Florida SB 1552: Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases

Bill Text

1552 
Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases 
2026-01-09T03:26:53Z 
Citing this act as the “Promising Pathways Act"; authorizing licensed physicians to prescribe and eligible facilities to administer experimental treatments, if certain requirements are met; requiring the Department of Health to establish and maintain a patient registry for specified purposes; encouraging health insurers and health maintenance organizations to provide specified insurance coverage for experimental treatments; authorizing licensed physicians and eligible facilities to receive reimbursement for the prescription or administration of experimental treatments if certain requirements are met; requiring manufacturers of experimental treatments to provide for a specified temporary price concession set by the department, etc. 
Original Filed Version 
2026 
S 
GB 
General Bill 
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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 (