BILL ANALYSIS Ó AB 446 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 446 (Mitchell) As Amended September 6, 2013 Majority vote ----------------------------------------------------------------- |ASSEMBLY: |72-1 |(May 29, 2013) |SENATE: |36-0 |(September 11, | | | | | | |2013) | ----------------------------------------------------------------- Original Committee Reference: JUD. SUMMARY : Expands voluntary human immunodeficiency virus (HIV) testing outreach to certain patients at primary care clinics, and revises requirements for obtaining consent from, and providing information to, persons being tested for HIV infection. Specifically, this bill : 1)Modifies the information that a medical provider is required to give to a person about to receive an HIV test in a clinical setting. 2)Removes the requirement to obtain a signed written statement of informed consent before administering an HIV test in a non-clinical setting, and instead provides that informed consent may be provided orally or in writing, but the person administering the test must maintain documentation of consent, whether obtained orally or in writing, in the client's medical record. 3)Provides that the informed consent requirements above do not apply when a person independently requests an HIV test from an HIV counseling and testing site that employs a trained HIV counselor, provided that the person is given the required pre-test information and his or her independent request for an HIV test is documented by the person administering the test. 4)Exempts clinical laboratories from informed consent requirements for HIV testing, as specified. 5)Specifies information that a medical care provider must give to a patient after the results of the patient's HIV test have been received, including information specific to a positive test result and different information in the case of a negative test. AB 446 Page 2 6)Requires each patient who has blood drawn at a primary care clinic, as defined, to be offered an HIV test, unless within the previous year the primary care clinic has tested the patient for HIV or offered an HIV test that the patient declined. Further provides that any subsequent testing of a patient by the primary care clinic shall be consistent with the most recent guidelines issued by the United States (U.S.) Preventive Services Task Force (USPSTF). 7)Requires the primary care clinic to attempt to provide the test results to the patient before he or she leaves the facility if possible; otherwise the facility must inform a patient of a positive HIV test result consistent with existing law, and may inform the patient of a negative HIV test result by letter or telephone, as provided. 8)Allows, under specified circumstances, the result of an HIV test to be posted on a secure Internet Web site viewable only 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, and allows the result to be posted only if there is no link to any information that identifies the test subject and certain post-result advice and information is also provided. The Senate amendments exempt clinical laboratories from the informed consent requirements, and, under certain circumstances, exempt persons who independently request an HIV test from an HIV counseling and testing site from the same informed consent requirements. In addition, the amendments preserve existing law specifying information that medical providers must give to a person about to be tested for HIV in a clinical setting, and modify the confidentiality parameters for posting HIV test results on a secure Web site. Finally, the amendments delete the condition that only those patients aged 18 to 65 who have had blood drawn at a primary care clinic and who have consented to an HIV test must be offered an HIV test, expanding this requirement to all patients regardless of age, and make other clarifying changes. FISCAL EFFECT : According to the Senate Appropriations Committee: 1)Minor anticipated costs to provide information and technical AB 446 Page 3 assistance to providers of HIV testing services by the Department of Public Health (General Fund). 2)Unknown increase in HIV testing costs by the state's Medi-Cal program (50% General Fund, 50% federal funds). Under the bill, the number of Medi-Cal enrollees being tested for HIV is likely to increase, increasing program costs. 3)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 the bill increases testing rates, HIV positive Medi-Cal enrollees would become aware of their HIV status earlier and begin treatment earlier (current clinical guidelines recommend anti-viral treatment begin immediately upon diagnosis). 4)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. COMMENTS : This bill, sponsored by the AIDS Healthcare Foundation (AHF), seeks to make a number of changes to state HIV testing law that the author believes will help facilitate greater HIV screening of people who are hard to reach within traditional clinical settings and using traditional testing protocols. Under this bill, an HIV counselor working in a non-clinical setting would no longer be required to obtain a separate, signed written statement of informed consent from the patient before administering the HIV test. This bill would still require informed consent in the non-clinical setting, but would allow it to be provided orally or in writing, as long as the person administering the test maintains documentation of the AB 446 Page 4 consent, whether obtained orally or in writing, in the patient's record. This bill would also authorize the tester to disclose an HIV