SUMMARY As proposed to be amended, this bill allows optometrists to perform simple lab tests. Specifically, this bill: 1)Adds optometrists to the list of individuals authorized to perform tests or exams classified as waived under the Clinical Laboratory Improvement Amendments (CLIA), the federal act establishing quality standards for laboratory testing. 2)Allows optometrists who are certified to use therapeutic pharmaceutical agents (TPA-certified optometrists) to function as laboratory directors, only for purposes of a clinical laboratory test or exam classified as waived under CLIA and necessary for the diagnosis of ocular conditions and diseases. 3)Adds performance of CLIA-waived tests or exams necessary for the diagnosis of ocular conditions and diseases to the list of activities constituting the practice of optometry, for TPA-certified optometrists. FISCAL EFFECT This bill results in additional fee-supported workload at the California Department of Public Health (CDPH) in the range of $150,000 annually. Under current law, to perform CLIA-waived tests, optometrists would be required to register with CDPH as clinical laboratories and pay annual fees of $100. Revenues would accrue to the Clinical Laboratory Improvement Fund and would be used to fund oversight of the individuals performing laboratory tests. AB 761 Page 2 COMMENTS 1)Rationale . According to the author, there is a deficiency in existing law that renders optometrists unable to perform very simple tests that aid in diagnosing conditions optometrists are allowed to treat, such as viral conjunctivitis (pink eye). The author also contends that sending so-called CLIA-waived tests to an outside lab unnecessarily delays appropriate diagnosis and treatment. 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 optometrists to perform eye-related CLIA-waived tests that they currently are not authorized to perform. One example of a CLIA-waived test that might be used in optometric offices is the RPS Adeno Detector, which tests for contagious viral conjunctivitis (pink eye). Another simple test that may gain CLIA-waived status this year is TearLab, a handheld device that diagnoses dry eye. 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 . Section 2 of this bill includes an erroneous reference to Section 3041(e)(9) of the Business and Professions Code, instead of Section 3041(e)(10). The proposed amendments correct this technical drafting error. AB 761 Page 3 5)Policy Questions Resolved and Opposition Removed . A previous analysis of this bill raised technical and policy questions related to whether optometrists have sufficient training to act as lab directors for certain types of CLIA-waived tests that are unrelated to the eye, such as HIV or other infectious disease tests. Recent amendments adopted in Health committee restrict the tests that can be performed to those necessary to diagnose ocular diseases and conditions, addressing this concern. Adoption of those prior amendments and the technical amendment proposed today removes all registered opposition to the bill. Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081