AB378 - Creates the Alternative Therapy Pilot Program. (BDR 40-820)

REQUIRES TWO-THIRDS MAJORITY VOTE (§ 12.5) EXEMPT (Reprinted with amendments adopted on April 16, 2025) FIRST REPRINT A.B. 378 - *AB378_R1* ASSEMBLY BILL NO. 378–ASSEMBLYMEMBERS CARTER, GRAY, D’SILVA, HANSEN, BROWN-MAY; ANDERSON, CONSIDINE, DALIA, DICKMAN, EDGEWORTH, GONZÁLEZ, HIBBETTS, HUNT, JACKSON, KARRIS, MOSCA, NGUYEN, ORENTLICHER, ROTH AND WATTS MARCH 10, 2025 ____________ JOINT SPONSORS: SENATORS HANSEN, NGUYEN, STONE; AND OHRENSCHALL ____________ Referred to Committee on Health and Human Services SUMMARY—Creates the Alternative Therapy Pilot Program. (BDR 40-820) FISCAL NOTE: Effect on Local Government: No. Effect on the State: Yes. ~ EXPLANATION – Matter in bolded italics is new; matter between brackets [omitted material] is material to be omitted. AN ACT relating to controlled substances; creating the Alternative Therapy Pilot Program; requiring the Division of Public and Behavioral Health of the Department of Health and Human Services to administer and adopt certain regulations governing the Program; authorizing and requiring the Division to take certain actions with respect to the Program; requiring the Division to authorize at least one person to cultivate, manufacture or produce psychedelic substances for use in the Program; requiring the Division to submit to the Legislature an annual report concerning the Program; requiring the Division to establish an advisory committee with certain duties relating to the Program; prohibiting certain causes of action from being brought against the Department, its officers or employees relating to the Program; providing immunity from civil, criminal and administrative liability to a participant in the Program for certain conduct relating to the Program; and providing other matters properly relating thereto. – 2 – - *AB378_R1* Legislative Counsel’s Digest: Section 9 of this bill creates the Alternative Therapy Pilot Program for the 1 purpose of providing certain patients who have been diagnosed with a mental 2 health condition access to treatment involving the administration, under medical 3 supervision and control, of psychedelic substances through the development and 4 implementation of experimental and investigational pilot clinic programs. Section 9 5 requires the Division of Public and Behavioral Health of the Department of Health 6 and Human Services to administer the Program and, within the limits of available 7 funds, develop and implement experimental and investigational pilot programs for 8 the provision of alternative therapies. Section 7 of this bill defines “psychedelic 9 substance” to mean psilocybin, psilocin, dimethyltryptamine, ibogaine or 10 mescaline. 11 Section 10 of this bill requires the Division to adopt regulations to carry out the 12 provisions governing the Program. Section 11 of this bill authorizes the Division to 13 carry out or contract for certain programs for research and education. Section 12 of 14 this bill requires the Division to authorize at least one person to cultivate, 15 manufacture or otherwise produce psychedelic substances for use in the Program. 16 Section 12 requires such a person to comply with certain requirements. Section 17 12.5 of this bill authorizes the Division to require a person who wishes to 18 participate in the Program by operating a pilot clinic program or by cultivating, 19 manufacturing or otherwise producing psychedelic substances for use in a pilot 20 clinic program to reimburse the Division for certain costs incurred by the Division. 21 Section 13 of this bill requires the Division to collect comprehensive data 22 concerning all alternative therapies provided under any pilot clinic program 23 developed and implemented under the Program. Sections 13 and 17 of this bill 24 require any data collected that would lead to the identification of any patient 25 participating in a pilot clinic program developed and implemented under the 26 Program to be kept confidential and securely maintained. Section 13 also requires 27 the Division to submit an annual report concerning the Program to the Legislature. 28 Section 13.5 of this bill requires the Division to establish an advisory committee, 29 which is required to assist the Division with oversight of the Program and submit to 30 the Department a quarterly report concerning the operations of pilot clinic programs 31 developed and implemented under the Program. 32 Section 14.5 of this bill prohibits the provisions of this bill from being 33 construed to imply the creation of any warranty or guarantee by the Department, its 34 officers or employees as to the success, safety or any particular outcome of any 35 alternative therapy provided through a pilot clinic program developed and 36 implemented under the Program. Section 14.5 prohibits a cause of action from 37 being brought on the basis of an alleged breach of such a warranty or guarantee and 38 requires the Department to post certain notice on its Internet website. 