Amended in Assembly April 5, 2016

California Legislature—2015–16 Regular Session

Assembly BillNo. 2325


Introduced by Assembly Member Bonilla

February 18, 2016


An act to amend Section 103885 of, and to add Section 103887 to, 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.

begin delete

This bill would delete the reporting exception described above and require any physician, dentist, podiatrist, or other health care practitioner diagnosing and providing treatment for cancer patients to report each cancer case to the department or the authorized representative of the department in a format prescribed by the department. The bill would also require reimbursements if a physician, dentist, podiatrist, or other health care practitioner fails to report in the prescribed format, as specified. The bill would require the department to prescribe the data required to be included in reports submitted by physicians, dentists, podiatrists, or other health care practitioners diagnosing cancer patients and to designate a standardized electronic format for the submission of those reports.

end delete
begin insert

This bill, on or after January 1, 2019, would require a pathologist diagnosing cancer to report cancer diagnoses to the department in a format prescribed by the department. If a pathologist fails to report in that format, the bill would authorize the department’s authorized representative to access the information from the pathologist in the appropriate 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 designate a standardized electronic format for submission of the reports.

end insert

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.

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

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

P2    1

SECTION 1.  

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

P3    1

103885.  

(a) The director shall establish a statewide system for
2the collection of information determining the incidence of cancer,
3using population-based cancer registries modeled after the Cancer
4Surveillance Program of Orange County. As of the effective date
5of this section the director shall begin phasing in the statewide
6cancer reporting system. By July 1, 1988, all county or regional
7registries shall be implemented or initiated. By July 1, 1990, the
8statewide cancer reporting system shall be fully operational. Within
960 days of the effective date of this section, the director shall
10submit an implementation and funding schedule to the Legislature.

11(b) The department may designate any demographic parts of
12the state as regional cancer incidence reporting areas and may
13 establish regional cancer registries, with the responsibility and
14authority to carry out the intent of this section in designated areas.
15Designated regional registries shall provide, on a timely basis,
16cancer incidence data as designated by the state department to the
17department. The department may establish a competitive process
18to receive applications for, and issue, the award of a contract, grant,
19or allocation of funds, including, but not limited to, a cooperative
20agreement, subvention agreement, or any other agreement allowed
21by law, to an agency, including, but not limited to, a health systems
22agency, single county health department, multicounty health
23department grouping, or nonprofit professional association to
24operate the statewide cancer reporting system and to enter into
25contracts, or issue grants or funding allocations to other agencies
26representing a designated cancer reporting region for the purposes
27of collecting and collating cancer incidence data. The award of
28these contracts, grants, or funding allocations shall be exempt from
29Part 2 (commencing with Section 10100) of Division 2 of the
30Public Contract Code. The department shall include appropriate
31terms and conditions in a contract, grant, or funding allocation to
32ensure the proper use of state funds, including provision for
33reimbursement of allowable costs, financial reporting, program
34performance reporting, monitoring of subgrants, subcontracts, or
35suballocations to an agency representing a designated cancer
36reporting region, retention and access requirements for records,
37data use and management, independent auditing, termination, and
38disposition of assets acquired under the contract, grant, or funding
39allocation.

P4    1(c) The director shall designate cancer as a disease required to
2be reported in the state or any demographic parts of the state in
3which cancer information is collected under this section. All
4cancers diagnosed or treated in the reporting area shall thereafter
5be reported to the representative of the department authorized to
6compile the cancer data, or any individual, agency, or organization
7designated to cooperate with that representative.

8(d) (1) Any hospital or other facility providing therapy to cancer
9patients within an area designated as a cancer reporting area shall
10report each case of cancer to the department or the authorized
11representative of the department in a format prescribed by the
12department. If the hospital or other facility fails to report in a
13format prescribed by the department, the department’s authorized
14representative may access the information from the hospital or the
15facility and report it in the appropriate format. In these cases, the
16hospital or other health facility shall reimburse the state department
17or the authorized representative for its cost to access and report
18the information.

