Bill Text: NY A03581 | 2023-2024 | General Assembly | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Relates to medical use of psilocybin; establishes a psilocybin assisted therapy grant program; makes an appropriation therefor.
Spectrum: Strong Partisan Bill (Democrat 37-4)
Status: (Introduced) 2024-01-03 - referred to health [A03581 Detail]
Download: New_York-2023-A03581-Introduced.html
Bill Title: Relates to medical use of psilocybin; establishes a psilocybin assisted therapy grant program; makes an appropriation therefor.
Spectrum: Strong Partisan Bill (Democrat 37-4)
Status: (Introduced) 2024-01-03 - referred to health [A03581 Detail]
Download: New_York-2023-A03581-Introduced.html
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. LBD07859-01-3A. 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 ofA. 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.
