TN HB0192

Allows patients with life-threatening or severely debilitating illnesses to access individualized investigational treatments—drugs, biological products, or devices uniquely produced based on the patient's own genetic profile, including gene therapy and neoantigen vaccines

Requires eligible patients to obtain physician attestation of their condition, consider all FDA-approved options, provide written informed consent acknowledging risks including possible death, and sign liability releases for physicians, hospitals, and manufacturers

Protects healthcare providers from licensing board actions and Medicare certification penalties based solely on recommending individualized investigational treatments to eligible patients

Prohibits state officials from blocking eligible patient access to these treatments, while clarifying that insurers, health plans, and government agencies are not required to cover costs

Shields manufacturers and care providers from private lawsuits for harm resulting from the treatment if they acted in good faith and exercised reasonable care; effective July 1, 2025