Indiana 2023 Regular Session

Indiana House Bill HB1158 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. 1158
4	4	_____
5	5	DIGEST OF INTRODUCED BILL
6	6	Citations Affected: IC 16-42-26; IC 25-22.5-1-2.1.
7	7	Synopsis: Breakthrough therapies. Provides that a drug, biological
8	8	product, or medical device that has been designated as a breakthrough
9	9	therapy under federal law may be made available to a qualified patient
10	10	and offered by a physician as a part of the patient's medical treatment.
11	11	Specifies that a civil or criminal cause of action is not created against
12	12	a manufacturer or health care provider for any harm to a qualified
13	13	patient resulting from use of an investigational drug, biological
14	14	product, or device.
15	15	Effective: July 1, 2023.
16	16	Moed
17	17	January 10, 2023, read first time and referred to Committee on Public Health.
18	18	2023 IN 1158—LS 6954/DI 77 Introduced
19	19	First Regular Session of the 123rd General Assembly (2023)
20	20	PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
21	21	Constitution) is being amended, the text of the existing provision will appear in this style type,
22	22	additions will appear in this style type, and deletions will appear in this style type.
23	23	Additions: Whenever a new statutory provision is being enacted (or a new constitutional
24	24	provision adopted), the text of the new provision will appear in this style type. Also, the
25	25	word NEW will appear in that style type in the introductory clause of each SECTION that adds
26	26	a new provision to the Indiana Code or the Indiana Constitution.
27	27	Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
28	28	between statutes enacted by the 2022 Regular Session of the General Assembly.
29	29	HOUSE BILL No. 1158
30	30	A BILL FOR AN ACT to amend the Indiana Code concerning
31	31	health.
32	32	Be it enacted by the General Assembly of the State of Indiana:
33	33	1 SECTION 1. IC 16-42-26-2, AS ADDED BY P.L.2-2015,
34	34	2 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
35	35	3 JULY 1, 2023]: Sec. 2. As used in this chapter, "investigational drug,
36	36	4 biological product, or device" means an investigational or
37	37	5 experimental:
38	38	6 (1) drug;
39	39	7 (2) biological product; or
40	40	8 (3) medical device;
41	41	9 that has successfully completed Phase I of a federal Food and Drug
42	42	10 Administration approved clinical trial, but has not been approved for
43	43	11 general use by the federal Food and Drug Administration and remains
44	44	12 under investigation in a clinical trial or that has been designated as
45	45	13 a breakthrough therapy under 21 U.S.C. 356(a) of the federal
46	46	14 Food, Drug, and Cosmetic Act.
47	47	15 SECTION 2. IC 16-42-26-5, AS ADDED BY P.L.2-2015,
48	48	16 SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
49	49	17 JULY 1, 2023]: Sec. 5. This chapter does not create a civil or criminal
50	50	2023 IN 1158—LS 6954/DI 77 2
51	51	1 cause of action against a manufacturer of an investigational drug,
52	52	2 biological product, or device for any harm to a qualified patient
53	53	3 resulting from use of an investigational drug, biological product, or
54	54	4 device.
55	55	5 SECTION 3. IC 25-22.5-1-2.1, AS AMENDED BY P.L.2-2015,
56	56	6 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
57	57	7 JULY 1, 2023]: Sec. 2.1. (a) An individual who consents under
58	58	8 IC 34-18-12 may receive any experimental or nonconventional medical
59	59	9 treatment if:
60	60	10 (1) a licensed physician has personally examined the individual
61	61	11 and agrees to treat the individual;
62	62	12 (2) the treating physician determines:
63	63	13 (A) there is no reasonable basis to conclude that the medical
64	64	14 treatment, when administered as directed, poses an
65	65	15 unreasonable and significant risk of danger to the individual
66	66	16 receiving the medical treatment; or
67	67	17 (B) the:
68	68	18 (i) individual has been diagnosed with a terminal disease or
69	69	19 condition and does not have comparable or satisfactory
70	70	20 treatment options that are approved by the federal Food and
71	71	21 Drug Administration and that are available to diagnose,
72	72	22 monitor, or treat the individual's disease or condition; and
73	73	23 (ii) probable risk to the individual from the experimental or
74	74	24 nonconventional medical treatment is not greater than the
75	75	25 probable risk from the individual's disease or condition; and
76	76	26 (3) the treating physician has provided the individual with a
77	77	27 written statement and an oral explanation of the medical treatment
78	78	28 that the individual has acknowledged by the individual's signature
79	79	29 or the signature of the individual's legal representative and that
80	80	30 discloses the following:
81	81	31 (A) That the medical treatment is experimental or
82	82	32 nonconventional.
83	83	33 (B) That the investigational drug, biological product, or device
84	84	34 (as defined in IC 16-42-26-2) has not been approved by the
85	85	35 federal Food and Drug Administration for any indication.
86	86	36 (C) The material risks generally recognized by a reasonably
87	87	37 prudent physician of the medical treatment's side effects.
88	88	38 (D) An explanation of the medical treatment, including
89	89	39 expected frequency and duration of the treatment.
90	90	40 (b) If the medical treatment is to be provided on an inpatient or
91	91	41 outpatient basis at a hospital licensed under IC 16-21, then that type of
92	92	42 treatment must have been approved by the governing board of the
93	93	2023 IN 1158—LS 6954/DI 77 3
94	94	1 hospital or by a committee of the hospital authorized by the governing
95	95	2 board to approve the types of experimental or nonconventional medical
96	96	3 treatments that may be provided at the hospital on an inpatient or
97	97	4 outpatient basis.
98	98	5 (c) The medical licensing board shall develop protocols for medical
99	99	6 treatments that are provided in a setting other than the inpatient or
100	100	7 outpatient hospital setting specified in subsection (b). A physician who
101	101	8 fails to comply with a protocol developed under this subsection shall
102	102	9 be subject to discipline by the medical licensing board.
103	103	10 (d) This section does not require any person or organization to
104	104	11 provide an individual with access to a medical treatment not otherwise
105	105	12 commercially available to that individual.
106	106	13 (e) This section does not require:
107	107	14 (1) an insurer;
108	108	15 (2) a fraternal benefit society;
109	109	16 (3) a nonprofit corporation;
110	110	17 (4) a health maintenance organization (as defined in
111	111	18 IC 27-13-1-19);
112	112	19 (5) a preferred provider arrangement under IC 27-8-11; or
113	113	20 (6) a limited service health maintenance organization (as defined
114	114	21 in IC 27-13-34-4);
115	115	22 to provide coverage or make payment beyond the terms and conditions
116	116	23 of the contract for medical treatment authorized under this section.
117	117	24 (f) This section does not create a civil or criminal cause of action
118	118	25 against a health care provider involved in connection with the use of an
119	119	26 investigational drug, biological product, or device by a patient for any
120	120	27 harm to the patient from the investigational drug, biological product,
121	121	28 or device.
122	122	29 (g) An experimental medical treatment under this section may
123	123	30 include a:
124	124	31 (1) drug;
125	125	32 (2) biological product; or
126	126	33 (3) medical device;
127	127	34 that has been designated as a breakthrough therapy under 21
128	128	35 U.S.C. 356(a) of the federal Food, Drug, and Cosmetic Act.
129	129	2023 IN 1158—LS 6954/DI 77