BILL ANALYSIS SENATE HEALTH COMMITTEE ANALYSIS Senator Elaine K. Alquist, Chair BILL NO: AB 2541 A AUTHOR: Portantino, Fletcher B AMENDED: August 20, 2010 HEARING DATE: August 25, 2010 2 CONSULTANT: 5 Orr 4 1 PURSUANT TO S.R. 29.10 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. Authorizes additional disclosures of public health records relating to human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) between specified local and state public health agency staff, health care providers, and HIV positive individuals who are the subject of the records. Increases the penalties for negligent, willful or malicious disclosure of content of any confidential public health record to a third party, except as otherwise authorized by law. CHANGES TO EXISTING LAW Existing law: Permits certain laboratory test results to be posted on the Continued--- STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 2 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 unduplicated HIV cases by patient name to the California Department of Public Health (CDPH). 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. Declares public health records relating to HIV or AIDS as confidential and prohibits their disclosure, except as otherwise provided by law for public health purposes or pursuant to a written authorization by the person who is the subject of the record. Allows state or local public health agencies to disclose personally identifying information in public health records as described to other local, state, or federal public health agencies or to corroborating medical researchers, when the 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. Permits state or local public health agencies to disclose personally identifying information in public health records, as described, to other local, state, or federal public health agencies or to corroborating medical researchers, when the 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. STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 3 Prohibits the negligent, willful or malicious disclosure of the content of any confidential public health record, as defined, to any third party, except pursuant to a written authorization, as described or as otherwise authorized by law, and establishes civil penalties for violations of these provisions. Establishes that any person who willfully, negligently, or maliciously discloses the content of any confidential public health record to a third party that results in economic, bodily, or psychological harm to the person whose record was disclosed, is guilty of a misdemeanor, punishable by imprisonment in the county jail and/or a fine of up to twenty-five thousand dollars ($25,000). 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, by electronic mail or by non-traceable mail. 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. Provides that health care providers and LHOs may submit cases of HIV infection, including facsimile and electronically by a secure and confidential electronic STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 4 reporting system established by the department, to be implemented using the existing resources of the department. Allows CDPH to advise out-of-state laboratories that are known to the department to test specimens from California residents of the new reporting requirements through its internet website. Authorizes specified disclosures of public health records relating to HIV or AIDS between specified local public health agency staff, health care providers, specified state public health agency staff, and HIV positive individuals who are the subject of the records, for the purposes of enhancing completeness of sexually transmitted disease reporting to the federal Centers for Disease Control and Prevention (CDC) and offering and coordinating care and treatment services to HIV positive persons. Increases the penalties for negligent, willful or malicious disclosure of content of any confidential public health record to a third party, except as otherwise authorized by law. Contains contingent language to avoid chaptering out provisions contained in AB 2786 (Committee on Health). FISCAL IMPACT Senate Appropriations Committee estimates one-time resources of up to $75,000 General Fund in FY 2010-2011 to add an HIV/AIDS reporting module to CDPH's California Reportable Disease Information Exchange/Electronic Laboratory Reporting (ELR) system. To the extent that this bill furthers the goal of making California competitive in obtaining federal HIV/AIDS funding, there could be additional federal Ryan White Act and CDC funding available due to an increase in the number of HIV infections reported to CDPH, on which the funding allocation is based. BACKGROUND AND DISCUSSION STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 5 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 CDC. This bill implements a 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. According to the author, the recent floor amendments will allow further disclosure of personally identifying information contained in HIV/AIDS-related public health records for the purposes of HIV/AIDS reporting, care and treatment services and case management. These amendments will also allow HIV/AIDS, STD, and TB co-infection reporting, medical care, and treatment. This will help further CDPH's goals of increased reporting for HIV/AIDS and increased reporting for HIV/AIDS, STD, and TB co-infections. This should also help secure a maximum amount of Ryan White and CDC federal funding for HIV/AIDS, and improve the quality of patient care through better coordination of HIV/AIDS, STD, and TB co-infection care and treatment. 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 6 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 number. 