S T A T E O F N E W Y O R K
________________________________________________________________________
3845--A
2025-2026 Regular Sessions
I N A S S E M B L Y
January 30, 2025
___________
Introduced by M. of A. BURKE, McDONALD, BURDICK, FALL, HEVESI, CONRAD,
SIMON, CRUZ -- 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 establishing a psilocybin assisted therapy pilot program
for veterans and first responders and a psilocybin assisted therapy
pilot program fund; and making an appropriation therefor
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. The public health law is amended by adding a new section
3309-c to read as follows:
§ 3309-C. PSILOCYBIN ASSISTED THERAPY PILOT PROGRAM. 1. FOR THE
PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING
MEANINGS:
(A) "CERTIFIED MEDICAL USE" INCLUDES USE OF MEDICAL PSILOCYBIN FOR A
PATIENT TO TREAT OR ALLEVIATE A PATIENT'S MEDICAL CONDITION OR SYMPTOMS
ASSOCIATED WITH THE PATIENT'S MEDICAL CONDITION.
(B) "FACILITATOR" SHALL MEAN A MENTAL HEALTH COUNSELOR, PSYCHOANALYST,
PSYCHOLOGIST, 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 PSYCHEDELIC ASSISTED THERAPY WHO HAS COMPLETED ALL REQUIREMENTS
OF THIS SECTION.
(C) "MEDICAL PSILOCYBIN" SHALL MEAN PSILOCYBIN INTENDED FOR A CERTI-
FIED MEDICAL USE, AS DETERMINED BY THE DEPARTMENT.
(D) "PILOT PROGRAM" SHALL MEAN THE PSILOCYBIN ASSISTED THERAPY
PILOT PROGRAM ESTABLISHED UNDER THIS SECTION.
(E) "PSILOCYBIN" SHALL MEAN A NATURALLY OCCURRING PSYCHEDELIC PRODRUG
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.
LBD05253-06-6
A. 3845--A 2
GENUS PSILOCYBE. SUCH TERM SHALL INCLUDE PSILOCIN, THE SUBSTANCE INTO
WHICH PSILOCYBIN IS CONVERTED IN THE HUMAN BODY.
2. (A) THE DEPARTMENT SHALL ESTABLISH A PSILOCYBIN ASSISTED THERAPY
PILOT PROGRAM. SUCH PILOT PROGRAM SHALL PROVIDE PATIENT PARTICIPANTS, AS
DESCRIBED IN PARAGRAPH (B) OF THIS SUBDIVISION, WITH THE FUNDING NECES-
SARY TO RECEIVE PSILOCYBIN ASSISTED THERAPY. SUCH PILOT PROGRAM SHALL BE
TERMINATED UPON THE APPROVAL OF PSILOCYBIN FOR MEDICAL USE BY THE FEDER-
AL DRUG ENFORCEMENT ADMINISTRATION, OR ANY SUCCESSOR AGENCY.
(B) PARTICIPANTS IN THE PILOT PROGRAM SHALL INCLUDE VETERANS, FIRST
RESPONDERS AND RETIRED FIRST RESPONDERS.
(C) THE DEPARTMENT SHALL SCALE THE NUMBER OF PATIENT PARTICIPANTS
BASED ON THE OUTCOMES OF THE PILOT PROGRAM AND CHANGES TO FEDERAL LAWS,
RULES, REGULATIONS, AND APPROVALS.
(D) THE DEPARTMENT SHALL IMPLEMENT THE PILOT PROGRAM IN PARTNERSHIP
WITH THE STATE UNIVERSITY OF NEW YORK'S ACADEMIC HEALTH CENTERS WHICH
MAY INCLUDE, BUT SHALL NOT BE LIMITED TO, UPSTATE MEDICAL UNIVERSITY,
DOWNSTATE HEALTH SCIENCES UNIVERSITY, STONY BROOK UNIVERSITY AND THE
UNIVERSITY AT BUFFALO'S JACOBS SCHOOL OF MEDICINE AND BIOMEDICAL
SCIENCES.
