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---



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          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 




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          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 




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          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 




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          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 




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          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 




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          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 




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          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.


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