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SENATE RULES COMMITTEE Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 AB 2325 THIRD READING Bill No: Author: Amended: Vote: AB 2325 Bonilla (D) 8/10/16 in Senate 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: 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 AB 2325 Page 2 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, 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 AB 2325 Page 3 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. 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 AB 2325 Page 4 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. 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 AB 2325 Page 5 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. 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.: SUPPORT: (Verified 8/10/16) American Cancer Society Action Network (co-source) University of Southern California (co-source) California Chronic Care Coalition California Society of Pathologists Stanford Health Care Yes Local: No AB 2325 Page 6 OPPOSITION: (Verified 8/10/16) 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 realtime 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 **** END ****