Florida 2025 Regular Session

Florida House Bill H1333 Compare Versions

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

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3	3	HB 1333 2025
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10	10	F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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14	14	A bill to be entitled 1
15	15	An act relating to individualized investigational 2
16	16	treatments; creating s. 381.992, F.S.; providing 3
17	17	definitions; authorizing certain actions by eligible 4
18	18	facilities, manufacturers operating within eligible 5
19	19	facilities, and eligible patients relating to 6
20	20	individualized investigational treatments; authorizing 7
21	21	health plans, third-party administrators, and 8
22	22	governmental agencies to provide coverage for the cost 9
23	23	of an individualized investigational drug, biological 10
24	24	product, or device, or the cost of certain services; 11
25	25	limiting liability; prohibiting licensing boards, 12
26	26	disciplinary subcommittees, and entities responsible 13
27	27	for Medicare certification from taking certain a ctions 14
28	28	against a health care provider's license under certain 15
29	29	circumstances; prohibiting certain persons from 16
30	30	blocking or attempting to block an eligible patient's 17
31	31	access to an individualized investigational drug, 18
32	32	biological product, or device; providing c onstruction; 19
33	33	providing an effective date. 20
34	34	21
35	35	Be It Enacted by the Legislature of the State of Florida: 22
36	36	23
37	37	Section 1. Section 381.992, Florida Statutes, is created 24
38	38	to read: 25
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47	47	F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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51	51	381.992 Individualized investigational treatments. — 26
52	52	(1) As used in this sect ion, the term: 27
53	53	(a) "Eligible facility" means an institution that is 28
54	54	operating under a Federalwide Assurance (FWA), and is subject to 29
55	55	the FWA laws, regulations, policies, and guidelines including 30
56	56	renewals or updates, for the protection of human subjects i n 31
57	57	research under 42 U.S.C. s. 289(a) and 45 C.F.R. part 46. 32
58	58	(b) "Eligible patient" means an individual who has: 33
59	59	1. A life-threatening or severely debilitating illness as 34
60	60	determined by the patient's treating physician. 35
61	61	2. Considered all other treatmen t options currently 36
62	62	approved by the federal Food and Drug Administration. 37
63	63	3. Received a recommendation from his or her treating 38
64	64	physician for an individualized investigational treatment based 39
65	65	on analysis of the patient's genomic sequence, human 40
66	66	chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, 41
67	67	gene products, or metabolites. 42
68	68	4. Given written, informed consent for the use of the 43
69	69	individualized investigational drug, biological product, or 44
70	70	device. 45
71	71	5. Documentation from his or her treating physi cian that 46
72	72	he or she meets the requirements of this section. 47
73	73	(c) "Individualized investigational treatment" means 48
74	74	individualized investigational drugs, biological products, or 49
75	75	devices that are unique to and produced exclusively for use by 50
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81	81	CODING: Words stricken are deletions; words underlined are additions.
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84	84	F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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88	88	an individual patient based on his or her genetic profile. The 51
89	89	term includes, but is not limited to, individualized gene 52
90	90	therapy antisense oligonucleotides and individualized neoantigen 53
91	91	vaccines. 54
92	92	(d) "Life-threatening or severely debilitating illness" 55
93	93	has the same meaning as in 21 C.F.R. s. 312.81 or any successor 56
94	94	regulation. 57
95	95	(e) "Written, informed consent" means a written document 58
96	96	that is signed by the patient; a parent, if the patient is a 59
97	97	minor; a legal guardian; or a patient advocate designated by the 60
98	98	patient and attested to by the patient's physician and a 61
99	99	witness. The written, informed consent shall include, but is not 62
100	100	limited to, all of the following: 63
101	101	1. An explanation of the currently approved products and 64
102	102	treatments for the disease or condition from which th e patient 65
103	103	suffers. 66
104	104	2. A determination that the patient agrees with his or her 67
105	105	treating physician that all currently approved products and 68
106	106	treatments are unlikely to prolong the patient's life. 69
107	107	3. Clear identification of the specific proposed 70
108	108	individualized investigational drug, biological product, or 71
109	109	device that the patient is seeking to use. 72
110	110	4. A description of the potentially best and worst 73
111	111	outcomes of using the individualized investigational drug, 74
112	112	biological product, or device and a realistic descr iption of the 75
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121	121	F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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125	125	most likely outcome. The description shall include the 76
126	126	possibility that new, unanticipated, different, or worse 77
127	127	symptoms might result from, and death could be hastened by, the 78
128	128	proposed treatment. The description shall be based on the 79
129	129	treating physician's knowledge of the proposed treatment and 80
130	130	knowledge of the patient's condition. 81
131	131	5. A statement that the patient's health insurance plan or 82
132	132	third-party administrator and health care provider are not 83
133	133	obligated to pay for any care or treatments r esulting from the 84
134	134	use of the individualized investigational drug, biological 85
