BILL ANALYSIS                                                                                                                                                                                                    

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          Date of Hearing:  April 19, 2016

                            ASSEMBLY COMMITTEE ON HEALTH

                                   Jim Wood, Chair

          AB 2325  
          (Bonilla) - As Amended April 5, 2016

          SUBJECT:  Ken Maddy California Cancer Registry.

          SUMMARY:  Requires, on or after January 1, 2019, a pathologist  
          diagnosing cancer to report cancer diagnoses to the Department  
          of Public Health (DPH) in a format prescribed by DPH and  
          establishes a pilot project to enable DPH and authorized users  
          to conduct electronic specific data element searches of the  
          information collected by the Ken Maddy California Cancer  
          Registry (CCR).  Specifically, this bill:  

          1)Requires, on or after January 1, 2019, a pathologist  
            diagnosing cancer to report cancer diagnoses to DPH in a  
            format prescribed by DPH. 

          2)Permits an authorized representative of DPH to access the  
            information from a pathologist if a pathologist fails to  
            report in the appropriate format. 

          3)Requires, if an authorized representative of DPH has to access  
            information from a pathologist, the pathologist to reimburse  
            DPH or the authorized representative for its cost to access  
            and report the information. 

          4)Requires DPH to prescribe the data required to be included in  
            the report and designated a standardized electronic format for  


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          5)Requires DPH to establish a pilot project to enable DPH and  
            authorized users to conduct electronic specific data element  
            searches of the information collected by the registry for the  
            purpose of identifying individuals who meet cancer clinical  
            trial eligibility requirements.

          EXISTING LAW:  

          1)Requires DPH to conduct a program of epidemiological  
            assessments of the incidence of cancer.  Requires the program  
            to encompass all areas of the state for which cancer incidence  
            data are available, and to include monitoring of cancers  
            associated with suspected carcinogens encountered by the  
            general public both in occupational locations and in the  
          2)Allows DPH to contract with an agency, including, but not  
            limited to a health systems agency, single or multiple county  
            health departments, or nonprofit professional associations,  
            representing a designated cancer reporting region for the  
            purposes of collecting and collating cancer incidence data. 

          3)Requires the Director of DPH (Director) to establish the CCR,  
            a statewide system to collect information on the incidence of  
            cancer using population-based cancer registries.  Requires  
            these registries to be implemented or initiated by July 1,  
            1988, and requires that the statewide cancer reporting system  
            be fully operational by July 1, 1990.

          4)Authorizes the Director to enter into contracts as necessary  
            to conduct the program, and accept grants of public or private  
            funds for the program on behalf of the state.  Requires the  
            Director to analyze available incidence data and prepare  
            reports and perform studies as necessary to identify cancer  


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            hazards to the public health and their remedies.

          5)Mandates the Director to require the reporting of cancer to  
            DPH, or its authorized representative, in areas of the state  
            where cancer information is being collected. 

          6)Requires any hospital or other facility providing therapy to  
            cancer patients to report all cancers diagnosed or treated, in  
            designated cancer reporting areas, to DPH or an authorized  
            representative, and allows DPH access to those records.

          7)Requires specified health care providers diagnosing or  
            providing treatment for cancer patients to report all cancers  
            to DPH or an authorized representative, with specified  
            exemptions, and allows DPH access to those records. 

          8)Authorizes DPH to fine entities that do not comply with these  
            record-sharing requirements, and requires that fines collected  
            be deposited into the General Fund.

          9)Requires all information collected for the purpose of the CCR  
            to be kept confidential. 

          10)Permits DPH and any regional cancer registry designated by  
            DPH to use the information to determine the sources of cancer  
            and evaluate measures designed to eliminate, alleviate, or  
            ameliorate its effect.

          11)Permits persons with a valid scientific interest who are  
            engaged in demographic, epidemiological, or other similar  
            studies related to health who meet certain qualifications as  
            determined by DPH, and who agree, in writing, to maintain  
            confidentiality, to access confidential information.

