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2 | 2 | | SENATE DOCKET, NO. 1759 FILED ON: 1/19/2023 |
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3 | 3 | | SENATE . . . . . . . . . . . . . . No. 1263 |
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4 | 4 | | The Commonwealth of Massachusetts |
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5 | 5 | | _________________ |
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6 | 6 | | PRESENTED BY: |
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7 | 7 | | Susan L. Moran |
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8 | 8 | | _________________ |
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9 | 9 | | To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General |
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10 | 10 | | Court assembled: |
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11 | 11 | | The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: |
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12 | 12 | | An Act regulating the safe use of psilocybin. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :Susan L. MoranPlymouth and Barnstable 1 of 5 |
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16 | 16 | | SENATE DOCKET, NO. 1759 FILED ON: 1/19/2023 |
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17 | 17 | | SENATE . . . . . . . . . . . . . . No. 1263 |
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18 | 18 | | By Ms. Moran, a petition (accompanied by bill, Senate, No. 1263) of Susan L. Moran for |
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19 | 19 | | legislation to regulate the safe use of psilocybin. Mental Health, Substance Use and Recovery. |
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20 | 20 | | The Commonwealth of Massachusetts |
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21 | 21 | | _______________ |
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22 | 22 | | In the One Hundred and Ninety-Third General Court |
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23 | 23 | | (2023-2024) |
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24 | 24 | | _______________ |
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25 | 25 | | An Act regulating the safe use of psilocybin. |
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26 | 26 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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27 | 27 | | of the same, as follows: |
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28 | 28 | | 1 SECTION 1. The General Laws are hereby amended by inserting, after Chapter 94I, the |
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29 | 29 | | 2following chapter:- |
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30 | 30 | | 3 CHAPTER 94J. PSILOCYBIN TREATMENT PROGRAM |
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31 | 31 | | 4 Section 1. Definitions |
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32 | 32 | | 5 For the purposes of this chapter, the following words shall have the following definitions: |
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33 | 33 | | 6 “Approved treatment site”, means the location where a qualified applicant that has been |
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34 | 34 | | 7selected under subsection (e) of this section as a provider of psilocybin-assisted therapy under |
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35 | 35 | | 8the pilot program established pursuant to subsection (b) of this section will provide such therapy. |
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36 | 36 | | 9 “Bureau”, the bureau of substance use addiction services. |
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37 | 37 | | 10 “Department”, the department of mental health. 2 of 5 |
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38 | 38 | | 11 “Psilocybin”, a serotonin receptor agonist that occurs naturally in some mushroom |
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39 | 39 | | 12species. |
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40 | 40 | | 13 "Qualified applicant", a provider of mental or behavioral health services that has received |
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41 | 41 | | 14approval from the federal Food and Drug Administration as an approved treatment site with an |
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42 | 42 | | 15expanded access protocol that allows the provider access to an investigational drug for treatment |
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43 | 43 | | 16use, including emergency use, pursuant to 21 CFR 312, as amended from time to time. |
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44 | 44 | | 17 "Qualified patient", a resident of the commonwealth who is suffering from a mental |
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45 | 45 | | 18health or substance use disorder. |
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46 | 46 | | 19 Section 2. Psilocybin-assisted therapy pilot program |
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47 | 47 | | 20 There shall be a psilocybin-assisted therapy pilot program operated by the bureau of |
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48 | 48 | | 21substance use addiction services to provide qualified patients with the funding necessary to |
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49 | 49 | | 22receive psilocybin-assisted therapy as part of any expanded access program approved by the |
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50 | 50 | | 23federal Food and Drug Administration pursuant to 21 CFR 312, and located within the |
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51 | 51 | | 24commonwealth. The bureau shall cease to operate the pilot program when psilocybin has been |
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52 | 52 | | 25approved to have a medical use by the federal Drug Enforcement Administration, or any |
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53 | 53 | | 26successor agency. |
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54 | 54 | | 27 Section 3. Qualified Patients for Approved Treatment Sites Fund |
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55 | 55 | | 28 There is hereby established a Qualified Patients for Approved Treatment Sites Fund |
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56 | 56 | | 29administered by the bureau of substance use addiction services. The fund shall consist of |
