NEW YORK – Dermatology genomics testing company DermTech said on Thursday that Medicare Administrative Contractor Palmetto GBA MolDx has issued a final local coverage determination for the company's Pigmented Lesion Assay (PLA).
The LCD will take effect on Feb. 10, 2020, Palmetto said. The MAC issued a draft LCD for PLA in March 2019, proposing to cover the non-invasive RNA gene expression test to rule out primary cutaneous melanoma and to help decide if patients with skin lesions that display one or more clinical characteristics suggestive of cancer should be biopsied. The test, which obtains skin samples non-invasively through an adhesive skin patch, had to be ordered by a doctor or a healthcare professional with expertise in melanoma.
The final LCD calls for limited coverage of the PLA conducted on skin samples obtained non-invasively via adhesive patches. The PLA is indicated only for use on pigmented skin lesions, for which a diagnosis of melanoma is being considered, Palmetto notes, and the test may only be ordered by clinicians who evaluate pigmented skin lesions and perform biopsies. The test is covered in the LCD as a source of information on whether or not to perform a biopsy.
"The PLA should not be used on clinically obvious melanoma. The PLA result is one 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," according to the LCD. "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."
Palmetto also required that the ordering clinician have a plan at the time of ordering the test to continue monitoring the skin lesion for changes if the test is negative. Further, the MAC outlined, the test may not be ordered for the same lesion a second time.
"We are excited that Palmetto reviewed the clinical dossier for the PLA test and recognized that our test aids in the diagnosis of melanoma and may spare the patient the need for an unnecessary biopsy," DermTech CEO John Dobak said in a statement. "It is our mission to enhance the early detection of melanoma through the power of precision genomics, and eliminate unnecessary surgery, leading to improved patient care and lower costs."