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Medical Policy Confocal Laser Endomicroscopy Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 618 BCBSA Reference Number: 2.01.87 (For Plan internal use only) NCD/LCD: N/A Related Policies
• Endoscopic Radiofrequency Ablation or Cryoablation for Barrett Esophagus, #218 • Chromoendoscopy as an Adjunct to Colonoscopy, #904 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Use of confocal laser endomicroscopy is considered INVESTIGATIONAL. Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

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CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list. The following CPT codes are considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT codes:

Code Description 43206 Esophagoscopy flexible, transoral; with optical endomicroscopy 43252 Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy 88375 Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endoscopic session 0397T Endoscopic retrograde cholangiopancreatography (ercp), with optical endomicroscopy (list separately in addition to code for primary procedure)

Description Confocal laser endomicroscopy (CLE), also known as confocal fluorescent endomicroscopy and optical endomicroscopy, allows in vivo microscopic imaging of the mucosal epithelium during endoscopy. The process uses light from a low-power laser to illuminate tissue and, subsequently, the same lens detects light reflected from the tissue through a pinhole. The term confocal refers to having both illumination and collection systems in the same focal plane. Light reflected and scattered at other geometric angles that are not reflected through the pinhole is excluded from detection, which dramatically increases the resolution of CLE images.

To date, 2 CLE systems have been cleared by the U.S. Food and Drug Administration (FDA). One is an endoscope-based system with a confocal probe incorporated onto the tip of a conventional endoscope. The other is a probe-based system; the probe is placed through the biopsy channel of a conventional endoscope. The depth of view is up to 250 μm with the endoscopic system and about 120 mm with the probe-based system. A limited area can be examined; no more than 700 μm in the endoscopic-based system and less with the probe-based system. As pointed out in systematic reviews, the limited viewing area emphasizes the need for careful conventional endoscopy to target areas for evaluation. Both CLE systems are optimized using a contrast agent. The most widely used agent is intravenous fluorescein, which is FDA-approved for ophthalmologic imaging of blood vessels when used with a laser scanning ophthalmoscope.

Unlike techniques such as chromoendoscopy (see policy #904), which are primarily intended to improve the sensitivity of colonoscopy, CLE is unique in that it is designed to characterize the cellular structure of lesions immediately. Confocal laser endomicroscopy can thus potentially be used to make a diagnosis of polyp histology, particularly in association with screening or surveillance colonoscopy, which could allow for small hyperplastic lesions to be overlooked rather than removed and sent for histologic evaluation. Using CLE would reduce risks associated with biopsy and reduce the number of biopsies and histologic evaluations.

Another potential application of CLE technology is targeting areas for biopsy in individuals with Barrett esophagus undergoing surveillance endoscopy. CLE would be proposed as an alternative to the current standard approach, recommended by the American Gastroenterological Association, which is that

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individuals with Barrett esophagus who do not have dysplasia undergo endoscopic surveillance every 3 to 5 years.1, The American Gastroenterological Association has further recommended that random 4- quadrant biopsies every 2 cm be taken with white-light endoscopy in individuals without known dysplasia. Other potential uses of CLE under investigation include better diagnosis and differentiation of conditions such as gastric metaplasia, lung cancer, and bladder cancer.

As noted, limitations of CLE systems include a limited viewing area and depth of view. Another issue is the standardization of systems for classifying lesions viewed with CLE devices. Although there is currently no internationally accepted classification system for colorectal lesions, 2 systems have been used in a number of studies conducted in different countries. These include the Mainz criteria for endoscopy-based CLE devices and the Miami classification system for probe-based CLE devices.2, Lesion classification systems are less developed for non-gastrointestinal lesions viewed by CLE devices (eg, those in the lung or bladder). Another challenge is the learning curve for obtaining high-quality images and classifying lesions. Several studies, however, have found that the ability to acquire high-quality images and interpret them accurately can be learned relatively quickly; these studies were specific to colorectal applications of CLE.3,4,

Summary Confocal laser endomicroscopy (CLE), also known as confocal fluorescent endomicroscopy and optical endomicroscopy, allows in vivo microscopic imaging of cells during endoscopy. Confocal laser endomicroscopy is proposed for a variety of purposes, especially as a real-time alternative to biopsy/polypectomy and histopathologic analysis during colonoscopy and for targeting areas to undergo biopsy in individuals with inflammatory bowel disease or Barrett esophagus. For individuals who have suspected or known colorectal lesions who receive confocal laser endomicroscopy (CLE) as an adjunct to colonoscopy, the evidence includes multiple diagnostic accuracy studies. Relevant outcomes are overall survival (OS), disease-specific survival, test validity, and resource utilization. In 3 published systematic reviews, pooled estimates of the overall sensitivity of CLE ranged from 81% to 94%, and pooled estimates of the specificity ranged from 88% to 95%. It is uncertain whether the accuracy is sufficiently high to replace biopsy/polypectomy and histopathologic analysis. Moreover, issues remain concerning the use of this technology in clinical practice (eg, the learning curve, interpretation of lesions). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have Barrett esophagus (BE) who are undergoing surveillance and receive CLE with targeted biopsy, the evidence includes several randomized-controlled trials (RCTs) and meta-analyses. Relevant outcomes are OS, disease-specific survival, test validity, and resource utilization. Evidence from RCTs has suggested that CLE has similar or higher sensitivity than standard endoscopy for identifying areas of dysplasia. However, a 2014 meta-analysis found that the pooled sensitivity, specificity, and negative predictive value (NPV) of available studies were not sufficiently high to replace the standard surveillance protocol. In a 2022 meta-analysis, the absolute increase in neoplasia detection using CLE compared with the Seattle protocol randomized biopsies was 5%. Additionally, dysplasia prevalence was 4% with Seattle protocol randomized biopsies and 9% with CLE. National guidelines continue to recommend 4-quadrant random biopsies for patients with BE undergoing surveillance. One RCT, which compared high-definition white-light endoscopy with high-definition white-light endoscopy plus CLE, was stopped early because an interim analysis did not find a between-group difference in outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have gastrointestinal lesions and have had endoscopic treatment who receive CLE to assess the adequacy of endoscopic treatment, the evidence includes a systematic review that includes a single RCT and 2 prospective, nonrandomized studies. Relevant outcomes are OS, disease-specific survival, test validity, and resource utilization. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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For individuals who have a suspicion of a condition diagnosed by identification and biopsy of lesions (eg, lung, bladder, or gastric cancer) who receive CLE, the evidence mainly consists of a small number of diagnostic accuracy studies. Relevant outcomes are OS, disease-specific survival, test validity, and resource utilization. There is limited evidence on the diagnostic accuracy of CLE for these other indications. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 1/2026 Annual policy review. References updated. Policy statements unchanged. 1/2025 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2024 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 12/2016 Annual policy review. New references added. 1/2016 Annual policy review. New references added. 1/2016 Clarified coding information. 3/2015 Annual policy review. New references added. 4/2014 Annual policy review. New references added. Coding information clarified. 1/2014 Coding information clarified. 7/2013 New medical policy describing non-coverage. Effective 7/1/2013. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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