Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases

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A bill to be entitled 1
An act relating to experimental treatments for 2
terminal conditions and life-threatening rare 3
diseases; providing a short title; amending s. 4
499.0295, F.S.; providing legislative findings and 5
intent; defining terms; authorizing licensed 6
physicians to prescribe and eligible facilities to 7
administer experimental treatments if certain 8
requirements are met; requiring the department to 9
adopt certain rules; requiring a specified written 10
informed consent from eligible patients; requiring 11
approval of a specified platform or master protocol by 12
an institutional review board; requiring the 13
Department of Health to establish and maintain a 14
patient registry for specified purposes; requiring 15
eligible facilities to submit certain information to 16
the registry; requiring the department to enter into 17
specified contracts with eligible facilities; 18
providing a penalty for breach of such contact; 19
requiring the department to annually publish a 20
specified report; encouraging health insurers and 21
health maintenance organizations to provide specified 22
insurance coverage for experimental treatments; 23
prohibiting such insurers and organizations from 24
denying insurance coverage for experimental 25

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treatments; providing construction; authorizing 26
licensed physicians and eligible facilities to receive 27
reimbursement for the prescription or administration 28
of experimental treatments if certain requirements are 29
met; establishing the reimbursement rate; requiring 30
the department to adopt specified rules; providing for 31
reimbursement rate expiration; requiring manufacturers 32
of experimental treatments to provide for a specified 33
temporary price concession set by the department; 34
providing for expiration of such concession; 35
authorizing the Department of Management Services to 36
enter into a specified contract with an eligible 37
facility or manufacturer; requiring the department to 38
adopt a specified rule for such contract; requiring 39
the Department of Health to adopt by rule certain 40
procedures for licensing of experimental treatment 41
centers; requiring the department to approve or deny a 42
completed application within a specified timeframe; 43
requiring the department to establish by rule certain 44
procedural and operational standards; prohibiting 45
certain actions by specified licensing boards and a 46
specified state agency against a licensed physician in 47
certain circumstances; providing construction and 48
applicability; providing for limitation of liability; 49
providing that certain participation is entirely 50

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voluntary at all times; prohibiting public officials, 51
public employees, and public agents from denying or 52
attempting to deny access to experimental treatment; 53
providing construction; requiring the department to 54
adopt rules; providing an effective date. 55
56
Be It Enacted by the Legislature of the State of Florida: 57
58
Section 1. "This act may be cited as the "Promising 59
Pathways Act." 60
Section 2. Section 499.0295, Florida Statutes, is amended 61
to read: 62
(Substantial rewording of section. See 63
s. 499.0295, F.S., for present text.) 64
499.0295 Experimental treatments for terminal conditions 65
and life-threatening rare diseases.— 66
(1) The Legislature finds that residents of this state 67
with terminal conditions and life-threatening rare diseases may 68
benefit from access to experimental treatments that have 69
demonstrated initial human safety but are not yet approved by 70
the United States Food and Drug Administration. 71
(2) It is the intent of the Legislature to: 72
(a) Create a safe, regulated, and transparent pathway to 73
experimental treatments through licensed state institutions with 74
board oversight. 75

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(b) Condition payment on evidence development. 76
(c) Encourage coverage parity by state-regulated health 77
plans. 78
(d) Align temporary pricing during the conditional period 79
with the maturity of clinical evidence. 80
(3) As used in this section, the term: 81
(a) "Board" means the Board of Medicine, created under 82
chapter 458, or the Board of Osteopathic Medicine, created under 83
chapter 459, as applicable. 84
(b) "Department" means the Department of Health, created 85
under s. 20.43. 86
(c) "Eligible facility" means a hospital or health care 87
facility licensed under chapter 395 that operates under the 88
federal policy for the protection of human subjects under 45 89
C.F.R. part 46 and maintains, or participates under, 90
Institutional Review Board oversight for experimental 91
treatments. 92
(d) "Eligible patient" means a person who: 93
1.a. Has a terminal condition that is attested to by the 94
treating physician and confirmed by a board-certified physician 95
in an appropriate specialty for that condition; or 96
b. Has a life-threatening rare disease that is attested to 97
by the treating physician and confirmed by a board-certified 98
physician in an appropriate specialty. 99
2. Has considered and exhausted all other treatment 100

