Massachusetts 2023-2024 Regular Session

Massachusetts Senate Bill S1263 Compare Versions

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22 SENATE DOCKET, NO. 1759 FILED ON: 1/19/2023
33 SENATE . . . . . . . . . . . . . . No. 1263
44 The Commonwealth of Massachusetts
55 _________________
66 PRESENTED BY:
77 Susan L. Moran
88 _________________
99 To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
1010 Court assembled:
1111 The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
1212 An Act regulating the safe use of psilocybin.
1313 _______________
1414 PETITION OF:
1515 NAME:DISTRICT/ADDRESS :Susan L. MoranPlymouth and Barnstable 1 of 5
1616 SENATE DOCKET, NO. 1759 FILED ON: 1/19/2023
1717 SENATE . . . . . . . . . . . . . . No. 1263
1818 By Ms. Moran, a petition (accompanied by bill, Senate, No. 1263) of Susan L. Moran for
1919 legislation to regulate the safe use of psilocybin. Mental Health, Substance Use and Recovery.
2020 The Commonwealth of Massachusetts
2121 _______________
2222 In the One Hundred and Ninety-Third General Court
2323 (2023-2024)
2424 _______________
2525 An Act regulating the safe use of psilocybin.
2626 Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
2727 of the same, as follows:
2828 1 SECTION 1. The General Laws are hereby amended by inserting, after Chapter 94I, the
2929 2following chapter:-
3030 3 CHAPTER 94J. PSILOCYBIN TREATMENT PROGRAM
3131 4 Section 1. Definitions
3232 5 For the purposes of this chapter, the following words shall have the following definitions:
3333 6 “Approved treatment site”, means the location where a qualified applicant that has been
3434 7selected under subsection (e) of this section as a provider of psilocybin-assisted therapy under
3535 8the pilot program established pursuant to subsection (b) of this section will provide such therapy.
3636 9 “Bureau”, the bureau of substance use addiction services.
3737 10 “Department”, the department of mental health. 2 of 5
3838 11 “Psilocybin”, a serotonin receptor agonist that occurs naturally in some mushroom
3939 12species.
4040 13 "Qualified applicant", a provider of mental or behavioral health services that has received
4141 14approval from the federal Food and Drug Administration as an approved treatment site with an
4242 15expanded access protocol that allows the provider access to an investigational drug for treatment
4343 16use, including emergency use, pursuant to 21 CFR 312, as amended from time to time.
4444 17 "Qualified patient", a resident of the commonwealth who is suffering from a mental
4545 18health or substance use disorder.
4646 19 Section 2. Psilocybin-assisted therapy pilot program
4747 20 There shall be a psilocybin-assisted therapy pilot program operated by the bureau of
4848 21substance use addiction services to provide qualified patients with the funding necessary to
4949 22receive psilocybin-assisted therapy as part of any expanded access program approved by the
5050 23federal Food and Drug Administration pursuant to 21 CFR 312, and located within the
5151 24commonwealth. The bureau shall cease to operate the pilot program when psilocybin has been
5252 25approved to have a medical use by the federal Drug Enforcement Administration, or any
5353 26successor agency.
5454 27 Section 3. Qualified Patients for Approved Treatment Sites Fund
5555 28 There is hereby established a Qualified Patients for Approved Treatment Sites Fund
5656 29administered by the bureau of substance use addiction services. The fund shall consist of
5757 30amounts credited to the fund from any appropriations, grants, gifts or other money authorized by
5858 31the general court or other parties and specifically designated to be credited to the fund and any 3 of 5
5959 32income derived from the investment of amounts credited to the fund. Any unexpended balance in
6060 33the fund at the end of a fiscal year shall not revert to the General Fund and shall be available for
6161 34expenditure in the subsequent fiscal year. The fund shall be used, without further appropriation,
6262 35for grants to qualified applicants to provide psilocybin-assisted therapy to qualified patients
6363 36under the pilot program established in section 2 of this chapter.
6464 37 Section 4. Psilocybin Treatment Advisory Board
6565 38 There is hereby established a Psilocybin Treatment and Advisory Board within the
6666 39department of mental health.
6767 40 The board shall consist of the following members: the secretary of health and human
6868 41services or a designee, the secretary of public safety and security or a designee, the director of
6969 42the department of mental health or a designee, the director of the bureau of substance use and
7070 43addiction services, a representative from a licensed substance abuse rehabilitation program in the
7171 44commonwealth appointed by the governor, a member appointed by the president of the Senate,
7272 45and a member appointed by the speaker of the house of representatives.
7373 46 The board shall advise the department and the legislature on the design and development
7474 47of the regulations, infrastructure, or legislation necessary to safely allow for therapeutic access to
7575 48psilocybin-assisted therapy upon the legalization of psilocybin. In advising the department and
7676 49legislature under this subsection, the board shall:
7777 50 (a) report on the data from the psilocybin-assisted therapy pilot program established
7878 51under section 2 of this chapter to inform the development of such regulations; 4 of 5
7979 52 (b) compile the necessary education, training, licensing and credentialing of therapists
8080 53and facilitators, patient safety, harm reduction, the establishment of equity measures in both
8181 54clinical and therapeutic settings, cost and insurance reimbursement considerations and standards
8282 55of treatment facilities;
8383 56 (c) examine the use of group therapy and other therapy options to reduce cost and
8484 57maximize public health benefits from psilocybin treatments;
8585 58 (d) monitor federal regulations and guidelines for referral and consideration by the state
8686 59agencies of cognizance for implementation of such regulations and guidelines;
8787 60 (e) develop a long-term strategic plan to improve mental health care through the use of
8888 61psilocybin treatment;
8989 62 (f) recommend equity measures for clinical subject recruitment and facilitator training
9090 63recruitment;
9191 64 (g) assist with the development of public awareness and education campaigns and;
9292 65 (h) comply with any other mandates from the legislature of bureau of substance abuse
9393 66addiction services.
9494 67 The board may establish committees and subcommittees necessary for the operation of
9595 68the board.
9696 69 Annually, the board shall compile a report of its findings from its charges detailed above,
9797 70including but not limited to the current status of federal regulations and guidelines surrounding
9898 71the use of psilocybin, and progress on development of the long-term strategic plan. The report 5 of 5
9999 72shall be transmitted to all members of the Psilocybin Treatment Advisory Board, and the clerks
100100 73of the senate and house of representatives.
101101 74 SECTION 2. This act shall take effect upon its passage.