HB 543

Create a new section of KRS Chapter 217 to define terms; permit a manufacturer operating within an eligible facility to make available to an eligible patient an individualized investigational drug, biological product, or device; permit the manufacturer to provide the individualized investigational drug, biological product, or device or require the patient to cover the costs; provide that if a patient dies while being treated his or her heirs are not liable for costs; provide that health care provider licensing boards may not take actions against licensees for their recommendations relating to an individualized investigational drug, biological product, or device; provide that official attempts shall not be made to block an eligible patient's access to an individualized investigational drug, biological product, or device; prohibit private actions against a manufacturer of an individualized investigational drug, biological product, or device that has exercised reasonable care in accordance with this section; preclude any conclusion that health insurance coverage is required or that hospitals are required to provide new or additional services.