Texas 2025 - 89th Regular

Texas House Bill HB3318 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	89R1259 KKR-F
2	2	By: King H.B. No. 3318
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7	7	A BILL TO BE ENTITLED
8	8	AN ACT
9	9	relating to access to individualized investigational treatments
10	10	for patients with life-threatening or severely debilitating
11	11	illnesses.
12	12	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
13	13	SECTION 1. Subtitle C, Title 6, Health and Safety Code, is
14	14	amended by adding Chapter 491 to read as follows:
15	15	CHAPTER 491. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENTS
16	16	FOR PATIENTS WITH LIFE-THREATENING OR SEVERELY DEBILITATING
17	17	ILLNESSES
18	18	SUBCHAPTER A. GENERAL PROVISIONS
19	19	Sec. 491.001. DEFINITIONS. In this chapter:
20	20	(1) "Individualized investigational treatment" means
21	21	a drug, biological product, or device unique to and produced
22	22	exclusively for use by a patient, based on the patient's genetic
23	23	profile. The term includes individualized gene therapy antisense
24	24	oligonucleotides and individualized neoantigen vaccines.
25	25	(2) "Life-threatening illness" means a disease or
26	26	condition with:
27	27	(A) a significantly increased likelihood of
28	28	death unless the course of the disease or condition is interrupted;
29	29	or
30	30	(B) potentially fatal outcomes and for which the
31	31	goal of clinical trials is survival.
32	32	(3) "Severely debilitating illness" means a disease or
33	33	condition that causes major irreversible morbidity.
34	34	SUBCHAPTER B. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENT
35	35	Sec. 491.051. HEALTH CARE FACILITY ELIGIBILITY. A health
36	36	care facility is eligible to provide an individualized
37	37	investigational treatment under this chapter if the facility is
38	38	operating under a federal assurance for the protection of human
39	39	subjects under 42 U.S.C. Section 289(a) and 45 C.F.R. Part 46 and is
40	40	subject to the federal assurance laws, regulations, policies, and
41	41	guidelines.
42	42	Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible
43	43	to access an individualized investigational treatment under this
44	44	chapter if:
45	45	(1) the patient:
46	46	(A) has a life-threatening illness or severely
47	47	debilitating illness;
48	48	(B) has considered all other treatment options
49	49	currently approved by the United States Food and Drug
50	50	Administration; and
51	51	(C) has given written informed consent for access
52	52	to the treatment; and
53	53	(2) the patient's physician:
54	54	(A) attests to the patient's life-threatening
55	55	illness or severely debilitating illness and the patient's
56	56	eligibility under this section; and
57	57	(B) recommends the treatment for the patient
58	58	based on analysis of the patient's genomic sequence, human
59	59	chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene
60	60	products such as enzymes and other types of proteins, or
61	61	metabolites.
62	62	Sec. 491.053. INFORMED CONSENT. (a) An eligible patient
63	63	may not access an individualized investigational treatment unless
64	64	the patient provides written informed consent. If the patient is a
65	65	minor or lacks the mental capacity to provide informed consent, a
66	66	parent, legal guardian, managing conservator, or patient's agent as
67	67	defined by Section 166.151 may provide written informed consent on
68	68	the patient's behalf.
69	69	(b) Informed consent under this chapter must be attested to
70	70	in writing by the patient's physician and a witness.
71	71	(c) Informed consent under this chapter must include at a
72	72	minimum:
73	73	(1) an explanation of the currently approved
74	74	treatments for the patient's disease or condition;
75	75	(2) the patient's attestation that the patient concurs
76	76	with the assessment of the patient's physician that all currently
77	77	approved and conventionally recognized treatments are unlikely to
78	78	prolong the patient's life;
79	79	(3) clear identification of the specific proposed
80	80	individualized investigational drug, biological product, or device
81	81	the patient's physician recommends;
82	82	(4) a description, based on the physician's knowledge
83	83	of the proposed treatment in conjunction with an awareness of the
84	84	patient's disease or condition, of the potentially best and worst
85	85	outcomes of using the treatment, and of the most likely outcome,
86	86	including the possibility that new, unanticipated, different, or
87	87	worse symptoms might result and that death could be hastened by the
88	88	treatment;
89	89	(5) a statement that the patient's health benefit plan
90	90	issuer or third-party administrator and provider are not obligated
91	91	to pay the cost of any care related to the use of the treatment
92	92	unless payment is specifically required by law or contract;
93	93	(6) a statement that the patient's eligibility for
94	94	hospice care may be withdrawn if the patient begins the treatment
95	95	and that care may be reinstated if the treatment ends and the
96	96	patient meets hospice eligibility requirements; and
97	97	(7) a statement that the patient understands the
98	98	patient is liable for all expenses related to the use of the
99	99	treatment and the liability extends to the patient's estate, unless
100	100	a contract between the patient and the manufacturer of the
101	101	treatment provides otherwise.
