(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;
The centers for disease control and prevention;
The agency for health care research and quality;
The federal centers for medicare and medicaid services;
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;
A qualified nongovernmental research entity identified in guidelines issued by thenational institutes of health for center support grants; or
The federal department of veterans affairs, the federal department of defense, or thefederal 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.
"Life-threatening or debilitating disease or condition" means a disease or conditionfrom 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.
"Qualified individual" means an individual who is eligible for and enrolled in thestate 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.
(I) "Routine costs" means medically necessary items and services that are includedunder the medical assistance program for a medical assistance recipient, to the extent that the provision of such 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 recipient is enrolled in a clinical trial. For medical assistance recipients 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 recipient's medical care, including complications relating to participation in the clinical trial, to the extent that the provision of such 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:
The investigational item, device, or service itself;
Items and services provided solely to satisfy the data collection and analysis needs ofthe clinical trial;
Items, drugs, or services customarily provided free of charge to any qualified individual enrolled in the clinical trial; or
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.
Source: L. 2020: Entire section added, (HB 20-1232), ch. 266, p. 1277, § 1, effective July 10.