Bill S.1263

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:

SECTION 1. The General Laws are hereby amended by inserting, after Chapter 94I, the following chapter:-

CHAPTER 94J. PSILOCYBIN TREATMENT PROGRAM

Section 1. Definitions

For the purposes of this chapter, the following words shall have the following definitions:

“Approved treatment site”, means the location where a qualified applicant that has been selected under subsection (e) of this section as a provider of psilocybin-assisted therapy under the pilot program established pursuant to subsection (b) of this section will provide such therapy.

“Bureau”, the bureau of substance use addiction services.

“Department”, the department of mental health.

“Psilocybin”, a serotonin receptor agonist that occurs naturally in some mushroom species.

"Qualified applicant", a provider of mental or behavioral health services that has received approval from the federal Food and Drug Administration as an approved treatment site with an expanded access protocol that allows the provider access to an investigational drug for treatment use, including emergency use, pursuant to 21 CFR 312, as amended from time to time.

"Qualified patient", a resident of the commonwealth who is suffering from a mental health or substance use disorder.

Section 2. Psilocybin-assisted therapy pilot program

There shall be a psilocybin-assisted therapy pilot program operated by the bureau of substance use addiction services to provide qualified patients with the funding necessary to receive psilocybin-assisted therapy as part of any expanded access program approved by the federal Food and Drug Administration pursuant to 21 CFR 312, and located within the commonwealth. The bureau shall cease to operate the pilot program when psilocybin has been approved to have a medical use by the federal Drug Enforcement Administration, or any successor agency.

Section 3. Qualified Patients for Approved Treatment Sites Fund

There is hereby established a Qualified Patients for Approved Treatment Sites Fund administered by the bureau of substance use addiction services. The fund shall consist of amounts credited to the fund from any appropriations, grants, gifts or other money authorized by the general court or other parties and specifically designated to be credited to the fund and any income derived from the investment of amounts credited to the fund. Any unexpended balance in the fund at the end of a fiscal year shall not revert to the General Fund and shall be available for expenditure in the subsequent fiscal year. The fund shall be used, without further appropriation, for grants to qualified applicants to provide psilocybin-assisted therapy to qualified patients under the pilot program established in section 2 of this chapter.

Section 4. Psilocybin Treatment Advisory Board

There is hereby established a Psilocybin Treatment and Advisory Board within the department of mental health.

The board shall consist of the following members: the secretary of health and human services or a designee, the secretary of public safety and security or a designee, the director of the department of mental health or a designee, the director of the bureau of substance use and addiction services, a representative from a licensed substance abuse rehabilitation program in the commonwealth appointed by the governor, a member appointed by the president of the Senate, and a member appointed by the speaker of the house of representatives.

The board shall advise the department and the legislature on the design and development of the regulations, infrastructure, or legislation necessary to safely allow for therapeutic access to psilocybin-assisted therapy upon the legalization of psilocybin. In advising the department and legislature under this subsection, the board shall:

(a) report on the data from the psilocybin-assisted therapy pilot program established under section 2 of this chapter to inform the development of such regulations;

(b) compile the necessary education, training, licensing and credentialing of therapists and facilitators, patient safety, harm reduction, the establishment of equity measures in both clinical and therapeutic settings, cost and insurance reimbursement considerations and standards of treatment facilities;

(c) examine the use of group therapy and other therapy options to reduce cost and maximize public health benefits from psilocybin treatments;

(d) monitor federal regulations and guidelines for referral and consideration by the state agencies of cognizance for implementation of such regulations and guidelines;

(e) develop a long-term strategic plan to improve mental health care through the use of psilocybin treatment;

(f) recommend equity measures for clinical subject recruitment and facilitator training recruitment;

(g) assist with the development of public awareness and education campaigns and;

(h) comply with any other mandates from the legislature of bureau of substance abuse addiction services.

The board may establish committees and subcommittees necessary for the operation of the board.

Annually, the board shall compile a report of its findings from its charges detailed above, including but not limited to the current status of federal regulations and guidelines surrounding the use of psilocybin, and progress on development of the long-term strategic plan. The report shall be transmitted to all members of the Psilocybin Treatment Advisory Board, and the clerks of the senate and house of representatives.

SECTION 2. This act shall take effect upon its passage.

Name:	District/Address:
Susan L. Moran	Plymouth and Barnstable