72 This Exclusion includes, but is not limited to, commercial weight loss programs (Weight Watchers, Jenny Craig, LA Weight Loss) and fasting programs. This Exclusion does not apply to weight management programs required under federal law as part of the “Preventive Care” benefit. EXPERIMENTAL OR INVESTIGATIONAL SERVICES EXCLUSION Any Drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply, used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health problem which is determined to be Ex perimental or Investigational is not covered by your Plan. The Plan will deem any Drug, biologic, device, Diagnostic, product, equipment, procedure, treatment, service, or supply to be Experimental or Investigational if determined that one of more of the criteria listed below apply when the service is rendered wit h respect to the use for which benefits are sought. The Drug, biologic, device, Diagnostic, product, equipment, procedure, treatment, service, or supply: • cannot be legally marketed in the United States without the final approval of the Food and Drug Administration (FDA), or other licensing or regulatory agency, and such final approval has not been granted; • has been determined by the FDA to be contraindicated for the specific use; or • is subject to review and approval of an Institutional Review Board (IRB) or other body serving a similar function; or • is given because of informed consent documents that describe the Drug, biologic, device, Diagnostic, product, equipment, procedure, treatment, service, or supply as Experimental or Investigational, or otherwise show that the safety, toxicity, or efficacy o f 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 belo w 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 f ollowing 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; o r • 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