BILL ANALYSIS Ó SENATE HEALTH COMMITTEE ANALYSIS Senator Ed Hernandez, O.D., Chair BILL NO: AB 861 A AUTHOR: Hill and Nestande B AMENDED: May 27, 2011 HEARING DATE: July 6, 2011 8 CONSULTANT: 6 Orr 1 SUBJECT California Stroke Registry SUMMARY Establishes the California Stroke Registry (CSR) within the California Department of Public Health (CDPH) to serve as a centralized repository for stroke data to promote quality improvement for acute stroke treatment. Requires that CSR only be implemented to the extent funds from federal or private sources are made available for this purpose. CHANGES TO EXISTING LAW Existing law: Requires CDPH to administer the California Heart Disease and Stroke Prevention (CHDSP) Program. Establishes the Heart Disease and Stroke Prevention and Treatment Task Force (Task Force) within CDPH to create California's Master Plan for Heart Disease and Stroke Prevention and Treatment (Master Plan) to reduce the morbidity, mortality, and economic burden of heart disease and stroke in the state. Continued--- STAFF ANALYSIS OF ASSEMBLY BILL 861 (Hill and Nestande) Page 2 This bill: Establishes the CSR in the CHDSP Program to serve as a centralized repository for stroke data to promote quality improvement for acute stroke treatment. Requires the 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. Provides that data will be submitted voluntarily and encompass all areas of the state for which stroke data are available. Authorizes CDPH to contract with an agency or a nonprofit professional association, representing a designated reporting region for the purposes of collecting and collating acute stroke data. Authorizes CDPH to provide grant awards to implement public health activities to fulfill required funding award objectives. Requires the CHDSP director to: Maintain a statewide stroke database that compiles information and statistics voluntarily reported on stroke care; Recommend the voluntary reporting of case-specific data on the treatment of individuals with suspected acute stroke by hospitals and emergency medical services agencies; Encourage sharing of information and data among health care providers to improve the quality of care for stroke, and facilitate the communication and analysis of information and data among the health care professionals providing care for individuals with stroke; Consult with the Stroke Advisory Committee; Specifies that information collected under this bill be confidential. Authorizes persons with valid scientific interest in the collected confidential information, who meet specified criteria and who undergo specified processes to obtain approval, to access the information for research purposes. Specifies that disclosures authorized by this bill include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed. Excludes confidential information from being available or disclosed STAFF ANALYSIS OF ASSEMBLY BILL 861 (Hill and Nestande) Page 3 for specified legal proceedings, unless otherwise allowed by law. Allows the publication of reports and statistical compilations using this information, provided no individual cases or institutional or individual sources of information are disclosed. Allows an individual to whom the information pertains to have access to his or her own information. Requires CDPH to maintain a record of persons who are given access to confidential information. Provides that this bill be implemented only to the extent funds from federal or private sources are made available for this purpose. Excludes contracts with the program's fiscal intermediary from specified provisions of the Public Contract Code. 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. FISCAL IMPACT The Assembly Appropriations Committee analysis estimates one-time start-up costs, likely in the range of $200,000 to $400,000, and ongoing costs of around $800,000 annually to fund stroke registry operations. Although a federal grant program exists to fund state stroke registries, only six states have received funding through this program. If federal or private funds are not identified, the establishment in statute of an unfunded program would result in cost pressure to the General Fund. BACKGROUND AND DISCUSSION AB 861 establishes a voluntary California Stroke Registry within CDPH to collect data on stroke as a means to improve treatment. The author asserts that the establishment of a STAFF ANALYSIS OF ASSEMBLY BILL 861 (Hill and Nestande) Page 4 stroke registry in statute will improve the potential for California to receive and accept federal grants through the CDC and the Paul Coverdell National Acute Stroke Registry (Coverdell Registry). A voluntary stroke registry was established by CDPH in 2007 and approximately 42 hospitals across the state have participated so far. According to the author, increasing the amount of information that can be collected on strokes, the types of treatment stroke patients receive, and the impacts of those treatments will provide medical professionals with a roadmap to improved care. The author believes that codifying the voluntary registry will likely lead to a much greater rate of participation. In addition, a second round of CDC funding is forthcoming in 2012 but absent a stroke registry in statute, the author claims that California will be ineligible to receive funds. Stroke prevalence in the U.S. A stroke occurs when the blood supply to part of the brain is suddenly blocked (ischemic stroke) or when a blood vessel in the brain bursts, spilling blood into the spaces surrounding brain cells (hemorrhagic stroke). 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 severe narrowing of an artery in or leading to the brain, called stenosis. When there is sudden bleeding into or around the brain or when brain cells no longer receive oxygen and nutrients from the blood, the brain cells die. Stroke can cause death or significant disability, such as paralysis, speech difficulties, and emotional problems. According to the CDC, about 137,000 Americans die of stroke every year, making stroke the third leading cause of death in the U.S. More than 795,000 Americans suffer from a stroke each year, and 15-30 percent remain permanently disabled. The AHA estimates the total cost from heart disease and stroke in the U.S. for 2007 (including health expenditures and lost productivity) was $286 billion. Federal funding for stroke prevention While evidence-based medical guidelines for stroke care have been developed, as well as new and improved diagnostic and treatment tools, the CDC reports that many hospitals STAFF ANALYSIS OF ASSEMBLY BILL 861 (Hill and Nestande) Page 5 still do not have the organization, staff, and equipment to effectively diagnose and treat stroke patients. In