Relating to access to individualized investigational treatments for patients with life-threatening or severely debilitating illnesses.
The bill introduces a framework that allows healthcare facilities operating under federal regulations to administer these treatments provided that patients meet specific eligibility criteria. The criteria stipulate that patients must have a diagnosed life-threatening or severely debilitating illness, have explored all FDA-approved treatment options, and must provide written informed consent. While this bill opens avenues for experimental treatments, it meticulously safeguards both patient privacy and rights throughout the process, ensuring informed decision-making is at the forefront of treatment access.
House Bill 3318 proposes to enhance patient access to individualized investigational treatments for those suffering from life-threatening or severely debilitating illnesses. Under this bill, the term 'individualized investigational treatment' is defined to include drug therapies and biological products tailored to a patient’s genetic profile. The primary objective is to enable physicians to recommend and facilitate access to personalized treatments that have not yet gained approval from the FDA, under certain stipulations that prioritize patient safety and informed decision-making.
Despite the bill's supportive aim of broadening treatment options, it may lead to disputes regarding patient liability for treatment costs, as the bill states that no state agency is obliged to cover these expenses. Additionally, healthcare providers are protected from repercussions if they recommend these investigational treatments, which could raise concerns among some regarding the ethics of such promotional practices. The provisions ensuring that patients or their estates are not liable for outstanding debts if a patient dies while receiving treatment might also provoke discussions surrounding healthcare costs and responsibilities.