The "Promising Pathways Act" is a proposed bill in Florida designed to enhance access to experimental treatments for patients suffering from terminal conditions and life-threatening rare diseases. It allows licensed physicians to prescribe these treatments and mandates that eligible healthcare facilities administer them under specific conditions, including obtaining written informed consent from patients and approval from an Institutional Review Board (IRB). The bill also requires the Department of Health to establish a patient registry to collect and analyze treatment outcomes, while encouraging health insurers to cover experimental treatments and prohibiting them from denying coverage based solely on the experimental nature of the treatment.

Key provisions of the bill include the creation of a reimbursement framework for physicians and facilities, with rates determined by the Department of Health, and a requirement for manufacturers to offer temporary price concessions until FDA approval is obtained. The bill sets forth new procedural and operational standards for administering experimental treatments, including oversight, safety standards, and staff training. It protects physicians from having their licenses revoked based solely on their recommendations for patients seeking experimental treatments and ensures that state agencies cannot penalize physicians for such recommendations. Additionally, the bill clarifies that it does not create a private cause of action against manufacturers or patient care entities, and it protects the heirs of patients who die while using experimental treatments from related debts. Overall, the bill aims to create a regulated pathway for patients to access potentially life-saving therapies while ensuring patient and provider protections.

Statutes affected:
S 1552 Filed: 499.0295