Texas 2023 - 88th Regular

Texas Senate Bill SB1580 Compare Versions

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1	1	88R12381 KKR-F
2	2	By: Bettencourt S.B. No. 1580
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the right to try cutting-edge treatments for patients
8	8	with life-threatening or severely debilitating illnesses.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Title 6, Health and Safety Code, is amended by
11	11	adding Subtitle C-1 to read as follows:
12	12	SUBTITLE C-1. INVESTIGATIONAL TREATMENTS
13	13	CHAPTER 491. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENTS
14	14	FOR PATIENTS WITH LIFE-THREATENING OR SEVERELY DEBILITATING
15	15	ILLNESSES
16	16	SUBCHAPTER A. GENERAL PROVISIONS
17	17	Sec. 491.001. DEFINITIONS. In this chapter:
18	18	(1) "Individualized investigational treatment" means
19	19	a drug, biological product, or device that is unique to and produced
20	20	exclusively for use by an individual patient, based on the
21	21	patient's genetic profile. The term includes individualized gene
22	22	therapy antisense oligonucleotides and individualized neoantigen
23	23	vaccines.
24	24	(2) "Life-threatening illness" means a disease or
25	25	condition with:
26	26	(A) a significantly increased likelihood of
27	27	death unless the course of the disease or condition is interrupted;
28	28	or
29	29	(B) potentially fatal outcomes and for which the
30	30	goal of clinical trials is survival.
31	31	(3) "Severely debilitating illness" means a disease or
32	32	condition that causes major irreversible morbidity.
33	33	SUBCHAPTER B. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENT
34	34	Sec. 491.051. HEALTH CARE FACILITY ELIGIBILITY. A health
35	35	care facility is eligible to provide an individualized
36	36	investigational treatment under this chapter if the facility is
37	37	operating under a federal assurance for the protection of human
38	38	subjects under 42 U.S.C. Section 289(a) and 45 C.F.R. Part 46 and is
39	39	subject to the federal assurance laws, regulations, policies, and
40	40	guidelines and renewals or updates to the laws, regulations,
41	41	policies, and guidelines.
42	42	Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible
43	43	to receive 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 the
52	52	use of the individualized investigational 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 that the patient meets
56	56	the requirements under this section; and
57	57	(B) recommends an individualized investigational
58	58	treatment for the patient based on analysis of the patient's
59	59	genomic sequence, human chromosomes, deoxyribonucleic acid,
60	60	ribonucleic acid, genes, gene products such as enzymes and other
61	61	types of proteins, or metabolites.
62	62	Sec. 491.053. INFORMED CONSENT. (a) An eligible patient
63	63	may not receive 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 products
74	74	and treatments for the patient's disease or condition;
75	75	(2) an attestation that the patient concurs with the
76	76	patient's physician in believing that all currently approved and
77	77	conventionally recognized treatments are unlikely to prolong the
78	78	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 individualized investigational treatment,
86	86	and of the most likely outcome, including the possibility that new,
87	87	unanticipated, different, or worse symptoms might result and that
88	88	death could be hastened by the proposed 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 or treatments related to the use of the
92	92	individualized investigational treatment unless payment is
93	93	specifically required by law or contract;
94	94	(6) a statement that the patient's eligibility for
95	95	hospice care may be withdrawn if the patient begins curative
96	96	treatment with the individualized investigational treatment and
97	97	that care may be reinstated if this treatment ends and the patient
98	98	meets hospice eligibility requirements; and
99	99	(7) a statement that the patient understands the
100	100	patient is liable for all expenses related to the use of the
101	101	individualized investigational treatment and the liability extends
102	102	to the patient's estate, unless a contract between the patient and
103	103	the manufacturer of the individualized investigational treatment
104	104	states otherwise.
