BILL ANALYSIS Ó AB 2179 Page 1 Date of Hearing: April 27, 2016 ASSEMBLY COMMITTEE ON APPROPRIATIONS Lorena Gonzalez, Chair AB 2179 (Gipson) - As Amended April 14, 2016 ----------------------------------------------------------------- |Policy |Business and Professions |Vote:|16 - 0 | |Committee: | | | | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | |Health | |19 - 0 | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | | | | | | | | | | | | | | | ----------------------------------------------------------------- Urgency: No State Mandated Local Program: NoReimbursable: No SUMMARY: This bill allows a new category of personnel, Hepatitis C counselors, to perform simple, easy-to-use rapid tests for Hepatitis C virus (HCV) when they are working under specified supervision, training, and work site conditions. AB 2179 Page 2 FISCAL EFFECT: Uncertain, potential cost pressure to the California Department of Public Health (CDPH). This bill does not place direct requirements on the department, but is intended to allow local health jurisdictions (LHJs) flexibility to approve and implemented their own training programs. However, CDPH indicates cost pressure in the hundreds of thousands of dollars to promulgate and implement regulations, provide technical assistance, and review, approve, and potentially implement Hepatitis C counselor trainings. COMMENTS: 1)Purpose. This bill is intended to streamline training requirements for non-medical personnel to perform rapid Hepatitis C tests, to allow local health departments to respond in a safe and appropriate manner to the urgency of the Hepatitis C epidemic. This bill is sponsored by Project Inform, a statewide HIV and Hepatitis C advocacy group based in the Bay Area. It has no opposition. 2)Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. As a leading cause of liver disease, liver cancer, and liver transplants, chronic viral hepatitis is an important public health problem in California and nationwide. Since 2007, the annual number of deaths due to Hepatitis C nationwide has surpassed those due to Human Immunodeficiency Virus (HIV). It is estimated 3.5 million in the United States have chronic Hepatitis C. Current law allows HIV counselors who meet certain training requirements to perform HIV, HCV, or combined HIV/HCV. AB 2179 Page 3 3)Clinical Laboratory Improvement Act (CLIA)-waived tests. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services. The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed-waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements under CLIA. Waived tests are simple tests with a low risk for an incorrect result, which can be performed by participants without laboratory training, no prior experience of the test, and no verbal instruction. 4)Impact of this bill. Although HIV/HCV counselor training is available, limited availability of state-sponsored training in recent years has led to delays in certifying counselors and rendered local health jurisdictions unable to afford required trainings. This bill creates a new "Hepatitis C counselor" authorization to perform waived HCV tests under prescribed circumstances, which will allow LHJs to train and deploy the workforce more rapidly and at a lower cost. 5)Prior legislation. a) AB 1382 (Roger Hernández), Chapter 643, Statutes of 2011 authorized HIV test counselors to perform HCV or combined HIV/HCV tests in addition to HIV tests. AB 2179 Page 4 b) AB 1263 (Migden), Chapter 324, Statutes of 2001, among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA. 6)Staff Comments. The intent of the bill appears to be to empower LHJs to more rapidly train and deploy Hepatitis C counselors in order to address the Hepatitis C epidemic. However, if CDPH interprets the bill to require promulgation of regulations through a multi-year process as well as state approval and delivery of training, it could negate the intent of the bill and put additional cost pressure on the state. At the same time, there may be some role for the state to ensure quality control and proper oversight. The author may wish to clarify the role of CDPH and LHJs to ensure this bill delivers on its intent and does not result in undue state administrative and cost pressure. Analysis Prepared by:Lisa Murawski / APPR. / (916) 319-2081