CurrentCapital BluecrossPolicy MP 2.093

CONFOCAL LASER ENDOMICROSCOPY

Capital BlueCross medical policy MP 2.093 addresses the use of confocal laser endomicroscopy (CLE) across GI and non-GI indications and provides the plan's coverage stance, rationale, coding, and references. It applies to certain products/programs with benefit variations and does not guarantee coverage under all member benefit plans.

Policy Summary

PayerCapital Bluecross

PolicyCONFOCAL LASER ENDOMICROSCOPY

Policy CodePolicy MP 2.093

Change TypeClarified; coding/reference updates

Effective DateMar 1, 2025

Next Review Date

Key ActionVerify member's specific health benefit plan language because existence of this medical policy does not imply the service is a covered benefit; benefit determinations are based on the applicable health benefit plan.

POLICY UPDATE CHANGES

Policy statement remains that CLE is investigational and not covered.

1Coverage stance (Investigational/Not covered)

4Procedure/diagnostic codes listed

2024-11-17Last consensus review date

Coverage Summary

Confocal Laser Endomicroscopy (CLE) — investigational / not covered. Capital BlueCross medical policy MP 2.093 addresses the use of confocal laser endomicroscopy across GI and non-GI indications and provides the plan's coverage stance, rationale, coding, and references. Effective date: 3/1/2025; Last review: 11/17/2024.

Key policy facts

Policy numberMP 2.093

Effective date2025-03-01

Last review2024-11-17

Coverage stanceInvestigational / Not covered

Scope summaryCapital BlueCross medical policy addressing confocal laser endomicroscopy (CLE) across GI and non-GI indications; provides coverage stance, rationale, coding, and references and applies to certain products/programs with benefit variations.

Medical Necessity / Coverage Determination

Coverage Determination

Use of confocal laser endomicroscopy is considered investigational.

ALL of the following

Insufficient evidence: There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with confocal laser endomicroscopy (CLE).
Coverage conclusion: Therefore CLE is considered investigational and not covered.

Coding note: Investigational; therefore not covered: 0397T (CLE procedure) and related procedure codes such as 43206, 43252, 88375 (claims for CLE may be denied unless member benefit plan provides coverage).

Not Covered / Investigational Statement

Use of confocal laser endomicroscopy (CLE) is considered investigational and therefore not covered. The policy states there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with CLE; benefit determinations depend on the applicable member health benefit plan language.

Coding

Investigational; therefore not coveredmixedNot Covered

0397T	Confocal laser endomicroscopy procedure (proprietary CPT Category III for CLE)
43206	Esophagoscopy, flexible, transoral; with directed submucosal injection, any solution (listed here paired with 0397T in coding table)
43252	Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple
88375	Special staining, gross and microscopic examination related code listed in coding table

Because CLE is considered investigational by this policy, claims billed with the identified CLE procedure codes may be denied unless the member's benefit plan language provides coverage.

Provider Actions / Billing Impact

Documentation Required

Benefit verification required

Verify member's specific health benefit plan language because existence of this medical policy does not imply the service is a covered benefit; benefit determinations are based on the applicable health benefit plan.

Denial Risk

Claims for CLE are at risk of denial

Because CLE is considered investigational by this policy, claims billed with the identified CLE procedure codes may be denied unless member benefit plan language provides coverage.

0397T
43206
43252
88375

Background, Evidence, and Definitions

Confocal laser endomicroscopy (CLE) is an in vivo microscopic imaging technique performed during endoscopy using a low‑power laser and confocal optics to visualize mucosal cellular structure; FDA‑cleared systems include endoscope‑based and probe‑based devices. Reported applications include characterization of colorectal lesions, Barrett esophagus surveillance, targeting biopsies, and investigational uses in lung, bladder, gastric, pancreatic, biliary, head and neck, and central nervous system lesions. Limitations noted in the policy include a limited viewing area and depth of view, variable lesion classification systems, and a learning curve for image acquisition and interpretation.

Evidence

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

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

11/17/2024consensus_reviewLatest

No change to policy statement; periodic coding/reference updates