Mental Health & Substance Abuse Services, Dept. of

Plain English Breakdown

Using official source text because the generated explanation was unavailable or could not be confirmed against the official bill text.

Mental Health & Substance Abuse Services, Dept. of

This bill authorizes a cohort established and selected by the department of mental health and substance abuse services ("department") to conduct drug development clinical trials with ibogaine for the purpose of obtaining approval from the United States fo od and drug administration ("FDA") for ibogaine as a medication to treat opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions for which ibogaine demonstrates efficacy.

What This Bill Does

• This bill authorizes a cohort established and selected by the department of mental health and substance abuse services ("department") to conduct drug development clinical trials with ibogaine for the purpose of obtaining approval from the United States fo od and drug administration ("FDA") for ibogaine as a medication to treat opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions for which ibogaine demonstrates efficacy.
• A cohort must include one or m or e drug developers, one or more research institutions, which may be an institution of higher education, and one or more hospitals.
• This bill requires a cohort to select a project lead from among the cohort's members to represent the cohort and perform administrative functions, including contracting with and reporting to the department.
• A project lead selected by the department is a uthorized to employ clinical, administrative, and data management personnel necessary to support cohort activities, which may include participation in the Texas consortium for clinical trial collaboration.

Limits and Unknowns

• This entry is temporarily using official source text because the generated explanation could not be confirmed against the official bill text during the last sync.

Official Summary Text

This bill authorizes a cohort established and selected by the department of mental health and substance abuse services ("department") to conduct drug development clinical trials with ibogaine for the purpose of obtaining approval from the United States fo
od and drug administration ("FDA") for ibogaine as a medication to treat opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions for which ibogaine demonstrates efficacy. A cohort must include one or m
or
e drug developers, one or more research institutions, which may be an institution of higher education, and one or more hospitals.

This bill requires a cohort to select a project lead from among the cohort's members to represent the cohort and perform administrative functions, including contracting with and reporting to the department. A project lead selected by the department is a
uthorized to employ clinical, administrative, and data management personnel necessary to support cohort activities, which may include participation in the Texas consortium for clinical trial collaboration. The cohort project lead must submit a proposal a
nd
request for funding to the department. The proposal must provide:



The identity of all cohort members.



A detailed strategy for obtaining FDA approval for drug development clinical trials.



A clinical trial design including team composition, participant recruitment plans, cardiac safety protocols, administration protocols, aftercare plans, and data integrity plans.



A plan to seek a breakthrough therapy designation for ibogaine from the FDA under federal law aimed at expedited approval of drugs for serious or life-threatening diseases or conditions.



A proposal to recognize the state's commercial interest in all intellectual property generated during the trials, including treatments, protocols, treatment models and techniques, and technology.



Plans for a state corporate presence and the promotion of ibogaine-related research, manufacturing, and distribution within the state.



Plans to secure third-party payor approval, such as private insurers, medicare, medicaid, and the TRICARE program, and ensure access for uninsured individuals following FDA approval.



Plans to ensure ibogaine treatment access to uninsured individuals following approval by the FDA;



A plan to train and credential medical providers.



Financial disclosures verifying the capacity to match state funding with non-state sources.

This bill grants the department sole discretion to select a cohort for the purpose of conducting clinical trials. After making a selection, the department must enter into an interagency agreement with the project lead to provide funding. The contract must specify goals, objectives, proposed budgets, timelines, collaborating entities, the percentage of revenue arising from the trials to be paid to the state, and any other information requested by the department. After entering into the interagency contract, the department must report the existence of the contract to the chief clerks of the senate and the house of representatives. The department is prohibited from disbursing funds until it verifies the cohort's receipt of matching funds from non-state sources.

OPERATIONAL REQUIREMENTS AND REPORTING

This bill requires the selected cohort to submit an investigational new drug application to the FDA and seek breakthrough therapy designation as soon as practicable. However, only research institutions or hospitals are permitted to serve as a trial site.

This bill authorizes the department and cohort members to solicit and accept gifts, grants, and donations from non-state sources. Disbursements by the department may be made incrementally based on the completion of defined objectives as negotiated in the interagency contract.

