California Assembly Bill AB1174 Amended / Bill

 BILL NUMBER: AB 1174AMENDED BILL TEXT AMENDED IN ASSEMBLY JANUARY 4, 2016 AMENDED IN ASSEMBLY APRIL 20, 2015 INTRODUCED BY Assembly Member Bonilla FEBRUARY 27, 2015 An act to  add Sections 100240, 100241, 100242, and 100243 to the Health and Safety Code, relating to health research.   amend Section 800 of the Business and Professions   Code, relating to healing arts.  LEGISLATIVE COUNSEL'S DIGEST AB 1174, as amended, Bonilla.  Health research: women's health.   Healing arts: licensee records.   Existing law provides for the licensure and regulation of various professions and vocations by boards within the Department of Consumer Affairs. Existing law requires various state licensing boards, including the Medical Board of California and the Board of Psychology, to create and maintain a central file of the names of licensees to provide an individual historical record for each licensee with information on acts of licensee misconduct and discipline, as specified.   This bill would add the California Board of Podiatric Medicine to the list of state licensing boards required to create and maintain such records.   Existing law establishes the Inclusion of Women and Minorities in Clinical Research Act, which requires a grantee, as defined, in conducting or supporting a project of clinical research, as defined, to ensure that women of all ages, and members of minority groups, as defined, are included as subjects in the clinical research projects, except under prescribed circumstances. Existing law also requires state agencies to, and would declare legislative intent that the University of California include in specified progress reports, data on the extent to which state funds administered by state agencies and the University of California are used by grantees for research on diseases, disorders, and health conditions, that includes women and minorities in the research trials, and that studies diseases, disorders, and health conditions of particular concern to women and minorities. Existing law also states the legislative intent that research include, but not be limited to, specified diseases, disorders, and health conditions.   This bill would create the State Contingency Fund for Ancillary Costs and the Ancillary Costs Committee. The bill would authorize the fund to receive private donations. The bill would require the committee to develop grant criteria once a to be determined amount is deposited into the fund. The bill would authorize the committee to award, on a competitive basis, grants to various organizations, to increase patient access to cancer clinical trials.  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 800 of t   he   Business and Professions Code  is amended to read:  800. (a) The Medical Board of California, the Board of Psychology, the Dental Board of California, the Dental Hygiene Committee of California, the Osteopathic Medical Board of California, the State Board of Chiropractic Examiners, the Board of Registered Nursing, the Board of Vocational Nursing and Psychiatric Technicians of the State of California, the State Board of Optometry, the Veterinary Medical Board, the Board of Behavioral Sciences, the Physical Therapy Board of California, the California State Board of Pharmacy, the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board, the California Board of Occupational Therapy, the Acupuncture Board,  the California Board of Podiatric Medicine,  and the Physician Assistant Board shall each separately create and maintain a central file of the names of all persons who hold a license, certificate, or similar authority from that board. Each central file shall be created and maintained to provide an individual historical record for each licensee with respect to the following information: (1) Any conviction of a crime in this or any other state that constitutes unprofessional conduct pursuant to the reporting requirements of Section 803. (2) Any judgment or settlement requiring the licensee or his or her insurer to pay any amount of damages in excess of three thousand dollars ($3,000) for any claim that injury or death was proximately caused by the licensee's negligence, error or omission in practice, or by rendering unauthorized professional services, pursuant to the reporting requirements of Section 801 or 802. (3) Any public complaints for which provision is made pursuant to subdivision (b). (4) Disciplinary information reported pursuant to Section 805, including any additional exculpatory or explanatory statements submitted by the licentiate pursuant to subdivision (f) of Section 805. If a court finds, in a final judgment, that the peer review resulting in the 805 report was conducted in bad faith and the licensee who is the subject of the report notifies the board of that finding, the board shall include that finding in the central file. For purposes of this paragraph, "peer review" has the same meaning as defined in Section 805. (5) Information reported pursuant to Section 805.01, including any explanatory or exculpatory information submitted by the licensee pursuant to subdivision (b) of that section. (b) (1) Each board shall prescribe and promulgate forms on which members of the public and other licensees or certificate holders may file written complaints to the board alleging any act of misconduct in, or connected with, the performance of professional services by the licensee. (2) If a board, or division thereof, a committee, or a panel has