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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
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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
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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
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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
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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
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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
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