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Bill H.4200
Notwithstanding any general or special law to the contrary, the department of public health shall establish a pilot program to allow for the monitored mental health care of clinically appropriate patients using psychedelic materials as defined by the department of public health for on-site administration by a multi-disciplinary care team in a supervised licensed mental health clinic setting. The department shall issue pilot permits to no more than three licensed mental health clinic facilities to participate in the pilot program for the purposes of establishing the best and safest clinical practices for psychedelic mental health treatment programs in the commonwealth and for the purposes of collecting patient outcomes data regarding the benefits of psychedelic pharmacotherapy. Authorization shall be given to clinics licensed in mental health services as defined by the department of public health. Eligible pilot program organizations must exclusively focus operations and treatment on mental health and cannot be subsidiaries, affiliates or members of cannabis industry organizations, psychedelic molecule development companies or pharmaceutical companies.
The department shall promulgate the rules and regulations necessary for the operation of a supervised psychedelic pilot in a clinical setting, including but not limited to, establishing a process to apply for participation in the pilot. The regulations must include but not be limited to: the definitions and standards for clinic participation; the process of initial patient assessment and ongoing monitoring; the composition of the clinical staff and the role of a licensed physician to oversee the program; the process of ensuring coordination and medical management of psychiatric medications with prescribers outside of the participating outpatient clinical pilot; and, the process of storage, dispensing and administration of psychedelics within the participating pilot.
All pilot program participant organizations must track patient care outcomes data related to the identification, diagnosis and psychedelic treatment of depression, anxiety, post-traumatic stress disorder and substance use disorder. These data sets must be shared with the department to assist in the refinement of best clinical protocols and final regulatory frameworks for the safe use of psychedelic material in Massachusetts.
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