BILL ANALYSIS Ó AB 2640 Page 1 Date of Hearing: April 19, 2016 ASSEMBLY COMMITTEE ON HEALTH Jim Wood, Chair AB 2640 (Gipson) - As Amended March 16, 2016 SUBJECT: Public Health: HIV. SUMMARY: Requires a medical care provider or person administering a test for human immunodeficiency virus (HIV) to inform individuals who test negative for HIV infection, yet are at high risk for HIV infection, of the effectiveness and safety of all federal Food and Drug Administration (FDA) -approved methods that prevent or reduce the risk of contracting HIV, including pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC). EXISTING LAW: 1)Requires a medical provider or person administering a test for HIV, after receiving results indicating no infection for a patient who is at high risk for HIV infection, to advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results. 2)Establishes the Office of AIDS (OA) within the Department of AB 2640 Page 2 Public Health (DPH), to coordinate state programs, services, and activities related to HIV/acquired immune deficiency syndrome (AIDS). 3)Establishes the AIDS Drug Assistance Program within DPH to subsidize the cost of AIDS drugs for persons who do not have private health coverage, are not eligible for Medi-Cal, or cannot afford to purchase the drug privately. Indicates that the subsidy program is to be funded by state and federal sources. FISCAL EFFECT: This bill has not been analyzed by a fiscal committee. COMMENTS: 1)PURPOSE OF THIS BILL. According to the author, this bill 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. 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. 2)BACKGROUND. AB 2640 Page 3 a) 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. b) 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 respondents indicated AB 2640 Page 4 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. The FDA first approved the use of ARVs as a form of HIV prevention for at-risk, HIV-negative individuals in 2012. Various studies have since demonstrated the efficacy of PrEP among different populations, however, African American MSM lag behind in PrEP use despite their disproportionate HIV incidence and prevalence. c) HIV in America. More than 1.2 million people in the United States are living with HIV infection, and almost one in eight (12.8%) are unaware of their infection. Gay, bisexual, and other MSM, particularly young African AB 2640 Page 5 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 United States with an AIDS diagnosis have died overall. The deaths of persons with an AIDS diagnosis can be due to any cause-that is, the death may or may not be related to AIDS. 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 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. d) 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 AB 2640 Page 6 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. e) CDC guidelines on PrEP. 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 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. AB 2640 Page 7 f) 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. g) 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 AB 2640 Page 8 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. As a result of a statewide request for applications, on March 3, 2016 OA announced the nine applicants that were selected to receive funding for the PrEP Navigator Services Program are as follows: i) AltaMed Health Services Corporation; ii) Asian Health Services; iii) Desert AIDS Project; iv) Friends Research Institute, Inc.; v) Humboldt County Department of Health and Human Services; vi) Kern County Public Health Services Department; vii) La Clinica de la Raza, Inc.; viii) Alta Bates Summit Medical Center; and, ix) Tarzana Treatment Centers. 3)SUPPORT. AIDS Project Los Angeles and the Los Angeles LGBT Center are the cosponsors of this bill and they state that awareness and use of PrEP and PEP among Californians at risk AB 2640 Page 9 for HIV remain extremely low. They 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 proponents 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. 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. 4)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 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. 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 AB 2640 Page 10 likely to be useful. The California Medical Association (CMA) is opposed to this bill stating, 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 notes that many preventative treatment options are not appropriate for every patient, and this bill would require a physician to inform the patient of a treatment option the physician might actually recommend against. 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. CHA also contends that this bill would eliminate the medical provider's option to refer the patient to another, more appropriate physician for prevention counseling and explains, the option to refer the patient to another physician is very important - many physicians who may order an HIV test, such as hospital emergency physicians and psychiatrists, do not routinely treat infectious disease patients as part of their practice. They instead refer such patients to internal medicine physicians or infectious disease specialist who keep themselves up-to-date on the most recent pronouncements and guidance from the FDA and the CDC. CHA concludes that medical discussion should be between the patient and the physician. AB 2640 Page 11 5)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 pending in the Assembly Health Committee. 6)PREVIOUS LEGISLATION. a) AB 446 (Mitchell), Chapter 589, Statutes of 2013, revises 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. b) 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. c) AB 1894 (Krekorian), Chapter 631, Statutes of 2008, AB 2640 Page 12 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. d) 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 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. 7)SUGGESTED AMENDMENT. As currently drafted, this bill requires the medical provider or person who administers an HIV test to provide a patient who tests negative for HIV with information on the effectiveness and safety of all FDA approved methods that prevent or reduce the risk of contracting HIV, including PrEP and PEP. While it is a valid goal to improve awareness and use of PrEP and PEP, that treatment may not be appropriate for every patient. The Committee may wish to amend this bill to instead require that written information be provided to all persons who test negative regarding all methods that prevent or reduce the risk of contracting HIV, including, but not limited to, PrEP and PEP. AB 2640 Page 13 REGISTERED SUPPORT / OPPOSITION: Support AIDS Project Los Angeles (cosponsor) Los Angeles LGBT Center (cosponsor) Access Support Network Bienestar Human Services, Inc. Black AIDS Institute California Primary Care Association Community Clinic Association of Los Angeles County Desert AIDS Project Equality California Free Speech Coalition Friends Community Center Gender Health Center JWCH Institute Our Family Coalition Positive Women's Network Project Inform San Francisco AIDS Foundation Tarzana Treatment Centers, Inc. UCLA Center for Behavioral and Addiction Medicine Opposition AIDS Healthcare Foundation California Hospital Association California Medical Association AB 2640 Page 14 Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097