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A08569 Memo:

submitted in accordance with Assembly Rule III, Sec 1(f)
  PURPOSE OR GENERAL IDEA OF BILL: To enable medical professionals to receive training to administer psilo- cybin therapy ushering in an innovative treatment option for ailments such as PTSD, depression, alcohol dependency, anxiety, among others.   SUMMARY OF PROVISIONS: Section 1 amends public health law adding a new title for Medical Use of Psilocybin. Details include: * Medical psilocybin facilitators may be a mental health counselor, psychoanalyst, physician, physician assistant, registered professional nurse, clinical nurse specialist, nurse practitioner, occupational ther- apist, occupational therapy assistant, or licensed clinical social work- er. * Facilitators must complete a course offered by the department of health in order to certify patients for psilocybin and administer it. Patients can be certified if in the facilitator's professional opinion and review of past treatments, the patient is likely to receive thera- peutic or palliative benefit from psilocybin. * Administration must be held in a clinical setting under the super- vision of the facilitator unless the patient is medically unable to travel. * A naturally grown medical psilocybin pilot program will be established to allow naturally grown, cost effective psilocybin to be accessible to facilitators to administer to patients. * The Department of Health may analyze and evaluate the implementation and effectiveness of Medical Use of Psilocybin. They will make recommen- dations to the Governor and legislature every two years. * A psilocybin research license will be established for testing potency, conducting clinical investigations, researching efficacy and safety, and agricultural research. * The psilocybin therapy advisory board will be created and consist of fourteen voting members and the commissioner and representative of the department serving as non-voting ex-officio members. The board will make recommendations to the health department regarding available medical, psychological, scientific studies and research, specifications and guidelines for providing services, safety standards, industry best prac- tices, code of professional conduct, education, training, and examina- tion for facilitators, production, and a long term strategic plan for services. Section 2 amends the state finance law by creating the psilocybin services grant program fund for veterans, first responders, and low-in- come individuals to be jointly managed by the commissioner of health and the state comptroller. Section 3 sets the effective date.   JUSTIFICATION: Struggles with mental ailments like PTSD, depression, anxiety, and substance abuse disorder can be major disruptors to a person's liveli- hood as well as their family's. These ailments can deteriorate physical health, result in performance deficits on tasks, and increase rates of suicide. Psilocybin therapy is a breakthrough avenue for providing people with treatment for these ailments. 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. The FDA recognizes psilocybin therapy as substantially better than pres- ent treatment options. Establishing a widespread route to provide New Yorkers with this medical treatment would be a monumental step forward in providing mental health care to improve lives. Oregon, Texas, and several cities have taken similar steps to increase access to psilocybin treatment. Beyond enabling the use of this treatment, this legislation would also create a fund for veterans, firefighters, police officers, EMS workers, and low-income individuals who can apply for financial support towards treatment. There is increased suffering occurring in modern society and using every tool at our disposal to alleviate that suffering is the state's duty.   PRIOR LEGISLATIVE HISTORY: New bill   FISCAL IMPLICATIONS: To be determined   EFFECTIVE DATE: 90 days after becoming law
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A08569 Text:

                STATE OF NEW YORK
                               2021-2022 Regular Sessions
                   IN ASSEMBLY
                                    December 13, 2021
        Introduced  by  M. of A. BURKE, LUPARDO -- read once and referred to the
          Committee on Health -- recommitted  to  the  Committee  on  Health  in
          accordance  with Assembly Rule 3, sec. 2 -- committee discharged, bill
          amended, ordered reprinted as amended and recommitted to said  commit-

        AN  ACT  to  amend  the  public health law and the state finance law, in
          relation to medical use of psilocybin
          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. Certification of patients.
     7          3369-cc. Lawful medical use.
     8          3369-dd. Certification of facilitators.
     9          3369-ee. Evaluation; research programs; report by department.
    10          3369-ff. Relation to other laws.
    11          3369-gg. Protections for the medical use of psilocybin.
    12          3369-hh. Regulations.
    13          3369-ii. Psilocybin therapy grant program.
    14          3369-jj. Naturally grown medical psilocybin pilot.
    15          3369-kk. Psilocybin therapy advisory board.
    16    § 3369-aa. Definitions. For the purposes of this title, the  following
    17  terms shall have the following meanings:
    18    1.  "Psilocybin"  means  a  naturally  occurring  psychedelic  prodrug
    19  compound produced by fungi, including but not limited to members of  the
    20  genus  Psilocybe.   Such term shall include psilocin, the substance into
    21  which psilocybin is converted in the human body.
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.

