Drug manufacturers - availability of investigational drugs, biological products, or devices - costs - insurance coverage

(1) A manufacturer of an investigational drug, biological product, or device may make available the manufacturer's investigational drug, biological product, or device to eligible patients pursuant to this part 1. This part 1 does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient. (2) A manufacturer may: (a) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or (b) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device. (3) (a) Nothing in this part 1 expands the coverage provided in section 10-16-104 (20) or 10-16-104.6. (b) A health insurance carrier may, but is not required to, provide coverage for the cost of an investigational drug, biological product, or device. (c) An insurer may deny coverage to an eligible patient from the time the eligible patient begins use of the investigational drug, biological product, or device through a period not to exceed six months from the time the investigational drug, biological product, or device is no longer used by the eligible patient; except that coverage may not be denied for a preexisting condition and for coverage for benefits which commenced prior to the time the eligible patient begins use of such drug, biological product, or device. (4) If a patient dies while being treated by an investigational drug, biological product, or device, the patient's heirs are not liable for any outstanding debt related to the treatment or lack of insurance due to the treatment.