CurrentCapital BluecrossPolicy MP 2.093

Confocal Laser Endomicroscopy

This Capital BlueCross medical policy MP 2.093 governs coverage determinations for confocal laser endomicroscopy (CLE) across applicable products and programs administered by Capital BlueCross, stating the technology is investigational and therefore not covered. It includes background, regulatory status, evidence summary, coding guidance, and policy history.

Policy Summary

PayerCapital Bluecross

PolicyConfocal Laser Endomicroscopy

Policy CodePolicy MP 2.093

Change TypeClarified (no material change)

Effective DateFeb 1, 2026

Next Review Date

Key ActionCLE is considered investigational and therefore not covered; providers should not expect coverage/payment for CLE procedures billed with investigational codes (e.g., 0397T) unless member benefits allow otherwise.

POLICY UPDATE CHANGES

Policy statement unchanged across recent consensus reviews; coding and references periodically reviewed and updated.

1Coverage stance (Investigational)

4Example associated CPT/HCPCS/Other codes listed

2004-2022FDA device clearances described (years)

Coverage Summary

This policy MP 2.093 governs coverage determinations for confocal laser endomicroscopy (CLE) across applicable Capital BlueCross products and programs and states that CLE is considered investigational and therefore not covered, with applicability to probe-based and endoscope-based CLE systems and associated procedure codes.

Diagnostic accuracy evidence for colorectal applications reports pooled sensitivity of 81%–94% and pooled specificity of 88%–95%. For Barrett esophagus surveillance, randomized trials and meta-analyses found a small absolute increase in neoplasia detection of 5% for CLE versus the Seattle protocol. Two CLE systems have received FDA 510(k) clearance (probe-based and endoscope-based devices), but the evidence is judged insufficient to support replacing biopsy/histopathology or standard surveillance protocols.

Medical Necessity / Investigational Determination

Coverage Determination

Use of confocal laser endomicroscopy is considered investigational.

General investigational rationale: CLE is investigational due to insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with the procedure.
Colorectal adjunct use: Investigational status applies to CLE as an adjunct to colonoscopy for suspected or known colorectal lesions (pooled sensitivity 81%-94% and specificity 88%-95% reported in systematic reviews; accuracy uncertain to replace biopsy/polypectomy and histopathology).
Barrett esophagus surveillance: Investigational status applies to CLE with targeted biopsy for surveillance of Barrett esophagus (RCTs and meta-analyses show similar or higher sensitivity but pooled metrics not sufficiently high to replace standard surveillance; a 2022 meta-analysis reported an absolute 5% increase in neoplasia detection versus the Seattle protocol; guidelines continue to recommend 4-quadrant biopsies).
Assessment of endoscopic treatment adequacy: Investigational status applies to CLE to assess adequacy of endoscopic treatment of gastrointestinal lesions (evidence limited to a systematic review including one RCT and two prospective nonrandomized studies).
Other applications: Investigational status applies to CLE for other suspected lesions diagnosed by identification and biopsy (e.g., lung, bladder, gastric, pancreatic cysts, biliary strictures, head and neck) due to limited diagnostic accuracy evidence.

Codes Associated with Policy (Not Covered / Investigational)

Investigational / therefore not covered procedure and associated codesmixedNot Covered

0397T	Confocal laser endomicroscopy procedure code (listed as investigational)
43206	Esophagogastroduodenoscopy, diagnostic, with confocal endomicroscopy (listed in document association with 0397T)
43252	Esophagogastroduodenoscopy with dilation, etc. (listed in document association with 0397T)
88375	Specimen handling/microscopic examination code (listed in document association with 0397T)

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization / coverage requirement

CLE is considered investigational and therefore not covered; providers should not expect coverage/payment for CLE procedures billed with investigational codes (e.g., 0397T) unless member benefits allow otherwise. Payment determinations are subject to member's benefit program and eligibility on date of service.

0397T
43206
43252
88375

Documentation Required

Documentation and benefit verification

Providers must verify member benefits and eligibility and supply documentation demonstrating medical necessity per member's contract; the policy disclaimer notes final claim processing is based on member contract terms.

Billing Rule

Coding note

This coding list may not be all-inclusive; identification of a code does not denote coverage and not all covered services are eligible for separate reimbursement.

Background & Definitions

Confocal laser endomicroscopy (CLE) provides in vivo microscopic imaging of the mucosal epithelium during endoscopy using a low-power laser and contrast agents (commonly intravenous fluorescein). Two CLE systems (probe-based and endoscope-based) have received FDA 510(k) clearance for use in gastrointestinal and related tracts.

Limitations noted in the policy include a limited viewing area and limited depth of view (endoscopic system depth up to ~250 μm, probe-based ~120 μm; limited examined area up to ~700 μm for endoscope-based systems), need for standardized lesion classification systems, and an operator learning curve for obtaining and interpreting high-quality images.

Confocal Laser Endomicroscopy (CLE): In vivo microscopic imaging technique during endoscopy using a low-power laser and either probe-based or endoscope-based systems to visualize mucosal cellular structure.

Evidence Summary

Evidence highlights

Pooled sensitivity (colorectal)81%-94%

Pooled specificity (colorectal)88%-95%

Absolute increase in neoplasia detection (BE)5% (CLE vs Seattle protocol)

Overall evidence interpretation: available studies demonstrate that CLE can achieve moderate-to-high sensitivity and specificity in certain diagnostic settings, but the evidence is insufficient to replace biopsy with histopathology or to supplant standard surveillance protocols such as 4-quadrant biopsies for Barrett esophagus; therefore CLE remains investigational.

Revision History

02/28/2020consensus_review

Consensus review; no change to policy statement.

11/23/2020consensus_review

Consensus review; no change to policy statement. References updated.

10/29/2021consensus_review

Consensus review; FEP, background, and references updated. No changes to coding.

11/17/2022consensus_review

Consensus review; no change to policy statement. Updated coding table and references.

12/20/2023consensus_review

Consensus review; no change to policy statement. Coding reviewed; references and rationale updated.

11/18/2024consensus_review

Consensus review; no changes to policy statement. Coding reviewed; references updated.

09/02/2025consensus_reviewLatest

Consensus review; no changes to policy statement. Background and references updated. Coding reviewed.