BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 446
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          CONCURRENCE IN SENATE AMENDMENTS
          AB 446 (Mitchell)
          As Amended September 6, 2013
          Majority vote 
           
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          |ASSEMBLY:  |72-1 |(May 29, 2013)  |SENATE: |36-0 |(September 11, |
          |           |     |                |        |     |2013)          |
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           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.








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          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  








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            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  








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          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.)  









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          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  








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          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