This bill requires selected cohorts to submit quarterly reports to the department regarding trial progress and financial status, including verification of expenditures for state and matching funds. The department must submit an annual progress report to the general assembly no later than December 1 of each year.

REVENUE ALLOCATION

This bill requires that revenue attributable to intellectual property and commercial rights arising from the trials, including (i) intellectual property, technology, and inventions; (ii) patents, trademarks, and licenses; (iii) proprietary and confidential information; (iv) trade secrets, data, and databases; (v) tools, methods, and processes; (vi) treatment models or techniques; (vii) administration protocols; and (viii) works of authorship, to be allocated as follows:



No less than 5% to the state.


The remainder to cohort members in amounts specified by written agreement.

TENNESSEE MENTAL HEALTH INNOVATION FUND

This bill establishes the Tennessee mental health innovation fund as a special account within the general fund. The fund is primarily capitalized through moneys realized from intellectual property and other commercial rights arising from ibogaine clinic
al trials and appropriations made specifically to the fund by the general assembly. Funds must only be expended in accordance with this bill and pursuant to appropriations made by the general assembly. In order to ensure accountability, all expenditures
a
re subject to review via an annual report submitted by the commissioner of mental health and substance abuse services ("commissioner") to the general assembly. State revenue from the trials must be deposited as follows:



No less than 50% into the innovation fund.


The remainder into the general fund.

This bill requires the commissioner to administer the fund to support proposals from behavioral health providers to train and support staff in best practices for patients undergoing ibogaine therapy.

APPLICABILITY AND MEDICAL OVERSIGHT

This bill requires a licensed physician who has prescribed ibogaine to supervise its administration at a hospital or other licensed healthcare facility to ensure patient safety. However, this bill does not preclude a physician from administering ibogain
e in accordance with federal law.

Further, this bill applies only if ibogaine is approved by the FDA to treat a medical condition. If the department determines a federal waiver is necessary for implementation, then the department must request the waiver and may delay implementation of t
his bill until the waiver is granted. However, the department must begin accepting cohort proposals no later than September 1, 2026.

ON APRIL 15, 2026, THE SENATE ADOPTED AMENDMENT #2 AND PASSED SENATE BILL 2149, AS AMENDED.

AMENDMENT #2 rewrites the bill to, instead, establish the council on emerging behavioral health treatments ("council") to oversee this state's participation in emerging behavioral health treatment research. The council must be composed of the following
11 members:



The chair of the committee of the house of representatives having jurisdiction over health.


The chair of the health and welfare committee of the senate
.


One person appointed by the governor.


One person appointed by the speaker of the house of representatives.


One person appointed by the speaker of the senate.


One non-voting representative from the department of mental health and substance abuse services.


One non-voting representative from the department of health.


Two non-voting representatives
of nonprofit advocacy-focused organizations, selected by majority vote of the voting members of the council pursuant to a published selection process
.


Two
non-voting representatives of licensed mental health providers, selected by majority vote of the voting members of the council pursuant to a published selection process.

This amendment requires appointments to the council to be made by September 1, 2026. The organizational meeting of the
council must occur within 30 days after all five voting members are appointed. The non-voting members must be selected within 90 days of the organizational meeting. Three voting members constitute a quorum and official actions require an affirmative vot
e of a majority of voting members present.

Conflicts of Interest

This amendment requires a voting member of the council to disclose, in writing, any financial interest in an entity that has applied for or received authorization for funding under this amendment. Such a member is required to recuse themselves from any
deliberation or vote involving an entity in which they have a financial interest. Further, an entity in which a voting member holds a board position, employment relationship, or ownership interest is not eligible to receive authorization or funding under
t
his chapter during that member's tenure on the council.

MULTISTATE IBOGAINE RESEARCH CONSORTIUM

This amendment permits the council to authorize one or more qualified institutions in this state to participate in a multistate ibogaine drug development clinical trial consortium. However, this authorization must not require the formation of a Tennesse
e-specific cohort or consortium. A qualified institution in this state may participate individually or jointly with other institutions in this state as a member of an existing multistate consortium. The council may provide funding to a participating ins
ti
tution.

