NEW YORK – Medicare Administrative Contractor CGS Administrators has aligned its coverage for melanoma risk stratification tests in patients with cutaneous melanoma, including Castle Biosciences' DecisionDx-Melanoma test.
The revised local coverage determination goes into effect Dec. 21 and aligns coverage for molecular diagnostic tests used to aid in risk stratification of melanoma patients with Palmetto GBA's previously announced expanded LCD.
The LCD is a general policy covering the tests when patients have a history of melanoma and either stage T1b and above or T1a with documented concern about adequacy of microstaging. Patients cannot have metastatic disease, must also be undergoing workups or being evaluated for treatment, and must have presumed risk greater than 5 percent for a positive sentinel lymph node biopsy based on clinical or histological information. The patient also must have a disease stage, grade, and Breslow thickness within the intended use of the test.
The tests must demonstrate clinical validity of the analytes tested, utility beyond clinical, histological, and radiographical factors when stratifying patients into risk groups, and appropriate analytical validity.
The coverage decision is a general decision for any molecular melanoma tests meeting these standards, but Castle Bio's DecisionDx-Melanoma test was specifically cited in the evidence review and is covered under the LCD. Last month, Noridian aligned its coverage with Palmetto's decision as well.