Optical Coherence Tomography of the Breast
RAD601.053
This policy addresses optical coherence tomography (OCT) of the breast as a high‑resolution, non‑ionizing imaging technique proposed for intraoperative tumor margin assessment during breast cancer surgery (lumpectomy, mastectomy, lymph node dissection) and for evaluation of excised tissue microstructure. However, OCT for pre‑, intra‑ or post‑surgical breast assessment is considered experimental/investigational and unproven; FDA clearance is limited to two devices with labeling restricted to excised tissue, evidence is limited to small studies with inadequate diagnostic accuracy and outcome data, and the policy is inactive and not for current claims adjudication.
"Intraoperative assessment of tumor margins during breast cancer resection (mastectomy, lumpectomy, and lymph node dissection) to provide rapid, accurate margin evaluation."
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