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