BILL ANALYSIS Ó
AB 2325
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2325
(Bonilla) - As Amended April 5, 2016
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 (DPH) 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). Specifically, this bill:
1)Requires, on or after January 1, 2019, a pathologist
diagnosing cancer to report cancer diagnoses to DPH in a
format prescribed by DPH.
2)Permits an authorized representative of DPH to access the
information from a pathologist if a pathologist fails to
report in the appropriate format.
3)Requires, if an authorized representative of DPH has to access
information from a pathologist, the pathologist to reimburse
DPH or the authorized representative for its cost to access
and report the information.
4)Requires DPH to prescribe the data required to be included in
the report and designated a standardized electronic format for
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submission.
5)Requires DPH to establish a pilot project to enable DPH and
authorized users to conduct electronic specific data element
searches of the information collected by the registry for the
purpose of identifying individuals who meet cancer clinical
trial eligibility requirements.
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)Authorizes the Director to enter into contracts as necessary
to conduct the program, 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
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hazards to the public health and their remedies.
5)Mandates the Director to require the reporting of cancer to
DPH, or its authorized representative, in areas of the state
where cancer information is being collected.
6)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.
7)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.
8)Authorizes DPH to fine entities that do not comply with these
record-sharing requirements, and requires that fines collected
be deposited into the General Fund.
9)Requires all information collected for the purpose of the CCR
to be kept confidential.
10)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.
11)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.
12)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
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designed to eliminate, alleviate, or ameliorate their effect.
13)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.
14)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.
15)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.
16)Requires records of those who access the CCR, pursuant to 15)
above, to be open to public inspection.
17)Requires the individual to whom the information pertains to
have access to his or her own information made available in
the CCR.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
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COMMENTS:
1)PURPOSE OF THIS BILL. 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.
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2)BACKGROUND. 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 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.
a) University of Southern California (USC) Cancer Registry
Program. The Los Angeles County Cancer Surveillance
Program (CSP) is the population-based cancer registry for
Los Angeles County. It identifies and obtains information
on all new cancer diagnoses made among residents of Los
Angeles County. The CSP was established in 1970 and
operates within the administrative structure of the USC
School of Medicine. It was developed with the voluntary
cooperation of hospitals and other institutions, clinics,
and medical laboratories equipped to diagnose cancer in Los
Angeles County. By 1972, the CSP became population-based
and complete incidence data for Los Angeles County were
made available from that year onward. To date, the CSP
master file contains over 1.7 million records and about
41,000 incident cancers are added annually.
Since 1981, the CSP has been the designated legal agent of
Los Angeles County for collecting information on all new
cancer cases occurring among County residents for the
purpose of monitoring cancer incidence patterns and trends.
In 1987, it became the regional registry for Los Angeles
County for the new California Cancer Registry. The CSP is
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one of eight such regional registries providing, as a
group, statewide coverage. In September 1992, the CSP
became the largest registry of the National Cancer
Institute-funded Surveillance, Epidemiology, and End
Results (SEER) program. The consortium of 18
population-based SEER registries provides the federal
government with a "snapshot" of cancer incidence and
survival across the United States.
b) DPH Pilot Program. In July of 2015, DPH announced
participation in a pilot project with St. Joseph's Health
System (St. Joseph) to better understand cancer trends in
California. This partnership is the first 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. Work on this pilot program began
in January 2014. The first complete data-set was sent by
St. Joseph's to CCR in March 2015.
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,
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
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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.
c) Barriers to Trial Participation. The Coalition to
Eliminate Disparities and to Research Inclusion in Clinical
Trials identified a number of reasons that are major
barriers to minority recruitment in clinical trials. There
are many different factors that have been attributed, in
part, to the very low participation rate of all eligible
patients in clinical trials, and the disproportionately low
participation rate of minority populations including, but
not limited to:
i) Lack of awareness: A national survey of cancer
patients found that 85% of respondents were unaware that
participating in a clinical trial was a treatment option
for them.
ii) Language/Linguistic differences: Many U.S. clinical
trials require English proficiency for potential
participants, automatically excluding those who do not
speak the language. Language factors also pose a serious
barrier to provider-patient communications and attempts
to recruit patients into clinical trials.
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iii) Mistrust: According to a review conducted by the
Agency for Healthcare Research and Quality, mistrust of
research and the medical system is a frequently reported
barrier to participating in clinical trials.
iv) Practical obstacles: Transportation to and from a
trial, particularly if it is located in a distant
location, can be a barrier for many patients.
Individuals with low incomes may find it difficult to
take time off from work, find childcare or manage other
family responsibilities while participating in a trial.
v) Public misconception: Among patients that are aware
of clinical trials, a large percentage choose not to
enroll, often due to fear of getting a placebo in place
of actual treatment, belief that standard treatment is
better than what they would be offered in a clinical
trial and fear of being a "guinea pig." However,
placebos are rarely used in cancer treatment trials, and
never in lieu of standard treatment.
vi) Physician lack of awareness: Being unaware that
clinical trials are available is one of the most common
reasons physicians fail to refer patients to trials.
Primary care physicians do not have sufficient
information on available clinical trials, and often leave
the discussion of clinical research to the patient's
oncologist. Yet, many oncologists outside of the
academic setting may also not be aware of trials or
otherwise choose not to participate in or refer their
eligible patients to clinical trials.
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d) Federal Efforts to Increase Women and Minority
Participation. The federal Food and Drug Administration
(FDA) Office of Women's Health (OWH) was established by
congressional mandate to advocate for the participation of
women in clinical trials and the analyses of data by sex.
OWH supports studies to track the participation of women in
clinical trials and collaborates with the FDA and external
partners to understand sex and gender differences in
disease prevalence and response to therapy through science
and research. The FDA Office of Minority Health (Office)
is housed within the Office of the Commissioner and is the
principal advisor on minority health and health
disparities. The Office is responsible for coordinating
efforts throughout the FDA and has focused its efforts on
three key areas: communicating and disseminating agency
information to vulnerable populations; increasing
participation of diverse health professionals in FDA
activities to strengthen its capacity to address health
disparities; and, advocating for meaningful participation
of minorities in clinical trials as well as the analysis of
subpopulation data.
According to a 2011 report titled "Successful Strategies
for Engaging Women and Minorities in Clinical Trials," the
National Institutes of Health funded studies have specific
diversity requirements, but aside from FDA recommendations,
there are no regulations currently in place that require
industry sponsors to include women and minorities in their
trials. Diversity is not a natural priority for industry,
where decisions often are made by market attractiveness and
potential profit.
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3)SUPPORT. 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.
4)RELATED LEGISLATION. AB 2174 (Jones) would requires, prior to
researchers contacting a cancer patient, DPH to ensure that a
patient whose name appears in the CCR has received specified
notice regarding the registry including, among other things,
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that DPH is authorized to release confidential patient
information to health researchers. This bill is pending in the
Assembly Health Committee.
5)PREVIOUS LEGISLATION.
a) 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.
b) AB 48 (Cedillo), Chapter 368, Statutes of 2000, renames
the California Cancer Registry to the Ken Maddy California
Cancer Registry, after the late state Senator Kenneth
Maddy, former Minority Leader of the State Senate.
c) AB 136 (Connelly), Chapter 841, Statutes of 1985,
established the California Cancer Registry.
REGISTERED SUPPORT / OPPOSITION:
Support
American Cancer Society Cancer Action Network
California Society of Pathologists
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University of Southern California
Opposition
None on file.
Analysis Prepared by:Paula Villescaz / HEALTH / (916) 319-2097