          12)Authorizes contracting between state agencies and private  
            contractors to furnish confidential information to other  
            states' cancer registries, federal cancer control agencies,  
            local health officers, or health researchers for the purposes  
            of determining the sources of cancer and evaluating measures  


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            designed to eliminate, alleviate, or ameliorate their effect. 

          13)Requires, prior to confidential information being disclosed  
            to designated entities, those designated entities to agree in  
            writing to maintain the confidentiality of the information,  
            and requires researchers to do both of the following:

             a)   Obtain approval of their committee for the protection of  
               human subjects in accordance with federal regulations; and,

             b)   Provide documentation to DPH that demonstrates that the  
               entity has established appropriate procedures and its  
               ability to maintain the confidentiality of the information.

          14)Specifies that any disclosure of information include only the  
            information necessary for the stated purpose of the requested  
            disclosure, used for the approved purpose, and not be further  

          15)Requires DPH to maintain an accurate record of all persons  
            who are given access to confidential information in the CCR  

             a)   The name of the person authorizing access; 
             b)   Name, title, address, and organizational affiliation of  
               persons given access; 
             c)   Dates of access; and,
             d)   The specific purpose for which information is to be  

          16)Requires records of those who access the CCR, pursuant to 15)  
            above, to be open to public inspection.

          17)Requires the individual to whom the information pertains to  
            have access to his or her own information made available in  
            the CCR.

          FISCAL EFFECT:  This bill has not yet been analyzed by a fiscal  


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          1)PURPOSE OF THIS BILL.  According to the author, this bill  
            creates an innovative, new tool which will allow researchers  
            working on clinical trials to reach out to patients to provide  
            them the opportunity to participate in cutting edge  
            treatments.  This bill removes the burden of searching for a  
            cancer clinical trial from patients who are battling cancer  
            and places it on the clinician.  The author states that  
            roadblocks to innovative uses of the CCR data stem from long  
            delays in cancer reporting.  At best, cancer diagnosis  
            information is reported to the CCR within six to nine months  
            after diagnosis.  In reality, it could take one to two years  
            before information is fully reported.

            Modernization of the CCR, through electronic pathology  
            reporting, will significantly increase the speed at which  
            diagnosis reports are deposited within the CCR.  Because of  
            the real-time reporting, researchers will be able to request  
            diagnosis information to identify matches to ongoing cancer  
            clinical trials.  As a result, trial participants will be  
            identified much faster with no burden on cancer patients.  Due  
            to the rapid matching of patients to trials and increased  
            participation, cancer therapies will be developed and improved  
            much faster than currently possible because patients will be  
            connected to potentially lifesaving treatments.


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          2)BACKGROUND.  According to the DPH and the American Cancer  
            Society 2015 report of California Cancer Facts and Figures,  
            figures show that cancer incidence rates have dropped 13% and  
            death rates have declined 26% in California since 1988.   
            Additionally, the overall incidence rate remains lower than  
            the rest of the nation.  Even with those declines, an  
            estimated 172, 090 Californians will be diagnosed with cancer  
            and 58,180 will die of the disease in 2015. The most commonly  
            diagnosed cancers in men will be prostate, lung and colorectal  
            cancers and breast, lung and colorectal cancers will be the  
            most frequently diagnosed among women. 

             a)   University of Southern California (USC) Cancer Registry  
               Program.  The Los Angeles County Cancer Surveillance  
               Program (CSP) is the population-based cancer registry for  
               Los Angeles County.  It identifies and obtains information  
               on all new cancer diagnoses made among residents of Los  
               Angeles County.  The CSP was established in 1970 and  
               operates within the administrative structure of the USC  
               School of Medicine.  It was developed with the voluntary  
               cooperation of hospitals and other institutions, clinics,  
               and medical laboratories equipped to diagnose cancer in Los  
               Angeles County. By 1972, the CSP became population-based  
               and complete incidence data for Los Angeles County were  
               made available from that year onward.  To date, the CSP  
               master file contains over 1.7 million records and about  
               41,000 incident cancers are added annually.