39 Section 15 of this bill authorizes the Division to coordinate with other state 40 agencies for certain purposes relating to the Program. Section 15 also requires the 41 Division to take all actions which are feasible to ensure that all pilot clinic 42 programs developed and implemented under the Program comply with all 43 applicable federal requirements or guidelines relating to the clinical or experimental 44 use of controlled substances. 45 Existing law requires the State Board of Pharmacy to administer the Uniform 46 Controlled Substances Act and to add substances to or delete or reschedule all 47 substances enumerated in schedules I, II, III, IV and V by regulation. (NRS 48 453.146) Existing regulations list psilocybin, psilocin, dimethyltryptamine, 49 ibogaine and mescaline as schedule I controlled substances. (NAC 453.510) 50 Existing law prohibits certain acts relating to controlled substances, including, 51 without limitation: (1) importing, transporting, selling, exchanging, bartering, 52 supplying, prescribing, dispensing, giving away or administering the controlled 53 substance; (2) manufacturing or compounding the controlled substance; (3) 54 – 3 – - *AB378_R1* unlawfully possessing the controlled substance; and (4) trafficking in the controlled 55 substance. (NRS 453.321, 453.322, 453.336, 453.337, 453.338, 453.3385) Section 56 14 of this bill provides that any person who has been approved by the Division to 57 participate in a pilot clinic program developed and implemented under the Program 58 who engages in certain conduct involving a psychedelic substance within the scope 59 of the participation of the person in the Program is immune from civil, criminal and 60 administrative liability arising from that conduct and any such conduct must not 61 constitute the basis for any investigation, detention, search, seizure, arrest, 62 prosecution or other legal penalty against the person. 63 Section 16 of this bill authorizes the Division to accept certain sources of 64 money and enter into certain contracts and agreements to carry out the Program. 65 Sections 2-7 of this bill add necessary definitions of terms. Section 8 of this 66 bill sets forth certain legislative findings and declarations. 67 THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS: Section 1. Chapter 453 of NRS is hereby amended by adding 1 thereto the provisions set forth as sections 2 to 16, inclusive, of this 2 act. 3 Sec. 2. As used in sections 2 to 16, inclusive, of this act, 4 unless the context otherwise requires, the words and terms defined 5 in sections 3 to 7, inclusive, of this act have the meanings ascribed 6 to them in those sections. 7 Sec. 3. “Alternative therapy” means any treatment of a 8 patient for a mental health condition that involves administering 9 to the patient, under medical supervision and control, a 10 psychedelic substance. 11 Sec. 4. “Division” means the Division of Public and 12 Behavioral Health of the Department. 13 Sec. 5. “Medical facility” has the meaning ascribed to it in 14 NRS 449.0151. 15 Sec. 6. “Program” means the Alternative Therapy Pilot 16 Program created by section 9 of this act. 17 Sec. 7. “Psychedelic substance” means any of the following 18 substances: 19 1. Psilocybin. 20 2. Psilocin. 21 3. Dimethyltryptamine. 22 4. Ibogaine. 23 5. Mescaline. 24 Sec. 8. The Legislature hereby finds and declares that: 25 1. Mental health conditions, including, without limitation, 26 post-traumatic stress disorder, depression and anxiety disorders 27 require innovative approaches to treatment. 28 2. It is the policy of this State to encourage and promote 29 programs which provide for the treatment and rehabilitation of 30 – 4 – - *AB378_R1* persons with a mental health condition through alternative 1 treatments that may include, without limitation, the administration 2 of controlled substances in a clinical setting. 3 3. Providing access to treatments that involve the 4 administration of psychedelic substances, under proper medical 5 supervision, may contribute to the public welfare by fostering 6 enhanced treatment outcomes. 7 Sec. 9. 1. The Alternative Therapy Pilot Program is hereby 8 created for the purpose of providing certain patients who have 9 been diagnosed with a mental health condition access to treatment 10 involving the administration, under medical supervision and 11 control, of psychedelic substances through the development and 12 implementation of experimental and investigational pilot clinic 13 programs. The Division shall administer the Program. 