This amendment requires an institution seeking authorization to participate in a multistate consortium to submit an application to the council that includes all of the following:



The identity of the institution and its proposed role within the multistate consortium
.


Evidence of the institution's eligibility for membership in the multistate consortium, including a letter of intent, invitation, or executed agreement from the consortium
.


A description of clinical trial activities proposed to be conducted in this state, including patient recruitment, trial sites, and safety protocols
.


Cardiac safety protocols and patient screening criteria consistent with current United States federal food and drug administration (FDA) guidance on ibogaine research
.


An aftercare and post-acute treatment support plan
.


Documentation of FDA investigational new drug authorization or evidence of a pending application
.


A plan to serve populations of this state disproportionately impacted by opioid use disorder, including veterans and rural residents
.


Financial disclosures demonstrating the institution's capacity to manage state funds and fulfill any matching requirements imposed by the council.

However, this amendment authorizes the council to waive or modify application requirements upon a finding that the multistate consortium's existing documentation satisfies the relevant requirements.

In order to participate in a multistate ibogaine drug development clinical trial consortium, this amendment requires a participating institution to (i) execute
a participation agreement required by the multistate consortium and provide a copy to the council
; (ii) agree
to report to the council on a quarterly basis
; and (iii) ensure
that any clinical trial activity conducted in this state complies with applicable state and federal law
. If two or more institutions in this
state participate in a multistate consortium, the council must designate one institution as the coordinating institution for the purposes of contracting with and reporting to the council. Such a coordinating institution may employ personnel necessary to
support the activities of participating institutions in this state.

This amendment authorizes the council and participating institutions to solicit and accept gifts, grants, and donations of any kind received from sources other than the state for purposes of funding drug developmental clinical trials for ibogaine. The c
ouncil may disburse funds incrementally, based on the completion of clearly defined objectives as negotiated in the contract with a coordinating institution.

Contracting with the Coordinating Institution

This amendment requires the council to enter into an interagency contract with the coordinating institution to provide funding to implement the authorized ibogaine drug development clinical trials as soon as practicable after authorizing a participating i
nstitution. Such an interagency contract must specify (i) the goals and objectives of the proposed ibogaine drug development clinical trials; (ii) the proposed budget; (iii) the timeline for completing the proposed objectives; (iv) the for-profit, nonpro
fi
t, or public benefit corporate entities collaborating with the participating institutions in this state in the drug development clinical trials, including any multistate consortiums that the participating institutions in this state are members; (v) the st
ate's financial interest or monetary return on any FDA-approved medication that is developed by the drug development clinical trials; and (vi) any other information required by the council. The council must report the existence of an interagency contract
t
o the general assembly.

This amendment prohibits the council from disbursing funds to or for a participating institution under the interagency contract until the institution receives and the council verifies the receipt of matching funds from sources other than the state. Howe
ver, the council may waive this requirement upon a finding, adopted by majority vote, that extraordinary circumstances make compliance impracticable.

INVESTIGATIONAL NEW DRUG APPLICATION

This amendment requires a participating institution that is conducting clinical trials in this state to ensure that such activities are conducted pursuant to a valid investigational new drug (IND) application submitted to the United States food and drug
administration in accordance with federal regulations. If a participating institution joins a multistate consortium that holds or is pursuing a consortium-level IND, compliance with that IND satisfies this requirement.

This amendment clarifies that it does not authorize the administration of ibogaine to human subjects in this state except in the context of a clinical trial conducted pursuant to a valid FDA investigational new drug authorization.

CLINICAL TRIAL SITES

This amendment provides that a drug development clinical trial site for an ibogaine clinical trial must be either a research institution, institution of higher education with clinical research capacity, or a hospital.

REPORTING REQUIREMENTS

This amendment requires a participating institution to prepare and submit to the council a quarterly report on the progress of the drug development clinical trials for ibogaine. Further, a participating institution must submit a quarterly financial stat
us report.

