BILL ANALYSIS Ó
AB 2174
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2174
(Jones) - As Amended March 18, 2016
SUBJECT: Ken Maddy California Cancer Registry.
SUMMARY: Requires the Department of Public Health (DPH), prior
to researchers contacting a cancer patient pursuant to the Ken
Maddy California Cancer Registry (CCR), to ensure that the
person contacted has received specified notice regarding the CCR
including, among other things, that DPH is authorized to release
confidential patient information to health researchers.
Specifically, this bill:
1)Requires DPH, prior to any researcher contacting a person
whose name appears on the CCR, for any purpose, to ensure that
the person to be contacted has received notice of the
following information:
a) A description of the cancer registry;
b) An explanation of how DPH obtains all records that would
identify cases of cancer and the type of information
collected by DPH;
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c) The purpose for which the information obtained by DPH is
collected and intended to be used;
d) The authority of DPH to release confidential patient
information to any person with a valid scientific interest,
other states' cancer registries, federal cancer control
agencies, local health officers, or health researchers;
e) The discretion of a patient to refuse to participate in
any research study and to request that his or her contact
information be withheld; and,
f) The benefits of participating in cancer research,
including, but not limited to, the opportunity to
contribute to the discovery of improved treatments and
survival rates for cancer patients.
2)Requires all notifications to the patient required pursuant to
this section to be distributed in a cost-effective manner,
including, but not limited to, by email.
3)Requires all notifications to patients to be provided at no
cost to the person receiving them.
4)Requires DPH to adopt any necessary regulations to implement
this measure.
EXISTING LAW:
1)Requires DPH to conduct a program of epidemiological
assessments of the incidence of cancer in all areas of the
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state for which data is available, including the monitoring of
cancers associated with suspected carcinogens.
2)Allows DPH to enter into contracts to conduct the program and
requires the director to analyze available data, prepare
reports, and perform studies to identify cancer hazards to the
public health and their remedies.
3)Requires DPH to establish a statewide system for the
collection of information determining the incidence of cancer,
using population-based cancer registries and to create a
statewide cancer reporting system. Allows DPH to establish
regional cancer registries and to designate cancer as a
disease required to be reported in the state.
4)Requires any hospital or other facility treating cancer
patients to report each case of cancer to DPH in a format
prescribed by DPH.
5)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.
6)Requires all physicians, hospitals, outpatient clinics,
nursing homes and all other facilities, individuals, or
agencies providing diagnostic or treatment services to cancer
patients to give DPH access to all records that identify cases
of cancer, would establish characteristics of the cancer,
treatment of the cancer, or medical status of any identified
cancer patient. Provides that willful failure to do so is
punishable by a fine of up to $500 each day access is refused.
7)Requires all information collected for purposes of the CCR to
be kept confidential.
8)Permits DPH and any regional cancer registry designated by DPH
to use the information to determine the sources of malignant
cancer and evaluate measures designed to eliminate, alleviate,
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or ameliorate its effect.
9)Allows DPH to grant access to the information to persons with
a valid scientific interest who are engaged in demographic,
epidemiological, or other similar studies related to health,
who meet certain qualifications and who agree, in writing, to
maintain confidentiality.
10)Allows DPH to furnish confidential information to other
states' cancer registries, federal cancer control agencies,
local health officers, or health researchers for the purpose
of determining the sources of cancer and evaluating measures
designed to ameliorate its effect, provided the requesting
entity agrees, in writing, to maintain the confidentiality of
the information.
11)Requires out of state researchers to obtain the approval of
their committee for the protection of human subjects and
provide documentation to DPH that they have established
procedures to maintain the confidentiality of the information.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, a person
diagnosed with cancer frequently undergoes rigorous treatment,
and much information is being shared between doctors and
patients during treatment. Although the information collected
is generally required to be kept confidential, patients are
oftentimes unaware that their personal identifying information
(including name, birthdate, social security number, and
address) and medical information has been given to the CCR
without their permission, or that they have the choice to
opt-out. Many patients therefore feel confused and shocked
when they are contacted by a complete stranger, who obviously
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knows of their cancer diagnosis, about participating in cancer
research. The author states that in order to ensure the
patients are fully informed of their rights and of the
important work the CCR performs, this measure requires DPH to
ensure that patients are provided with important information
to prior to any researcher contacting the patient.
2)BACKGROUND. In response to public concerns over the need to
determine the causes and cures for cancer, the California
legislature passed legislation in 1985 to mandate the
reporting of all diagnosed or treated cancers (excluding basal
and squamous cell carcinomas of the skin) and all deaths due
to cancer. The CCR was fully implemented and statewide cancer
reporting began with cases diagnosed as of January 1, 1988.
