The definition of “investigational” is based on the BlueCross and BlueShield of Tennessee’s technology evaluation criteria. Any technology that fails to meet ALL of the following four criteria is considered to be investigational.
The technology must have final approval from the appropriate governmental regulatory bodies, as demonstrated by:
This criterion applies to drugs, biological products, devices and any other product or procedure that must have final approval to market from the U.S. Food and Drug Administration or any other federal governmental body with authority to regulate the use of the technology.
Any approval that is granted as an interim step in the U.S. Food and Drug Administration’s or any other federal governmental body’s regulatory process is not sufficient.
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, as demonstrated by:
The evidence should consist of well-designed and well-conducted investigations published in peer-reviewed journals. The quality of the body of studies and the consistency of the results are considered in evaluating the evidence.
The evidence should demonstrate that the technology could measure or alter the physiological changes related to a disease, injury, illness, or condition. In addition, there should be evidence or a convincing argument based on established medical facts that such measurement or alteration affects health outcomes.
The technology must improve the net health outcome, as demonstrated by:
The technology's beneficial effects on health outcomes should outweigh any harmful effects on health outcomes.
The improvement must be attainable outside the investigational settings, as demonstrated by:
In reviewing the criteria above, the Medical Policy Panel will consider physician specialty society recommendations, the view of prudent medical practitioners practicing in relevant clinical areas and any other relevant factors.
The Medical Director, in accordance with applicable ERISA standards, shall have discretionary authority to make a determination concerning whether a service or supply is an 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.