This amendment requires the council to submit a report to the general assembly on the progress of the drug development clinical trials conducted on ibogaine by December 1st of each year. The council must include in its report a projection of the anticip
ated revenue attributable to the state's financial interest or monetary return for the succeeding fiscal year.

ALLOCATION OF REVENUE

This amendment requires the revenue attributable to the state's financial interest o monetary return on any FDA-approved medication that is developed by the drug developmental clinical to be allocated as follows:



At least 2% of the state's financial interest or monetary return to the state as specified in the interagency contract.


The remained to the members of the participating institutions in the amounts specified by written agreement of the members.

State Revenue

This amendment requires at least 50% of any revenue allocated to the state must be deposited into the emerging behavioral health treatment innovation fund. The remainder of the revenue must be deposited into the state general fund.

EMERGING BEHAVIORAL HEALTH TREATMENT INNOVATION FUND

This amendment establishes the emerging behavioral health treatment innovation fund and requires the moneys realized from the state's financial interest or monetary return on any FDA-approved medication that is developed by the drug development clinical
trials to be deposited into the fund. The council may accept other funds, public or private, to the fund. The state treasurer must invest moneys in the fund, investments and deposits of the fund must be credited to and remain part of the fun. Unencumbe
re
d and unexpended moneys must be carried forward until expended.

This amendment requires that moneys in the fund be expended only for the following purposes:



Fund research by behavioral health providers and institutions into emerging and innovative behavioral health treatments, including ibogaine and other psychedelic-assisted therapies
.


Support training and credentialing of clinical and supportive care staff in evidence-based and emerging behavioral health treatment modalities
.


Fund grants to nonprofit organizations providing direct behavioral health services, patient navigation, and recovery support to residents of this state
.


Support public education and provider outreach regarding emerging behavioral health treatments authorized under this
amendments.


Fund community education and public policy education efforts by nonprofit organizations working to expand access to emerging behavioral health treatments for citizens of this state
.

This amendment provides that all expenditures from the fund are subject to review in the form of an annual report submitted to the general assembly.

MISCELLANEOUS REQUIREMENTS

This amendment requires a physician that has prescribed ibogaine to a patient to supervise the administration of ibogaine at a hospital or other licensed healthcare facility participating in an ibogaine clinical trial.

Federal Law

This amendment clarifies that it does not preclude a physician from administering ibogaine in accordance with federal law.

This amendment requires the council, or another entity of state government, to request a waiver or authorization from a federal agency if necessary to effectuate this amendment. Further, implementation of a provision of this amendment may be delayed unti
l the necessary waiver or authorization is granted.

Exemption from Controlled Substances Liability

This amendment clarifies that a physician, researcher, or institution participating in an ibogaine clinical trial authorized by the council is not subject to criminal liability under this state's controlled substances laws solely on the basis of possessi
on, administration, or use of ibogaine in furtherance of participation in such a trial. However, all activities must be conducted in compliance with this amendment, the terms of the council's authorization, and applicable federal law

Current Bill Text

HOUSE BILL 2075
By Terry

SENATE BILL 2149
By Walley
SB2149
010579
- 1 -

AN ACT to amend Tennessee Code Annotated, Title 9;
Title 33; Title 53; Title 63 and Title 68, relative to
clinical trials.

WHEREAS, ibogaine is a naturally occurring psychoactive compound that has
demonstrated promise in treating a wide range of mental health and neurological conditions,
including opioid use disorder, post-traumatic stress disorder (PTSD), traumatic brain injury,
depression, anxiety, multiple sclerosis, and more; and
WHEREAS, ibogaine is classified as a Schedule I drug by the federal government,
making research and access difficult, and forcing patients to seek unregulated treatment
abroad; and
WHEREAS, multiple states have authorized and funded research into ibogaine, and
Texas has launched a research consortium facilitating a multistate effort to conduct clinical trials
on ibogaine as a medical treatment; and
WHEREAS, recent studies demonstrate ibogaine's ability to significantly reduce
symptoms of substance use addiction, PTSD, depression, and anxiety after one treatment; and
WHEREAS, ibogaine treatment has been associated with marked improvements in
patients with traumatic brain injury, with results that include significant improvements in
concentration, information processing, memory, and impulse control; and
WHEREAS, Stanford University has studied the impact of treatment on veterans who
have been supported by nonprofit organizations that facilitate veterans traveling to ibogaine
retreats abroad with reported substantial improvements in depression scores, PTSD symptoms,
anxiety, sleep, quality of life, substance abuse, and emotional well-being; and

