Bill
Bill > H1381
FL H1381
FL H1381Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases
summary
Introduced
01/09/2026
01/09/2026
In Committee
01/15/2026
01/15/2026
Crossed Over
Passed
Dead
03/13/2026
03/13/2026
Introduced Session
2026 Regular Session
Bill Summary
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 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 a specified temporary price concession set by the department; providing for expiration of such concession; authorizing the Department of Management Services to enter into a specified contract with an eligible facility or manufacturer; requiring the department to adopt a specified rule for such contract; requiring the Department of Health to adopt by rule certain procedures for licensing of experimental treatment centers; requiring the department to approve or deny a completed application within a specified timeframe; requiring the department to establish by rule certain procedural and operational standards; prohibiting certain actions by specified licensing boards and a specified state agency against a licensed physician in certain circumstances; providing construction and applicability; providing for limitation of liability; providing that certain participation is entirely voluntary at all times; prohibiting public officials, public employees, and public agents from denying or attempting to deny access to experimental treatment; providing construction; requiring the department to adopt rules; providing an effective date.
AI Summary
This bill, titled the "Promising Pathways Act," establishes a regulated pathway for patients with terminal conditions or life-threatening rare diseases to access experimental treatments that have shown initial safety but are not yet approved by the U.S. Food and Drug Administration (FDA). Licensed physicians can prescribe these treatments, and eligible facilities, such as hospitals licensed under chapter 395 and operating under Institutional Review Board (IRB) oversight, can administer them. An IRB is a committee that reviews and approves research involving human subjects. Patients must provide written informed consent, confirming they have exhausted all FDA-approved options and understand the potential risks and benefits. The bill mandates the Department of Health (DOH) to create a patient registry to collect and analyze treatment outcomes, requiring eligible facilities to submit anonymized health information. Health insurers and health maintenance organizations are encouraged, but not required, to cover these experimental treatments and are prohibited from denying coverage solely because a treatment is experimental or not FDA-approved. The bill also addresses reimbursement for these treatments, setting discounted rates and requiring manufacturers to provide temporary price concessions. It outlines procedures for licensing experimental treatment centers, establishes standards for their operation, and protects physicians from disciplinary action by licensing boards or state agencies solely for recommending experimental treatments. Importantly, participation in this program is voluntary for all parties, and public officials are prohibited from denying access to these treatments.
Committee Categories
Health and Social Services
Sponsors (1)
Last Action
Died in Health Professions & Programs Subcommittee (on 03/13/2026)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.flsenate.gov/Session/Bill/2026/1381 |
| BillText | https://www.flsenate.gov/Session/Bill/2026/1381/BillText/Filed/PDF |
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