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SENATE DOCKET, NO. 1759 FILED ON: 1/19/2023
SENATE . . . . . . . . . . . . . . No. 1263
The Commonwealth of Massachusetts
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PRESENTED BY:
Susan L. Moran
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To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
Court assembled:
The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
An Act regulating the safe use of psilocybin.
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PETITION OF:
NAME:DISTRICT/ADDRESS :Susan L. MoranPlymouth and Barnstable 1 of 5
SENATE DOCKET, NO. 1759 FILED ON: 1/19/2023
SENATE . . . . . . . . . . . . . . No. 1263
By Ms. Moran, a petition (accompanied by bill, Senate, No. 1263) of Susan L. Moran for
legislation to regulate the safe use of psilocybin. Mental Health, Substance Use and Recovery.
The Commonwealth of Massachusetts
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In the One Hundred and Ninety-Third General Court
(2023-2024)
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An Act regulating the safe use of psilocybin.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
of the same, as follows:
1 SECTION 1. The General Laws are hereby amended by inserting, after Chapter 94I, the
2following chapter:-
3 CHAPTER 94J. PSILOCYBIN TREATMENT PROGRAM
4 Section 1. Definitions
5 For the purposes of this chapter, the following words shall have the following definitions:
6 “Approved treatment site”, means the location where a qualified applicant that has been
7selected under subsection (e) of this section as a provider of psilocybin-assisted therapy under
8the pilot program established pursuant to subsection (b) of this section will provide such therapy.
9 “Bureau”, the bureau of substance use addiction services.
10 “Department”, the department of mental health. 2 of 5
11 “Psilocybin”, a serotonin receptor agonist that occurs naturally in some mushroom
12species.
13 "Qualified applicant", a provider of mental or behavioral health services that has received
14approval from the federal Food and Drug Administration as an approved treatment site with an
15expanded access protocol that allows the provider access to an investigational drug for treatment
16use, including emergency use, pursuant to 21 CFR 312, as amended from time to time.
17 "Qualified patient", a resident of the commonwealth who is suffering from a mental
18health or substance use disorder.
19 Section 2. Psilocybin-assisted therapy pilot program
20 There shall be a psilocybin-assisted therapy pilot program operated by the bureau of
21substance use addiction services to provide qualified patients with the funding necessary to
22receive psilocybin-assisted therapy as part of any expanded access program approved by the
23federal Food and Drug Administration pursuant to 21 CFR 312, and located within the
24commonwealth. The bureau shall cease to operate the pilot program when psilocybin has been
25approved to have a medical use by the federal Drug Enforcement Administration, or any
26successor agency.
27 Section 3. Qualified Patients for Approved Treatment Sites Fund
28 There is hereby established a Qualified Patients for Approved Treatment Sites Fund
29administered by the bureau of substance use addiction services. The fund shall consist of
30amounts credited to the fund from any appropriations, grants, gifts or other money authorized by
31the general court or other parties and specifically designated to be credited to the fund and any 3 of 5
32income derived from the investment of amounts credited to the fund. Any unexpended balance in
33the fund at the end of a fiscal year shall not revert to the General Fund and shall be available for
34expenditure in the subsequent fiscal year. The fund shall be used, without further appropriation,
35for grants to qualified applicants to provide psilocybin-assisted therapy to qualified patients
36under the pilot program established in section 2 of this chapter.
37 Section 4. Psilocybin Treatment Advisory Board
38 There is hereby established a Psilocybin Treatment and Advisory Board within the
39department of mental health.
40 The board shall consist of the following members: the secretary of health and human
41services or a designee, the secretary of public safety and security or a designee, the director of
42the department of mental health or a designee, the director of the bureau of substance use and
43addiction services, a representative from a licensed substance abuse rehabilitation program in the
44commonwealth appointed by the governor, a member appointed by the president of the Senate,
45and a member appointed by the speaker of the house of representatives.
46 The board shall advise the department and the legislature on the design and development
47of the regulations, infrastructure, or legislation necessary to safely allow for therapeutic access to
48psilocybin-assisted therapy upon the legalization of psilocybin. In advising the department and
49legislature under this subsection, the board shall:
50 (a) report on the data from the psilocybin-assisted therapy pilot program established
51under section 2 of this chapter to inform the development of such regulations; 4 of 5
52 (b) compile the necessary education, training, licensing and credentialing of therapists
53and facilitators, patient safety, harm reduction, the establishment of equity measures in both
54clinical and therapeutic settings, cost and insurance reimbursement considerations and standards
55of treatment facilities;
56 (c) examine the use of group therapy and other therapy options to reduce cost and
57maximize public health benefits from psilocybin treatments;
58 (d) monitor federal regulations and guidelines for referral and consideration by the state
59agencies of cognizance for implementation of such regulations and guidelines;
60 (e) develop a long-term strategic plan to improve mental health care through the use of
61psilocybin treatment;
62 (f) recommend equity measures for clinical subject recruitment and facilitator training
63recruitment;
64 (g) assist with the development of public awareness and education campaigns and;
65 (h) comply with any other mandates from the legislature of bureau of substance abuse
66addiction services.
67 The board may establish committees and subcommittees necessary for the operation of
68the board.
69 Annually, the board shall compile a report of its findings from its charges detailed above,
70including but not limited to the current status of federal regulations and guidelines surrounding
71the use of psilocybin, and progress on development of the long-term strategic plan. The report 5 of 5
72shall be transmitted to all members of the Psilocybin Treatment Advisory Board, and the clerks
73of the senate and house of representatives.
74 SECTION 2. This act shall take effect upon its passage.