36-1331. Definitions In this chapter, unless the context otherwise requires: 1. " Eligible facility" means a health care institution that operates under a federalwide assurance for the protection of human subjects pursuant to 45 Code of Federal Regulations part 46 and that is subject to the federal federalwide assurance regulations, policies and guidelines, including renewals […]
36-1332. Individualized investigational treatment; availability A. A manufacturer operating within an eligible facility and pursuant to all applicable federalwide assurance regulations may make available to an eligible patient an individualized investigational treatment. An eligible patient’s physician may request an individualized investigational drug, biological product or device from an eligible facility or manufacturer operating within the […]
36-1333. Insurance providers; third-party payors; coverage or payment not required A. A health plan, third-party administrator or other third-party payor may, but is not required to, provide coverage for the cost of an individualized investigational drug, biological product or device or the cost of services related to the use of an individualized investigational drug, biological […]
36-1334. Heirs; no debt liability related to treatment Notwithstanding any other law, if a patient dies while being treated with an individualized investigational drug, biological product or device, the patient’s heirs are not liable for any outstanding debt related to the treatment.
36-1335. Eligible patient’s access; blocking by state prohibited An official, employee or agent of this state may not block or attempt to block an eligible patient’s access to an individualized investigational drug, biological product or device. Counseling, advice or a recommendation consistent with medical standards of care from a licensed physician is not a violation […]
36-1336. No private cause of action This article does not create a private cause of action against a manufacturer of an individualized investigational drug, biological product or device or against any other person or entity involved in the care of an eligible patient using the individualized investigational drug, biological product or device for any harm […]