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WHEREAS, trusted institutions, including the federal Food and Drug Administration and
Department of Veterans Affairs, are actively supporting and investing in research on
psychedelic-assisted therapies for PTSD and related mental health conditions; and
WHEREAS, expediting research into the medical potential of ibogaine is an effective and
safe way to ensure patients have access to a potentially groundbreaking treatment; now,
therefore,
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Title 33, is amended by adding the following
as a new chapter:
33-12-101. Short title.
This chapter is known and may be cited as the "Helping Open Pathways to
Effective (HOPE) Treatment Act."
33-12-102. Chapter definitions.
As used in this chapter:
(1) "Commissioner" means the commissioner of mental health and
substance abuse services;
(2) "Department" means the department of mental health and substance
abuse services;
(3) "Drug developer" means a pharmaceutical company, biotechnology
company, or contract development and manufacturing organization engaged in
drug development and manufacturing;
(4) "Hospital" means any institution, place, building, or agency
represented and held out to the general public as ready, willing, and able to
furnish care, accommodations, facilities, and equipment for the use, in
connection with the services of a physician or dentist, of one (1) or more

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nonrelated persons who may be suffering from deformity, injury, or disease or
from any other condition for which nursing, medical, or surgical services would be
appropriate for care, diagnosis, or treatment;
(5) "Ibogaine" means ibogaine and ibogaine-based therapeutics,
including ibogaine analogs; and
(6) "Institution of higher education" means any postsecondary institution
operated by the board of trustees for the University of Tennessee system, the
board of regents, or a state university board that offers courses of instruction
leading to a certificate or degree.
33-12-103. Establishment of cohort.
(a) A cohort may be established under this section and apply for department
selection under this chapter to conduct drug development clinical trials with ibogaine and
secure the United States food and drug administration's approval of ibogaine as a
medication for the treatment of:
(1) Opioid use disorder;
(2) Co-occurring substance use disorder; and
(3) Any other neurological or mental health condition for which ibogaine
demonstrates efficacy.
(b) A cohort established under this section must include one (1) or more of each
of the following entities:
(1) A drug developer;
(2) A research institution, which may be an institution of higher
education; and
(3) A hospital.
33-12-104. Lead institution - Administration - Personnel.

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(a) A cohort established under this chapter shall select a project lead from
among the cohort's members to represent the cohort and perform administrative
functions under this chapter, including contracting with and reporting to the department
as required by this chapter. It is the intent of the general assembly that the research
institution be selected as project lead.
(b) A project lead selected by the department under this chapter may employ
personnel, including clinical, administrative, and data management personnel, necessary
to support any cohort member's activities related to drug development clinical trials
conducted under this chapter. Such activities may include participation in the Texas
consortium for the purpose of clinical trial collaboration.
33-12-105. Cohort proposal.
(a) The cohort project lead shall submit to the department a proposal and
request for funding on behalf of the cohort for purposes of conducting ibogaine drug
development clinical trials in accordance with this chapter.
(b) A proposal submitted under subsection (a) must provide:
(1) The identity of all cohort members;
(2) A detailed description of the planned strategy for obtaining approval
for the drug development clinical trials from the United States food and drug
administration;
(3) A detailed drug development clinical trial design that includes:
(A) A description of the composition of the cohort's drug
development clinical trial team and the expertise of the team members;
(B) A drug development clinical trial participant recruitment plan;
(C) Patient screening criteria and cardiac safety protocols;
(D) Administration protocols;

