BILL ANALYSIS Ó AB 2174 Page 1 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; AB 2174 Page 2 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 AB 2174 Page 3 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, AB 2174 Page 4 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 AB 2174 Page 5 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. AB 2174 Page 6 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. AB 2174 Page 7 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 AB 2174 Page 8 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. AB 2174 Page 9 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 Page 10 Support None on file. Opposition American Cancer Society Cancer Action Network Analysis Prepared by:Paula Villescaz / HEALTH / (916) 319-2097