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Florida Senate
-
2026
SB 1552
By
Senator Burgess
23-01055A-26 20261552__
1 A bill to be entitled
2 An act relating to experimental treatments for
3 terminal conditions and life-threatening rare
4 diseases; providing a short title; amending s.
5 499.0295, F.S.; providing legislative findings and
6 intent; defining terms; authorizing licensed
7 physicians to prescribe and eligible facilities to
8 administer experimental treatments, if certain
9 requirements are met; requiring the department to
10 adopt certain rules; requiring a specified written
11 informed consent from eligible patients; requiring
12 approval of a specified platform or master protocol by
13 an institutional review board; requiring the
14 Department of Health to establish and maintain a
15 patient registry for specified purposes; requiring
16 eligible facilities to submit certain information to
17 the registry; requiring the department to enter into
18 specified contracts with eligible facilities;
19 providing a penalty for breach of such contact;
20 requiring the department to annually publish a
21 specified report; encouraging health insurers and
22 health maintenance organizations to provide specified
23 insurance coverage for experimental treatments;
24 prohibiting such insurers and organizations from
25 denying insurance coverage for experimental
26 treatments; providing construction; authorizing
27 licensed physicians and eligible facilities to receive
28 reimbursement for the prescription or administration
29 of experimental treatments if certain requirements are
30 met; establishing the reimbursement rate; requiring
31 the department to adopt specified rules; providing for
32 reimbursement rate expiration; requiring manufacturers
33 of experimental treatments to provide for a specified
34 temporary price concession set by the department;
35 providing for expiration of such concession;
36 authorizing the Department of Management Services to
37 enter into a specified contract with an eligible
38 facility or manufacturer; requiring the department to
39 adopt a specified rule for such contract; requiring
40 the Department of Health to adopt by rule certain
41 procedures for licensing of experimental treatment
42 centers; requiring the department to approve or deny a
43 completed application within a specified timeframe;
44 requiring the department to establish by rule certain
45 procedural and operational standards; prohibiting
46 certain actions by specified licensing boards and a
47 specified state agency against a licensed physician in
48 certain circumstances; providing construction and
49 applicability; providing for limitation of liability;
50 providing that certain participation is entirely
51 voluntary at all times; prohibiting public officials,
52 public employees, and public agents from denying or
53 attempting to deny access to experimental treatment;
54 providing construction; requiring the department to
55 adopt rules; providing an effective date.
56
57 Be It Enacted by the Legislature of the State of Florida:
58
59 Section 1.
This
act may be cited as the “Promising Pathways
60
Act.”
61 Section 2. Section 499.0295, Florida Statutes, is amended
62 to read:
63
(Substantial rewording of section. See
64
s. 499.0295, F.S., for present text.)
65
499.0295
Experimental treatments for terminal conditions
66
and life-threatening rare diseases.—
67
(1)
The Legislature finds that residents of this state with
68
terminal conditions and life-threatening rare diseases may
69
benefit from access to experimental treatments that have
70
demonstrated initial human safety but are not yet approved by
71
the United States Food and Drug Administration.
72
(2)
It is the intent of the Legislature to:
73
(a)
Create a safe, regulated, and transparent pathway to
74
experimental treatments through licensed state institutions with
75
board oversight.
76
(b)
Condition payment on evidence development.
77
(c)
Encourage coverage parity by state-regulated health
78
plans.
79
(d)
Align temporary pricing during the conditional period
80
with the maturity of clinical evidence.
81
(3)
As used in this section, the term:
82
(a)
“Board” means the Board of Medicine, created under
83
chapter 458, or the Board of Osteopathic Medicine, created under
84
chapter 459, as applicable.
85
(b)
“Department” means the Department of Health, created
86
under s. 20.43.
87
(c)
“Eligible facility” means a hospital or health care
88
facility licensed under chapter 395 that operates under the
89
federal policy for the protection of human subjects under 45
90
C.F.R. part 46 and maintains, or participates under,
91
Institutional Review Board oversight for experimental
92
treatments.
93
(d)
“Eligible patient” means a person who:
94
1.a.
Has a terminal condition that is attested to by the
95
treating physician and confirmed by a board-certified physician
96
in an appropriate specialty for that condition; or
97
b.
Has a life-threatening rare disease that is attested to
98
by the treating physician and confirmed by a board-certified
99
physician in an appropriate specialty.
100
2.
Has considered and exhausted all other treatment options
101
for the terminal condition or life-threatening rare disease
102
currently approved by the United States Food and Drug
103
Administration.
104
3.
Has given written informed consent pursuant to paragraph
105
(4)(c).
106
4.
Has documentation from the treating physician that the
107
patient meets the requirements of this paragraph.
108
(e)
“Experimental treatment” means:
109
1.
A drug, biological product, or medical device that has
110
successfully completed phase 1 of a clinical trial but has not
111
been approved for general use by the United States Food and Drug
112
Administration (FDA) and remains under investigation in a
113
clinical trial approved by the FDA; or
114
2.
Personalized treatment for use by a patient based on his
115
or her genomic or molecular profile, including, but not limited
116
to, gene-targeted therapies, antisense oligonucleotides (ASOs)
117
mediated therapies, and neoantigen-targeting personalized cancer
118
vaccines (PCVs), which have not been approved for general use by
119
the FDA and remain under investigation in a clinical trial
120
approved by the FDA.
