A technology evaluation is a process of identification, review, and evaluation of data about medical products and services (laboratory tests, diagnostic procedures, preventive interventions, and treatments) to assess their safety, effect on health outcomes, and appropriate use. The process embodies adherence to the standards of the National Committee for Quality Assurance (NCQA), a private, not-for-profit agency that maintains accreditation standards for health plans. The goal of this process is to promote a consistent approach in the evaluation of new technology by using the general principles of research methodology and evaluation.
A technology evaluation provides information on new technology or changes to existing technology. It is based on a review of multimedia sources including any of the following:
- Published medical literature, including peer-reviewed journals
- Nationally recognized professional organizations’ opinions, consensus statements, or clinical practice guidelines
- National physician specialty society recommendations
- Clinical trial data
- Continuing medical education (CME) event reports, meetings, and reviews
- Manufacturer’s guidelines for use
- Government agencies
- Technology review associations and various medical and professional associations
- Public print mass media
They also perform clinical reviews of the quarterly and annual additions, deletions, and revisions for the defined procedure, diagnosis, revenue, and modifier codes.
Associates of the Company, participating providers, and members in the Company’s health plans can use various standard communications procedures to request that the Company perform a technology evaluation on a medical product or service. The technology assessment weighs the available evidence against the following criteria:
- The technology must have final approval from the appropriate government regulatory bodies.
- This criterion applies to drugs, biological products, devices, and diagnostics.
- A drug or biological product must have final approval from the US Food and Drug Administration (FDA).
- A device must have final approval from the FDA for those specific indications and the methods of use that are being evaluated.
- Any approval that is granted as an interim step in the FDA regulatory process is not sufficient.
- FDA regulation does not apply to procedures that involve implantation of devices.
- 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 could measure or alter the physiologic 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 measurements 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. This is frequently necessary for newer technologies where the volume and quality of available studies for review are sparse. In these situations, recommendations from subject matter experts and/or national physician specialty societies can help guide our determination. Expert opinion alone is generally not adequate for a positive coverage position, but it may add credibility to available published evidence that may have various biases and flaws.
- The technology must improve the net health outcome.
- The technology’s beneficial effects on health outcomes should offset any harmful effects on health outcomes. “Health outcomes” refers to the measurable physiologic responses of medical nature that are directly attributable to the service on the prevention, diagnosis, detection, symptomatology, prognosis, morbidity, recovery, or mortality related to the medical condition. Net health outcome means that the advantages outweigh the disadvantages of the service. Again, the quality of the available evidence plays a pivotal role in the determination of coverage position.
- 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. Published reports of direct comparisons of the service with established standard treatments for the medical condition provide the best evidence for review. Again, the quality of these types of comparison studies is of paramount importance when using this measure to determine coverage.
- The improvement must be attainable outside the investigative settings.
- To meet this objective, the service must be available to members in our plans and be an acceptable medical practice as evaluated by participating professional providers with direct experience in the practice of that service.
Members of the network provider community (who are board-certified, clinically practicing, specialty-matched consultants) review, evaluate, and critique the resulting technology assessment. National experts may also be enlisted to participate in this review process. This analysis of the research data results in a medical necessity determination. |  |