BILL ANALYSIS                                                                                                                                                                                                    Ó






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          |SENATE RULES COMMITTEE            |                       AB 2325|
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                                   THIRD READING 


          Bill No:  AB 2325
          Author:   Bonilla (D) 
          Amended:  8/10/16 in Senate
          Vote:     21 

           SENATE HEALTH COMMITTEE:  7-0, 6/8/16
           AYES:  Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth
           NO VOTE RECORDED:  Hall, Wolk

           SENATE APPROPRIATIONS COMMITTEE:  Senate Rule 28.8

           ASSEMBLY FLOOR:  79-0, 5/5/16 (Consent) - See last page for  
            vote

           SUBJECT:   Ken Maddy California Cancer Registry


          SOURCE:    American Cancer Society Action Network
                     University of Southern California
          
          DIGEST:  This bill 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.

          Senate Floor Amendments of 8/10/16 clarify reporting  
          requirements by pathologists to the Department of Public Health.

          ANALYSIS:  

          Existing law:










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          1)Requires, pursuant to the Ken Maddy California Cancer Registry  
            (CCR), 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. 


          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,  







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            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 to DPH utilizing  
            the College of American Pathologists cancer protocols or any  
            other standardized format approved by DPH. Requires the  
            reporting to be by electronic means, including, but not  
            limited to, either directly from an electronic medical record  
            or using a designated Internet Web portal that DPH provides  
            for pathologists' use. 


          2)Prohibits the reporting requirements from being interpreted to  
            require a pathologist to submit the same report more than  
            once, regardless of the format used.


          3)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.


          4)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.








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          5)Requires DPH to prescribe the data required to be included in  
            a report, work collaboratively with stakeholders to designate  
            a standardized electronic format for submission, and designate  
            an Internet Web portal for electronic submission. 

          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.








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          Issues with clinical trial participation. According to a  
          document published by the Society for Women's Health Research  
          and the United States Food and Drug Administration 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 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.

          Comments

          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  







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          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.

          Related/Prior Legislation
          
          AB 2174 (Jones, 2016) 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.

          AB 1329 (Davis, Chapter 642, Statutes of 2011) required 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 the  
          CCR. 


          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:YesLocal:   No


          SUPPORT:   (Verified8/10/16)


          American Cancer Society Action Network (co-source)
          University of Southern California (co-source)







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          California Chronic Care Coalition
          California Society of Pathologists
          Stanford Health Care


          OPPOSITION:   (Verified8/10/16)


          None received


          ARGUMENTS IN 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 this 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.

          ASSEMBLY FLOOR:  79-0, 5/5/16
          AYES:  Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,  
            Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,  
            Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,  
            Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier,  
            Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson,  
            Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger  
            Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey,  
            Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes,  
            McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte,  
            O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez,  
            Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,  
            Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
          NO VOTE RECORDED:  Beth Gaines

          Prepared by:Reyes Diaz / HEALTH / (916) 651-4111
          8/12/16 13:22:02








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