BILL ANALYSIS                                                                                                                                                                                                    Ó




         SENATE COMMITTEE ON HEALTH
                         Senator Ed Hernandez, O.D., Chair

         BILL NO:                    AB 2640             
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         |AUTHOR:        |Gipson                                         |
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         |VERSION:       |April 21, 2016                                 |
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         |HEARING DATE:  |June 29, 2016  |               |               |
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         |CONSULTANT:    |Melanie Moreno                                 |
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          SUBJECT  :  Public health:  HIV

          SUMMARY  :  Requires a medical provider or a person administering a HIV  
         test, in the case that a patient that is known to be at high risk  
         for HIV infection tests negative for HIV to provide written  
         information about the effectiveness and safety of all methods  
         that prevent or reduce the risk of contracting HIV, including,  
         but not limited to, preexposure prophylaxes and postexposure  
         prophylaxes, consistent with guidance of the federal Centers for  
         Disease Control and Prevention.
         
         Existing law:
         1)Places certain requirements on the information shared by  
           medical providers with patients for HIV testing, including  
           informing the patient that the test is planned, providing  
           information about the test, informing the patient that there  
           are numerous treatment options available for a patient who  
           tests positive for HIV and that a person who tests negative for  
           HIV should continue to be routinely tested, and advising the  
           patient that he or she has the right to decline the test. If a  
           patient declines the test, the medical care provider shall note  
           that fact in the patient's medical file.

         2)Requires the medical provider or other person performing a HIV  
           test, after the results of a test have been received, to ensure  
           that the patient receives timely information and counseling, as  
           appropriate, to explain the results and the implications for  
           the patient's health. If the patient tests positive for HIV  
           infection, the medical provider or the person who administers  
           the test is required to inform the patient that there are  
           numerous treatment options available and identify follow-up  
           testing and care that may be recommended, including contact  







         AB 2640 (Gipson)                                   Page 2 of ?
         
         
           information for medical and psychological services. If the  
           patient tests negative for HIV infection and is known to be at  
           high risk for HIV infection, the medical provider or the person  
           who administers the test is required to advise the patient of  
           the need for periodic retesting, explain the limitations of  
           current testing technology and the current window period for  
           verification of results, and may offer prevention counseling or  
           a referral to prevention counseling. 

         This bill: Requires a medical provider or a person administering  
         a HIV test, in the case that a patient that is known to be at  
         high risk for HIV infection tests negative for HIV to provide  
         written information about the effectiveness and safety of all  
         methods that prevent or reduce the risk of contracting HIV,  
         including, but not limited to, preexposure prophylaxes (PrEP) and  
         postexposure prophylaxes (PEP), consistent with guidance of the  
         federal Centers for Disease Control and Prevention (CDC).

         FISCAL  
         EFFECT  :  According to the Assembly Appropriations Committee, to  
         the extent this bill raises awareness of drug therapy for people  
         at high risk for HIV, this bill could potentially increase demand  
         for and utilization of drug treatment for HIV prevention,  
         particularly PrEP.  According to the New York State Department of  
         Health, Truvada, the drug used in PrEP therapy, costs between  
         $8,000 and $14,000 per year.  Medi-Cal prices for the drug are  
         unknown, but even assuming significant discounts are available,  
         costs to Medi-Cal could be in the millions annually if even a few  
         hundreds more people a year take the medication (General  
         Fund/federal).  To the extent increased utilization with PrEP  
         among high-risk populations reduces the number of HIV infections,  
         there would be offsetting cost savings for less HIV/AIDS  
         treatment in Medi-Cal and the AIDS Drug Assistance Program.  

         Costs to the California Department of Public Health (DPH) to  
         produce updated written material, and to modify HIV counselor  
         training, are minor and absorbable.

          PRIOR  
         VOTES  :  
         
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         |Assembly Floor:                     |57 - 20                     |
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         |Assembly Appropriations Committee:  |14 - 6                      |








         AB 2640 (Gipson)                                   Page 3 of ?
         
         
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         |Assembly Health Committee:          |12 - 5                      |
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         COMMENTS  :
         1)Author's statement.  According to the author, AB 2640 seeks to  
           reduce 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.  
           In 2013, California was second among the fifty states in the  
           number of new HIV diagnoses, with approximately 5,000 new HIV  
           diagnoses. A 2015 survey of individuals at risk for HIV by the  
           California HIV/AIDS Research Program found that only 1 in 10  
           respondents had ever used 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. 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 PrEP and  
           PEP medications.