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options for the terminal condition or life-threatening rare 101
disease currently approved by the United States Food and Drug 102
Administration. 103
3. Has given written informed consent pursuant to 104
subsection (4)(c). 105
4. Has documentation from the treating physician that the 106
patient meets the requirements of this paragraph. 107
(e) "Experimental treatment" means: 108
1. A drug, biological product, or medical device that has 109
successfully completed phase 1 of a clinical trial but has not 110
been approved for general use by the United States Food and Drug 111
Administration (FDA) and remains under investigation in a 112
clinical trial approved by the FDA; or 113
2. Personalized treatment for use by a patient based on 114
his or her genomic or molecular profile, including, but not 115
limited to, gene-targeted therapies, antisense oligonucleotides 116
(ASOs)-mediated therapies, and neoantigen-targeting personalized 117
cancer vaccines (PCVs), which have not been approved for general 118
use by the FDA and remain under investigation in a clinical 119
trial approved by the FDA. 120
(f) "Institutional Review Board" or "IRB" has the same 121
meaning as in s. 381.86. 122
(g) "Patient registry" or "registry" means a clinical data 123
collections system from which health information is collected at 124
specific points during the course of treatment and all personal 125

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identifiers have been removed or obscured to protect patient 126
privacy. 127
(h) "Rare life-threatening disease" means a progressive 128
disease or medical or surgical condition that affects less than 129
200,000 persons in the United States. The term includes any 130
progressive disease or medical or surgical condition that meets 131
the criteria of a rare disease under 21 U.S.C. s. 360bb. 132
(i) "Terminal condition" means a progressive disease or 133
medical or surgical condition that causes significant functional 134
impairment, is not considered by a treating physician to be 135
reversible even with the administration of available treatment 136
options currently approved by the FDA, and, without the 137
administration of life-sustaining procedures, will result in 138
death within 1 year after diagnosis if the condition runs its 139
normal course. 140
(4)(a) A physician licensed under chapter 458 or chapter 141
459 may prescribe to an eligible patient an experimental 142
treatment pursuant to this section. 143
(b)1. An eligible facility may administer to an eligible 144
patient an experimental treatment if such treatment is 145
administered pursuant to a platform or master protocol approved 146
by an IRB pursuant to subsection (5) and complies with the 147
registry requirements established in subsection (6). 148
2.a. An eligible facility that does not maintain its own 149
IRB may establish and maintain an affiliation with another 150

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eligible facility that maintains IRB oversight. 151
b. The department shall adopt rules for affiliations 152
pursuant to this subparagraph, to include, but not be limited 153
to, the handling of drugs, adverse-event escalation, quality 154
assurance, and health data submission. 155
(c) Written informed consent, signed by an eligible 156
patient, a court-appointed guardian for an eligible patient, or 157
a health care surrogate designated by an eligible patient, is 158
required, and must include: 159
1. An explanation of the currently approved treatments for 160
the patient's terminal condition or life-threatening rare 161
disease and that such treatments have been considered and 162
exhausted. 163
2. Identification of the specific experimental treatment 164
that the patient is seeking to use. 165
3. A description of the potential risks and benefits of 166
using the experimental treatment, including best-case outcome 167
and worst-case outcome. The description must be based on the 168
physician's knowledge of the experimental treatment for the 169
patient's terminal condition or life-threatening rare disease. 170
4. A statement that the patient's health plan or third-171
party administrator and physician are not obligated to pay for 172
care or treatment consequent to the use of the experimental 173
treatment unless required to do so by law or contract. 174
5. A statement that the patient's eligibility for hospice 175

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care may be affected by the use of experimental treatment. 176
6. A statement that the patient understands he or she is 177
liable for all expenses consequent to the use of the 178
experimental treatment but that liability does not extend to the 179
patient's estate, unless a contract between the patient and the 180
manufacturer states otherwise. 181
7. An authorization from the patient to release his or her 182
health information, collected at specific points during 183
treatment, for submission into the registry established in 184
subsection (6). 185
(5) A platform or master protocol must be approved by an 186
IRB under which treating physicians and eligible facilities may 187
adapt dosing, sequencing, or combinations of authorized 188
experimental treatments, within predefined limitations, without 189
seeking approval of an IRB for each adaptation. The platform or 190
master protocol must specify safety limits, stopping 191
requirements, and patient registry information pursuant to 192
subsection (6). 193
(6)(a) The department shall establish and maintain a 194
patient registry for the collection and analysis of experimental 195
treatment outcomes under this section. Eligible facilities shall 196
submit health information to the registry from which all 197
personal identifiers have been removed or obscured to protect 198
patient privacy. 199
(b) The department shall enter into a written contract 200