105	105	Sec. 491.054. PROVISION OF TREATMENT; COSTS. (a) A
106	106	manufacturer operating within an eligible health care facility and
107	107	in compliance with all applicable federal assurance laws and
108	108	regulations may make available an individualized investigative
109	109	treatment, and an eligible patient may request to receive an
110	110	individualized investigational treatment from an eligible health
111	111	care facility or manufacturer operating within an eligible health
112	112	care facility under this chapter.
113	113	(b) A manufacturer is not required under this chapter to
114	114	make available an individualized investigational treatment to an
115	115	eligible patient.
116	116	(c) An eligible health care facility or manufacturer
117	117	operating within an eligible health care facility may:
118	118	(1) provide an individualized investigational
119	119	treatment to an eligible patient without receiving compensation; or
120	120	(2) require an eligible patient to pay the costs of, or
121	121	the costs associated with, the manufacture of the individualized
122	122	investigational treatment.
123	123	Sec. 491.055. DEBT LIABILITY ON DEATH OF PATIENT. If a
124	124	patient dies while being treated under an individualized
125	125	investigational treatment, the patient's heirs are not liable for
126	126	any outstanding debt related to the treatment or lack of health
127	127	coverage due to the treatment.
128	128	Sec. 491.056. NO PRIVATE CAUSE OF ACTION. This chapter does
129	129	not create a private cause of action against a manufacturer of an
130	130	individualized investigational treatment or against any other
131	131	person involved in the care of an eligible patient using the
132	132	individualized investigational treatment for any harm to the
133	133	eligible patient resulting from the individualized investigational
134	134	treatment if the manufacturer or other person is complying in good
135	135	faith with the terms of this chapter and has exercised reasonable
136	136	care.
137	137	Sec. 491.057. STATE MAY NOT INTERFERE WITH ACCESS TO
138	138	TREATMENT. (a) An officer, employee, or agent of this state may
139	139	not block or attempt to block an eligible patient's access to an
140	140	individualized investigational treatment that complies with this
141	141	chapter and rules adopted under this chapter.
142	142	(b) Notwithstanding Subsection (a), counseling, advice, or
143	143	a recommendation consistent with medical standards of care from a
144	144	licensed health care provider is not a violation of this section.
145	145	SUBCHAPTER C. HEALTH COVERAGE AND SERVICES
146	146	Sec. 491.101. HEALTH COVERAGE. This chapter does not
147	147	affect:
148	148	(1) the coverage required of an insurer under the
149	149	Insurance Code; or
150	150	(2) health care coverage of enrollees in clinical
151	151	trials under Chapter 1379, Insurance Code.
152	152	Sec. 491.102. GOVERNMENTAL AGENCY NOT RESPONSIBLE FOR
153	153	COSTS. This chapter does not require a governmental agency to pay
154	154	costs associated with the use, care, or treatment of a patient with
155	155	an individualized investigational treatment.
156	156	Sec. 491.103. HOSPITAL SERVICES. This chapter does not
157	157	require a hospital or health care facility licensed under Subtitle
158	158	B, Title 4, to provide new or additional services unless approved by
159	159	the hospital or facility.
160	160	Sec. 491.104. COVERAGE OPTIONAL. A health benefit plan
161	161	issuer, third-party administrator, or governmental agency may, but
162	162	is not required to, provide coverage for the cost of an
163	163	individualized investigational treatment or the cost of services
164	164	related to the use of an individualized investigational treatment
165	165	under this chapter.
166	166	SUBCHAPTER D. HEALTH CARE PROVIDERS
167	167	Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE OR
168	168	CERTIFICATION HOLDER. (a) A state licensing board may not revoke,
169	169	fail to renew, suspend, or take any action against a health care
170	170	provider's license issued under Title 3, Occupations Code, based
171	171	solely on the health care provider's recommendation to an eligible
172	172	patient regarding access to or treatment with an individualized
173	173	investigational treatment.
174	174	(b) The Health and Human Services Commission may not take
175	175	action against a health care provider's Medicare certification
176	176	based solely on the health care provider's recommendation that a
177	177	patient have access to an individualized investigational
178	178	treatment.
179	179	SECTION 2. This Act takes effect September 1, 2023.