        A. 8569--A                          2
     1    2. "Psilocybin product" means psilocybin, concentrated psilocybin, and
     2  psilocybin-infused products for use by a certified patient.
     3    3.  "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    4.  "Certified  medical  use"  includes  the acquisition, cultivation,
     7  manufacture,  delivery,  harvest,  possession,  preparation,   transfer,
     8  transportation,  or use of medical psilocybin for a certified patient to
     9  treat or alleviate a certified patient's medical condition  or  symptoms
    10  associated with the patient's medical condition.
    11    5.  "Certified  patient" means a patient who is a resident of New York
    12  state or receiving care and treatment in New York state as determined by
    13  the board in regulation, and is certified under this chapter.
    14    6. "Condition" means having a life threatening or disrupting condition
    15  certified by the facilitator.
    16    7. "License" means a written  authorization  as  provided  under  this
    17  title  permitting  persons  to engage in a specified activity authorized
    18  pursuant to this title.
    19    8. "Licensee" means an individual or an entity who has been granted  a
    20  license under this title.
    21    9.  "Medical  psilocybin" means psilocybin as defined in this section,
    22  intended for a certified medical use, as determined by the department.
    23    10. "Package" means any  container  or  receptacle  used  for  holding
    24  psilocybin or psilocybin products.
    25    11.  "Facilitator"  means  a  mental  health counselor, psychoanalyst,
    26  physician, physician assistant, registered professional nurse,  clinical
    27  nurse  specialist,  nurse  practitioner, occupational therapist, occupa-
    28  tional therapy assistant, or licensed clinical social worker
    29    12. "Terminally ill" means an individual has a medical prognosis  that
    30  the  individual's  life expectancy is approximately two years or less if
    31  the illness runs its normal course.
    32    § 3369-bb. Certification of patients. 1. A patient  certification  may
    33  only be issued if:
    34    (a)  the  patient  has  a  condition,  which shall be specified in the
    35  patient's health care record;
    36    (b) the facilitator by training or experience is  qualified  to  treat
    37  the condition;
    38    (c)  the  patient  is  under the facilitator's continuing care for the
    39  condition; and
    40    (d) in the facilitator's  professional  opinion  and  review  of  past
    41  treatments,  the  patient is likely to receive therapeutic or palliative
    42  benefit from the primary or adjunctive treatment  with  medical  use  of
    43  psilocybin for the condition.
    44    2.  The  certification  shall include: (a) the name, date of birth and
    45  address of the patient; (b) a statement that the patient has a condition
    46  and the patient is under the facilitator's care for the condition; (c) a
    47  statement attesting that all requirements of  subdivision  one  of  this
    48  section  have  been  satisfied; (d) the date; and (e) the name, address,
    49  telephone number, and the signature of the certifying facilitator.   The
    50  department  may require by regulation that the certification shall be on
    51  a form provided by the department.
    52    3. The facilitator shall place a copy  of  the  certification  in  the
    53  patient's health care record.
    54    4.  No  facilitator shall issue a certification under this section for
    55  themselves.

