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.