CurrentCignaPolicy 0578

Wide-area transepithelial sampling with 3D analysis (WATS3D) for Barrett's esophagus

This Coverage Policy governs use of wide-area transepithelial sampling with computer-assisted 3D analysis (WATS3D) as an adjunct or alternative to standard forceps biopsies for detection and surveillance of Barrett's esophagus in Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyWATS3D for Barrett's esophagus detection/surveillance

Policy CodePolicy 0578

Change TypeAnnual review — no clinical changes

Effective DateNov 15, 2024

Next Review DateNov 15, 2025

Key ActionDo not expect coverage for WATS3D; follow plan terms for prior authorization and use standard forceps biopsy (Seattle protocol) as the preferred sampling method.

SourceLink

POLICY UPDATE CHANGES

No clinical policy statement changes. Content moved from Omnibus Codes CP 0504.

experimentalcoverage stance

23,933registry size

47.6%adjunctive yield

23added HGD/EAC

11/15/2024last review

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Determination and Evidence

Not covered (experimental/investigational)

Coverage determination:

Coverage stance: The use of WATS3D is experimental, investigational or unproven.

Policy does not support coverage based on current evidence.

Evidence summaries and study-specific outcomes

Studies reviewed report adjunctive use of WATS3D with forceps biopsy in various populations (screening for GERD, suspected BE, surveillance of known BE, and post‑ablation surveillance). Findings summarized by study:

Vennalaganti et al. (referral BE surveillance RCT): In a referral BE population (n=160) adding WATS to biopsy sampling yielded 23 additional HGD/EAC cases (absolute increase 14.4%); most added cases had prior dysplasia history; WATS added ~4.5 minutes to procedure.

Central laboratory pathology for WATS; population enriched for prior dysplasia; generalizability limited.

Shaheen et al. (2024 registry): In 23,933 patients screened for BE with both FB and WATS3D, WATS3D had higher diagnostic yield for intestinal metaplasia (25.6% vs 16.3%) and identified BE by WATS3D only in 19.3% of patients meeting endoscopic criteria; no significant difference in dysplasia detection between modalities; WATS3D findings changed care plans in 90.7% of patients with positive WATS3D and negative FB.

Prospective registry without central pathology review; registry limitations and selection criteria applied.

Smith et al. (2019 multicenter prospective): Among 12,899 patients, WATS adjunctive to FB detected an additional 213 ED cases missed by FB (absolute increase 1.65%), increasing ED detection by 242% and detected an additional 2,570 BE cases (absolute yield 19.9%).

WATS specimens analyzed centrally; FB read locally.

Trindade pooled registry analysis (2023): Adjunctive yield of WATS for any BE was 47.6% (absolute yield 17.5%), with higher adjunctive yields in shorter BE segments (<1 cm: 64%; 1–2.9 cm: 59.8%; ≥3 cm: 22.7%).

Adverse events not reported; suggests greater incremental yield in short segments.

Post‑ablation surveillance (Corbett et al.): WATS3D adjunctive yield for residual/recurrent intestinal metaplasia and dysplasia was 52.5% and 91.5% respectively; absolute yields 16% (IM) and 4.4% (dysplasia).

Heterogeneous cohort; adverse events not reported; inclusion criteria potentially inconsistent.

Progression outcomes (Shaheen et al. 2022): In 4,545 patients with baseline WATS3D diagnosis and ≥12 months follow‑up, overall progression to HGD/EAC was low (0.33%); progression rates per patient‑year: NDBE 0.08%, crypt dysplasia 1.42%, LGD 5.79%.

Mean follow‑up ~1.97 years; forceps biopsy used to confirm progression.

Coverage determination: The use of wide-area transepithelial tissue sampling with computer-assisted three-dimensional (3D) analysis (WATS3D) is considered experimental, investigational or unproven and is not supported for coverage under this policy.

Clinical studies and registries often excluded patients with prior esophageal interventions or lesions requiring resection. Typical trial and registry exclusion criteria included prior esophageal surgery, prior endoscopic ablation or endoscopic mucosal resection (EMR), and suspicious lesions requiring endoscopic resection; some analyses also excluded patients with incomplete records or without visible columnar-lined epithelium.

No explicit patient exclusions beyond those reported in study protocols are stated in the provided sections of the policy.

Per this policy, WATS3D is designated as experimental/investigational/unproven (not medically necessary) and therefore the policy does not support coverage for this technology.

The policy specifically characterizes reporting of WATS3D using certain cytology and pathology codes as Considered Experimental/Investigational/Unproven. Codes listed in the policy for this designation include: 88104, 88112, 88305, 88312, and 88361 when used to report WATS3D.

Revision notes: the annual review documented No clinical policy statement changes and moved content from Omnibus Codes CP 0504. The provided excerpt does not report changes to the coverage stance.

Coding and Billing

Considered Experimental/Investigational when used to report WATS3DCPT

88104	Cytopathology, fluids, washings or brushings, except cervical or vaginal; smears with interpretation.
88112	Cytopathology, selective cellular enhancement technique with interpretation (eg, liquid based slide preparation method), except cervical or vaginal.
88305	Level IV - Surgical pathology, gross and microscopic examination.
88312	Special stain including interpretation and report; Group I for microorganisms (eg, acid fast, methenamine silver).
88361	Morphometric analysis, tumor immunohistochemistry, quantitative or semiquantitative, per specimen, each single antibody stain procedure; using computer-assisted technology.

Prior Authorization, Documentation, and Operational Notes

Prior Authorization

WATS3D Prior Authorization / Coverage Status

The use of wide-area transepithelial tissue sampling with computer-assisted three-dimensional (WATS3D) is considered experimental, investigational, or unproven; prior authorization is not supported by this policy. Coverage determinations require review of the applicable benefit plan language, applicable laws/regulations, and relevant collateral source materials. Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered.

WATS3D is classified as experimental/investigational/unproven — coverage not supported.
Prior authorization for WATS3D is not supported by this policy (no PA requirement specified).
Coverage decisions require the terms of the applicable benefit plan, laws/regulations, and collateral materials.

Note

Medicare Coverage Determinations

Medicare local and national coverage determinations may vary. No national coverage determination (NCD) was found in this policy; numerous Local Coverage Determinations (LCDs) may exist. Reviewers should consult the most current Medicare policies (NCD/LCD) for up-to-date guidance.

Background and Rationale

WATS3D combines an abrasive brush-based sampling technique with computer-assisted three-dimensional analysis of sampled esophageal tissue. The method is intended as an adjunct to standard forceps biopsy sampling to increase detection of Barrett’s esophagus and associated dysplasia by sampling a larger surface area and applying software-assisted morphometric analysis with pathologist review.

Key Terms and Definitions

Definition — WATS3D

TermWATS3D (wide-area transepithelial sampling with computer-assisted 3-dimensional analysis)

MethodAbrasive brush biopsy technique that samples larger esophageal surface areas to collect sheets of cells while preserving three-dimensional tissue architecture

AnalysisSpecimens analyzed by software algorithms to identify abnormal cells with subsequent confirmation by an expert pathologist

Intended useProposed as an adjunct to standard forceps biopsy during endoscopy for detection and surveillance of Barrett's esophagus

Device historyFirst-generation system previously known as EndoCDx; current commercial name WATS3D (CDx Diagnostics)

Definition — Seattle protocol

Policy Review and Revision History

2024-11-15Annual reviewLatest

Annual review noted; content moved from Omnibus Codes CP 0504 and no clinical policy statement changes were made.