36-1312. Availability of investigational drugs, biological products or devices; costs; insurance coverage
A. 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 article. This article does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.
B. A manufacturer may:
1. Provide an investigational drug, biological product or device to an eligible patient without receiving compensation.
2. Require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biological product or device.
3. Require an eligible patient to participate in data collection relating to the use of the investigational drug, biological product or device.
C. This article does not require a health care insurer or any state agency to provide coverage for the cost of any investigational drug, biological product or device. A health care insurer may provide coverage for an investigational drug, biological product or device.
Section: Previous 36-1151 36-1161 36-1162 36-1163 36-1201 36-1301 36-1311 36-1312 36-1313 36-1314 36-1401 36-1402 36-1403 36-1404 36-1405 NextLast modified: October 13, 2016