NEW YORK – Castle Biosciences announced Thursday its DecisionDx-Melanoma test has received expanded coverage from Medicare Administrative Contractor Palmetto for patients with cutaneous melanoma.
The future local coverage determination released by Palmetto covers molecular diagnostic tests to assist in risk stratification of melanoma patients when the patient has a personal history of melanoma and has either stage T1b and above or has stage T1a with documented concern about the adequacy of microstaging. They must also be undergoing workup or being evaluated for treatment, not have metastatic disease, have presumed risk greater than 5 percent for a positive sentinel lymph node biopsy, and has a disease stage, grade, and Breslow thickness within the intended use of the test. The expanded LCD establishes a 0.3mm and thicker threshold for any use of the test, lower than the original coverage, according to an analyst note from SVB Leerink's Puneet Souda.
The tests covered in the LCD must have demonstrated through a technical assessment the clinical validity of analytes tested in predicting metastatic disease in peer-reviewed scientific literature, as well as utility beyond clinical, histological, and radiographical factors to accurately stratify patients into risk groups. It must also demonstrae  appropriate analytical validity and performance characteristics equal to other similar, covered tests.
The LCD covers these tests generally but cites an evaluation of the DecisionDx-Melanoma test in its evidence review, and the company confirmed the gene expression profile test is included under the expanded coverage decision. Palmetto's LCD goes into effect for services covered on or after Nov. 22. Another MAC, Wisconsin Physicians Service Insurance Corporation, aligned its coverage with Palmetto's, and its LCD goes into effect the same day.
Castle Bio's test uses a patient's tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, along with sentinel lymph node positivity. Palmetto originally released a draft LCD proposing expanded coverage for the test last year.