14 2. As part of the Program, the Division shall, within the limits 15 of available funds, including, without limitation, legislative 16 appropriations, develop and implement experimental and 17 investigational pilot clinic programs for the provision of 18 alternative therapies. All alternative therapies provided under such 19 a pilot clinic program must be provided: 20 (a) By or under the supervision of a practitioner who has been 21 approved by the Division; 22 (b) At a medical facility or other location that has been 23 approved by the Division; 24 (c) To a patient who has been approved by the Division and 25 who meets all of the following criteria: 26 (1) The patient has been diagnosed with a mental health 27 condition; 28 (2) The patient is 21 years of age or older; and 29 (3) The patient has either: 30 (I) Received an honorable discharge or general 31 discharge under honorable conditions from the Armed Forces of 32 the United States; or 33 (II) Previously been employed as a first responder, as 34 defined in NRS 193.1678. 35 (d) In compliance with all applicable medical and ethical 36 standards; and 37 (e) In conjunction with any supporting or rehabilitative 38 services necessary to enhance the efficacy of treatment with 39 psychedelic substances. 40 3. In administering the Program, the Division shall: 41 (a) Ensure that all alternative therapies provided under a pilot 42 clinic program pursuant to subsection 2 are provided in 43 accordance with the requirements set forth in that subsection. 44 – 5 – - *AB378_R1* (b) Approve qualified practitioners, patients and medical 1 facilities or other locations to participate in a pilot clinic program 2 pursuant to subsection 2. 3 (c) Ensure that comprehensive data concerning all aspects of 4 alternative therapies provided under a pilot clinic program 5 pursuant to subsection 2 is collected and reported to the Division. 6 Such data must include, data concerning longitudinal outcomes 7 for participants in such a program. 8 (d) Provide for the participation in the Program of institutions 9 of higher education in this State, which may include, without 10 limitation, the training of practitioners, research on alternative 11 therapies and the evaluation of therapeutic protocols. 12 Sec. 10. 1. The Division shall adopt regulations to carry 13 out the provisions of sections 2 to 16, inclusive, of this act. The 14 regulations must include, without limitation: 15 (a) Procedures and criteria for determining whether to 16 approve a practitioner, patient, medical facility or other location to 17 participate in a pilot clinic program developed and implemented 18 under the Program; 19 (b) Procedures to ensure that each patient who participates in 20 a pilot clinic program developed and implemented under the 21 Program receives a plan for the continuation of care upon the 22 completion of his or her participation in the Program which has 23 been approved by the Division; 24 (c) Protocols to ensure that psychedelic substances are 25 handled, stored and administered safely, ethically and in a manner 26 consistent with federal and state law; 27 (d) Standards for the reporting of the outcomes and 28 effectiveness of any alternative therapies provided through a pilot 29 clinic program developed and implemented under the Program; 30 (e) Any provisions the Division determines to be necessary to 31 ensure that pilot clinic programs developed and implemented 32 under the Program receive appropriate medical supervision; and 33 (f) Any provisions the Division determines to be necessary to 34 protect the public health and safety. 35 2. The regulations adopted pursuant to subsection 1 must be 36 designed to: 37 (a) Ensure that the provision of any alternative therapy under 38 a pilot clinic program developed and implemented under the 39 Program conforms to the highest standards of patient safety, 40 medical ethics and informed consent; and 41 (b) Promote the health and welfare of persons with a mental 42 health condition, consistent with the declared policy of this State. 43 Sec. 11. In developing and implementing pilot clinic 44 programs under the Program, the Division may carry out or 45 – 6 – - *AB378_R1* contract for any programs of research and education that the 1 Division deems necessary to: 2 1. Develop new approaches for the treatment of mental health 3 conditions through the administration of psychedelic substances; 4 2. Improve the quality or availability of prevention and 5 treatment services; and 6 3. Train practitioners and other personnel who require 7 specialized instruction to safely provide alternative therapies 8 under a pilot clinic program. 9 Sec. 12. 1. The Division shall authorize at least one perso [Text truncated for display. Full text available on LegiScan.]