CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Adjunctive Techniques for Screening, Surveillance, and Risk Classification of Barrett Esophagus and Esophageal Dysplasia

This policy governs coverage and prior authorization for adjunctive laboratory and nonendoscopic tests (EsoCheck/EsoGuard, TissueCypher, BarreGEN) used to screen, surveil, or stratify risk for Barrett esophagus and esophageal dysplasia for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAdjunctive Techniques for Screening, Surveillance, and Risk Classification of Barrett Esophagus and Esophageal Dysplasia

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 7, 2025

Next Review DateN/A

Key ActionObtain prior authorization via the online tool (ordering physician only) for Medicare Advantage members and check member-specific benefits before proceeding.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3tests addressed

3CPT/HCPCS codes referenced

Not coveredCoverage stance

Required (MA)Prior auth

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Coverage determinations and medical necessity

Not covered / Not medically necessary determinations

Coverage determinations for Medicare Advantage Plans and Commercial Products

EsoCheck / EsoGuard: Considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products for screening and surveillance of Barrett esophagus and esophageal dysplasia due to insufficient evidence of improvement in net health outcome.

Diagnostic accuracy studies report sensitivities of 85%–92.9% and specificities of 72.2%–85%; studies lack comprehensive follow-up and direct evidence of clinical utility or improved long-term health outcomes.

TissueCypher: Considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products for assessing risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus due to insufficient evidence of improved health outcomes.

Clinical validity studies report sensitivities 29%–71% and specificities 79%–95% with hazard ratios 3.23–5.26; impact studies rely on simulated cases or short-term management changes and lack direct assessment of long-term outcomes.

BarreGEN: Considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products for assessing risk of progression to high-grade dysplasia or esophageal adenocarcinoma in individuals with Barrett esophagus due to insufficient evidence; no clinical studies identified.

No studies were identified evaluating BarreGEN; therefore clinical utility and impact on health outcomes have not been demonstrated.

Some genetic testing services may be contractually excluded for self-funded groups under the state Biomarker Mandate and related plan sponsor agreements. Benefit coverage for these members varies by employer and plan; providers must consult the member's Benefit Booklet or the Genetic Services and Proprietary Laboratory Analyses policies to determine whether a specific test is covered, requires prior authorization, is not medically necessary, or is a contractual exclusion.

Services that are determined to be not medically necessary or that are non-covered benefits under the member's subscriber agreement or employer agreement may be excluded from payment. Verify member-specific benefits and eligibility with the provider call center before providing services, and obtain written informed consent if the provider intends to bill the member for non-covered services.

For both Medicare Advantage Plans and Commercial Products, EsoCheck/EsoGuard, TissueCypher, and BarreGEN are considered not covered for Medicare Advantage and not medically necessary for Commercial Products for the uses described in this policy due to insufficient evidence demonstrating improved net health outcomes.

CPT/HCPCS coding and status

Not covered / Not medically necessary CPT codes - TissueCypherCPTNot Covered

0108U

Gastroenterology (Barrett's esophagus), whole slide-digital imaging, including morphometric analysis, computer-assisted quantitative immunolabeling of 9 biomarkers (p16, AMACR, p53, CD68, COX-2, CDASRO, HIFIa, HER-2, K2O) and morphology, formalin-fixed paraffin-embedded tissue, algorithm reported as risk of progression to high-grade dysplasia or cancer

Not covered / Not medically necessary CPT codes - EsoCheck/EsoGuardCPTNot Covered

0114U

Gastroenterology (Barrett's esophagus), VIM and CCNA1 methylation analysis, esophageal cells, algorithm reported as likelihood for Barrett's esophagus

Unlisted CPT codesCPT

81479

Unlisted molecular pathology procedure (used for BarreGEN)

Authorization, documentation, billing, and denial risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products. For unlisted CPT services (including 81479) or tests without a specific CPT, prior authorization must be obtained to determine the specific service rendered and whether it is covered or not medically necessary. Authorization for participating providers is obtained via the online tool. See Related Policies for PLA/MAAA medical necessity criteria that will be applied when a test is filed with an Unlisted CPT code.

Prior authorization required for Medicare Advantage Plans; recommended for Commercial Products
Unlisted CPT 81479 requires prior authorization to define the service and coverage status
Tests filed with an Unlisted CPT code will be reviewed using PLA and MAAA medical necessity criteria

Note

Check Member Benefits

Verify member-specific benefits and eligibility before ordering services. Benefits and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement; those documents supersede this medical policy. For member-specific questions, contact the provider call center.

Clinical background on Barrett esophagus and assays

Barrett esophagus (BE) is the replacement of normal esophageal squamous epithelium with intestinal-type columnar epithelium and is associated with gastroesophageal reflux disease and an increased risk of esophageal adenocarcinoma. Prevalence estimates and risk factors (including chronic GERD, male sex, central obesity, and age >50) underpin why screening and surveillance strategies have been developed. Adjunctive tests addressed in this policy — nonendoscopic sampling (e.g., EsoCheck/EsoGuard) and tissue-based molecular assays (e.g., TissueCypher, BarreGEN) — aim to detect BE or stratify progression risk, but the evidence evaluated did not demonstrate that use of these technologies improves long-term clinical outcomes compared with established endoscopic surveillance and management approaches.

