MolDX: Pigmented Lesion Assay

The Pigmented Lesion Assay (PLA) is covered as a decision tool for atypical primary melanocytic skin lesions (5–19 mm) with one or more ABCDE features when a trained clinician is considering biopsy to rule out melanoma. Coverage requires intact, non-scarred, non-inflamed lesions not located on palms/soles/nails/mucous membranes or untrimable hair-covered areas; documentation must include lesion site, a photograph, clinician competency, and a follow-up monitoring plan if the PLA is negative. Use is limited to qualified clinicians, generally one test per lesion and usually one test per clinical encounter (limited exceptions for a second test in ~10% of encounters; >2 tests require appeal).

"PLA is indicated for evaluation of pigmented (melanocytic) skin lesions when a clinician trained in skin cancer diagnosis is considering the need for a biopsy to rule out melanoma."