BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       AB 2541                                      
          A
          AUTHOR:        Portantino, Fletcher                         
          B
          AMENDED:       June 24, 2010                               
          HEARING DATE:  June 30, 2010                                
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          CONSULTANT:                                                 
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          Orr                                                          
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                                     SUBJECT
                                         
                   Reporting of certain communicable diseases


                                     SUMMARY  

          Deletes the HIV exemption from authorized electronic  
          reporting in order to increase federal funding provided to  
          California for HIV and AIDS services.

                             CHANGES TO EXISTING LAW  

          Existing law:
          Permits certain laboratory test results to be posted on the  
          Internet or other electronic method if requested by the  
          patient and deemed appropriate by the health care provider  
          who ordered the test. Prohibits the electronic delivery of  
          clinical laboratory test results or any other related  
          results for HIV antibody tests, regardless of  
          authorization. 
          
          Requires health care providers and clinical laboratories to  
          report HIV infection by patient name to the local health  
          officer, and mandates local health officers to report  
                                                         Continued---



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          unduplicated HIV cases by patient name to the California  
          Department of Public Health (CDPH). 

          Stipulates that public health records relating to HIV or  
          AIDS, containing personally identifying information,  
          developed or acquired by state or local public health  
          agencies or an agent of such an agency, shall be  
          confidential and shall not be disclosed, except as provided  
          by law for public health purposes or in accordance with a  
          written authorization by the person who is the subject of  
          the record or by his or her guardian or conservator. 

          Allows state or local public health agencies, or an agent  
          of such an agency, to disclose personally identifying  
          information in public health records to other local, state,  
          or federal public health agencies or to corroborating  
          medical researchers, when the confidential information is  
          necessary to carry out the duties of the agency or  
          researcher in the investigation, control, or surveillance  
          of disease, as determined by the state or local public  
          health agency. 

          Requires CDPH to establish a list of communicable and  
          noncommunicable diseases and conditions which local health  
          officers are required to report to CDPH.  Exempts from  
          civil and criminal penalties any person or facility that  
          fails to provide  notification of a reportable disease or  
          condition, unless the disease or condition that is required  
          to be reported has been printed in the California Code of  
          Regulations (CCR) for at least six months. 
          
          Existing regulations:
          Require that all reports containing personal information,  
          including HIV/AIDS Case Reports, shall be sent to the local  
          health officer (LHO) or his or her designee by courier  
          service, U.S. Postal Service Express or registered mail, or  
          other traceable mail, or by person-to-person transfer with  
          the LHO or his or her designee.  

          Prohibit the health care provider and laboratory from  
          submitting reports containing personal information to the  
          LHO or his or her designee by electronic facsimile  
          transmission or by electronic mail or by non-traceable  
          mail. 
          




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          Require all local health department (LHD) employees and  
          contractors to sign a HIV/AIDS Confidentiality Agreement  
          prior to accessing confidential HIV-related public health  
          records, required to be renewed annually. Stipulates that  
          information reported pursuant to these regulations is  
          acquired in confidence and shall not be disclosed by the  
          LHO or his or her authorized designee except as authorized.  
          

          This bill: 
          Deletes the provision in existing law that that excludes  
          HIV infections from being reported electronically. 

          Describes the methods health care providers and LHOs may  
          submit cases of HIV infection, including facsimile and  
          electronically by a secure and confidential electronic  
          reporting system established by the department, to be  
          implemented using the existing resources of the department.  

          
                                  FISCAL IMPACT  

          According to a recent report by the Legislative Analyst's  
          Office (LAO) on HIV surveillance and federal funding, by  
          increasing the number of HIV infections reported,  
          California could potentially increase receipt of federal  
          Ryan White Act funding by several million to low tens of  
          millions of dollars annually. These increased federal funds  
          would be used to reduce GF spending for HIV/AIDS. 

          Unknown costs to CDPH to modify an effort already underway  
          to develop a web-based electronic laboratory reporting  
          (ELR) system. 

                                         


                           BACKGROUND AND DISCUSSION

           According to the author, this bill would enable  
          laboratories to report HIV test results through CDPH's  
          electronic laboratory reporting system (ELR), in order to  
          enhance the completeness of HIV/AIDS data reported by CDPH,  
          Office of AIDS (CDPH/OA) to the federal Centers for Disease  
          Control and Prevention (CDC).  This bill implements a  




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          recommendation from a February 2010 Legislative Analysts  
          Office (LAO) report on California's HIV/AIDS reporting  
          system, 'Maximizing Federal Funds for HIV/AIDS: Improving  
          Surveillance and Reporting." The recommendation was to  
          enact legislation requiring laboratories to electronically  
          report HIV test results, in order to ensure that California  
           receives the maximum amount possible of federal funding  
          from the Ryan White Treatment Extension Act of 2009 (Ryan  
          White Act) for HIV/AIDS care and treatment services. 

