H 1381

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    HB 1381  2026
1A bill to be entitled
2An act relating to experimental treatments for
3terminal conditions and life-threatening rare
4diseases; providing a short title; amending s.
5499.0295, F.S.; providing legislative findings and
6intent; defining terms; authorizing licensed
7physicians to prescribe and eligible facilities to
8administer experimental treatments if certain
9requirements are met; requiring the department to
10adopt certain rules; requiring a specified written
11informed consent from eligible patients; requiring
12approval of a specified platform or master protocol by
13an institutional review board; requiring the
14Department of Health to establish and maintain a
15patient registry for specified purposes; requiring
16eligible facilities to submit certain information to
17the registry; requiring the department to enter into
18specified contracts with eligible facilities;
19providing a penalty for breach of such contact;
20requiring the department to annually publish a
21specified report; encouraging health insurers and
22health maintenance organizations to provide specified
23insurance coverage for experimental treatments;
24prohibiting such insurers and organizations from
25denying insurance coverage for experimental
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26treatments; providing construction; authorizing
27licensed physicians and eligible facilities to receive
28reimbursement for the prescription or administration
29of experimental treatments if certain requirements are
30met; establishing the reimbursement rate; requiring
31the department to adopt specified rules; providing for
32reimbursement rate expiration; requiring manufacturers
33of experimental treatments to provide for a specified
34temporary price concession set by the department;
35providing for expiration of such concession;
36authorizing the Department of Management Services to
37enter into a specified contract with an eligible
38facility or manufacturer; requiring the department to
39adopt a specified rule for such contract; requiring
40the Department of Health to adopt by rule certain
41procedures for licensing of experimental treatment
42centers; requiring the department to approve or deny a
43completed application within a specified timeframe;
44requiring the department to establish by rule certain
45procedural and operational standards; prohibiting
46certain actions by specified licensing boards and a
47specified state agency against a licensed physician in
48certain circumstances; providing construction and
49applicability; providing for limitation of liability;
50providing that certain participation is entirely
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51voluntary at all times; prohibiting public officials,
52public employees, and public agents from denying or
53attempting to deny access to experimental treatment;
54providing construction; requiring the department to
55adopt rules; providing an effective date.
56
57    Be It Enacted by the Legislature of the State of Florida:
58
59Section 1.        "This act may be cited as the "Promising
60    Pathways Act."
61Section 2.        Section 499.0295, Florida Statutes, is amended
62    to read:
63(Substantial rewording of section. See
64s. 499.0295, F.S., for present text.)
65499.0295        Experimental treatments for terminal conditions
66    and life-threatening rare diseases.—
67(1)     The Legislature finds that residents of this state
68    with 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.
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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:
941.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
97b.      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.
1002.      Has considered and exhausted all other treatment
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101    options for the terminal condition or life-threatening rare
102    disease currently approved by the United States Food and Drug
103    Administration.
1043.      Has given written informed consent pursuant to
105    subsection (4)(c).
1064.      Has documentation from the treating physician that the
107    patient meets the requirements of this paragraph.
108(e)      "Experimental treatment" means:
1091.      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
1142.      Personalized treatment for use by a patient based on
115    his or her genomic or molecular profile, including, but not
116    limited to, gene-targeted therapies, antisense oligonucleotides
117    (ASOs)-mediated therapies, and neoantigen-targeting personalized
118    cancer vaccines (PCVs), which have not been approved for general
119    use by the FDA and remain under investigation in a clinical
120    trial 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
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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).
1492.a.        An eligible facility that does not maintain its own
150    IRB may establish and maintain an affiliation with another
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151    eligible facility that maintains IRB oversight.
152b.      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:
1601.      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.
1642.      Identification of the specific experimental treatment
165    that the patient is seeking to use.
1663.      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.
1714.      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.
1755.      A statement that the patient's eligibility for hospice
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176    care may be affected by the use of experimental treatment.
1776.      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.
