CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Laboratory Testing for the Diagnosis of Inflammatory Bowel Disease

This policy governs coverage for laboratory tests used in the diagnosis and monitoring of inflammatory bowel disease (IBD), including serologic markers and proprietary algorithm‑based tests, for BlueCross BlueShield of Tennessee members.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyLaboratory Testing for the Diagnosis of Inflammatory Bowel Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not order serologic marker or proprietary algorithm‑based tests for IBD diagnosis or monitoring when seeking coverage, as these do not meet coverage criteria and may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Not covered categories

~20References

>=81401Codes referenced

14+Guideline/research citations

2024Vendor reference year

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Coverage Criteria

inv-01: Not Medically Necessary / Not Covered

The following testing does not meet coverage criteria due to insufficient evidence:

Not Covered Tests: 1) Serologic markers for workup and monitoring of inflammatory bowel disease (examples include ANCA, pANCA, ASCA, antibody to E. coli outer membrane porin C, anti‑CBir1 flagellin antibody, antibody to Pseudomonas fluorescens‑associated sequence I2, antichitobioside, antilaminaribioside, antimannobioside antibodies, pyruvate kinase M2) DO NOT MEET COVERAGE CRITERIA.

Not Covered Tests: 2) Diagnostic algorithm‑based testing for diagnosis or monitoring of IBD (examples include ibs‑smart™, PredictSURE IBD™ Test, Prometheus® testing) DO NOT MEET COVERAGE CRITERIA.

The policy explicitly states that certain laboratory approaches for inflammatory bowel disease (IBD) do not meet coverage criteria because there is insufficient published evidence that they are required and beneficial for diagnosis or treatment. Specifically, the policy excludes (1) use of serologic markers for the workup and monitoring of IBD and (2) use of diagnostic algorithm‑based proprietary tests for diagnosis or monitoring of IBD. These exclusions apply to the named examples and comparable tests.

The policy references peer‑reviewed literature that highlights variable diagnostic precision for serologic assays. Cited studies (for example, investigations of ASCA and pANCA) and critical appraisals of vendor panels note limitations in sensitivity, specificity, and the potential that a panel’s reported predictive value may be driven largely by only a few components rather than the whole algorithm.

Consistent with the summarized evidence, the policy declares that the listed serologic markers (e.g., ANCA, ASCA, anti‑CBir1, antichitobioside/antilaminaribioside/antimannobioside antibodies, PKM2) and diagnostic algorithm‑based tests (e.g., ibs‑smart™, PredictSURE IBD™, Prometheus® testing) do not meet coverage criteria for diagnosis or monitoring of IBD.

The policy bibliography includes citations that question the diagnostic precision and incremental value of some serologic panels. Examples cited include studies assessing the diagnostic accuracy of ASCA and pANCA and a commentary suggesting that the predictive performance of a Prometheus IBD panel may be attributable primarily to a few inexpensive, widely available components rather than the proprietary algorithm.

inv-21: Diagnosis and differentiation of IBD using serologic and biomarker panels — supporting evidence

Serologic and combined biomarker panels have been evaluated for differentiating Crohn disease, ulcerative colitis, and non‑IBD (including IBS); the policy cites published studies and vendor materials but does not find sufficient evidence to support coverage of these tests for routine diagnosis or monitoring.

Evidence and Guidance: Published studies and reviews (examples cited) have examined combined serologic, genetic, and inflammatory marker panels for distinguishing non‑IBD, Crohn disease, and ulcerative colitis (e.g., Plevy et al. 2013) and evaluated traditional serologic markers such as pANCA, ASCA, and APA (e.g., Sandborn et al. 2000).

Policy Conclusion: Despite cited studies and vendor test materials (Prometheus IBD sgi Diagnostic, Monitr Crohn's, PredictrPK IFX), diagnostic algorithm‑based and serologic marker testing for diagnosis or monitoring of IBD DO NOT MEET COVERAGE CRITERIA due to lack of sufficient published evidence of clinical utility.

Critical Appraisal: Critiques in the literature note limitations in diagnostic precision and incremental value for some panels (for example, concerns that predictive value of some commercial panels may be driven by a few components), indicating variable performance across studies.

