Purpose of the Manual
The purpose of The Regence Group (TRG) medical policy is to provide guidelines for determining coverage criteria for specific procedures, equipment, and services; in order to be eligible for coverage, all services must be medically necessary (unless otherwise defined in the member's benefits contract). In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between TRG medical policy guidelines and applicable contract language, the contract language prevails. TRG medical policy is not intended to override the health insurance policy that defines the insured’s benefits, nor is it intended to dictate to providers how to practice medicine. Physicians and other health care providers are expected to exercise their medical judgment in providing the most appropriate care.

Policy Development
Medical policy issues are identified through TRG affiliate staff or through the physician and provider community. Development, periodic review, and updating of medical policies are ongoing processes.

The following sources are considered in the development of TRG medical policy:

1. Policies and technology assessments published by the BlueCross BlueShield Association and the BlueCross BlueShield Association Technology Evaluation Center
2. Current published medical literature and peer reviewed publications
3. Generally accepted standards of medical practice
4. Evidence-based guidelines developed by national organizations and recognized authorities
5. Physician review
6. Government approval status

The published scientific evidence related to medical technologies is reviewed against five technology assessment criteria, all of which must be met:

1. The technology must have final approval from the appropriate government regulatory bodies.
   • A device must have final approval from the Food and Drug Administration (FDA) for those specific indications and methods of use that The Regence Group is evaluating.
   • Any approval that is granted as an interim step (i.e. Treatment IND) in the FDA regulatory process is not sufficient.
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. Scientific evidence and expert opinion provide the basis for summarizing the potential net health outcome.
• 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 the 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.

Definition of Investigational Services
Solely for the purpose of this manual, the term "investigational" means that the medical technology does not meet The Regence Group's technology assessment criteria, as defined above. If any one or more of the criteria listed above are not met, the will be determined to be investigational. In addition, all services specifically associated with the technology, including but not limited to associated procedures, treatments, supplies, devices, equipment, facilities or drugs, will also be considered investigational.