841 Form

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Medical Policy Adjunctive Techniques for Screening and Surveillance and Risk Classification of Barrett Esophagus and Esophageal Dysplasia
Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 841 BCBSA Reference Number: 7.01.167 (For Plan internal use only) NCD/LCD: N/A Related Policies
Endoscopic Radiofrequency Ablation or Cryoablation for Barrett Esophagus #218 Oncologic Applications of Photodynamic Therapy, Including Barrett Esophagus #454 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Wide-area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) is considered INVESTIGATIONAL for all indications, including but not limited to the screening and surveillance of Barrett esophagus and esophageal dysplasia.

EsoCheck is considered INVESTIGATIONAL for the screening and surveillance of Barrett esophagus and esophageal dysplasia.

TissueCypher is considered INVESTIGATIONAL for assessing the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus.

Esopredict is considered INVESTIGATIONAL for assessing the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus.

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.

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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.

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 CPT code is 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 0108U Gastroenterology (Barrett’s esophagus), whole slide–digital imaging, including morphometric analysis, computer-assisted quantitative immunolabeling of 9 protein biomarkers (p16, AMACR, p53, CD68, COX-2, CD45RO, HIF1a, HER-2, K20) and morphology, formalin-fixed paraffin-embedded tissue, algorithm reported as risk of progression to high-grade dysplasia or cancer 0398U Gastroenterology (Barrett esophagus), P16, RUNX3, HPP1, and FBN1 DNA methylation analysis using PCR, formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as risk score for progression to high-grade dysplasia or cancer Description Barrett Esophagus Barrett esophagus (BE) is a condition in which the squamous epithelium that normally lines the esophagus is replaced by specialized columnar-type epithelium known as intestinal metaplasia in response to irritation and injury caused by gastroesophageal reflux disease (GERD). Barrett esophagus occurs in the distal esophagus. It may involve any length of the esophagus, be focal or circumferential, and is visualized on endoscopy with a different color than background squamous mucosa. Confirmation of BE requires a biopsy of the columnar epithelium and microscopic identification of intestinal metaplasia.1, The prevalence of BE in the United States is estimated at 5.6%.2, Risk factors associated with the development of BE include GERD, male gender, central obesity, and age over 50 years. The diagnosis of GERD is associated with a 10% to 15% risk of BE.3, However, a population-based analysis from Sweden observed that 40% of the study cohort with esophageal cancer reported no prior history of GERD symptoms.4,

Cancer Risk and Management Intestinal metaplasia is a precursor to esophageal adenocarcinoma, and patients with BE are at a 40-fold increased risk for developing this disease compared to the general population.1,

However, there are few data to guide recommendations about management and surveillance, and many issues are controversial. Guidelines from the American College of Gastroenterology (ACG)3, and a consensus statement from an international group of experts (Benign Barrett's and CAncer Taskforce) on the management of BE are published.5,The ACG recommendations for surveillance are stratified by the presence and grade of dysplasia.

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When no dysplasia is detected, ACG has reported the estimated risk of progression to cancer ranges from 0.2% to 0.5% per year and endoscopic surveillance every 3 to 5 years is recommended. For low-grade dysplasia, the estimated risk of progression is 0.7% per year, and endoscopic therapy is preferred; however, endoscopic surveillance every 12 months is considered an acceptable alternative. It is recommended that both options are discussed with the patient.3, Precise estimates of cancer risk are not available for individuals with low-grade dysplasia due to large disparities among studies on its natural history. Interobserver variability in the diagnosis of low-grade dysplasia with standard biopsy may be responsible, with expert pathologists commonly downgrading initial diagnoses made by community pathologists.6,

The Benign Barrett's and Cancer Taskforce consensus group did not endorse routine surveillance for people without dysplasia and was unable to agree on surveillance intervals for low-grade dysplasia.5, For high-grade dysplasia, the estimated risk of progression is about 7% per year, and ACG has recommended endoscopic eradication therapy, with the type of procedure dependent on patient age and life expectancy, comorbidities, the extent of dysplasia, local expertise in surgery and endoscopy, and patient preference.3, Approximately 40% of patients with high-grade dysplasia on biopsy are found to have associated carcinoma in the resection specimen.7,

