The bill amends and reenacts section 16-51-3 of the Code of West Virginia, 1931, while repealing section 16-51-2, which contained legislative findings. The primary focus of the bill is to redefine the criteria for "eligible patients" who may seek access to investigational treatments. The definition of an eligible patient is updated to include those with a "life-threatening or severely debilitating illness" as opposed to a "terminal illness," and it requires that the patient has considered all FDA-approved treatment options. Additionally, the bill modifies the consent process, ensuring that written, informed consent is obtained from the patient or their legal guardian, and it clarifies the definition of investigational drugs to include those tailored to an individual's genetic profile.

Furthermore, the bill introduces new language regarding the potential implications of using investigational treatments, such as the possibility of losing hospice care eligibility and the financial responsibilities that may arise from treatment. The definition of "life-threatening or severely debilitating illness" is aligned with federal regulations, and the bill emphasizes the importance of informed consent by detailing the necessary components that must be included in the consent document. Overall, the bill aims to enhance patient access to experimental therapies while ensuring that patients are fully informed of the risks and implications associated with such treatments.

Statutes affected:
Introduced Version: 16-51A-1, 16-51A-2, 16-51A-3, 16-51A-4, 16-51A-5, 16-51A-6, 16-51A-7, 16-51A-8
Committee Substitute: 16-51-1
Committee Substitute for the Committee Substitute: 16-51-3, 16-51-2
Engrossed Committee Substitute for the Committee Substitute: 16-51-3, 16-51-2