NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A3581 Revised 3/1/2023
SPONSOR: Burke TITLE OF BILL:
An act to amend the public health law and the state finance law, in
relation to medical use of psilocybin; and making an appropriation
therefor
PURPOSE:
To enable licensed facilitators to administer psilocybin-assisted thera-
py to those qualified patients as defined by this bill.
SUMMARY OF PROVISIONS:
§ 3369-aa: Definitions.
* Facilitator means a mental health counselor, psychoanalyst, physician,
physician assistant, registered professional nurse, clinical nurse
specialist, nurse practitioner, occupational therapist, occupational
therapy assistant, licensed clinical social worker, or an individual
with evidence of prior experience and knowledge in the field of psilocy-
bin assisted therapies.
§ 3369-bb: Lawful medical use.
* Psilocybin used by a patient shall have occurred in a clinical setting
including but not limited to, a facilitator's office or hospital, under
the supervision of a certified facilitator. Those patients unable to
travel may receive psilocybin treatment in the home.
§ 3369-cc: Certification of facilitators.
* A facilitator must complete a course as determined by the department
of health in 'regulation prior to facilitating a session.
§ 3369-dd: Evaluation;research programs;report by department.
* The department may enter into agreements with not-for-profit corpo-
rations, accredited NY universities or other organizations for the
performance evaluation of the effectiveness of this title.
* The department may develop or seek any necessary federal approval for,
and carry out research programs relating to medical use of psilocybin.
* The department shall report every two years, beginning two years after
the effective date of this title, to the governor and the legislature on
the medical use of psilocybin under this title and make appropriate
recommendations.
§ 3369-ee: Relation to other laws. *Medical psilocybin shall not be
deemed a "drug" for purposes of article one hundred thirty-seven of the
education law.
§ 3369-ff: Protections for the medical use of psilocybin.
* Patients and practitioners/facilitators shall not be subject to penal-
ty in any manner or denied any right solely for the certified medical
use of psilocybin.
* A person currently under parole, probation or other state or local
supervision, or released on bail awaiting trial may not be punished or
otherwise penalized for conduct allowed under this title.
* This subdivision shall not bar the enforcement of a policy prohibiting
an employee from performing his or her employment duties while impaired
by a controlled substance. This subdivision shall not require any person
or entity to do any act that would put that person/entity in direct
violation of federal law or cause it to lose a federal contract or fund-
ing.
* A person currently under parole, probation or other state or local
supervision, or released on bail awaiting trial may not be punished or
otherwise penalized for conduct allowed under this title.
§ 3699-gg: Regulations.
* Department will regulate.
§ 3699-hh: Psilocybin Assisted Therapy (P.A.T)grant program.
* Grant program shall provide veterans, first responders, retired first
responders, and low income individuals with the funding necessary to
receive psilocybin and/or MDMA assisted therapy.
* Grant program will expire upon approval of psilocybin and/or MDMA for
medical use by the federal drug enforcement administration or any
successor agency.
* The department shall promulgate any necessary rules and regulations
for the application and distribution of any funds pursuant to this
section.
§ 3699-ii: Naturally grown medical psilocybin pilot program. *The
department of agriculture and markets shall establish and oversee the
implementation of a pilot program for psilocybin to be grown in the
state to allow for reduced costs in accessing psilocybin for patients
via their facilitators.
§ 3699-jj: Psilocybin Assisted Therapy advisory board.
* advisory board shall consist of thirteen voting appointed members,
along with the following members serving as non-voting ex-officio
members: the commissioner, or his or her designee; and (ii) a represen-
tative from the department who is familiar with public health programs
and public health activities in the state. *The governor shall have
seven appointments, at least one appointment being a member of a feder-
ally recognized Native American tribe in NYS. The temporary president of
the senate and speaker of the assembly shall each have three appoint-
ments to the board.
* Appointed members shall have an expertise in public and behavioral
health, substance use disorder treatment, psilocybin-assisted therapy
research, MDMA-assisted therapy research and/or clinical practice, trau-
ma and mental health, access to care in underserved communities, veteran
mental health, and harm reduction.
* The advisory board is expected to work with established religious,
cultural and community-based psilocybin groups and cultivators on recom-
mendations to the department regarding guidelines for safe and effective
services, safety standards, industry best practices, code of profes-
sional conduct, education, training, and examination for facilitators,
production, and long term strategic plans for service.
