BILL ANALYSIS                                                                                                                                                                                                    



                                                                    AB 2179


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          GOVERNOR'S VETO


          AB  
          2179 (Gipson)


          As Enrolled  August 31, 2016


          2/3 vote


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          |ASSEMBLY:  |80-0  |(May 31, 2016) |SENATE: |36-0  |(August 19,      |
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          |ASSEMBLY:  |79-1  |(August 24,    |        |      |                 |
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          Original Committee Reference:  B. & P.




          SUMMARY:  Authorizes a hepatitis C counselor, who meets  
          specified training requirements and works in specified testing  








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          sites, to perform hepatitis C virus (HCV) tests classified as  
          waived under the federal Clinical Laboratory Improvement  
          Amendments of 1988 (CLIA).  Specifically, this bill:


          1)Authorizes a hepatitis C counselor to perform a HCV test that  
            is classified as waived under CLIA if the following conditions  
            exist: 
             a)   The performance of the HCV test meets the requirements  
               of CLIA and California's clinical laboratory requirements;
             b)   The counselor i) is trained as a Human Immunodeficiency  
               Virus (HIV) counselor to perform a HCV test or ii) is  
               working in a HCV counseling and testing site that meets  
               specified criteria;


             c)   The HCV test is performed under the overall operation  
               and administration of a laboratory director;  


             d)   The patient is informed that the preliminary result of  
               the test is indicative of the likelihood of HCV exposure  
               and that the result must be confirmed by an additional,  
               more specific test, or, if approved by the Center for  
               Disease Control and Prevention (CDC) for that purpose, a  
               second, different rapid HCV test; and,


             e)   If performing a skin punctures for the purpose of  
               withdrawing blood for HCV testing, the counselor meets the  
               following requirements:


               i)     Works under the direction of a licensed physician  
                 and surgeon;
               ii)Has specific authorization from a licensed physician and  
                 surgeon; and, 










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               iii)Is trained to perform rapid test proficiency either for  
                 skin puncture blood tests or oral swab tests in universal  
                 infection control precautions, as specified.


          2)Authorizes the counselor to order and report the results from  
            the HCV tests performed to a patient without authorization  
            from a licensed health care practitioner or the patient's  
            authorized representative.  
          3)Requires the counselor to refer a patient who has an  
            indeterminate or positive test result to a licensed health  
            care practitioner whose scope of practice includes the  
            authority to refer a patient for laboratory testing for  
            further evaluation.


          4)Provides that a hepatitis C counselor is not authorized to  
            perform any other test unless that person meets the statutory  
            and regulatory requirements for performing the other test,  
            including those requiring certifications in phlebotomy.


          The Senate amendments delete the requirement that a HCV  
          counselor must also be trained in HIV testing and made technical  
          and clarifying changes.


          FISCAL EFFECT:  According to the Senate Appropriations  
          Committee:


          1)One-time costs of about $150,000 for the development and  
            adoption of regulations by the Department of Health Care  
            Services.


          2)Minor ongoing costs to train hepatitis C counselors and  
            provide technical assistance to local health jurisdictions.









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          3)Unknown additional costs to the Medi-Cal program to provide  
            treatment for newly diagnosed hepatitis C cases.  By making it  
            easier for hepatitis C counselors working in certain  
            situations to perform hepatitis C tests, the bill is likely to  
            result in additional testing and additional diagnoses of  
            hepatitis C.  For those individuals who are eligible for  
            Medi-Cal, there would likely be increased costs to provide  
            treatment for newly diagnosed hepatitis C cases.  The costs to  
            provide such treatment are unknown and would depend on the  
            number of new diagnoses amongst the Medi-Cal population.  New  
            hepatitis C drugs on the market have very high upfront costs  
            (in the tens of thousands per course of treatment), but are  
            very effective at curing hepatitis C.  In the long-run, early  
            diagnosis and treatment for some patients, may actually save  
            money.  However, a very low percentage of hepatitis C patients  
            will ever receive a costly liver transplant.  Therefore, it is  
            not known whether widespread use of these very expensive drugs  
            will actually save money for the Medi-Cal program in the  
            long-run.


