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S03520 Summary:

BILL NOS03520A
 
SAME ASSAME AS A03581-A
 
SPONSORFERNANDEZ
 
COSPNSRSCARCELLA-SPANTON, COMRIE, JACKSON, MYRIE, SALAZAR
 
MLTSPNSR
 
Add Art 33 Title 5-B §§3369-aa - 3369-jj, Pub Health L; add §97-uuuu, St Fin L
 
Relates to medical use of psilocybin; establishes a psilocybin assisted therapy grant program; makes an appropriation therefor.
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S03520 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         3520--A
 
                               2023-2024 Regular Sessions
 
                    IN SENATE
 
                                    January 31, 2023
                                       ___________
 
        Introduced by Sens. FERNANDEZ, SCARCELLA-SPANTON, COMRIE, MYRIE, SALAZAR
          -- read twice and ordered printed, and when printed to be committed to
          the  Committee  on  Finance  --  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  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.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD07859-03-3

        S. 3520--A                          2
 
     1    2. "Caring for" means treating a patient, in the course of  which  the
     2  practitioner  has  completed  a full assessment of the patient's medical
     3  history and current medical condition.
     4    3.  "Certified  medical  use" includes use of medical psilocybin for a
     5  patient to treat or alleviate a patient's medical condition or  symptoms
     6  associated with the patient's medical condition.
     7    4.  "License"  means  a  written  authorization as provided under this
     8  title permitting persons to engage in a  specified  activity  authorized
     9  pursuant to this title.
    10    5.  "Licensee" means an individual or an entity who has been granted a
    11  license under this title.
    12    6. "Medical psilocybin" means  psilocybin  intended  for  a  certified
    13  medical use, as determined by the department.
    14    7.  "Facilitator"  means  a  mental  health  counselor, psychoanalyst,
    15  psychologist, physician, physician  assistant,  registered  professional
    16  nurse, clinical nurse specialist, nurse practitioner, occupational ther-
    17  apist,  occupational therapy assistant, licensed clinical social worker,
    18  or an individual with evidence of prior experience and knowledge in  the
    19  field of psychedelic assisted therapy who has completed all requirements
    20  under section thirty-three hundred sixty-nine-cc of this title.
    21    §  3369-bb.  Lawful  medical  use.  The use of medical psilocybin by a
    22  patient for certified medical use, shall  be  lawful  under  this  title
    23  provided that:
    24    1.  The psilocybin used by a patient shall have occurred in a clinical
    25  setting, including but not limited  to,  a  facilitator's  office  or  a
    26  hospital,  under  the supervision of a facilitator certified pursuant to
    27  section thirty-three hundred sixty-nine-cc of this title.  Patients  who
    28  are  unable  to travel may receive psilocybin treatment in the home. The
    29  course developed to certify facilitators by the department shall include
    30  regulations and recommendations for creating  appropriate  settings  for
    31  psilocybin treatment;
    32    2.  Facilitators shall receive psilocybin to use through the naturally
    33  grown medical psilocybin pilot, pursuant to section thirty-three hundred
    34  sixty-nine-ii  of  this title.   Facilitators who are able to access any
    35  forthcoming Federal Food  and  Drug  Administration  approved  synthetic
    36  psilocybin products or MDMA shall be permitted to do so.
    37    §  3369-cc.    Certification of facilitators.  Prior to facilitating a
    38  psilocybin session, a facilitator shall complete a course as  determined
    39  by the department in regulation.
    40    §  3369-dd.  Evaluation;  research programs; report by department.  1.
    41  The department may provide for the analysis and evaluation of the opera-
    42  tion of this title. The department may enter into agreements with one or
    43  more persons, not-for-profit corporations, universities or other  organ-
    44  izations, for the performance of an evaluation of the implementation and
    45  effectiveness of this title.
    46    2.  The  department  may  develop, seek any necessary federal approval
    47  for, and carry out research programs relating to medical use of psilocy-
    48  bin.  Participation in any such research program shall be  voluntary  on
    49  the part of facilitators, patients, and designated caregivers.
    50    3.  The  department  shall report every two years, beginning two years
    51  after the effective date of this title, to the governor and the legisla-
    52  ture on the medical use of psilocybin under this title and  make  appro-
    53  priate recommendations.
    54    §  3369-ee.  Relation  to  other laws. 1. The provisions of this title
    55  shall apply, except that where a provision of this title conflicts  with
    56  another provision of this chapter, this title shall apply.