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(E) An aftercare and post-acute treatment support plan; and
(F) A data integrity plan;
(4) A detailed plan to seek a breakthrough therapy designation for
ibogaine from the United States food and drug administration under 21 U.S.C. §
356;
(5) A proposal to recognize this state's commercial interest in all
intellectual property that may be generated over the course of the drug
development clinical trials, including:
(A) The treatment that is the subject of the trials;
(B) Administration protocols;
(C) Treatment models or techniques; and
(D) Technology used in the trials;
(6) A plan to establish a corporate presence in this state and to promote
and maintain ibogaine-related biomedical research, development, treatment,
manufacturing, and distribution in this state;
(7) A plan to secure third-party payor approval for ibogaine treatment
following approval by the United States food and drug administration through:
(A) Private insurers;
(B) Medicare;
(C) Medicaid; and
(D) The TRICARE program of the United States department of
defense;
(8) A plan to ensure ibogaine treatment access to uninsured individuals
following approval by the United States food and drug administration;

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(9) A plan to train and credential medical providers to administer ibogaine
treatment according to developed clinical standards; and
(10) Financial disclosures that verify the cohort's capacity to fully match
state funding with funds received from non-state sources.
33-12-106. Department selection.
The department, in the department's sole discretion, shall select a cohort
established in accordance with § 33-12-103 for the purpose of conducting ibogaine drug
development clinical trials under this chapter.
33-12-107. Contract with lead institution.
(a) As soon as practicable after selecting a cohort to conduct ibogaine drug
development clinical trials under § 33-12-106, the department shall enter into an
interagency agreement with the project lead of the selected cohort to provide funding to
implement the cohort's proposed ibogaine drug development clinical trials.
(b) The interagency contract described by subsection (a) must specify:
(1) The goals and objectives of the proposed ibogaine drug development
clinical trials;
(2) The proposed budget;
(3) The timeline for completing the proposed objectives;
(4) The for-profit, nonprofit, or public benefit corporate entities
collaborating with the cohort in the drug development clinical trials under this
chapter or a clinical trial initiated in another state, including the clinical trial
conducted by the Texas consortium;
(5) The percentage of the revenue arising from the drug development
clinical trials to be paid to the state; and
(6) Any other information required by the department.

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(c) As soon as practicable after entering into an interagency contract under
subsection (a), the department shall report the existence of the contract to the general
assembly by sending notice to the chief clerks of the senate and house of
representatives.
(d) The department shall not disburse funds to or for a selected cohort under the
interagency contract described by subsection (a) until the cohort receives and the
department verifies the receipt of matching funds from sources other than the state.
33-12-108. Investigational new drug application.
On the department's notification that a cohort is selected to conduct the drug
development clinical trials under this chapter, a drug developer or hospital member of
the selected cohort or the project lead of the cohort, as specified by written agreement of
the cohort members, shall, as soon as practicable:
(1) Submit an investigational new drug application to the United States
food and drug administration in accordance with 21 CFR Part 312; and
(2) Seek a breakthrough therapy designation for ibogaine from the United
States food and drug administration under 21 U.S.C. § 356.
33-12-109. Drug development clinical trial sites.
For purposes of conducting a drug development clinical trial under this chapter,
only a research institution or a hospital shall serve as a trial site.
33-12-110. Funding - Disbursement by department.
(a) The department and cohort members may solicit and accept gifts, grants,
and donations of any kind received from sources other than the state for purposes of
funding drug development clinical trials under this chapter.
(b) Disbursements of funds by the department may be made incrementally
based on the completion of clearly defined objectives as negotiated in the contract

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described by § 33-12-107, including verifiable documentation demonstrating the efficient
expenditure of both state and matching funds.
33-12-111. Reporting requirements.
(a) A cohort selected to conduct ibogaine drug development clinical trials shall
prepare and submit to the department quarterly:
(1) A report on the progress of the drug development clinical trials
conducted under this chapter; and
(2) A financial status report, including information to verify expenditures
of state funds and required matching funds.
(b) The department shall submit a report to the general assembly on the
progress of the drug development clinical trials conducted under this chapter no later
than December 1 of each year. The report must be submitted to the chief clerk of the
senate, the chief clerk of the house of representatives, and the legislative librarian, and
may be submitted by electronic means.
33-12-112. Allocation of revenue attributable to intellectual property and other
rights.
(a) The revenue attributable to all intellectual property rights and other
commercial rights arising from drug development clinical trials conducted by a cohort
under this chapter during the period for which the trials are funded and any following
period of commercialization shall be allocated as follows:
(1) No less than five percent (5%) to the state as specified in the contract
under § 33-12-107; and
(2) The remainder to the members of the cohort in the amounts specified
by written agreement of the members.

