Amended in Senate May 31, 2016

Amended in Assembly April 5, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 2325

Introduced by Assembly Member Bonilla

February 18, 2016

An act to amend Section 103885 begin delete of, and to add Section 103887 to, end delete begin insert of end insert the Health and Safety Code, relating to cancer.

LEGISLATIVE COUNSEL’S DIGEST

AB 2325, as amended, Bonilla. Ken Maddy California Cancer Registry.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law authorizes the department to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries to provide cancer incidence data. Existing law requires any hospital or other facility providing therapy to cancer patients within a cancer reporting area to report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. Existing law provides that if the hospital or other facility fails to report in a format prescribed by the department, the department’s authorized representative is authorized to access the information from the hospital or the facility and report it in the appropriate format. In these cases, existing law requires the hospital or other health facility to reimburse the department or the authorized representative for its cost to access and report the information. Existing law also requires any physician, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients to report each cancer case to the department or the authorized representative of the department, except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnosis or treatment of that instance of cancer.

This bill, on or after January 1, 2019, would require a pathologist diagnosing cancer to begin insert electronically end insert report cancer diagnoses to the begin delete department in a format prescribed by the department. end delete begin insert department, as specified. end insert If a pathologist fails to report begin delete in that end delete begin insert electronically and with an approved end insert format, the bill would authorize the department’s authorized representative to access the information from the pathologist in begin delete the end delete begin insert an end insert appropriate begin insert alternative end insert format. In these cases, the bill would require the pathologist to reimburse the department or the authorized representative for its cost to access and report the information. The bill would require the department to prescribe the data required to be included in the reports and to begin insert work collaboratively with stakeholders to end insert designate a standardized electronic format for submission of the reports.

begin delete

This bill would also require the department to establish a pilot program to enable the department and other authorized users to conduct electronic specific data element searches for the purpose of identifying individuals who meet cancer clinical trial eligibility requirements.

end delete

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

Section 103885 of the Health and Safety Code
is amended to read:

103885.  

(a) The director shall establish a statewide system for
the collection of information determining the incidence of cancer,
using population-based cancer registries modeled after the Cancer
Surveillance Program of Orange County. As of the effective date
of this section the director shall begin phasing in the statewide
cancer reporting system. By July 1, 1988, all county or regional
registries shall be implemented or initiated. By July 1, 1990, the
statewide cancer reporting system shall be fully operational. Within
60 days of the effective date of this section, the director shall
submit an implementation and funding schedule to the Legislature.

(b) The department may designate any demographic parts of
the state as regional cancer incidence reporting areas and may
establish regional cancer registries, with the responsibility and
authority to carry out the intent of this section in designated areas.
Designated regional registries shall provide, on a timely basis,
cancer incidence data as designated by the state department to the
department. The department may establish a competitive process
to receive applications for, and issue, the award of a contract, grant,
or allocation of funds, including, but not limited to, a cooperative
agreement, subvention agreement, or any other agreement allowed
by law, to an agency, including, but not limited to, a health systems
agency, single county health department, multicounty health
department grouping, or nonprofit professional association to
operate the statewide cancer reporting system and to enter into
contracts, or issue grants or funding allocations to other agencies
representing a designated cancer reporting region for the purposes
of collecting and collating cancer incidence data. The award of
these contracts, grants, or funding allocations shall be exempt from
Part 2 (commencing with Section 10100) of Division 2 of the
Public Contract Code. The department shall include appropriate
terms and conditions in a contract, grant, or funding allocation to
ensure the proper use of state funds, including provision for
reimbursement of allowable costs, financial reporting, program
performance reporting, monitoring of subgrants, subcontracts, or
suballocations to an agency representing a designated cancer
reporting region, retention and access requirements for records,
data use and management, independent auditing, termination, and
disposition of assets acquired under the contract, grant, or funding
allocation.

(c) The director shall designate cancer as a disease required to
be reported in the state or any demographic parts of the state in
which cancer information is collected under this section. All
cancers diagnosed or treated in the reporting area shall thereafter
be reported to the representative of the department authorized to
compile the cancer data, or any individual, agency, or organization
designated to cooperate with that representative.

(d) (1) Any hospital or other facility providing therapy to cancer
patients within an area designated as a cancer reporting area shall
report each case of cancer to the department or the authorized
representative of the department in a format prescribed by the
department. If the hospital or other facility fails to report in a
format prescribed by the department, the department’s authorized
representative may access the information from the hospital or the
facility and report it in the appropriate format. In these cases, the
hospital or other health facility shall reimburse the state department
or the authorized representative for its cost to access and report
the information.

(2) Any physician and surgeon, dentist, podiatrist, or other health
care practitioner diagnosing or providing treatment for cancer
patients shall report each cancer case to the department or the
authorized representative of the department, except for those cases
directly referred to a treatment facility or those previously admitted
to a treatment facility for diagnoses or treatment of that instance
of cancer.

(3) On or after January 1, 2019, a pathologist diagnosing cancer
shall begin insert electronically end insert report cancer diagnoses to the department begin delete in
a format prescribed by the department. end delete begin insert utilizing the College of
American Pathologists cancer protocols or any other standardized
format approved by the department. end insert If a pathologist fails to report
begin delete in that end delete begin insert electronically and with an approved end insert format, the
department’s authorized representative may access the information
from the pathologist in begin delete the end delete begin insert an end insert appropriate begin insert alternative end insert format. In
these cases, the pathologist shall reimburse the department or the
authorized representative for its cost to access and report the
information. begin insert A pathologist shall not be 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. end insert For purposes of reports submitted
pursuant to this paragraph, the department shall prescribe the data
required to be included in the report and begin insert work collaboratively with
stakeholders to end insert designate a standardized electronic format for
submission.

