NEW YORK – CGS Administrators, a Medicare Administrative Contractor that participates in the MolDx program, released its final local coverage determination for DermTech's Pigmented Lesion Assay (PLA).
CGS's decision aligns with Palmetto GBA's previously announced coverage determination for the test. The contractors will cover the non-invasive RNA gene expression test to rule out primary cutaneous melanoma and to help decide if patients with melanocytic skin lesions that display one of more clinical characteristics suggestive of melanoma should be biopsied.
The test is conducted on skin samples obtained through adhesive patches and must be ordered by a physician or other qualified healthcare professional with expertise in melanoma.
The PLA test should only be used on lesions where the skin is intact, there is no scar or previous biopsy, and that haven't been clinically diagnosed with melanoma. The test isn't covered as an adjunctive test in lesions that already warrant a biopsy, the determination said.