“Routine Patient Care Costs” Defined

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.