        A. 8569--A                          3

     1    § 3369-cc. Lawful medical use. The use  of  medical  psilocybin  by  a
     2  certified  patient for certified medical use, shall be lawful under this
     3  title provided that:
     4    1. The psilocybin used by a certified patient shall have occurred in a
     5  clinical  setting,  including but not limited to, a facilitator's office
     6  or a hospital, under the supervision of a facilitator certified pursuant
     7  to section thirty-three hundred sixty-nine-dd of this  title.  Certified
     8  patients  who  are  unable to travel may receive psilocybin treatment in
     9  the home. The course developed to certify facilitators by the department
    10  shall include regulations and recommendations for  creating  appropriate
    11  settings for psilocybin treatment;
    12    2.  Facilitators shall receive psilocybin to use through the naturally
    13  grown medical psilocybin pilot, pursuant to section thirty-three hundred
    14  sixty-nine-jj of this title, upon certification of a patient.  Facilita-
    15  tors  who are able to access any forthcoming Federal Drug Administration
    16  approved synthetic psilocybin products shall be permitted to do so.
    17    § 3369-dd.  Certification of facilitators.   Prior to  facilitating  a
    18  psilocybin  session,  a facilitator must complete a course as determined
    19  by the department in regulation.
    20    § 3369-ee. Evaluation; research programs; report by  department.    1.
    21  The department may provide for the analysis and evaluation of the opera-
    22  tion of this title. The department may enter into agreements with one or
    23  more  persons,  not-for-profit  corporations or other organizations, for
    24  the performance of an evaluation of the implementation and effectiveness
    25  of this title.
    26    2. The department may develop, seek  any  necessary  federal  approval
    27  for, and carry out research programs relating to medical use of psilocy-
    28  bin.    Participation in any such research program shall be voluntary on
    29  the part of facilitators, patients, and designated caregivers.
    30    3. The department shall report every two years,  beginning  two  years
    31  after the effective date of this title, to the governor and the legisla-
    32  ture  on  the medical use of psilocybin under this title and make appro-
    33  priate recommendations.
    34    § 3369-ff. Relation to other laws. 1. The  provisions  of  this  title
    35  shall  apply, except that where a provision of this title conflicts with
    36  another provision of this chapter, this title shall apply.
    37    2. Medical psilocybin shall not be deemed to be a "drug" for  purposes
    38  of article one hundred thirty-seven of the education law.
    39    §  3369-gg.  Protections for the medical use of psilocybin. 1.  Certi-
    40  fied patients and practitioners and facilitators shall not be subject to
    41  arrest, prosecution, or penalty in any manner, or denied  any  right  or
    42  privilege,  including  but  not limited to civil penalty or disciplinary
    43  action by a business or occupational or professional licensing board  or
    44  bureau,  solely  for the certified medical use of psilocybin, or for any
    45  other action or conduct in accordance with this title.
    46    2. This subdivision shall not bar the enforcement of a policy  prohib-
    47  iting  an  employee  from  performing his or her employment duties while
    48  impaired by a controlled substance. This subdivision shall  not  require
    49  any  person  or entity to do any act that would put the person or entity
    50  in direct violation of federal  law  or  cause  it  to  lose  a  federal
    51  contract or funding.
    52    3.  The  fact  that  a  person is a certified patient and/or acting in
    53  accordance with this title, shall not be a consideration in a proceeding
    54  pursuant to applicable sections  of  the  domestic  relations  law,  the
    55  social services law and the family court act.

        A. 8569--A                          4
     1    4.  (a)  Certification  forms  and  any  certified patient information
     2  contained within a database shall be deemed exempt from  public  disclo-
     3  sure  under sections eighty-seven and eighty-nine of the public officers
     4  law. Upon specific request by a certified patient to the department, the
     5  department  shall  verify  the  requesting  patient's  status as a valid
     6  certified patient to the patient's school or employer  or  other  desig-
     7  nated  party, to ensure compliance with the protections afforded by this
     8  section.
     9    (b) The name, contact information, and other information  relating  to
    10  facilitators  registered  with  the department under this title shall be
    11  public information and shall be maintained on the  department's  website
    12  accessible  to the public in searchable form.  However, if a facilitator
    13  notifies the department in writing that he or she does not want  his  or
    14  her  name  and  other  information  disclosed, that facilitator name and
    15  other information shall thereafter not be public  information  or  main-
    16  tained  on  the department's website, unless the facilitator cancels the
    17  request.
    18    5. A person currently under parole, probation or other state or  local
    19  supervision,  or  released on bail awaiting trial may not be punished or
    20  otherwise penalized for conduct allowed under this title.
    21    § 3369-hh. Regulations. The department shall promulgate regulations to
    22  implement this title.
    23    § 3369-ii. Psilocybin therapy  grant  program.  The  department  shall
    24  establish  a program of awarded grants within the amount in the psilocy-
    25  bin therapy grant program fund established under  section  ninety-seven-
    26  uuuu  of  the  state finance law for veterans, first responders, and low
    27  income individuals to receive monetary assistance for psilocybin therapy
    28  pursuant to this title. The department shall  promulgate  any  necessary
    29  rules  and regulations for the application and distribution of any funds
    30  pursuant to this section.
    31    § 3369-jj.  Naturally grown medical psilocybin pilot.  The  department
    32  of  agriculture  and markets shall establish and oversee the implementa-
    33  tion of a pilot program for psilocybin to be grown in the state to allow
    34  for reduced costs in accessing psilocybin for patients via their facili-
    35  tators. The department, in conjunction with the department  of  environ-
    36  mental  conservation,  shall  promulgate  all  necessary rules and regu-
    37  lations,  as  well  as  a  process  for  approval,  governing  the  safe
    38  production  of  psilocybin, including, but not limited to, environmental
    39  and energy standards and restrictions on the use of pesticides.
    40    § 3369-kk. Psilocybin therapy advisory board. 1. The psilocybin thera-
    41  py advisory board or "advisory board" is established within the  depart-
    42  ment  to advise and issue recommendations on the use of medical psilocy-
    43  bin in the state of New York.
    44    2. (a) The advisory board shall consist of fourteen  voting  appointed
    45  members, along with the following members serving as non-voting ex-offi-
    46  cio  members:  (i)  the commissioner, or his or her designee; and (ii) a
    47  representative from the department who is familiar  with  public  health
    48  programs and public health activities in the state.
    49    (b)  The  governor shall have eight appointments, the temporary presi-
    50  dent of the senate and the speaker of the assembly shall each have three
    51  appointments to the board. Advisory board members shall  have  statewide
    52  geographic  representation  that is balanced and diverse in its composi-
    53  tion. Appointed members shall have an expertise in public and behavioral
    54  health, substance use disorder  treatment,  psilocybin-assisted  therapy
    55  research  and/or  clinical practice, trauma and mental health, access to

