124 STAT. 894 PUBLIC LAW 111–148—MAR. 23, 2010 offering group or individual health insurance coverage, to provide benefits for routine patient care services provided outside of the plan’s (or coverage’s) health care provider network unless out-of- network benefits are otherwise provided under the plan (or cov- erage). ‘‘(d) APPROVED CLINICAL TRIAL DEFINED.— ‘‘(1) IN GENERAL.—In this section, the term ‘approved clin- ical trial’ means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening dis- ease or condition and is described in any of the following subparagraphs: ‘‘(A) FEDERALLY FUNDED TRIALS.—The study or inves- tigation is approved or funded (which may include funding through in-kind contributions) by one or more of the fol- lowing: ‘‘(i) The National Institutes of Health. ‘‘(ii) The Centers for Disease Control and Preven- tion. ‘‘(iii) The Agency for Health Care Research and Quality. ‘‘(iv) The Centers for Medicare & Medicaid Serv- ices. ‘‘(v) cooperative group or center of any of the enti- ties described in clauses (i) through (iv) or the Depart- ment of Defense or the Department of Veterans Affairs. ‘‘(vi) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ‘‘(vii) Any of the following if the conditions described in paragraph (2) are met: ‘‘(I) The Department of Veterans Affairs. ‘‘(II) The Department of Defense. ‘‘(III) The Department of Energy. ‘‘(B) The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration. ‘‘(C) The study or investigation is a drug trial that is exempt from having such an investigational new drug application. ‘‘(2) CONDITIONS FOR DEPARTMENTS.—The conditions described in this paragraph, for a study or investigation con- ducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines— ‘‘(A) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, and ‘‘(B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review. ‘‘(e) LIFE-THREATENING CONDITION DEFINED.—In this section, the term ‘life-threatening condition’ means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. ‘‘(f) CONSTRUCTION.—Nothing in this section shall be construed to limit a plan’s or issuer’s coverage with respect to clinical trials. Determination.
