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Local Coverage Determinations Roundup: Castle Bio, SkylineDx

NEW YORK – Medicare Administrative Contractor Palmetto GBA recently released a foundational local coverage determination (LCD) for melanoma risk stratification molecular tests that provides coverage for assays from at least two companies.

Both Castle Biosciences and SkylineDx announced that, under the final LCD, their DecisionDx-Melanoma and Merlin tests are covered through Palmetto's MolDX program for molecular tests. The LCD is not brand-specific but rather outlines coverage for any test that meets its criteria and passes a technical assessment.

The final LCD was released last week and goes into effect on July 3. The LCD provides coverage for molecular melanoma risk stratification tests when the patient has a personal history of melanoma and either stage T1b and above or T1a with documented concern about adequacy of microstaging. The patient must also be undergoing workup or being evaluated for treatment and cannot have metastatic disease. They should also have presumed risk for a positive sentinel lymph node biopsy greater than 5 percent based on clinical, histological, or other information. In addition, the patient must have a disease stage, grade, and Breslow thickness — or other qualifying conditions — within the intended use of the test.

The test itself must have demonstrated in a technical assessment the clinical validity of the analytes tested in predicting either metastatic disease or the absence of metastatic disease in peer-reviewed scientific literature. It should show utility beyond clinical, histological, and radiographical factors in the ability to accurately stratify patients into risk groups to manage patient care, such as by precluding unnecessary sentinel lymph node biopsies, as well as appropriate analytical validity. In addition, the performance characteristics must be equivalent or superior to other covered, similar tests.

Two other MolDX MACs, CGS Administrators and Wisconsin Physicians Service Insurance Corporation, have aligned their coverage decisions with Palmetto.

Friendswood, Texas-based Castle Bio's DecisionDx-Melanoma test is a prognostic gene expression profile assay that uses a patient's tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, along with the risk of sentinel lymph node positivity, independent of traditional staging factors.

Rotterdam, Netherlands-based SkylineDx's Merlin Test relies on a proprietary algorithm that calculates the risk of metastasis in a patient's lymph nodes by analyzing eight genes from the patient's primary tumor, the tumor thickness, and the patient's age.