Florida Senate - 2025 SB 680
By Senator Rodriguez
40-01725-25 2025680__
1 A bill to be entitled
2 An act relating to individualized investigational
3 treatments for life-threatening or severely
4 debilitating illnesses; creating s. 499.0296, F.S.;
5 defining terms; authorizing eligible patients to
6 request and receive individualized investigational
7 treatment if they meet specified conditions;
8 authorizing eligible facilities and certain
9 manufacturers to provide individualized
10 investigational treatments to eligible patients;
11 providing construction with respect to insurance
12 coverage and health care services related to an
13 eligible patient’s use of an individualized
14 investigational treatment; providing that an eligible
15 patient’s heirs are not liable for any outstanding
16 debt related to the patient’s use of an individualized
17 investigational treatment; prohibiting a licensing
18 board and certain state entities from taking
19 disciplinary action against a physician solely for
20 recommending an individualized investigational
21 treatment for an eligible patient; prohibiting
22 officials, employees, and agents of the state from
23 blocking or attempting to block an eligible patient’s
24 access to individualized investigational treatment;
25 providing construction; providing that a cause of
26 action may not arise against the manufacturer of an
27 individualized investigational treatment or any person
28 or entity involved in the care of an eligible patient
29 using such treatment under certain circumstances;
30 providing construction; providing an effective date.
31
32 Be It Enacted by the Legislature of the State of Florida:
33
34 Section 1. Section 499.0296, Florida Statutes, is created
35 to read:
36 499.0296 Patient right to try individualized
37 investigational treatment.—
38 (1) As used in this section, the term:
39 (a) “Eligible facility” means an institution that is
40 operating under a Federalwide Assurance (FWA) for the Protection
41 of Human Subjects under 42 U.S.C. s. 289(a) and 45 C.F.R. part
42 46 subject to the FWA laws, regulations, policies, and
43 guidelines.
44 (b) “Eligible patient” means an individual authorized to
45 receive individualized investigational treatment under this
46 section.
47 (c) “Individualized investigational treatment” means drugs,
48 biological products, or devices that are unique to and produced
49 exclusively for use by an individual patient, based on his or
50 her own genetic profile. The term includes, but is not limited
51 to, individualized gene therapy antisense oligonucleotides and
52 individualized neoantigen vaccines.
53 (d) “Life-threatening or severely debilitating illness” has
54 the same meaning as provided in 21 C.F.R. s. 312.81.
55 (e) “Written, informed consent” means a written document
56 that is signed by a patient, a parent or legal guardian of a
57 patient who is a minor, a court-appointed guardian for a
58 patient, or a health care surrogate designated by a patient,
59 attested to by the patient’s physician and a witness, and
60 includes all of the following:
61 1. An explanation of the currently approved products and
62 treatments for the life-threatening or severely debilitating
63 illness from which the patient suffers.
64 2. An attestation that the patient concurs with his or her
65 physician in believing that all currently approved and
66 conventionally recognized treatments are unlikely to prolong the
67 patient’s life.
68 3. Clear identification of the specific proposed
69 individualized investigational treatment that the patient is
70 seeking to use.
71 4. A description of all of the best and worst potential
72 outcomes of using the individualized investigational treatment
73 and a realistic description of the most likely outcome. The
74 description must include the possibility that new,
75 unanticipated, different, or worse symptoms may result and that
76 death could be hastened by the proposed treatment. The
77 description must be based on the physician’s knowledge of the
78 proposed individualized investigational treatment in conjunction
79 with an awareness of the patient’s life-threatening or severely
80 debilitating illness.
81 5. A statement that the patient’s health plan or third
82 party administrator and physician are not obligated to pay for
83 any care or treatment consequent to the use of the
84 individualized investigational treatment, unless they are
85 specifically required to do so by law or contract.
86 6. A statement that the patient’s eligibility for hospice
87 care may be withdrawn if the patient begins curative treatment
88 with the individualized investigational drug, biological
89 product, or device and that hospice care may be reinstated if
90 the treatment ends and the patient meets hospice eligibility
91 requirements.
92 7. A statement that the patient understands that he or she
93 is liable for all expenses consequent to the use of the
94 individualized investigational treatment and that this liability
95 extends to the patient’s estate, unless a contract between the
96 patient and the manufacturer of the individualized
97 investigational treatment states otherwise.
98 (2) In addition to the options available under s. 499.0295,
99 an eligible patient may request and receive individualized
100 experimental treatment if he or she meets all of the following
101 conditions:
102 (a) Has a life-threatening or severely debilitating
103 illness, attested to by the patient’s treating physician.
104 (b) Has considered all other treatment options currently
105 approved by the United States Food and Drug Administration.
106 (c) Has received a recommendation from his or her physician
107 for an individualized investigational treatment, based on
108 analysis of the patient’s genomic sequence, human chromosomes,
109 deoxyribonucleic acid, ribonucleic acid, genes, gene products,
110 such as enzymes and other types of proteins, or metabolites.
111 (d) Has given written, informed consent for the use of the
112 individualized investigational treatment.
113 (e) Has documentation from his or her physician
114 demonstrating that he or she meets the requirements of this
115 section.
116 (3) Upon the request of an eligible patient, an eligible
117 facility or a manufacturer operating within an eligible facility
118 and pursuant to all applicable FWA laws and regulations may, but
119 is not required to, do all of the following:
120 (a) Make available an individualized investigational
121 treatment requested by an eligible patient.
122 (b) Provide an individualized investigational treatment to
123 an eligible patient without receiving compensation.
124 (c) Require an eligible patient to pay the costs of, or the
125 costs associated with, the manufacture of an individualized
126 investigational treatment.
127 (4) A health plan, third-party administrator, or
128 governmental agency may, but is not required to, provide
129 coverage for the cost of, or the cost of services related to the
130 use of, an individualized investigational treatment under this
131 section.
132 (5) This section does not require a hospital or health care
133 facility licensed under chapter 395 to provide new or additional
134 services unless those services are approved by the hospital or
135 health care facility.
136 (6) If an eligible patient dies while being treated by an
137 individualized investigational treatment under this section, the
138 patient’s heirs are not liable for any outstanding debt related
139 to the patient’s use of the treatment.
140 (7) A licensing board may not revoke, fail to renew,
141 suspend, or take any action against a physician’s license issued
142 under chapter 458 or chapter 459 based solely on the physician’s
143 recommendations to an eligible patient regarding access to or
144 treatment with an individualized investigational treatment under
145 this section. A state entity responsible for Medicare
146 certification may not take action against a physician’s Medicare
147 certification based solely on the physician’s recommendation
148 that an eligible patient use an individualized investigational
149 treatment.
150 (8) An official, an employee, or any agent of the state may
151 not block or attempt to block an eligible patient’s access to an
152 individualized investigational treatment. Counseling, advice, or
153 a recommendation consistent with medical standards of care from
154 a licensed health care provider is not a violation of this
155 section.
156 (9) This section does not create a private cause of action
157 against a manufacturer of an individualized investigational
158 treatment or against any other person or entity involved in the
159 care of an eligible patient using the individualized
160 investigational treatment for any harm done to the eligible
161 patient resulting from the use of the individualized
162 investigational treatment if the manufacturer or other person or
163 entity complied in good faith with the terms of this section and
164 exercised reasonable care.
165 (10) This section does not expand the coverage an insurer
166 must provide under the Florida Insurance Code.
167 Section 2. This act shall take effect July 1, 2025.