         2)Background. According to the CDC, more than 1.2 million people  
           in the U.S. are living with HIV infection, and 13% are unaware  
           of their infection.  Gay, bisexual, and men who have sex with  
           men (MSM), particularly young African American MSM, are most  
           seriously affected by HIV.  By race, African Americans face the  
           most severe burden of HIV. Over the past decade, the number of  
           people living with HIV has increased, while the annual number  
           of new HIV infections has remained relatively stable.  Still,  
           the pace of new infections continues at far too high a level,  
           particularly among certain groups. An estimated 13,712 people  
           with an AIDS diagnosis died in 2012, and approximately 658,507  
           people in the U.S. with an AIDS diagnosis have died overall.   
           The OA estimates that approximately 126,000 Californians are  
           living with HIV, and of these, 23,000 or 18% are unaware of  
           their HIV status.  An estimated 6,000 Californians are newly  
           diagnosed with HIV each year. People living with HIV/AIDS have  
           an estimated life expectancy of 32 years after infection and  
           that number is increasing.  According to DPH's Office of AIDS  
           (OA), with treatment costs averaging around $23,000 per year,  
           lifetime treatment is currently estimated at around $740,000 or  








         AB 2640 (Gipson)                                   Page 4 of ?
         
         
           more per person.  With that estimate, the 6,000 new infections  
           per year in California will cost an estimated $4.5 billion to  
           treat.  
           
         3)PrEP and PEP.  "Treatment as prevention" (TasP) refers to HIV  
           prevention methods that use antiretroviral treatment (ART) to  
           decrease the risk of HIV transmission.  According to the World  
           Health Organization, TasP needs to be considered as a key  
           element of combination HIV prevention and as a major part of  
           the solution to ending the HIV epidemic. Through 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.  

         4)Public awareness and use of PrEP.  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 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  








         AB 2640 (Gipson)                                   Page 5 of ?
         
         
           respondents indicated they had never talked to their doctor or  
           healthcare provider about PrEP.

         Another recent study found that few doctors are prescribing PrEP  
           to those who could benefit.  The study found that out of more  
           than 1,000 gay and bisexual men, only 83 reported using PrEP.  
           The author of the study concluded, "The majority of gay men who  
           are good candidates for PrEP are not on the medication, and  
           many haven't spoken to their medical providers about PrEP.  We  
           need to get conversations going, and in general promote more  
           open dialogue between doctors and patients regarding sexual  
           health."  The findings are from One Thousand Strong, a  
           three-year observational study of a U.S. national sample of gay  
           and bisexual men ages 18 to 80 that is now underway. 

         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 (MSM),  
           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.

         5)Research supporting PrEP use.  On May 14, 2014, the U.S. Public  
           Health Service released the first comprehensive clinical  
           practice guidelines for PrEP.  This followed the earlier  
           publication of brief interim guidelines that were based on  
           findings from several large national and international clinical  
           trials.  Those trials evaluated PrEP among gay and bisexual  
           men, heterosexual men and women, and injection drug users.  All  
           participants in the trials received pills containing either  
           PrEP or placebo, along with intensive counseling on safe-sex  
           behavior, regular testing for sexually transmitted diseases,  
           and a regular supply of condoms.  In all of the studies, the  
           risk of getting HIV infection was lower-up to 92% lower-for  
           participants who took the medicines consistently than for those  
           who did not take the medicines. 

         6)CDC guidelines. The most recent federal guidelines for health  
           care providers recommend that PrEP be considered for people who  
           are HIV-negative and at substantial risk for HIV infection.   
           For sexual transmission, this includes anyone who is in an  
           ongoing relationship with an HIV-positive partner.  It also  
           includes anyone who is not in a mutually monogamous  








         AB 2640 (Gipson)                                   Page 6 of ?
         
         
           relationship with a partner who recently tested HIV-negative,  
           and, is a gay or bisexual man who has had anal sex without a  
           condom or been diagnosed with asexually transmitted disease in  
           the past six months; or, a heterosexual man or woman who does  
           not regularly use condoms during sex with partners of unknown  
           HIV status who are at substantial risk of HIV infection (e.g.,  
           people who inject drugs or have bisexual male partners). For  
           people who inject drugs, this includes those who have injected  
           illicit drugs in past six months and who have shared injection  
           equipment or been in drug treatment for injection drug use in  
           the past six months.  Health care providers should also discuss  
           PrEP with heterosexual couples in which one partner is  
           HIV-positive and the other is HIV-negative as one of several  
           options to protect the partner who is HIV-negative during  
           conception and pregnancy.  The CDC is currently updating  
           recommendations about use of PEP for HIV prevention.
         
