Noblesville Schools Medical Plan 41 Section 1: Covered Health Care Services • Other diseases or disorders which are not life threatening, when the Claims Administrator determines the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with terminal illnesses. ▪ Other items and services that meet specified criteria in accordance with the Claims Administrator's medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part 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. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It 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). (Includes 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).