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Technology Evaluation Center Criteria

The Blue Cross and Blue Shield Association uses the five criteria below to assess whether a technology improves health outcomes such as length of life, quality of life and functional ability.

1. The technology must have final approval from the appropriate governmental regulatory bodies.

  • 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 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 indications for which the technology is approved need not be the same as those which Blue Cross and Blue Shield Association's Technology Evaluation Center is evaluating.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
  • 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 can 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.
  • Opinions and evaluations by national medical associations, consensus panels, or other technology evaluation bodies are evaluated according to the scientific quality of the supporting evidence and rationale.
3. The technology must improve the net health outcome.
  • The technology's beneficial effects on health outcomes should outweigh any harmful effects on health outcomes.
4. The technology must be as beneficial as any established alternatives.
  • The technology should improve the net health outcome as much as, or more than, established alternatives.
5. The improvement must be attainable outside the investigational settings.
  • When used under the usual conditions of medical practice, the technology should be reasonably expected to satisfy TEC criteria #3 and #4.