121
(f)
“Institutional Review Board” or “IRB” has the same
122
meaning as in s. 381.86.
123
(g)
“Patient registry” or “registry” means a clinical data
124
collections system from which health information is collected at
125
specific points during the course of treatment and all personal
126
identifiers have been removed or obscured to protect patient
127
privacy.
128
(h)
“Rare life-threatening disease” means a progressive
129
disease or medical or surgical condition that affects less than
130
200,000 persons in the United States. The term includes any
131
progressive disease or medical or surgical condition that meets
132
the criteria of a rare disease under 21 U.S.C. s. 360bb.
133
(i)
“Terminal condition” means a progressive disease or
134
medical or surgical condition that causes significant functional
135
impairment, is not considered by a treating physician to be
136
reversible even with the administration of available treatment
137
options currently approved by the FDA, and, without the
138
administration of life-sustaining procedures, will result in
139
death within 1 year after diagnosis if the condition runs its
140
normal course.
141
(4)(a)
A physician licensed under chapter 458 or chapter
142
459 may prescribe to an eligible patient an experimental
143
treatment pursuant to this section.
144
(b)1.
An eligible facility may administer to an eligible
145
patient an experimental treatment if such treatment is
146
administered pursuant to a platform or master protocol approved
147
by an IRB pursuant to subsection (5) and complies with the
148
registry requirements established in subsection (6).
149
2.a.
An eligible facility that does not maintain its own
150
IRB may establish and maintain an affiliation with another
151
eligible facility that maintains IRB oversight.
152
b.
The department shall adopt rules for affiliations
153
pursuant to this subparagraph, to include, but not be limited
154
to, the handling of drugs, adverse-event escalation, quality
155
assurance, and health data submission.
156
(c)
Written informed consent, signed by an eligible
157
patient, a court-appointed guardian for an eligible patient, or
158
a health care surrogate designated by an eligible patient, is
159
required, and must include:
160
1.
An explanation of the currently approved treatments for
161
the patient’s terminal condition or life-threatening rare
162
disease and that such treatments have been considered and
163
exhausted.
164
2.
Identification of the specific experimental treatment
165
that the patient is seeking to use.
166
3.
A description of the potential risks and benefits of
167
using the experimental treatment, including best-case outcome
168
and worst-case outcome. The description must be based on the
169
physician’s knowledge of the experimental treatment for the
170
patient’s terminal condition or life-threatening rare disease.
171
4.
A statement that the patient’s health plan or third
172
party administrator and physician are not obligated to pay for
173
care or treatment consequent to the use of the experimental
174
treatment unless required to do so by law or contract.
175
5.
A statement that the patient’s eligibility for hospice
176
care may be affected by the use of experimental treatment.
177
6.
A statement that the patient understands he or she is
178
liable for all expenses consequent to the use of the
179
experimental treatment but that liability does not extend to the
180
patient’s estate, unless a contract between the patient and the
181
manufacturer states otherwise.
182
7.
An authorization from the patient to release his or her
183
health information, collected at specific points during
184
treatment, for submission into the registry established in
185
subsection (6).
186
(5)
A platform or master protocol must be approved by an
187
IRB under which treating physicians and eligible facilities may
188
adapt dosing, sequencing, or combinations of authorized
189
experimental treatments, within predefined limitations, without
190
seeking approval of an IRB for each adaptation. The platform or
191
master protocol must specify safety limits, stopping
192
requirements, and patient registry information pursuant to
193
subsection (6).
194
(6)(a)
The department shall establish and maintain a
195
patient registry for the collection and analysis of experimental
196
treatment outcomes under this section. Eligible facilities shall
197
submit health information to the registry from which all
198
personal identifiers have been removed or obscured to protect
199
patient privacy.
200
(b)
The department shall enter into a written contract with
201
eligible facilities which specifies the scope of services
202
provided, the service level, the duration of the agreement, the
203
responsible parties, and the service costs. Failure to meet the
204
contract requirements may result in the filing of an action by
205
the department and a temporary suspension of reimbursement for
206
the prescription or administration of experimental treatment
207
pursuant to subsection (8).
208
(c)
The department shall annually publish a public report
209
of experimental treatment outcomes and safety signals in the
210
aggregate.
211
(7)(a)
A health insurer or a health maintenance
212
organization regulated under the Florida Insurance Code are
213
encouraged to provide insurance coverage for experimental
214
treatments in the same manner as any other covered treatment or
215
therapy.
216
(b)
A health insurer or a health maintenance organization
217
may not deny insurance coverage based solely on a treatment
218
being experimental or denied approval for general use by the
219
FDA.
220
(c)
This subsection does not require insurance coverage and
221
does not expand the coverage an insurer or health maintenance
222
organization must provide under the Florida Insurance Code.
223
(8)(a)
A licensed physician or an eligible facility may
224
receive reimbursement for the prescription or administration of
225
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
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 shall adopt by rule procedures for
259
licensing experimental treatment centers and shall approve or
260
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
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 an
282
eligible patient who is using an experimental treatment; or
283
c.
For any harm to the eligible patient that is a result of
284
the use of an experimental treatment,
285
286
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 brought
290
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
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.