Massachusetts 2025-2026 Regular Session

Massachusetts House Bill H2203 Compare Versions

Only one version of the bill is available at this time.

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2	2	HOUSE DOCKET, NO. 4196 FILED ON: 1/17/2025
3	3	HOUSE . . . . . . . . . . . . . . . No. 2203
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Marjorie C. Decker
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act establishing a pilot program for access to regulated psilocybin.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :DATE ADDED:Marjorie C. Decker25th Middlesex1/17/2025 1 of 5
16	16	HOUSE DOCKET, NO. 4196 FILED ON: 1/17/2025
17	17	HOUSE . . . . . . . . . . . . . . . No. 2203
18	18	By Representative Decker of Cambridge, a petition (accompanied by bill, House, No. 2203) of
19	19	Marjorie C. Decker for legislation to authorize the Department of Public Health to establish a
20	20	pilot program for psilocybin services for adults with post-traumatic stress disorder and other
21	21	specified conditions. Mental Health, Substance Use and Recovery.
22	22	The Commonwealth of Massachusetts
23	23	_______________
24	24	In the One Hundred and Ninety-Fourth General Court
25	25	(2025-2026)
26	26	_______________
27	27	An Act establishing a pilot program for access to regulated psilocybin.
28	28	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
29	29	of the same, as follows:
30	30	1 SECTION 1. (a) Notwithstanding any general or special law to the contrary, the
31	31	2department of public health shall develop a pilot program to allow for the research and
32	32	3development of psilocybin services for adults with post-traumatic stress disorder, end-of-life
33	33	4distress, depression, or other specified conditions, as determined by program criteria and needs in
34	34	5designated geographic areas, as established by the department. This pilot shall be known as the
35	35	6Psilocybin-Assisted Therapy Program.
36	36	7 (b) For the purposes of this act, the following terms shall have the following meanings,
37	37	8unless the context clearly requires otherwise:-
38	38	9 “Community-based providers”, licensed healthcare and community-based organizations,
39	39	10including but not limited to, mental health clinics, hospice organizations, veterans' administration
40	40	11facilities and other community-based therapeutic care organizations that provide services and 2 of 5
41	41	12care to adults with post-traumatic stress disorder, end-of-life distress, depression, or other
42	42	13specified conditions, as determined by the department.
43	43	14 “Department”, the department of public health.
44	44	15 “Local pilot”, the operation of the pilot within each of the designated sites.
45	45	16 “Pilot”, the Psilocybin-Assisted Therapy Program, as established in this act.
46	46	17 “Psilocybin”, a psychedelic compound produced by fungi, including but not limited to,
47	47	18members of the genus Psilocybe. Such term shall include psilocin, the substance into which
48	48	19psilocybin is converted in the human body.
49	49	20 (c) The pilot shall provide psilocybin therapy through pathways approved by the federal
50	50	21food and drug administration to test the effects of providing psilocybin services to adults in
51	51	22controlled, community-based settings under the supervision of university researchers with
52	52	23experience administering psychedelic substances in clinical trials. Individuals eligible to
53	53	24participate in the pilot program must be adults who are 21 years of age or older.
54	54	25 (d) The department shall establish professional standards for regulated psychedelic use
55	55	26and criteria for participation in the pilot, including the number of universities that may
56	56	27participate in the pilot; provided, that preference shall be given to universities within the
57	57	28Commonwealth’s public university system. The department shall develop local training and
58	58	29certification frameworks for psilocybin facilitators to sustain capacity beyond the pilot’s
59	59	30conclusion. A local pilot shall collect and provide data relevant to potential coverage for the cost
60	60	31of psilocybin-assisted therapy, as determined by the department. 3 of 5
61	61	32 (e) Upon selection to participate in the pilot, qualifying universities shall enter into an
62	62	33agreement with the department specifying, at minimum:
63	63	34 (i) The amount of funding available to the university, through funding mechanisms as
64	64	35outlined in subsection (k), for the purpose of overseeing the applicable local pilot;
65	65	36 (ii) The conditions under which payments will be made to the university;
66	66	37 (iii) Data collection and sharing requirements; and
67	67	38 (iv) Reporting requirements including, but not limited to, frequency and method of data
68	68	39reporting and specific data to be reported to the department.
69	69	40 (f) The pilot shall collaborate with community-based providers that provide services to
70	70	41conduct pilot studies of administering psilocybin services to adults with post-traumatic stress
71	71	42disorder, end-of-life distress, depression, or other specified conditions, as determined by the
72	72	43department.
73	73	44 (g) A university selected to participate in the pilot shall be responsible for:
74	74	45 (i) protocol design, except that the research design shall use naturally occurring
75	75	46psilocybin if there is a federally legal source of natural psilocybin available for FDA-approved
76	76	47research purposes;
77	77	48 (ii) securing institutional review board approvals;
78	78	49 (iii) training psilocybin facilitators; and
79	79	50 (iv) data collection and reporting as outlined in the university’s agreement with the
80	80	51department. 4 of 5
81	81	52 (h) A university overseeing a local pilot shall maintain strict protocols for participant
82	82	53screening, ensuring facilitator qualifications and training, informed consent, dosing, and follow-
83	83	54up.
84	84	55 (i) The department shall report not later than 12 months after the effective date of this act
85	85	56and annually thereafter to the clerks of the house of representatives and the senate, the joint
86	86	57committee on public health and the joint committee on mental health, substance use, and
87	87	58recovery. The report shall be peer-reviewed and shall include a study of the statewide efficacy of
88	88	59the pilot, including local community impacts and the feasibility of coverage for psilocybin-
89	89	60assisted therapy under MassHealth, consistent with any applicable federal guidelines.
90	90	61 (j) The sharing of health information, records, and other data with and among pilot
91	91	62entities and other participating entities shall be permitted to the extent necessary for the activities
92	92	63and purposes set forth in this act. The department shall establish guidelines consistent with this
93	93	64act for protecting confidential patient information during the course of the pilot.
94	94	65 (k) The pilot may be funded by appropriation, grants, donations, trust funds, or other
95	95	66funding sources. The funds for establishing a pilot shall be used for:
96	96	67 (i) program administration and oversight;
97	97	68 (ii) training and qualification of facilitators;
98	98	69 (iii) data collection, analysis, and reporting; and
99	99	70 (iv) community engagement and education initiatives.
100	100	71 (l) The department may establish additional guidelines pursuant to this section through
101	101	72notice and comment rulemaking in compliance with chapter 111 of the General Laws. 5 of 5
102	102	73 (m) The pilot shall have a total duration of no less than two years.
103	103	74 SECTION 2. This Act shall take effect on January 1, 2026.