(E) THE PILOT PROGRAM SHALL COMPLY WITH AND FOLLOW ALL APPLICABLE
REGULATIONS AND STANDARDS OF THE FEDERAL FOOD AND DRUG ADMINISTRATION,
FEDERAL DRUG ENFORCEMENT ADMINISTRATION, AND ANY RELEVANT INSTITUTIONAL
REVIEW BOARDS INCLUDING, BUT NOT LIMITED TO, CLINICAL TRIAL PROCESSES,
INVESTIGATIONAL NEW DRUG PATHWAYS, SCHEDULE I RESEARCH LICENSE REQUIRE-
MENTS, PROTOCOLS FOR ETHICAL OVERSIGHT.
(F) THE PILOT PROGRAM SHALL NOT DUPLICATE ANY MANDATED ELIGIBILITY
CRITERIA, SAFETY REPORTING, OR PROTECTIONS FOR PARTICIPANT PATIENTS THAT
THE FEDERAL FOOD AND DRUG ADMINISTRATION, FEDERAL DRUG ENFORCEMENT
ADMINISTRATION, AND ANY OTHER RELEVANT INSTITUTIONAL REVIEW BOARDS AND
SHALL DEFER TO SUCH ADMINISTRATIONS AND BOARDS FOR SUCH.
(G) THE DEPARTMENT SHALL PROMULGATE ANY NECESSARY RULES AND REGU-
LATIONS FOR THE APPLICATION AND DISTRIBUTION OF ANY FUNDS PURSUANT TO
THIS SUBDIVISION. SUCH RULES AND REGULATIONS SHALL SUPPORT THE PILOT
PROGRAM OPERATING WITHIN FEDERAL REGULATIONS, STANDARDS, AND PROGRAMS
AND SHALL NOT CREATE ANY NEW STATE RULES OR REGULATIONS WHICH ARE NOT
CONSISTENT WITH SUCH FEDERAL REGULATIONS, STANDARDS, AND PROGRAMS.
3. A FACILITATOR SHALL BE AN INDIVIDUAL QUALIFIED UNDER THE FEDERAL
RESEARCH PROTOCOL UTILIZED BY A PARTICIPATING STATE UNIVERSITY OF NEW
YORK ACADEMIC HEALTH CENTER.
4. (A) THE DEPARTMENT MAY PROVIDE FOR THE ANALYSIS AND EVALUATION OF
THE OPERATION OF THIS SECTION. THE DEPARTMENT MAY ENTER INTO AGREEMENTS
WITH ONE OR MORE PERSONS, NOT-FOR-PROFIT CORPORATIONS, UNIVERSITIES OR
OTHER ORGANIZATIONS, FOR THE PERFORMANCE OF AN EVALUATION OF THE IMPLE-
MENTATION AND EFFECTIVENESS OF THIS SECTION.
(B) THE DEPARTMENT MAY DEVELOP, SEEK ANY NECESSARY FEDERAL APPROVAL
FOR, AND CARRY OUT RESEARCH PROGRAMS RELATING TO MEDICAL USE OF PSILOCY-
BIN. PARTICIPATION IN ANY SUCH RESEARCH PROGRAM SHALL BE VOLUNTARY ON
THE PART OF FACILITATORS, PATIENTS, AND DESIGNATED CAREGIVERS.
(C) NO LATER THAN TWO YEARS AFTER THE EFFECTIVE DATE OF THIS SECTION
AND EVERY TWO YEARS THEREAFTER, THE DEPARTMENT SHALL REPORT TO THE
GOVERNOR AND THE LEGISLATURE ON THE MEDICAL USE OF PSILOCYBIN UNDER THIS
SECTION AND MAKE APPROPRIATE RECOMMENDATIONS.
(D) BASED ON THE FINDINGS OF THE REPORT REQUIRED UNDER PARAGRAPH (C)
OF THIS SUBDIVISION, THE DEPARTMENT, IN CONSULTATION WITH PARTICIPATING
STATE UNIVERSITY OF NEW YORK ACADEMIC HEALTH CENTERS, MAY DEVELOP AND
IMPLEMENT A STATE-FUNDED PSILOCYBIN ASSISTED THERAPY TRAINING PROGRAM.
A. 3845--A 3
SUCH PROGRAM SHALL BE INFORMED BY THE OUTCOMES, BEST PRACTICES, SAFETY
DATA, AND CLINICAL STANDARDS OBSERVED DURING THE PILOT PROGRAM.
