Florida legislation · 2026 Regular Session
Florida H1381: Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases
Status: Failed, March 13, 2026
Authorizes licensed physicians to prescribe & eligible facilities to administer experimental treatments; requires approval of specified platform or master protocol by institutional review board; requires DOH to establish & maintain patient registry; requires DOH to annually publish specified report; encourages health insurers & health maintenance organizations to provide specified insurance coverage for experimental treatments; authorizes licensed physicians & eligible facilities to receive reimbursement for experimental treatments; requires manufacturers of experimental treatments to provide for specified temporary price concession; requires DOH to adopt by rule certain procedures for licensing of experimental treatment centers.
What the bill says
An act relating to experimental treatments for terminal conditions and life-threatening rare diseases; providing a short title; amending s. 499.0295, F.S.; providing legislative findings and intent; defining terms; authorizing licensed physicians to prescribe and eligible facilities to administer experimental treatments if certain requirements are met; requiring the department to adopt certain rules; requiring a specified written informed consent from eligible patients; requiring approval of a specified platform or master protocol by an institutional review board…
From the introduced text, January 9, 2026:
An act relating to experimental treatments for terminal conditions and life-threatening rare diseases; providing a short title; amending s. 499.0295, F.S.; providing legislative findings and intent; defining terms; authorizing licensed physicians to prescribe and eligible facilities to administer experimental treatments if certain requirements are met; requiring the department to adopt certain rules; requiring a specified written informed consent from eligible patients; requiring approval of a specified platform or master protocol by an institutional review board; requiring the Department of Health to establish and maintain a patient registry for specified purposes; requiring eligible facilities to submit certain information to the registry; requiring the department to enter into specified contracts with eligible facilities; providing a penalty for breach of such contact; requiring the department to annually publish a specified report; encouraging health insurers and health maintenance organizations to provide specified insurance coverage for experimental treatments; prohibiting such insurers and organizations from denying insurance coverage for experimental HB 1381 2026 CODING: Words stricken are deletions; words underlined are additions. hb1381-00 Page 2 of FLORIDAHOUSEOFREPRESENTATIVES treatments; providing construction; authorizing licensed physicians and eligible facilities to receive reimbursement for the prescription or administration of experimental treatments if certain requirements are met; establishing the reimbursement rate; requiring the department to adopt specified rules; providing for reimbursement rate expiration; requiring manufacturers of experimental treatments to provide for …