Texas 2015 - 84th Regular

Texas House Bill HB438 Compare Versions

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

Old	New	Differences
1	1	84R494 JSC-D
2	2	By: Canales H.B. No. 438
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to authorizing patients with certain terminal conditions
8	8	to access certain investigational drugs, biological products, and
9	9	devices that are in clinical trials.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. (a) This Act shall be known as the "Right To Try
12	12	Act."
13	13	(b) The legislature finds that:
14	14	(1) the process of approval for investigational drugs,
15	15	biological products, and devices in the United States protects
16	16	future patients from premature, ineffective, and unsafe
17	17	medications and treatments over the long run, but the process often
18	18	takes many years;
19	19	(2) patients with a terminal condition do not have the
20	20	luxury of waiting until an investigational drug, biological
21	21	product, or device receives final approval from the United States
22	22	Food and Drug Administration;
23	23	(3) patients with a terminal condition have a
24	24	fundamental right to attempt to pursue the preservation of their
25	25	own lives by accessing available investigational drugs, biological
26	26	products, and devices;
27	27	(4) the use of available investigational drugs,
28	28	biological products, and devices is a decision that should be made
29	29	by the patient with a terminal condition in consultation with the
30	30	patient's physician and the patient's health care team, if
31	31	applicable; and
32	32	(5) the decision to use an investigational drug,
33	33	biological product, or device should be made with full awareness of
34	34	the potential risks, benefits, and consequences to the patient with
35	35	a terminal condition and the patient's family.
36	36	(c) It is the intent of the legislature to allow for
37	37	patients with a terminal condition to use potentially life-saving
38	38	investigational drugs, biological products, and devices.
39	39	SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
40	40	amended by adding Chapter 489 to read as follows:
41	41	CHAPTER 489. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
42	42	WITH TERMINAL CONDITIONS
43	43	SUBCHAPTER A. GENERAL PROVISIONS
44	44	Sec. 489.001. DEFINITIONS. In this chapter:
45	45	(1) "Investigational drug, biological product, or
46	46	device" means a drug, biological product, or device that has
47	47	successfully completed phase one of a clinical trial but has not yet
48	48	been approved for general use by the United States Food and Drug
49	49	Administration and remains under investigation in a United States
50	50	Food and Drug Administration approved clinical trial.
51	51	(2) "Terminal condition" means an incurable condition
52	52	caused by injury, disease, or illness that, without life-sustaining
53	53	procedures, will soon result in death or a state of permanent
54	54	unconsciousness from which recovery is unlikely.
55	55	SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
56	56	PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL CONDITIONS
57	57	Sec. 489.051. PATIENT ELIGIBILITY. A patient is eligible
58	58	to access and use an investigational drug, biological product, or
59	59	device under this chapter if:
60	60	(1) the patient has a terminal condition, attested to
61	61	by the patient's treating physician;
62	62	(2) the patient's physician:
63	63	(A) in consultation with the patient, has
64	64	considered all other treatment options currently approved by the
65	65	United States Food and Drug Administration and determined that
66	66	those treatment options are unlikely to prolong the patient's life;
67	67	and
68	68	(B) has recommended in writing that the patient
69	69	use a specific investigational drug, biological product, or device;
70	70	and
71	71	(3) the patient:
72	72	(A) is unable to participate in a clinical trial
73	73	of the recommended investigational drug, biological product, or
74	74	device within 100 miles of the patient's home address; or
75	75	(B) has not been accepted to the clinical trial
76	76	before the eighth calendar day after the patient completed the
77	77	application process for the trial.
78	78	Sec. 489.052. INFORMED CONSENT. (a) Before receiving an
79	79	investigational drug, biological product, or device, an eligible
80	80	patient must sign a written informed consent described by this
81	81	section that is attested to by the patient's physician and a
82	82	witness.
83	83	(b) The informed consent must:
84	84	(1) explain the currently approved products and
85	85	treatments for the disease or condition from which the patient
86	86	suffers;
87	87	(2) attest to the fact that the patient concurs with
88	88	the patient's physician in believing that all currently approved
89	89	and conventionally recognized treatments are unlikely to prolong
90	90	the patient's life;
91	91	(3) identify the specific proposed investigational
92	92	drug, biological product, or device that the patient is seeking to
93	93	use;
94	94	(4) describe the potentially best and worst outcomes
95	95	of using the investigational drug, biological product, or device
96	96	with a realistic description of the most likely outcome, including
97	97	the possibility that new, unanticipated, different, or worse
98	98	symptoms might result, and that death could be hastened by the
99	99	proposed treatment, based on the physician's knowledge of the
100	100	proposed treatment in conjunction with an awareness of the
101	101	patient's condition;
102	102	(5) state that the patient's health benefit plan is not
103	103	obligated to pay for any care or treatments resulting from the use
104	104	of the investigational drug, biological product, or device;
105	105	(6) state that the patient's eligibility for hospice
106	106	care may be withdrawn if the patient begins curative treatment and
107	107	that care may be reinstated if the curative treatment ends and the
108	108	patient meets hospice eligibility requirements;
109	109	(7) state that in-home health care may be denied if
110	110	treatment begins; and
111	111	(8) state that the patient understands that the
112	112	patient is liable for all expenses resulting from the use of the
113	113	investigational drug, biological product, or device, and that this
114	114	liability extends to the patient's estate, unless a contract
115	115	between the patient and the manufacturer of the drug, biological
116	116	product, or device provides otherwise.
117	117	(c) The executive commissioner of the Health and Human