failed to act upon a complaint or report within five years, or has found that the complaint or report is without merit, the central file shall be purged of information relating to the complaint or report. (3) Notwithstanding this subdivision, the Board of Psychology, the Board of Behavioral Sciences, and the Respiratory Care Board of California shall maintain complaints or reports as long as each board deems necessary. (c) (1) The contents of any central file that are not public records under any other  provision of  law shall be confidential except that the licensee involved, or his or her counsel or representative, shall have the right to inspect and have copies made of his or her complete file except for the provision that may disclose the identity of an information source. For the purposes of this section, a board may protect an information source by providing a copy of the material with only those deletions necessary to protect the identity of the source or by providing a comprehensive summary of the substance of the material. Whichever method is used, the board shall ensure that full disclosure is made to the subject of any personal information that could reasonably in any way reflect or convey anything detrimental, disparaging, or threatening to a licensee's reputation, rights, benefits, privileges, or qualifications, or be used by a board to make a determination that would affect a licensee's rights, benefits, privileges, or qualifications. The information required to be disclosed pursuant to Section 803.1 shall not be considered among the contents of a central file for the purposes of this subdivision. (2) The licensee may, but is not required to, submit any additional exculpatory or explanatory statement or other information that the board shall include in the central file. (3) Each board may permit any law enforcement or regulatory agency when required for an investigation of unlawful activity or for licensing, certification, or regulatory purposes to inspect and have copies made of that licensee's file, unless the disclosure is otherwise prohibited by law. (4) These disclosures shall effect no change in the confidential status of these records.  SECTION 1.   The Legislature finds and declares the following: (a) Almost 50 percent of clinical trial studies do not finish in time due to low patient participation, recruitment and navigation difficulties, and other barriers for patients. Due to economic and socioeconomic circumstances and lack of patient knowledge, clinical oncology trial participation and retention are both very low as they relate to eligible participants. (b) Overall, only 3 percent of eligible cancer patients participate in clinical trials and of those, only 5 percent of trial participants are from racial or ethnic minority communities. (c) One barrier that prevents patients from participating in federal Food and Drug Administration clinical trials is finances. Patients can't bear the burden of the ancillary costs of participating, such as airfare, lodging, rental cars, and fuel.   SEC. 2.   Section 100240 is added to the Health and Safety Code, to read: 100240. The Ancillary Costs Committee is hereby created to be made up of private and public health stakeholders.   SEC. 3.   Section 100241 is added to the Health and Safety Code, to read: 100241. (a) The State Contingency Fund for Ancillary Costs is hereby created in the State Treasury to be made up of donations from private entities. Moneys in the State Contingency Fund for Ancillary Costs shall, upon appropriation by the Legislature to the committee, be allocated by the committee as provided by Section 100242. (b) The board shall not use more than 10 percent of funds made available for the grant program for administrative costs.   SEC. 4.   Section 100242 is added to the Health and Safety Code, to read: 100242. (a) Upon an unspecified amount of moneys being donated to the fund, the committee shall establish a grant program to determine grant parameters and criteria, and to make grant awards. (b) In order to increase patient access to clinical trials, the committee may award grants from any funds that may be made available pursuant to Section 100241, on a competitive basis, to both of the following: (1) Public and private research institutions and hospitals that conduct cancer trials approved by the federal Food and Drug Administration approved cancer clinical trials. (2) A nonprofit organization described in Section 501(c)(3) of the Internal Revenue Code of 1954 which is exempt from income tax under Section 501(a) of that code that specializes in direct patient support for improved clinical trial enrollment and retention. (c) The funds awarded pursuant to subdivision (b) shall be used for activities to increase patient access to clinical trials, including, but not limited to: (1) Payment of ancillary costs for patients and caregivers, including, but not limited to: (A) Airfare during the clinical trial. (B) Lodging during the clinical trial. (C) Rental cars during the clinical trial. (D) Fuel during the clinical trial (E) Meals during the clinical trial. (F) Child care costs during the clinical trial. (2) Patient navigator services or programs. (3) Education and community outreach. (4) Patient-friendly technical tools to assist patients in identifying available clinical trials.   SEC. 5.   Section 100243 is added to the Health and Safety Code, to read: 100243. Grant recipients shall report to the committee to ensure the appropriate use of the funds.