117 otherwise show that the safety, toxicity, or efficacy of the Drug, biologic, device, Diagnostic, product, equipment, procedure, treatment, service, or supply is under evaluation. Any service not deemed Experimental or Investigational based on the criteria above may still be deemed Experimental or Investigational. In deciding whether a service is Experimental or Investigational, the Plan will consider the information described below and assess whether: • the scientific evidence is conclusory concerning the effect of the service on health outcomes; • the evidence demonstrates the service improves net health outcomes of the total population for whom the service might be proposed by producing beneficial effects that outweigh any harmful effects; • the evidence demonstrates the service has been shown to be as beneficial for the total population for whom the service might be proposed as any established alternatives; and • the evidence demonstrates the service has been shown to improve the net health outcomes of the total population for whom the service might be proposed under the usual conditions of medical practice outside clinical investigatory settings. The information considered or reviewed to decide whether a drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is Experimental or Investigational under the above criteria may include one or more items from the following list which is not all inclusive: • published authoritative, peer-reviewed medical or scientific literature, or the absence thereof; or • evaluations of national medical associations, consensus panels, and other technology evaluation bodies; or • documents issued by and/or filed with the FDA or other federal, state or local agency with the authority to approve, regulate, or investigate the use of the Drug, biologic, device, Diagnostic, product, equipment, procedure, treatment, service, or supply; or • documents of an IRB or other similar body performing substantially the same function; or • consent document(s) and/or the written protocol(s) used by the treating Physicians, other medical professionals, or facilities or by other treating Physicians, other medical professionals or facilities studying substantially the same Drug, biologic, device, Diagnostic, product, equipment, procedure, treatment, service, or supply; or • medical records; or • the opinions of consulting Providers and other experts in the field. The Plan has the sole authority and discretion to identify and weigh all information and decide all questions pertaining to whether a Drug, biologic, device, Diagnostic, product, equipment, procedure, treatment, service, or supply is Experimental or Investigational.