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Local Coverage Determinations Roundup: Castle Biosciences

NEW YORK – Multiple Medicare Administrative Contractors under the MolDx program released draft local coverage determinations earlier this month denying coverage for Castle Biosciences' test for squamous cell carcinoma. 

The draft decisions from Palmetto GBA, Noridian Healthcare Solutions, and CGS Administrators were posted after fellow MolDx MAC Wisconsin Physicians Service Insurance Corporation released a proposed LCD at the beginning of June that would not cover any current molecular biomarker tests that risk stratify patients with cutaneous squamous cell carcinoma, including the DecisionDx-SCC test.

In addition to the MolDx contractors, earlier this month another MAC, Novitas Solutions, rescinded coverage for multiple cancer genetic tests, including Castle Bio's DecisionDx-Melanoma and DecisionDx-SCC assays.

The new decisions, like the WPSIC decision, noted that there is a lack of clarity surrounding how results from these tests impact patient management. The Castle Bio gene expression profile test measures 34 metastasis-associated genes, along with six control genes, to identify patients with a high risk of metastasis and is intended for use in patients with localized, invasive cancer and the presence of at least one risk factor to guide treatment plans, according to the LCDs. 

It stratifies patients into low metastatic risk, moderate metastatic risk, or high metastatic risk groups. The LCDs note that the company has presented clinician surveys and clinical vignettes at conferences to show that the test's results would cause physicians to change their treatment decisions, but the outcomes data from prospective studies with documented specific changes in management is lacking. 

The literature presented by the company also doesn't adopt a consistent and recommended patient management strategy regarding follow-up frequency, nodal assessment, and adjuvant therapy for each risk group, the MACs said. "It is important to clearly define the difference in management of patients" for each risk group and the net benefit, they said.

The LCDs also noted that the clinical utility and test performance have been reported in a mostly white and male population, leaving a potential evidence gap. The representation of test performance characteristics "should be inclusive of and addressed in patients of color, who have been shown to have a higher metastatic rate compared to Caucasians," the MACs added. 

Although the MACs said that there is apparent need and clinical utility for molecular markers to improve risk stratification of patients with cutaneous squamous cell carcinoma, the current evaluated tests have not demonstrated definitive value above the combination of available clinical, pathological, and staging criteria in accurate risk stratification, meaning clinical validity and utility haven't been established. 

The MACs also said they will continue to monitor evidence and could change coverage based on new data and society recommendations.

The comment periods for the Palmetto and Noridian draft LCDs are open until July 22, 2023. The comment period for the CGS Administrators draft LCD is open until July 29.