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. Appeals regarding KFHPWA denial of coverage can be submitted to the Member Appeal Department, or to KFHPWA's medical director at P.O. Box 34593, Seattle, WA 98124-1593. 10. Hypnotherapy and all services related to hypnotherapy. 11. Directed umbilical cord blood donations. 12. Prognostic (predictive) genetic testing and related services, unless specifically provided in Section IV. Testing for non- Enrollees. 13. Autopsy and associated expenses. PEBB_VA_2024 47