(a) The medical assistance program shall provide coverage for routine care costs that are incurred in the course of an approved clinical trial if the medical assistance program would provide coverage for the same routine care costs not incurred in a clinical trial. "Routine care cost" shall be defined by the Department by rule. (b) The coverage that must be provided under this Section is subject to the terms, conditions, restrictions, exclusions, and limitations that apply generally under the medical assistance program, including terms, conditions, restrictions, exclusions, or limitations that apply to health care services rendered by participating providers and nonparticipating providers. (c) Implementation of this Section shall be contingent upon federal approval. Upon receipt of federal approval, if required, the Department shall adopt any rules necessary to implement this Section. (d) As used in this Section: "Approved clinical trial" means a phase I, II, III, or IV clinical trial involving the prevention, detection, or treatment of cancer or any other life-threatening disease or condition if one or more of the following conditions apply: (1) the Department makes a determination that the study or investigation is an approved clinical trial; (2) the study or investigation is conducted under an investigational new drug application or an investigational device exemption reviewed by the federal Food and Drug Administration; (3) the study or investigation is a drug trial that is exempt from having an investigational new drug application or an investigational device exemption from the federal Food and Drug Administration; or (4) the study or investigation is approved or funded (which may include funding through in-kind contributions) by: (A) the National Institutes of Health; (B) the Centers for Disease Control and Prevention; (C) the Agency for Healthcare Research and Quality; (D) the Patient-Centered Outcomes Research Institute; (E) the federal Centers for Medicare and Medicaid Services; (F) a cooperative group or center of any of the entities described in subparagraphs (A) through (E) or the United States Department of Defense or the United States Department of Veterans Affairs; (G) a qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants; or (H) the United States Department of Veterans Affairs, the United States Department of Defense, or the United States Department of Energy, provided that review and approval of the study or investigation occurs through a system of peer review that is comparable to the peer review of studies 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. "Care method" means the use of a particular drug or device in a particular manner. "Life-threatening disease or condition" means a disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. study or investigation is an approved clinical trial; investigational new drug application or an investigational device exemption reviewed by the federal Food and Drug Administration; is exempt from having an investigational new drug application or an investigational device exemption from the federal Food and Drug Administration; or (which may include funding through in-kind contributions) by: Prevention; Quality; Institute; Services; entities described in subparagraphs (A) through (E) or the United States Department of Defense or the United States Department of Veterans Affairs; identified in the guidelines issued by the National Institutes of Health for center support grants; or Affairs, the United States Department of Defense, or the United States Department of Energy, provided that review and approval of the study or investigation occurs through a system of peer review that is comparable to the peer review of studies 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.
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