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57 | 57 | | 30amounts credited to the fund from any appropriations, grants, gifts or other money authorized by |
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58 | 58 | | 31the general court or other parties and specifically designated to be credited to the fund and any 3 of 5 |
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59 | 59 | | 32income derived from the investment of amounts credited to the fund. Any unexpended balance in |
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60 | 60 | | 33the fund at the end of a fiscal year shall not revert to the General Fund and shall be available for |
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61 | 61 | | 34expenditure in the subsequent fiscal year. The fund shall be used, without further appropriation, |
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62 | 62 | | 35for grants to qualified applicants to provide psilocybin-assisted therapy to qualified patients |
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63 | 63 | | 36under the pilot program established in section 2 of this chapter. |
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64 | 64 | | 37 Section 4. Psilocybin Treatment Advisory Board |
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65 | 65 | | 38 There is hereby established a Psilocybin Treatment and Advisory Board within the |
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66 | 66 | | 39department of mental health. |
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67 | 67 | | 40 The board shall consist of the following members: the secretary of health and human |
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68 | 68 | | 41services or a designee, the secretary of public safety and security or a designee, the director of |
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69 | 69 | | 42the department of mental health or a designee, the director of the bureau of substance use and |
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70 | 70 | | 43addiction services, a representative from a licensed substance abuse rehabilitation program in the |
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71 | 71 | | 44commonwealth appointed by the governor, a member appointed by the president of the Senate, |
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72 | 72 | | 45and a member appointed by the speaker of the house of representatives. |
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73 | 73 | | 46 The board shall advise the department and the legislature on the design and development |
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74 | 74 | | 47of the regulations, infrastructure, or legislation necessary to safely allow for therapeutic access to |
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75 | 75 | | 48psilocybin-assisted therapy upon the legalization of psilocybin. In advising the department and |
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76 | 76 | | 49legislature under this subsection, the board shall: |
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77 | 77 | | 50 (a) report on the data from the psilocybin-assisted therapy pilot program established |
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78 | 78 | | 51under section 2 of this chapter to inform the development of such regulations; 4 of 5 |
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79 | 79 | | 52 (b) compile the necessary education, training, licensing and credentialing of therapists |
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80 | 80 | | 53and facilitators, patient safety, harm reduction, the establishment of equity measures in both |
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81 | 81 | | 54clinical and therapeutic settings, cost and insurance reimbursement considerations and standards |
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82 | 82 | | 55of treatment facilities; |
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83 | 83 | | 56 (c) examine the use of group therapy and other therapy options to reduce cost and |
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84 | 84 | | 57maximize public health benefits from psilocybin treatments; |
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85 | 85 | | 58 (d) monitor federal regulations and guidelines for referral and consideration by the state |
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86 | 86 | | 59agencies of cognizance for implementation of such regulations and guidelines; |
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87 | 87 | | 60 (e) develop a long-term strategic plan to improve mental health care through the use of |
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88 | 88 | | 61psilocybin treatment; |
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89 | 89 | | 62 (f) recommend equity measures for clinical subject recruitment and facilitator training |
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90 | 90 | | 63recruitment; |
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91 | 91 | | 64 (g) assist with the development of public awareness and education campaigns and; |
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92 | 92 | | 65 (h) comply with any other mandates from the legislature of bureau of substance abuse |
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93 | 93 | | 66addiction services. |
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94 | 94 | | 67 The board may establish committees and subcommittees necessary for the operation of |
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95 | 95 | | 68the board. |
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96 | 96 | | 69 Annually, the board shall compile a report of its findings from its charges detailed above, |
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97 | 97 | | 70including but not limited to the current status of federal regulations and guidelines surrounding |
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98 | 98 | | 71the use of psilocybin, and progress on development of the long-term strategic plan. The report 5 of 5 |
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99 | 99 | | 72shall be transmitted to all members of the Psilocybin Treatment Advisory Board, and the clerks |
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100 | 100 | | 73of the senate and house of representatives. |
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101 | 101 | | 74 SECTION 2. This act shall take effect upon its passage. |
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