BILL ANALYSIS Ó AB 861 Page 1 Date of Hearing: March 29, 2011 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair AB 861 (Hill and Nestande) - As Introduced: February 17, 2011 SUBJECT : California Stroke Registry. SUMMARY : Establishes the California Stroke Registry (CSR) within the Department of Public Health (DPH) to serve as a centralized repository for stroke data to promote quality improvement for acute stroke treatment. Requires that the program will only be implemented to the extent funds from federal or private sources are made available for this purpose. Specifically, this bill : 1)Requires DPH to establish a statewide CSR to serve as a centralized repository for stroke data to promote quality improvement for acute stroke treatment. 2)Requires CSR to align with the stroke consensus metrics developed by national health organizations such as the federal Centers for Disease Control and Prevention (CDC), the Joint Commission, the American Heart Association (AHA), and the American Stroke Association (ASA). 3)Requires the acquisition of data for CSR to encompass all areas of the state for which stroke data are available. 4)Requires CSR to be under the direction of the Director of DPH and housed within DPH's California Heart Disease and Stroke Prevention Program (CHDSP) and permits CHDSP to accept, on behalf of the state, grants of public or private funds for CSR. 5)Permits DPH to contract with an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department groupings, or nonprofit professional associations, representing a designated reporting region for the purposes of collecting and collating acute stroke data. 6)Permits DPH to contract, or provide grant awards, to implement public health activities to fulfill required funding award objectives. AB 861 Page 2 7)Requires the Director of DPH, in establishing the CSR, to do the following: a) Maintain a statewide stroke database that compiles information and statistics on stroke care. Requires DPH, to the extent possible, to coordinate with the CDC, the Joint Commission, AHA and ASA to avoid duplication and redundancy; b) Recommend that hospitals and emergency medical services agencies report case-specific data on the treatment of individuals with suspected acute stroke to the representative of DPH, or any individual, agency, or organization designated to cooperate with that representative; c) Encourage sharing of information and data among health care providers to improve the quality of care for stroke; d) Facilitate the communication and analysis of health information and data among the health care professionals providing care for individuals with stroke; and, e) Consult with the Stroke Advisory Committee of the ASA regarding ways in which to improve the quality of stroke care and delivery in California. 8)Requires all information collected for the CSR to be confidential. Requires DPH, or its designee, to use this information to evaluate measures designed to improve the quality of acute stroke treatment. 9)Authorizes persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health, and who meet qualifications as determined by DPH, and who agree, in writing, to maintain confidentiality, to have access to confidential information. Requires, before confidential information is disclosed for study, researchers to do both of the following: a) Obtain approval of their committee for the protection of human subjects established in accordance with existing law; and, b) Provide documentation to DPH that demonstrates to DPH's AB 861 Page 3 satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information. 10)Requires any disclosure authorized by this bill to include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not to be further disclosed. 11)Requires that the furnishing of confidential information to DPH or its authorized representative, in accordance with this bill, to not expose any person, agency, or entity furnishing information to liability, and is prohibited from being considered a waiver of any privilege or a violation of a confidential relationship. 12)Requires DPH to maintain an accurate record of all persons who are given access to confidential information. Requires the record to include the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and, the specific purpose for which information is to be used. Requires the record of access to be open to public inspection during normal operating hours of DPH. 13)Prohibits any part of the confidential information from being available for subpoena, from being disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, or from being deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. 14)Requires that this bill not prohibit the publication by DPH of reports and statistical compilations that do not in any way identify individual cases or individual sources of information. 15)Requires that the individual to whom the information pertains have access to his or her own information in accordance with existing law. 16)Makes the following definitions: a) Ischemic stroke means an occlusion of a blood vessel that blocks blood flow to the brain, depriving the brain of AB 861 Page 4 oxygen, and resulting in brain tissue death. This definition includes transient ischemic attacks, defined as stoke-like symptoms for less than 24 hours; and, b) Hemorrhagic stroke means as a rupture of a blood vessel, resulting in bleeding into or around the brain. 17)Prohibits this bill from preempting the authority of facilities or individuals providing diagnostic or treatment services to patients with stroke to maintain their own facility-based stroke registries. 18)Prohibits this bill from being construed as a medical practice guideline and from being used to restrict the authority of a hospital to provide services for which it has received a license under state law. 19)Requires this bill to be implemented only to the extent funds from federal or private sources are made available for this purpose. 20)Makes various finding and declarations regarding the prevalence of stroke in California and the importance of rapid identification, diagnosis, and treatment of stroke to save lives. EXISTING LAW : 1)Permits DPH to do all of the following in order to protect, preserve, and advance public health: a) studies; b) demonstrations of innovative methods; c) evaluations of existing projects; d) provisions of training programs; and, e) dissemination of information. 