“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.