MolDX: Pigmented Lesion Assay
L38051
The Pigmented Lesion Assay (PLA) is covered only for evaluation of primary melanocytic pigmented skin lesions (5–19 mm, intact skin, no prior biopsy/scar) when a clinician trained in skin cancer diagnosis is considering whether to biopsy for possible melanoma and the lesion meets one or more ABCDE criteria. The test is not for screening, not for clinically obvious melanoma or lesions already warranting biopsy, and is not covered for lesions in inflammatory skin conditions or in excluded anatomic sites (palms, soles, nails, mucous membranes, untrimable hair-covered areas). Required documentation includes a lesion photograph, clinician qualification/credentialing, documentation of lesion site, and a plan to monitor if PLA is negative; generally one test per clinical encounter is allowed (rarely a second test; >2 tests require appeal).
"PLA is covered for use on pigmented (melanocytic) skin lesions when a clinician trained in skin cancer diagnosis is considering whether to perform a biopsy to rule out melanoma."