        S. 3520--A                          3
 
     1    2.  For  the  purposes  of this title, medical psilocybin shall not be
     2  deemed to be a "drug" for purposes of article one  hundred  thirty-seven
     3  of the education law.
     4    § 3369-ff. Protections for the medical use of psilocybin.  1. Patients
     5  and practitioners and facilitators shall not be subject to arrest, pros-
     6  ecution,  or  penalty  in  any manner, or denied any right or privilege,
     7  including but not limited to civil penalty or disciplinary action  by  a
     8  business  or  occupational  or  professional  licensing board or bureau,
     9  solely for the certified medical use of  psilocybin  or  for  any  other
    10  action or conduct in accordance with this title.
    11    2.  This subdivision shall not bar the enforcement of a policy prohib-
    12  iting an employee from performing his or  her  employment  duties  while
    13  impaired  by  a controlled substance. This subdivision shall not require
    14  any person or entity to do any act that would put the person  or  entity
    15  in  direct  violation  of  federal  law  or  cause  it to lose a federal
    16  contract or funding.
    17    3. The fact that a person is a patient  and/or  acting  in  accordance
    18  with  this  title, shall not be a consideration in a proceeding pursuant
    19  to applicable  sections  of  the  domestic  relations  law,  the  social
    20  services law and the family court act.
    21    4. (a) Certification forms and any patient information contained with-
    22  in  a  database  shall  be  deemed  exempt  from public disclosure under
    23  sections eighty-seven and eighty-nine of the public officers  law.  Upon
    24  specific  request  by  a patient to the department, the department shall
    25  verify the requesting  patient's  status  as  a  valid  patient  to  the
    26  patient's  school  or  employer  or  other  designated  party, to ensure
    27  compliance with the protections afforded by this section.
    28    (b) The name, contact information, and other information  relating  to
    29  facilitators  registered  with  the department under this title shall be
    30  public information and shall be maintained on the  department's  website
    31  accessible  to the public in searchable form.  However, if a facilitator
    32  notifies the department in writing that he or she does not want  his  or
    33  her  name  and  other information disclosed, that facilitator's name and
    34  other information shall thereafter not be public  information  or  main-
    35  tained  on  the department's website, unless the facilitator cancels the
    36  request.
    37    5. A person currently under parole, probation or other state or  local
    38  supervision,  or  released on bail awaiting trial may not be punished or
    39  otherwise penalized for conduct allowed under this title.
    40    § 3369-gg. Regulations. The department shall promulgate regulations to
    41  implement this title.
    42    § 3369-hh. Psilocybin assisted therapy grant program. 1.  The  depart-
    43  ment  shall establish a psilocybin assisted therapy grant program within
    44  the amount in the psilocybin and MDMA  assisted  therapy  grant  program
    45  fund  established  under  section ninety-seven-uuuu of the state finance
    46  law. Such  grant  program  shall  provide  veterans,  first  responders,
    47  retired  first  responders, and low-income individuals, with the funding
    48  necessary to receive psilocybin and/or MDMA  assisted  therapy.  Funding
    49  may  be  initially applied toward an expanded access program approved by
    50  the federal food and drug administration pursuant to 21 CFR 312 or other
    51  psilocybin and/or MDMA therapies available pursuant to this title.  Such
    52  grant program shall be terminated upon the approval of psilocybin and/or
    53  MDMA for medical use by the federal drug enforcement administration,  or
    54  any successor agency.

        S. 3520--A                          4
 
     1    2. The department shall promulgate any necessary rules and regulations
     2  for  the  application  and  distribution  of  any funds pursuant to this
     3  section.
     4    § 3369-ii. Naturally grown medical psilocybin pilot. The department of
     5  agriculture  and  markets shall establish and oversee the implementation
     6  of a pilot program for psilocybin-containing mushrooms to  be  grown  in
     7  the  state.    The  department  shall promulgate all necessary rules and
     8  regulations,  regarding  medical,  therapeutic,  or  supported  use   of
     9  naturally  grown  psilocybin  mushrooms.  The department, in conjunction
    10  with the department of environmental conservation, shall  establish  and
    11  implement  a  process  for  approval,  governing  the safe production of
    12  psilocybin, including, but not  limited  to,  environmental  and  energy
    13  standards  and  restrictions  on  the use of pesticides.  The department
    14  shall make a good faith effort to work with the  federal  Department  of
    15  Justice  and  Drug  Enforcement Agency to receive public health research
    16  exemption from the Controlled Substances Act under section  872  (e)  or
    17  any  similar  provision. Accredited universities and colleges within the
    18  state may apply to the department to participate in  pilot  cultivation,
    19  treatment, and research programs.
    20    § 3369-jj. Psilocybin assisted therapy advisory board. 1. The psilocy-
    21  bin  assisted  therapy advisory board or "advisory board" is established
    22  within the department to advise and issue recommendations on the use  of
    23  medical psilocybin in the state of New York.
    24    2.  (a)  The advisory board shall consist of thirteen voting appointed
    25  members, along with the following members serving as non-voting ex-offi-
    26  cio members: (i) the commissioner, or his or her designee;  and  (ii)  a
    27  representative  from  the  department who is familiar with public health
    28  programs and public health activities in the state.
    29    (b) The governor shall have seven appointments, at least one of  which
    30  shall  be  a member of a federally recognized Native American tribe, the
    31  temporary president of the senate and the speaker of the assembly  shall
    32  each  have three appointments to the board. Advisory board members shall
    33  have statewide geographic representation that is balanced and diverse in
    34  its composition. Appointed members shall have an expertise in public and
    35  behavioral health, substance use disorder treatment, psilocybin-assisted
    36  therapy research, MDMA-assisted therapy research and/or  clinical  prac-
    37  tice,  trauma  and mental health, access to care in underserved communi-
    38  ties, veteran mental health care, and harm reduction.
    39    3. The members shall be appointed to the advisory board to each  serve
    40  four-year  terms  and  in  the  event of a vacancy, the vacancy shall be
    41  filled in the manner of the original appointment for  the  remainder  of
    42  the  term.  The  appointed  members and representatives shall receive no
    43  compensation for their services but shall be allowed  their  actual  and
    44  necessary  expenses incurred in the performance of their duties as board
    45  members.
    46    4. The chairperson of the advisory  board  and  the  vice  chairperson
    47  shall  be  elected  from  among the members of the advisory board by the
    48  members of such advisory board. The vice chairperson shall represent the
    49  advisory board in the absence of the chairperson at all  official  advi-
    50  sory board functions.
    51    5.  The  advisory  board  shall  enact and from time to time may amend
    52  bylaws or rules in relation to its meetings and the transaction  of  its
    53  business.  The  board  may  also  establish committees and subcommittees
    54  necessary for the operation  of  the  board.    The  advisory  board  is
    55  expected  to  work  with  established religious, cultural and community-
    56  based psilocybin  groups  and  cultivators  on  recommendations  to  the

