MolDX: Biomarker Testing for Risk Stratification in DCIS

Biomarker tests for risk stratification of DCIS to identify patients who may safely forgo adjuvant radiation therapy are currently non‑covered unless all policy criteria are met. Coverage may be considered only when the patient has DCIS without invasive disease, is not a mastectomy candidate, has no prior RT to the same breast, has a documented treatment plan (including RT consent and intent to forgo RT if classified low‑risk), the specimen is within the test's validated use, the test has completed a Technical Assessment, and peer‑reviewed evidence demonstrates improved or non‑inferior accuracy for identifying a 'sufficiently low‑risk' group (defined as an absolute IBTR risk reduction from RT of ≤5% versus BCS alone).

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

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