Arkansas 2025 Regular Session

Arkansas Senate Bill SB136 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		Stricken language would be deleted from and underlined language would be added to present law.
2		-	Act 201 of the Regular Session
3	2		JMB027 01/28/2025 7:59:29 AM JMB027
4	3		State of Arkansas 1
5	4		95th General Assembly A Bill 2
6	5		Regular Session, 2025 SENATE BILL 136 3
7	6		4
8	7		By: Senator J. Boyd 5
9	8		By: Representative Gramlich 6
10	9		7
11	10		For An Act To Be Entitled 8
12	11		AN ACT TO CREATE THE RIGHT TO TRY INDIVIDUALIZED 9
13	12		INVESTIGATIONAL TREATMENT ACT; TO ESTABLISH 10
14	13		PROCEDURES FOR PATIENTS TO TRY INDIVIDUALIZED 11
15	14		INVESTIGATIONAL TREATMENTS; TO ENSURE THAT PATIENTS 12
16	15		WITH LIFE-THREATENING OR SEVERELY DEBILITATING 13
17	16		ILLNESS HAVE ACCESS TO INDIVIDUALIZED INVESTIGATIONAL 14
18	17		TREATMENT; AND FOR OTHER PURPOSES. 15
19	18		16
20	19		17
21	20		Subtitle 18
22	21		TO CREATE THE RIGHT TO TRY 19
23	22		INDIVIDUALIZED INVESTIGATIONAL TREATMENT 20
24	23		ACT; AND TO ENSURE THAT PATIENTS HAVE 21
25	24		ACCESS TO INDIVIDUALIZED INVESTIGATIONAL 22
26	25		TREATMENT. 23
27	26		24
28	27		BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 25
29	28		26
30	29		SECTION 1. Arkansas Code Title 20, Chapter 15, is amended to add an 27
31	30		additional subchapter to read as follows: 28
32	31		Subchapter 25 — Right to Try Individualized Investigational Treatment Act 29
33	32		30
34	33		20-15-2501. Title. 31
35	34		This subchapter shall be known and may be cited as the "Right to Try 32
36	35		Individualized Investigational Treatment Act". 33
37	36		34
38	37		20-15-2502. Definitions. 35
39	38		As used in this subchapter: 36 SB136
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42	41		(1) “Costs associated with the manufacture of the individualized 1
43	42		investigational treatment” means the actual out -of-pocket costs incurred in 2
44	43		providing the individualized investigational treatment to the patient in his 3
45	44		or her specific case; 4
46	45		(2) "Eligible facility" means an institution that is operating 5
47	46		under a Federalwide Assurance for the Protection of Human Subjects under 42 6
48	47		U.S.C. § 289(a) and 45 C.F.R. Part 46, as existing on January 1, 2025, and is 7
49	48		subject to the laws, regulations, policies, and guidelines relating to 8
50	49		Federalwide Assurance for the Protection of Human Subjects, including 9
51	50		renewals or updates; 10
52	51		(3) “Eligible patient” means a person who meets the requirements 11
53	52		of eligibility under § 20 -15-2503; 12
54	53		(4) "Individualized investigational treatment" means a drug, 13
55	54		biological product, or device that is unique to and produced exclusively for 14
56	55		use for an individual patient, based on his or her own genetic profile, 15
57	56		including without limitation an individualized gene therapy antisense 16
58	57		oligonucleotide and individualized neoantigen vaccines; 17
59	58		(5) "Life-threatening" means a disease or condition: 18
60	59		(A) Where the likelihood of death is high unless the 19
61	60		course of the disease or condition is interrupted; and 20
62	61		(B) With a potentially fatal outcome, where the endpoint 21
63	62		of clinical trial analysis is survival; 22
64	63		(6) “Physician” means an individual licensed to practice 23
65	64		medicine in the State of Arkansas under the Arkansas Medical Practices Act, § 24
66	65		17-95-201 et seq., § 17-95-301 et seq., and § 17 -95-401 et seq.; and 25
67	66		(7) "Severely debilitating" means a disease or condition that 26
68	67		causes major irreversible morbidity. 27
69	68		28
70	69		20-15-2503. Eligibility. 29
71	70		In order for a patient to access an individualized investigational 30
72	71		treatment under this subchapter, a physician shall document in the patient's 31
73	72		medical record and chart that the patient: 32
74	73		(1) Has a life-threatening or severely debilitating illness ; 33
75	74		(2) Has considered all other treatment options currently 34
76	75		approved by the United States Food and Drug Administration; 35
77	76		(3) Has received a recommendation from the physician for an 36 SB136
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80	79		individualized investigational treatment based on analysis of the patient's 1
81	80		genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, 2
82	81		genes, gene products such as enzymes and other types of proteins, or 3
83	82		metabolites; 4
84	83		(4)(A) Has given written, informed consent for the use of the 5
85	84		individualized investigational treatment. 6
86	85		(B) If the patient is a minor or lacks the mental capacity 7
87	86		to provide informed consent, a parent or legal guardian may provide written, 8
88	87		informed consent on the patient's behalf. 9
89	88		(C) The written, informed consent shall include at a 10
90	89		minimum: 11
91	90		(i) An explanation of the currently approved 12
92	91		products and treatments for the disease or condition of which the patient 13
93	92		suffers; 14
94	93		(ii) An attestation that the patient, or if the 15
95	94		patient is a minor or lacks the mental capacity to concur, a parent or legal 16
96	95		guardian, concurs with his or her physician in believing that all currently 17
97	96		approved and conventionally recognized treatments are unlikely to prolong the 18
98	97		patient’s life; 19
99	98		(iii) Clear identification of the specific proposed 20
100	99		individualized investigational treatment that the patient is seeking to use; 21
101	100		(iv) A description of the potentially best and worst 22
102	101		outcomes of using the individualized investigational treatment and a 23
103	102		realistic description of the most likely outcome, including without 24
104	103		limitation the possibility that new, unanticipated, different, or worse 25
105	104		symptoms might result, and that death could be hastened by the individualized 26
106	105		investigational treatment, which is based on the physician’s knowledge of the 27
107	106		individualized investigational treatment in conjunction with an awareness of 28
