HB0192, as enacted as Public Chapter No. 45, creates the “Individualized Investigational Treatment Act” and adds a new part to Tennessee Code Annotated Title 63 governing access to highly personalized experimental medical treatments. The bill defines an “eligible patient” as someone with a life-threatening or severely debilitating illness who has exhausted approved treatment options, has physician recommendation and informed written consent, and has documentation showing the patient meets the statutory criteria. It defines “individualized investigational treatment” as drugs, biological products, or devices made uniquely for one patient based on that patient’s genetic profile, including individualized gene therapies, antisense oligonucleotides, and neoantigen vaccines.
The act allows manufacturers operating within an eligible facility to make such treatments available, but it does not require them to do so. It also permits eligible facilities or manufacturers to provide the treatment without compensation and to require the patient to pay manufacturing or related costs. The bill expressly states that it does not expand insurance coverage requirements, does not require state agencies, hospitals, facilities, physicians, or healthcare providers to provide or pay for the treatment, and does not create a private cause of action against manufacturers or other participants acting in good faith and with reasonable care. It also protects providers from licensure or Medicare certification discipline based solely on recommending access to these treatments.
The bill’s impact on state law is to create a new statutory framework for access to individualized experimental therapies while limiting state interference and clarifying liability, coverage, and payment rules. It also includes patient-consent disclosures about risks, possible hospice implications, and financial responsibility, and it shields heirs from liability for outstanding treatment-related debt after a patient’s death. The act takes effect July 1, 2025.
The general sentiment around the bill appears strongly supportive in committee and on the floor, with unanimous favorable votes in the House Health Subcommittee and House Health Committee reflected in the available history. The lack of recorded opposition in the provided materials suggests broad agreement with the bill’s goal of expanding access to cutting-edge, patient-specific treatments for individuals with terminal or severe illnesses.
The main points of contention likely center on patient safety, informed consent, cost, and liability. The bill addresses these concerns by requiring detailed disclosures, making clear that insurers and government programs are not obligated to pay, and limiting legal exposure for providers and manufacturers who comply in good faith. Another potential issue is the balance between patient access and regulatory oversight, since the act bars state officials from blocking access and protects providers from discipline based solely on recommending these treatments.
This bill adds a new part to Title 63 establishing Tennessee’s rules for individualized investigational treatments, including eligibility standards, consent requirements, provider protections, and liability limits. It does not mandate insurance coverage, state payment, or provider participation, but it does prohibit disciplinary action or state interference based solely on a provider’s recommendation for access to these treatments. It also clarifies that the act does not create a private cause of action and does not alter existing clinical-trial coverage requirements under Tennessee law.
The available voting history shows clear, unanimous support in the House Health Subcommittee and House Health Committee, with no recorded dissent in the provided materials. That suggests the bill was viewed favorably as a patient-access measure for people facing life-threatening or severely debilitating illnesses. The enacted status further indicates the proposal advanced with little visible opposition in the materials provided.
The likely areas of concern are the experimental nature of the treatments, the possibility of serious or unforeseen harm, and who bears the financial risk. The bill responds to those concerns by requiring informed consent, warning that treatment could worsen symptoms or hasten death, and making patients responsible for costs unless another contract or law says otherwise. Another potential point of tension is regulatory and professional oversight: the bill limits state action against providers and manufacturers, which may raise concerns among those who favor stronger safeguards for unproven therapies.