19(2) Any physician and surgeon, dentist, podiatrist, or other health
20care practitioner diagnosing or providing treatment for cancer
21patients shall report each cancer case to the department or the
22authorized representative of thebegin delete department in a format prescribed
23by the department. If the physician and surgeon, dentist, podiatrist,
24or other healthcare practitioner fails to report in a format prescribed
25by the department, the department’s authorized representative may
26access the information from that person and report it in the
27appropriate format. In these cases, the physician and surgeon,
28dentist, podiatrist, or other healthcare practitioner shall reimburse
29the state department or the authorized representative for its cost
30to access and report the information. For purposes of reports
31submitted pursuant to this paragraph by a physician and surgeon,
32dentist, podiatrist, or other healthcare practitioner diagnosing
33cancer patients, the department shall prescribe the data required
34to be included in the report and designate a standardized electronic
35format for submission.end delete
begin insert department, except for those cases directly
36referred to a treatment facility or those previously admitted to a
37treatment facility for diagnoses or treatment of that instance of
38canceend insert
begin insertr.end insert

begin insert

39
(3) On or after January 1, 2019, a pathologist diagnosing cancer
40shall report cancer diagnoses to the department in a format
P5    1prescribed by the department. If a pathologist fails to report in
2that format, the department’s authorized representative may access
3the information from the pathologist in the appropriate format. In
4these cases, the pathologist shall reimburse the department or the
5authorized representative for its cost to access and report the
6information. For purposes of reports submitted pursuant to this
7paragraph, the department shall prescribe the data required to be
8included in the report and designate a standardized electronic
9format for submission.

end insert

10(e) Any hospital or otherbegin delete facility, or any physician and surgeon,
11dentist, podiatrist, or other health care practitioner,end delete
begin insert facilityend insert that is
12required to reimburse the department or its authorized
13representative for the cost to access and report the information
14pursuant to subdivision (d) shall provide payment to the department
15or its authorized representative within 60 days of the date this
16payment is demanded. In the event any hospital or other begin delete facility,
17or any physician and surgeon, dentist, podiatrist, or other health
18care practitioner,end delete
begin insert facilityend insert fails to make the payment to the
19department or its authorized representative within 60 days of the
20date the payment is demanded, the department or its authorized
21representative may, at its discretion, assess a late fee not to exceed
22112 percent per month of the outstanding balance. Further, in the
23event that the department or its authorized representative takes a
24legal action to recover its costs and any associated fees, and the
25department or its authorized representative receives a judgment in
26its favor, the hospital or otherbegin delete facility, or the physician and surgeon,
27dentist, podiatrist, or other health care practitioner,end delete
begin insert facilityend insert shall
28also reimburse the department or its authorized representative for
29any additional costs it incurred to pursue the legal action. Late fees
30and payments made to the departmentbegin insert by hospitals or other
31facilitiesend insert
pursuant to this subdivision shall be considered as
32reimbursements of the additional costs incurred by the department.

33(f) All physicians and surgeons, hospitals, outpatient clinics,
34nursing homes and all other facilities, individuals, or agencies
35providing diagnostic or treatment services to patients with cancer
36shall grant to the department or the authorized representative access
37to all records that would identify cases of cancer or would establish
38characteristics of the cancer, treatment of the cancer, or medical
39status of any identified cancer patient. Willful failure to grant
40access to those records shall be punishable by a fine of up to five
P6    1hundred dollars ($500) each day access is refused. Any fines
2collected pursuant to this subdivision shall be deposited in the
3General Fund.

4(g) (1) Except as otherwise provided in this section, all
5information collected pursuant to this section shall be confidential.
6For purposes of this section, this information shall be referred to
7as “confidential information.”

8(2) The department and any regional cancer registry designated
9by the department shall use the information to determine the
10sources of malignant neoplasms and evaluate measures designed
11to eliminate, alleviate, or ameliorate their effect.

