Noblesville Schools Medical Plan 104 Section 9: Defined Terms e) Any other conditions as specified by the Secretary. The above conditions do not apply to unforeseen or urgent medical needs that arise at the time the service is provided regardless of whether notice and consent criteria has been satisfied Enrolled Dependent - a Dependent who is properly enrolled under the Plan. Experimental or Investigational Service(s) - medical, surgical, diagnostic, psychiatric, mental health, substance-related and addictive disorders or other health care services, technologies, supplies, treatments, procedures, drug therapies, medications or devices that, at the time the Claims Administrator makes a determination regarding coverage in a particular case, are determined to be any of the following: • Not approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use and not identified as appropriate for the proposed use in any of the following: ▪ AHFS Drug Information (AHFS DI) under therapeutic uses section; ▪ Elsevier Gold Standard's Clinical Pharmacology under the indications section; ▪ DRUGDEX System by Micromedex under the therapeutic uses section and has a strength recommendation rating of class I, class IIa, or class IIb; or ▪ National Comprehensive Cancer Network (NCCN) drugs and biologics compendium category of evidence 1, 2A, or 2B. • Subject to review and approval by any institutional review board for the proposed use. (Devices which are FDA approved under the Humanitarian Use Device exemption are not Experimental or Investigational.) • The subject of an ongoing clinical trial that meets the definition of a Phase I, II or III clinical trial set forth in the FDA regulations, regardless of whether the trial is actually subject to FDA oversight. • Only obtainable, with regard to outcomes for the given indication, within research settings. Exceptions: • Clinical trials for which Benefits are available as described under Clinical Trials in Section 1: Covered Health Care Services. • The Claims Administrator may at its discretion, consider an otherwise Experimental or Investigational Service to be a Covered Health Care Service for that Sickness or condition if: ▪ You are not a participant in a qualifying clinical trial, as described under Clinical Trials in Section 1: Covered Health Care Services: and ▪ You have a Sickness or condition that is likely to cause death within one year of the request for treatment. Prior to such a consideration, the Claims Administrator must first establish that there is sufficient evidence to conclude that, even though unproven, the service has significant potential as an effective treatment for that Sickness or condition. Freestanding Facility - an outpatient, diagnostic or ambulatory center or independent laboratory which performs services and submits claims separately from a Hospital. Gene Therapy - therapeutic delivery of nucleic acid (DNA or RNA) into a patient's cells as a drug to treat a disease. Genetic Counseling - counseling by a qualified clinician that includes: • Identifying your potential risks for suspected genetic disorders; • An individualized discussion about the benefits, risks and limitations of Genetic Testing to help you make informed decisions about Genetic Testing; and