§ 27-8-25-7 — "Routine care cost"

As used in this chapter, "routine care cost"
means the cost of medically necessary services related to the care
method that is under evaluation in a clinical trial. The term does not
include the following:
(1) The health care service, item, or investigational drug that is
the subject of the clinical trial.
(2) Any treatment modality that is not part of the usual and
customary standard of care required to administer or support the
health care service, item, or investigational drug that is the subject
of the clinical trial.
(3) Any health care service, item, or drug provided solely to
satisfy data collection and analysis needs that are not used in the
direct clinical management of the patient.
(4) An investigational drug or device that has not been approved
for market by the federal Food and Drug Administration.
(5) Transportation, lodging, food, or other expenses for the patient
or a family member or companion of the patient that are
associated with travel to or from a facility where a clinical trial is
conducted.
(6) A service, item, or drug that is provided by a clinical trial
sponsor free of charge for any new patient.
(7) A service, item, or drug that is eligible for reimbursement
from a source other than a covered individual's policy of accident
and sickness insurance, including the sponsor of the clinical trial.

Legislative History

As added by P.L.109-2009, SEC.3.