§ 12-15-5-9.2 — Coverage for care related to cancer clinical trials

Indiana § 12-15-5-9.2

• Jurisdiction: Indiana
• Art. 15: MEDICAID
• Ch. 5: Services Provided

Text

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, "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 drug or device that is under evaluation in a clinical trial.
(2) Items or services that are:
(A) provided solely for data collection and analysis and not in
the direct clinical management of an individual enrolled in a
clinical trial;
(B) customarily provided at no cost by a research sponsor to an
individual enrolled in a clinical trial; or
(C) provided solely to determine eligibility of an individual for
participation in a clinical trial.
(d) The Medicaid program must provide coverage for routine care
costs that are incurred in the course of a clinical trial if the Medicaid
program would provide coverage for the same routine care costs not
incurred in a clinical trial.
(e) The coverage that must be provided under this section is subject
to the terms, conditions, restrictions, exclusions, and limitations that
apply generally under the Medicaid program, including terms,
conditions, restrictions, exclusions, or limitations that apply to health
care services rendered by participating providers and nonparticipating
providers.
(f) This section does not do any of the following:
(1) Require the Medicaid program to provide coverage for clinical
trial services rendered by a participating provider.
(2) Prohibit the Medicaid program from providing coverage for
clinical trial services rendered by a participating provider.
(3) Require reimbursement 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.

Legislative History

As added by P.L.109-2009, SEC.2.