        S. 3520--A                          5
 
     1  department  regarding guidelines for safe and effective services, safety
     2  standards, industry best practices, code of professional conduct, educa-
     3  tion, training, and examination for facilitators, production,  and  long
     4  term  strategic  plans  for service.   A majority of the total number of
     5  voting members which the board would have were there no vacancies, shall
     6  constitute a quorum and shall be required for the board to conduct busi-
     7  ness. All meetings of the advisory board shall be conducted  in  accord-
     8  ance with the provisions of article seven of the public officers law.
     9    6. (a) Within the first two years of the establishment of the advisory
    10  board, the board shall meet at least once every calendar month at a time
    11  and  place  determined  by  the  chairperson or a majority of the voting
    12  members of the board. After the first  two  years,  the  advisory  board
    13  shall  meet  at  least  once  every calendar quarter at a time and place
    14  determined by the chairperson or a majority of the voting members of the
    15  board. The advisory board may also meet at other times and places speci-
    16  fied by the call of the chairperson or  of  a  majority  of  the  voting
    17  members of the board.
    18    (b)  After the first year of the program's implementation, there shall
    19  be:  (i) a program audit incorporating  patient  feedback;  and  (ii)  a
    20  state  and independent review of efficacy, efficiency, cost, and equity.
    21  The audit will include consideration of whether and how to expand psilo-
    22  cybin access, provided that the pilot program results are successful.
    23    7. The advisory board shall have the following duties:
    24    (a) Provide advice to the department regarding the provisions of  this
    25  title  and  make  recommendations  on  available medical, psychological,
    26  scientific studies, research and other information relating to the safe-
    27  ty and efficacy of psilocybin  in  treating  mental  health  conditions,
    28  including  but  not  limited to addiction, depression, anxiety disorders
    29  and end-of-life psychological distress.
    30    (b) Make recommendations to the department on the requirements,  spec-
    31  ifications and guidelines for providing psilocybin services to a client.
    32    (c) Make recommendations to the department on public health and safety
    33  standards and industry best practices under this title.
    34    (d)  Develop  a  long-term strategic plan for ensuring that psilocybin
    35  services will become and remain a safe, accessible and affordable thera-
    36  peutic option for all persons eighteen years of age  and  older  in  the
    37  state for whom psilocybin services may be appropriate.
    38    (e) Monitor and study federal laws, regulations and policies regarding
    39  psilocybin.
    40    (f)  Advise  on  and  helping  develop  public awareness and education
    41  campaigns.
    42    § 2. The state finance law is amended by adding a new section  97-uuuu
    43  to read as follows:
    44    § 97-uuuu. Psilocybin and MDMA assisted therapy grant program fund. 1.
    45  There  is hereby established in the joint custody of the commissioner of
    46  health and the comptroller a fund to be known  as  the  "psilocybin  and
    47  MDMA assisted therapy grant program fund".
    48    2.  The fund shall consist of all monies appropriated for its purpose,
    49  and all monies required by this section or any other provision of law to
    50  be paid into or credited to such fund. The fund shall  not  contain  any
    51  monies which are not intended for the fund.
    52    3.  Monies  shall be payable from the fund on the audit and warrant of
    53  the state comptroller on vouchers approved and certified by the  commis-
    54  sioner of health.
    55    §  3. The sum of five million dollars ($5,000,000), or so much thereof
    56  as may be necessary, is hereby appropriated to the psilocybin  and  MDMA

        S. 3520--A                          6
 
     1  assisted  therapy or P.A.T grant program fund, established under section
     2  97-uuuu of the state finance law, out of any moneys in the state  treas-
     3  ury in the general fund, not otherwise appropriated, and made immediate-
     4  ly  available,  for  the  purpose of carrying out the provisions of this
     5  act. Such moneys shall be payable on the audit and warrant of the  comp-
     6  troller  on vouchers certified or approved by the commissioner of health
     7  in the manner prescribed by law.
     8    § 4. This act shall take effect immediately.
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