* Within the first two years of the establishment of the advisory board,
the board shall meet at least once every calendar month at a time and
place determined by the chairperson or a majority of the voting members
of the board. After the first two years, the advisory board shall meet
at least once every calendar quarter at a time and place determined by
the chairperson or a majority of the voting members of the board. The
advisory board may also meet at other times and places specified by the
call of the chairperson or of a majority of the voting 13 members of the
board.
* After the first year of program implementation, there must be a
program audit incorporating patient feedback, and a state and independ-
ent review of efficacy, efficiency, cost, and equity. The audit will
include consideration of whether and how to expand psilocybin access,
provided that the pilot program results are successful.
§ 9 7 -uuuu
* To establish a "Psilocybin Assisted Therapy (P.A.T.)" fund in the
joint custody of the commissioner of health and the comptroller.
* The sum of five million dollars ($5,000,000) or so much thereof as may
be necessary
JUSTIFICATION:
Struggles with mental health ailments like PTSD, depression, .anxiety,
and substance abuse disorder are often a major disruptor to a person's
livelihood. These ailments can deteriorate physical health, result in
performance deficits on tasks, and increase rates of suicide. Psilocybin
assisted therapies have been called a "breakthrough therapy" by the FDA
for providing people facing these mental ailments unbelievable response
rates and even high remission rates.
Certain populations have an increased prevalence of these health disrup-
tors. Data from the RAND Corporation show that 8,000 New York veterans
from the Wars in Iraq and Afghanistan suffer from PTSD. Firefighters,
police officers, and EMS workers have a higher prevalence of depression,
PTSD, and substance abuse than the general population. Beyond occupa-
tional hazards, a 2020 study in Science finds that people with low
incomes are three times as likely to have depression and anxiety. 1 in
5 New Yorkers suffer from symptoms but do not obtain care in programs
operated, funded, or regulated by the State but instead suffer in
silence or seek private therapy that is often out of network and cost
prohibitive. Establishing an accessible, widespread pathway to provide
New Yorkers with a medical treatment that yields immediate and signif-
icant results would be a monumental step forward in the mental health
crisis our state is facing. Oregon, Colorado, Texas, Washington and
several other states and cities across the U.S. have taken similar
steps in increasing access to psilocybin treatment.
Beyond enabling the use of this treatment, this legislation would also
create a fund for veterans, active and retired first responders, and
low-income individuals who can apply for financial support towards this
life changing treatment. This treatment gives a promising alternative to
a crisis that is only being exacerbated in today's society. As a State,
it is our duty to use every tool at our disposal to alleviate that
suffering for New Yorkers.
PRIOR LEGISLATIVE HISTORY:
2021: A8569 referred to health
2022: A8569a recommit to health
FISCAL IMPLICATIONS:
Unknown.
EFFECTIVE DATE:
Immediately.
STATE OF NEW YORK
________________________________________________________________________
3581
2023-2024 Regular Sessions
IN ASSEMBLY
February 3, 2023
___________
Introduced by M. of A. BURKE, LUPARDO, KELLES, DARLING, SIMON, FORREST,
ZEBROWSKI, REYES, GONZALEZ-ROJAS, RIVERA -- read once and referred to
the Committee on Health
AN ACT to amend the public health law and the state finance law, in
relation to medical use of psilocybin; 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. Article 33 of the public health law is amended by adding a
2 new title 5-B to read as follows:
3 TITLE V-B
4 MEDICAL USE OF PSILOCYBIN
5 Section 3369-aa. Definitions.
6 3369-bb. Lawful medical use.
7 3369-cc. Certification of facilitators.
8 3369-dd. Evaluation; research programs; report by department.
9 3369-ee. Relation to other laws.
10 3369-ff. Protections for the medical use of psilocybin.
11 3369-gg. Regulations.
12 3369-hh. Psilocybin assisted therapy grant program.
13 3369-ii. Naturally grown medical psilocybin pilot.
14 3369-jj. Psilocybin assisted therapy advisory board.
15 § 3369-aa. Definitions. For the purposes of this title, the following
16 terms shall have the following meanings:
17 1. "Psilocybin" means a naturally occurring psychedelic prodrug
18 compound produced by fungi, including but not limited to members of the
19 genus Psilocybe. Such term shall include psilocin, the substance into
20 which psilocybin is converted in the human body.