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(b) For purposes of this section, intellectual property rights and other commercial
rights arising from the drug development clinical trials conducted under this chapter
include any of the following as related to the trials:
(1) Intellectual property, technology, and inventions;
(2) Patents, trademarks, and licenses;
(3) Proprietary and confidential information;
(4) Trade secrets, data, and databases;
(5) Tools, methods, and processes;
(6) Treatment models or techniques;
(7) Administration protocols; and
(8) Works of authorship.
33-12-113. Use of state revenue.
(a) The state treasurer shall deposit the revenue received under § 33-12-
112(a)(1) as follows:
(1) No less than fifty percent (50%) into the Tennessee mental health
innovation fund, created by § 33-12-114; and
(2) The remainder into the general fund.
(b) The state treasurer shall develop accounting procedures for the purpose of
implementing this section.
33-12-114. Creation of innovation fund - Purpose.
(a) There is created within the state general fund a special account to be known
as the Tennessee mental health innovation fund.
(b) Unless otherwise specified in this part, moneys realized from intellectual
property and other commercial rights pursuant to § 33-12-112(a)(1) and allocated
pursuant to § 33-12-113(a)(1) must be deposited in the fund and used only to implement

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and administer the purposes set forth in subsection (f). In addition to appropriations
made to the fund, the commissioner may accept other funds, public or private, by way of
gift or grant to the fund. Any such gift or grant must be deposited into the fund to be
expended in accordance with this part.
(c) The state treasurer shall invest moneys in the fund for the benefit of the fund
in accordance with § 9-4-603. Interest accruing on investments and deposits of the fund
must be credited to and remain part of the fund.
(d) Any unencumbered moneys and any unexpended balance of the fund
remaining at the end of a fiscal year do not revert to the general fund, but must be
carried forward until expended in accordance with this part. No part of the fund shall be
diverted to the general fund or any other public fund.
(e) The commissioner shall administer the fund, and moneys in the fund must be
expended and obligated only in accordance with this part and in accordance with
appropriations made by the general assembly. All expenditures from the fund are
subject to review in the form of an annual report submitted by the commissioner to the
general assembly.
(f) The purpose of the Tennessee mental health innovation fund is to fund
proposals from behavioral health providers to train and support clinical and supportive
care staff in best practices for supporting patients who have undergone ibogaine
therapy.
33-12-115. Applicability of chapter.
This chapter applies only if ibogaine is approved by the United States food and
drug administration to treat a medical condition.
33-12-116. Medical supervision.

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A physician licensed under title 63, chapter 6 or 9, who has prescribed ibogaine
for a patient shall supervise the administration of ibogaine at a hospital or other licensed
healthcare facility to ensure the patient's safety while the patient is undergoing ibogaine
treatment.
33-12-117. Administration under federal law.
This chapter does not preclude a physician from administering ibogaine in
accordance with federal law.
33-12-118. Waiver authority - Deadline to begin accepting proposals.
(a) If the department, or another department of state government involved in the
administration of this chapter, determines that a waiver or authorization from a federal
agency is necessary to implement a provision of this chapter, then the department
responsible for implementing such provision shall request the waiver or authorization
and may delay implementing that provision until the waiver or authorization is granted.
(b) The department shall begin accepting proposals from cohorts under this
chapter no later than September 1, 2026.
SECTION 2. The headings in this act are for reference purposes only and do not
constitute a part of the law enacted by this act. However, the Tennessee Code Commission is
requested to include the headings in any compilation or publication containing this act.
SECTION 3. This act takes effect July 1, 2026, the public welfare requiring it.