BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 446| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 446 Author: Mitchell (D) Amended: 7/8/13 in Senate Vote: 21 SENATE HEALTH COMMITTEE : 9-0, 6/26/13 AYES: Hernandez, Anderson, Beall, De León, DeSaulnier, Monning, Nielsen, Pavley, Wolk SENATE JUDICIARY COMMITTEE : 6-0, 7/2/13 AYES: Walters, Anderson, Corbett, Jackson, Leno, Monning NO VOTE RECORDED: Evans SENATE APPROPRIATIONS COMMITTEE : 6-0, 8/30/13 AYES: De León, Walters, Gaines, Hill, Padilla, Steinberg NO VOTE RECORDED: Lara ASSEMBLY FLOOR : 72-1, 5/29/13 - See last page for vote SUBJECT : HIV testing SOURCE : AIDS Healthcare Foundation DIGEST : This bill 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 CONTINUED AB 446 Page 2 laboratories from the informed consent requirements; requires every patient who has blood drawn at a primary care clinic, as defined, who is between 12 and 65 years of age and 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, as specified. ANALYSIS : Existing law: 1.Requires a medical care provider, prior to ordering an HIV test, to provide information about the test to the patient, to inform the patient that there are numerous treatment options available, and to inform the patient that a person who tests negative for HIV should continue to be routinely tested (informed consent in clinical settings). This requirement does not apply when a person independently requests an HIV test from the medical care provider. 2.Prohibits an HIV test from being administered, unless the person being tested or his/her parent, guardian, or conservator, signs a written statement documenting his/her informed consent to the test (written informed consent in non-clinical settings). 3.Sets forth the powers and duties of an HIV counselor in a HIV counseling and testing site funded by the Department of Public Health (DPH) through a local health jurisdiction or its agents. 4.Establishes DPH and sets forth its powers and duties, including, but not limited to, administration of a program to provide information, establish testing sites, and award contracts for AIDS early intervention projects to provide appropriate medical treatment to prevent or delay the progression of disease that results from HIV infection, to coordinate related services, and to provide information and education to prevent the spread of the infection to others. This bill: 1.Revises existing law related to informed consent in clinical settings for an HIV test, including adding a new requirement CONTINUED AB 446 Page 3 that a medical care provider inform patients that a person who tests negative for HIV should continue to be routinely tested. 2.Clarifies that a provision in existing law exempting clinical settings from the informed consent requirements applies when a person independently requests a test from a medical care provider. Requires the person's independent request for an HIV test to be documented by the person administering the test. 3.Deletes a requirement that a written statement documenting informed consent for an HIV test be signed and instead requires the informed consent to be provided orally or in writing. Requires the person administering the test to maintain documentation of consent, whether obtained orally or in writing, in the client's medical record. Clarifies that this provision does not apply when a person independently requests an HIV test from an HIV counseling and testing site that employs a trained HIV counselor, as defined. 4.Requires, after the results of a test have been received, the medical care provider or the person who administers the test to ensure that the patient receives timely information and counseling, as appropriate, to explain the results and the implications for the patient's health. 5.Requires, if the patient tests positive for HIV infection, the medical provider or the person who administers the test 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. 6.Requires, 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 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. 7.Requires a patient between 12 and 65 years of age who has blood drawn at a primary care clinic, and who has consented to the HIV test to be offered an HIV test. Deems the primary care clinic to be in compliance with this bill if it chooses CONTINUED AB 446 Page 4 to test the patient using a rapid HIV test. Prohibits this bill from applying if the primary care clinic has tested the patient for HIV, or if the patient has been offered and declined the HIV test within the previous 12 months. Requires subsequent testing of a patient who has been tested by the primary care clinic to be consistent with the most recent guidelines issued by the federal Centers for Disease Control and Prevention (CDC) and the United States Preventive Services Task Force. 8.Requires HIV testing of minors 12 years of age or older to comply with existing law related to consent by a minor. 9.Specifies that nothing in this bill prohibits a primary care clinic from charging a patient to cover the cost of HIV testing. 