§ 5-10-8-15 — Coverage for care related to cancer clinical trials

(a) As used in this section, "care method"
means the use of a particular drug or device in a particular manner.
(b) As used in this section, "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.
(c) As used in this section, "covered individual" means an individual
entitled to coverage under a state employee plan.
(d) As used in this section, "nonparticipating provider" means a
health care provider that has not entered into a contract with a state
employee plan to serve as a participating provider.
(e) As used in this section, "participating provider" means a health
care provider that has entered into a contract with a state employee plan
to provide health care services to covered individuals with an
expectation of directly or indirectly receiving payment from the state
employee plan.
(f) As used in this section, "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 state employee
plan, including the sponsor of the clinical trial.
(g) As used in this section, "state employee plan" means one (1) of
the following:
(1) A self-insurance program established under section 7(b) of
this chapter to provide group health coverage.
(2) A contract with a prepaid health care delivery plan that is
entered into or renewed under section 7(c) of this chapter.
(h) A state employee plan must provide coverage for routine care
costs that are incurred in the course of a clinical trial if the state
employee plan would provide coverage for the same routine care costs
not incurred in a clinical trial.
(i) The coverage that must be provided under this section is subject
to the terms, conditions, restrictions, exclusions, and limitations that
apply generally under the state employee plan, including terms,
conditions, restrictions, exclusions, or limitations that apply to health
care services rendered by participating providers and nonparticipating
providers.
(j) This section does not do any of the following:
(1) Require a state employee plan to provide coverage for clinical
trial services rendered by a participating provider.
(2) Prohibit a state employee plan from providing coverage for
clinical trial services rendered by a participating provider.
(3) Require reimbursement under a state employee plan for
services that are rendered in a clinical trial by a nonparticipating
provider at the same rate of reimbursement that would apply to
the same services rendered by a participating provider.
(k) This section does not create a cause of action against a person
for any harm to a covered individual resulting from a clinical trial.

Legislative History

As added by P.L.109-2009, SEC.1.