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.

  1. The technology must have final approval from the appropriate governmental regulatory bodies, as demonstrated by:

  1. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, as demonstrated by:

  1. The technology must improve the net health outcome, as demonstrated by:

  1. The improvement must be attainable outside the investigational settings, as demonstrated by:

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:

  1. Your medical records, or

  2. the protocol(s) under which proposed service or supply is to be delivered, or

  3. any consent document that You have executed or will be asked to execute, in order to received the proposed service or supply, or

  4. 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

  5. regulations or other official publications issued by the FDA and HHS, or

  6. 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

  7. the findings of the BlueCross BlueShield Association Technology Evaluation Center or other similar qualified evaluation entities.

This document has been classified as public information.