CHAPTER 25. COVERAGE FOR CARE RELATED TO CLINICAL TRIALS
IC 27-8-25
Chapter 25. Coverage for Care Related to Clinical Trials
IC 27-8-25-1
"Care method"
Sec. 1. As used in this chapter, "care method" means the use of a
particular drug or device in a particular manner.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-2
"Clinical trial"
Sec. 2. As used in this chapter, "clinical trial" means a Phase I, II,
III, or IV research study:
(1) that is conducted:
(A) using a particular care method to prevent, diagnose, or
treat a cancer for which:
(i) there is no clearly superior, noninvestigational
alternative care method; and
(ii) available clinical or preclinical data provides a
reasonable basis from which to believe that the care
method used in the research study is at least as effective as
any noninvestigational alternative care method;
(B) in a facility where personnel providing the care method
to be followed in the research study have:
(i) received training in providing the care method;
(ii) expertise in providing the type of care required for the
research study; and
(iii) experience providing the type of care required for the
research study to a sufficient volume of patients to
maintain expertise; and
(C) to scientifically determine the best care method to
prevent, diagnose, or treat the cancer; and
(2) that is approved or funded by one (1) of the following:
(A) A National Institutes of Health institute.
(B) A cooperative group of research facilities that has an
established peer review program that is approved by a
National Institutes of Health institute or center.
(C) The federal Food and Drug Administration.
(D) The United States Department of Veterans Affairs.
(E) The United States Department of Defense.
(F) The institutional review board of an institution located
in Indiana that has a multiple project assurance contract
approved by the National Institutes of Health Office for
Protection from Research Risks as provided in 45 CFR
46.103.
(G) A research entity that meets eligibility criteria for a
support grant from a National Institutes of Health center.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-3
"Contracted provider"
Sec. 3. As used in this chapter, "contracted provider" means a
health care provider that has entered into an agreement under
IC 27-8-11-3 with an insurer that issues a policy of accident and
sickness insurance.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-4
"Covered individual"
Sec. 4. As used in this chapter, "covered individual" means an
individual entitled to coverage under a policy of accident and
sickness insurance.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-5
"Noncontracted provider"
Sec. 5. As used in this chapter, "noncontracted provider" means
a health care provider that has not entered into an agreement to serve
as a contracted provider.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-6
"Policy of accident and sickness insurance"
Sec. 6. As used in this chapter, "policy of accident and sickness
insurance" has the meaning set forth in IC 27-8-5-1.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-7
"Routine care cost"
Sec. 7. 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.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-8
Coverage for routine care costs
Sec. 8. (a) A policy of accident and sickness insurance must
provide coverage for routine care costs that are incurred in the course
of a clinical trial if the policy of accident and sickness insurance
would provide coverage for the same routine care costs not incurred
in a clinical trial.
(b) The coverage that must be provided under this section is
subject to the terms, conditions, restrictions, exclusions, and
limitations that apply generally under the policy of accident and
sickness insurance, including terms, conditions, restrictions,
exclusions, or limitations that apply to health care services rendered
by contracted providers and noncontracted providers.
(c) This section does not do any of the following:
(1) Require an insurer that issues a policy of accident and
sickness insurance to provide coverage for clinical trial services
rendered by a contracted provider.
(2) Prohibit an insurer that issues a policy of accident and
sickness insurance from providing coverage for clinical trial
services rendered by a contracted provider.
(3) Require reimbursement under a policy of accident and
sickness insurance for services that are rendered in a clinical
trial by a noncontracted provider at the same rate of
reimbursement that would apply to the same services rendered
by a contracted provider.
As added by P.L.109-2009, SEC.3.
IC 27-8-25-9
No cause of action created by chapter
Sec. 9. This chapter does not create a cause of action against a
person for any harm to a covered individual resulting from a clinical
trial.
As added by P.L.109-2009, SEC.3.