21 2. "Caring for" means treating a patient, in the course of which the
22 practitioner has completed a full assessment of the patient's medical
23 history and current medical condition.
24 3. "Certified medical use" includes use of medical psilocybin for a
25 patient to treat or alleviate a patient's medical condition or symptoms
26 associated with the patient's medical condition.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD07859-01-3
A. 3581 2
1 4. "License" means a written authorization as provided under this
2 title permitting persons to engage in a specified activity authorized
3 pursuant to this title.
4 5. "Licensee" means an individual or an entity who has been granted a
5 license under this title.
6 6. "Medical psilocybin" means psilocybin intended for a certified
7 medical use, as determined by the department.
8 7. "Facilitator" means a mental health counselor, psychoanalyst,
9 physician, physician assistant, registered professional nurse, clinical
10 nurse specialist, nurse practitioner, occupational therapist, occupa-
11 tional therapy assistant, licensed clinical social worker, or an indi-
12 vidual with evidence of prior experience and knowledge in the field of
13 psychedelic assisted therapy who has completed all requirements under
14 section thirty-three hundred sixty-nine-cc of this title.
15 § 3369-bb. Lawful medical use. The use of medical psilocybin by a
16 patient for certified medical use, shall be lawful under this title
17 provided that:
18 1. The psilocybin used by a patient shall have occurred in a clinical
19 setting, including but not limited to, a facilitator's office or a
20 hospital, under the supervision of a facilitator certified pursuant to
21 section thirty-three hundred sixty-nine-cc of this title. Patients who
22 are unable to travel may receive psilocybin treatment in the home. The
23 course developed to certify facilitators by the department shall include
24 regulations and recommendations for creating appropriate settings for
25 psilocybin treatment;
26 2. Facilitators shall receive psilocybin to use through the naturally
27 grown medical psilocybin pilot, pursuant to section thirty-three hundred
28 sixty-nine-ii of this title. Facilitators who are able to access any
29 forthcoming Federal Food and Drug Administration approved synthetic
30 psilocybin products or MDMA shall be permitted to do so.
31 § 3369-cc. Certification of facilitators. Prior to facilitating a
32 psilocybin session, a facilitator shall complete a course as determined
33 by the department in regulation.
34 § 3369-dd. Evaluation; research programs; report by department. 1.
35 The department may provide for the analysis and evaluation of the opera-
36 tion of this title. The department may enter into agreements with one or
37 more persons, not-for-profit corporations, universities or other organ-
38 izations, for the performance of an evaluation of the implementation and
39 effectiveness of this title.
40 2. The department may develop, seek any necessary federal approval
41 for, and carry out research programs relating to medical use of psilocy-
42 bin. Participation in any such research program shall be voluntary on
43 the part of facilitators, patients, and designated caregivers.
44 3. The department shall report every two years, beginning two years
45 after the effective date of this title, to the governor and the legisla-
46 ture on the medical use of psilocybin under this title and make appro-
47 priate recommendations.
48 § 3369-ee. Relation to other laws. 1. The provisions of this title
49 shall apply, except that where a provision of this title conflicts with
50 another provision of this chapter, this title shall apply.
51 2. For the purposes of this title, medical psilocybin shall not be
52 deemed to be a "drug" for purposes of article one hundred thirty-seven
53 of the education law.
54 § 3369-ff. Protections for the medical use of psilocybin. 1. Patients
55 and practitioners and facilitators shall not be subject to arrest, pros-
56 ecution, or penalty in any manner, or denied any right or privilege,
A. 3581 3
1 including but not limited to civil penalty or disciplinary action by a
2 business or occupational or professional licensing board or bureau,
3 solely for the certified medical use of psilocybin or for any other
4 action or conduct in accordance with this title.
5 2. This subdivision shall not bar the enforcement of a policy prohib-
6 iting an employee from performing his or her employment duties while
7 impaired by a controlled substance. This subdivision shall not require
8 any person or entity to do any act that would put the person or entity
9 in direct violation of federal law or cause it to lose a federal
10 contract or funding.
11 3. The fact that a person is a patient and/or acting in accordance
12 with this title, shall not be a consideration in a proceeding pursuant
13 to applicable sections of the domestic relations law, the social
14 services law and the family court act.
