AN ACT to amend Tennessee Code Annotated, Title 53 and Title 63, relative to medical treatment.
SB 282 creates the “Individualized Investigational Treatment Act,” a new part of Tennessee law governing access to highly personalized experimental medical products for patients with life-threatening or severely debilitating illnesses. The bill defines an eligible patient as someone who has exhausted approved FDA treatment options, has a physician recommendation, and gives written informed consent. It also defines “individualized investigational treatment” to include patient-specific drugs, biological products, or devices made from the patient’s genetic profile, including individualized gene therapies, antisense oligonucleotides, and neoantigen vaccines.
The bill allows eligible facilities and manufacturers operating under federal human-subjects protections to make these treatments available, but it does not require them to do so. It permits providers to offer the treatment without compensation and to require the patient to pay manufacturing and related costs. The informed-consent process must include warnings about uncertain outcomes, possible worsening of symptoms, possible hastening of death, liability waivers, insurance and hospice implications, and the patient’s responsibility for costs. The bill also states that it does not expand insurance coverage, does not require government payment, and does not create a private cause of action against compliant manufacturers or providers.
In practical terms, the bill amends Tennessee Code Annotated Titles 53 and 63 by creating a legal framework for access to individualized experimental therapies while limiting state interference and provider liability. It also protects healthcare providers from licensure or Medicare-certification action based solely on recommending access to such treatment, and bars state officials from blocking access. The act takes effect July 1, 2025.
The overall sentiment appears strongly favorable. The bill passed the Senate Health and Welfare Committee 8-1 and then cleared the Senate floor by wide margins, including 84-5 on third consideration and 28-1 on the amended version. Those votes suggest broad bipartisan support for expanding patient access to experimental, last-resort treatments, especially for individuals with serious or terminal conditions.
The main points of contention are likely cost, liability, and the scope of state involvement. The bill places financial responsibility on patients and their estates, limits insurer and government payment obligations, and requires extensive informed consent acknowledging risks and uncertainty. It also preserves provider discretion by making participation voluntary, which suggests concern about forcing hospitals, physicians, or manufacturers to provide treatments they may view as too experimental or risky.
SB 282 adds a new statutory framework in Title 63 for individualized investigational treatments and makes conforming policy changes affecting healthcare providers, facilities, insurers, and state agencies. It limits regulatory and disciplinary action against providers who recommend such treatments, bars state officials from obstructing access, and clarifies that the act does not expand insurance coverage or create new payment obligations for insurers, health plans, or government entities. It also provides liability protections for compliant participants and shields heirs from outstanding treatment-related debt after a patient’s death.
The bill’s reception was generally positive and supportive, with strong committee and floor votes indicating little organized opposition in the legislative process. The broad margins suggest lawmakers were receptive to the bill’s patient-access rationale, especially for individuals facing life-threatening or severely debilitating illnesses. The lone or small number of dissenting votes indicate some reservations, but the overall legislative sentiment was clearly favorable.
The likely areas of disagreement are the risks of authorizing highly experimental, patient-specific treatments and the financial and legal consequences of doing so. Critics may be concerned about uncertain efficacy, potential harm, and whether patients can meaningfully consent under desperate circumstances. Others may object to the bill’s explicit limits on insurance coverage, government payment, and provider liability, while supporters likely view those limits as necessary to make access possible without mandating participation or shifting costs to the state.