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SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO:
AUTHOR:
VERSION:
HEARING DATE:
CONSULTANT:
AB 2325
Bonilla
May 31, 2016
June 8, 2016
Reyes Diaz
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.
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
AB 2325 (Bonilla)
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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 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:
Assembly Floor:
Assembly Appropriations Committee:
Assembly Health Committee:
79 - 0
19 - 0
16 - 0
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 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, lowincome, 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
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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 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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