Establishes the psilocybin assisted therapy pilot program; provides such program will be offered to veterans and first responders from New York state; establishes a psilocybin assisted therapy pilot program fund.
STATE OF NEW YORK
________________________________________________________________________
3845--A
2025-2026 Regular Sessions
IN ASSEMBLY
January 30, 2025
___________
Introduced by M. of A. BURKE, McDONALD, BURDICK, FALL, HEVESI, CONRAD,
SIMON, CRUZ -- read once and referred to the Committee on Health --
committee discharged, bill amended, ordered reprinted as amended and
recommitted to said committee
AN ACT to amend the public health law and the state finance law, in
relation to establishing a psilocybin assisted therapy pilot program
for veterans and first responders and a psilocybin assisted therapy
pilot program fund; and making an appropriation therefor
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The public health law is amended by adding a new section
2 3309-c to read as follows:
3 § 3309-c. Psilocybin assisted therapy pilot program. 1. For the
4 purposes of this section, the following terms shall have the following
5 meanings:
6 (a) "Certified medical use" includes use of medical psilocybin for a
7 patient to treat or alleviate a patient's medical condition or symptoms
8 associated with the patient's medical condition.
9 (b) "Facilitator" shall mean a mental health counselor, psychoanalyst,
10 psychologist, physician, physician assistant, registered professional
11 nurse, clinical nurse specialist, nurse practitioner, occupational ther-
12 apist, occupational therapy assistant, licensed clinical social worker,
13 or an individual with evidence of prior experience and knowledge in the
14 field of psychedelic assisted therapy who has completed all requirements
15 of this section.
16 (c) "Medical psilocybin" shall mean psilocybin intended for a certi-
17 fied medical use, as determined by the department.
18 (d) "Pilot program" shall mean the psilocybin assisted therapy
19 pilot program established under this section.
20 (e) "Psilocybin" shall mean a naturally occurring psychedelic prodrug
21 compound produced by fungi, including but not limited to members of the
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD05253-06-6
A. 3845--A 2
1 genus Psilocybe. Such term shall include psilocin, the substance into
2 which psilocybin is converted in the human body.
3 2. (a) The department shall establish a psilocybin assisted therapy
4 pilot program. Such pilot program shall provide patient participants, as
5 described in paragraph (b) of this subdivision, with the funding neces-
6 sary to receive psilocybin assisted therapy. Such pilot program shall be
7 terminated upon the approval of psilocybin for medical use by the feder-
8 al drug enforcement administration, or any successor agency.
9 (b) Participants in the pilot program shall include veterans, first
10 responders and retired first responders.
11 (c) The department shall scale the number of patient participants
12 based on the outcomes of the pilot program and changes to federal laws,
13 rules, regulations, and approvals.
14 (d) The department shall implement the pilot program in partnership
15 with the state university of New York's academic health centers which
16 may include, but shall not be limited to, upstate medical university,
17 downstate health sciences university, Stony Brook University and the
18 university at Buffalo's Jacobs school of medicine and biomedical
19 sciences.
20 (e) The pilot program shall comply with and follow all applicable
21 regulations and standards of the federal food and drug administration,
22 federal drug enforcement administration, and any relevant institutional
23 review boards including, but not limited to, clinical trial processes,
24 investigational new drug pathways, schedule I research license require-
25 ments, protocols for ethical oversight.
26 (f) The pilot program shall not duplicate any mandated eligibility
27 criteria, safety reporting, or protections for participant patients that
28 the federal food and drug administration, federal drug enforcement
29 administration, and any other relevant institutional review boards and
30 shall defer to such administrations and boards for such.
31 (g) The department shall promulgate any necessary rules and regu-
32 lations for the application and distribution of any funds pursuant to
33 this subdivision. Such rules and regulations shall support the pilot
34 program operating within federal regulations, standards, and programs
35 and shall not create any new state rules or regulations which are not
36 consistent with such federal regulations, standards, and programs.