15 4. (a) Certification forms and any patient information contained with-
16 in a database shall be deemed exempt from public disclosure under
17 sections eighty-seven and eighty-nine of the public officers law. Upon
18 specific request by a patient to the department, the department shall
19 verify the requesting patient's status as a valid patient to the
20 patient's school or employer or other designated party, to ensure
21 compliance with the protections afforded by this section.
22 (b) The name, contact information, and other information relating to
23 facilitators registered with the department under this title shall be
24 public information and shall be maintained on the department's website
25 accessible to the public in searchable form. However, if a facilitator
26 notifies the department in writing that he or she does not want his or
27 her name and other information disclosed, that facilitator's name and
28 other information shall thereafter not be public information or main-
29 tained on the department's website, unless the facilitator cancels the
30 request.
31 5. A person currently under parole, probation or other state or local
32 supervision, or released on bail awaiting trial may not be punished or
33 otherwise penalized for conduct allowed under this title.
34 § 3369-gg. Regulations. The department shall promulgate regulations to
35 implement this title.
36 § 3369-hh. Psilocybin assisted therapy grant program. 1. The depart-
37 ment shall establish a psilocybin assisted therapy grant program within
38 the amount in the psilocybin and MDMA assisted therapy grant program
39 fund established under section ninety-seven-uuuu of the state finance
40 law. Such grant program shall provide veterans, first responders,
41 retired first responders, and low-income individuals, with the funding
42 necessary to receive psilocybin and/or MDMA assisted therapy. Funding
43 may be initially applied toward an expanded access program approved by
44 the federal food and drug administration pursuant to 21 CFR 312 or other
45 psilocybin and/or MDMA therapies available pursuant to this title. Such
46 grant program shall be terminated upon the approval of psilocybin and/or
47 MDMA for medical use by the federal drug enforcement administration, or
48 any successor agency.
49 2. The department shall promulgate any necessary rules and regulations
50 for the application and distribution of any funds pursuant to this
51 section.
52 § 3369-ii. Naturally grown medical psilocybin pilot. The department of
53 agriculture and markets shall establish and oversee the implementation
54 of a pilot program for psilocybin-containing mushrooms to be grown in
55 the state. The department shall promulgate all necessary rules and
56 regulations, regarding medical, therapeutic, or supported use of
A. 3581 4
1 naturally grown psilocybin mushrooms. The department, in conjunction
2 with the department of environmental conservation, shall establish and
3 implement a process for approval, governing the safe production of
4 psilocybin, including, but not limited to, environmental and energy
5 standards and restrictions on the use of pesticides. The department
6 shall make a good faith effort to work with the federal Department of
7 Justice and Drug Enforcement Agency to receive public health research
8 exemption from the Controlled Substances Act under section 872 (e) or
9 any similar provision. Accredited universities and colleges within the
10 state may apply to the department to participate in pilot cultivation,
11 treatment, and research programs.
12 § 3369-jj. Psilocybin assisted therapy advisory board. 1. The psilocy-
13 bin assisted therapy advisory board or "advisory board" is established
14 within the department to advise and issue recommendations on the use of
15 medical psilocybin in the state of New York.
16 2. (a) The advisory board shall consist of thirteen voting appointed
17 members, along with the following members serving as non-voting ex-offi-
18 cio members: (i) the commissioner, or his or her designee; and (ii) a
19 representative from the department who is familiar with public health
20 programs and public health activities in the state.
21 (b) The governor shall have seven appointments, at least one of which
22 shall be a member of a federally recognized Native American tribe, the
23 temporary president of the senate and the speaker of the assembly shall
24 each have three appointments to the board. Advisory board members shall
25 have statewide geographic representation that is balanced and diverse in
26 its composition. Appointed members shall have an expertise in public and
27 behavioral health, substance use disorder treatment, psilocybin-assisted
28 therapy research, MDMA-assisted therapy research and/or clinical prac-
29 tice, trauma and mental health, access to care in underserved communi-
30 ties, veteran mental health care, and harm reduction.