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, 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 7 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 CCR, 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 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 that report 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. STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 8 The California Department of Health Services (now CDPH) 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 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 the 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. Confidential public health records According to CDPH, all HIV/AIDS case reports and any information collected or maintained in the course of surveillance-related activities that may directly or indirectly identify an individual are considered confidential public health record(s) under California Health and Safety Code (HSC) Section 121035(c) and must be handled with the utmost confidentiality. Furthermore, HSC 121025(a) prohibits the disclosure of HIV/AIDS-related public health records that contain any personally identifying information to any third party, unless STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 9 authorized by law for public health purposes, or by the written consent of the individual identified in the record or his/her guardian/conservator. Except as permitted by law, any person who negligently discloses information contained in a confidential public health record to a third party is subject to a civil penalty of up to $2,500 plus court costs. Any person who willfully or maliciously discloses the content of a public health record, except as authorized by law, is subject to a civil penalty of $5,000 to $10,000 plus court costs. Any willful, malicious, or negligent disclosure of information contained in a public health record in violation of state law that results in economic, bodily, or psychological harm to the person named in the record is a misdemeanor, punishable by imprisonment for a period of up to one year and/or a fine of up to $25,000 plus court costs. Each disclosure in violation of California law is a separate, actionable offense. Because an assurance of case confidentiality is the foremost concern of the California Department of Public Health, Office of AIDS (OA), employees are required to sign a Confidentiality Agreement. In the event of any suspected breach, staff immediately notify the director or supervisor of the local health department's HIV/AIDS surveillance unit who in turn notify the Chief of the HIV/AIDS Case Registry Section or designee. OA, in conjunction with the local health department and the local health officer promptly investigate the suspected breach. Any evidence of an actual breach is reported to the law enforcement agency that has jurisdiction. 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 10 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 specified. Pending in the Senate Health Committee. Prior legislation SB 541 (Alquist), Chapter 605, Statues of 2008, requires health care facilities to prevent unlawful or unauthorized access to use, or disclosure of, patients' medical information and to establish safeguards to protect the privacy of patients' medical information. Authorizes CDPH to levy administrative penalties against facilities for failure to prevent unlawful or unauthorized access, use, or disclosure of patients' medical information, and for failure to report instances of unlawful or unauthorized access, use, or disclosure of information. AB 211 (Jones), Chapter 602, Statutes of 2008, requires every provider of health care to implement appropriate specified safeguards to protect the privacy of a patient's medical information. The bill would require every provider of health care to reasonably safeguard confidential medical information from unauthorized or unlawful access, use, or disclosure. 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. STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 11 SB 356 (Negrete McLeod) of 2007 would have required CDPH to establish a list of communicable diseases and conditions for which clinical laboratories are required to submit specimens to the local public health laboratory and state public health laboratory for further testing. This bill would have permitted the list to be modified by CDPH at any time, in consultation with the California Conference of Local Health Officers, and to exempt the modifications from APA regulation change and rulemaking requirements. 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. 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. AB 1091 (Negrete McLeod), Chapter 262, Statutes of 2003, allows CDPH, in consultation with the California Conference of Local Health Officers, to modify the list of reportable diseases that health care providers are required to report. CDPH can modify this list at any time without having to comply with APA requirements. Arguments in support AIDS Project Los Angeles supports this measure because they believe it will bring California 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 STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 12 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 Assembly Health: 18-0 Assembly Appropriations: 16-0 Assembly Floor: 72-0 Senate Health: 8-0 Senate Appropriations: 11-0 COMMENTS 1. Recent amendments. When this bill passed Senate Health Committee on June 30, 2010, the bill: a) deleted the provision in existing law that that excludes HIV infections from being reported electronically; and, b) described 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. Recent Senate Floor amendments: a. Authorize specified disclosures between specified local public health agency staff, health care providers, and specified state public health agency staff for the purposes of enhancing completeness of STD reporting to the federal Centers for Disease Control and Prevention (CDC) and offering and coordinating care and treatment services to HIV positive persons. b. Increase the penalties for negligent, willful or malicious disclosure of content of any confidential public health record to a third party, except as otherwise authorized by law. STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino, Fletcher)Page 13 c. Add contingent language to avoid chaptering out provisions in AB 2786 (Committee on Health). POSITIONS Support: AIDS Project Los Angeles AIDS Healthcare Foundation Oppose: None received -- END --