               Since 1981, the CSP has been the designated legal agent of  
               Los Angeles County for collecting information on all new  
               cancer cases occurring among County residents for the  
               purpose of monitoring cancer incidence patterns and trends.  
               In 1987, it became the regional registry for Los Angeles  
               County for the new California Cancer Registry.  The CSP is  


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               one of eight such regional registries providing, as a  
               group, statewide coverage.  In September 1992, the CSP  
               became the largest registry of the National Cancer  
               Institute-funded Surveillance, Epidemiology, and End  
               Results (SEER) program.  The consortium of 18  
               population-based SEER registries provides the federal  
               government with a "snapshot" of cancer incidence and  
               survival across the United States.

             b)   DPH Pilot Program.  In July of 2015, DPH announced  
               participation in a pilot project with St. Joseph's Health  
               System (St. Joseph) to better understand cancer trends in  
               California.  This partnership is the first in the United  
               States in which a health system electronically collects and  
               securely sends structured pathology cancer data directly to  
               the CCR.  According to DPH, this project has given the  
               cancer registry the opportunity to perform real-time  
               surveillance activities on data reported by project  
               partners while opening the door to many new research  
               opportunities that will ultimately improve patient  
               treatment and outcomes.  Work on this pilot program began  
               in January 2014. The first complete data-set was sent by  
               St. Joseph's to CCR in March 2015.

               Ten hospitals within St. Joseph's are now sending data  
               directly to the CCR with other health care facilities  
               expected to participate in the future.  The St. Joseph  
               pilot project is a collaboration between DPH, St Joseph,  
               mTuitive, a synoptic reporting system, and the College of  
               American Pathologists (CAP).  Prior to this project, a  
               cancer diagnosis by a pathologist was only able to be  
               stored as narrative text data within the hospital's or  
               laboratory's electronic records system.  The use of text  


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               data limited the practical uses of the pathology report for  
               research into cancer causes and possible cures.  Synoptic  
               reporting is the use of structured checklists to produce  
               standardized clinical documentation. For pathologists, this  
               usually means using the CAP Cancer Protocols and electronic  
               Cancer Checklists. 


             c)   Barriers to Trial Participation.  The Coalition to  
               Eliminate Disparities and to Research Inclusion in Clinical  
               Trials identified a number of reasons that are major  
               barriers to minority recruitment in clinical trials.  There  
               are many different factors that have been attributed, in  
               part, to the very low participation rate of all eligible  
               patients in clinical trials, and the disproportionately low  
               participation rate of minority populations including, but  
               not limited to: 

               i)     Lack of awareness:  A national survey of cancer  
                 patients found that 85% of respondents were unaware that  
                 participating in a clinical trial was a treatment option  
                 for them.

               ii)    Language/Linguistic differences:  Many U.S. clinical  
                 trials require English proficiency for potential  
                 participants, automatically excluding those who do not  
                 speak the language.  Language factors also pose a serious  
                 barrier to provider-patient communications and attempts  
                 to recruit patients into clinical trials. 


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               iii)   Mistrust:  According to a review conducted by the  
                 Agency for Healthcare Research and Quality, mistrust of  
                 research and the medical system is a frequently reported  
                 barrier to participating in clinical trials.

               iv)    Practical obstacles:  Transportation to and from a  
                 trial, particularly if it is located in a distant  
                 location, can be a barrier for many patients.   
                 Individuals with low incomes may find it difficult to  
                 take time off from work, find childcare or manage other  
                 family responsibilities while participating in a trial.

               v)     Public misconception:  Among patients that are aware  
                 of clinical trials, a large percentage choose not to  
                 enroll, often due to fear of getting a placebo in place  
                 of actual treatment, belief that standard treatment is  
                 better than what they would be offered in a clinical  
                 trial and fear of being a "guinea pig."  However,  
                 placebos are rarely used in cancer treatment trials, and  
                 never in lieu of standard treatment.  

               vi)    Physician lack of awareness:  Being unaware that  
                 clinical trials are available is one of the most common  
                 reasons physicians fail to refer patients to trials.   
                 Primary care physicians do not have sufficient  
                 information on available clinical trials, and often leave  
                 the discussion of clinical research to the patient's  
                 oncologist.  Yet, many oncologists outside of the  
                 academic setting may also not be aware of trials or  
                 otherwise choose not to participate in or refer their  
                 eligible patients to clinical trials.


