All uses of blood‑based autoimmune multianalyte and proprietary algorithm panels — including multianalyte assay panels, proprietary algorithm‑based panels, AVISE‑type tests, and cell‑bound complement activation product panels — for diagnosis, differentiation, prognosis, risk stratification, or management of autoimmune disease (including systemic lupus erythematosus and related connective tissue diseases) are addressed by this policy and are considered investigational/not medically necessary.

Autoimmune disease diagnostic panel testing refers to blood‑based tests that combine multiple serum‑ or cell‑associated biomarkers with a proprietary interpretive score or algorithm. Examples include multianalyte assay panels, proprietary algorithm‑based autoimmune panels, AVISE‑type autoimmune diagnostic panels, and cell‑bound complement activation product panels. These tests generate composite or algorithmic risk or likelihood scores intended to support evaluation for suspected systemic autoimmune disease rather than replacing conventional serologic testing or clinical assessment.

Multianalyte autoimmune diagnostic panels measure multiple biomarkers — serum or cell‑associated — and apply proprietary interpretive algorithms to produce composite scores or risk assessments intended to inform evaluation for systemic autoimmune diseases, primarily systemic lupus erythematosus. While these panels report individual components along with algorithmic outputs, conventional serologic testing (for example, ANA, anti‑dsDNA, anti‑Smith, complement proteins) and clinical assessment remain the basis for diagnosis. The rationale for the policy stance is that current evidence is limited regarding clinical utility of these algorithm‑based panels; laboratory certification (e.g., CAP/CLIA) does not substitute for demonstrated clinical benefit, and therefore the tests are considered investigational and not medically necessary.