Montana's Senate Bill 535, introduced on March 21, 2025, aims to enhance patient autonomy and safety regarding experimental treatments. The bill mandates that patients or their legal guardians provide written informed consent before receiving any investigational drugs, biological products, or devices. This legislation addresses critical issues surrounding the use of unapproved medical treatments, ensuring that patients are fully aware of their options and the potential risks involved.

Key provisions of the bill require that the informed consent document includes detailed information about currently approved treatments, the specific experimental treatment being sought, and a realistic assessment of potential outcomes. Notably, it emphasizes that patients must acknowledge their financial responsibility for any expenses related to the experimental treatment, which could extend to their estate. Additionally, the bill outlines implications for patients eligible for hospice care, clarifying that their eligibility may be affected if they pursue curative treatments.

The introduction of SB 535 has sparked significant debate among lawmakers and healthcare advocates. Proponents argue that the bill empowers patients by ensuring they have all necessary information to make informed decisions about their health. Critics, however, express concerns that the stringent requirements may deter patients from seeking potentially life-saving treatments, particularly in dire health situations.

The economic implications of this bill are noteworthy, as it could influence healthcare costs and insurance coverage for experimental treatments. By clarifying the financial responsibilities of patients, the bill may lead to increased scrutiny from insurance providers regarding coverage for investigational therapies.

As the legislative process unfolds, experts suggest that SB 535 could set a precedent for similar laws in other states, potentially reshaping the landscape of patient rights and experimental treatment access. The bill's progress will be closely monitored, as its outcomes could significantly impact patient care and the healthcare system in Montana.