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A03581 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A3581A
 
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 OR GENERAL IDEA OF BILL: 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 ther- apist, occupational therapy assistant, licensed clinical social worker, or an individual with evidence of prior experience and knowledge in the field of psilocybin 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: Certif- ication of facilitators.* A facilitator must complete a course as deter- mined by the department of health in 'regulation prior to facilitating a session.§ 33.69-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 depart- ment 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 recom- mendations.§ 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 penalty 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 enforce- ment of a policy prohibiting an employee from performing his or her employment duties while impaired by a controlled substance. This subdi- vision 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 funding.* 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 depart- ment of agriculture and markets shall establish and oversee the imple- mentation 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 representative 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 federally recognized Native American tribe in NYS. The temporary president of the senate and speaker of the assembly shall each have three appointments 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 recommendations to the department regarding guidelines for safe and effective services, safety standards, industry best practices, code of professional 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 implementa- tion, there must be a program audit incorporating patient feedback, and a state and independent review of efficacy, efficiency, cost, and equi- ty. The audit will include consideration of whether and how to expand psilocybin access, provided that the pilot program results are success- ful.§ 9 7uuuu* To establish a "Psilocybin Assisted Therapy (P.A.T.)" fund in the joint custody of the commissioner of health and the comp- troller.* The sum of five million dollars ($5,000,000) or so much there- of as may be necessary.   DIFFERENCE BETWEEN ORIGINAL AND AMENDED VERSION (IF APPLICABLE): This amendment adds'"psychologist" to the list of accepted clinical facilitators.   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. Psilocy- bin 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 FOR STATE AND LOCAL GOVERNMENTS:   EFFECTIVE DATE:
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A03581 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         3581--A
 
                               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, DICKENS, WALLACE, SEAWRIGHT,
          McDONALD, BRONSON, STIRPE, CLARK, CRUZ, FALL,  HEVESI,  CONRAD,  McDO-
          NOUGH,  DeSTEFANO,  MAMDANI,  BURDICK, GLICK, PAULIN, BENDETT, SAYEGH,
          MITAYNES, BORES, GIBBS, BLUMENCRANZ, BURGOS,  EPSTEIN,  DE LOS SANTOS,
          WEPRIN,  SANTABARBARA, SHRESTHA, RAGA -- 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 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
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD07859-02-3

        A. 3581--A                          2
 
     1  genus Psilocybe.  Such term shall include psilocin, the  substance  into
     2  which psilocybin is converted in the human body.
     3    2.  "Caring  for" means treating a patient, in the course of which the
     4  practitioner has completed a full assessment of  the  patient's  medical
     5  history and current medical condition.
     6    3.  "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    4.  "License"  means  a  written  authorization as provided under this
    10  title permitting persons to engage in a  specified  activity  authorized
    11  pursuant to this title.
    12    5.  "Licensee" means an individual or an entity who has been granted a
    13  license under this title.
    14    6. "Medical psilocybin" means  psilocybin  intended  for  a  certified
    15  medical use, as determined by the department.
    16    7.  "Facilitator"  means  a  mental  health  counselor, psychoanalyst,
    17  psychologist, physician, physician  assistant,  registered  professional
    18  nurse, clinical nurse specialist, nurse practitioner, occupational ther-
    19  apist,  occupational therapy assistant, licensed clinical social worker,
    20  or an individual with evidence of prior experience and knowledge in  the
    21  field of psychedelic assisted therapy who has completed all requirements
    22  under section thirty-three hundred sixty-nine-cc of this title.
    23    §  3369-bb.  Lawful  medical  use.  The use of medical psilocybin by a
    24  patient for certified medical use, shall  be  lawful  under  this  title
    25  provided that:
    26    1.  The psilocybin used by a patient shall have occurred in a clinical
    27  setting, including but not limited  to,  a  facilitator's  office  or  a
    28  hospital,  under  the supervision of a facilitator certified pursuant to
    29  section thirty-three hundred sixty-nine-cc of this title.  Patients  who
    30  are  unable  to travel may receive psilocybin treatment in the home. The
    31  course developed to certify facilitators by the department shall include
    32  regulations and recommendations for creating  appropriate  settings  for
    33  psilocybin treatment;
    34    2.  Facilitators shall receive psilocybin to use through the naturally
    35  grown medical psilocybin pilot, pursuant to section thirty-three hundred
    36  sixty-nine-ii  of  this title.   Facilitators who are able to access any
    37  forthcoming Federal Food  and  Drug  Administration  approved  synthetic
    38  psilocybin products or MDMA shall be permitted to do so.
    39    §  3369-cc.    Certification of facilitators.  Prior to facilitating a
    40  psilocybin session, a facilitator shall complete a course as  determined
    41  by the department in regulation.
    42    §  3369-dd.  Evaluation;  research programs; report by department.  1.
    43  The department may provide for the analysis and evaluation of the opera-
    44  tion of this title. The department may enter into agreements with one or
    45  more persons, not-for-profit corporations, universities or other  organ-
    46  izations, for the performance of an evaluation of the implementation and
    47  effectiveness of this title.
    48    2.  The  department  may  develop, seek any necessary federal approval
    49  for, and carry out research programs relating to medical use of psilocy-
    50  bin.  Participation in any such research program shall be  voluntary  on
    51  the part of facilitators, patients, and designated caregivers.
    52    3.  The  department  shall report every two years, beginning two years
    53  after the effective date of this title, to the governor and the legisla-
    54  ture on the medical use of psilocybin under this title and  make  appro-
    55  priate recommendations.

