Texas 2023 - 88th Regular

Texas House Bill HB4059 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New	Differences
1	1	88R12381 KKR-F
2	2	By: King of Hemphill, Kacal, H.B. No. 4059
3	3	A. Johnson of Harris, Thompson of Harris,
4	4
5	5
6	6	A BILL TO BE ENTITLED
7	7	AN ACT
8	8	relating to the right to try cutting-edge treatments for patients
9	9	with life-threatening or severely debilitating illnesses.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. Title 6, Health and Safety Code, is amended by
12	12	adding Subtitle C-1 to read as follows:
13	13	SUBTITLE C-1. INVESTIGATIONAL TREATMENTS
14	14	CHAPTER 491. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENTS
15	15	FOR PATIENTS WITH LIFE-THREATENING OR SEVERELY DEBILITATING
16	16	ILLNESSES
17	17	SUBCHAPTER A. GENERAL PROVISIONS
18	18	Sec. 491.001. DEFINITIONS. In this chapter:
19	19	(1) "Individualized investigational treatment" means
20	20	a drug, biological product, or device that is unique to and produced
21	21	exclusively for use by an individual patient, based on the
22	22	patient's genetic profile. The term includes individualized gene
23	23	therapy antisense oligonucleotides and individualized neoantigen
24	24	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 and renewals or updates to the laws, regulations,
42	42	policies, and guidelines.
43	43	Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible
44	44	to receive an individualized investigational treatment under this
45	45	chapter if:
46	46	(1) the patient:
47	47	(A) has a life-threatening illness or severely
48	48	debilitating illness;
49	49	(B) has considered all other treatment options
50	50	currently approved by the United States Food and Drug
51	51	Administration; and
52	52	(C) has given written informed consent for the
53	53	use of the individualized investigational treatment; and
54	54	(2) the patient's physician:
55	55	(A) attests to the patient's life-threatening
56	56	illness or severely debilitating illness and that the patient meets
57	57	the requirements under this section; and
58	58	(B) recommends an individualized investigational
59	59	treatment for the patient based on analysis of the patient's
60	60	genomic sequence, human chromosomes, deoxyribonucleic acid,
61	61	ribonucleic acid, genes, gene products such as enzymes and other
62	62	types of proteins, or metabolites.
63	63	Sec. 491.053. INFORMED CONSENT. (a) An eligible patient
64	64	may not receive an individualized investigational treatment unless
65	65	the patient provides written informed consent. If the patient is a
66	66	minor or lacks the mental capacity to provide informed consent, a
67	67	parent, legal guardian, managing conservator, or patient's agent as
68	68	defined by Section 166.151 may provide written informed consent on
69	69	the patient's behalf.
70	70	(b) Informed consent under this chapter must be attested to
71	71	in writing by the patient's physician and a witness.
72	72	(c) Informed consent under this chapter must include at a
73	73	minimum:
74	74	(1) an explanation of the currently approved products
75	75	and treatments for the patient's disease or condition;
76	76	(2) an attestation that the patient concurs with the
77	77	patient's physician in believing that all currently approved and
78	78	conventionally recognized treatments are unlikely to prolong the
79	79	patient's life;
80	80	(3) clear identification of the specific proposed
81	81	individualized investigational drug, biological product, or device
82	82	the patient's physician recommends;
83	83	(4) a description, based on the physician's knowledge
84	84	of the proposed treatment in conjunction with an awareness of the
85	85	patient's disease or condition, of the potentially best and worst
86	86	outcomes of using the individualized investigational treatment,
87	87	and of the most likely outcome, including the possibility that new,
88	88	unanticipated, different, or worse symptoms might result and that
89	89	death could be hastened by the proposed treatment;
90	90	(5) a statement that the patient's health benefit plan
91	91	issuer or third-party administrator and provider are not obligated
92	92	to pay the cost of any care or treatments related to the use of the
93	93	individualized investigational treatment unless payment is
94	94	specifically required by law or contract;
95	95	(6) a statement that the patient's eligibility for
96	96	hospice care may be withdrawn if the patient begins curative
97	97	treatment with the individualized investigational treatment and
98	98	that care may be reinstated if this treatment ends and the patient
99	99	meets hospice eligibility requirements; and
100	100	(7) a statement that the patient understands the
101	101	patient is liable for all expenses related to the use of the
102	102	individualized investigational treatment and the liability extends
103	103	to the patient's estate, unless a contract between the patient and
104	104	the manufacturer of the individualized investigational treatment
105	105	states otherwise.
