Indiana 2024 Regular Session

Indiana House Bill HB1184 Compare Versions

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

Old	New	Differences
1	1
2	2	Introduced Version
3	3	HOUSE BILL No. 1184
4	4	_____
5	5	DIGEST OF INTRODUCED BILL
6	6	Citations Affected: IC 16-18-2; IC 16-42-26; IC 16-46-18;
7	7	IC 25-22.5-1-2.1.
8	8	Synopsis: Breakthrough therapies. Establishes the breakthrough
9	9	therapies research fund. Provides that a drug, biological product, or
10	10	medical device that has been designated as a breakthrough therapy
11	11	under federal law may be made available to a qualified patient and
12	12	offered by a physician as a part of the patient's medical treatment.
13	13	Specifies that a civil or criminal cause of action is not created against
14	14	a manufacturer or health care provider for any harm to a qualified
15	15	patient resulting from use of an investigational drug, biological
16	16	product, or device.
17	17	Effective: July 1, 2024.
18	18	Moed
19	19	January 9, 2024, read first time and referred to Committee on Public Health.
20	20	2024 IN 1184—LS 6360/DI 147 Introduced
21	21	Second Regular Session of the 123rd General Assembly (2024)
22	22	PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
23	23	Constitution) is being amended, the text of the existing provision will appear in this style type,
24	24	additions will appear in this style type, and deletions will appear in this style type.
25	25	Additions: Whenever a new statutory provision is being enacted (or a new constitutional
26	26	provision adopted), the text of the new provision will appear in this style type. Also, the
27	27	word NEW will appear in that style type in the introductory clause of each SECTION that adds
28	28	a new provision to the Indiana Code or the Indiana Constitution.
29	29	Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
30	30	between statutes enacted by the 2023 Regular Session of the General Assembly.
31	31	HOUSE BILL No. 1184
32	32	A BILL FOR AN ACT to amend the Indiana Code concerning
33	33	health.
34	34	Be it enacted by the General Assembly of the State of Indiana:
35	35	1 SECTION 1. IC 16-18-2-39.5 IS ADDED TO THE INDIANA
36	36	2 CODE AS A NEW SECTION TO READ AS FOLLOWS
37	37	3 [EFFECTIVE JULY 1, 2024]: Sec. 39.5. "Breakthrough therapy",
38	38	4 for purposes of IC 16-46-18, has the meaning set forth in
39	39	5 IC 16-46-18-1.
40	40	6 SECTION 2. IC 16-18-2-143, AS AMENDED BY P.L.1-2010,
41	41	7 SECTION 69, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
42	42	8 JULY 1, 2024]: Sec. 143. (a) "Fund", for purposes of IC 16-26-2, has
43	43	9 the meaning set forth in IC 16-26-2-2.
44	44	10 (b) "Fund", for purposes of IC 16-31-8.5, has the meaning set forth
45	45	11 in IC 16-31-8.5-2.
46	46	12 (c) "Fund", for purposes of IC 16-41-39.4, refers to the childhood
47	47	13 lead poisoning prevention fund established by IC 16-41-39.4-3.1.
48	48	14 (d) "Fund", for purposes of IC 16-41-39.8, refers to the lead trust
49	49	15 fund established by IC 16-41-39.8-7.
50	50	16 (e) "Fund", for purposes of IC 16-46-5, has the meaning set forth in
51	51	17 IC 16-46-5-3.
52	52	2024 IN 1184—LS 6360/DI 147 2
53	53	1 (f) "Fund", for purposes of IC 16-46-12, has the meaning set forth
54	54	2 in IC 16-46-12-1.
55	55	3 (g) "Fund", for purposes of IC 16-41-42.2, has the meaning set forth
56	56	4 in IC 16-41-42.2-2.
57	57	5 (h) "Fund", for purposes of IC 16-35-8, has the meaning set forth in
58	58	6 IC 16-35-8-2.
59	59	7 (i) "Fund", for purposes of IC 16-46-18, has the meaning set
60	60	8 forth in IC 16-46-18-2.
61	61	9 SECTION 3. IC 16-42-26-2, AS ADDED BY P.L.2-2015,
62	62	10 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
63	63	11 JULY 1, 2024]: Sec. 2. As used in this chapter, "investigational drug,
64	64	12 biological product, or device" means an investigational or experimental
65	65	13 (1) drug,
66	66	14 (2) biological product, or
67	67	15 (3) medical device
68	68	16 that has:
69	69	17 (1) successfully completed Phase I of a federal Food and Drug
70	70	18 Administration approved clinical trial, but has not been approved
71	71	19 for general use by the federal Food and Drug Administration and
72	72	20 remains under investigation in a clinical trial; or
73	73	21 (2) been designated as a breakthrough therapy under 21
74	74	22 U.S.C. 356(a) of the federal Food, Drug, and Cosmetic Act.
75	75	23 SECTION 4. IC 16-42-26-5, AS ADDED BY P.L.2-2015,
76	76	24 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
77	77	25 JULY 1, 2024]: Sec. 5. This chapter does not create a civil or criminal
78	78	26 cause of action against a manufacturer of an investigational drug,
79	79	27 biological product, or device for any harm to a qualified patient
80	80	28 resulting from use of an investigational drug, biological product, or
81	81	29 device.
82	82	30 SECTION 5. IC 16-46-18 IS ADDED TO THE INDIANA CODE
83	83	31 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
84	84	32 JULY 1, 2024]:
85	85	33 Chapter 18. Breakthrough Therapies Research Fund
86	86	34 Sec. 1. As used in this chapter, "breakthrough therapy" refers
87	87	35 to a drug, biological product, or medical device that has been
88	88	36 designated as a breakthrough therapy under 21 U.S.C. 356(a) of
89	89	37 the federal Food, Drug, and Cosmetic Act.
90	90	38 Sec. 2. As used in this chapter, "fund" refers to the
91	91	39 breakthrough therapies research fund established by section 3 of
92	92	40 this chapter.
93	93	41 Sec. 3. The breakthrough therapies research fund is established
94	94	42 for the purpose of providing financial assistance to research
95	95	2024 IN 1184—LS 6360/DI 147 3
