IBOGAINE TREATMENT

Tex. HEALTH & SAFETY Code ch. 491
in effect

Tex. HEALTH & SAFETY Code § 491.001. DEFINITIONS.

In this chapter: (1) "Individualized investigational treatment" means a drug, biological product, or device unique to and produced exclusively for use by a patient, based on the patient's genetic profile. The term includes individualized gene therapy antisense oligonucleotides and individualized neoantigen vaccines. (2) "Life-threatening illness" means a disease or condition with: (A) a significantly increased likelihood of death unless the course of the disease or condition is interrupted; or (B) potentially fatal outcomes and for which the goal of clinical trials is survival. (3) "Severely debilitating illness" means a disease or condition that causes major irreversible morbidity. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025. SUBCHAPTER B. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENT

Tex. HEALTH & SAFETY Code § 491.051. HEALTH CARE FACILITY ELIGIBILITY.

A health care facility is eligible to provide an individualized investigational treatment under this chapter if the facility is operating under a federal assurance for the protection of human subjects under 42 U.S.C. Section 289(a) and 45 C.F.R. Part 46 and is subject to the federal assurance laws, regulations, policies, and guidelines. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.052. PATIENT ELIGIBILITY.

A patient is eligible to access an individualized investigational treatment under this chapter if: (1) the patient: (A) has a life-threatening illness or severely debilitating illness; (B) has considered all other treatment options currently approved by the United States Food and Drug Administration; and (C) has given written informed consent for access to the treatment; and (2) the patient's physician: (A) attests to the patient's life-threatening illness or severely debilitating illness and the patient's eligibility under this section; and (B) recommends the treatment for the patient based on analysis of the patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as enzymes and other types of proteins, or metabolites. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.053. INFORMED CONSENT.

(a) An eligible patient may not access an individualized investigational treatment unless the patient provides written informed consent. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, legal guardian, managing conservator, or patient's agent as defined by Section 166.151 may provide written informed consent on the patient's behalf. (b) Informed consent under this chapter must be attested to in writing by the patient's physician and a witness. (c) Informed consent under this chapter must include at a minimum: (1) an explanation of the currently approved treatments for the patient's disease or condition; (2) the patient's attestation that the patient concurs with the assessment of the patient's physician that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life; (3) clear identification of the specific proposed individualized investigational drug, biological product, or device the patient's physician recommends; (4) a description, based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's disease or condition, of the potentially best and worst outcomes of using the treatment, and of the most likely outcome, including the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the treatment; (5) a statement that the patient's health benefit plan issuer or third-party administrator and provider are not obligated to pay the cost of any care related to the use of the treatment unless payment is specifically required by law or contract; (6) a statement that the patient's eligibility for hospice care may be withdrawn if the patient begins the treatment and that care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements; and (7) a statement that the patient understands the patient is liable for all expenses related to the use of the treatment and the liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the treatment provides otherwise. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.054. ACCESS TO TREATMENT; COSTS.

(a) A manufacturer operating within an eligible health care facility and in compliance with all applicable federal assurance laws and regulations may make available an individualized investigational treatment, and an eligible patient may request access to the treatment from an eligible health care facility or manufacturer operating within an eligible health care facility under this chapter. (b) A manufacturer is not required under this chapter to make available an individualized investigational treatment to an eligible patient. (c) An eligible health care facility or manufacturer operating within an eligible health care facility may: (1) provide an individualized investigational treatment to an eligible patient without receiving compensation; or (2) require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the treatment. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.055. DEBT LIABILITY ON DEATH OF PATIENT.

If a patient dies while receiving an individualized investigational treatment, the patient's heirs are not liable for any outstanding debt related to the treatment or lack of health coverage due to the treatment. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.056. NO PRIVATE CAUSE OF ACTION.

This chapter does not create a private cause of action against a manufacturer of an individualized investigational treatment or against any other person involved in the care of an eligible patient using the treatment for any harm to the patient resulting from the treatment if the manufacturer or other person is complying in good faith with the terms of this chapter and has exercised reasonable care. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.057. PROHIBITED STATE INTERFERENCE WITH ACCESS TO TREATMENT.

