Article 6. Veterans and Former First Responders Research Pilot Program
11310.
This article shall apply to the University of California to the extent that the Regents of the University of California, by appropriate resolution, make that provision applicable.
11310.11311.
For the purposes of this article, the following definitions apply:
(a)“Agency” means the California Health and Human Services Agency.
(b)“Community-based providers” means licensed health care and community-based providers, including, but not limited to, mental health clinics, hospice organizations, veterans organizations, and other therapeutic care organizations.
(c)
(a) “Veterans and Former First Responders Research Pilot Program” or “Pilot Program” refers to a structured initiative designed to provide regulated and investigational psilocybin services for adults within a target population with qualifying conditions, compliant with United States Food and Drug Administration and United States Drug Enforcement Administration regulations.
(b) “Pilot Program providers” means licensed health care and licensed community-based providers with the ability and authorization to provide services under the Pilot Program and is limited to mental health clinics, United States Department of Veterans Affairs clinics, hospice care agencies, and other therapeutic care organizations.
(d)
(c) “Local pilot” refers to the operation of the Veterans and First Responders Research Pilot Program within each of the participating counties.
(e)
(d) “Psilocybin” means a naturally occurring psychedelic compound derived from specific species of fungi.
(f)
(e) “Target population” refers to veterans and inactive former first responders with post-traumatic stress disorder, end-of-life distress, or other specified conditions, as determined by program criteria and local needs. responders.
(f) “Qualifying condition” means a severe mental health disorder.
(g) “University partners” refers to accredited institutions within the University of California system responsible for overseeing Veterans and First Responders Research Pilot Program activities. Pilot Program activities within each local pilot.
11311.(a)Notwithstanding any other law, the agency shall establish and oversee the Veterans and First Responders Research Pilot Program to allow for the research and development of psilocybin services for target populations in up to five counties.
(b)The pilot program may operate in partnerships with the University of California system.
11312.
(a) The University of California is requested to
oversee each local pilot program as a university partner. establish local pilots in up to five counties to allow for the research and development of psilocybin services for target populations and to oversee each university partner. These university partners shall be responsible for protocol design, institutional review board approvals, administration, data collection, and reporting.
(b) The local pilot shall partner with local mental health clinics, hospice programs, veterans facilities, or other community-based with Pilot Program providers that provide services and care to the target population. Psilocybin shall be provided by or under the supervision of a practitioner who has experience in providing or overseeing psilocybin or other psychedelic therapy services.
11313.
The university partner overseeing each local pilot shall maintain strict protocols following the most recent guidelines from the United States Food and Drug Administration related to clinical trials for psychedelics.
11314.
(a) Each local pilot shall ensure that each person being considered for the Pilot Program meets, at a minimum, all of the following criteria:
(1) Is part of the target population.
(2) Has a documented qualifying condition under this article.
(3) Is 21 years of age or older.
(4) (A) Has been given an initial assessment by the practitioner in subdivision (b) of Section 11312 to determine the person is appropriate to participate in the Pilot Program.
(B) The purpose of the assessment shall be to understand each participant’s goals and expectations and to assess their mental and physical health history for any concerns that require further intervention or information before receiving psilocybin therapy services and an integration session after receiving psilocybin therapy services.
(b) Each local pilot shall ensure that, prior to being enrolled in the Pilot Program, each person in the target population has been informed about, at a minimum, all of the following:
(1) The implications of being treated with psilocybin and any possible or documented side effects or immediate and lasting aftereffects.
(2) Other treatments that may be effective if the person has not previously been treated.
(3) The option to speak to a peer or other counselor prior to accepting participation in the Pilot Program, as well as future opportunities to speak to a peer or other counselor.
(4) The option to withdraw from the Pilot Program at any time, and their right to receive aftercare, if necessary, upon ending treatment with psilocybin.
11314.11315.
Each local pilot shall collect and provide
data relevant to the success of the pilot program to the agency, data, including how each person in the target population inquired about, was referred to, or learned about the Pilot Program, as well as longitudinal data after treatments have concluded, that is relevant to the outcomes of the Pilot Program to the university partner, as determined with input from the
agency. university partner.11315.11316.
(a) The
agency shall University of California is requested to enter into an agreement with each university partner approved for participation in the
pilot program. Pilot Program. The agreement shall specify, at a minimum, all of the following:
(1) The amount of funding available to the local pilot.
(2) The conditions under which payments will be made.
(3) Data collection and sharing requirements.
(4) Reporting requirements.
(b) The sharing of health information, records, and other data with and among pilot entities and participating entities shall be permitted to the extent necessary for the activities and purposes set forth in this chapter.
(c) The agency shall University of California is requested to research whether national data-sharing programs or practice-based research networks exist for psychedelic research and shall to encourage university partners to participate in those programs if they are operational and consistent with quality standards for similar collaborative research networks in other health fields.
11316.11317.
(a) University partners are requested to submit midyear and annual reports to the
agency, office of the President of the University of California in accordance with schedules and guidelines established by the
agency. office of the President.(b) University partners are requested to confer and choose a single independent entity to conduct a peer-reviewed study of the statewide efficacy of the pilot program Pilot Program and the community impacts of the local pilots. The study shall be submitted to the Legislature and the Governor’s office on or before January 15, 2029. pilots to be completed on or before January 15, 2029, and are requested to submit the study to the Legislature and the Secretary of California Health and Human Services by that date.
(c) By no later than January 15, 2030, the agency shall University of California is requested to compile and submit the pilot program outcomes, data analysis, and recommendations from the university partners into a comprehensive report to the Legislature. Legislature, the Secretary of California Health and Human Services, and the Governor’s office.
(d) A report to be submitted pursuant to this section shall be submitted in compliance with Section 9795 of the Government Code.
11317.11318.
(a) The Veterans and
Former First Responders Research Pilot Special Fund is hereby established in the State Treasury. Notwithstanding Section 13340 of the Government Code, moneys deposited in the Veterans and
Former First Responders Research Pilot Special Fund pursuant to this section shall be continuously appropriated, without regard to fiscal years, to the
agency University of California for allocation to each local pilot for the purposes of this article.
(b) The agency may University of California is requested to apply for and accept grants, donations, and federal funding for the purposes of this article. Any moneys received pursuant to this subdivision shall be deposited in the Veterans and Former First Responders Research Pilot Special Fund.
(c) Moneys in the Veterans and Former First Responders Research Pilot Special Fund shall be used for, but are not limited to, all of the following purposes:
(1) Program administration and oversight.
(2) Training of medical staff and research supervisors.
(3) Data collection, analysis, and reporting.
(4) Community engagement and education initiatives.
(5) Requested peer or other counseling services by any person in the target population either prior to, during, or after participating in the local pilot.
11318.11319.
This article shall remain in effect only until January 1, 2031, and as of that date is repealed.