For patients who are indefinite for dysplasia, a repeat endoscopy should be performed at 3 to 6 months following optimization of acid suppressive medications. A surveillance interval of 12 months is recommended if an indefinite for dysplasia reading is confirmed on repeat endoscopy in these individuals.3, Many patients who are indefinite for dysplasia show regression to nondysplastic BE with subsequent endoscopic evaluation. It is unclear whether some cases of regression are observed due to sampling error.8,

Summary
Description Several adjunctive technologies and tests are available for screening, surveillance, and risk stratification of Barrett esophagus (BE). The wide-area transepithelial sampling with three-dimensional analysis (WATS3D) is performed during the endoscopic examination of the esophagus, using a computer-assisted brush biopsy procedure as an adjunct to standard four-quadrant forceps biopsy. TissueCypher is a tissue systems pathology test that analyzes biopsy samples to predict the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in patients with BE. EsoCheck is a non-endoscopic cell collection device used in conjunction with EsoGuard, a DNA methylation test, to detect BE and esophageal dysplasia. Esopredict is a DNA methylation assay that assesses the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in patients with BE. These technologies and tests are intended to complement standard procedures in the screening, surveillance, and risk stratification of individuals with BE or at risk of developing BE.

Summary of Evidence For individuals with a history of Barrett esophagus (BE) who receive standard surveillance with adjunctive WATS3D, the evidence includes a meta-analysis of studies of diagnostic yield, a randomized controlled trial, a physician impact study, a decision analytic model, and a retrospective analysis of the manufacturer database. Relevant outcomes are test validity, overall survival, disease-specific survival, change in disease status, and quality of life. A meta-analysis reported incremental diagnostic yields of 6.9% and 2.4% for any dysplasia or esophageal adenocarcinoma (EAC) or high-grade dysplasia (HGD)/EAC, respectively. These studies are limited by heterogeneity in classification and reporting of test results and selection bias stemming from the enrichment of patients with a prior history of dysplasia. It is also unclear to what extent results obtained from academic centers are generalizable to community-based settings, where adherence to endoscopic biopsy guidelines is poor. In discordant cases where BE or dysplasia were identified only by WATS3D, significant physician management changes included initiation of invasive treatments. Health outcomes stemming from management changes were not reported, and risks associated with overdiagnosis, and overtreatment require elucidation. Follow-up data on disease progression in these patients are limited. A retrospective analysis of the manufacturer database found a disease progression rate of 5.79% per patient-year (95% CI, 1.02% to 10.55%) for baseline low-grade dysplasia diagnoses via WATS3D sampling; however, study interpretation is limited as only 16 cases (0.33%) of progression defined as high-grade dysplasia or esophageal adenocarcinoma on follow-up forceps biopsy were identified.

