Experimental or Investigational Treatment or Care
Experimental or investigational treatment or care will not be considered medically necessary care under this Plan. The terms “Experimental or Investigational” mean services, supplies, care and treatment which do not constitute an accepted medical practice properly within the range of appropriate medical practice under the standards of the case and by the standards of a reasonably substantial, qualified, responsible, relevant segment of the medical or dental community or government oversight agencies at the time services were rendered. The Claims Administrator must make an independent evaluation of specific technologies to determine whether they are experimental. The Claims Administrator shall be guided by a reasonable interpretation of the Plan provisions. The Claims Administrator’s decisions shall be made in good faith and rendered following a detailed factual background investigation of the claim and the proposed treatment. The decision of the Claims Administrator will be final and binding on the Plan. In addition, drugs will be considered experimental or investigational if they are not commercially available for purchase and/or they are not approved by the United States Food and Drug Administration (FDA) for general use. The Claims Administrator will consider the following as indications that the drug, device or treatment is experimental or investigational:
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If the drug or device cannot be lawfully marketed without approval of the FDA and approval for marketing has not been given by the FDA at the time the drug or device is furnished; or
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If the device has been granted a Category A experimental/investigational device exemption by the FDA; or
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If the drug, device, medical treatment or procedure, or the patient informed consent document utilized with the drug, device, medical treatment or procedure, was reviewed and approved by the treating facility’s institutional review board or other body serving a similar function, or if federal law requires such review or approval; or
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If reliable evidence shows that the drug, device, medical treatment or procedure is the subject of ongoing phase I or phase II clinical trials, is in the research, experimental, study or investigational arm of ongoing phase III clinical trials, or is otherwise under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy or its efficacy as compared with a standard means of treatment or diagnosis; or
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If reliable evidence shows that the prevailing opinion among experts regarding the drug, device, medical treatment, or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy or its efficacy as compared with a standard means of treatment or diagnosis.