31 3. The members shall be appointed to the advisory board to each serve
32 four-year terms and in the event of a vacancy, the vacancy shall be
33 filled in the manner of the original appointment for the remainder of
34 the term. The appointed members and representatives shall receive no
35 compensation for their services but shall be allowed their actual and
36 necessary expenses incurred in the performance of their duties as board
37 members.
38 4. The chairperson of the advisory board and the vice chairperson
39 shall be elected from among the members of the advisory board by the
40 members of such advisory board. The vice chairperson shall represent the
41 advisory board in the absence of the chairperson at all official advi-
42 sory board functions.
43 5. The advisory board shall enact and from time to time may amend
44 bylaws or rules in relation to its meetings and the transaction of its
45 business. The board may also establish committees and subcommittees
46 necessary for the operation of the board. The advisory board is
47 expected to work with established religious, cultural and community-
48 based psilocybin groups and cultivators on recommendations to the
49 department regarding guidelines for safe and effective services, safety
50 standards, industry best practices, code of professional conduct, educa-
51 tion, training, and examination for facilitators, production, and long
52 term strategic plans for service. A majority of the total number of
53 voting members which the board would have were there no vacancies, shall
54 constitute a quorum and shall be required for the board to conduct busi-
55 ness. All meetings of the advisory board shall be conducted in accord-
56 ance with the provisions of article seven of the public officers law.
A. 3581 5
1 6. (a) Within the first two years of the establishment of the advisory
2 board, the board shall meet at least once every calendar month at a time
3 and place determined by the chairperson or a majority of the voting
4 members of the board. After the first two years, the advisory board
5 shall meet at least once every calendar quarter at a time and place
6 determined by the chairperson or a majority of the voting members of the
7 board. The advisory board may also meet at other times and places speci-
8 fied by the call of the chairperson or of a majority of the voting
9 members of the board.
10 (b) After the first year of the program's implementation, there shall
11 be: (i) a program audit incorporating patient feedback; and (ii) a
12 state and independent review of efficacy, efficiency, cost, and equity.
13 The audit will include consideration of whether and how to expand psilo-
14 cybin access, provided that the pilot program results are successful.
15 7. The advisory board shall have the following duties:
16 (a) Provide advice to the department regarding the provisions of this
17 title and make recommendations on available medical, psychological,
18 scientific studies, research and other information relating to the safe-
19 ty and efficacy of psilocybin in treating mental health conditions,
20 including but not limited to addiction, depression, anxiety disorders
21 and end-of-life psychological distress.
22 (b) Make recommendations to the department on the requirements, spec-
23 ifications and guidelines for providing psilocybin services to a client.
24 (c) Make recommendations to the department on public health and safety
25 standards and industry best practices under this title.
26 (d) Develop a long-term strategic plan for ensuring that psilocybin
27 services will become and remain a safe, accessible and affordable thera-
28 peutic option for all persons eighteen years of age and older in the
29 state for whom psilocybin services may be appropriate.
30 (e) Monitor and study federal laws, regulations and policies regarding
31 psilocybin.
32 (f) Advise on and helping develop public awareness and education
33 campaigns.
34 § 2. The state finance law is amended by adding a new section 97-uuuu
35 to read as follows:
36 § 97-uuuu. Psilocybin and MDMA assisted therapy grant program fund. 1.
37 There is hereby established in the joint custody of the commissioner of
38 health and the comptroller a fund to be known as the "psilocybin and
39 MDMA assisted therapy grant program fund".
40 2. The fund shall consist of all monies appropriated for its purpose,
41 and all monies required by this section or any other provision of law to
42 be paid into or credited to such fund. The fund shall not contain any
43 monies which are not intended for the fund.
44 3. Monies shall be payable from the fund on the audit and warrant of
45 the state comptroller on vouchers approved and certified by the commis-
46 sioner of health.
47 § 3. The sum of five million dollars ($5,000,000), or so much thereof
48 as may be necessary, is hereby appropriated to the psilocybin and MDMA
49 assisted therapy or P.A.T grant program fund, established under section
50 97-uuuu of the state finance law, out of any moneys in the state treas-
51 ury in the general fund, not otherwise appropriated, and made immediate-
52 ly available, for the purpose of carrying out the provisions of this
53 act. Such moneys shall be payable on the audit and warrant of the comp-
54 troller on vouchers certified or approved by the commissioner of health
55 in the manner prescribed by law.
56 § 4. This act shall take effect immediately.
