The "Promising Pathways Act" aims to enhance access to experimental treatments for patients with terminal conditions and life-threatening rare diseases in Florida by amending section 499.0295 of the Florida Statutes. The bill establishes a regulated pathway for licensed physicians to prescribe and eligible facilities to administer these treatments, contingent upon obtaining written informed consent from patients, approval from an Institutional Review Board (IRB), and the creation of a patient registry by the Department of Health. It encourages health insurers to cover these treatments and prohibits denial of coverage based solely on their experimental status. Additionally, the bill outlines a reimbursement process for physicians and facilities, requiring manufacturers to provide temporary price concessions until FDA approval is granted.

House Bill 1381 further establishes a framework for licensing and regulating experimental treatment centers in Florida, mandating the Department of Health to adopt rules that include minimum operational standards. The bill protects physicians who recommend experimental treatments from having their licenses or Medicare certifications revoked based solely on these recommendations and clarifies that there is no private cause of action against manufacturers or caregivers who comply with the law. It emphasizes the voluntary nature of participation in experimental treatments and ensures that public officials cannot deny access to these options, while also making it clear that the bill does not permit illegal possession or use of controlled substances.

Statutes affected:
H 1381 Filed: 499.0295