BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: AB 2640 --------------------------------------------------------------- |AUTHOR: |Gipson | |---------------+-----------------------------------------------| |VERSION: |April 21, 2016 | --------------------------------------------------------------- --------------------------------------------------------------- |HEARING DATE: |June 29, 2016 | | | --------------------------------------------------------------- --------------------------------------------------------------- |CONSULTANT: |Melanie Moreno | --------------------------------------------------------------- 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 : ----------------------------------------------------------------- |Assembly Floor: |57 - 20 | |------------------------------------+----------------------------| |Assembly Appropriations Committee: |14 - 6 | AB 2640 (Gipson) Page 3 of ? |------------------------------------+----------------------------| |Assembly Health Committee: |12 - 5 | | | | ----------------------------------------------------------------- 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, providewritteninformation 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 -- END --