Required Coverage

TITLE 41 INSURANCE CHAPTER 65 COVERAGE FOR PARTICIPANTS IN CLINICAL TRIALS 41-6502. required coverage. The issuer of a health benefit plan shall provide benefits for routine patient care costs to an enrollee in connection with an approved clinical trial. For purposes of this chapter, "approved clinical trial" means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of a disease or condition and: (1) The study or investigation is approved or funded, which may include funding through in-kind contributions, by one (1) or more of the following: (a)  The national institutes of health; (b)  The centers for disease control and prevention; (c)  The agency for healthcare research and quality; (d)  The centers for medicare and medicaid services; (e)  A cooperative group or center of any of the entities through the department of defense or the department of veterans affairs; or (f)  A qualified nongovernmental research entity identified in the guidelines issued by the national institutes of health for center support grants; (2)  The study or investigation is conducted under an investigational new drug application reviewed by the food and drug administration; (3)  The study or investigation is not a new drug trial and therefore exempt from having such an investigational new drug application by the food and drug administration; or (4)  The study or investigation has been reviewed and approved by an institutional review board of an institution that has an agreement with the office for human research protections of the United States department of health and human services.