        A. 3581--A                          3
 
     1    §  3369-ee.  Relation  to  other laws. 1. The provisions of this title
     2  shall apply, except that where a provision of this title conflicts  with
     3  another provision of this chapter, this title shall apply.
     4    2.  For  the  purposes  of this title, medical psilocybin shall not be
     5  deemed to be a "drug" for purposes of article one  hundred  thirty-seven
     6  of the education law.
     7    § 3369-ff. Protections for the medical use of psilocybin.  1. Patients
     8  and practitioners and facilitators shall not be subject to arrest, pros-
     9  ecution,  or  penalty  in  any manner, or denied any right or privilege,
    10  including but not limited to civil penalty or disciplinary action  by  a
    11  business  or  occupational  or  professional  licensing board or bureau,
    12  solely for the certified medical use of  psilocybin  or  for  any  other
    13  action or conduct in accordance with this title.
    14    2.  This subdivision shall not bar the enforcement of a policy prohib-
    15  iting an employee from performing his or  her  employment  duties  while
    16  impaired  by  a controlled substance. This subdivision shall not require
    17  any person or entity to do any act that would put the person  or  entity
    18  in  direct  violation  of  federal  law  or  cause  it to lose a federal
    19  contract or funding.
    20    3. The fact that a person is a patient  and/or  acting  in  accordance
    21  with  this  title, shall not be a consideration in a proceeding pursuant
    22  to applicable  sections  of  the  domestic  relations  law,  the  social
    23  services law and the family court act.
    24    4. (a) Certification forms and any patient information contained with-
    25  in  a  database  shall  be  deemed  exempt  from public disclosure under
    26  sections eighty-seven and eighty-nine of the public officers  law.  Upon
    27  specific  request  by  a patient to the department, the department shall
    28  verify the requesting  patient's  status  as  a  valid  patient  to  the
    29  patient's  school  or  employer  or  other  designated  party, to ensure
    30  compliance with the protections afforded by this section.
    31    (b) The name, contact information, and other information  relating  to
    32  facilitators  registered  with  the department under this title shall be
    33  public information and shall be maintained on the  department's  website
    34  accessible  to the public in searchable form.  However, if a facilitator
    35  notifies the department in writing that he or she does not want  his  or
    36  her  name  and  other information disclosed, that facilitator's name and
    37  other information shall thereafter not be public  information  or  main-
    38  tained  on  the department's website, unless the facilitator cancels the
    39  request.
    40    5. A person currently under parole, probation or other state or  local
    41  supervision,  or  released on bail awaiting trial may not be punished or
    42  otherwise penalized for conduct allowed under this title.
    43    § 3369-gg. Regulations. The department shall promulgate regulations to
    44  implement this title.
    45    § 3369-hh. Psilocybin assisted therapy grant program. 1.  The  depart-
    46  ment  shall establish a psilocybin assisted therapy grant program within
    47  the amount in the psilocybin and MDMA  assisted  therapy  grant  program
    48  fund  established  under  section ninety-seven-uuuu of the state finance
    49  law. Such  grant  program  shall  provide  veterans,  first  responders,
    50  retired  first  responders, and low-income individuals, with the funding
    51  necessary to receive psilocybin and/or MDMA  assisted  therapy.  Funding
    52  may  be  initially applied toward an expanded access program approved by
    53  the federal food and drug administration pursuant to 21 CFR 312 or other
    54  psilocybin and/or MDMA therapies available pursuant to this title.  Such
    55  grant program shall be terminated upon the approval of psilocybin and/or

