WATS3D Biopsy (EndoCDx)

Policy ID: L-194-010

Section: Laboratory

Effective Date: November 01, 2019

Revised Date: March 12, 2025

Revision Effective Date: May 05, 2025

Last Reviewed: March 11, 2025

Applies To: Commercial and Medicaid Expansion

Description

The WATS3D (wide-area transepithelial sampling) biopsy procedure is performed by a gastroenterologist during endoscopic examination of the esophagus. The computer-assisted procedure is intended as an adjunct to standard four-quadrant focal biopsies for screening, diagnosis, or surveillance of cancerous or precancerous esophageal lesions.

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The WATS3D biopsy (formally known as EndoCDx), may be considered medically necessary for ONE or more of the following indications:

- Surveillance of Low, Moderate or High-Grade Barrett's Esophagus; or
- Surveillance of chronic gastroesophageal reflux (GERD) disease.

The WATS3D biopsy procedure not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

43191

43193

43197

43198

43200

43202

88104

88160

88305

88312

Diagnosis Codes

K21.9

K21.00

K21.01

K22.70

K22.710

K22.711

K22.719

Professional Statements and Societal Positions Guidelines

American Society for Gastrointestinal Endoscopy

The 2019 ASGE guideline on screening and surveillance of Barrett's esophagus suggests that WATS3D be used in addition to WLE and Seattle protocol biopsy sampling.

ND Committee Review

Internal Medical Policy Committee 9-21-2020 Annual Review

Internal Medical Policy Committee 7-22-2021 Coding update

Added procedure codes 88305; 88312; 88361

Internal Medical Policy Committee 11-23-2021 Revision

Updated criteria

Internal Medical Policy Committee 01-20-2022 Coding update

Removed procedure code 99000

Internal Medical Policy Committee 7-21-2022 Annual Review - no changes in criteria

Internal Medical Policy Committee 7-26-2023 Annual Review - no changes in criteria

Internal Medical Policy Committee 1-16-2024 Coding update- Effective March 04, 2024

Removed procedure code 88361

Internal Medical Policy Committee 1-14-2025 Annual Review - no changes in criteria

Added Policy Application

Internal Medical Policy Committee 3-11-2025 Revision - Effective May 05, 2025

Changed verbiage from (e.g., EndoDx) to ('formally known as EndoCDx'); and
Changed verbiage from ' ANY ' to ' ONE or more '; and
Added Professional Statement and Societal Positions Guidelines; and
Added diagnosis codes K21.9; K21.00; K21.01; K22.70; K22.710; K22.711; and K22.719.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: L-194-009

Section: Laboratory

Effective Date: November 01, 2019

Revised Date: January 08, 2024

Revision Effective Date: March 03, 2025

Last Reviewed: January 14, 2025

Archived Date: May 04, 2025

Applies To: Commercial and Medicaid Expansion

Description

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The WATS3D biopsy (e.g., EndoDx), may be considered medically necessary for ANY of the following indications:

- Surveillance of Low, Moderate or High-Grade Barrett's Esophagus; or
- Surveillance of chronic gastroesophageal reflux (GERD) disease.

Procedure Codes

43191

43193

43197

43198

43200

43202

88104

88160

88305

88312

Diagnosis Codes

Not Applicable

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-21-2020 Annual Review

Internal Medical Policy Committee 7-22-2021 Coding update;

Added procedure codes 88305, 88312, 88361

Internal Medical Policy Committee 11-23-2021 Revision

Updated criteria

Internal Medical Policy Committee 01-20-2022 Coding update;

Removed procedure code 99000

Internal Medical Policy Committee 7-21-2022 Annual Review - no changes in criteria

Internal Medical Policy Committee 7-26-2023 Annual Review - no changes in criteria

Internal Medical Policy Committee 1-16-2024 Coding update- Effective March 04, 2024

Removed procedure code 88361

Internal Medical Policy Committee 1-14-2025 Annual Review - no changes in criteria

Added Policy Application

Medical Policies Quick Search

WATS3D Biopsy (EndoCDx)

Description

Policy Application

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer