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. 14. Over-the-counter items such as hearing aids unless specifically listed as covered in Section IV. 15. Academic/career counseling, counseling for overeating, work/school ordered assessments, relationship counseling, custodial care 16. Court-ordered or forensic treatment, including reports and summaries, not considered Medically Necessary. VI. Eligibility, Enrollment and Termination In these sections, the term “retiree” or “retiring employee” includes a retiring employee from a Public Employees Benefits Board (PEBB) employing agency or employer group, and an elected or full-time appointed official of the legislative and executive branch of state government eligible to continue enrollment in PEBB retiree insurance coverage. The term “retiree” or “retiring school employee” includes a retiring school employee from a School Employees Benefits Board (SEBB) organization or employer group. Additionally, “health plan” is used to refer to a plan offering medical or dental, or both, developed by PEBB and provided by a contracted vendor or self-insured plans administered by the Health Care Authority (HCA). PEBB_CRCOB_2024 46