135	135	product, or device, unless specifically required to do so by 86
136	136	general law or contract. 87
137	137	6. A statement that the patient's eligibility for hospice 88
138	138	care may be withdrawn if the pati ent begins curative treatment 89
139	139	with the individualized investigational drug, biological 90
140	140	product, or device, and that hospice care may be reinstated if 91
141	141	such treatment ends and the patient meets the eligibility 92
142	142	requirements for hospice care. 93
143	143	7. A statement that the patient understands that he or she 94
144	144	is liable for all expenses for the use of the individualized 95
145	145	investigational drug, biological product, or device and that 96
146	146	this liability extends to the patient's estate, unless a 97
147	147	contract between the patient and the manufacturer of such drug, 98
148	148	product, or device states otherwise. 99
149	149	(2)(a) Pursuant to all applicable FWA laws and 100
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158	158	F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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160	160
161	161
162	162	regulations, an eligible facility or a manufacturer operating 101
163	163	within an eligible facility may provide an individualized 102
164	164	investigational treatment and an eligible patient may request an 103
165	165	individualized investigational drug, biological product, or 104
166	166	device from an eligible facility or a manufacturer operating 105
167	167	within an eligible facility. This section does not require that 106
168	168	a manufacturer operating within an eligible facility provide an 107
169	169	individualized investigational drug, biological product, or 108
170	170	device to an eligible patient. 109
171	171	(b) An eligible facility or a manufacturer operating 110
172	172	within an eligible facility may do all of the following: 111
173	173	1. Provide an individualized investigational drug, 112
174	174	biological product, or device to an eligible patient without 113
175	175	receiving compensation. 114
176	176	2. Require an eligible patient to pay the costs of, or the 115
177	177	costs associated with, the manufacture of the individualized 116
178	178	investigational drug, biological product, or device. 117
179	179	(3)(a) A health plan, third -party administrator, or 118
180	180	governmental agency may provide coverage for the cost of an 119
181	181	individualized investigational drug, biological product, or 120
182	182	device, or the cost of services related to the use of an 121
183	183	individualized investigational drug, biological product, or 122
184	184	device. 123
185	185	(b) This subsection does not: 124
186	186	1. Expand the coverage required of an insurer under the 125
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192	192	CODING: Words stricken are deletions; words underlined are additions.
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195	195	F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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199	199	Florida Insurance Code. 126
200	200	2. Require a governmental agency to pay costs associat ed 127
201	201	with the use, care, or treatment of a patient with an 128
202	202	individualized investigational drug, biological product, or 129
203	203	device. 130
204	204	3. Require a hospital or facility licensed under chapter 131
205	205	395 to provide new or additional services, unless approved by 132
206	206	the hospital or facility. 133
207	207	(4) If a patient dies while being treated by an 134
208	208	individualized investigational drug, biological product, or 135
209	209	device, the patient's heirs are not liable for any outstanding 136
210	210	debt related to the treatment or lack of insurance due to the 137
211	211	treatment. 138
212	212	(5) A licensing board or disciplinary subcommittee may not 139
213	213	revoke, fail to renew, suspend, or take any action against a 140
214	214	health care provider's license based solely on the health care 141
215	215	provider's recommendation to an eligible patient regarding 142
216	216	access to or treatment with an individualized investigational 143
217	217	drug, biological product, or device. An entity responsible for 144
218	218	Medicare certification may not take any action against a health 145
219	219	care provider's Medicare certification based solely on the 146
220	220	health care provider's recommendation that a patient have access 147
221	221	to or be treated with an individualized investigational drug, 148
222	222	biological product, or device. 149
223	223	(6) An official, employee, or agent of this state may not 150
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232	232	F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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236	236	block or attempt to block an eligible patient's acce ss to an 151
237	237	individualized investigational drug, biological product, or 152
238	238	device. Counseling, advice, or a recommendation consistent with 153
239	239	medical standards of care from a health care provider is not a 154
240	240	violation of this section. 155
241	241	(7) This section does not: 156
242	242	(a) Create a private cause of action against a 157
243	243	manufacturer of an individualized investigational drug, 158
244	244	biological product, or device or against any other person or 159
245	245	entity involved in the care of an eligible patient using the 160
246	246	individualized investigational dr ug, biological product, or 161
247	247	device for any harm done to the eligible patient resulting from 162
248	248	the individualized investigational drug, biological product, or 163
249	249	device if the manufacturer or other person or entity is 164
250	250	complying in good faith with the terms of thi s section and has 165
251	251	exercised reasonable care. 166
252	252	(b) Affect any mandatory health care coverage for 167
253	253	participation in clinical trials under the Florida Insurance 168
254	254	Code. 169
255	255	Section 2. This act shall take effect July 1, 2025. 170