         7)Cost of PrEP and PEP.  Costs for PrEP may include payment for  
           the medication as well as payment for required medical visits  
           and laboratory tests.  While most public and private insurance  
           companies cover PEP and PrEP prescriptions, there is high  
           variability in out-of-pocket costs such as deductibles or  
           co-pays.  Some health plans cover PrEP at a lower, generic  
           co-pay, while others place it in a specialty, or higher, more  
           expensive tier.  For individuals without any insurance  
           coverage, the cost is approximately $12,000 - $15,000 per year.  
            There are currently several payment assistance programs  
           available through both the manufacturer and community groups  
           that can help individuals without insurance, and those with  
           high out-of-pocket costs through their insurance company.

         8)DPH PrEP Navigator Services Program.  In the 2015-2016 Budget  
           Act, the California Legislature appropriated $2 million  
           annually (General Fund, $1.764 million in local assistance,  
           $236,000 for state support) to DPH to establish a PrEP  
           Navigator Services Program to "?ensure access for and serve the  
           most vulnerable Californians at high risk for HIV." The primary  
           client target for the PrEP Navigator Services Programs are gay,  
           bisexual, transgender, or other MSM, transgender women who have  
           sex with men, and partners of HIV-positive people with a  
           detectable viral load and/or inconsistent antiretroviral use.   
           Special emphasis is to be placed on young gay and bisexual men,  
           young transgender women, and gay and bisexual men and  
           transgender women of color. The PrEP Navigator Services  
           programs established through this funding are meant to  








         AB 2640 (Gipson)                                   Page 7 of ?
         
         
           identify, conduct outreach, and provide culturally competent  
           services to target populations, provide assistance to  
           participants allowing them to access, enroll in, and utilize  
           insurance or patient assistance programs to pay for PrEP, link  
           to PrEP providers, and support adherence to PrEP and  
           PrEP-related follow-up participants.

         9)Related legislation. AB 2439 (Nazarian), would require every  
           hospital emergency department, if it otherwise draws blood from  
           a patient, to offer to test that blood for HIV with the  
           patients consent.  AB 2439 is set to be heard in this Committee  
           on June 29, 2016.

         10)Prior legislation. AB 446 (Mitchell, Chapter 589, Statutes of  
           2013), revised requirements related to information provided at  
           the time an HIV test is administered and after the test results  
           are received; requires informed consent, as specified, either  
           orally or in writing, except when a person independently  
           requests an HIV test from an HIV counseling and testing site,  
           as specified; requires documentation of the person's  
           independent request for the test and exempts clinical  
           laboratories from the informed consent requirements; requires  
           every patient who has blood drawn at a primary care clinic, as  
           defined, who has consented to the test, to be offered an HIV  
           test; and, authorizes disclosure of HIV test results by  
           Internet posting or other electronic means if the HIV test  
           subject is anonymously tested.

           AB 491 (Portantino of 2011), would have allocated state and  
           federal funds to test persons for HIV, would have specified  
           that an HIV counselor is a medical care provider, and would  
           have authorized a clinical laboratory test result of a negative  
           HIV antibody test to be posted on a secure website if specified  
           conditions were met.  AB 491 was amended to deal with a  
           different subject matter.

           AB 1894 (Krekorian, Chapter 631, Statutes of 2008), requires  
           health care service plans and disability insurers selling  
           health insurance to offer testing for HIV antibodies and AIDS,  
           regardless of whether the testing is related to a primary  
           diagnosis.

           AB 682 (Berg, Chapter 550, Statutes of 2007), revises the  
           written and informed consent standards associated with testing  
           blood for HIV, including prenatal HIV testing, to no longer  








         AB 2640 (Gipson)                                   Page 8 of ?
         
         
           require affirmative approval prior to administering an HIV  
           test.  Establishes the new HIV testing consent standard as the  
           right to decline the test, providing that medical care  
           providers present specified information to the individual about  
           treatment options and the individual's right to decline the  
           test, and the medical care provider notes in the chart when the  
           patient declines to be tested.  Exempts HIV testing at an  
           alternative test site, as part of an autopsy, or when part of  
           scientific research from these provisions.

