Bill > HB0192

This bill establishes the "Individualized Investigational Treatment Act" in Tennessee, which creates a framework for patients with life-threatening or severely debilitating illnesses to access highly personalized medical treatments not yet approved by the FDA. The bill defines an "eligible patient" as someone with a serious illness who has exhausted standard treatment options and receives a recommendation from their physician for a unique, personalized treatment based on their individual genetic profile, such as gene therapy or neoantigen vaccines. To access such treatments, patients must provide written, informed consent that explicitly outlines the potential risks, benefits, and financial responsibilities, including acknowledging that health insurance may not cover the experimental treatment. The legislation protects healthcare providers from professional disciplinary actions for recommending these treatments and prevents state officials from blocking patient access. Importantly, the bill does not require manufacturers or healthcare facilities to provide these investigational treatments, and it absolves patients' heirs from outstanding treatment-related debt if the patient dies. The act also includes provisions that limit liability for manufacturers and healthcare providers who act in good faith and exercise reasonable care, while ensuring that patients understand they are primarily responsible for the costs associated with these highly specialized treatments. The law is set to take effect on July 1, 2025.

Health and Social Services

https://wapp.capitol.tn.gov/apps/Billinfo/default.aspx?BillNumber=HB0192&ga=114