The proposed bill establishes a new section, 381.992, in the Florida Statutes, which focuses on individualized investigational treatments. It defines key terms such as "eligible facility," "eligible patient," and "individualized investigational treatment," and outlines the criteria for patients to qualify for such treatments. The bill authorizes eligible facilities and manufacturers to provide individualized investigational drugs, biological products, or devices to patients who meet specific medical criteria, including having a life-threatening illness and having exhausted other treatment options. It also allows health plans and governmental agencies to cover the costs associated with these treatments while limiting liability for healthcare providers and prohibiting actions against their licenses based solely on their recommendations for these investigational treatments.
Additionally, the bill includes provisions to protect patients and their families from financial liability related to treatment costs if the patient dies while receiving an individualized investigational treatment. It prohibits state officials from blocking patient access to these treatments and clarifies that the bill does not create a private cause of action against manufacturers or providers if they comply with the law. The act is set to take effect on July 1, 2025.