Confocal Laser Endomicroscopy (CLE)

Confocal laser endomicroscopy (CLE) provides real‑time, in vivo microscopic imaging during endoscopy to characterize cellular structure of colorectal lesions and image internal microstructure of gastrointestinal and respiratory tracts using FDA‑cleared systems/miniprobes (e.g., Cellvizio, GastroFlex/ColoFlex, CranioFlex) and contrast agents such as fluorescein, ICG, and pafolacianine. However, the policy notes CLE is considered experimental/investigational and not covered; it has limited depth (~120–250 µm) and field of view requiring targeted conventional endoscopy, is restricted to FDA‑cleared indications and trained operators, and most evidence is limited to patients at increased colorectal cancer risk.

"Characterization of cellular structure of colorectal lesions during screening or surveillance colonoscopy to help determine polyp histology in real time."

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