1827.      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
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201    with 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
221    and does not expand the coverage an insurer or health
222    maintenance organization must provide under the Florida
223    Insurance Code.
224(8)(a)      A licensed physician or an eligible facility may
225    receive reimbursement for the prescription or administration of
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226    an experimental treatment under this section. However, in order
227    to receive such reimbursement, an eligible facility must
228    actively participate in the patient registry established under
229    subsection (6). Failure to participate in the patient registry
230    may result in temporary suspension of reimbursement until
231    compliance is restored.
232(b)1.       Reimbursement for a prescribed or administered
233    experimental treatment under this subsection may not exceed a
234    discounted rate set by the department as a percentage of a
235    recognized pricing benchmark, including wholesale acquisition
236    cost or average sales price.
2372.      The department shall adopt rules that:
238a.      Establish an allowable discount band to reflect
239    evidentiary uncertainty.
240b.      Apply a registry noncompliance adjustment which
241    increases the discounted rate set by the department.
242c.      Provide for renewal and potential adjustment of the
243    discounted rate every 2 years based on registry compliance.
244(c)      Upon approval by the FDA of an experimental treatment,
245    the discounted rate set by the department for reimbursement
246    expires and the standard reimbursement rate applies.
247(9)     A manufacturer of an experimental treatment shall
248    provide for a temporary price concession, which price must be
249    set by the department by rule as a percentage of a recognized
250    pricing benchmark. The temporary price concession expires upon
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251    approval by the FDA of the experimental treatment.
252(10)        An eligible facility or manufacturer and the
253    Department of Management Services pursuant to s. 110.123 may
254    enter into a healthcare contract under which a portion of
255    payment is linked to experimental treatment outcomes. The
256    department shall adopt a rule for such contract, which rule must
257    provide for standard contract terms and authorize reconciliation
258    intervals not to exceed 2 years.
259(11)(a)        The Department of Health shall adopt by rule
260    procedures for licensing experimental treatment centers and
261    shall approve or deny a completed application within 90 days.
262(b)      The department shall establish by rule the following
263    minimum procedural and operational standards:
2641.      Written policies and procedures.
2652.      Oversight and governance standards.
2663.      Inspection and safety standards.
2674.      Staff training provisions.
2685.      Recordkeeping provisions.
2696.      Data quality assurance.
270(12)(a)        A licensing board may not revoke, deny renewal,
271    suspend, or take any action against a physician's license issued
272    under chapter 458 or chapter 459 based solely on the physician's
273    recommendations to an eligible patient regarding access to or
274    treatment with experimental treatment authorized under this
275    section. A state agency responsible for Medicare certification
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276    may not take action against a physician's Medicare certification
277    based solely on the physician's recommendation that an eligible
278    patient have access to experimental treatment.
279(b)1.       This section does not create a private cause of
280    action:
281a.      Against a manufacturer of an experimental treatment;
282b.      Against a person or an entity involved in the care of
283    an eligible patient who is using an experimental treatment; or
284c.      For any harm to the eligible patient that is a result
285    of the use of an experimental treatment,
286
287    if the manufacturer or other person or entity complies in good
288    faith with the terms of this section and exercises reasonable
289    care.
2902.      This paragraph does not apply to judicial action
291    brought for gross negligence or intentional, willful, or wanton
292    misconduct.
293(c)      If an eligible patient dies while using experimental
294    treatment pursuant to this section, the patient's heirs are not
295    liable for any outstanding debt related to the patient's use of
296    such treatment.
297(d)      A hospital or licensed health care facility is not
298    required to provide new or additional health care services or
299    treatments under this section without prior consent of the
300    hospital or licensed health care facility. Participation
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301    pursuant to this section is entirely voluntary at all times.
302(e)     A public official, a public employee, or an agent of
303    this state, or any political subdivision thereof, may not deny
304    or attempt to deny access to experimental treatment under this
305    section. Counseling, advice, or recommendations by a licensed
306    physician consistent with the standard of care do not constitute
307    the denial of access or the attempted denial of access to
308    experimental treatment under this paragraph.
309(13)        This section does not authorize the possession, use,
310    dispensing, or administration of a controlled substance in
311    violation of chapter 893, except to the extent expressly
312    permitted by state or federal law.
313(14)        The department shall adopt rules pursuant to ss.
314    120.536(1) and 120.54 to implement this section.
315Section 3.        This act shall take effect upon becoming a law.
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