TITLE 41

INSURANCE

CHAPTER 65

COVERAGE FOR PARTICIPANTS IN CLINICAL TRIALS

41-6501.  "ROUTINE PATIENT CARE costs" defined. "Routine patient care costs" means the costs of any medically necessary health care service for which benefits are provided under a health benefit plan, without regard to whether the enrollee is participating in a clinical trial. Routine patient care costs do not include the cost:

(1)  Of an investigational new drug or device that is not approved for any indication by the United States food and drug administration;

(2)  Of a service that is not a health care service, regardless of whether the service is required in connection with participation in a clinical trial;

(3)  Of a service that is inconsistent with widely accepted and established standards of care for a particular diagnosis;

(4)  Associated with managing a clinical trial; or

(5)  Of a health care service that is specifically excluded from coverage under a health benefit plan.

History:

[41-6501, added 2019, ch. 192, sec. 1, p. 604.]