MolDX: Pigmented Lesion Assay

Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. Type: Active LCD

This Medicare contractor will provide limited coverage for the Pigmented Lesion Assay / PLA (DermTech, Inc., La Jolla, CA), RNA gene expression test conducted on skin samples obtained noninvasively via adhesive patches. This test is intended to help rule out primary cutaneous melanoma and guide biopsy decisions of melanocytic skin lesions with one or more clinical or historical characteristics suggestive of melanoma. The evaluation with the PLA is limited to order by a physician or other qualified health care professional with expertise in melanoma. Specific Coverage Criteria The PLA is indicated for use on melanocytic skin lesions with 1 or more clinical or historical characteristics suggestive of melanoma, including 1 or more ABCDE criteria when a clinician trained in the clinical diagnosis of skin cancer is considering the need for biopsy to rule out melanoma. The PLA should not be used on clinically obvious melanoma. The PLA result is 1 element of the overall clinical assessment, and should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. (PLA positive lesions [LINC (LINC00518) and/or PRAME (preferentially expressed antigen of melanoma) detected] should be considered for biopsy. The biopsy decision of a PLA negative lesion should be based on the remainder of the entire clinical context.) The PLA is indicated only for use on: Primary melanocytic skin lesions between 5mm and 19mm Lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions) Lesions that do not contain a scar or were previously biopsied Lesions not located in areas of psoriasis, eczema or similar skin conditions Lesions not clinically diagnosed as melanoma Lesions in areas other than palms of hands, soles of feet, nails, mucous membranes and hair covered areas that cannot be trimmed The PLA is not intended to be used as a screening test in patients without melanocytic skin lesions. It is also not covered as an adjunctive test in lesions that are considered to already warrant a biopsy. The PLA is a decision tool for atypical melanocytic lesions prior to the decision to biopsy. The evaluation with the PLA is limited to order by a physician or other qualified healthcare professional.