Autoimmune disease diagnostic panel testing
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Defines coverage stance for multianalyte and proprietary algorithm-based autoimmune diagnostic panels (e.g., AVISE, cell-bound complement activation products) for evaluation of suspected systemic autoimmune diseases, affecting Select Health of South Carolina members.
No material clinical or coverage changes in this revision.
Coverage Determination
Not Medically Necessary — Primary coverage determination
Not covered — investigational/not clinically proven
Based on available evidence that shows diagnostic associations but not improved independently confirmed diagnosis or patient-important outcomes; evidence is concentrated in SLE and includes diagnostic-performance studies, short-term decision-impact studies, retrospective analyses, and economic models with limitations (see supporting findings).
Proprietary multianalyte autoimmune diagnostic panels (including AVISE-type tests and cell-bound complement activation product panels) are designated as investigational/not clinically proven by this policy. As such, these tests are not medically necessary for members and are excluded from coverage when used to evaluate autoimmune disease.
This exclusion applies to multianalyte assay panels and proprietary algorithm–based autoimmune panels regardless of setting or indication because the available evidence does not establish sufficient clinical validity or clinical utility to support routine coverage.
These panels are considered not medically necessary for the diagnosis, differentiation, prognosis, risk stratification, or management of autoimmune diseases, including systemic lupus erythematosus and related connective tissue diseases.
Providers should not rely on these proprietary multianalyte panels as standalone tools for confirming diagnosis, directing therapy, or monitoring disease because the policy finds diagnostic associations but insufficient evidence demonstrating improvement in independent diagnostic confirmation or patient‑important outcomes.
Related Codes
| 0062U | Autoimmune (systemic lupus erythematosus), IgG and IgM analysis of 80 biomarkers, utilizing serum, algorithm reported with a risk score. |
| 0312U | Autoimmune diseases (e.g., systemic lupus erythematosus [SLE]), analysis of 8 IgG autoantibodies and 2 cell-bound complement activation products using ELISA, flow cytometry, and indirect immunofluorescence, serum, or plasma and whole blood, individual components reported along with an algorithmic SLE-likelihood assessment. |
| 0446U | Autoimmune diseases (systemic lupus erythematosus [SLE]), analysis of 10 cytokine soluble mediator biomarkers by immunoassay, plasma, individual components reported with an algorithmic risk score for current disease activity. |
| 0447U | Autoimmune diseases (systemic lupus erythematosus [SLE]), analysis of 11 cytokine soluble mediator biomarkers by immunoassay, plasma, individual components reported with an algorithmic prognostic risk score for developing a clinical flare. |
| 81599 | Unlisted multianalyte assay with algorithmic analysis. |
Provider Billing and Authorization Guidance
Prior authorization not supported for listed panel codes
Proprietary multianalyte autoimmune diagnostic panels identified by codes 0062U, 0312U, 0446U, 0447U, and 81599 are designated investigational/not clinically proven and therefore not medically necessary; prior authorization will not make these services covered.
- Applies to AVISE-type panels and cell-bound complement activation product panels.
No step therapy—panels are investigational/not medically necessary
There are no step therapy requirements for these tests because the policy states these multianalyte/proprietary autoimmune panels are investigational and not medically necessary.
Coding and submission note — use listed related codes; submissions are noncovered/investigational
When submitting claims for these services, code the test using the related codes listed in the policy (0062U, 0312U, 0446U, 0447U, or 81599). Claims submitted for these codes are subject to noncoverage review because the panels are investigational and not medically necessary.
- Providers should consult coding manuals and bill accordingly.
- Submissions using these codes will be reviewed as noncovered/investigational services.
Exclusion—proprietary multianalyte autoimmune panels (e.g., AVISE-type, cell-bound complement tests)
Multianalyte, proprietary algorithm–based autoimmune diagnostic panels (including AVISE-type panels and cell-bound complement activation product panels) are excluded as investigational/not clinically proven and are not medically necessary for diagnosis, differentiation, prognosis, risk stratification, or management of autoimmune disease.
Definitions and Examples
Background and Clinical Context
Autoimmune disease diagnostic panel testing refers to blood‑based assays that combine multiple serum or cell‑associated biomarkers with a proprietary interpretive algorithm or scoring system to produce a composite result intended to supplement clinical assessment.
These panels have been evaluated primarily in systemic lupus erythematosus (SLE) and related connective tissue diseases. Conventional serologic testing (for example, ANA, anti‑dsDNA, anti‑Smith, and complement proteins) remains the basis for diagnosis; panels are proposed to assist when conventional testing is inconclusive, but current evidence does not demonstrate that panel use improves patient‑important outcomes or provides sufficient independent diagnostic confirmation.
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