HEALTH AND SAFETY CODE

TITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCES

SUBTITLE C. SUBSTANCE ABUSE REGULATION AND CRIMES

Chapter 491, consisting of Secs. 491.001 to 491.151, was added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984), Sec. 1.

For another Chapter 491, consisting of Secs. 491.001 to 491.103, added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec. 1, see Sec. 491.001 et seq., post.

For another Chapter 491, consisting of Secs. 491.001 to 491.151, added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, see Sec. 491.001 et seq., post.

CHAPTER 491.  ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENTS FOR PATIENTS WITH LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESSES

SUBCHAPTER A.  GENERAL PROVISIONS

Sec. 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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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

Sec. 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.