96	96	1 institutions in Indiana to study breakthrough therapies to treat
97	97	2 serious mental illness.
98	98	3 Sec. 4. (a) The fund shall be administered by the state
99	99	4 department.
100	100	5 (b) The expenses of administering the fund shall be paid from
101	101	6 money in the fund.
102	102	7 Sec. 5. (a) The fund consists of the following:
103	103	8 (1) Appropriations from the general assembly.
104	104	9 (2) Donations to the fund.
105	105	10 (3) Gifts to the fund.
106	106	11 (b) The treasurer of state shall invest the money in the fund not
107	107	12 currently needed to meet the obligations of the fund in the same
108	108	13 manner as other public money may be invested. Interest that
109	109	14 accrues from these investments shall be deposited in the fund.
110	110	15 (c) Money in the fund at the end of a state fiscal year does not
111	111	16 revert to the state general fund.
112	112	17 SECTION 6. IC 25-22.5-1-2.1, AS AMENDED BY P.L.2-2015,
113	113	18 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
114	114	19 JULY 1, 2024]: Sec. 2.1. (a) An individual who consents under
115	115	20 IC 34-18-12 may receive any experimental or nonconventional medical
116	116	21 treatment if:
117	117	22 (1) a licensed physician has personally examined the individual
118	118	23 and agrees to treat the individual;
119	119	24 (2) the treating physician determines:
120	120	25 (A) there is no reasonable basis to conclude that the medical
121	121	26 treatment, when administered as directed, poses an
122	122	27 unreasonable and significant risk of danger to the individual
123	123	28 receiving the medical treatment; or
124	124	29 (B) the:
125	125	30 (i) individual has been diagnosed with a terminal disease or
126	126	31 condition and does not have comparable or satisfactory
127	127	32 treatment options that are approved by the federal Food and
128	128	33 Drug Administration and that are available to diagnose,
129	129	34 monitor, or treat the individual's disease or condition; and
130	130	35 (ii) probable risk to the individual from the experimental or
131	131	36 nonconventional medical treatment is not greater than the
132	132	37 probable risk from the individual's disease or condition; and
133	133	38 (3) the treating physician has provided the individual with a
134	134	39 written statement and an oral explanation of the medical treatment
135	135	40 that the individual has acknowledged by the individual's signature
136	136	41 or the signature of the individual's legal representative and that
137	137	42 discloses the following:
138	138	2024 IN 1184—LS 6360/DI 147 4
139	139	1 (A) That the medical treatment is experimental or
140	140	2 nonconventional.
141	141	3 (B) That the investigational drug, biological product, or device
142	142	4 (as defined in IC 16-42-26-2) has not been approved by the
143	143	5 federal Food and Drug Administration for any indication.
144	144	6 (C) The material risks generally recognized by a reasonably
145	145	7 prudent physician of the medical treatment's side effects.
146	146	8 (D) An explanation of the medical treatment, including
147	147	9 expected frequency and duration of the treatment.
148	148	10 (b) If the medical treatment is to be provided on an inpatient or
149	149	11 outpatient basis at a hospital licensed under IC 16-21, then that type of
150	150	12 treatment must have been approved by the governing board of the
151	151	13 hospital or by a committee of the hospital authorized by the governing
152	152	14 board to approve the types of experimental or nonconventional medical
153	153	15 treatments that may be provided at the hospital on an inpatient or
154	154	16 outpatient basis.
155	155	17 (c) The medical licensing board shall develop protocols for medical
156	156	18 treatments that are provided in a setting other than the inpatient or
157	157	19 outpatient hospital setting specified in subsection (b). A physician who
158	158	20 fails to comply with a protocol developed under this subsection shall
159	159	21 be subject to discipline by the medical licensing board.
160	160	22 (d) This section does not require any person or organization to
161	161	23 provide an individual with access to a medical treatment not otherwise
162	162	24 commercially available to that individual.
163	163	25 (e) This section does not require:
164	164	26 (1) an insurer;
165	165	27 (2) a fraternal benefit society;
166	166	28 (3) a nonprofit corporation;
167	167	29 (4) a health maintenance organization (as defined in
168	168	30 IC 27-13-1-19);
169	169	31 (5) a preferred provider arrangement under IC 27-8-11; or
170	170	32 (6) a limited service health maintenance organization (as defined
171	171	33 in IC 27-13-34-4);
172	172	34 to provide coverage or make payment beyond the terms and conditions
173	173	35 of the contract for medical treatment authorized under this section.
174	174	36 (f) This section does not create a civil or criminal cause of action
175	175	37 against a health care provider involved in connection with the use of an
176	176	38 investigational drug, biological product, or device by a patient for any
177	177	39 harm to the patient from the investigational drug, biological product,
178	178	40 or device.
179	179	41 (g) An experimental medical treatment under this section may
180	180	42 include a:
181	181	2024 IN 1184—LS 6360/DI 147 5
182	182	1 (1) drug;
183	183	2 (2) biological product; or
184	184	3 (3) medical device;
185	185	4 that has been designated as a breakthrough therapy under 21
186	186	5 U.S.C. 356(a) of the federal Food, Drug, and Cosmetic Act.
187	187	2024 IN 1184—LS 6360/DI 147