Sec. 1379.051. ROUTINE PATIENT CARE COSTS. For purposes of this chapter, 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:
(1) the cost of an investigational new drug or device that is not approved for any indication by the United States Food and Drug Administration, including a drug or device that is the subject of the clinical trial;
(2) the cost 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) the cost of a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis;
(4) a cost associated with managing a clinical trial; or
(5) the cost of a health care service that is specifically excluded from coverage under a health benefit plan.
Added by Acts 2009, 81st Leg., R.S., Ch. 719 (S.B. 39), Sec. 1, eff. September 1, 2009.
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