Healthcare

SB 282, the "Individualized Investigational Treatment Act," creates a legal framework for patients with life-threatening or severely debilitating illnesses to access personalized medical treatments (like gene therapies or vaccines tailored to their genetic profile) when standard FDA-approved options have been exhausted. It directly affects eligible patients (who must meet specific criteria including physician attestation and written informed consent) and eligible facilities (those complying with federal human subjects protections). Key provisions require detailed written consent covering all treatment options, risks, and financial liability, while clarifying that insurers, health plans, and providers are **not obligated** to cover these treatments or related costs (TCA §§ 63-6-1304(a)-(d)). The law takes effect July 1, 2025, and explicitly states that heirs cannot be held liable for unpaid treatment debts if a patient dies during treatment (TCA § 63-6-1305).

This bill adds hepatitis C antibody (anti-HCV) testing to the standard blood screening required for all pregnant women in Tennessee during initial prenatal visits and between weeks 28-32 of pregnancy. If the anti-HCV test is reactive, labs must automatically conduct a follow-up HCV RNA test without requiring additional orders. It directly affects all pregnant women receiving routine prenatal care in Tennessee, expanding the required screening panel to include hepatitis C alongside existing tests for syphilis, rubella, and hepatitis B. The changes take effect July 1, 2025, and align hepatitis C testing protocols with existing disease reporting requirements for maternal health.