88R12381 KKR-F
	By: Harrison	H.B. No. 4348

	A BILL TO BE ENTITLED
	AN ACT
	relating to the right to try cutting-edge treatments for patients
	with life-threatening or severely debilitating illnesses.
	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
	SECTION 1.  Title 6, Health and Safety Code, is amended by
	adding Subtitle C-1 to read as follows:
	SUBTITLE C-1. INVESTIGATIONAL TREATMENTS
	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 that is unique to and produced
	exclusively for use by an individual 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 and renewals or updates to the laws, regulations,
	policies, and guidelines.
	Sec. 491.052.  PATIENT ELIGIBILITY. A patient is eligible
	to receive 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 the
	use of the individualized investigational treatment; and
	(2)  the patient's physician:
	(A)  attests to the patient's life-threatening
	illness or severely debilitating illness and that the patient meets
	the requirements under this section; and
	(B)  recommends an individualized investigational
	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 receive 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 products
	and treatments for the patient's disease or condition;
	(2)  an attestation that the patient concurs with the
	patient's physician in believing 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 individualized investigational 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 proposed 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 or treatments related to the use of the
	individualized investigational 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 curative
	treatment with the individualized investigational treatment and
	that care may be reinstated if this 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
	individualized investigational treatment and the liability extends
	to the patient's estate, unless a contract between the patient and
	the manufacturer of the individualized investigational treatment
	states otherwise.
	Sec. 491.054.  PROVISION OF 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 investigative
	treatment, and an eligible patient may request to receive an
	individualized investigational 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 individualized
	investigational treatment.
	Sec. 491.055.  DEBT LIABILITY ON DEATH OF PATIENT. If a
	patient dies while being treated under 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
	individualized investigational treatment for any harm to the
	eligible patient resulting from the individualized investigational
	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.  STATE MAY NOT INTERFERE 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 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.  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 with
	an individualized investigational treatment.
	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.  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.
	SUBCHAPTER D. HEALTH CARE PROVIDERS
	Sec. 491.151.  PROHIBITED ACTION AGAINST LICENSE OR
	CERTIFICATION HOLDER. (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 health care 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's Medicare certification
	based solely on the health care provider's recommendation that a
	patient have access to an individualized investigational
	treatment.
	SECTION 2.  This Act takes effect September 1, 2023.