AB 378 — Alternative Therapy Pilot Program (BDR 40‑820) — Summary
Status and timeline (as provided)
- Introduced in 2025 (referred to Health & Human Services). The measure underwent committee hearings and amendments in spring–summer 2025 (including Assembly Amendment No. 446 adding a two‑thirds vote requirement for final passage of one section). According to the legislative action record included, the bill was passed by both houses, presented to the Governor on 9/24/2025, approved and chaptered as Chapter 258 on 10/03/2025.
Purpose
- To create a regulated, state‑supervised pilot program that allows medically supervised administration of specified psychedelic substances for treatment of certain mental health conditions, with initial eligibility focused on military veterans and former first responders.
Key provisions
- Program administration: Creates the Alternative Therapy Pilot Program administered by the Division of Public and Behavioral Health (DPBH), Department of Health and Human Services (DHHS).
- Defined substances: “Psychedelic substance” specifically includes psilocybin, psilocin, dimethyltryptamine (DMT), ibogaine and mescaline.
- Pilot clinic structure: DPBH must develop and implement experimental/investigational pilot clinic programs, adopt regulations, set clinical and licensing standards, and license at least one entity to cultivate/manufacture substances for program use.
- Eligibility and care: Eligibility is limited to patients diagnosed with qualifying mental health conditions (with emphasis on veterans and first responders in the bill text). Regulations must include clinical safeguards, patient screening, and (in proposed amendments) plans for continuation of care and referral to follow‑up services.
- Data, oversight and reporting: DPBH must collect comprehensive data on all therapies provided, keep identifying data confidential, and submit annual reports to the Legislature. The Division is required to establish an advisory committee/panel to oversee financial viability, implementation and evaluation and to provide periodic reports.
- Legal protections and limits:
- Immunity: Persons approved to participate in an approved pilot clinic program (including patients, practitioners and facilities acting within scope) are granted immunity from civil, criminal and administrative liability for conduct involving psychedelic substances within the program’s scope; such conduct is not to trigger investigation, arrest, prosecution or other legal penalties.
- Warranty/hold‑harmless: Amendments clarify DHHS, its officers and employees do not warrant or guarantee specific outcomes and are immune from claims asserting such a warranty.
- Funding and costs: DPBH may accept grants, gifts and contracts and may require program operators to reimburse inspection/certification costs; one amendment added explicit authority to require reimbursement of Division costs for inspection/certification.
- Federal compliance: DPBH is required to take all feasible actions to ensure pilot programs comply with applicable federal requirements or guidelines for clinical or experimental use of controlled substances.
Who is affected
- Directly affected: qualifying patients (veterans and former first responders initially), participating clinicians and licensed pilot clinics, entities authorized to cultivate/manufacture specified psychedelic substances, DPBH/DHHS (regulatory and oversight responsibilities).
- Indirectly affected: other state agencies (coordination duties), law enforcement (changes in enforcement within program scope), payors/insurers if coverage/continuation of care addresses costs.
Potential impacts and considerations
- Expands access (in controlled settings) to novel, investigational therapies for populations with treatment‑resistant mental health conditions.
- Creates a state regulatory framework for production, administration, oversight and data collection on psychedelic‑assisted therapies.
- Grants broad immunity for authorized program participants, which supporters argue is necessary to allow research and treatment; opponents raised concerns about scope of immunity, program breadth, funding transparency and public safety.
- Fiscal effects: bill allows state expenditure (effect on the state was noted as “Yes”); the Division may accept external funding and recoup inspection costs, but pilot implementation will require regulatory and administrative resources.
- Federal law tension: substances remain Schedule I under federal and state controlled‑substance laws; the bill requires DPBH to act consistent with federal requirements “to the extent feasible.”
Stakeholder input (as recorded)
- Supportive testimony from veteran advocates, law‑enforcement reform groups, researchers and policy organizations emphasizing potential benefits for PTSD, treatment‑resistant depression and substance use disorders.
- Opposition testimony raising concerns about program scope, safety, evidentiary strength, immunity breadth and the potential pathway toward broader legalization.
For more detail
- The bill text and amendment language set out specific regulatory, reporting and immunity provisions; the legislative record includes committee analyses, proposed amendments (e.g., continuation‑of‑care, advisory panel, inspection cost reimbursement) and testimony reflecting both support and opposition.
