ModifiedCignaPolicy 0121

Fecal calprotectin testing for inflammatory bowel disease

Covers use of fecal calprotectin testing to distinguish IBS from IBD in chronic diarrhea and to manage inflammatory bowel disease for members of Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyFecal calprotectin testing for inflammatory bowel disease

Policy CodePolicy 0121

Change TypeRemoved statements on serological/genetic testing and therapeutic drug monitoring

Effective DateApr 15, 2025

Next Review DateMar 15, 2026

Key ActionDocument and bill fecal calprotectin (CPT 83993) only with an appropriate listed ICD-10 diagnosis and supported indication.

SourceLink

POLICY UPDATE CHANGES

Removed policy statements related to testing for serological and genetic markers for the diagnosis or management of IBD, and therapeutic drug monitoring for IBD.

Focused Review on 11/01/2024 reported no policy statement changes.

Annual Review on 3/15/2024 reported no policy statement changes.

2Medically necessary uses specified

83993CPT listed

≥250 μg/gCommon active disease threshold

2025-04-15Most recent review

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Serological/genetic & TDM

Coverage Criteria for Fecal Calprotectin Testing

Medically necessary indications

Fecal calprotectin is considered medically necessary when EITHER of the following criteria is met:

Indications: 1) For distinguishing irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD) in individuals with chronic diarrhea; 2) For the management of inflammatory bowel disease.

Fecal calprotectin for any other indication is not covered or reimbursable.

General medical necessity

Considered Medically Necessary when criteria in the applicable policy statements listed above are met:

General coverage statement: Fecal calprotectin (CPT 83993) is considered medically necessary when the applicable policy criteria (see 'Medically necessary indications' and the ICD-10 diagnosis list) are met.

Documentation should support use with an appropriate ICD-10 diagnosis from the policy list; claims without a covered diagnosis or procedure code will be denied.

Supported clinical contexts

Clinical contexts where FC testing is supported by evidence or guidelines:

Use to differentiate IBD vs IBS: Consider fecal calprotectin to help differentiate inflammatory bowel disease from irritable bowel syndrome (ACG: strong recommendation, moderate evidence).

ACG guideline: FC helpful to differentiate IBD from IBS (chunk 24).

Monitoring disease activity: Use fecal calprotectin as an adjunctive test to monitor IBD disease activity and to inform biomarker-guided escalation strategies (e.g., CALM tight-control algorithm combining FC and CRP to trigger stepwise therapy escalation).

CALM trial used FC ≥ 250 μg/g as a treatment-failure threshold in the tight control arm (chunks 18-19).

Postoperative recurrence surveillance: Use fecal calprotectin to assist in predicting postoperative endoscopic recurrence of Crohn's disease; study-derived optimal cut-offs (e.g., 62 μg/g) showed high sensitivity but variable specificity.

Verdejo et al. reported AUC 0.698 and optimal cut-off 62 μg/g with 85.7% sensitivity (chunk 20).

Fecal calprotectin is considered medically necessary when either of the following indications is met: (1) to distinguish irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD) in individuals with chronic diarrhea, or (2) for the management of inflammatory bowel disease. Fecal calprotectin for any other indication is not covered or reimbursable.

Diagnoses not listed in the policy’s ICD-10 code list are considered not covered or reimbursable. In other words, use of fecal calprotectin for indications associated with ICD-10 codes outside the listed codes will not be covered.

Policy statements related to testing for serological and genetic markers for the diagnosis or management of IBD, and statements regarding therapeutic drug monitoring for IBD, were removed as part of the Annual Review dated 4/15/2025. Providers should align documentation and testing requests with the current policy statements following this revision.

Use of fecal calprotectin for any indication other than the two specified medically necessary uses (distinguishing IBS from IBD in chronic diarrhea, or management of IBD) is considered not medically necessary / not covered and will not be reimbursed.

Use of fecal calprotectin when billed with diagnoses other than those listed in the policy’s ICD-10 code list is considered not covered / not reimbursable (i.e., all other ICD-10 codes).