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A RCT enrolling patients with a recent history of dysplasia reported an absolute increase of 10% in the diagnostic yield of HGD/EAC but did not report on long-term disease progression or mortality outcomes. No direct evidence of clinical utility was identified. Because combined use of WATS3D with standard surveillance is intended to replace the current standard of care for guiding patient management decisions regarding initiation of treatment or surveillance, direct evidence of clinical utility is required. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals at increased risk of BE who undergo standard screening with adjunctive WATS3D, the evidence includes a meta-analysis of studies of diagnostic yield, a physician impact study, a decision analytic model, and a retrospective analysis of the manufacturer database. Relevant outcomes are test validity, overall survival, disease-specific survival, change in disease status, and quality of life. A meta- analysis reported incremental diagnostic yields of 7.2% and 2.1% for any dysplasia/EAC or HGD/EAC, respectively. However, available studies have incomplete descriptions of selection criteria, and it is unclear whether study patients are at increased risk as defined by guideline recommendations for screening. In fact, 2 studies were enriched with women in whom screening is generally not recommended by society guidelines. These studies also noted that detected cases of BE in short-segment patients may actually reflect intestinal metaplasia of the cardia, which is thought to carry a significantly lower risk of cancer development compared to traditional BE. In discordant cases where BE or dysplasia were identified only by WATS3D, significant physician management changes included initiation of invasive treatments. Health outcomes from management changes were not reported, and risks associated with overdiagnosis, and overtreatment require elucidation. Follow-up data on disease progression in these patients are limited. A retrospective analysis of the manufacturer database found a disease progression rate of 5.79% per patient- year (95% CI, 1.02% to 10.55%) for baseline low-grade dysplasia diagnoses via WATS3D sampling; however, study interpretation is limited as only 16 cases (0.33%) of progression defined as high-grade dysplasia or esophageal adenocarcinoma on follow-up forceps biopsy were identified. No direct evidence of clinical utility was identified. Because combined use of WATS3D with standard screening is intended to replace the current standard of care for guiding patient management decisions regarding initiation of treatment or surveillance, direct evidence of clinical utility is required. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with non-dysplastic, indefinite dysplasia, or low-grade dysplasia BE who undergo standard screening with adjunctive TissueCypher, the evidence includes multiple clinical validity studies and physician impact studies. Relevant outcomes are test validity, overall survival, disease-specific survival, change in disease status, and quality of life. Clinical validity studies have reported sensitivities ranging from 29% to 71% and specificities between 79% to 95% for predicting progression to high-grade dysplasia or esophageal adenocarcinoma. Hazard ratios for high-risk versus low-risk groups ranged from 3.23 to 5.26, indicating increased progression risk for individuals classified as high-risk by TissueCypher. The assay showed improved risk stratification compared to expert pathologist reviews in several studies. Clinical utility studies have focused on the impact of TissueCypher results on patient management decisions. One author found that TissueCypher results influenced more than half of management decisions, leading to both upstaging and downstaging of treatment approaches. Another study reported that incorporating TissueCypher results significantly increased the percentage of patients receiving guideline-appropriate management compared to pathology review alone. A randomized trial using simulated patients found that physicians with access to TissueCypher results were more likely to correctly assess progression risk and offer guideline-concordant treatment. However, these studies primarily relied on simulated cases or management decision changes, and long-term patient outcomes resulting from TissueCypher-guided management have not been directly assessed. The use of adjunct TissueCypher is intended to classify individuals with BE based on their risk of progression to high-grade dysplasia or esophageal adenocarcinoma, this can change patient management decisions regarding the initiation of treatment such as esophageal eradication therapy or enhanced surveillance. Therefore, direct evidence of improvement in health outcomes is required. 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 Barrett esophagus who receive standard prognostic techniques plus Esopredict, the evidence included multiple clinical validity studies. Relevant outcomes are test validity, overall survival, disease-specific survival, change in disease status, and quality of life. Clinical validity studies have reported sensitivities ranging from 63% to 100% and specificities between 54% to 75% for predicting progression to high-grade dysplasia or esophageal adenocarcinoma. There is no evidence evaluating the clinical utility of the Esopredict test for assessing Barrett esophagus thus, there is no evidence that Esopredict testing for prognosis of Barrett esophagus adds incremental value to current prognostic assessments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 4/2026 Annual policy review. Policy updated with literature review through September 26, 2025; references added. Added Esopredict is considered investigational for assessing the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus. All other policy statements are unchanged. 4/2025 Policy clarified to remove EsoGuard and BarreGen. These tests are managed by Carelon.
3/2025 Annual policy review. Policy updated with literature review through June 26, 2024; references added. Policy title changed to: Adjunctive Techniques for Screening, Surveillance, and Risk Classification of Barrett Esophagus and Esophageal Dysplasia Three new policy statements were added: EsoCheck and Esoguard are considered investigational for the screening and surveillance of Barrett esophagus and esophageal dysplasia. TissueCypher is considered investigational for assessing the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus. BarreGen is considered investigational for the risk stratification of Barrett esophagus and esophageal dysplasia. Coding Clarified. Effective 3/1/2025. 10/2023 Annual policy review. Description, summary and references updated. Policy statements unchanged. 10/2022 Annual policy review. Description, summary and references updated. Policy statements unchanged. 1/2022 New medical policy describing investigational indications. Effective 1/1/2022. 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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3. Shaheen NJ, Falk GW, Iyer PG, et al. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. Jan 2016; 111(1): 30-50; quiz 51. PMID 26526079
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