2)Permits DPH, in performing activities listed in 2) above, to do all of the following: a) perform the activity directly; b) enter into contracts, cooperative agreements, or other agreements for the performance of the activity; and, c) award grants for the performance of the activity. FISCAL EFFECT : This bill has not yet been heard by a fiscal committee. COMMENTS : AB 861 Page 5 1)PURPOSE OF THIS BILL . According to the author, a voluntary stroke registry was established in DPH in 2007 and approximately 42 hospitals across the state have participated. The author maintains that codifying the voluntary registry will likely lead to a much greater rate participation and increasing the amount of information that can be collected on strokes, the types of treatment victims receive, and the impacts of those treatments will provide medical professionals with a roadmap to improved care. Additionally, the author maintains that establishment of a stroke registry in statute will improve the potential for California to receive and accept federal grants through CDC. The author asserts that the CDC has been tasked with implementing state-based registries to measure and track acute stroke care. According to the author, a second round of CDC funding is forthcoming but absent a stroke registry in statute, California will be ineligible to receive those federal funds. 2)BACKGROUND . According to the National Institute of Neurological Disorders and Stroke (NINDS), a stroke, or "brain attack," occurs when blood circulation to the brain fails. Brain cells can die from decreased blood flow and the resulting lack of oxygen. NINDS states that there are two broad categories of stroke: those caused by a blockage of blood flow and those caused by bleeding. While not usually fatal, a blockage of a blood vessel in the brain or neck, called an ischemic stroke (PRONOUNCED i-skee-meek), is the most frequent cause of stroke and is responsible for about 80% of strokes. These blockages stem from three conditions: the formation of a clot within a blood vessel of the brain or neck, called thrombosis; the movement of a clot from another part of the body such as the heart to the neck or brain, called embolism; or, a sever narrowing of an artery in or leading to the brain, called stenosis. Bleeding into the brain or the spaces surrounding the brain causes the second type of stroke, called hemorrhagic stroke. Stroke occurs in all age groups, in both sexes, and in all races. In African Americans, stroke is more common, and more deadly - even in young and middle-aged adults - than for any ethnic or other racial group in the United States. Scientists have found more and more severe risk factors in some minority groups and continue to look for patterns of stroke in these groups. Some of the most important treatable risk factors for stroke are: high blood pressure; cigarette smoking; heart AB 861 Page 6 disease; history of stroke; and, diabetes. According to AHA and ASA, stroke is the third leading cause of death in California. Each year stroke kills approximately 15,585 Californians and accounts for almost 200,000 hospitalizations. Stroke is the leading cause of severe, long-term disability in California. While 50-70% of stroke survivors regain functional independence, 15-30% are permanently disabled and 20% of stroke survivors require institutional care at three months after the onset. According to the CDC, the estimated direct and indirect costs in 2010 of stroke in the United States was $73.3 billion. 3)PAUL COVERDALE NATIONAL ACUTE STROKE REGISTRY . In 2001, Congress charged CDC with implementing state-based registries to track acute stroke care and to use data from the registries to improve the quality of care. Congress named the registry the Paul Coverdale National Acute Stroke Registry (PCNASR) after the late U.S. Senator Paul Coverdell of Georgia, who suffered a fatal stroke in 2000 while serving in Congress. The goals of PCNASR include: to measure, track, and improve the quality of care and access to care for stroke patients; decrease rate of premature death and disability; eliminate disparities in care; support the development of stroke systems of care that emphasize quality of care; improve access to rehabilitation and opportunities for recovery; and, increase the workforce and scientific knowledge for stroke surveillance within stroke systems of care. In June 2004, the CDC funded the state health departments of Georgia, Illinois, Massachusetts, and North Carolina to establish statewide stroke registries to improve acute care in hospitals. According to the CDC, by the end of the three-year project period, over 180 hospitals were participating and over 45,000 stroke patients benefited from hospital participation. In July of 2007, CDC awarded funds to Georgia, Massachusetts, Michigan, Minnesota, North Carolina, and Ohio to continue to improve this work. According to the author, explicit statutory authority is needed for California to be eligible for the CDC funds. 4)STATE ACTIVITY . In 2003, the state of California recognized the need to take the lead in coordinating and focusing the statewide assault on heart disease and stroke. The California Legislature passed AB 1220 (Berg), Chapter 395, Statutes of 2003, which established a 12-member Heart Disease and Stroke AB 861 Page 7 Prevention and Treatment Task Force to develop California's Master Plan for Heart Disease and Stroke Prevention and Treatment for 2007-2015 to reduce the morbidity, mortality, and economic burden of heart disease and stroke in the state. Establishment of a stroke registry is consistent with the recommendations contained in the Mater Plan. CHDSP is housed within DPH and was established to reduce premature death and disability from heart disease and stroke among Californians. CHDSP currently administers the state's voluntary stroke registry. DPH also administers a Birth Defects Monitoring Program, a Parkinson's Disease Registry and the Ken Maddy California Cancer Registry. 5)SUPPORT . According to the sponsors of this bill, AHA and ASA, by centralizing stroke data, the state will be able to identify geographic areas that are doing well and what their best practices are which can then be implemented statewide and improve the care and treatment of stroke victims. All other supporters attest to the need for immediate diagnosis and treatment of stroke to save lives as well as to significantly reduce long term disability such as neurological damage, paralysis, and speech and language difficulties. Supporters write that by providing vital information on stroke care, this bill will improve quality of patient care and contribute to a substantial cost savings to the state. 6)RELATED LEGISLATION . ACR 8 (Butler and Bonnie Lowenthal), Resolution Chapter 2, Statutes of 2011 recognizes the Month of February 2011 as American Heart Month in California, and February 4, 2011, as Wear Red Day in California in order to raise awareness of the importance of the ongoing fight against heart disease and stroke; and urges public support for Go Red for Women events. 7)PREVIOUS LEGISLATION . AB 1220 (Berg), Chapter 395, Statutes of 2003, established a 12-member Heart Disease and Stroke Prevention and Treatment Task Force to develop a Master Plan for California. REGISTERED SUPPORT / OPPOSITION : Support American Health Association (co-sponsor) American Stroke Association (co-sponsor) AB 861 Page 8 Adelante Media Group California Pacific Medical Center San Mateo County Health System University of California, Los Angeles Numerous Individuals Opposition None on file. Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916) 319-2097