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with eligible facilities which specifies the scope of services 201
provided, the service level, the duration of the agreement, the 202
responsible parties, and the service costs. Failure to meet the 203
contract requirements may result in the filing of an action by 204
the department and a temporary suspension of reimbursement for 205
the prescription or administration of experimental treatment 206
pursuant to subsection (8). 207
(c) The department shall annually publish a public report 208
of experimental treatment outcomes and safety signals in the 209
aggregate. 210
(7)(a) A health insurer or a health maintenance 211
organization regulated under the Florida Insurance Code are 212
encouraged to provide insurance coverage for experimental 213
treatments in the same manner as any other covered treatment or 214
therapy. 215
(b) A health insurer or a health maintenance organization 216
may not deny insurance coverage based solely on a treatment 217
being experimental or denied approval for general use by the 218
FDA. 219
(c) This subsection does not require insurance coverage 220
and does not expand the coverage an insurer or health 221
maintenance organization must provide under the Florida 222
Insurance Code. 223
(8)(a) A licensed physician or an eligible facility may 224
receive reimbursement for the prescription or administration of 225

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an experimental treatment under this section. However, in order 226
to receive such reimbursement, an eligible facility must 227
actively participate in the patient registry established under 228
subsection (6). Failure to participate in the patient registry 229
may result in temporary suspension of reimbursement until 230
compliance is restored. 231
(b)1. Reimbursement for a prescribed or administered 232
experimental treatment under this subsection may not exceed a 233
discounted rate set by the department as a percentage of a 234
recognized pricing benchmark, including wholesale acquisition 235
cost or average sales price. 236
2. The department shall adopt rules that: 237
a. Establish an allowable discount band to reflect 238
evidentiary uncertainty. 239
b. Apply a registry noncompliance adjustment which 240
increases the discounted rate set by the department. 241
c. Provide for renewal and potential adjustment of the 242
discounted rate every 2 years based on registry compliance. 243
(c) Upon approval by the FDA of an experimental treatment, 244
the discounted rate set by the department for reimbursement 245
expires and the standard reimbursement rate applies. 246
(9) A manufacturer of an experimental treatment shall 247
provide for a temporary price concession, which price must be 248
set by the department by rule as a percentage of a recognized 249
pricing benchmark. The temporary price concession expires upon 250

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approval by the FDA of the experimental treatment. 251
(10) An eligible facility or manufacturer and the 252
Department of Management Services pursuant to s. 110.123 may 253
enter into a healthcare contract under which a portion of 254
payment is linked to experimental treatment outcomes. The 255
department shall adopt a rule for such contract, which rule must 256
provide for standard contract terms and authorize reconciliation 257
intervals not to exceed 2 years. 258
(11)(a) The Department of Health shall adopt by rule 259
procedures for licensing experimental treatment centers and 260
shall approve or deny a completed application within 90 days. 261
(b) The department shall establish by rule the following 262
minimum procedural and operational standards: 263
1. Written policies and procedures. 264
2. Oversight and governance standards. 265
3. Inspection and safety standards. 266
4. Staff training provisions. 267
5. Recordkeeping provisions. 268
6. Data quality assurance. 269
(12)(a) A licensing board may not revoke, deny renewal, 270
suspend, or take any action against a physician's license issued 271
under chapter 458 or chapter 459 based solely on the physician's 272
recommendations to an eligible patient regarding access to or 273
treatment with experimental treatment authorized under this 274
section. A state agency responsible for Medicare certification 275

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may not take action against a physician's Medicare certification 276
based solely on the physician's recommendation that an eligible 277
patient have access to experimental treatment. 278
(b)1. This section does not create a private cause of 279
action: 280
a. Against a manufacturer of an experimental treatment; 281
b. Against a person or an entity involved in the care of 282
an eligible patient who is using an experimental treatment; or 283
c. For any harm to the eligible patient that is a result 284
of the use of an experimental treatment, 285
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if the manufacturer or other person or entity complies in good 287
faith with the terms of this section and exercises reasonable 288
care. 289
2. This paragraph does not apply to judicial action 290
brought for gross negligence or intentional, willful, or wanton 291
misconduct. 292
(c) If an eligible patient dies while using experimental 293
treatment pursuant to this section, the patient's heirs are not 294
liable for any outstanding debt related to the patient's use of 295
such treatment. 296
(d) A hospital or licensed health care facility is not 297
required to provide new or additional health care services or 298
treatments under this section without prior consent of the 299
hospital or licensed health care facility. Participation 300

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pursuant to this section is entirely voluntary at all times. 301
(e) A public official, a public employee, or an agent of 302
this state, or any political subdivision thereof, may not deny 303
or attempt to deny access to experimental treatment under this 304
section. Counseling, advice, or recommendations by a licensed 305
physician consistent with the standard of care do not constitute 306
the denial of access or the attempted denial of access to 307
experimental treatment under this paragraph. 308
(13) This section does not authorize the possession, use, 309
dispensing, or administration of a controlled substance in 310
violation of chapter 893, except to the extent expressly 311
permitted by state or federal law. 312
(14) The department shall adopt rules pursuant to ss. 313
120.536(1) and 120.54 to implement this section. 314
Section 3. This act shall take effect upon becoming a law. 315