BILL ANALYSIS                                                                                                                                                                                                    



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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          2325 (Bonilla)


          As Amended  August 10, 2016


          Majority vote


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          |ASSEMBLY:  | 79-0 |(May 5, 2016)  |SENATE: | 39-0 |(August 17,      |
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          Original Committee Reference:  HEALTH


          SUMMARY:  Requires, on or after January 1, 2019, a pathologist  
          diagnosing cancer to report cancer diagnoses to the Department  
          of Public Health (DPH) by electronic means 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).  


          The Senate amendments clarify that the College of American  
          Pathologists cancer protocols may be used to report cancer  
          diagnoses to DPH in addition to any other standardized format  
          approved by DHCS, specify that a pathologist who submits an  
          electronic report does not need to submit the same report more  
          than once, delete provisions establishing a pilot project within  
          DPH to enable users to conduct electronic specific data element  
          searches of the information collected by the CCR, and make other  
          technical changes.








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          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  
            environment. 


          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)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. 


          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.










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          6)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.


          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.


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


             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  
               used. 


          9)Requires records of those who access the CCR, pursuant to 8)  
            above, to be open to public inspection.








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


          FISCAL EFFECT:  According to Senate Appropriations Committee,  
          pursuant to Senate Rule 28.8, this bill has negligible state  
          fiscal effect.


          COMMENTS:  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.


          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  








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          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. 


          The University of Southern California (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.


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








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          0003979