BILL ANALYSIS                                                                                                                                                                                                    



          SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:                    AB 2325             
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          |AUTHOR:        |Bonilla                                        |
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          |VERSION:       |May 31, 2016                                   |
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          |HEARING DATE:  |June 8, 2016   |               |               |
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          |CONSULTANT:    |Reyes Diaz                                     |
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           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, as specified, for purposes of the Ken Maddy California  
          Cancer Registry.
          
          Existing law:
          1)Pursuant to the Ken Maddy California Cancer Registry (CCR),  
            requires the Department of Public Health (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 environment. 

          2)Authorizes the DPH Director to enter into contracts as  
            necessary to conduct the CCR, 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  
            hazards to the public health and their remedies.

          3)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.  
            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. 








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          4)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.

          5)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.

          6)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  
            designed to eliminate, alleviate, or ameliorate their effect. 

          7)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  
            disclosed. Requires the individual to whom the information  
            pertains to have access to his or her own information made  
            available in the CCR.

          This bill:
          1)Requires, on or after January 1, 2019, a pathologist  
            diagnosing cancer to report cancer diagnoses electronically to  
            DPH utilizing the College of American Pathologists cancer  
            protocols or any other standardized format approved by DPH. 

          2)Allows a DPH authorized representative to access the  
            information from the pathologist in an alternate format if a  
            pathologist fails to report electronically and with an  
            approved format. Requires a pathologist to reimburse DPH or  
            the authorized representative for its cost to access and  
            report the information.

          3)Provides that a pathologist is not responsible for acquiring  
            missing or inaccessible patient demographic information not  
            provided to him or her beyond the content of the required  
            cancer-specific data elements.

          4)Requires DPH to prescribe the data required to be included in  
            a report and work collaboratively with stakeholders to  








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            designate a standardized electronic format for submission.

           FISCAL  
          EFFECT  : According to the Assembly Appropriations Committee,  
          since the business model of the CCR already incorporates a move  
          to standardized electronic reporting and the CCR already has the  
          technical capacity to conduct electronic data searches, costs  
          are expected to be minor and absorbable (Proposition 99 funds). 

           PRIOR  
          VOTES  :  
          
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          |Assembly Floor:                     |79 - 0                      |
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          |Assembly Appropriations Committee:  |19 - 0                      |
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          |Assembly Health Committee:          |16 - 0                      |
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          COMMENTS  :
          1)Author's statement. According to the author, every cancer case  
            diagnosed or treated in California is reported to the CCR.  
            This vast repository of cancer data provides vital information  
            to public health officers and researchers. With CCR data, it  
            is possible to determine cancer risk factors and conduct early  
            detection of cancer clusters. Although the CCR is a powerful  
            tool, it is possible to use it in new and meaningful ways.  
            Roadblocks to innovative uses of CCR data stem from long  
            delays in cancer reporting. Under the current system, cancer  
            diagnosis information is deposited in the CCR months even  
            years after patient diagnosis. This long delay prevents rapid  
            cancer research from taking place. AB 2325 will fix this issue  
            by requiring pathologists who diagnose cancer to report  
            diagnosis information electronically to the CCR. An additional  
            barrier to innovative cancer research is low participation  
            rates in cancer clinical trials. One of the major barriers to  
            participation is simply lack of knowledge about available  
            trials. AB 2325 will lift the burden of patients identifying  
            trials and place it with researchers. After electronic  
            reporting of cancer diagnosis information goes into effect,  
            researchers will be able to request that information to  
            identify potential matches to their own clinical trials.
            








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          2)Background. According to the DPH and American Cancer Society  
            2015 report, "California Cancer Facts and Figures," 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. 

            In July of 2015, DPH announced participation in a pilot  
            project with St. Joseph's Health System (St. Joseph's) to  
            better understand cancer trends in California. This  
            partnership was the first of its kind 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. 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's, 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 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.

          3)Issues with clinical trial participation. According to a  
            document published by the Society for Women's Health Research  
            and United States Food and Drug Administration (FDA) Office of  
            Women's Health, "Dialogues on Diversifying Clinical Trials,"  
            the most important diseases that disproportionately affect  
            ethnic minorities include type 2 diabetes, cardiovascular  
            disease, stroke, infectious diseases (HIV/AIDS, STDs), and  








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            different types of cancer (colon, prostate, cervix, and lung).  
            Many racial health disparities stem from lack of access to  
            quality health care and proper health awareness. Unfortunately  
            this means that incidence of disease does not always match  
            trial populations. For example, African Americans represent  
            12% of the U.S. population but only 5% of clinical trial  
            participants. Hispanics make up 16% of the population but only  
            1% of clinical trial participants. Sex distribution in  
            cardiovascular device trials is 67% male. According to the  
            American Cancer Society Cancer Action Network, only  
            approximately 3% of adults diagnosed with cancer participate  
            in clinical trials, and the participation rate is lower for  
            people who are racial and ethnic minorities, elderly,  
            low-income, and live in rural areas.

            The Coalition to Eliminate Disparities and to Research  
            Inclusion in Clinical Trials identified minority lack of  
            disease education as a major barrier to recruitment. Other  
            significant barriers to diversify enrollment, as reported by  
            investigators and coordinators, are insurance status, patient  
            inconvenience costs, availability of transportation, distance  
            to the study site, and patient and family concerns about risk.  
            However, race, age, and sex have been shown to play more  
            significant roles in trial participation compared to proximity  
            to trial location.

          4)Related legislation. AB 2174 (Jones), would have required DPH,  
            prior to researchers contacting a cancer patient, to ensure  
            that a patient whose name appears in the CCR has received  
            specified notice regarding the registry, including, among  
            other things, that DPH is authorized to release confidential  
            patient information to health researchers. AB 2174 was held  
            under submission in the Assembly Appropriations Committee.

          5)Prior legislation. 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.  

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

            AB 136 (Connelly, Chapter 841, Statutes of 1985), established  








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            the CCR. 

          6)Support. Supporters argue that the current CCR system relies  
            on a 30-year-old method that can take from six months to two  
            years before information is fully reported. The CCR is  
            recognized as one of the leading cancer registries in the  
            world and has collected detailed information on more than 3.4  
            million cases of cancer among Californians diagnosed since  
            1988, and more than 162,000 new cases are added annually.  
            Supporters state that his bill makes needed updates to the CCR  
            to make it more efficient and effective and that through  
            real-time reporting researching will be able to request  
            diagnosis information to identify matches to ongoing cancer  
            clinical trials. The California Society of Pathologists states  
            that it has been engaged with DPH and the CCR to move to a  
            standardized reporting format, which would greatly enhance the  
            CCR's mission.
          
           SUPPORT AND OPPOSITION  :
          Support:  American Cancer Society Action Network (co-sponsor)
                    University of Southern California (co-sponsor)
                    California Chronic Care Coalition
                    California Society of Pathologists
                    Stanford Health Care

          Oppose:   None received
          
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