BILL ANALYSIS                                                                                                                                                                                                    Ó

          |SENATE RULES COMMITTEE            |                       AB 2179|
          |Office of Senate Floor Analyses   |                              |
          |(916) 651-1520    Fax: (916)      |                              |
          |327-4478                          |                              |

                                   THIRD READING 

          Bill No:  AB 2179
          Author:   Gipson (D) 
          Amended:  8/16/16 in Senate
          Vote:     21 

           SENATE BUS., PROF. & ECON. DEV. COMMITTEE:  9-0, 6/20/16
           AYES:  Hill, Bates, Block, Gaines, Galgiani, Hernandez,  
            Jackson, Mendoza, Wieckowski

           SENATE HEALTH COMMITTEE:  8-0, 6/29/16
           AYES:  Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,  
            Pan, Roth
           NO VOTE RECORDED:  Wolk

           AYES:  Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen

           ASSEMBLY FLOOR:  80-0, 5/31/16 - See last page for vote

           SUBJECT:   Hepatitis C testing

          SOURCE:    Project Inform

          DIGEST:  This bill authorizes a hepatitis C counselor to perform  
          any hepatitis C virus (HCV) test that is classified as waived  
          under the federal Clinical Laboratory Improvement Act (CLIA), as  

          Existing law:


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          1)Provides for the licensure, registration, and regulation of  
            clinical laboratories and various clinical laboratory  
            personnel, including cytotechnologists, by the California  
            Department of Public Health (DPH).  (Business and Professions  
            Code (BPC) §§ 1200-1327)

          2)Requires an individual who draws blood to be certified by the  
            DPH as a certified phlebotomy technician.  (BPC § 1246)

          3)Authorizes an HIV counselor who meets specified requirements  
            to perform any HIV, HCV, or combination HIV/HCV test that is  
            classified as waived under CLIA as specified, and is  
            authorized to perform skin punctures for the purpose of  
            withdrawing blood for a test without being certified as a  
            phlebotomy technician or a limited phlebotomy technician.  
            (Health & Safety Code § 120917)

          4)Establishes conditions that laboratories must meet for  
            certification to perform testing on human specimens under  
            CLIA.  (Title 42, Code of Federal Regulations (CFR) § 493.1)  

          5)Classifies laboratory tests using three categories: "waived,"  
            "moderate complexity," or "high complexity."  (42 CFR § 493.5)

          6)Requires tests for certificate of waiver to be simple  
            laboratory examinations and procedures which:

             a)   Are cleared by FDA for home use; 

             b)   Employ methodologies that are so simple and accurate as  
               to render the likelihood of erroneous results negligible;  

             c)   Pose no reasonable risk of harm to the patient if the  
               test is performed incorrectly.  (42 CFR § 493.15)

          This bill:

         1)Authorizes a hepatitis C counselor to perform a HCV test under  
            the overall operation and administration of a laboratory  
            director, as specified.


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         2)Requires a hepatitis C counselor to meet one of the following  

             a)   Is authorized to perform an HCV test as a HIV counselor,  
               as specified.

             b)   Is working in a hepatitis C counseling and testing site  
               that meets both of the following criteria:

               i)     Utilizes hepatitis C counselors who are trained by  
                 DPH or its agents to provide testing and hepatitis C  
                 counseling and testing.  States that a training agent may  
                 include, but is not limited to, a local health department  
                 or its designee, an academic medical center, or a  
                 community-based organization. 

               ii)         Has and retains a quality assurance plan and  
                 has hepatitis C counseling and testing staff who comply  
                 with the quality assurance protocols and guidelines made  
                 available by DPH, as specified.

         3)Authorizes a hepatitis C counselor to do all of the following:

             a)   Perform any HCV test that is classified as waived under  
               CLIA if all of the following conditions exist:

               i)     The performance of the HCV test meets the  
                 requirements of state and federal law regarding clinical  

               ii)         Perform skin punctures for the purpose of  
                 withdrawing blood for waived HCV testing without a  
                 certificate as a certified phlebotomy technician, upon  
                 specific authorization from a licensed physician and  
                 surgeon, provided that the person meets both of the  
                 following requirements:

                  (1)            He or she works under the direction of a  
                    licensed physician and surgeon.

                  (2)            He or she has been trained in rapid test  
                    proficiency for skin puncture blood tests and in  
                    universal infection control precautions, consistent  
                    with best infection control practices established by  


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                    the Division of Occupational Safety and Health in the  
                    Department of Industrial Relations and the federal  
                    Centers for Disease Control and Prevention (CDC).

                iii)        The person performing the HCV test meets the  
                  requirements for the performance of waived laboratory  
                  testing, as specified. 

                iv)         The patient is informed that the preliminary  
                  result of the HCV 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  
                  federal CDC for that purpose, a second, different rapid  
                  HCV test. This does not allow a hepatitis C counselor to  
                  perform any HCV test that is not classified as waived  
                  under CLIA.
             b)   Order and report HCV test results to patients without  
               authorization from a licensed health care practitioner or  
               his or her authorized representative.  A patient who has an  
               indeterminate or positive test result shall be referred to  
               a licensed health care practitioner whose scope of practice  
               includes the authority to refer a patient for laboratory  
               testing for further evaluation.

