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In a local coverage article, Medicare contractors in the MolDx program added prostate cancer to the covered indications for the test.
The LCD will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors for Prospera, Noridian, CGS, and more for the week of 4/12/2019.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
Palmetto's MolDx has agreed to cover Myriad's MyPath Melanoma to help rule out the disease when the biopsy can't be definitively classified by standard clinical and histopathological characteristics.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
The Medicare contractor is proposing to not cover Vectra DA, but to extend coverage for Prolaris, Xpresys, and DecisionDx-UM under specific circumstances.