BILL ANALYSIS Ó
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.
AB 2325 (Bonilla) Page 2 of ?
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
AB 2325 (Bonilla) Page 3 of ?
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.
AB 2325 (Bonilla) Page 4 of ?
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
AB 2325 (Bonilla) Page 5 of ?
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
AB 2325 (Bonilla) Page 6 of ?
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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