BILL ANALYSIS                                                                                                                                                                                                    ”



                                                                    AB 2179


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          Date of Hearing:  April 27, 2016


                        ASSEMBLY COMMITTEE ON APPROPRIATIONS


                               Lorena Gonzalez, Chair


          AB  
          2179 (Gipson) - As Amended April 14, 2016


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          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


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          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.  








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          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 HernŠndez), Chapter 643, Statutes of 2011  
               authorized HIV test counselors to perform HCV or combined  
               HIV/HCV tests in addition to HIV tests.










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             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