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: 9/6/13 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 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. Senate Floor Amendments of 9/6/13 delete a reference to the age of a patient who has consented to a HIV test at a primary care clinic; delete a reference to HIV testing guidelines issued by the Centers for Disease Control (CDC) and prevention and instead refer only to the United States Preventative Services Task Force recommendations and guidelines; limit online notification of HIV test results to instances in which the test subject is being anonymously tested; and cross reference other provisions in this bill related to HIV information and counseling in the provisions related to online notification of HIV test results. 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 CONTINUED AB 446 Page 3 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 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 CONTINUED AB 446 Page 4 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 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 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 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.Limits the results of an HIV test 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 to instances in which the test subject is being anonymously tested. 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. CONTINUED AB 446 Page 5 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 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 CONTINUED AB 446 Page 6 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 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. 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 CONTINUED AB 446 Page 7 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. 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 9/9/13) CONTINUED AB 446 Page 8 AIDS Healthcare Foundation (source) Beyond AIDS Black AIDS Institute Black Women for Wellness California California Medical Association Communities United Institute OPPOSITION : (Verified 9/9/13) ACLU-California legislative Office APAIT Health Center Being Alive Disability Rights Legal Center Los Angeles HIV Law and Policy Project Los Angeles HIV Women's Task Force Minority AIDS Project The Alliance Health Project The Stigma Project 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 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. 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, this bill will encourage patients to forego the receipt of HIV test results with the direct support of a trained mental health professional, instead being able to access information about their HIV status online, alone, without additional counseling or information. This change means that many people who find out about their HIV status will do so with no mental health CONTINUED AB 446 Page 9 intervention, which may lead to depression, suicidality, increased high-risk behavior, and other negative health outcomes. ASSEMBLY FLOOR : 72-1, 5/29/13 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 9/10/13 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED