Immune Cellular Function Assay to Monitor and Predict Immune Function

This policy covers use of immune cell function assays (e.g., Immune Cell Function Assay/Cylex, Pleximmune) to monitor and predict immune function and guide immunosuppressive therapy in solid organ transplant recipients, including assessment of rejection and infection risk. Major limitations: the policy is inactive and coverage is limited to solid organ transplantation (assays are considered experimental/investigational for other indications, including hematopoietic stem cell transplant); tests must demonstrate clinical validity and utility tied to specific management decisions and appropriate timing, are not validated to diagnose current infection or rejection, and supporting studies must use the marketed test version.

"Clinical documentation of toxicity testing results (examples: leukopenia, renal failure) when used to assess immunosuppression."

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