Multiplex Autoantigen Microarray Testing for Systemic Lupus Erythematosus
This policy governs coverage of multiplex autoantigen microarray tests (e.g., Avise Lupus, Avise CTD, Avise SLE Monitor, SLE-key) for the screening, diagnosis, or management of systemic lupus erythematosus (SLE) for Anthem members; it states the tests are investigational and not medically necessary.
No material clinical or coverage changes in this revision.
Coverage Determination
Investigational / Not Medically Necessary
Covered when ALL of the following are met
Policy stance based on available evidence and lack of FDA-labeled indications or guideline support.
No FDA-labeled indications have been identified for multiplex autoantigen microarray testing for systemic lupus erythematosus (SLE), and there are no applicable CMS National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) addressing these tests. In addition, no nationally recognized clinical practice guidelines recommend the use of these multiplex autoantigen microarray tests for SLE. Given the absence of regulatory clearance and guideline support, these tests are considered investigational when used to screen for, diagnose, or manage SLE.
This policy applies to multiplex autoantigen microarray testing platforms that evaluate multiple autoantibodies and may generate algorithm-derived risk scores (for example, laboratory-developed tests marketed by Exagen, Inc., such as Avise® Lupus, Avise CTD, and Avise SLE Monitor, and other array-based tests described in the literature such as SLE-key®). These multiplex autoantigen microarray tests are considered investigational and not medically necessary when used for screening, diagnosis, or management of systemic lupus erythematosus (SLE).
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