          HIV/AIDS reporting 
          AIDS has been reportable in California for more than 20  
          years.  Since AIDS cases represent later stages of the  
          disease, AIDS data are less useful than HIV data for public  
          health professionals to monitor the epidemic, and target  
          and evaluate prevention programs.  Historically, HIV has  
          been treated differently than many other diseases, due in  
          part to the misperceptions and stigmas associated with its  
          transmission. Under current law, HIV cannot be reported  
          electronically and must be reported using methods such as  
          hand delivery or registered mail. This handling of HIV  
          reporting is administratively burdensome and does not  
          maximize data matching opportunities to increase the  
          identification of HIV-positive patients. Public health  
          professionals found they needed accurate HIV case data in  
          addition to AIDS data to assess the spread and impact of  
          the HIV/AIDS epidemic. 

          To address this, in 1997, the CDC called for all states to  
          conduct HIV surveillance as an extension of their on-going  
          AIDS surveillance programs. CDC published draft guidelines  
          outlining criteria for ensuring the quality and  
          confidentiality of HIV data, which set forth the standard  
          data that needs to be collected from each patient (date of  
          diagnosis, demographics, risk exposure, etc.), and also set  
          performance standards that reporting systems must meet.

          California responded to this need by implementing  
          code-based HIV reporting in July 2002.  The code contains  
          information about the patient's gender, date of birth, and  
          a code derived from the last name and the last four digits  
          of their social security.  Since then, local health  
          departments have reported over 33,000 cases of HIV,  
          representing more than 35 percent of reported cases of  
          individuals living with HIV/AIDS in California.  However,  




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          the CDC has since acknowledged that they consider HIV data  
          from code-based systems to be less reliable than name-based  
          systems, and would not accept the data and will not confirm  
          them for use in allocating Ryan White funds, putting some  
          of the state's federal grant money at risk. It is noted  
          that, at the time, the state used name-based reporting for  
          AIDS, and that California had had no documented or reported  
          cases of illegal or inappropriate disclosure of case  
          information from the state's AIDS Case Registry. To address  
          this, SB 699 (Soto) was passed in 2006 to report HIV cases  
          by  patient's name rather than code in order to comply with  
          federal funding requirements.

          
          Communicable disease reporting and surveillance
          California has a dual reporting system for communicable  
          diseases. Both health care providers (physicians) and  
          laboratories are required to report a case, or suspected  
          case, of notifiable diseases to public health officials.  
          They are both responsible for reporting dozens of named  
          conditions, as well as any outbreaks of unusual diseases,  
          within a specified timeframe of identifying the disease.  
          Laboratories report these specific conditions to the LHD,  
          based on the location of the physician's office. The  
          laboratory report may be submitted to the appropriate LHD  
          by various means including a phone call, facsimile, mail,  
          or electronically. Once the LHD receives a laboratory  
          disease report for a suspected or confirmed case, it  
          notifies the appropriate public health staff to manage and  
          track the case. LHDs then report disease case information  
          directly to the state. 
          
          Public health officials use disease reporting to monitor  
          public health, develop prevention strategies, set  
          priorities and evaluate programs, allocate resources and  
          facilitate research. While there are many surveillance  
          strategies, disease reporting originating from health care  
          providers and laboratories is at the core of surveillance.  
          Disease reporting is mandated by the California Code of  
          Regulations, and California requires health care providers  
          to confidentially report more than 80 diseases and  
          conditions to local health officers.

          Electronic disease surveillance
          At the national level, the Centers for Disease Control and  




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          Prevention (CDC) initiated an effort to streamline the  
          collection, management, and reporting of data - primarily  
          for the surveillance of communicable diseases. In 1999, the  
          CDC introduced the National Electronic Disease Surveillance  
          System (NEDSS), designed to:(1) facilitate the electronic  
          transfer of appropriate information from clinical  
          information systems used in the delivery of health services  
          to public health departments; (2) reduce the burden on  
          health service providers of collecting and reporting such  
          information; and, (3) enhance the timeliness and quality of  
          public health information. 

          In late 2002, the CDC introduced the concept of the Public  
          Health Information Network (PHIN), to provide a network of  
          information that functionally and organizationally  
          integrates public health partners across the country. Other  
          CDC initiatives promoting the integration of technology in  
          public health, in addition to NEDSS, include the Health  
          Alert Network (HAN), the Laboratory Response Network (LRN),  
          the Epidemic Information Exchange (EPI-X) and the redesign  
          of the CDC website for public information and public health  
          education. CDC began providing funds to those public health  
          jurisdictions reporting public health data to CDC and who  
          are working to develop or procure applications that comply  
          with the specified requirements of their public health  
          information technology initiatives.

