Response to Comments for MolDX: Breast Cancer Assay: Prosigna

This response acknowledges support for coverage of Prosigna, an FDA-approved molecular breast cancer assay, and confirms it may be provided in qualified local laboratories. Per CMS Pub 100-08, Chapter 13, bill types and revenue codes have been removed from the LCD and are not included in the policy.

"Prosigna, an FDA-approved molecular breast cancer assay, is acknowledged for coverage and may be provided in local qualified laboratories."

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