ModifiedBlue Cross Blue Shield - MassachusettsPolicy 841

Adjunctive techniques for Barrett esophagus (WATS3D, EsoCheck, TissueCypher, Esopredict)

Defines coverage and investigational status for adjunctive sampling, nonendoscopic collection, and tissue-based prognostic tests used for screening, surveillance, and risk stratification of Barrett esophagus and esophageal dysplasia for Blue Cross Blue Shield - Massachusetts members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyAdjunctive techniques for Barrett esophagus (WATS3D, EsoCheck, TissueCypher, Esopredict)

Policy CodePolicy 841

Change TypeAnnual review — investigational statements added/clarified

Effective Date

Next Review Date

Key ActionObtain precertification when the procedure is performed inpatient; vendor-managed tests may require external authorization.

SourceLink

POLICY UPDATE CHANGES

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

Policy clarified to remove EsoGuard and BarreGen; these tests are managed by Carelon.

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

Policy clarified to remove EsoGuard and BarreGen; these tests are managed by Carelon.

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.

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Coverage Criteria and Policy Statements

Investigational Technologies

Covered when ALL of the following are met

Investigational stance: WATS3D, EsoCheck, TissueCypher, and Esopredict are considered investigational for all indications, including screening and surveillance of Barrett esophagus and esophageal dysplasia and for risk assessment of progression to high-grade dysplasia or esophageal adenocarcinoma.

Applies to listed technologies as stated in policy.

Investigational / Not Covered Assays

Policy statements added or clarified by annual reviews

Investigational tests for screening/surveillance: EsoCheck and EsoGuard are considered investigational for the screening and surveillance of Barrett esophagus and esophageal dysplasia.

Statement added effective 3/1/2025; clarification that EsoGuard management was removed from policy and is managed by Carelon.

Investigational tests for risk stratification: TissueCypher, BarreGen, and Esopredict are considered investigational for assessing risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus.

Added across 2024-2026 annual updates; Esopredict added in 4/2026.

Outpatient use of the services described in this policy is not a covered service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM members. Providers should anticipate that outpatient claims for the listed adjunctive tests or sampling techniques may be denied when submitted for these product lines.

The policy explicitly identifies several specific tests as investigational for the uses listed: 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; and Esopredict is considered investigational for assessing the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus. Policy history notes these statements were added or affirmed during annual reviews (most recently 4/2026 for Esopredict).

WATS3D, EsoCheck, TissueCypher, and Esopredict are considered investigational for all indications, including but not limited to the screening and surveillance of Barrett esophagus and esophageal dysplasia and for risk assessment of progression to high-grade dysplasia or esophageal adenocarcinoma.

In addition to the tests named above, the policy lists other adjunctive techniques and tests — including certain swallowable-cell collection devices, DNA/methylation assays, and automated tissue systems pathology tests — as investigational when used for screening, surveillance, or risk stratification of Barrett esophagus and related progression. Specific investigational assays called out in the policy history include BarreGen (risk stratification) and investigational statements covering uses added or clarified in the 2024–2026 reviews.

Coding and Billing

Investigational CPT Codes (molecular/pathology)CPTNot Covered

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.

Codes mentioned or impliedmixed

No codes listed

Investigational molecular/pathology CPT codes0108U, 0398U (listed as investigational in coding section)

Code systemCPT (molecular/pathology) as listed in policy coding table

Code descriptions available in policyDescriptions provided for 0108U and 0398U in coding section

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Inpatient prior authorization required. For services described in this policy, precertification/preauthorization is required for all products when the procedure is performed inpatient. Lack of required precertification may affect payment.

Precertification is required for all inpatient procedures covered by this policy.

Prior Authorization

Vendor-Managed Tests Require External Authorization

Vendor-managed tests require external authorization. Specific tests (e.g., EsoGuard, BarreGen) are managed by Carelon and require authorization through that vendor. Providers should follow Carelon's authorization process before ordering these tests.

Examples: EsoGuard, BarreGen — authorization managed by Carelon.
Contact vendor (Carelon) for precertification and submission requirements.

Background and Clinical Context

Barrett esophagus (BE) is a condition in which the normal squamous epithelium of the distal esophagus is replaced by specialized columnar intestinal metaplasia. BE is associated with gastroesophageal reflux disease and confers an increased risk of progression to esophageal adenocarcinoma; surveillance and management are typically guided by the presence and grade of dysplasia.

Definitions and Test Descriptions

Barrett esophagus — definition

DefinitionReplacement of normal squamous epithelium in the distal esophagus by specialized columnar intestinal metaplasia confirmed by biopsy and microscopic identification of intestinal metaplasia.

LocationOccurs in the distal esophagus; may be focal or circumferential and any length

AssociationAssociated with gastroesophageal reflux disease (GERD) and increased risk of esophageal adenocarcinoma

WATS3D

TechniqueWide-area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) performed during endoscopy using a brush biopsy as an adjunct to standard four-quadrant forceps biopsy.

UseAdjunct to standard endoscopic four-quadrant biopsy for detection of intestinal metaplasia and dysplasia

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyAdjunctive techniques for Barrett esophagus (WATS3D, EsoCheck, TissueCypher, Esopredict)

Policy CodePolicy 841

Change TypeAnnual review — investigational statements added/clarified

Effective Date

Next Review Date

Key ActionObtain precertification when the procedure is performed inpatient; vendor-managed tests may require external authorization.

SourceLink

On This Page

Denial Risk

Outpatient Noncoverage

Outpatient use is not a covered service for multiple product lines. For the services described in this policy, outpatient procedures are not covered for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue, and Medicare PPO Blue. Providers must verify member-specific benefits prior to rendering outpatient services.

Commercial Managed Care (HMO and POS), Outpatient = Not a covered service.
Commercial PPO and Indemnity, Outpatient = Not a covered service.
Medicare HMO Blue, Outpatient = Not a covered service.
Medicare PPO Blue, Outpatient = Not a covered service.

Documentation Required

Coding and Documentation Guidance

Coding and documentation guidance. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including applicable modifiers. Document the clinical indication, relevant history, and any applicable exclusions when submitting authorization requests or claims.

Report services with current CPT, HCPCS, revenue, and ICD-10 codes and modifiers as appropriate.
Document clinical indication and supporting clinical information for medical necessity and authorization.
Tests identified as investigational should include documentation of clinical indication; claims may be denied if investigational.

Adjunctive techniques — definition

DefinitionNon-standard methods used in addition to standard forceps biopsy to detect Barrett esophagus or dysplasia or to predict progression risk.

ExamplesIncludes wide-area transepithelial sampling (WATS3D), swallowable or non-endoscopic cell collection devices (e.g., EsoCheck used with EsoGuard), DNA methylation assays (e.g., Esopredict), and automated tissue systems pathology tests (e.g., TissueCypher).

RoleIntended to complement standard screening, surveillance, and risk stratification procedures but are considered investigational per policy for the listed indications.