37 3. A facilitator shall be an individual qualified under the federal
38 research protocol utilized by a participating state university of New
39 York academic health center.
40 4. (a) The department may provide for the analysis and evaluation of
41 the operation of this section. The department may enter into agreements
42 with one or more persons, not-for-profit corporations, universities or
43 other organizations, for the performance of an evaluation of the imple-
44 mentation and effectiveness of this section.
45 (b) The department may develop, seek any necessary federal approval
46 for, and carry out research programs relating to medical use of psilocy-
47 bin. Participation in any such research program shall be voluntary on
48 the part of facilitators, patients, and designated caregivers.
49 (c) No later than two years after the effective date of this section
50 and every two years thereafter, the department shall report to the
51 governor and the legislature on the medical use of psilocybin under this
52 section and make appropriate recommendations.
53 (d) Based on the findings of the report required under paragraph (c)
54 of this subdivision, the department, in consultation with participating
55 state university of New York academic health centers, may develop and
56 implement a state-funded psilocybin assisted therapy training program.
A. 3845--A 3
1 Such program shall be informed by the outcomes, best practices, safety
2 data, and clinical standards observed during the pilot program.
3 5. The provisions of this section shall take precedence over any
4 conflicting provisions of this chapter and article one hundred thirty-
5 seven of the education law.
6 6. (a) Patients, practitioners and facilitators shall not be subject
7 to arrest, prosecution, or penalty in any manner, or denied any right or
8 privilege, including but not limited to civil penalty or disciplinary
9 action by a business or occupational or professional licensing board or
10 bureau, solely for the certified medical use of psilocybin or for any
11 other action or conduct in accordance with this section.
12 (b) This subdivision shall not bar the enforcement of a policy prohib-
13 iting an employee from performing such employee's employment duties
14 while impaired by a controlled substance. This subdivision shall not
15 require any person or entity to do any act that would put the person or
16 entity in direct violation of federal law or cause it to lose a federal
17 contract or funding.
18 (c) The fact that a person is a patient and/or acting in accordance
19 with this section, shall not be a consideration in a proceeding pursuant
20 to applicable sections of the domestic relations law, the social
21 services law, and the family court act.
22 (d) A person currently under parole, probation or other state or local
23 supervision, or released on bail awaiting trial may not be punished or
24 otherwise penalized for conduct allowed under this section.
25 7. The department shall promulgate any rules and regulations necessary
26 to implement the provisions of this section.
27 § 2. The state finance law is amended by adding a new section 99-uu
28 to read as follows:
29 § 99-uu. Psilocybin assisted therapy pilot program fund. 1. There is
30 hereby established in the joint custody of the commissioner of health
31 and the comptroller, a special fund to be known as the "psilocybin
32 assisted therapy pilot program fund".
33 2. Such fund shall consist of all moneys appropriated, credited, or
34 transferred thereto from any other fund or source pursuant to law.
35 Nothing contained in this section shall prevent the state from receiving
36 grants, gifts, or bequests for the purposes of the fund, as defined in
37 this section, and depositing them into the fund according to law.
38 3. Monies of the fund shall be expended only for the purposes operat-
39 ing the psilocybin assisted therapy pilot program established under
40 section thirty-three hundred nine-c of the public health law.
41 4. Monies of the fund shall be payable on the audit and warrant of the
42 comptroller on vouchers approved and certified by the commissioner of
43 health.
44 § 3. The sum of five million dollars ($5,000,000), or so much thereof
45 as may be necessary, is hereby appropriated from any moneys in the state
46 treasury in the general fund to the credit of the state purposes account
47 not otherwise appropriated to the psilocybin assisted therapy pilot
48 program fund established under section 99-uu of the state finance law in
49 carrying out the provisions of this act. Such sum shall be payable on
50 the audit and warrant of the state comptroller on vouchers certified or
51 approved in the manner provided by law.
52 § 4. This act shall take effect immediately.