102	102	Sec. 491.054. ACCESS TO TREATMENT; COSTS. (a) A
103	103	manufacturer operating within an eligible health care facility and
104	104	in compliance with all applicable federal assurance laws and
105	105	regulations may make available an individualized investigational
106	106	treatment, and an eligible patient may request access to the
107	107	treatment from an eligible health care facility or manufacturer
108	108	operating within an eligible health care facility under this
109	109	chapter.
110	110	(b) A manufacturer is not required under this chapter to
111	111	make available an individualized investigational treatment to an
112	112	eligible patient.
113	113	(c) An eligible health care facility or manufacturer
114	114	operating within an eligible health care facility may:
115	115	(1) provide an individualized investigational
116	116	treatment to an eligible patient without receiving compensation; or
117	117	(2) require an eligible patient to pay the costs of, or
118	118	the costs associated with, the manufacture of the treatment.
119	119	Sec. 491.055. DEBT LIABILITY ON DEATH OF PATIENT. If a
120	120	patient dies while receiving an individualized investigational
121	121	treatment, the patient's heirs are not liable for any outstanding
122	122	debt related to the treatment or lack of health coverage due to the
123	123	treatment.
124	124	Sec. 491.056. NO PRIVATE CAUSE OF ACTION. This chapter does
125	125	not create a private cause of action against a manufacturer of an
126	126	individualized investigational treatment or against any other
127	127	person involved in the care of an eligible patient using the
128	128	treatment for any harm to the patient resulting from the treatment
129	129	if the manufacturer or other person is complying in good faith with
130	130	the terms of this chapter and has exercised reasonable care.
131	131	Sec. 491.057. PROHIBITED STATE INTERFERENCE WITH ACCESS TO
132	132	TREATMENT. (a) An officer, employee, or agent of this state may
133	133	not block or attempt to block an eligible patient's access to an
134	134	individualized investigational treatment that complies with this
135	135	chapter and rules adopted under this chapter.
136	136	(b) Notwithstanding Subsection (a), counseling, advice, or
137	137	a recommendation consistent with medical standards of care from a
138	138	licensed health care provider is not a violation of this section.
139	139	SUBCHAPTER C. HEALTH COVERAGE, COSTS, AND SERVICES
140	140	Sec. 491.101. HEALTH COVERAGE. This chapter does not
141	141	affect:
142	142	(1) the coverage required of an insurer under the
143	143	Insurance Code; or
144	144	(2) health care coverage of enrollees in clinical
145	145	trials under Chapter 1379, Insurance Code.
146	146	Sec. 491.102. COVERAGE OPTIONAL. A health benefit plan
147	147	issuer, third-party administrator, or governmental agency may, but
148	148	is not required to, provide coverage for the cost of an
149	149	individualized investigational treatment or the cost of services
150	150	related to the use of an individualized investigational treatment
151	151	under this chapter.
152	152	Sec. 491.103. HOSPITAL SERVICES. This chapter does not
153	153	require a hospital or health care facility licensed under Subtitle
154	154	B, Title 4, to provide new or additional services unless approved by
155	155	the hospital or facility.
156	156	Sec. 491.104. GOVERNMENTAL AGENCY NOT RESPONSIBLE FOR
157	157	COSTS. This chapter does not require a governmental agency to pay
158	158	costs associated with the use, care, or treatment of a patient
159	159	accessing an individualized investigational treatment.
160	160	SUBCHAPTER D. HEALTH CARE PROVIDERS
161	161	Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE HOLDER OR
162	162	MEDICAID PARTICIPANT. (a) A state licensing board may not revoke,
163	163	fail to renew, suspend, or take any action against a health care
164	164	provider's license issued under Title 3, Occupations Code, based
165	165	solely on the provider's recommendation to an eligible patient
166	166	regarding access to or treatment with an individualized
167	167	investigational treatment.
168	168	(b) The Health and Human Services Commission may not take
169	169	action against a health care provider that adversely affects the
170	170	provider's participation in Medicaid based solely on the provider's
171	171	recommendation for a patient to access an individualized
172	172	investigational treatment.
173	173	SECTION 2. This Act takes effect September 1, 2025.