response to this need, Congress provided funding in 2001 to the CDC to implement state-based registries that measure, track, and improve the delivery and quality of stroke care, and named the project after the late U.S. Senator Paul Coverdell of Georgia who suffered a fatal stroke in 2000 while serving in Congress. The main goals of the Coverdell Registry are to: Measure, track, and improve the quality of care for acute stroke patients; Decrease the rate of premature death and disability from acute stroke through secondary prevention; Increase public awareness of stroke treatment and prevention; and Reduce disparities in acute stroke care by providing underserved populations with better access to care. Under the Coverdell Registry program, the CDC piloted eight prototype registry projects, led by academic and medical institutions across the country, to test models for measuring the quality of care delivered to stroke patients. California participated in the second phase of this project, receiving funding in 2002 to gather data concerning each step of emergency and hospital care for stroke patients, from emergency response to the patients' eventual discharge from a hospital. At the end of the three-year pilot period, the results showed that large gaps existed between generally recommended guidelines for treating stroke patients and actual hospital practices. In 2004, the CDC funded four state health departments to establish statewide Coverdell Registries, and expanded funding to three more states in 2007. California's Master Plan for Heart Disease and Stroke Prevention and Treatment In 2003, the state of California took the lead in coordinating and focusing statewide efforts on heart disease and stroke. The California Legislature passed AB 1220 (Berg), Chapter 395, Statutes of 2003, which established a 12-member Task Force to develop California's Master Plan for Heart Disease and Stroke Prevention and Treatment (Master Plan) for 2007 to 2015. The Master Plan STAFF ANALYSIS OF ASSEMBLY BILL 861 (Hill and Nestande) Page 6 establishes goals such as decreasing death and disability from heart disease and stroke through early detection, treatment, and management of acute events, through education of the public and health professionals, improving the quantity and quality of research, and expanding data acquisition and surveillance of cardiovascular disease, including the evaluation of programs targeting heart disease, stroke, and related risk factors. The CHDSP Program is housed within CDPH 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, established in 2007 with 42 hospitals participating. Similar programs that CDPH also administers include the Birth Defects Monitoring Program, the Parkinson's Disease Registry, the immunization registry and the Ken Maddy California Cancer Registry. Related bills AB 1329 (Davis) would authorize CDPH to establish a competitive process to receive applications for, and issue, the award of a grant to an agency to operate the statewide cancer reporting system. Authorizes CDPH to also issue grants to other agencies representing designated cancer reporting regions for the purposes of collecting and collating cancer incidence data. Would exempt the award of these grants from the State Contract Act. AB 1329 is set for hearing on July 6, 2011 in the Senate Health Committee. Prior legislation AB 1220 (Berg) Chapter 395, Statutes of 2003, establishes a 12-member Heart Disease and Stroke Prevention and Treatment Task Force to develop a Master Plan for California. Arguments in support The AHA believes that providing explicit statutory authority for a stroke registry is necessary to improve California's ability to access federal funds for a permanent, long-term registry. AHA believes that the centralized stroke data will enable the state 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. Other supporters believe that a registry will provide important data and lead to improvements in quality patient care that STAFF ANALYSIS OF ASSEMBLY BILL 861 (Hill and Nestande) Page 7 will result in cost savings for the state. They attest to the need for rapid intervention for stroke patients and immediate diagnosis as a means to minimize the damage of a stroke. They believe that the collection of data resulting from the registry will help identify effective treatments and standardize care. PRIOR ACTIONS Assembly Health: 16- 0 Assembly Appropriations:17- 0 Assembly Floor: 75- 0 COMMENTS 1. Federal funding. The CDC will be issuing competitive grants for state stroke registries in 2012. It is unclear that codifying the program will influence California's chances of receiving these grant funds. The Assembly Appropriations Committee analysis suggests that codifying this program without the clear assurance of a funding source can create cost pressure on the General Fund. 2. Increased participation. It is unclear if codifying the existing voluntary registry will actually lead to increased participation by hospitals, especially in the potential absence of funding for registry activities. 3. Stroke Advisory Committee. Page 3 line 24 requires the CHDSP Director to consult with the Stroke Advisory Committee, yet no such committee is named in statute. CDPH developed the Task Force in 2006 to create California's Master Plan. The Task Force then established three work groups in 2007 to develop implementation strategies for a stroke system of care and to provide continuing guidance as the system is developed in California. The author may wish to amend the bill to replace the Stroke Advisory Committee with either the Task Force or the one of the work groups. 4. Public Contract Code (PCC) exemption. The PCC is intended to provide fair and competitive bidding opportunities for public contracts, including ensuring that a fair proportion of the total number of contracts or STAFF ANALYSIS OF ASSEMBLY BILL 861 (Hill and Nestande) Page 8 subcontracts are awarded to minority, women, and disabled veteran business enterprises, and to also protect the public from the misuse of public funds. The PCC is enforced by the state Department of General Services (DGS). AB 861 excludes contracts with the program's fiscal intermediary from specified provisions of the PCC. It is unclear why the provisions of this bill need to be exempted from the PCC provisions. It is also unclear what process CDPH uses to ensure its contracts are as competitive as those awarded by DGS. POSITIONS Support: American Heart Association (co-sponsor) American Stroke Association (co-sponsor) Adelante Media Group California Medical Association California Pacific Medical Center San Mateo County EMS Agency San Ramon Regional Medical Center 11 individuals Oppose:None received. -- END --