Assay and test definitions

inv-18: EsoCheck / EsoGuard — nonendoscopic cell collection device (EsoCheck) and DNA methylation test (EsoGuard)

TestEsoCheck (nonendoscopic cell collection device) paired with EsoGuard (DNA methylation test)

PurposeIntended to collect esophageal surface cells without endoscopy and detect Barrett's esophagus and esophageal dysplasia via methylation analysis

Regulatory statusEsoCheck: FDA-cleared device (PMA approved May 31, 2019) with expanded indication in 2023 for ages 12 and older

CPT code0114U

Clinical roleAdjunct to standard screening and surveillance for BE; evidence cited includes observational and registry studies but lacks demonstrated improvement in net health outcome

inv-19: TissueCypher — tissue systems pathology assay analyzing formalin-fixed paraffin-embedded tissue with biomarkers and morphometrics

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAdjunctive Techniques for Screening, Surveillance, and Risk Classification of Barrett Esophagus and Esophageal Dysplasia

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 7, 2025

Next Review DateN/A

Key ActionObtain prior authorization via the online tool (ordering physician only) for Medicare Advantage members and check member-specific benefits before proceeding.

SourceLink

On This Page

Check member benefits and obtain any required prior authorization per the subscriber agreement
Member documents supersede this policy

Denial Risk

Denial Risk and Unauthorized Authorization Prohibited

If a service is determined to be not medically necessary or non‑covered, the service may be denied and the provider (or performing laboratory) may be financially responsible. Laboratories or third parties are not permitted to obtain authorization on behalf of the ordering physician; unauthorized third‑party authorization is a violation and may result in disciplinary action up to termination from the BCBSRI provider network. If a laboratory provides a laboratory service that has not been authorized, the service will be denied and may not be billed to the member.

Services determined not medically necessary or non‑covered may be denied and may result in provider billing consequences
Laboratories or third parties must not obtain or participate in obtaining authorization on behalf of the ordering physician; violations may lead to termination from the provider network
Unauthenticated/unauthorized laboratory services will be denied and may not be billed to the member

TestTissueCypher (tissue systems pathology assay)

PurposeAnalyzes formalin-fixed paraffin-embedded biopsy tissue using morphometrics and a panel of biomarkers to predict risk of progression to high-grade dysplasia or esophageal adenocarcinoma

CPT code0108U

Clinical validityReported sensitivity 29%–71% and specificity 79%–95% with hazard ratios 3.23–5.26; impact studies lack long-term outcome data

AvailabilityOffered as a proprietary/CLIA laboratory test (Castle BioSciences/Cernostics)

inv-20: BarreGEN — molecular test assessing mutational load / loss of heterozygosity at multiple loci to assess progression risk in BE

TestBarreGEN (molecular assay assessing mutational load and loss of heterozygosity)

PurposeAssesses cumulative derangement at multiple tumor suppressor gene loci (loss of heterozygosity / microsatellite instability) to estimate progression risk in Barrett's esophagus

CPT code81479 (Unlisted molecular pathology procedure) — commonly used for BarreGEN

Evidence summaryNo identified studies establishing clinical utility for predicting progression to high-grade dysplasia or cancer noted in policy

Regulatory/availabilityDescribed as a proprietary molecular test; laboratories offering such tests operate under CLIA regulations

inv-21: Nonendoscopic tests / sampling — tests such as EsoGuard/EsoCheck that collect esophageal cells without endoscopy to triage or screen for Barrett's esophagus

DefinitionNonendoscopic tests/sampling collect esophageal cells without endoscopy (e.g., EsoCheck device) for biomarker analysis (e.g., EsoGuard methylation assay)

Intended useTriage or screen individuals at increased risk for Barrett's esophagus and esophageal dysplasia as an adjunct to standard care

Performance notesDiagnostic accuracy studies report sensitivities ~85%–92.9% and specificities ~72.2%–85% in some studies, but clinical utility and long-term outcome benefit remain unproven

Regulatory noteDevice components (e.g., EsoCheck) may have FDA clearance; associated laboratory tests may be CLIA-developed assays

inv-22: Tissue-based risk assays — proprietary assays (e.g., TissueCypher, BarreGen) that analyze biopsy tissue for molecular markers to predict progression risk

DefinitionTissue-based risk assays are proprietary tests analyzing biopsy tissue for molecular markers and morphometric features to predict progression risk in Barrett's esophagus (examples: TissueCypher, BarreGEN)

Clinical intentProvide adjunctive risk stratification to guide surveillance or management decisions in patients with BE

Evidence considerationsClinical validity data exist for some assays (e.g., TissueCypher) but direct evidence of improved long-term health outcomes is insufficient; impact studies are limited

Coding and availabilityAssays are reported under specific CPT codes (e.g., 0108U for TissueCypher) or Unlisted code 81479 for tests without assigned CPT codes; offered as CLIA laboratory services