Adjunctive Techniques for Screening, Surveillance, and Risk Classification of Barrett Esophagus and Esophageal Dysplasia
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This policy governs coverage and medical necessity determinations for adjunctive tests and technologies (TissueCypher, EsoCheck/EsoGuard, Esopredict) used to screen, surveil, or risk-stratify Barrett esophagus for Blue Cross Blue Shield - Rhode Island members.
No material clinical or coverage changes in this revision.
Coverage Determinations
Not covered / Not medically necessary
The following tests are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:
Evidence insufficient to determine improvement in net health outcome.
Some genetic testing services may be excluded for certain self-funded groups when the employer has a contractual exclusion that omits the expanded coverage of biomarker testing described in the Biomarker Testing Mandate. For members in those groups, coverage determination (covered with prior authorization, not medically necessary, or not covered as a contract exclusion) should be verified in the member's Benefit Booklet and the Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses policies.
The following CPT codes are specifically identified as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 0108U, 0114U, and 0398U. These codes correspond to the TissueCypher, EsoCheck/EsoGuard, and Esopredict proprietary assays as listed in the Coding section; prior authorization will not make these services payable under the stated product lines.
For Commercial Products, the policy concludes that the named adjunctive tests (EsoCheck/EsoGuard, TissueCypher, Esopredict) are not medically necessary because the evidence is insufficient to demonstrate an improvement in the net health outcome. As a result, these tests are not covered for routine screening, surveillance, or risk stratification of Barrett esophagus under Commercial Plans.
Coding and Billing
| 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 |
| 0114U | Gastroenterology (Barrett's esophagus), VIM and CCNA1 methylation analysis, esophageal cells, algorithm reported as likelihood for Barrett's esophagus |
| 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 |
| 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 |
| 0114U | Gastroenterology (Barrett's esophagus), VIM and CCNA1 methylation analysis, esophageal cells, algorithm reported as likelihood for Barrett's esophagus |
| 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 |
Provider Requirements and Billing Implications
Obtain prior authorization (MA required; Commercial recommended)
Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products; unlisted genetic testing CPT codes require prior authorization to determine what service is being rendered and if the service is covered or not medically necessary. Authorization for participating members is obtained via the online tool; laboratories and their representatives are NOT permitted to obtain authorization on behalf of the ordering physician.
- PA required for Medicare Advantage; recommended for Commercial Products.
- All Unlisted genetic testing CPT codes require prior authorization to determine coverage/medical necessity.
- Only the ordering physician may be involved in prior authorization; laboratories may not obtain authorization on behalf of the physician.
Do not expect PA to authorize listed CPTs (0108U, 0114U, 0398U)
The listed CPT codes (0108U, 0114U, 0398U) are not covered for Medicare Advantage Plans and are considered not medically necessary for Commercial Products; prior authorization will not make these services payable under the stated product lines.
Use Unlisted CPTs only with prior authorization
All Unlisted genetic testing CPT codes require prior authorization so the payer can determine what service is being rendered and whether it is covered or not medically necessary.
- If a service is billed with an Unlisted CPT, follow the PLA/MAAA policy medical necessity criteria and obtain PA.
- Use the online prior authorization tool for participating providers.
No step therapy requirements
This policy does not describe any step therapy requirements for the referenced tests.
Prior authorization required for Unlisted CPTs
If a test is filed with an Unlisted CPT code, obtain prior authorization to determine the specific service and coverage; the PLA/MAAA policy medical necessity criteria will be used when applicable.
- All Unlisted genetic testing CPT codes require prior authorization to determine coverage/medical necessity.
- Refer to the Proprietary Laboratory Analyses (PLA) and MAAA policy for medical necessity criteria when an Unlisted CPT is used.
No extra documentation required by policy
No additional documentation requirements beyond the prior authorization and related policy references are specified in this policy.
Unauthorized lab services will be denied; lab bears financial liability
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will rest with the participating laboratory; such services may not be billed to the member.
- Laboratories and their representatives must not obtain authorization on behalf of the ordering physician; violations may result in severe action including network termination.
Do not use listed CPTs for proprietary Barrett's assays — not covered / not medically necessary
Use of CPT codes 0108U (TissueCypher), 0114U (EsoCheck/EsoGuard), and 0398U (Esopredict) for the named proprietary assays is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products.
- 0108U — TissueCypher assay (whole-slide digital imaging and 9 biomarker immunolabeling) is not covered/not medically necessary.
- 0114U — EsoCheck/EsoGuard methylation analysis is not covered/not medically necessary.
- 0398U — Esopredict DNA methylation risk classifier is not covered/not medically necessary.
Clinical Background
Barrett esophagus (BE) is the replacement of the normal squamous epithelium of the distal esophagus by specialized columnar intestinal metaplasia, a condition associated with gastroesophageal reflux disease (GERD) and an increased risk of progression to esophageal adenocarcinoma. Surveillance and management are guided by the presence and grade of dysplasia: individuals with no dysplasia typically undergo surveillance every 3–5 years, those with low-grade dysplasia have either endoscopic therapy preferred or surveillance at about 12-month intervals, and high-grade dysplasia is generally managed with endoscopic eradication therapy. Adjunctive tests addressed in this policy aim to detect BE or stratify progression risk but have not demonstrated sufficient evidence of improved health outcomes to change standard management.
Definitions and Test Descriptions
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