BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 2640| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 2640 Author: Gipson (D) Amended: 8/15/16 in Senate Vote: 21 SENATE HEALTH COMMITTEE: 7-1, 6/29/16 AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth NOES: Nielsen NO VOTE RECORDED: Wolk SENATE APPROPRIATIONS COMMITTEE: 5-2, 8/11/16 AYES: Lara, Beall, Hill, McGuire, Mendoza NOES: Bates, Nielsen ASSEMBLY FLOOR: 57-20, 6/1/16 - See last page for vote SUBJECT: Public health: HIV SOURCE: AIDS Project Los Angeles Los Angeles LGBT Center DIGEST: 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 methods that prevent or reduce the risk of contracting HIV, including, but not limited to, pre-exposure prophylaxes (PrEP) and post-exposure prophylaxes (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC). ANALYSIS: Existing law places certain requirements on the information shared by medical providers with patients for HIV AB 2640 Page 2 testing, as specified. 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 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, PrEP and PEP, consistent with guidance of the CDC. 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 50 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 AB 2640 Page 3 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 Department of Public Health's (DPH) Office of AIDS (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 the OA, with treatment costs averaging around $23,000 per year, lifetime treatment is currently estimated at around $740,000 or 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 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 possible exposure. Daily PrEP AB 2640 Page 4 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)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. 5)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 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 AB 2640 Page 5 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. 6)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 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. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: No According to the Senate Appropriations Committee: 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, Senate Appropriations 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 AB 2640 Page 6 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. SUPPORT: (Verified 8/12/16) AIDS Project Los Angeles (co-source) Los Angeles LGBT Center (co-source) Access Support Network Bienestar Human Services, Inc. Black AIDS Institute California Health+ Advocates California Life Sciences Association City of West Hollywood Community Clinic Association of Los Angeles County Desert AIDS Project Equality California Free Speech Coalition Friends Community Center AB 2640 Page 7 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 OPPOSITION: (Verified 8/15/16) AIDS Healthcare Foundation American College of Emergency Physicians, California Chapter ARGUMENTS IN SUPPORT: AIDS Project Los Angeles and the Los Angeles LGBT Center are the co-sponsors 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 AB 2640 Page 8 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 accurate information about the benefits these interventions. California Health+ Advocates writes that California's clinics are committed to keeping our patients healthy and this bill will assist in this mission. ARGUMENTS IN 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 Web site 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. ASSEMBLY FLOOR: 57-20, 6/1/16 AYES: Alejo, Travis Allen, Atkins, Baker, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chau, Chiu, Chu, Cooley, Cooper, Dababneh, Daly, Dodd, Eggman, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Harper, Roger Hernández, Holden, Irwin, Jones-Sawyer, Levine, Lopez, Low, Maienschein, Mayes, McCarty, Medina, Mullin, Nazarian, O'Donnell, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Mark Stone, Thurmond, Ting, Waldron, Weber, Wilk, Williams, Wood, Rendon NOES: Achadjian, Arambula, Bigelow, Brough, Chávez, Dahle, Beth Gaines, Gallagher, Grove, Jones, Kim, Lackey, Linder, Mathis, AB 2640 Page 9 Melendez, Obernolte, Olsen, Patterson, Steinorth, Wagner NO VOTE RECORDED: Chang, Frazier, Hadley Prepared by:Melanie Moreno / HEALTH / (916) 651-4111 8/15/16 20:22:28 **** END ****