Establishes Psilocybin Behavioral Health Access and Therapy Pilot Program; appropriates $6 million.

A1526

ASSEMBLY, No. 1526

STATE OF NEW JERSEY

222nd LEGISLATURE

�

PRE-FILED FOR INTRODUCTION IN THE 2026 SESSION

Sponsored by:

Assemblyman CLINTON CALABRESE

District 36 (Bergen and Passaic)

Assemblyman ANTHONY S. VERRELLI

District 15 (Hunterdon and Mercer)

Co-Sponsored by:

Assemblywomen Speight, Haider and Assemblyman Egan

SYNOPSIS

���� Establishes Psilocybin Behavioral Health Access and
Therapy Pilot Program; appropriates $6 million.

CURRENT VERSION OF TEXT

���� Introduced Pending Technical Review by Legislative
Counsel.

��

An Act

concerning a pilot program for psilocybin research and making an appropriation.

����
Be It Enacted

by the Senate and General Assembly of the State of New Jersey:

���� 1.��� The Legislature finds
and declares that:

���� a.��� New Jersey has a high
prevalence of adults living with behavioral health conditions.

���� b.��� Studies conducted by
nationally and internationally recognized medical institutions indicate that
psilocybin has shown efficacy, tolerability, and safety in the treatment of a
variety of behavioral health conditions, including, but not limited to, substance
use disorders, depression, anxiety disorders, and end-of-life psychological
distress.

���� c.��� The United States Food
and Drug Administration has determined that preliminary clinical evidence
indicates psilocybin may demonstrate substantial improvement over available
therapies for treatment-resistant depression, and has granted a breakthrough
therapy designation for the use of psilocybin as a therapy for
treatment-resistant depression.

���� d.��� The Legislature intends
to establish a psilocybin pilot program to support hospitals to advance
psilocybin research in a manner compliant with United States Food and Drug
Administration and United States Drug Enforcement Administration regulations,
and as a means for the State to evaluate the establishment of a safe, legal,
and affordable Statewide medical psilocybin care delivery system.

���� e. It is the intent of the
Legislature that research funded and conducted pursuant to this act will be
compliant with United States Food and Drug Administration and United States
Drug Enforcement Administration regulations, and that the State will work to
facilitate and support the research.

���� f.���� In establishing this
pilot program, the Legislature seeks to improve the physical, mental, and
social well-being of the residents of New Jersey, and to prevent and reduce the
prevalence of behavioral health disorders in adults.

���� g.��� It is necessary and
appropriate to assess whether a comprehensive Statewide delivery scheme can be
developed and implemented in the future that ensures that psilocybin can be
accessed in safe, controlled environments that are designed to foster improvements
in behavioral health for adult patients.

���� 2.��� As used in this act:

���� �Board� means the Psychedelic
Therapy and Research Advisory Board established pursuant to section 4 of this
act.

���� �Central region� means
Middlesex, Monmouth, Mercer, and Union counties.

���� �Commissioner� means the
Commissioner of Health.

���� �Department� means the
Department of Health.

���� �Hospital� means a health care
facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) or a
community-based organization with a formal partnership with a healthcare
facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.).

���� �Northern region� means
Bergen, Essex, Hudson, Hunterdon, Morris, Passaic, Somerset, Sussex, and Warren
counties.

���� �Participating hospital� means
a hospital that has been selected by the department to participate in the pilot
program.��

���� �Pilot program� means the
Psilocybin Behavioral Health Access and Therapy Pilot
Program
established pursuant to section 3 of this act.

���� �Psilocybin� means psilocybin
or psilocin.

���� �Psychedelic substance� means
a psychoactive substance that produces changes in a person�s perception, mood,
and cognitive processes, including but not limited to psilocybin.

���� �Psychedelic therapy� means a
method of mental health care treatment provided by a qualified health care
professional that combines psychedelic substances and psychotherapy.

���� �Southern region� means
Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, Ocean, and
Salem counties.

���� 3.��� a.� There is established
in the department a �Psilocybin Behavioral Health Access and Therapy Pilot
Program.�

���� b.��� The pilot program shall
be overseen by the department and the Psychedelic Therapy and Research Advisory
Board, established pursuant to section 4 of this act, in accordance with the
provisions of this act.�

���� c.��� The pilot program shall
commence upon the selection of hospitals by the department pursuant to
subsection a. of section 5 of this act.

