Bill
Bill > S1552
FL S1552
FL S1552Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases
summary
Introduced
01/09/2026
01/09/2026
In Committee
01/16/2026
01/16/2026
Crossed Over
Passed
Dead
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 framework for patients with terminal conditions or life-threatening rare diseases to access experimental treatments that have shown initial safety but are not yet FDA-approved. It allows licensed physicians to prescribe these treatments and eligible facilities, such as hospitals, to administer them, provided certain requirements are met. These requirements include obtaining written informed consent from the patient, which details potential risks, benefits, and the fact that insurance may not cover the treatment. An Institutional Review Board (IRB), which is a committee that reviews and approves research involving human subjects, must approve the platform or master protocol for the experimental treatment. The Department of Health (DOH) will maintain a patient registry to collect and analyze treatment outcomes, and eligible facilities must submit anonymized health information to this registry. The bill encourages health insurers and health maintenance organizations (HMOs) to cover these experimental treatments and prohibits them from denying coverage solely because a treatment is experimental or not FDA-approved. Physicians and facilities can receive reimbursement for administering these treatments, with rates set by the DOH and tied to participation in the patient registry. Manufacturers will also provide temporary price concessions. The bill includes provisions for licensing experimental treatment centers, limits liability for those involved in good faith compliance, and clarifies that participation is voluntary. It also prohibits public officials from denying access to these treatments.
Sponsors (1)
Last Action
Introduced (on 01/22/2026)
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/2026/1552 |
| BillText | https://www.flsenate.gov/Session/Bill/2026/1552/BillText/Filed/HTML |
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