106	106	Sec. 491.054. PROVISION OF TREATMENT; COSTS. (a) A
107	107	manufacturer operating within an eligible health care facility and
108	108	in compliance with all applicable federal assurance laws and
109	109	regulations may make available an individualized investigative
110	110	treatment, and an eligible patient may request to receive an
111	111	individualized investigational treatment from an eligible health
112	112	care facility or manufacturer operating within an eligible health
113	113	care facility under this chapter.
114	114	(b) A manufacturer is not required under this chapter to
115	115	make available an individualized investigational treatment to an
116	116	eligible patient.
117	117	(c) An eligible health care facility or manufacturer
118	118	operating within an eligible health care facility may:
119	119	(1) provide an individualized investigational
120	120	treatment to an eligible patient without receiving compensation; or
121	121	(2) require an eligible patient to pay the costs of, or
122	122	the costs associated with, the manufacture of the individualized
123	123	investigational treatment.
124	124	Sec. 491.055. DEBT LIABILITY ON DEATH OF PATIENT. If a
125	125	patient dies while being treated under an individualized
126	126	investigational treatment, the patient's heirs are not liable for
127	127	any outstanding debt related to the treatment or lack of health
128	128	coverage due to the treatment.
129	129	Sec. 491.056. NO PRIVATE CAUSE OF ACTION. This chapter does
130	130	not create a private cause of action against a manufacturer of an
131	131	individualized investigational treatment or against any other
132	132	person involved in the care of an eligible patient using the
133	133	individualized investigational treatment for any harm to the
134	134	eligible patient resulting from the individualized investigational
135	135	treatment if the manufacturer or other person is complying in good
136	136	faith with the terms of this chapter and has exercised reasonable
137	137	care.
138	138	Sec. 491.057. STATE MAY NOT INTERFERE WITH ACCESS TO
139	139	TREATMENT. (a) An officer, employee, or agent of this state may
140	140	not block or attempt to block an eligible patient's access to an
141	141	individualized investigational treatment that complies with this
142	142	chapter and rules adopted under this chapter.
143	143	(b) Notwithstanding Subsection (a), counseling, advice, or
144	144	a recommendation consistent with medical standards of care from a
145	145	licensed health care provider is not a violation of this section.
146	146	SUBCHAPTER C. HEALTH COVERAGE AND SERVICES
147	147	Sec. 491.101. HEALTH COVERAGE. This chapter does not
148	148	affect:
149	149	(1) the coverage required of an insurer under the
150	150	Insurance Code; or
151	151	(2) health care coverage of enrollees in clinical
152	152	trials under Chapter 1379, Insurance Code.
153	153	Sec. 491.102. GOVERNMENTAL AGENCY NOT RESPONSIBLE FOR
154	154	COSTS. This chapter does not require a governmental agency to pay
155	155	costs associated with the use, care, or treatment of a patient with
156	156	an individualized investigational treatment.
157	157	Sec. 491.103. HOSPITAL SERVICES. This chapter does not
158	158	require a hospital or health care facility licensed under Subtitle
159	159	B, Title 4, to provide new or additional services unless approved by
160	160	the hospital or facility.
161	161	Sec. 491.104. COVERAGE OPTIONAL. A health benefit plan
162	162	issuer, third-party administrator, or governmental agency may, but
163	163	is not required to, provide coverage for the cost of an
164	164	individualized investigational treatment or the cost of services
165	165	related to the use of an individualized investigational treatment
166	166	under this chapter.
167	167	SUBCHAPTER D. HEALTH CARE PROVIDERS
168	168	Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE OR
169	169	CERTIFICATION HOLDER. (a) A state licensing board may not revoke,
170	170	fail to renew, suspend, or take any action against a health care
171	171	provider's license issued under Title 3, Occupations Code, based
172	172	solely on the health care provider's recommendation to an eligible
173	173	patient regarding access to or treatment with an individualized
174	174	investigational treatment.
175	175	(b) The Health and Human Services Commission may not take
176	176	action against a health care provider's Medicare certification
177	177	based solely on the health care provider's recommendation that a
178	178	patient have access to an individualized investigational
179	179	treatment.
180	180	SECTION 2. This Act takes effect September 1, 2023.