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H 4200

An Act authorizing a pilot for the use of psychedelics in licensed treatment facilities

194th Legislature (2025-2026) Introduced by Sean Garballey and 1 co-sponsor

Authorizes a limited on-site psychedelic treatment pilot in up to three licensed mental health clinics to study safety, outcomes, and guide future regulation.

Reporting date extended to Thursday, December 31, 2026
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Bill Summary · H 4200

Summary: H.4200 – An Act authorizing a pilot for the use of psychedelics in licensed treatment facilities

Overview

H.4200 seeks to establish a limited pilot program under the Massachusetts Department of Public Health (DPH) to evaluate the on-site, supervised use of psychedelic materials in licensed mental health clinics. The program aims to identify best clinical practices and collect patient outcomes data to inform future regulatory frameworks for psychedelic-assisted mental health care in the Commonwealth.

Purpose and Intent

  • Authorize a monitored, on-site psychedelic treatment pilot in up to three licensed mental health clinics.
  • Generate evidence on safety, efficacy, and best practices for psychedelic pharmacotherapy in clinical settings.
  • Create regulatory standards and processes to guide future implementation, if expanded.

Key Provisions

  • Pilot Authorization and Scope

    • DPH shall establish a pilot program permitting on-site administration of psychedelic materials by a multidisciplinary care team within supervised licensed mental health clinics.
    • Up to three licensed mental health clinic facilities may participate.
    • Eligible organizations must exclusively focus on mental health and cannot be subsidiaries, affiliates, or members of cannabis industry groups, psychedelic molecule developers, or pharmaceutical companies.

  • Regulatory Framework

    • DPH must promulgate rules and regulations to operate the pilot, including:
    • Application process and eligibility criteria for participation.
    • Definitions and standards for clinic participation.
    • Procedures for initial patient assessment and ongoing monitoring.
    • Composition of the clinical staff and the role of a licensed physician overseeing the program.
    • Coordination of psychiatric medication management with external prescribers.
    • Storage, dispensing, and administration of psychedelics within the pilot.

  • Data Collection and Sharing

    • Participating organizations must track patient outcomes related to identification, diagnosis, and psychedelic treatment of depression, anxiety, PTSD, and substance use disorder.
    • Collected data must be shared with DPH to refine protocols and final regulatory frameworks.

Pilot Details and Eligibility

  • The pilot is designed to discover the “best and safest” practices for psychedelic-assisted mental health treatment and to gather data on patient outcomes.
  • Strict affiliation exclusions apply to prevent overlap with cannabis/b suitability concerns or industry interests.

Stakeholders and Impact

  • Affected Entities: Licensed mental health clinics seeking participation in the pilot; multidisciplinary clinical teams; licensed physicians overseeing care; patients receiving psychedelic-assisted treatment (for eligible mental health conditions).
  • Public Health Impact: Potential development of a regulatory framework governing psychedelic use in clinical settings, informed by data from the pilot.

Timeline and Procedural Status

  • Introduced: March 27, 2025.
  • Filed as House No. 4200 (HD 4509 related).
  • Legislative actions:
    • 2025-03-27: Referred to House Rules.
    • 2025-05-15: Reported, referred to Joint Rules; rules suspended and referred to Mental Health, Substance Use and Recovery.
    • 2025-06-05: Senate concurred.
  • Hearing: Scheduled for November 10, 2025, from 1:00 PM to 5:00 PM (A-2).

Related Information

  • Related bill: HD 4509 (replaces).

This summary captures the bill’s core purpose, the proposed pilot’s structure, eligibility criteria, regulatory requirements, data commitments, and the key procedural milestones and dates.

Compiled from official sources — confirm details with the bill’s official record.

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