���� 4.��� a.� There is established
in the department the Psychedelic Therapy and Research Advisory Board.

���� b.��� The board shall comprise
11 members, as follows:

���� (1)� the Commissioner and the
Deputy Commissioner for Public Health Services, or their designees, who shall
serve as ex officio, nonvoting members; and

���� (2)� nine public members,
three to be appointed by the Governor, two to be appointed by the President of
the Senate, two to be appointed by the Speaker of the General Assembly, one to
be appointed by the Minority Leader of the Senate, and one to be appointed by
the Minority Leader of the General Assembly. Each public member shall represent
at least one of the following categories:

���� (a)�� a behavioral healthcare
provider who is a physician licensed pursuant to Title 45 of the Revised
Statutes;

���� (b)� a facilitator, or trainer
or supervisor of a facilitator, with experience in United States Food and Drug
Administration-approved clinical trials involving psychedelics;

���� (c)�� a public health
official with experience in policy development;

���� (d) a health care access
expert focused on ensuring affordable access to psychedelic therapy,
particularly for underserved or historically marginalized communities;

���� (e)�� a scientist with
experience in conducting clinical trials with psychedelics;

���� (f)�� an individual with
expertise or experience in traditional or Indigenous uses of natural medicines;

���� (g)� a licensed behavioral
health care provider with experience providing mental health care to veterans
or first responders;

���� (h)� an attorney or legal
expert specializing in drug policy and regulation; or

���� (i)�� a professional focused
on researching ethical practices in psychedelic therapy.

���� c.��� The public members of
the board shall serve from the date of appointment through the duration of the
pilot program.

���� d.��� Members shall be
appointed to the board no later than 60 days after the effective date of this
act.� Vacancies in the board shall be filled in the same manner as is provided
for the initial appointment. The board shall organize upon the appointment of
the public members and shall select a chairperson and a vice-chairperson from
among the membership. The chairperson shall appoint a secretary, who need not
be a member of the board.

���� e.��� A majority of the public
members of the board shall constitute a quorum for the purpose of conducting
official board business. The official adoption of guidelines by the board shall
require the approval of a majority of the public members.

���� f.���� The board shall meet at
least quarterly at a time and place designated by the chairperson. The board
shall meet at any time at the call of the chairperson or at the call of a
majority of the public members.

���� g.��� The members of the board
shall serve without compensation but may be reimbursed for reasonable expenses
incurred in the performance of their official duties, within the limits of
funds made available to the board for this purpose.

���� h.��� The board may establish
committees and subcommittees as may be necessary for the board�s operation.�
The department shall provide such stenographic, clerical, and other
administrative assistants and such professional staff as the board requires to
carry out its work.� The board shall be entitled to call to its assistance and
avail itself of the services of the employees of any State, county, or
municipal department, board, bureau, commission, or agency as it may require
and as may be available for its purposes.

���� i. The responsibilities of the
board shall include:

���� (1)� researching and gathering
available medical, psychological, and scientific studies, social scientific
research, and other information relating to the safety of psilocybin and any
other psychedelic substances and their efficacy in ameliorating behavioral health
conditions, including, but not limited to, clinical dependence disorders,
depression, anxiety disorders, and end-of-life psychological distress, and the
potential for psilocybin and any other psychedelic substances to promote
community, address trauma, and enhance physical and mental wellness;

���� (2)� evaluating outcomes of
the pilot program and any research, pilot programs, and access programs related
to psilocybin or other psychedelic substances under the laws of other states;
and

���� (3)� making recommendations,
in collaboration with the department, to the Legislature that consider
efficacy, safety, and affordability for the development and implementation of a
comprehensive plan to provide therapeutic access to psilocybin in New Jersey for
individuals who could benefit.

���� 5.��� a.� With input from the
board established pursuant to section 4 of this act, the department shall
administer the pilot program in accordance with this act.� Under no
circumstance shall the department establish, implement, or enforce a
requirement, specification, or guideline under the pilot program that conflicts
with protocols and guidelines from the United States Food and Drug
Administration related to clinical trials for psychedelic substances.�

���� b.��� No later than 180 days
after the effective date of this act, the department shall establish and
implement a process and issue a request for proposals by which hospitals may
submit applications for participation in the pilot program. The department
shall develop a set of criteria by which applying hospitals shall be evaluated
for participation in the pilot program and perform selections no later than 60
days after the release of the request for proposals.