12(3) Persons with a valid scientific interest who are engaged in
13demographic, epidemiological, or other similar studies related to
14health who meet qualifications as determined by the department,
15and who agree, in writing, to maintain confidentiality, may be
16authorized access to confidential information.

17(4) The department and any regional cancer registry designated
18by the department may enter into agreements to furnish confidential
19information to other states’ cancer registries, federal cancer control
20agencies, local health officers, or health researchers for the
21purposes of determining the sources of cancer and evaluating
22measures designed to eliminate, alleviate, or ameliorate their effect.
23Before confidential information is disclosed to those agencies,
24officers, researchers, or out-of-state registries, the requesting entity
25shall agree in writing to maintain the confidentiality of the
26information, and in the case of researchers, shall also do both of
27the following:

28(A) Obtain approval of their committee for the protection of
29human subjects established in accordance with Part 46
30(commencing with Section 46.101) of Title 45 of the Code of
31Federal Regulations.

32(B) Provide documentation to the department that demonstrates
33to the department’s satisfaction that the entity has established the
34procedures and ability to maintain the confidentiality of the
35information.

36(5) Notwithstanding any other provision of law, any disclosure
37authorized by this section shall include only the information
38necessary for the stated purpose of the requested disclosure, used
39for the approved purpose, and not be further disclosed.

P7    1(6) The furnishing of confidential information to the department
2or its authorized representative in accordance with this section
3shall not expose any person, agency, or entity furnishing
4information to liability, and shall not be considered a waiver of
5any privilege or a violation of a confidential relationship.

6(7) The department shall maintain an accurate record of all
7persons who are given access to confidential information. The
8record shall include: the name of the person authorizing access;
9name, title, address, and organizational affiliation of persons given
10access; dates of access; and the specific purpose for which
11information is to be used. The record of access shall be open to
12public inspection during normal operating hours of the department.

13(8) Notwithstanding any other provision of law, no part of the
14confidential information shall be available for subpoena, nor shall
15it be disclosed, discoverable, or compelled to be produced in any
16civil, criminal, administrative, or other proceeding, nor shall this
17information be deemed admissible as evidence in any civil,
18criminal, administrative, or other tribunal or court for any reason.

19(9) Nothing in this subdivision shall prohibit the publication by
20the department of reports and statistical compilations that do not
21in any way identify individual cases or individual sources of
22information.

23(10) Notwithstanding the restrictions in this subdivision, the
24individual to whom the information pertains shall have access to
25his or her own information in accordance with Chapter 1
26(commencing with Section 1798) of Title 1.8 of the Civil Code.

27(h) For the purpose of this section, “cancer” means either of the
28following:

29(1) All malignant neoplasms, regardless of the tissue of origin,
30including malignant lymphoma, Hodgkins disease, and leukemia,
31but excluding basal cell and squamous cell carcinoma of the skin.

32(2) All primary intracranial and central nervous system (CNS)
33tumors occurring in the following sites, irrespective of histologic
34type: brain, meninges, spinal cord, caudae equina, cranial nerves
35and other parts of the CNS, pituitary gland, pineal gland, and
36craniopharyngeal duct.

37(i) Nothing in this section shall preempt the authority of facilities
38or individuals providing diagnostic or treatment services to patients
39with cancer to maintain their own facility-based cancer registries.

P8    1(j) It is the intent of the Legislature that the department, in
2establishing a system pursuant to this section, maximize the use
3of available federal funds.

4

SEC. 2.  

Section 103887 is added to the Health and Safety Code,
5to read:

6

103887.  

The department shall establish a pilot project to enable
7the department and users authorized pursuant to this chapter to
8conduct electronic specific data element searches of the information
9collected by the statewide cancer registry for the purpose of
10identifying individuals who meet cancer clinical trial eligibility
11requirements.



O

    98