        A. 3581--A                          4
 
     1  MDMA for medical use by the federal drug enforcement administration,  or
     2  any successor agency.
     3    2. The department shall promulgate any necessary rules and regulations
     4  for  the  application  and  distribution  of  any funds pursuant to this
     5  section.
     6    § 3369-ii. Naturally grown medical psilocybin pilot. The department of
     7  agriculture and markets shall establish and oversee  the  implementation
     8  of  a  pilot  program for psilocybin-containing mushrooms to be grown in
     9  the state.   The department shall promulgate  all  necessary  rules  and
    10  regulations,   regarding  medical,  therapeutic,  or  supported  use  of
    11  naturally grown psilocybin mushrooms.  The  department,  in  conjunction
    12  with  the  department of environmental conservation, shall establish and
    13  implement a process for  approval,  governing  the  safe  production  of
    14  psilocybin,  including,  but  not  limited  to, environmental and energy
    15  standards and restrictions on the use of  pesticides.    The  department
    16  shall  make  a  good faith effort to work with the federal Department of
    17  Justice and Drug Enforcement Agency to receive  public  health  research
    18  exemption  from  the  Controlled Substances Act under section 872 (e) or
    19  any similar provision. Accredited universities and colleges  within  the
    20  state  may  apply to the department to participate in pilot cultivation,
    21  treatment, and research programs.
    22    § 3369-jj. Psilocybin assisted therapy advisory board. 1. The psilocy-
    23  bin assisted therapy advisory board or "advisory board"  is  established
    24  within  the department to advise and issue recommendations on the use of
    25  medical psilocybin in the state of New York.
    26    2. (a) The advisory board shall consist of thirteen  voting  appointed
    27  members, along with the following members serving as non-voting ex-offi-
    28  cio  members:  (i)  the commissioner, or his or her designee; and (ii) a
    29  representative from the department who is familiar  with  public  health
    30  programs and public health activities in the state.
    31    (b)  The governor shall have seven appointments, at least one of which
    32  shall be a member of a federally recognized Native American  tribe,  the
    33  temporary  president of the senate and the speaker of the assembly shall
    34  each have three appointments to the board. Advisory board members  shall
    35  have statewide geographic representation that is balanced and diverse in
    36  its composition. Appointed members shall have an expertise in public and
    37  behavioral health, substance use disorder treatment, psilocybin-assisted
    38  therapy  research,  MDMA-assisted therapy research and/or clinical prac-
    39  tice, trauma and mental health, access to care in  underserved  communi-
    40  ties, veteran mental health care, and harm reduction.
    41    3.  The members shall be appointed to the advisory board to each serve
    42  four-year terms and in the event of a  vacancy,  the  vacancy  shall  be
    43  filled  in  the  manner of the original appointment for the remainder of
    44  the term. The appointed members and  representatives  shall  receive  no
    45  compensation  for  their  services but shall be allowed their actual and
    46  necessary expenses incurred in the performance of their duties as  board
    47  members.
    48    4.  The  chairperson  of  the  advisory board and the vice chairperson
    49  shall be elected from among the members of the  advisory  board  by  the
    50  members of such advisory board. The vice chairperson shall represent the
    51  advisory  board  in the absence of the chairperson at all official advi-
    52  sory board functions.
    53    5. The advisory board shall enact and from  time  to  time  may  amend
    54  bylaws  or  rules in relation to its meetings and the transaction of its
    55  business. The board may  also  establish  committees  and  subcommittees
    56  necessary  for  the  operation  of  the  board.    The advisory board is

