BlueCross BlueShield of Tennessee Medical Policy Manual

Multi-Analyte Assay with Algorithmic Analyses for Predicting Risk of Type II Diabetes

DESCRIPTION

A serum lab test that is a multi-analyte assay with algorithmic analysis (MAAA) and intended to predict the 5-year risk of type II diabetes is currently being marketed. (e.g. PreDx® Diabetes Risk Score)  This lab test combines the results of seven (7) serum biomarkers via a proprietary algorithm to predict individuals who may become diabetic. The proposed use is to identify patients at greater risk of developing type II diabetes and to potentially develop preventive interventions aimed at patients with the highest risk.

Type II diabetes mellitus is a highly prevalent disorder that is associated with an extremely high degree of morbidity and mortality. The incidence has been increasing rapidly over the last several decades, and current trends indicate that this increase will continue. Efforts to thwart this trend are aimed at early identification of those individuals at risk for developing this disease and development of preventive interventions targeted at the high risk population.

The biomarkers included in these tests are not subject to U.S. Food and Drug Administration (FDA) approval. Laboratories performing these tests are subject to Clinical Laboratory Improvement Amendment (CLIA) standards for laboratory testing.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The evidence is insufficient to determine the efficacy of a multi-analyte assay with algorithmic analysis score compared with other diabetes risk scores. This test has not been tested in a wide range of patient populations. As a result, there is some uncertainty in the predictive accuracy and generalizability of the risk score. Therefore, the use of a multi-analyte assay with algorithmic analysis score to predict diabetes remains investigational.

SOURCES

Abassi, A., Peelen, L., Corpeleijn, E., van der Schouw, Y., Stolk, R., Spijkerman, A., et al. (2012). Prediction models for risk of developing type 2 diabetes: systematic literature search and independent external validation study.  British Medical Journal. 2012 (345), e5900. (Level 1 Evidence- Independent)

American Diabetes Association.  (2012). Standards of medical care in diabetes . Retrieved April 17, 2013 from http://care.diabetesjournals.org/content/35/Supplement_1/S4.full#sec-2.

Australian Government, Department of Health and Ageing. (2010). The Australian Type II diabetes risk assessment tool. Retrieved April 16, 2013 from http://www.diabetesaustralia.com.au/PageFiles/937/AUSDRISK%20Web%2014%20July%2010.pdf.

BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2014). Multi-analyte assays with algorithmic analyses for predicting risk of type 2 diabetes (2.04.90). Retrieved September 22, 2014 from BlueWeb. (24 articles and/or guidelines reviewed)

Canadian Task Force on Preventive Health Issues. (2012). Recommendations on screening for type 2 diabetes in adults. Retrieved April 16, 2013 from http://www.guideline.gov.

Li, C., Chien, L., Liu, C., Lin, W., Lee, C., Chen, F., et al. (2011). Prospective validation of American Diabetes Association risk tool for predicting pre diabetes  and diabetes in Taiwan-Taichung community health study. Public Library of Science ONE, 6 (10), e25906. (Level 3 Evidence)

United States Preventive Services Task Force. (2008). Screening for type 2 diabetes mellitus in adults. Retrieved April 16, 2013 from http://www.uspreventiveservicestaskforce.org/uspstf08/type2/type2rs.htm.

Winifred S. Hayes, Inc. Genetic Test Evaluation (GTE) Report. (2012, November). PreDX® Diabetes Risk Score. Retrieved September 22, 2014 from www.Hayesinc.com/subscribers . (35 articles and/or guidelines reviewed - Archived December 2013).

ORIGINAL  EFFECTIVE DATE:  8/10/2013

MOST RECENT REVIEW DATE:  11/20/2014

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