Florida HB 1381: Interstate Mobility

Bill Text

HB 1381 2026

CODING: Words stricken are deletions; words underlined are additions.
hb1381-00
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S

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

HB 1381 2026

CODING: Words stricken are deletions; words underlined are additions.
hb1381-00
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S

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

HB 1381 2026

CODING: Words stricken are deletions; words underlined are additions.
hb1381-00
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S

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

HB 1381 2026

CODING: Words stricken are deletions; words underlined are additions.
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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