(a) An officer, employee, or agent of this state may not block or attempt to block an eligible patient's access to an individualized investigational treatment that complies with this chapter and rules adopted under this chapter. (b) Notwithstanding Subsection (a), counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider is not a violation of this section. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025. SUBCHAPTER C. HEALTH COVERAGE, COSTS, AND SERVICES

Tex. HEALTH & SAFETY Code § 491.058. FUNDING; DISBURSEMENT BY COMMISSION.

(a) The commission and consortium 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 subchapter. (b) Disbursements of funds by the commission may be made incrementally based on the completion of clearly defined objectives as negotiated in the contract described by Section 491.055 , including verifiable documentation demonstrating the efficient expenditure of both state and matching funds. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308 ), Sec. 1, eff. June 11, 2025.

Tex. HEALTH & SAFETY Code § 491.059. REPORTING REQUIREMENTS.

(a) A consortium selected to conduct ibogaine drug development clinical trials shall quarterly prepare and submit to the commission: (1) a report on the progress of the drug development clinical trials conducted under this subchapter; and (2) a financial status report, including information to verify expenditures of state funds and required matching funds. (b) The commission shall submit a report to the legislature on the progress of the drug development clinical trials conducted under this subchapter not later than December 1 of each year. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308 ), Sec. 1, eff. June 11, 2025.

Tex. HEALTH & SAFETY Code § 491.060. 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 consortium under this subchapter during the period for which the trials are funded and any following period of commercialization shall be allocated as follows: (1) not less than 20 percent to the state as specified in the contract under Section 491.055 ; and (2) the remainder to the members of the consortium in the amounts specified by written agreement of the members. (b) For purposes of this section, intellectual property rights and other commercial rights arising from the drug development clinical trials conducted under this subchapter 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. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308 ), Sec. 1, eff. June 11, 2025.

Tex. HEALTH & SAFETY Code § 491.061. USE OF STATE REVENUE.

(a) The comptroller shall deposit the revenue received under Section 491.060 to the credit of the general revenue fund. (b) Of the amount deposited under Subsection (a), 25 percent may be appropriated only to programs that assist veterans in this state. (c) The comptroller shall develop accounting procedures for the purpose of implementing this section. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308 ), Sec. 1, eff. June 11, 2025. SUBCHAPTER C. IBOGAINE TREATMENT ADMINISTRATION

Tex. HEALTH & SAFETY Code § 491.101. HEALTH COVERAGE.

This chapter does not affect: (1) the coverage required of an insurer under the Insurance Code; or (2) health care coverage of enrollees in clinical trials under Chapter 1379 , Insurance Code. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.102. COVERAGE OPTIONAL.

A health benefit plan issuer, third-party administrator, or governmental agency may, but is not required to, provide coverage for the cost of an individualized investigational treatment or the cost of services related to the use of an individualized investigational treatment under this chapter. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.103. HOSPITAL SERVICES.

This chapter does not require a hospital or health care facility licensed under Subtitle B, Title 4, to provide new or additional services unless approved by the hospital or facility. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.

Tex. HEALTH & SAFETY Code § 491.104. GOVERNMENTAL AGENCY NOT RESPONSIBLE FOR COSTS.

This chapter does not require a governmental agency to pay costs associated with the use, care, or treatment of a patient accessing an individualized investigational treatment. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025. SUBCHAPTER D. HEALTH CARE PROVIDERS

Tex. HEALTH & SAFETY Code § 491.151. PROHIBITED ACTION AGAINST LICENSE HOLDER OR MEDICAID PARTICIPANT.

(a) A state licensing board may not revoke, fail to renew, suspend, or take any action against a health care provider's license issued under Title 3, Occupations Code, based solely on the provider's recommendation to an eligible patient regarding access to or treatment with an individualized investigational treatment. (b) The Health and Human Services Commission may not take action against a health care provider that adversely affects the provider's participation in Medicaid based solely on the provider's recommendation for a patient to access an individualized investigational treatment. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984 ), Sec. 1, eff. September 1, 2025.
Source: TX Statutes (Official Site)URL: https://statutes.capitol.texas.gov/Fetched: 6/29/2026