        A. 8569--A                          5
     1  care in underserved communities, veteran mental health  care,  and  harm
     2  reduction.
     3    3.  The members shall be appointed to the advisory board to each serve
     4  four-year terms and in the event of a  vacancy,  the  vacancy  shall  be
     5  filled  in  the  manner of the original appointment for the remainder of
     6  the term. The appointed members and  representatives  shall  receive  no
     7  compensation  for  their  services but shall be allowed their actual and
     8  necessary expenses incurred in the performance of their duties as  board
     9  members.
    10    4.  The  chairperson  of  the  advisory board and the vice chairperson
    11  shall be elected from among the members of the  advisory  board  by  the
    12  members of such advisory board. The vice chairperson shall represent the
    13  advisory  board  in the absence of the chairperson at all official advi-
    14  sory board functions.
    15    5. The advisory board shall enact and from  time  to  time  may  amend
    16  bylaws  or  rules in relation to its meetings and the transaction of its
    17  business. The board may  also  establish  committees  and  subcommittees
    18  necessary for the operation of the board. A majority of the total number
    19  of  voting  members  which the board would have were there no vacancies,
    20  shall constitute a quorum and shall be required for the board to conduct
    21  business. All meetings of the  advisory  board  shall  be  conducted  in
    22  accordance  with  the provisions of article seven of the public officers
    23  law.
    24    6. Within the first two years of the  establishment  of  the  advisory
    25  board, the board shall meet at least once every calendar month at a time
    26  and  place  determined  by  the  chairperson or a majority of the voting
    27  members of the board. After the first  two  years,  the  advisory  board
    28  shall  meet  at  least  once  every calendar quarter at a time and place
    29  determined by the chairperson or a majority of the voting members of the
    30  board. The advisory board may also meet at other times and places speci-
    31  fied by the call of the chairperson or  of  a  majority  of  the  voting
    32  members of the board.
    33    7. The advisory board shall have the following duties:
    34    (a)  Provide advice to the department regarding the provisions of this
    35  title and make  recommendations  on  available  medical,  psychological,
    36  scientific studies, research and other information relating to the safe-
    37  ty  and  efficacy  of  psilocybin  in treating mental health conditions,
    38  including but not limited to addiction,  depression,  anxiety  disorders
    39  and end-of-life psychological distress.
    40    (b)  Make recommendations to the department on the requirements, spec-
    41  ifications and guidelines for providing psilocybin services to a client.
    42    (c) Make recommendations to the department on public health and safety
    43  standards and industry best practices under this title.
    44    (d) Develop a long-term strategic plan for  ensuring  that  psilocybin
    45  services will become and remain a safe, accessible and affordable thera-
    46  peutic  option  for  all  persons eighteen years of age and older in the
    47  state for whom psilocybin services may be appropriate.
    48    (e) Monitor and study federal laws, regulations and policies regarding
    49  psilocybin.
    50    (f) Advise on and  helping  develop  public  awareness  and  education
    51  campaigns.
    52    §  2. The state finance law is amended by adding a new section 97-uuuu
    53  to read as follows:
    54    § 97-uuuu. Psilocybin therapy grant program fund. 1. There  is  hereby
    55  established  in  the joint custody of the commissioner of health and the

        A. 8569--A                          6
     1  comptroller a fund to be known as the "psilocybin therapy grant  program
     2  fund".
     3    2.  The fund shall consist of all monies appropriated for its purpose,
     4  and all monies required by this section or any other provision of law to
     5  be paid into or credited to such fund. The fund shall  not  contain  any
     6  monies which are not intended for the fund.
     7    3.  Monies  shall be payable from the fund on the audit and warrant of
     8  the state comptroller on vouchers approved and certified by the  commis-
     9  sioner of health.
    10    §  3.  This  act shall take effect on the ninetieth day after it shall
    11  have become a law.    Effective  immediately,  the  addition,  amendment
    12  and/or repeal of any rule or regulation necessary for the implementation
    13  of  this  act  on  its  effective  date  are  authorized  to be made and
    14  completed on or before such effective date.
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