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             d)   Federal Efforts to Increase Women and Minority  
               Participation.  The federal Food and Drug Administration  
               (FDA) Office of Women's Health (OWH) was established by  
               congressional mandate to advocate for the participation of  
               women in clinical trials and the analyses of data by sex.   
               OWH supports studies to track the participation of women in  
               clinical trials and collaborates with the FDA and external  
               partners to understand sex and gender differences in  
               disease prevalence and response to therapy through science  
               and research.  The FDA Office of Minority Health (Office)  
               is housed within the Office of the Commissioner and is the  
               principal advisor on minority health and health  
               disparities.  The Office is responsible for coordinating  
               efforts throughout the FDA and has focused its efforts on  
               three key areas:  communicating and disseminating agency  
               information to vulnerable populations; increasing  
               participation of diverse health professionals in FDA  
               activities to strengthen its capacity to address health  
               disparities; and, advocating for meaningful participation  
               of minorities in clinical trials as well as the analysis of  
               subpopulation data.

               According to a 2011 report titled "Successful Strategies  
               for Engaging Women and Minorities in Clinical Trials," the  
               National Institutes of Health funded studies have specific  
               diversity requirements, but aside from FDA recommendations,  
               there are no regulations currently in place that require  
               industry sponsors to include women and minorities in their  
               trials.  Diversity is not a natural priority for industry,  
               where decisions often are made by market attractiveness and  
               potential profit.  


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          3)SUPPORT.  USC, a cosponsor of the bill, states that although  
            the CCR is a powerful tool, currently available technologies  
            would allow it to do so faster and more efficiently.  
            Roadblocks to innovative uses of the CCR data stem from long  
            delays in cancer reporting due to reliance on 30 year old  
            methods.  At best, cancer diagnosis information is reported to  
            the CCR within six to nine months after diagnosis.  In  
            reality, it can take one to two years before that information  
            is fully reported.  The long reporting times occur because of  
            inefficient data collection methods.  USC argues that this  
            measure will ensure that rapid, real-time electronic cancer  
            diagnosis reporting becomes standard in California, providing  
            higher quality data and allowing new uses of the CCR.  For  
            nearly all new cancer diagnoses, the pathology report is the  
            first available record and virtually all are prepared  
            electronically.  Yet, pathology reports are not prepared,  
            stored or accessed in a consistent method. 

            USC states that modernization of the CCR, through electronic  
            pathology reporting, will significantly increase the speed at  
            which diagnosis reports are available within the CCR. Public  
            health officials, researchers and medical providers will be  
            able to monitor cancer occurrence months to years earlier than  
            currently possible and the public will be reassured that the  
            identification of possible new risks will occur as early as  
            possible.  USC concludes that this measure will significantly  
            enhance cancer research and monitoring in California through  
            modernization of the CCR.

          4)RELATED LEGISLATION.  AB 2174 (Jones) would requires, prior to  
            researchers contacting a cancer patient, DPH to ensure that a  
            patient whose name appears in the CCR has received specified  
            notice regarding the registry including, among other things,  


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            that DPH is authorized to release confidential patient  
            information to health researchers. This bill is pending in the  
            Assembly Health Committee.

             a)   AB 1329 (Davis), Chapter 642, Statutes of 2011, requires  
               DPH to establish a process to receive applications for, and  
               award a grant to, an agency to operate the CCR.  

             b)   AB 48 (Cedillo), Chapter 368, Statutes of 2000, renames  
               the California Cancer Registry to the Ken Maddy California  
               Cancer Registry, after the late state Senator Kenneth  
               Maddy, former Minority Leader of the State Senate.  

             c)   AB 136 (Connelly), Chapter 841, Statutes of 1985,  
               established the California Cancer Registry. 



          American Cancer Society Cancer Action Network
          California Society of Pathologists


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          University of Southern California


          None on file.

          Analysis Prepared by:Paula Villescaz / HEALTH / (916) 319-2097