118	118	Services Commission by rule may adopt a form for the informed
119	119	consent under this section.
120	120	Sec. 489.053. PROVISION OF INVESTIGATIONAL DRUG,
121	121	BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer
122	122	of an investigational drug, biological product, or device may make
123	123	available the manufacturer's investigational drug, biological
124	124	product, or device to eligible patients in accordance with this
125	125	chapter if the patient provides to the manufacturer the informed
126	126	consent required under Section 489.052.
127	127	(b) This chapter does not require that a manufacturer make
128	128	available an investigational drug, biological product, or device to
129	129	an eligible patient.
130	130	(c) A manufacturer may:
131	131	(1) provide an investigational drug, biological
132	132	product, or device to an eligible patient without receiving
133	133	compensation; or
134	134	(2) require an eligible patient to pay the costs of, or
135	135	the costs associated with, the manufacture of the investigational
136	136	drug, biological product, or device.
137	137	Sec. 489.054. NO CAUSE OF ACTION CREATED. This chapter does
138	138	not create a private cause of action against a manufacturer of an
139	139	investigational drug, biological product, or device or against any
140	140	other person or entity involved in the care of an eligible patient
141	141	using the investigational drug, biological product, or device for
142	142	any harm done to the eligible patient resulting from the
143	143	investigational drug, biological product, or device.
144	144	Sec. 489.055. STATE MAY NOT INTERFERE WITH ACCESS TO
145	145	INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. (a) An
146	146	official, employee, or agent of this state may not block or attempt
147	147	to block an eligible patient's access to an investigational drug,
148	148	biological product, or device under this section.
149	149	(b) Counseling, advice, or a recommendation consistent with
150	150	medical standards of care from a licensed health care provider is
151	151	not a violation of this section.
152	152	SUBCHAPTER C. HEALTH INSURANCE
153	153	Sec. 489.101. APPLICABILITY OF SUBCHAPTER. (a) This
154	154	subchapter applies only to a health benefit plan that provides
155	155	benefits for medical or surgical expenses incurred as a result of a
156	156	health condition, accident, or sickness, including an individual,
157	157	group, blanket, or franchise insurance policy or insurance
158	158	agreement, a group hospital service contract, or a small or large
159	159	employer group contract or similar coverage document that is
160	160	offered by:
161	161	(1) an insurance company;
162	162	(2) a group hospital service corporation operating
163	163	under Chapter 842, Insurance Code;
164	164	(3) a fraternal benefit society operating under
165	165	Chapter 885, Insurance Code;
166	166	(4) a stipulated premium company operating under
167	167	Chapter 884, Insurance Code;
168	168	(5) a reciprocal exchange operating under Chapter 942,
169	169	Insurance Code;
170	170	(6) a health maintenance organization operating under
171	171	Chapter 843, Insurance Code;
172	172	(7) a multiple employer welfare arrangement that holds
173	173	a certificate of authority under Chapter 846, Insurance Code; or
174	174	(8) an approved nonprofit health corporation that
175	175	holds a certificate of authority under Chapter 844, Insurance Code.
176	176	(b) This subchapter applies to group health coverage made
177	177	available by a school district in accordance with Section 22.004,
178	178	Education Code.
179	179	(c) Notwithstanding Section 172.014, Local Government Code,
180	180	or any other law, this subchapter applies to health and accident
181	181	coverage provided by a risk pool created under Chapter 172, Local
182	182	Government Code.
183	183	(d) Notwithstanding any provision in Chapter 1551, 1575,
184	184	1579, or 1601, Insurance Code, or any other law, this subchapter
185	185	applies to:
186	186	(1) a basic coverage plan under Chapter 1551,
187	187	Insurance Code;
188	188	(2) a basic plan under Chapter 1575, Insurance Code;
189	189	(3) a primary care coverage plan under Chapter 1579,
190	190	Insurance Code; and
191	191	(4) basic coverage under Chapter 1601, Insurance Code.
192	192	(e) Notwithstanding any other law, this subchapter applies
193	193	to coverage under:
194	194	(1) the child health plan program under Chapter 62 or
195	195	the health benefits plan for children under Chapter 63; and
196	196	(2) the medical assistance program under Chapter 32,
197	197	Human Resources Code.
198	198	Sec. 489.102. HEALTH BENEFIT PLANS. (a) A health benefit
199	199	plan may, but is not required to, provide coverage for the cost of
200	200	an investigational drug, biological product, or device.
201	201	(b) Except as otherwise provided by this section, a health
202	202	benefit plan may deny coverage to an eligible patient from the date
203	203	the eligible patient begins use of the investigational drug,
204	204	biological product, or device until the 181st day after the date the
205	205	patient ceases using the investigational drug, biological product,
206	206	or device.
207	207	(c) A health benefit plan issuer may not deny covered
208	208	benefits under Subsection (b) for a condition that existed before
209	209	the date the eligible patient begins use of the investigational
210	210	drug, biological product, or device, regardless of whether the
211	211	issuer was providing benefits for the condition before that date.
212	212	Sec. 489.103. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
213	213	TRIAL ENROLLEES. This chapter does not affect the coverage of
214	214	enrollees in clinical trials under Chapter 1379, Insurance Code.
215	215	SUBCHAPTER D. PHYSICIANS
216	216	Sec. 489.151. ACTION AGAINST PHYSICIAN'S LICENSE
217	217	PROHIBITED. Notwithstanding any other law, the Texas Medical Board
218	218	may not revoke, fail to renew, suspend, or take any action against
219	219	a physician's license issued under Subchapter B, Chapter 164,
220	220	Occupations Code, based solely on the physician's recommendations
221	221	to an eligible patient regarding access to or treatment with an
222	222	investigational drug, biological product, or device.
223	223	SECTION 3. This Act takes effect immediately if it receives
224	224	a vote of two-thirds of all the members elected to each house, as
225	225	provided by Section 39, Article III, Texas Constitution. If this
226	226	Act does not receive the vote necessary for immediate effect, this
227	227	Act takes effect September 1, 2015.