89R1259 KKR-F
By: King H.B. No. 3318
A BILL TO BE ENTITLED
AN ACT
relating to access to individualized investigational treatments
for patients with life-threatening or severely debilitating
illnesses.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle C, Title 6, Health and Safety Code, is
amended by adding Chapter 491 to read as follows:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
SECTION 2. This Act takes effect September 1, 2025.