Coding and Diagnostic Codes

Covered CPT Codes, Not Covered, Experimental, Presumptivemixed

No codes listed

Covered CPT CodesCPTCovered

83993

Calprotectin, fecal

Applicable ICD-10 CodesICD-10

K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with intestinal obstruction

1–10 of 84

1/9

Not Covered Diagnosis CodesICD-10Not Covered

All other codes

Not covered or reimbursable

Reported fecal calprotectin cutoffs — examples from studies

Example cutoffs reported (~115 μg/g)115 μg/g (Yamamoto et al. prospective study cutoff with 83% sensitivity, 81% specificity for predicting relapse)

Example cutoff (164 μg/g)164 μg/g (Chen et al. prospective UC cohort reported cutoff with sensitivity 85.4% and specificity 73.7%)

Example cutoff (221 μg/g)221 μg/g (optimal ROC cutoff in Brand et al./related study with sensitivity 66% and specificity 67%)

Common study threshold (≥250 μg/g)≥ 250 μg/g (used in multiple studies to indicate active IBD)

Reported value rangeAdditional reported values include ~154.5 μg/g and other study-specific thresholds within ~115–250 μg/g range

Provider Actions, Billing, and Denial Triggers

Denial Risk

Denial Triggers

Denial triggers: Claims for fecal calprotectin testing (CPT 83993) submitted without an eligible covered diagnosis from the policy's ICD-10 list (e.g., the listed Crohn's disease codes) or submitted for indications other than those specified (distinguishing IBS from IBD in chronic diarrhea or management of IBD) will be denied as not covered. Providers must ensure the submitted diagnosis code exactly matches a covered ICD-10 code in the policy; all other diagnosis codes are considered not covered or reimbursable.

Affected CPT: 83993 (Calprotectin, fecal)
Not covered when used for any indication other than: distinguishing IBS from IBD in chronic diarrhea, or management of IBD
Claims without a covered ICD-10 diagnosis from the policy list will be denied

Note

Removed Policy Statements (4/15/2025)

Policy statements related to serological and genetic marker testing and therapeutic drug monitoring for IBD were removed during the 4/15/2025 annual review. As a result, those services are no longer addressed as covered indications in this policy and claims for those specific tests should be evaluated against remaining policy statements and plan benefit language.

Background and Rationale

Inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, is characterized by chronic gastrointestinal inflammation that can overlap clinically with irritable bowel syndrome (IBS). Diagnosis of IBD relies on clinical evaluation with radiologic, endoscopic, and pathologic confirmation; fecal calprotectin is a stool biomarker that is more specific for luminal inflammation and can be useful to help distinguish IBD from IBS in patients with chronic diarrhea and as an adjunct to monitor disease activity for management of IBD. Note that policy revisions on 4/15/2025 removed prior statements about serological/genetic testing and therapeutic drug monitoring, so testing strategies should follow the current policy language and documented indications.

Definitions

Chronic diarrhea

DefinitionChronic diarrhea: three or more loose or watery stools daily lasting for four or more weeks.

Common causes (examples)IBS, inflammatory bowel disease, malabsorption syndromes (e.g., lactose intolerance, celiac disease), chronic infections.

Recommended action when inflammation suspectedWhen diarrhea is thought to be caused by inflammation, calprotectin testing is recommended; positive FC should prompt ileocolonoscopy and biopsy to confirm IBD.

Fecal calprotectin

DefinitionFecal calprotectin: a stool biomarker that increases with intestinal inflammation and is used to distinguish IBD from IBS and to monitor IBD disease activity.

Clinical role

Revision History and Policy Changes

Policy Summary

PayerCigna

PolicyFecal calprotectin testing for inflammatory bowel disease

Policy CodePolicy 0121

Change TypeRemoved statements on serological/genetic testing and therapeutic drug monitoring

Effective DateApr 15, 2025

Next Review DateMar 15, 2026

Key ActionDocument and bill fecal calprotectin (CPT 83993) only with an appropriate listed ICD-10 diagnosis and supported indication.

SourceLink

On This Page

Fecal calprotectin positivity thresholds

Common positivity threshold for active IBD≥ 250 μg/g is commonly used to indicate active IBD in multiple studies

Study-specific optimal cut-off (postoperative recurrence)62 μg/g (Verdejo et al. reported AUC 0.698 with 85.7% sensitivity for detecting any recurrence)

Clinical impact of positive thresholdFC ≥ 250 μg/g in observational studies often triggered treatment escalation and correlated with endoscopic activity

Prior authorization and coverage stance

Coverage follows benefit plan termsCoverage determinations follow the terms of the applicable benefit plan; benefit plan documents supersede policy language where conflicts exist.

