A drug, device, treatment, therapy, procedure, or other services or supply that does not meet the definition of Medical Necessity:
cannot be lawfully marketed without the approval of the Food and Drug Administration ("FDA") when such approval has not been granted at that time of its use or proposed use, or
is the subject of a current Investigational new drug or new device application on file with the FDA, or
is being provided according the Phase I or Phase II clinical trial or the experimental or research portion of a Phase III clinical trial ( provided, however, that participation in a clinical trial shall not be the sole basis for determination of medical necessity), or
is being provided according to a written protocol which describes among its objectives, determining the safety, toxicity, efficacy or effectiveness of that service or supply in comparison with convention alternatives, or
is being delivered or should be delivered subject to the approval and supervision of an Institutional Review Board ("IRB") as required and defined by Federal regulations, particularly those of the FDA or the Department of Health and Human Services ("HHS"), or
in the predominant opinion of experts, as expressed in the published authoritative literature, that usage should be substantially confined to research settings, or
in the predominant opinion of experts, as expressed in the published authoritative literature, further research is necessary in order to define safety, toxicity, efficacy, or effectiveness of that Service compared with conventional alternatives, or
the service or supply is required to treat a complication of an Experimental or Investigational Service.
The Medical Director shall have discretionary authority, in accordance with applicable ERISA standards, to make a determination concerning whether a service or supply is an Experimental or Investigational Service. If the Medical Director does not Authorize the provision of a service or supply, it will not be a Covered Service. In making such determinations, the Medical Director shall rely upon any or all of the following, at his or her discretion:
Your medical records, or
the protocol(s) under which proposed service or supply is to be delivered, or
any consent document that You have executed or will be asked to execute, in order to received the proposed service or supply, or
the published authoritative medical or scientific literature regarding the proposed service or supply in connection with the treatment of injuries or illnesses such as those experienced by You, or
regulations or other official publications issued by the FDA and HHS, or
the opinions of any entities that contract with the Plan to assess and coordinate the treatment of Members requiring non-Experimental or Investigational Services, or
the findings of the BlueCross BlueShield Association Technology Evaluation Center or other similar qualified evaluation entities.
This document has been classified as public information.