Hospitals and other cancer reporting facilities report cancer
data from their medical records. Physicians and other health
care providers report information about cancer patients who
are not referred to a facility. This information is required
to be reported within six months after the patient is admitted
to the facility or care commenced for the patient. Cancer
reporting facilities and health care providers are required to
employ a mechanism to ensure that their cancer patients are
informed that cancer is a designated reportable disease and
that the facility will report each patient with cancer to the
DPH Chronic Disease Surveillance and Research Branch.
CCR staff ensures all information is accurate before data
aggregation occurs. Once quality control activities are
performed and the data are complete, they are integrated into
a statewide data set. Under the current procedures, the CCR
requires approximately eighteen months after the close of a
calendar year to collect, verify and consolidate data to
produce analysis files. These files include greater than 95%
of cancer cases for a given year.
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A 2014 CCR Procedures and Policies handbook published by DPH
directs researchers conducting projects that use CCR data and
involve patient contact to be sensitive to the physical and
emotional difficulties patients may be experiencing. The
handbook states that although some patients initially may be
disturbed to learn that their cancer diagnosis is known to
individuals other than their own care-takers, most patients
welcome the opportunity for their data to be used for research
on cancer.
In addition to the statutory requirements for accessing
information and confidentiality, researchers requesting
disclosure of CCR data for studies that involve patient
contact must comply with the following requirements:
a) In order to ensure that multiple researchers do not
contact cancer patients within a short time of each other,
especially during the first year after diagnosis while
undergoing therapy, researchers should request the Patient
Contact Availability Form from each of the regional
registries in whose territory each patient to be contacted
resides, and researchers must ensure that the patient is
not included in any currently funded studies. The CCR can
only limit multiple patient contacts by researchers using
CCR data. Patients may also have been contacted by
researchers who received contact information from another
source.
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b) No patient contact is allowed for six weeks after
diagnosis to give the appropriate attending physician time
to inform the patient of their diagnosis and possible
treatment.
c) The first contact with a patient must be in writing.
Specifically, the investigator must send a contact letter
to the patient that explains how the patient's name was
obtained and why the CCR was created. A CCR brochure
entitled "Cancer Research in California" must also be
included.
d) During the patient recruitment phase of a study, any
problems that arise with individual patients, for example
hostile refusals, must be reported to DPH or the regional
registry. Any patient who does not wish to be contacted
again by any researcher must be reported to DPH or regional
registry promptly in writing, which will be recorded in the
regional and statewide databases with a Do Not Contact
flag.
e) The researcher must notify DPH or the regional registry
liaison of any errors or omissions in the CCR data and any
more current information.
As noted above, the first contact with a patient must be in
writing and include a copy of the CCR brochure, Cancer
Research in California. The CCR brochure includes a
description of the cancer registry, an explanation of how DPH
obtains patient records, the purpose for which the information
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obtained by DPH is collected and intended to be used, the
authority of DPH to release patient information, the
discretion of a patient to refuse to participate in any
research study and the benefits of participating in cancer
research.
3)OPPOSE. The American Cancer Society Cancer Action Network
(ACS CAN) states that while the intent of this bill is
laudable, it is not necessary. California already requires
that patients be notified that their information is being
reported to the CCR, and they do have the opportunity to opt
out of Registry research. ACS CAN argues that this bill is not
an effective solution for the concern about current
notification practices and that while the bill requires DPH to
ensure the patient has been contacted and informed of their
rights, it does not specify how the information about the
notification is to be obtained.
4)RELATED LEGISLATION. AB 2325 (Bonilla) would require, on or
after January 1, 2019, a pathologist diagnosing cancer to
report cancer diagnoses to 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 CCR. This bill is pending in
the Assembly Health Committee
5)PREVIOUS LEGISLATION.
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a) AB 1638 (Jones) of 2014 would have required DPH to
inform all patients diagnosed with, or being treated for
cancer that their case has been reported to the CCR within
six months of their case being reported.
b) 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 statewide CCR.
c) 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.
d) AB 136 (Connelly), Chapter 841, Statutes of 1985,
established the California Cancer Registry.
6)COMMITTEE COMMENTS. Current CCR policy requires that the
first contact with a patient must be in writing and include a
copy of the CCR brochure, Cancer Research in California. The
CCR brochure includes most of the pieces of information
required by this bill, and as such this bill may be
duplicating activities already required by CCR policies.
REGISTERED SUPPORT / OPPOSITION:
AB 2174
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Support
None on file.
Opposition
American Cancer Society Cancer Action Network
Analysis Prepared by:Paula Villescaz / HEALTH / (916) 319-2097