58. Qualifying Clinical Trials as defined below, including routine patient care costs Incurred during participation in a Qualifying Clinical Trial for the treatment of: • Cancer or other Life-Threatening Disease or Condition. For purposes of this benefit, a Life- Threatening Disease or Condition is one from which the likelihood of death is probable unless the course of the disease or condition is interrupted. Benefits include the reasonable and necessary items and services used to prevent, diagnose, and treat complications arising from participation in a Qualifying Clinical Trial. Benefits are available only when the Covered Person is clinically eligible for participation in the Qualifying Clinical Trial as defined by the researcher. Routine patient care costs for Qualifying Clinical Trials may include: • Covered health services (e.g., Physician charges, lab work, X-rays, professional fees, etc.) for which benefits are typically provided absent a clinical trial; • Covered health services required solely for the administration of the Investigational item or service, the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and • Covered health services needed for reasonable and necessary care arising from the provision of an Investigational item or service. Routine costs for clinical trials do not include: • The Experimental or Investigational service or item as it is typically provided to the patient through the clinical trial. • Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; • A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis; and • Items and services provided by the research sponsors free of charge for any person enrolled in the trial. With respect to cancer or other Life-Threatening Diseases or Conditions, a Qualifying Clinical Trial is 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 Disease or Condition and that meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following: ➢ National Institutes of Health (NIH), including the National Cancer Institute (NCI); ➢ Centers for Disease Control and Prevention (CDC); ➢ Agency for Healthcare Research and Quality (AHRQ); ➢ Centers for Medicare and Medicaid Services (CMS); ➢ A cooperative group or center of any of the entities described above or the Department of Defense (DOD) or Veterans Administration (VA); ➢ A qualified non-governmental research entity identified in the guidelines issued by the NIH for center support grants; or ➢ The Department of Veterans Affairs, the DOD, or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of peer review that is determined by the Secretary of Health and Human Services to meet both of the following criteria: − It is comparable to the system of peer review of studies and investigations used by the NIH; and − It ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review. -65- 7670-00-413597