BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 2325|
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THIRD READING
Bill No: AB 2325
Author: Bonilla (D)
Amended: 8/10/16 in Senate
Vote: 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:
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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 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,
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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 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.
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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 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.
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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 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
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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.:YesLocal: No
SUPPORT: (Verified8/10/16)
American Cancer Society Action Network (co-source)
University of Southern California (co-source)
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California Chronic Care Coalition
California Society of Pathologists
Stanford Health Care
OPPOSITION: (Verified8/10/16)
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 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.
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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