���� c. The department shall select
one qualified hospital from the northern region, one from the central region,
and one from the southern region of the State, provided that an applicant from
each of these regions meets the criteria developed pursuant to subsection b. of
this section.

���� d.��� The department shall
require each participating hospital to collect and report data and information
related to the pilot program and patient outcomes, except that nothing in this
section shall be construed to require any participating hospital to disclose to
any personal identifying information for any individual patient.

���� e. The department shall assess
participation by the pilot program in national data-sharing programs, data
sharing programs established by other states, or practice-based research
networks for psychedelic research and participating in such programs if the
programs are operational and consistent with the quality standards for similar
collaborative research networks in other health fields.

���� 6.��� a.� Following the
completion of year two of the pilot program, the department shall prepare and
submit a report to the Governor, and to the Legislature, pursuant to section 2
of P.L.1991, c.164 (C.52:14-19.1), outlining the department�s implementation
and administration of this act and its findings and recommendations concerning
the continuation or expansion of the pilot program.� The report shall include,
at a minimum, the total number of participants in each completed operating year
of the pilot program organized by:�� participating hospitals; the types of
behavioral health conditions researched; and outcomes.

���� b.��� Following the completion
of year two of the pilot program, the board shall prepare and submit a report to
the Governor, and to the Legislature, pursuant to section 2 of P.L.1991, c.164
(C.52:14-19.1), with the board�s findings and recommendations as to the
development and implementation of a comprehensive plan for State and local
regulation of psilocybin to provide access in New Jersey for individuals who
could benefit and that considers efficacy, safety, and affordability.

���� 7.��� The Department of the
Treasury shall establish a non-lapsing, restricted fund to be referred as the
�Psychedelic Therapy and Research Fund.�� In addition to funds appropriated,
credited, or transferred by the Legislature, the department may seek and apply
for any available federal funds, and solicit and accept private gifts, grants,
or donations from any source, public or private, as necessary to ensure the
effective implementation of the pilot program.

���� 8.� There is appropriated
$6,000,000 from the General Fund to the Psychedelic Therapy and Research Fund,
which shall be administered by the Department of Health to implement the
provisions of this act. From the total amount herein appropriated to the fund, the
department shall allocate $2,000,000 to each of the three hospitals selected by
the department to participate in the Psilocybin Behavioral Health Services
Pilot Program.

���� 9.��� This act shall take
effect immediately and shall expire upon the submission of the reports
submitted pursuant to section 6 of this act.

STATEMENT

����� This bill
establishes Psilocybin Behavioral
Health Access and Therapy Pilot Program (pilot program), and appropriates $6
million to fulfill the bill�s purposes.

����� Under the bill,
the pilot program is to be
overseen by the Department of Health (department) and the
Psychedelic Therapy and Research
Advisory
Board (board), which is to comprise of 11 members as provided for in the bill.
The responsibilities of the board are to include:� (1) researching and
gathering available medical, psychological, and scientific studies, social
scientific research, and other information relating to the safety of psilocybin
and any other psychedelic substances and their efficacy in ameliorating
behavioral health conditions; (2) evaluating outcomes of the pilot program and
any research, pilot programs, and access programs related to psilocybin or
other psychedelic substances under the laws of other states; and (3) making
recommendations, in collaboration with the department, to the Legislature that
consider efficacy, safety, and affordability for the development and
implementation of a comprehensive plan to provide therapeutic access to
psilocybin.

���� The bill provides that the
department is not to establish, implement, or enforce a requirement,
specification, or guideline under the pilot program that conflicts with
protocols and guidelines from the United States Food and Drug Administration
related to clinical trials for psychedelic substances.�

���� No later than 180 days after
the bill�s effective date, the department is to establish and implement a
process and issue a request for proposals by which hospitals may submit
applications for participation in the pilot program.� The department is to develop
a set of criteria by which applying hospitals are to be evaluated for
participation in the pilot program and perform selections no later than 60 days
after the release of the request for proposals.� The department is to select
one qualified hospital from each of the northern, central, and southern regions
of the State, provided that an applicant from each of these regions meets the
department�s criteria.� The department is to require each participating
hospital to collect and report data and information related to the pilot
program and patient outcomes.�

���� Following the completion of
year two of the pilot program, the department and board are to prepare and
submit reports to the Governor and Legislature with findings and
recommendations, as provided in the bill.