FL H1381

Cited as the "Promising Pathways Act," amends s. 499.0295, F.S., to allow licensed physicians to prescribe and eligible facilities to administer experimental treatments (drugs, biologics, devices, or personalized therapies that have completed FDA phase 1 trials) to patients with terminal conditions (expected death within 1 year) or rare life-threatening diseases (affecting fewer than 200,000 U.S. persons), provided the patient has exhausted all FDA-approved options and gives written informed consent.

Requires all experimental treatments to be administered under a platform or master protocol approved by an Institutional Review Board (IRB), and directs the Department of Health to establish and maintain a de-identified patient registry to collect treatment outcome data, with an annual public report on outcomes and safety signals.

Establishes a reimbursement framework capping payment at a discounted rate set by the Department of Health as a percentage of wholesale acquisition cost or average sales price, subject to renewal every 2 years based on registry compliance; the discounted rate expires and standard reimbursement applies once the FDA approves the treatment.

Prohibits health insurers and HMOs from denying coverage solely because a treatment is experimental or lacks FDA approval, though does not mandate new coverage; requires manufacturers to offer a temporary price concession set by the department, expiring upon FDA approval.

Protects physicians from licensing board or Medicare certification actions based solely on recommending experimental treatments, limits private causes of action against manufacturers and providers acting in good faith (except for gross negligence or willful misconduct), and prohibits public officials or employees from denying patient access to experimental treatment.