BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 2640


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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          2640 (Gipson)


          As Amended  August 15, 2016


          Majority vote


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          |ASSEMBLY:  |57-20 |(June 1, 2016) |SENATE: |26-11 |(August 18,      |
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          Original Committee Reference:  HEALTH


          SUMMARY:  Requires a medical care provider or person  
          administering a test for human immunodeficiency virus (HIV) to  
          provide patients who test negative for HIV infection, and are  
          determined to be at high risk for HIV infection by the medical  
          provider or person administering the test, with information  
          about methods that prevent or reduce the risk of contracting  
          HIV, including, but not limited to, pre-exposure prophylaxis  
          (PrEP) and post-exposure prophylaxis (PEP), consistent with  
          guidance of the federal Centers for Disease Control and  
          Prevention (CDC).


          The Senate amendments delete the requirement that the  
          information be provided in writing and make other technical and  
          clarifying changes.


          FISCAL EFFECT:  








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          1)Likely ongoing costs in the millions to low tens of millions  
            to provide PrEP and PEP to high-risk individuals enrolled in  
            Medi-Cal (General Fund and federal funds).  Based on CDC  
            estimates for the number of individuals at high risk for HIV  
            infection, staff estimates that there are about 150,000  
            individuals in the state that would meet CDC guidelines for  
            using PrEP or PEP.  For each 1% of that population that elects  
            to begin taking PrEP, the proportional cost to the Medi-Cal  
            program to cover the cost of providing PrEP would be about $4  
            million per year.  (Costs for PEP would be considerable lower,  
            since it is only recommended for 28-day use, as opposed to  
            ongoing use for PrEP.)


          2)Unknown long-term savings to Medi-Cal and the Aids Drug  
            Assistance Program due to lower HIV infection rates (General  
            Fund and federal funds).  To the extent that the bill does  
            result in lower HIV infection rates, there would be cost  
            savings to the Medi-Cal and Aids Drug Assistance Programs.   
            However, there are some factors that limit the potential cost  
            savings from the bill.  First, it is not known how effective  
            greater knowledge and use of PrEP and PEP are at the  
            population level in reducing HIV infection.  There are  
            clinical studies that show a very dramatic decline in HIV  
            infections amongst users of PrEP.  Whether those findings  
            would translate to the larger population not part of a  
            research study is unknown.  Second, the annual cost to provide  
            PrEP is may not be substantially less than the current cost to  
            provide treatment to HIV positive Medi-Cal beneficiaries.  The  
            cost that Medi-Cal would pay for PreP is not public  
            information.  However, the New York State Department of Public  
            Health indicates that annual costs range from $8,000 to  
            $14,000 per year.  Even assuming that Medi-Cal receives  
            significant discounts, the cost to provide PreP is likely to  
            be in the thousands per patient per year.  On the other hand,  
            the current average annual cost of care for an HIV positive  
            Medi-Cal beneficiary is about $15,000 per year. 


          COMMENTS:  According to the author, this bill seeks to reduce  








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          the spread of HIV and save the lives of individuals at high risk  
          of HIV exposure by providing them with information about  
          preventive medications during HIV post-test counseling.  The  
          author notes that in 2013, California was second among the 50  
          states in the number of new HIV diagnoses, with approximately  
          5,000 new HIV diagnoses, and a 2015 survey of individuals at  
          risk for HIV by the California HIV/AIDS Research Program found  
          that only one in 10 respondents had ever used PrEP.  The author  
          concludes, considering the high volume of new HIV infections  
          being diagnosed in the state of California and the low awareness  
          of these medications, it is critical that those being tested are  
          aware of PEP and PrEP medications.


          Treatment as Prevention (TasP), PrEP, and PEP.  In TasP, people  
          living with HIV/AIDS use anti-retroviral (ARV) medications to  
          reduce their viral load (the amount of HIV in the body) to  
          undetectable levels.  With an undetectable viral load, the  
          amount of HIV in the body is so small it greatly reduces the  
          likelihood of passing the virus to another person.  Strict  
          adherence to TasP reduces the likelihood of transmission by up  
          to 96%.  PrEP is a new intervention that uses an established ARV  
          medication, Truvada to protect at-risk HIV-negative individuals  
          from HIV infection.  PrEP is different from PEP; the medication  
          is taken before, not after possible exposure.  Daily PrEP use  
          can lower the risk of getting HIV from sex by more than 90% and  
          from injection drug use by more than 70%.  Missing doses reduces  
          PrEP effectiveness.  Truvada is currently the only FDA drug  
          approved for HIV PrEP.  PEP uses ARV medications to prevent HIV  
          from replicating and spreading through the body after an  
          exposure to the virus.  PEP is a short-term (28-day)  
          intervention and must be started within three days of an  
          exposure - sooner, if possible - to be effective.  PEP was  
          originally developed for occupational exposures, such as  
          needle-sticks in hospitals, but is also effective for sexual  
          exposures.  


          In 2015, the CDC estimated that one in four sexually active gay  
          and bisexual men, one in five people who inject drugs, and one  
          in 200 sexually active heterosexual adults meet the criteria for  
          PrEP.  In 2015, the California HIV/AIDS Research Program  








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          conducted a survey of 602 young gay and bisexual men and found  
          that only one in 10 had ever taken PrEP.  Although awareness of  
          the intervention was high among those who had never taken PrEP,  
          awareness was significantly lower among Black and Latino  
          respondents compared to white respondents.  In addition, the  
          large majority of respondents indicated they had never talked to  
          their doctor or healthcare provider about PrEP.  


          In its November 24, 2015 Morbidity and Mortality Weekly Report,  
          the CDC estimated that 1.2 million Americans could benefit from  
          PrEP, including 492,000 men who have sex with men, 115,000  
          injection drug users, and 624,000 heterosexuals.  The report  
          concludes that clinical organizations, health departments, and  
          community-based organizations should raise awareness of PrEP  
          among persons with substantial risk for acquiring HIV infection  
          and their health care providers.


          AIDS Project Los Angeles and the Los Angeles LGBT (lesbian, gay,  
          bisexual, transgender) Center are the cosponsors of this bill  
          and they state that awareness and use of PrEP and PEP among  
          Californians at risk for HIV remain extremely low.  They  
          conclude it remains vital to ensure that all individuals at risk  
          for HIV receive accurate information about PrEP and PEP,  
          particularly highly-impacted communities of color.   


          The AIDS Healthcare Foundation (AHF) states in opposition that  
          HIV screening is intended to mirror other screening tests, which  
          require simple consent only and which do not burden the process  
          with additional activities that may or may not be necessary.   
          AHF asserts that its experience as the largest private tester in  
          the state is that the more time and demands placed on the person  
          it is encouraging to be tested, the more likely the person is to  
          decline.  


          Analysis Prepared by:                                             
                          Lara Flynn / HEALTH / (916) 319-2097  FN:  
          0004124









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