        A. 3581--A                          5
 
     1  expected to work with established  religious,  cultural  and  community-
     2  based  psilocybin  groups  and  cultivators  on  recommendations  to the
     3  department regarding guidelines for safe and effective services,  safety
     4  standards, industry best practices, code of professional conduct, educa-
     5  tion,  training,  and examination for facilitators, production, and long
     6  term strategic plans for service.   A majority of the  total  number  of
     7  voting members which the board would have were there no vacancies, shall
     8  constitute a quorum and shall be required for the board to conduct busi-
     9  ness.  All  meetings of the advisory board shall be conducted in accord-
    10  ance with the provisions of article seven of the public officers law.
    11    6. (a) Within the first two years of the establishment of the advisory
    12  board, the board shall meet at least once every calendar month at a time
    13  and place determined by the chairperson or  a  majority  of  the  voting
    14  members  of  the  board.  After  the first two years, the advisory board
    15  shall meet at least once every calendar quarter  at  a  time  and  place
    16  determined by the chairperson or a majority of the voting members of the
    17  board. The advisory board may also meet at other times and places speci-
    18  fied  by  the  call  of  the  chairperson or of a majority of the voting
    19  members of the board.
    20    (b) After the first year of the program's implementation, there  shall
    21  be:    (i)  a  program  audit incorporating patient feedback; and (ii) a
    22  state and independent review of efficacy, efficiency, cost, and  equity.
    23  The audit will include consideration of whether and how to expand psilo-
    24  cybin access, provided that the pilot program results are successful.
    25    7. The advisory board shall have the following duties:
    26    (a)  Provide advice to the department regarding the provisions of this
    27  title and make  recommendations  on  available  medical,  psychological,
    28  scientific studies, research and other information relating to the safe-
    29  ty  and  efficacy  of  psilocybin  in treating mental health conditions,
    30  including but not limited to addiction,  depression,  anxiety  disorders
    31  and end-of-life psychological distress.
    32    (b)  Make recommendations to the department on the requirements, spec-
    33  ifications and guidelines for providing psilocybin services to a client.
    34    (c) Make recommendations to the department on public health and safety
    35  standards and industry best practices under this title.
    36    (d) Develop a long-term strategic plan for  ensuring  that  psilocybin
    37  services will become and remain a safe, accessible and affordable thera-
    38  peutic  option  for  all  persons eighteen years of age and older in the
    39  state for whom psilocybin services may be appropriate.
    40    (e) Monitor and study federal laws, regulations and policies regarding
    41  psilocybin.
    42    (f) Advise on and  helping  develop  public  awareness  and  education
    43  campaigns.
    44    §  2. The state finance law is amended by adding a new section 97-uuuu
    45  to read as follows:
    46    § 97-uuuu. Psilocybin and MDMA assisted therapy grant program fund. 1.
    47  There is hereby established in the joint custody of the commissioner  of
    48  health  and  the  comptroller  a fund to be known as the "psilocybin and
    49  MDMA assisted therapy grant program fund".
    50    2. The fund shall consist of all monies appropriated for its  purpose,
    51  and all monies required by this section or any other provision of law to
    52  be  paid  into  or credited to such fund. The fund shall not contain any
    53  monies which are not intended for the fund.
    54    3. Monies shall be payable from the fund on the audit and  warrant  of
    55  the  state comptroller on vouchers approved and certified by the commis-
    56  sioner of health.

        A. 3581--A                          6
 
     1    § 3. The sum of five million dollars ($5,000,000), or so much  thereof
     2  as  may  be necessary, is hereby appropriated to the psilocybin and MDMA
     3  assisted therapy or P.A.T grant program fund, established under  section
     4  97-uuuu  of the state finance law, out of any moneys in the state treas-
     5  ury in the general fund, not otherwise appropriated, and made immediate-
     6  ly  available,  for  the  purpose of carrying out the provisions of this
     7  act. Such moneys shall be payable on the audit and warrant of the  comp-
     8  troller  on vouchers certified or approved by the commissioner of health
     9  in the manner prescribed by law.
    10    § 4. This act shall take effect immediately.
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