Title I, SEC. 1128. INVESTIGATIONAL TREATMENTS. (a) Coverage. Subject to subsection (b), the items and services described in this subsection are qualifying investigational treatments that are administered for a life-threatening disease, disorder, or other health condition (as defined by the National Health Board). (b) Discretion of Plan. A health plan may cover an investigational treatment described in subsection (a) at its discretion. (c) Routine Care During Investigational Treatments. The comprehensive benefit package includes an item or service described in any other section of this part, subject to the limitations and cost sharing requirements applicable to the item or service, when the item or service is provided to an individual in the course of an investigational treatment, if (1) the treatment is a qualifying investigational treatment; and (2) the item or service would have been provided to the individual even if the individual were not receiving the investigational treatment. (d) Definitions. For purposes of this subtitle: (1) Qualifying investigational treatment. The term ``qualifying investigational treatment'' means a treatment (A) the effectiveness of which has not been determined; and (B) that is under clinical investigation as part of an approved research trial. (2) Approved research trial. The term ``approved research trial'' means (A) a research trial approved by the Secretary of Health and Human Services, the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, the Secretary of Veterans Affairs, the Secretary of Defense, or a qualified nongovernmental research entity as defined in guidelines of the National Institutes of Health; or (B) a peer-reviewed and approved research program, as defined by the Secretary of Health and Human Services, conducted for the primary purpose of determining whether or not a treatment is safe, efficacious, or having any other characteristic of a treatment which must be demonstrated in order for the treatment to be medically necessary or appropriate.