Mass Spectrometry (MS) Testing in Monoclonal Gammopathy (MG)

Serum mass spectrometry (with concurrent serum or urine immunofixation) is medically necessary for: (1) confirming initial M-protein detection when SPEP or sFLC is abnormal, (2) distinguishing therapeutic monoclonal antibodies from endogenous M-proteins for monitoring, and (3) assessing treatment response per clinical guidelines. Mass spectrometry is not covered for screening purposes. Documentation must include the abnormal screening test (SPEP or sFLC) for diagnosis, evidence of therapeutic monoclonal antibody or need for discrimination for monitoring with concurrent IFE results, and guideline citation when used for response assessment.

"Serum mass spectrometry (MS), with concurrent serum or urine immunofixation electrophoresis (sIFE/uIFE), is covered to confirm initial detection of M-protein when there is an abnormal serum protein..."

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