Medically necessary indications (policy stance)Fecal calprotectin is considered medically necessary only to: 1) distinguish IBS from IBD in individuals with chronic diarrhea, or 2) for management of inflammatory bowel disease.

CPT 83993 medical necessityFecal calprotectin testing (CPT 83993) is listed as considered medically necessary when the policy criteria are met.

Prior authorization noteNo explicit prior authorization requirements are specified in these chunks; check the full policy and benefit plan for any code-level PA requirements.

Annual Review 4/15/2025: Removed policy statements for serological/genetic marker testing for diagnosis or management of IBD
Annual Review 4/15/2025: Removed policy statements for therapeutic drug monitoring for IBD
Providers should not rely on prior policy language for coverage of these removed services

Documentation Required

Billing and Documentation Requirements

Billing and documentation requirements: When billing, providers must use the most appropriate codes as of the date of submission and include documentation that supports medical necessity — e.g., clinical notes documenting chronic diarrhea with evaluation to distinguish IBS from IBD, or documentation supporting use for management of diagnosed IBD. Reimbursement is provided only if services are submitted in accordance with the policy's covered diagnosis and procedure codes.

Use CPT 83993 for fecal calprotectin testing when criteria are met
Include supporting clinical documentation and an eligible ICD-10 diagnosis from the policy list (see Crohn's disease codes e.g., K50.xx)
Ensure coding reflects the most current code set as of the claim submission date

Step Therapy

Biomarker-Guided Escalation

Biomarker-guided escalation: Clinical evidence (e.g., the CALM trial) supports using fecal calprotectin and CRP to guide stepwise escalation of therapy in Crohn's disease (tight control algorithms) which informed the policy's recognition of fecal calprotectin as medically necessary for IBD management. Providers using biomarker-guided treatment strategies should document biomarker results and how they were used to guide therapeutic decisions.

CALM trial: used fecal calprotectin ≥ 250 μg/g and CRP ≥ 5 mg/L among criteria to trigger escalation
Document serial biomarker values and corresponding treatment decisions when submitting for management-of-IBD indications

Note

Provider Reminders

Provider-facing reminders: Providers should be aware that removal of prior policy statements may affect coverage decisions for related tests; always verify current policy language and applicable plan benefits before ordering or billing. Claims for services not accompanied by covered diagnosis or procedure codes will be denied.

Verify policy and plan benefits after the 4/15/2025 annual review
Claims lacking covered codes will be denied as not covered

More specific for luminal inflammation than serologic markers; used as an adjunct to clinical assessment and endoscopy for diagnosis and monitoring.

Assay statusMultiple fecal calprotectin assays are FDA-listed/cleared and cited in the literature and regulatory references.

Positive fecal calprotectin

Common study definition of positive/active diseaseMany studies use ≥ 250 μg/g to indicate active IBD; positive FC of this magnitude is associated with endoscopic activity and often prompts treatment changes.

Alternative study thresholdsOther studies report lower optimal cut-offs for specific contexts (e.g., 62 μg/g for postoperative recurrence with high sensitivity but lower specificity).

Clinical implicationsPositive FC thresholds have been associated with subsequent treatment escalation and correlate with colonoscopy findings, but specificity varies across studies.

Tight control strategy (CALM trial)

DefinitionTight control strategy (CALM trial): a treatment algorithm combining clinical symptoms with biomarkers (fecal calprotectin and CRP) to trigger timely escalation of anti‑TNF therapy, resulting in improved endoscopic outcomes versus symptom-driven management.

Failure criteria usedIn CALM, failure criteria for tight control included fecal calprotectin ≥ 250 μg/g, CRP ≥ 5 mg/L, CDAI ≥ 150, or recent prednisone use.

Monitoring scheduleBiomarkers (FC and CRP) were assessed at weeks 11, 23, and 35 to guide stepwise adalimumab escalation at weeks 12, 24, and 36 if failure criteria were met.

Fecal calprotectin (additional definition entries)

Definition (alternate entry)Fecal calprotectin: a stool biomarker used to assess intestinal inflammation and assist in diagnosis and monitoring of IBD; multiple assays and guideline recommendations support its clinical use as an adjunct to endoscopy.

LimitationsNo fecal biomarker fully replaces endoscopy with biopsy; sensitivity and specificity vary by assay and clinical context.

Guideline contextProfessional guidelines (e.g., ECCO, ACG) recognize utility of FC for differentiating IBD from IBS and for monitoring, with graded recommendations.