(1)As used in this
section, unless the context otherwise requires:
(a)Approved clinical trial means a phase I, II, III, or IV clinical trial involving
the prevention, detection, diagnosis, or treatment of a life-threatening or
debilitating disease or condition if any one of the following conditions apply:
(I)The clinical trial is conducted under an investigational new drug
application or an investigational device exemption reviewed by the federal food and
drug administration, or is exempted from review by the federal food and drug
administration; or
(II)The clinical trial is approved or funded by:
(A)The national institutes of health;
(B)The centers for disease control and prevention;
(C)The agency for health care research and quality;
(D)The federal centers for medica
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(1) As used in this
section, unless the context otherwise requires:
(a) Approved clinical trial means a phase I, II, III, or IV clinical trial involving
the prevention, detection, diagnosis, or treatment of a life-threatening or
debilitating disease or condition if any one of the following conditions apply:
(I) The clinical trial is conducted under an investigational new drug
application or an investigational device exemption reviewed by the federal food and
drug administration, or is exempted from review by the federal food and drug
administration; or
(II) The clinical trial is approved or funded by:
(A) The national institutes of health;
(B) The centers for disease control and prevention;
(C) The agency for health care research and quality;
(D) The federal centers for medicare and medicaid services;
(E) A cooperative group or center of any of the entities described in
subsections (1)(a)(II)(A) to (1)(a)(II)(D) of this section, the federal department of
defense, or the federal department of veterans affairs;
(F) A qualified nongovernmental research entity identified in guidelines
issued by the national institutes of health for center support grants; or
(G) The federal department of veterans affairs, the federal department of
defense, or the federal department of energy, provided that review and approval of
the clinical trial occurs through a system of peer review that is comparable to the
peer review of clinical trials performed by the national institutes of health,
including an unbiased review of the highest scientific standards by qualified
individuals who have no interest in the outcome of the review.
(b) Life-threatening or debilitating disease or condition means a disease or
condition from which the likelihood of death is probable, or the disease or condition
is progressive or significantly debilitating, unless the course of the disease or
condition is interrupted.
(c) Qualified individual means an individual who is eligible for and enrolled
in the state medical assistance program and who a treating physician determines
has a life-threatening or debilitating disease or condition and meets the selection
criteria for the approved clinical trial.
(d) (I) Routine costs means medically necessary items and services that are
included under the medical assistance program for a medical assistance member,
to the extent that the provision of the items or services to the individual outside the
course of such participation would otherwise be covered under the medical
assistance program, without regard to whether the member is enrolled in a clinical
trial. For medical assistance members participating in an approved clinical trial,
routine costs include medically necessary items and services that are not
otherwise excluded pursuant to subsection (1)(d)(II)(D) of this section, relating to the
detection and treatment of complications arising from the medical assistance
member's medical care, including complications relating to participation in the
clinical trial, to the extent that the provision of the items or services to the
individual outside the course of such participation would otherwise be included
under the medical assistance program.
(II) Routine costs do not include:
(A) The investigational item, device, or service itself;
(B) Items and services provided solely to satisfy the data collection and
analysis needs of the clinical trial;
(C) Items, drugs, or services customarily provided free of charge to any
qualified individual enrolled in the clinical trial; or
(D) Items, drugs, or services that the clinical trial is required to provide.
(2) The medical assistance program established pursuant to this article 5
and articles 4 and 6 of this title 25.5 must include coverage and payment for the
routine costs associated with participation in an approved clinical trial for a
qualified individual.