Coding

Procedure / Test Codesmixed

81401	Molecular pathology procedure, Level 2
81479	Unlisted molecular pathology procedure
82397	Chemiluminescent assay
83516	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method
83520	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified
86021	Antibody identification; leukocyte antibodies
86036	Antineutrophil cytoplasmic antibody (ANCA); screen, each antibody
86037	Antineutrophil cytoplasmic antibody (ANCA); titer, each antibody
86255	Fluorescent noninfectious agent antibody; screen, each antibody
86671	Antibody; fungus, not elsewhere specified

1–10 of 13

1/2

Proprietary Test CodesHCPCS

0176U	Cytolethal distending toxin B (CdtB) and vinculin IgG antibodies by immunoassay (ie, ELISA) — IBSchek®
0203U	Autoimmune (inflammatory bowel disease), mRNA, gene expression profiling by quantitative RT-PCR, 17 genes (15 target and 2 reference genes) — PredictSURE IBD™ Test

Provider Actions and Billing Considerations

Prior Authorization

Prior Authorization Not Specified

Prior authorization is not specified in this section. There are no explicit prior authorization requirements detailed for the tests or services described in this policy excerpt; providers should follow any payer-specific PA processes if present elsewhere in member benefits or insurer portals.

Denial Risk

Denial Risk — Algorithm-Based / Proprietary Tests

Proprietary or algorithm-based diagnostic tests (for example, ibs-smart™, PredictSURE IBD™, Prometheus® testing) are identified in the policy as not meeting coverage criteria for diagnosis or monitoring of IBD. Use of these algorithm-based or proprietary diagnostics carries a denial risk when submitted for coverage for diagnosis or monitoring purposes.

Examples: ibs-smart™, PredictSURE IBD™, Prometheus® testing

Not Covered

For the workup and monitoring of individuals with IBD, use of serologic markers such as anti‑neutrophil cytoplasmic antibody (ANCA/pANCA), anti‑Saccharomyces cerevisiae antibody (ASCA), anti‑CBir1 flagellin antibody, antibodies to E. coli outer membrane porin C, I2, antichitobioside/antilaminaribioside/antimannobioside antibodies, and pyruvate kinase M2 (PKM2) is listed as not meeting coverage criteria and therefore may be denied if submitted for these indications.

Some reference sections do not enumerate a separate list of explicitly not‑covered tests but instead include literature that highlights limitations in serologic testing precision. Those citations are provided to support the policy’s overall conclusion about the lack of sufficient evidence for routine clinical use of these panels.

Ordering Requirements

Note

Ordering requirements not specified

The policy excerpt does not specify who is authorized to order the tests (e.g., primary care clinicians vs specialists).

Covered Indications

inv-21: Supporting studies and guidelines for serologic and biomarker panels

Summary of cited studies, vendor materials, and critical appraisals referenced in the policy relevant to serologic and algorithm‑based testing for IBD:

Primary study evidence: Plevy et al. (2013) evaluated combined serological, genetic, and inflammatory markers to differentiate non‑IBD, Crohn disease, and ulcerative colitis.

Traditional serologic marker studies: Sandborn et al. (2000) assessed pANCA, ASCA, and APA performance as serologic markers in a population‑based cohort of patients with CD and UC.

Comparative marker performance: Schoepfer et al. (2008) compared fecal markers, blood leukocytes, CRP, and IBD antibodies for discriminating IBD from IBS.

Critical commentary:

Frequency Limits

Frequency limits

Frequency limitsNo frequency limits specified in this section

Period specifiedNot stated

Per‑test restrictionsNone listed

Definitions

Ulcerative colitis (UC) — definition

DefinitionUlcerative colitis (UC): chronic relapsing and remitting mucosal inflammation of the colon beginning at the rectum and may extend proximally in a continuous fashion.

Pathologic layerLimited to the mucosal layer of the colon

DistributionBegins at the rectum and can extend proximally in a continuous manner

Crohn's disease (CD) — definition

DefinitionCrohn's disease (CD): patchy transmural inflammation (skip lesions) of the gastrointestinal tract that can result in sinus tracts, microperforations, fistulae, fibrosis and strictures.

Pathologic depthTransmural inflammation (involves full thickness of the bowel wall)