Local Coverage Determinations Roundup: Castle Bio

NEW YORK – Medicare Administrative Contractor Wisconsin Physicians Service Insurance Corporation recently released a local coverage determination (LCD) to align its coverage terms Palmetto’s MolDx program.

Below is a list and brief description for each of the LCDs. Each listing starts with the Medicare contractor that made the decision.

WPSIC: Castle Biosciences' DecisionDx-Melanoma

The MAC aligned its coverage for melanoma risk stratification tests in patients with cutaneous melanoma. The local coverage determination, which applies to services performed on or after Nov. 26, follows Palmetto GBA's expanded LCD from October covering molecular diagnostic tests used to help in risk stratification of melanoma patients. The LCD is for risk stratification tests that meet the following guidelines in general, but specifically cites Castle Biosciences' DecisionDx-Melanoma test. 

The policy covers the tests when patients have a history of melanoma and either stage T1b and above or T1a with documented concern about adequacy of microstaging and do not have metastatic disease. Patients must also be undergoing workups or being evaluated for treatment and have a disease stage, grade, and Breslow thickness within the intended use of the test. They must have presumed risk greater than 5 percent for a positive sentinel lymph node biopsy based on clinical or histological information. 

In addition, the tests themselves must show clinical validity of the tested analytes, as well as utility beyond clinical, histological, and radiographical factors when stratifying patients into risk groups. Tests must also have appropriate analytical validity.

Earlier this year, Noridian and CGS Administrators aligned their coverage policies with Palmetto's expanded LCD.  

**Palmetto administers the MolDX program, in which three other Medicare Administrative Contractors (MACs) participate, including Noridian, CGS, and Wisconsin Physicians Service Insurance Corporation. Each MAC issues its own draft and final policy to align with Palmetto’s coverage terms for a specific test.