         4)Prohibits a hepatitis C counselor who meets the requirements of  
            this section from performing any other test unless that person  
            meets the statutory and regulatory requirements for performing  
            that other test.

         5)States that compliance with this bill does not fulfill any  
            requirements for certification as a phlebotomy technician or a  
            limited phlebotomy technician, unless the hepatitis C  
            counselor has otherwise satisfied the certification  

          Hepatitis C.  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.  It results  
          from infection with HCV, which is spread primarily through  
          contact with the blood of an infected person.  While infection  
          rates are high among baby boomers who were exposed to the virus  


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          prior to effective blood screenings, most individuals become  
          infected currently by sharing injection equipment.  

          Hepatitis C's effects can be mitigated through early detection  
          and treatment, which can also reduce new infections.  This is  
          especially important in California, as the CDC reports that  
          between 2009 and 2013, reported rates of acute hepatitis C  
          increased by 100 percent in this state. 

          HIV Counselors.  Existing law allows HIV counselors to perform  
          HIV, HCV, and combination HIV/HCV tests that are classified, as  
          waived under CLIA, if the facility or clinic has obtained a  
          certificate of waiver from Center for Medicaid Services and DPH  
          approval, and the HIV counselor has attended trainings specific  
          to each type of test.  Currently, the Office of AIDS (OA)  
          establishes or approves a local healthcare jurisdiction's  
          (LHJ's) HIV Counseling and Testing training programs, which are  
          conducted by community-based, non-profit HIV organizations for  
          HIV testing.  However, not all LHJs are able to access the  

          According to the Office of AIDS Integrated HIV Surveillance,  
          Prevention, and Care Plan, budget cuts during fiscal year  
          2009-10 reduced the OA's funding for many of its AIDS programs.   
          Since 2012, the majority of the OA's HIV prevention activities  
          have been funded solely through a five-year funding opportunity  
          from the CDC.  The program established three funding areas in  
          California:  Los Angeles and San Francisco Metropolitan  
          Statistical Areas and the California Project Area (CPA).  The  
          CPA includes a limited number of local health jurisdictions that  
          have demonstrated a high incidence of HIV.  Local health  
          jurisdictions within the CPA receive counseling and testing  
          training as a part of the CDC's program, but the remaining local  
          health jurisdictions must pay for the counseling and testing  
          training out of their own funds, and spaces within those  
          trainings are limited.

          AB 2179's sponsor and supporters note that having to pay out of  
          pocket for the counseling and testing training is a burden for  
          the local health jurisdictions that have not met the  
          HIV-incidence thresholds but may still have a high incidence of  
          HCV.  Currently, the counselors working in local health  
          jurisdictions outside of the CPA cannot attend the HCV  
          counseling and testing training without attending the HIV  


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          counseling and testing training.  If the LHJ does not have the  
          funds or the offered training is full, the counselor will be  
          unable to provide HCV testing and screening at the testing site.  
           This bill seeks to remedy this situation by expanding the  
          entities allowed to train hepatitis C counselors separately from  
          HIV counseling and establishing parameters for hepatitis C  
          testing and practice.  

          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:YesLocal:   No

          According to the Senate Appropriations Committee: 

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

           Unknown additional costs to the Medi-Cal program to provide  
            treatment for newly diagnosed hepatitis C cases (General Fund  
            and federal funds).  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.

          SUPPORT:   (Verified8/15/16)

          Project Inform (source)
          Access Support Network


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          AIDS Community Research Consortium
          Asian Pacific Health Foundation
          Bay Area Black Nurses Association
          California Black Health Network
          California Chronic Care Coalition
          California Hepatitis Alliance
          California Life Sciences Association
          Comprehensive Opiate Recovery Experience Medical Clinic, Inc. 
          Desert AIDS Project
          Drug Policy Alliance
          Harm Reduction Coalition
          Health Officers Association of California
          HIV Education and Prevention Project of Alameda County
          Mendocino County AIDs/Viral Hepatitis Network
          Sacramento Area Task Force for the Outreach and Prevention of  
          San Francisco Hepatitis C Task Force
          The Wall Las Memorias Project
          One individual

          OPPOSITION:   (Verified8/15/16)

          None received

          ARGUMENTS IN SUPPORT:     Project Inform writes, "California  
          must 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."    

          ASSEMBLY FLOOR:  80-0, 5/31/16
          AYES:  Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,  
            Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,  
            Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,  
            Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth  
            Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto,  
            Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper,  
            Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim,  
            Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis,  
            Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte,  
            O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez,  


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            Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,  
            Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon

          Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
          8/17/16 9:19:41

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