2.
(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
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2. (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, "nonparticipating provider" means a
health care provider that has not entered into an agreement described
in IC 27-13-1-24.
(d) 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 an enrollee's individual contract or group
contract, including the sponsor of the clinical trial.
(e) An individual contract or a group contract must provide
coverage for routine care costs that are incurred in the course of a
clinical trial if the individual contract or group contract would provide
coverage for the same routine care costs not incurred in a clinical trial.
(f) The coverage that must be provided under this section is subject
to the terms, conditions, restrictions, exclusions, and limitations that
apply generally under the individual contract or group contract,
including terms, conditions, restrictions, exclusions, or limitations that
apply to health care services rendered by participating providers and
nonparticipating providers.
(g) This section does not do any of the following:
(1) Require a health maintenance organization to provide
coverage for clinical trial services rendered by a participating
provider.
(2) Prohibit a health maintenance organization from providing
coverage for clinical trial services rendered by a participating
provider.
(3) Require reimbursement under an individual contract or a
group contract 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.
(h) This section does not create a cause of action against a person
for any harm to an enrollee resulting from a clinical trial.