         11)Support.  AIDS Project Los Angeles and the Los Angeles LGBT  
           Center are the cosponsors of this bill and state that awareness  
           and use of PrEP and PEP among Californians at risk for HIV  
           remain extremely low.  The sponsors note that in 2015 the  
           California HIV/AIDS Research Program conducted a survey of  
           young gay and bisexual men and found that only one in 10 had  
           ever taken PrEP, and although awareness of the intervention was  
           high overall, awareness was significantly lower among black and  
           Latino respondents compared to white respondents.  The sponsors  
           also note the majority of respondents lacked the information  
           needed to make a decision about using PrEP, did not know where  
           to access PrEP, and that few respondents had ever talked to  
           their doctor or healthcare provider about PrEP.  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. Numerous supporters state  
           that roughly 4,700 individuals are newly diagnosed with HIV in  
           California each year and PrEP/PEP are highly effective HIV  
           prevention interventions that could dramatically reduce new  
           infections. Supporters state that PrEP and PEP are key  
           components of the National HIV/AIDS Strategy, but awareness and  
           use of these interventions remain extremely low, and it is  
           vital to increase awareness and use of PrEP and PEP among  
           communities at risk for HIV. Equality California states that  
           given the effectiveness of PrEP and PEP, it is now critically  
           important to ensure that individuals receiving an HIV test are  
           also provided with accurate information about the benefits of  
           these interventions.  Bienestar Human Services writes that this  
           bill builds on AB 446, which established what information must  
           be provided to individuals during HIV post-test counseling,  
           including advising the individual of the need for periodic  
           retesting and explaining the limitations of current testing  
           technology. Bienstar states that given the effectiveness of  
           PrEP and PEP, it is now critically important to ensure that  
           individuals receiving an HIV test are also provided with  








         AB 2640 (Gipson)                                   Page 9 of ?
         
         
           accurate information about the benefits these interventions.  
           CaliforniaHealth+ Advocates writes that California's clinics  
           are committed to keeping our patients healthy and this bill  
           will assist in this mission.
           
         12)Opposition. The AIDS Healthcare Foundation (AHF) states 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 also notes that guidelines for prevention and  
           risk reduction are fluid, based on the most recent advice from  
           the CDC and DPH, and that information to be shared must be  
           dictated by the needs and circumstances of the person being  
           tested.  Finally, AHF contends that recent changes to  
           California law that allowed for disclosure of a negative HIV  
           test result on a secure website already minimizes the  
           interaction between the tester and the test subject  
           post-testing and makes the conveying of any more than the most  
           basic information in current law less likely to be useful. The  
           California Medical Association (CMA) states that increased  
           awareness of preventative treatment options for HIV should be a  
           public health goal, however, it is concerned that the increased  
           medical resources required to accomplish the goal of this bill  
           are not worth the benefit of the mandate.  CMA also notes that  
           a physician is already required to provide a patient who tests  
           positive with treatment and counseling options as well as  
           mandated to schedule follow up appointments with relevant  
           specialists.  CMA concludes, for patients who test negative for  
           HIV, it believes it is best left to the physician's clinical  
           judgment as to what preventative treatment options should be  
                                                       given to the patient. The California Hospital Association (CHA)  
           opposes codifying standards of practice and interfering in the  
           physician-patient relationship by legislating what information  
           a physician should tell a patient.  CHA states this bill would  
           eliminate the physician's medical judgment as to what  
           information or treatment is in the best interest of the  
           patient.  

         13)Author's amendments. The author requests the Committee approve  
           the following amendment to clarify that information about PrEP  
           and PEP can be provided orally or in writing:

           On page 3, line 33:
           "?period for verification of results, provide  written  
            information about?"








         AB 2640 (Gipson)                                   Page 10 of ?
         
         

          SUPPORT AND OPPOSITION  :
         Support:  AIDS Project Los Angeles (sponsor)
                   Access Support Network
                   Black AIDS Institute
                   Bienestar Human Services, Inc.
                   California Health+ Advocates
                   California Life Sciences Association
                   City of West Hollywood
                   Community Clinic Association of Los Angeles County
                   Desert AIDS Project
                   Free Speech Coalition
                   Friends Community Center
                   Gender Health Center
                   JWCH Institute, Inc.
                   Men's Health Foundation
                   Our Family Coalition
                   Positive Women's Network
                   Project Inform
                   San Diego LGBT Community Center
                   San Francisco AIDS Foundation
                   Tarzana Treatment Centers
                   Transgender Law Center
                   UCLA Center for Behavioral and Addiction Medicine
                   California Life Sciences Association 
         
         Oppose:   AIDS Healthcare Foundation
                   American College of Emergency Physicians, California  
                             Chapter
                   California Hospital Association
                   California Medical Association
         
         
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