MolDX: Biomarker Testing for Risk Stratification in DCIS

Biomarker tests to stratify risk in DCIS are currently non-covered unless all specified patient-level and test-level criteria are met. Coverage consideration requires a DCIS diagnosis without invasive carcinoma, no prior ipsilateral RT, no consideration for mastectomy, a treatment plan including and consenting to RT with documented intent to forgo RT if the test categorizes the patient as 'sufficiently low-risk' (defined as an absolute IBTR risk reduction from RT of ≤5% vs BCS alone), and the test must have a completed Technical Assessment plus peer‑reviewed evidence showing superior or equivalent risk-stratification performance.

"Patient has a diagnosis of ductal carcinoma in situ (DCIS) and does not have concurrent invasive breast carcinoma."

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