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 2 CONSULTANT: 5 Orr 4 1 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--- STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 2 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. STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 3 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 4 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, STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 5 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 6 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 7 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 8 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 9 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 --