          The California Department of Health Services (now under the  
          California Department of Public Health) initiated the  
          California Public Health Information Network (CalPHIN)  
          initiative to support the CDC efforts and promote the  
          public health goals of the state. Applications included  
          within the CalPHIN framework include the California  
          Electronic Laboratory Reporting (CA-ELR), and the  
          California Web Based Morbidity Reporting (WebCMR), among  
          others. The overall objective of the Electronic Laboratory  
          Reporting application is to enhance and strengthen state  
          and local disease surveillance capacity and promote public  
          health. This type of application will improve the ability  
          to collect more complete and timely surveillance  
          information from laboratories on a statewide basis, and is  
          used to increase the efficiency of existing surveillance  
          activities and the early detection of public health events  
          (e.g. bioterrorism). This will be accomplished through  
          automating manual processes such as data importing and  




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          accuracy verification, decreasing paper-based data  
          submittals, eliminating data redundancy and duplicate data  
          entry, and providing easy accessibility to data for  
          planning, analysis, and decision making.

          Chapter 278 of Statutes of 2008 (AB 2658, Horton) requires  
          laboratories to submit all cases of reportable diseases and  
          conditions electronically within one year of the  
          establishment of the new state ELR system, which is slated  
          for completion in 2010. According to the LAO, HIV reports  
          were specifically excluded from this requirement in order  
          to allow CDPH sufficient time to ensure the new system's  
          data architecture is not at variance with the HIV-specific  
          reporting requirements and that the system would meet  
          federal standards for HIV reporting. 

          HIV/AIDS funding
          California switched to name-based reporting in 2006 in  
          order to not risk major losses of federal Ryan White Act  
          funding. The state has since been in a transition period  
          between code-based reporting and full name-based reporting.  
          According to CDPH estimates, California's failure to be  
          fully name-based in HIV reporting, meant the lost of $3  
          million to $7 million in federal funding in 2009. 
          
          According to the LAO, only about 36,000 cases of HIV have  
          been reported by name to local health jurisdictions. This  
          number likely represents only one-third to one-half of HIV  
          cases statewide. According to the LAO, California could  
          potentially increase receipt of federal Ryan White Act  
          funding by several million to low tens of millions of  
          dollars annually simply by increasing the number of HIV  
          infections reported. California spends roughly $1.2 billion  
          a year (40 percent GF) on medical treatment and HIV/AIDS  
          programs. The Ryan White Act provides $125 million in  
          federal funding per year to California. Increased federal  
          funds would likely be used to reduce GF spending for the  
          treatment of the disease. 

          Related bills
          AB 2786 (Committee on Health) of 2010 would require CDPH to  
          establish a list 
          of communicable diseases and conditions for which clinical  
          laboratories are required to submit a culture or specimen  
          to local and state public health laboratories, as  




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          specified.

          Prior legislation
          AB 2658 (Horton), Chapter 449, Statutes of 2008, required  
          laboratories to submit all cases of "reportable diseases  
          and conditions" electronically, within one year of the  
          establishment of the new state electronic laboratory  
          reporting system, with the exception of HIV reports.    
          
          SB 356 (Negrete McLeod) of 2007 was nearly identical to AB  
          2786.  SB 356 was vetoed by Governor Schwarzenegger because  
          the delay in passing the 2008-2009 state budget forced him  
          to prioritize the bills sent to his desk.  According to the  
          Governor, SB 356 did not meet his standard as priority  
          legislation.

          AB 682 (Berg), Chapter 550, Statutes of 2007, revised the  
          written and informed consent standards associated with  
          testing blood for the human immunodeficiency virus (HIV),  
          including prenatal HIV testing, to no longer require  
          affirmative approval prior to administering an HIV test.  
          Established the new HIV testing consent standard as the  
          right to decline the test.

          SB 699 (Soto), Chapter 20, Statutes of 2006,required health  
          care providers and laboratories to report HIV cases by the  
          patient's name rather than code in order to comply with  
          federal funding requirements.
          
          Arguments in support
          AIDS Project Los Angeles supports this measure because they  
          believe it will bring us closer to a full and accurate  
          database of people living with HIV/AIDS in the state. They  
          believe the existing prohibition on electronic reporting  
          has inhibited the speedy and accurate reporting of HIV  
          cases. The AIDS Healthcare Foundation believes this bill  
          will provide additional tools for the state to improve its  
          HIV surveillance and better ensure our competitiveness for  
          federal Ryan White CARE Act dollars beginning in the 2012  
          award cycle.  They claim that the state's plan has been to  
          implement SB 699 and strive for as mature a database as  
          possible by the 2012 funding award cycle, thereby  
          minimizing the loss of federal funding. 

                                  PRIOR ACTIONS




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           Assembly Health:                      18-0
          Assembly Appropriations:              16-0
          Assembly Floor         72-0


                                    POSITIONS  
                                        
          Support:  AIDS Project Los Angeles
                 AIDS Healthcare Foundation


          Oppose:  None received


                                   -- END --