          COMMENTS:  


          Purpose.  This bill is sponsored by Project Inform.  According  
          to the author, "The unchecked spread of HCV threatens the public  
          health and economic welfare of California.  It is necessary that  
          California reduce the costs and procedural barriers for training  
          non-medical personnel to perform rapid HCV tests in order that  
          local health departments can respond in a manner that is safe  
          and appropriate to the urgency of the epidemic.  [This bill]  
          will give local health departments greater flexibility to  
          respond to HCV in their communities and reduce costs related to  
          training non-medical personnel to administer the rapid test."


          Background.  Hepatitis means inflammation of the liver.   
          Hepatitis C is an infection of the liver caused by HCV, one of  








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          several contagious viruses that can cause hepatitis.  HCV is  
          spread by blood-to-blood contact and common ways people become  
          infected are through needle sharing, inadequate sterilization of  
          medical equipment, and unscreened blood transfusions.


          The CDC estimates that there are 3.5 million people in the  
          United States have chronic HCV infection.  Between 1994 and  
          2011, the California Department of Public Health (CDPH) had  
          received 501,664 newly reported chronic HCV cases in California.  
           As a result, the World Health Organization, the CDC, and the  
          CDPH suggest policies that promote prevention and education  
          among high-risk populations.  This bill seeks to do so by  
          authorizing HCV counselors to perform a HCV screening test if it  
          is classified as waived under CLIA.  The author states that  
          doing so will increase access to HCV counselors, who will  
          promote prevention by providing screening and education services  
          at a community level.


          Federal and State Laboratory Requirements.  Under the federal  
          CLIA law, laboratories that perform tests on human specimens  
          must be certified by the Centers for Medicare and Medicaid  
          Services (CMS).  The requirements for CLIA certification vary  
          depending on the complexity of the laboratory tests performed.   
          The three complexities are waived, moderate, and high  
          complexity.  In general, the more complicated the test, the more  
          stringent the requirements under CLIA.  Waived tests are simple,  
          consumer-level tests with a low risk for an incorrect result.   
          However, California law only allows specified personnel to  
          perform waived tests on others.


          HIV and HCV Counselors.  Existing law allows HIV counselors to  
          perform HIV, HCV, and combination HIV/HCV tests as long as the  
          tests are classified as waived under CLIA, the facility or  
          clinic has obtained a certificate of waiver from CMS and CDPH  
          approval, and the HIV counselor has attended a Counseling and  
          Testing (C&T) training specific to each type of test.  








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          Currently, the OA either establishes or approves  
          federally-funded HIV C&T training programs for a local health  
          jurisdiction's (LHJ) HIV counselors.  However, not all LHJs are  
          able to access the trainings.  Access to the trainings is  
          determined by incidence of HIV, but some LHJs have a high  
          incidence of HCV but not a high incidence of HIV.  The LHJs that  
          cannot meet the HIV thresholds must pay for the trainings. 


          The sponsor notes that having to pay out of pocket for the C&T  
          training means that if the LHJ does not have the funds or the  
          offered training is full, its counselors will not be able to  
          provide necessary HCV testing and screenings.  This bill seeks  
          to remedy this issue by establishing training and workplace  
          pathways for HCV counselors.


          GOVERNOR'S VETO MESSAGE:


          I am returning Assembly Bill 2179 without my signature.


          This bill creates a hepatitis C counselor classification  
          allowing a person who is trained to perform hepatitis C virus  
          rapid tests to do so.


          The Department of Public Health works with local health agencies  
          to train HIV counselors who test for both HIV and hepatitis C.   
          National health guidelines recommend people at risk for either  
          of these diseases be tested for both.  As such, I believe the  
          existing counselor classification is more protective of public  
          health.











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          Analysis Prepared by:                                             
                          Vincent Chee / B. & P. / (916) 319-3301  FN:  
          0005087