(e) Any hospital or other facility that is required to reimburse
the department or its authorized representative for the cost to access
and report the information pursuant to subdivision (d) shall provide
payment to the department or its authorized representative within
60 days of the date this payment is demanded. In the event any
hospital or other facility fails to make the payment to the
department or its authorized representative within 60 days of the
date the payment is demanded, the department or its authorized
representative may, at its discretion, assess a late fee not to exceed
11⁄2 percent per month of the outstanding balance. Further, in the
event that the department or its authorized representative takes a
legal action to recover its costs and any associated fees, and the
department or its authorized representative receives a judgment in
its favor, the hospital or other facility shall also reimburse the
department or its authorized representative for any additional costs
it incurred to pursue the legal action. Late fees and payments made
to the department by hospitals or other facilities pursuant to this
subdivision shall be considered as reimbursements of the additional
costs incurred by the department.

(f) All physicians and surgeons, hospitals, outpatient clinics,
nursing homes and all other facilities, individuals, or agencies
providing diagnostic or treatment services to patients with cancer
shall grant to the department or the authorized representative access
to all records that would identify cases of cancer or would establish
characteristics of the cancer, treatment of the cancer, or medical
status of any identified cancer patient. Willful failure to grant
access to those records shall be punishable by a fine of up to five
hundred dollars ($500) each day access is refused. Any fines
collected pursuant to this subdivision shall be deposited in the
General Fund.

(g) (1) Except as otherwise provided in this section, all
information collected pursuant to this section shall be confidential.
For purposes of this section, this information shall be referred to
as “confidential information.”

(2) The department and any regional cancer registry designated
by the department shall use the information to determine the
sources of malignant neoplasms and evaluate measures designed
to eliminate, alleviate, or ameliorate their effect.

(3) Persons with a valid scientific interest who are engaged in
demographic, epidemiological, or other similar studies related to
health who meet qualifications as determined by the department,
and who agree, in writing, to maintain confidentiality, may be
authorized access to confidential information.

(4) The department and any regional cancer registry designated
by the department may enter into agreements 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.
Before confidential information is disclosed to those agencies,
officers, researchers, or out-of-state registries, the requesting entity
shall agree in writing to maintain the confidentiality of the
information, and in the case of researchers, shall also do both of
the following:

(A) Obtain approval of their committee for the protection of
human subjects established in accordance with Part 46
(commencing with Section 46.101) of Title 45 of the Code of
Federal Regulations.

(B) Provide documentation to the department that demonstrates
to the department’s satisfaction that the entity has established the
procedures and ability to maintain the confidentiality of the
information.

(5) Notwithstanding any other provision of law, any disclosure
authorized by this section shall include only the information
necessary for the stated purpose of the requested disclosure, used
for the approved purpose, and not be further disclosed.

(6) The furnishing of confidential information to the department
or its authorized representative in accordance with this section
shall not expose any person, agency, or entity furnishing
information to liability, and shall not be considered a waiver of
any privilege or a violation of a confidential relationship.

(7) The department shall maintain an accurate record of all
persons who are given access to confidential information. The
record shall include: the name of the person authorizing access;
name, title, address, and organizational affiliation of persons given
access; dates of access; and the specific purpose for which
information is to be used. The record of access shall be open to
public inspection during normal operating hours of the department.

(8) Notwithstanding any other provision of law, no part of the
confidential information shall be available for subpoena, nor shall
it be disclosed, discoverable, or compelled to be produced in any
civil, criminal, administrative, or other proceeding, nor shall this
information be deemed admissible as evidence in any civil,
criminal, administrative, or other tribunal or court for any reason.

(9) Nothing in this subdivision shall prohibit the publication by
the department of reports and statistical compilations that do not
in any way identify individual cases or individual sources of
information.

(10) Notwithstanding the restrictions in this subdivision, the
individual to whom the information pertains shall have access to
his or her own information in accordance with Chapter 1
(commencing with Section 1798) of Title 1.8 of the Civil Code.

(h) For the purpose of this section, “cancer” means either of the
following:

(1) All malignant neoplasms, regardless of the tissue of origin,
including malignant lymphoma, Hodgkins disease, and leukemia,
but excluding basal cell and squamous cell carcinoma of the skin.

(2) All primary intracranial and central nervous system (CNS)
tumors occurring in the following sites, irrespective of histologic
type: brain, meninges, spinal cord, caudae equina, cranial nerves
and other parts of the CNS, pituitary gland, pineal gland, and
craniopharyngeal duct.

(i) Nothing in this section shall preempt the authority of facilities
or individuals providing diagnostic or treatment services to patients
with cancer to maintain their own facility-based cancer registries.

(j) It is the intent of the Legislature that the department, in
establishing a system pursuant to this section, maximize the use
of available federal funds.

begin delete

SEC. 2.  

Section 103887 is added to the Health and Safety Code,
to read:

103887.  

The department shall establish a pilot project to enable
the department and users authorized pursuant to this chapter to
conduct electronic specific data element searches of the information
collected by the statewide cancer registry for the purpose of
identifying individuals who meet cancer clinical trial eligibility
requirements.

end delete