test result on a secure Web site that a test subject may access with a secure code intended to protect the confidentiality of the patient's identity. This bill also requires each patient who has blood drawn at a primary care clinic to be offered an HIV test, unless within the previous year the primary care clinic has tested the patient for HIV or offered an HIV test that the patient declined. The bill also provides that any subsequent testing of a patient by the primary care clinic shall be consistent with the most recent guidelines issued by the USPSTF. Additionally, the bill requires the primary care clinic to attempt to provide the test results to the patient before he or she leaves the facility if possible; otherwise the facility must inform a patient of a positive HIV test result consistent with existing law, and may inform the patient of a negative HIV test result by letter or telephone, as provided. According to the author and sponsor, state laws specifying pre-test information and consent procedures need to be revised in order to facilitate greater HIV testing. The sponsor states, "The key is finding those persons living with HIV who do not know they are infected, linking them into care and suppressing the presence of HIV through adherence to medications. . . More and more testing is being administered by HIV Counselors, a profession created by statute and trained and certified by the state. As the largest private HIV testing entity in California, AHF places its testing professionals in the community where they can reach out to people who might otherwise never go to a physician or clinic for an HIV test." Informed consent for HIV testing, as defined by CDC, is "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." CDC also states "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." (CDC, "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings." Morbidity and Mortality Weekly Report (2006), 55(RR14), page 1-17.) AB 446 Page 5 By contrast, a requirement for written consent simply refers to the need to obtain a signed paper documenting that the person has given his or her consent to have the test done. Written consent may be independently required (or not required) where the legal standard is informed consent, or some alternative standard, such as simple consent. According to the sponsor, "the potential test subjects who visit community non-clinical settings often have to be convinced to have the test in the first place and are more likely to skip the test altogether the longer they are required to remain with the HIV Counselor, especially if they have to sign a consent form." Proponents also correctly note that CDC's 2006 recommendations for health care settings specifically state that separate written consent for HIV testing should not be required, and many states currently do not require separate written consent for HIV testing. Existing law requires both written consent and informed consent for HIV testing in non-clinical settings. Under this bill, a person working in a non-clinical setting would no longer need to obtain a separate, signed written statement of informed consent from the patient before administering the HIV test. This bill would still require informed consent in the non-clinical setting, but would allow informed consent to be provided orally or in writing, as long as the person administering the test maintains documentation of the consent, whether obtained orally or in writing, in the patient's record. As recently amended, the bill provides that these informed consent requirements do not apply when a person independently requests an HIV test from an HIV counseling and testing site that employs a trained HIV counselor, provided that the person is given the required pre-test information and his or her independent request for an HIV test is documented by the person administering the test. The bill would presumably help increase HIV testing by eliminating one of the major obstacles to testing, as reported by AHF, but at the same time preserve the important purposes that informed consent serves by ensuring exchange of information and an opportunity for dialogue. Finally, this bill requires the medical provider or the person administering the test, after the results of the test have been received, to ensure the patient receives timely information and counseling, as appropriate, to explain the results and implications for the patient's health. If the patient tests positive for HIV infection, the bill requires the provider or AB 446 Page 6 the person administering 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. If the patient tests negative for HIV infection and is known to be at high risk for HIV infection, the bill requires the provider or the person administering the test to advise the patient of: 1) the need for periodic retesting; 2) explain the limitations of current testing technology and the current window period for verification of results; and 3) may offer prevention counseling or a referral to prevention counseling. It is the author's intent that appropriately timed post-test delivery of information will not only streamline the pre-test informational procedure that may delay or defer the test, but will also lead to better linkages to care for those who test positive. As recently amended, the bill clarifies that this information shall also be provided on a secure Internet Web site that an anonymously tested person may use to access his or her test results, as specified. Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334 FN: 0002704