108	107		the patient’s condition; 29
109	108		(v) A statement that the patient’s health plan or 30
110	109		third-party administrator and provider are not obligated to pay for any care 31
111	110		or treatments consequent to the use of the individualized investigational 32
112	111		treatment, unless the patient’s health plan or third -party administrator and 33
113	112		provider are specifically required to do so by law or contract; 34
114	113		(vi) A statement that the patient’s eligibility for 35
115	114		hospice care may be withdrawn if the patient receives an individualized 36 SB136
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118	117		investigational treatment and that care may be reinstated if the 1
119	118		individualized investigational treatment ends and the patient meets hospice 2
120	119		eligibility requirements; and 3
121	120		(vii) A statement that the patient understands that 4
122	121		he or she is liable for all expenses consequent to the use of the 5
123	122		individualized investigational treatment and that this liability extends to 6
124	123		the patient’s estate, unless a contract between the patient and the 7
125	124		manufacturer of the individualized investigational treatment states 8
126	125		otherwise; and 9
127	126		(5) Has received written documentation from a physician that the 10
128	127		patient meets the requirements of this subchapter. 11
129	128		12
130	129		20-15-2504. Availability. 13
131	130		(a) A manufacturer of an individualized investigational treatment 14
132	131		operating within an eligible facility may make available an individualized 15
133	132		investigational treatment available to eligible patients under this 16
134	133		subchapter. 17
135	134		(b) This section does not require that a manufacturer make available 18
136	135		an individualized investigational treatment to an eligible patient. 19
137	136		20
138	137		20-15-2505. Costs. 21
139	138		(a) A manufacturer of an individualized investigational treatment or 22
140	139		an eligible facility may: 23
141	140		(1) Provide an individualized investigational treatment to an 24
142	141		eligible patient without receiving compensation; or 25
143	142		(2) Require an eligible patient to pay the costs associated with 26
144	143		the manufacture of the individualized investigational treatment. 27
145	144		(b) If an eligible patient dies while receiving individualized 28
146	145		investigational treatment, the eligible patient's heirs are not liable for 29
147	146		any outstanding debt to the manufacturer related to the individualized 30
148	147		investigational treatment. 31
149	148		32
150	149		20-15-2506. Insurance coverage. 33
151	150		(a) An insurance company: 34
152	151		(1) May, but is not required to, provide coverage for an 35
153	152		individualized investigational treatment; and 36 SB136
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156	155		(2) Shall not deny coverage for an item or service that is 1
157	156		otherwise covered by an insurance contract between the eligible person and 2
158	157		the insurance company. 3
159	158		(b) This subchapter does not affect any mandatory healthcare coverage 4
160	159		for participation in clinical trials or expand the health care coverage 5
161	160		required of an insurance company. 6
162	161		7
163	162		20-15-2507. Prohibited sanctions. 8
164	163		The recommendation, prescription, treatment, or participation in the 9
165	164		treatment of a life-threatening or severely debilitating illness with an 10
166	165		individualized investigational treatment shall not permit: 11
167	166		(1) A state agency or licensing board to revoke a license, fail 12
168	167		to renew a license, or take any other action against a medical professional's 13
169	168		license or a healthcare provider's license; 14
170	169		(2) A state agency, state official, or employee or agent of the 15
171	170		state to block or attempt to block an eligible patient's access to an 16
172	171		individualized investigational treatment; or 17
173	172		(3) An action against a hospital's Medicare certification. 18
174	173		19
175	174		20-15-2508. Counseling, advice, or recommendation not violation. 20
176	175		The counseling, advice, or recommendation consistent with medical 21
177	176		standards of care by a medical professional licensed under state law is not a 22
178	177		violation of this subchapter. 23
179	178		24
180	179		20-15-2509. Immunity. 25
181	180		(a) Except in the case of gross negligence or willful misconduct, a 26
182	181		person or entity that manufacturers, imports, distributes, prescribes, 27
183	182		dispenses, administers, or is otherwise involved in the care of an eligible 28
184	183		patient using an individualized investigational treatment is immune from 29
185	184		civil liability for any loss, damage, or injury arising out of, relating to, 30
186	185		or resulting from the individualized investigational treatment if the person 31
187	186		or entity is substantially complying in good faith with this subchapter and 32
188	187		has exercised reasonable care. 33
189	188		(b) This subchapter does not require a medical professional who is 34
190	189		licensed under the laws of this state to counsel, advise, prescribe, 35
191	190		dispense, administer, or otherwise be involved in the care of an eligible 36 SB136
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194	193		patient using an individualized investigational treatment. 1
195	194		(c) This subchapter does not require a hospital licensed under § 20 -9-2
196	195		213 to provide any new or additional service related to an individualized 3
197	196		investigational treatment, unless approved by the hospital. 4
198	197		5
199	198		20-15-2510. Medicaid coverage. 6
200	199		This subchapter does not require the Department of Human Services or 7
201	200		the Arkansas Medicaid Program to provide additional coverage for an 8
202	201		individualized investigational treatment. 9
203	202		10
204	203		11
205		-	~~APPROVED: 2/27/25~~ 12
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