5. THE PROVISIONS OF THIS SECTION SHALL TAKE PRECEDENCE OVER ANY
CONFLICTING PROVISIONS OF THIS CHAPTER AND ARTICLE ONE HUNDRED THIRTY-
SEVEN OF THE EDUCATION LAW.
6. (A) PATIENTS, PRACTITIONERS AND FACILITATORS SHALL NOT BE SUBJECT
TO ARREST, PROSECUTION, OR PENALTY IN ANY MANNER, OR DENIED ANY RIGHT OR
PRIVILEGE, INCLUDING BUT NOT LIMITED TO CIVIL PENALTY OR DISCIPLINARY
ACTION BY A BUSINESS OR OCCUPATIONAL OR PROFESSIONAL LICENSING BOARD OR
BUREAU, SOLELY FOR THE CERTIFIED MEDICAL USE OF PSILOCYBIN OR FOR ANY
OTHER ACTION OR CONDUCT IN ACCORDANCE WITH THIS SECTION.
(B) THIS SUBDIVISION SHALL NOT BAR THE ENFORCEMENT OF A POLICY PROHIB-
ITING AN EMPLOYEE FROM PERFORMING SUCH EMPLOYEE'S EMPLOYMENT DUTIES
WHILE IMPAIRED BY A CONTROLLED SUBSTANCE. THIS SUBDIVISION SHALL NOT
REQUIRE ANY PERSON OR ENTITY TO DO ANY ACT THAT WOULD PUT THE PERSON OR
ENTITY IN DIRECT VIOLATION OF FEDERAL LAW OR CAUSE IT TO LOSE A FEDERAL
CONTRACT OR FUNDING.
(C) THE FACT THAT A PERSON IS A PATIENT AND/OR ACTING IN ACCORDANCE
WITH THIS SECTION, SHALL NOT BE A CONSIDERATION IN A PROCEEDING PURSUANT
TO APPLICABLE SECTIONS OF THE DOMESTIC RELATIONS LAW, THE SOCIAL
SERVICES LAW, AND THE FAMILY COURT ACT.
(D) 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 SECTION.
7. THE DEPARTMENT SHALL PROMULGATE ANY RULES AND REGULATIONS NECESSARY
TO IMPLEMENT THE PROVISIONS OF THIS SECTION.
§ 2. The state finance law is amended by adding a new section 99-uu
to read as follows:
§ 99-UU. PSILOCYBIN ASSISTED THERAPY PILOT PROGRAM FUND. 1. THERE IS
HEREBY ESTABLISHED IN THE JOINT CUSTODY OF THE COMMISSIONER OF HEALTH
AND THE COMPTROLLER, A SPECIAL FUND TO BE KNOWN AS THE "PSILOCYBIN
ASSISTED THERAPY PILOT PROGRAM FUND".
2. SUCH FUND SHALL CONSIST OF ALL MONEYS APPROPRIATED, CREDITED, OR
TRANSFERRED THERETO FROM ANY OTHER FUND OR SOURCE PURSUANT TO LAW.
NOTHING CONTAINED IN THIS SECTION SHALL PREVENT THE STATE FROM RECEIVING
GRANTS, GIFTS, OR BEQUESTS FOR THE PURPOSES OF THE FUND, AS DEFINED IN
THIS SECTION, AND DEPOSITING THEM INTO THE FUND ACCORDING TO LAW.
3. MONIES OF THE FUND SHALL BE EXPENDED ONLY FOR THE PURPOSES OPERAT-
ING THE PSILOCYBIN ASSISTED THERAPY PILOT PROGRAM ESTABLISHED UNDER
SECTION THIRTY-THREE HUNDRED NINE-C OF THE PUBLIC HEALTH LAW.
4. MONIES OF THE FUND SHALL BE PAYABLE ON THE AUDIT AND WARRANT OF THE
COMPTROLLER ON VOUCHERS APPROVED AND CERTIFIED BY THE COMMISSIONER OF
HEALTH.
§ 3. The sum of five million dollars ($5,000,000), or so much thereof
as may be necessary, is hereby appropriated from any moneys in the state
treasury in the general fund to the credit of the state purposes account
not otherwise appropriated to the psilocybin assisted therapy pilot
program fund established under section 99-uu of the state finance law in
carrying out the provisions of this act. Such sum shall be payable on
the audit and warrant of the state comptroller on vouchers certified or
approved in the manner provided by law.
§ 4. This act shall take effect immediately.