medical coverage, medical “no fault” coverage, personal injury protection coverage or similar medical coverage contained in said policy. For the purpose of this exclusion, benefits shall be deemed to be “available” to the Enrollee if the Enrollee receives benefits under the policy either as a named insured or as an insured individual under the policy definition of insured. 6. Services or care needed for injuries or conditions resulting from active or reserve military service, whether such injuries or conditions result from war or otherwise. This exclusion will not apply to conditions or injuries resulting from previous military service unless the condition has been determined by the U.S. Secretary of Veterans Affairs to be a condition or injury incurred during a period of active duty. Further, this exclusion will not be interpreted to interfere with or preclude coordination of benefits under Tri-Care. 7. Services provided by government agencies, except as required by federal or state law. 8. Services covered by the national health plan of any other country. 9. Experimental or investigational services. KFHPWA consults with KFHPWA’s medical director and then uses the criteria described below to decide if a particular service is experimental or investigational. a. A service is considered experimental or investigational for a Enrollee’s condition if any of the following statements apply to it at the time the service is or will be provided to the Enrollee: 1) The service cannot be legally marketed in the United States without the approval of the Food and Drug Administration (“FDA”) and such approval has not been granted. 2) The service is the subject of a current new drug or new device application on file with the FDA. 3) The service is the trialed agent or for delivery or measurement of the trialed agent provided as part of a qualifying Phase I or Phase II clinical trial, as the experimental or research arm of a Phase III clinical trial. 4) The service is provided pursuant to a written protocol or other document that lists an evaluation of the service’s safety, toxicity or efficacy as among its objectives. 5) The service is under continued scientific testing and research concerning the safety, toxicity or efficacy of services. 6) The service is provided pursuant to informed consent documents that describe the service as experimental or investigational, or in other terms that indicate that the service is being evaluated for its safety, toxicity or efficacy. 7) The prevailing opinion among experts, as expressed in the published authoritative medical or scientific literature, is that (1) the use of such service should be substantially confined to research settings, or (2) further research is necessary to determine the safety, toxicity or efficacy of the service. b. The following sources of information will be exclusively relied upon to determine whether a service is experimental or investigational: 1) The Enrollee’s medical records. 2) The written protocol(s) or other document(s) pursuant to which the service has been or will be provided. 3) Any consent document(s) the Enrollee or Enrollee’s representative has executed or will be asked to execute, to receive the service. 4) The files and records of the Institutional Review Board (IRB) or similar body that approves or reviews research at the institution where the service has been or will be provided, and other information concerning the authority or actions of the IRB or similar body. 5) The published authoritative medical or scientific literature regarding the service, as applied to the Enrollee’s illness or injury. 6) Regulations, records, applications and any other documents or actions issued by, filed with or taken by, the FDA or other agencies within the United States Department of Health and Human Services, or any state agency performing similar functions. PEBB_SCA_2024 47