10.Requires a primary care clinic to attempt to provide test results to the patient before he/she leaves the facility. Permits, if that is not possible, the facility inform the patient who tests negative for HIV by letter or telephone, and requires the clinic to inform a patient with a positive test result in a manner consistent with existing law. 11.Permits, under specified circumstances, the result of an HIV test to be posted on a secure Internet Web site which can only be viewed with the use of a secure code that can access only a single set of test results and that is provided to the patient at the time of testing. Requires the test result to be posted only if there is no link to any information that identifies or refers to the subject of the test. Background According to a 2012 CDC report, an estimated 1,148,200 persons who are age 13 and older are living with HIV infection, including approximately 207,600 who are unaware of their infection. 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. The estimated incidence of HIV has remained stable overall in recent years, at about 50,000 new HIV infections per year. Within the overall estimates, however, some groups are affected more than others. Men who have sex with men continue to bear the greatest burden CONTINUED AB 446 Page 5 of HIV infection, and among races/ethnicities, African Americans continue to be disproportionately affected. In 2011, an estimated 49,273 people were diagnosed with HIV infection in the United States. In that same year, an estimated 32,052 people were diagnosed with AIDS. Since the epidemic began, an estimated 1,155,792 people in the United States have been diagnosed with AIDS. An estimated 15,529 people with an AIDS diagnosis died in 2010, and approximately 636,000 people in the United States with an AIDS diagnosis have died since the epidemic began. 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. HIV positive but unaware . According to the CDC, 18% of people living with HIV are unaware of their infection. According to the California Office of AIDS, as of the end of 2011, it is estimated that between 29,523 and 31,948 HIV-positive and unaware individuals reside in California. According to the CDC, when HIV is diagnosed early, appropriately timed interventions, particularly highly active antiretroviral therapy, can lead to improved health outcomes, including slower clinical progression and reduced mortality. Additionally, HIV counseling with testing has been demonstrated to be an effective intervention for HIV-infected participants, who increased their safer behaviors and decreased risk behaviors. Studies on written consent and testing . According to research findings published in the March 14, 2007 issue of the Journal of the American Medical Association, in May 2006, the San Francisco Department of Public Health Medical Care System, which includes an acute care hospital, a long-term care facility, and more than 15 primary health care centers, eliminated the requirement for written consent for HIV tests (but still obtained informed consent). According to the findings, the monthly rate of HIV testing increased steadily after the change in policy (from 13.5 HIV tests per 1000 patient-visits in June 2006 to 17.9 HIV tests per 1000 patient-visits in December 2006). The authors cautioned that other events may have contributed to this increase of HIV testing. For example, the XVI International AIDS Conference in mid-August 2006 and the release of the revised CDC recommendations for HIV testing in September 2006 may have heightened clinician and patient awareness and affected clinicians' testing practices. However, the authors stated that the increase in testing appears to have begun before those CONTINUED AB 446 Page 6 events and maintained a steady increase thereafter, so that these events are unlikely to explain the increase in HIV testing. In conclusion, the authors called the results "hypothesis generating," and called for further studies for confirmation. CDC testing recommendations . In September 2006, the CDC published a 17-page report titled "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings." The CDC indicated that its objectives in revising the recommendations were to increase HIV screening of patients; foster earlier detection of HIV infection; identify and counsel individuals with unrecognized HIV infection and link them to clinical and prevention service; and further reduce perinatal transmission of HIV in the country. The CDC also indicated that the updated recommendations were intended to inform the work of public and private sector policy makers and service providers. Major revisions from previous publications include: 1.HIV screening is recommended for patients in all health care settings after the patient is informed orally or in writing that testing will be performed unless the patient declines (opt-out screening); 2.Persons at high risk for HIV infection should be screened for HIV at least annually; 3.Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing; and 4.Prevention counseling should not be required with HIV diagnostic testing as part of HIV screening programs in health care settings. CDC consent recommendations . The CDC guidance with regard to consent and pretest information for adolescents and adults are as follows: 1.Screening should be voluntary and undertaken only with the patient's knowledge and understanding that HIV testing is planned; CONTINUED AB 446 Page 7 2.Patients should be informed orally or in writing that HIV testing will be performed unless they decline (opt-out screening). Oral or written information should include an explanation of HIV infection and the meanings of positive and negative test results, and the patient should be offered an opportunity to ask questions and to decline testing. With such notification, consent for HIV screening should be incorporated into the patient's general informed consent for medical care on the same basis as other screening or diagnostic tests (a separate consent form for HIV testing is not recommended); 3.Easily understood informational materials should be made available in the languages of the commonly encountered populations within the service area. The competence of interpreters and bilingual staff to provide language assistance to patients with limited English proficiency must be ensured; and 4.If a patient declines an HIV test, this decision should be documented in the medical record. The CDC has not issued guidelines specifically for HIV testing in non-clinical settings, however a 2012 "Guide for Program Managers" on implementation of HIV testing in those settings states that clients should be provided with information about HIV and HIV testing that is sufficient to obtain informed consent for testing. At a minimum, it is suggested that clients be provided with the following information: 1.Overview of HIV testing, what is being tested (e.g., antibodies), based on the test(s) that will be used, testing strategies and client options for testing, procedure for testing, procedure and timeline for obtaining results, next steps and procedure associated with HIV-positive results, and next steps and procedure associated with HIV-negative results. 2.Benefits of testing; 3.Drawbacks of testing; 4.HIV "basics" (e.g., transmission, prevention); CONTINUED AB 446 Page 8 5.Meaning of test results, especially the window period (relative to last exposure and test strategy used); 6.Applicable laws (e.g., disease reporting laws); and 7.Sources of additional information and support. AB 682 (Berg, Chapter 550, Statutes of 2007) . In 2007, there was extensive debate over AB 682, which, among other things, sought to revise statute that set forth informed consent requirements for HIV testing. The sponsors of that bill, which included the sponsor of this bill, argued that existing requirements created a barrier to administering HIV tests because many healthcare providers would rather avoid the subject of HIV than meet its high standard for consent, as they are not comfortable or knowledgeable about the disease. Opponents of AB 682 argued that specific written consent is beneficial both to the patient and the provider because it documents that providers have satisfied their ethical and legal obligations to obtain informed consent, and communication and trust between the patient and the provider is enhanced - leading to a greater likelihood that the person will seek, and continue, needed treatment. Both cited the 2006 CDC guidance in defense of their arguments. A compromise on the consent issue was reached in the Senate, and was based on the CDC recommendation that consent for HIV screening should be incorporated into a patient's general informed consent for medical care. The CDC recommendations define "informed consent" as a "process of communication between patient and provider through which an informed patient can choose whether to undergo HIV testing or decline to do so. Elements of informed consent typically include providing oral or written information regarding HIV, the risks and benefits of testing, the implications of HIV test results, how test results will be communicated, and the opportunity to ask questions." The final AB 682 language (which is now law) tracks fairly closely to these recommendations, and in effect permits HIV testing without written informed consent in clinical settings by medical care personnel, but did not amend the law with regard to testing in non-clinical settings by non-medical personnel. This bill seeks to modestly change the informed consent requirements, but expand the exemption from informed consent to include when a person independently request the test in non-clinical settings. CONTINUED AB 446 Page 9 Prior Legislation AB 491 (Portantino, 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 Internet Web site 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 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. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: No According to the Senate Appropriations Committee: Minor anticipated costs to provide information and technical assistance to providers of HIV testing services by DPH (General Fund). Unknown increase in HIV testing costs by the state's Medi-Cal program (50% General Fund, 50% federal funds). Under this bill, the number of Medi-Cal enrollees being tested for HIV is likely to increase, increasing program costs. CONTINUED AB 446 Page 10 Unknown increase in treatment costs for HIV positive Medi-Cal enrollees and participants in the AIDS Drug Assistance Program (General Fund and federal funds). The state spends about $25,000 per year per HIV positive Medi-Cal enrollee and about $12,000 per year per HIV positive AIDS Drug Assistance Program enrollee. To the extent that this bill increases testing rates, HIV positive Medi-Cal enrollees will become aware of their HIV status earlier and begin treatment earlier (current clinical guidelines recommend anti-viral treatment begin immediately upon diagnosis). Unknown long-term costs savings to Medi-Cal due to earlier medical intervention for HIV-positive Medi-Cal enrollees. To the extent that HIV-positive Medi-Cal enrollees are diagnosed earlier and begin treatment earlier, it is likely that the long-term health status of those individuals will improve and some of the health effects of HIV will be delayed or avoided. There are indications that untreated HIV causes long-term health impacts such as elevated risk of diabetes and heart disease, even before the effects of compromised immune system function associated with HIV infection become evident. Earlier diagnosis and treatment for HIV-positive individuals is likely to reduce long-term Medi-Cal expenditures for those individuals. SUPPORT : (Verified 8/30/13) AIDS Healthcare Foundation (source) Beyond AIDS Black AIDS Institute Black Women for Wellness California California Medical Association Communities United Institute OPPOSITION : (Verified 8/30/13) American Civil Liberties Union ARGUMENTS IN SUPPORT : AIDS Healthcare Foundation states that this bill addresses two testing reforms. First, it clarifies that HIV testing can be provided with informed consent in a non-clinical setting by any person statutorily authorized to administer an HIV test. More and more testing is being administered by HIV counselors who are authorized to administer CONTINUED AB 446 Page 11 the rapid HIV test. However, because of a shortcoming in the law, an HIV counselor is required to get a higher level of consent than other medical providers. Requiring HIV counselors to seek a more rigid form of consent undermines their ability to provide testing services to people who are out-of-sync with traditional health care delivery. Second, this bill authorizes the tester to disclose an HIV test result on a secure Internet Web site, for a test subject to access with a unique code, in order to increase the number of test subjects who actually learn of their test results. Since the CDC has long recommended routine HIV testing occur in all health care settings, it is a substantial drag on achieving the goal of real routine testing when we leave it to the patient to execute the state's public health policy on HIV testing. The Black AIDS Institute writes that in the absence of the legal right of an HIV tester to provide test results to patients in reasonable settings, persons infected with HIV are deprived of the timely benefit of first step in an essential process known as the "treatment cascade." ARGUMENTS IN OPPOSITION : According to opponents, writing in response to the provision that adds to the informed consent exemption a requested test at an HIV counseling and testing site, states that the CDC guidelines do not include a "no information, no informed consent" in any setting. Opponents state that regardless of whether someone is at a clinic or in a van they should understand and know about the test and that California adopted this standard in a clinical setting in AB 682, based in part on the rationale that the person would have some relationship with the provider and would be comfortable asking questions and the provider would know the individual's history and risk factors. Expanding this standard to the non-clinical setting may lead to people most in need of detailed information not actually getting the information. The opponents further assert that as a matter of practice and law, HIV counselors have been providing critical information and obtaining consent quickly and efficiently. Therefore, it is unclear what the need for this provision in the bill is. Opponents argue that this "no information, no informed consent" standard could very easily become the "default" standard for HIV testing; essentially, it might become very easy for HIV counselors to consider encounters a request for HIV testing, undermining the actual non-clinical standard written into law. ASSEMBLY FLOOR : 72-1, 5/29/13 CONTINUED AB 446 Page 12 AYES: Achadjian, Alejo, Ammiano, Atkins, Bigelow, Bloom, Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley, Dahle, Daly, Dickinson, Eggman, Fong, Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hernández, Jones, Jones-Sawyer, Levine, Logue, Lowenthal, Maienschein, Mansoor, Medina, Melendez, Mitchell, Morrell, Mullin, Muratsuchi, Nazarian, Nestande, Olsen, Pan, Perea, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Salas, Skinner, Stone, Ting, Wagner, Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, John A. Pérez NOES: Donnelly NO VOTE RECORDED: Allen, Fox, Gordon, Holden, Linder, Patterson, Vacancy JL:ej 8/31/13 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED