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    v1.0.28
    OpenPayerPolicy UpdatesGastroenterologyBlue Cross Blue Shield SD fecal biomarker Coverage…
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    CurrentBlue Cross Blue Shield - South DakotaPolicy N/A

    Fecal Calprotectin and Lactoferrin Testing for Inflammatory Bowel Disease

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    Defines medical necessity and investigational uses for fecal calprotectin and fecal lactoferrin testing to diagnose, monitor activity, or predict relapse of inflammatory bowel disease (Crohn's disease and ulcerative colitis) for Wellmark/Blue Cross Blue Shield - South Dakota members.

    Policy Summary
    PayerBlue Cross Blue Shield - South Dakota
    PolicyFecal Calprotectin and Lactoferrin Testing for Inflammatory Bowel Disease
    Policy CodePolicy N/A
    Change TypeAnnual review
    Effective DateN/A
    Last ReviewFeb 1, 2025
    Next Review DateN/A
    Key ActionDocument clinical indication, assay cutoff used (e.g., 50 µg/g), and how results will influence decision to proceed to endoscopy.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    50 µg/gcommon FCP cutoff
    93-99%sensitivity at 50 µg/g
    73–100%NPV (adults, 50 µg/g)
    66.7%modeled reduction in colonoscopy
    83993listed CPT

    Coverage Criteria

    inv-01: Medically Necessary Indications

    Fecal calprotectin or lactoferrin testing is considered medically necessary when used to establish diagnosis, manage active disease, or detect relapse in individuals with inflammatory bowel disease (Crohn disease or ulcerative colitis):

    Diagnosis of suspected IBD: Fecal calprotectin or fecal lactoferrin is used to aid diagnosis in individuals with clinical suspicion of IBD to inform the decision to proceed to endoscopy with biopsy; a low/normal result may support deferring endoscopy and an elevated result supports further evaluation.calprotectin ~50 µg/g commonly used

    Supported by systematic reviews and diagnostic accuracy studies showing high sensitivity

    Monitoring active IBD: Fecal calprotectin or fecal lactoferrin is used to assess disease activity in individuals with established Crohn disease or ulcerative colitis and to inform need for endoscopy or treatment escalation.no single optimal cutoff; 50 µg/g often cited for triage

    Systematic reviews and some RCT data support use as part of monitoring though additional RCTs are needed

    Policy Summary
    PayerBlue Cross Blue Shield - South Dakota
    PolicyFecal Calprotectin and Lactoferrin Testing for Inflammatory Bowel Disease
    Policy CodePolicy N/A
    Change TypeAnnual review
    Effective DateN/A
    Last ReviewFeb 1, 2025
    Next Review DateN/A
    Key ActionDocument clinical indication, assay cutoff used (e.g., 50 µg/g), and how results will influence decision to proceed to endoscopy.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions and DocumentationDefinitions and Background
    Predicting relapse in remission: Fecal calprotectin or fecal lactoferrin is used to monitor patients in remission to identify rising levels that may precede clinical relapse and prompt earlier evaluation or management changes.no ideal cutoff identified

    Meta-analyses show moderate pooled sensitivity/specificity for relapse prediction but optimal thresholds vary

    inv-02: Investigational/Not Covered Uses

    Investigational when not meeting the medically necessary criteria:

    Other uses: Use of fecal calprotectin or fecal lactoferrin outside the contexts of diagnosing IBD, monitoring active disease, or monitoring for relapse (as defined in the medical necessity criteria) is investigational and not medically necessary.

    Evidence is insufficient to demonstrate improved net health outcomes when used outside the specified indications

    inv-03: Use to triage need for endoscopy

    Covered when ALL of the following are met:

    Intended population: Patient presents with signs or symptoms suspicious for IBD for whom endoscopy with biopsy is being considered; alternative causes (e.g., enteric infection) have been considered and there is no other independent indication for endoscopy such as rectal bleeding or cancer risk factors.

    Target population is those in whom endoscopy is being contemplated

    Test selection and documentation: Fecal calprotectin or fecal lactoferrin testing is ordered with documentation of the assay used and the cutoff applied; results are explicitly used to inform the decision to proceed to endoscopy (e.g., low result may avoid endoscopy; elevated result prompts endoscopic evaluation).50 µg/g commonly used; some labs use higher thresholds up to 250 µg/g

    FDA-labeled interpretive ranges (e.g., PhiCal: <50 normal, 50-120 indeterminate, >120 abnormal) may be referenced

    inv-04: Diagnostic use / monitoring

    Covered when the following clinical context applies:

    Context and purpose: Test is used to evaluate patients with suspected IBD (Crohn disease or ulcerative colitis) to inform need for endoscopy or to monitor disease activity in diagnosed IBD.50 μg/g commonly used

    Evidence supports high negative predictive value at 50 μg/g to help rule out IBD and reduce unnecessary endoscopy; direct RCT evidence on clinical outcomes is limited

    inv-05: Monitoring Active IBD

    Covered when ALL of the following are met

    Population: Patient has established Crohn disease or ulcerative colitis and is being evaluated for possible active disease.

    Relevant population for monitoring disease activity

    Intended use: Fecal calprotectin is used as part of disease monitoring to assess intestinal inflammation and to inform the need for endoscopy or treatment escalation.

    Should be integrated with symptoms and serum markers (CRP/ESR) and other clinical data

    Evidence considerations: Test performance shows pooled sensitivity ~88% and specificity ~73% with an optimal threshold often cited as 50 μg/g; imaging (MRE/ultrasound) may have superior specificity in some settings.50 μg/g often reported as optimal

    Cutoffs vary across studies and clinical settings

    inv-06: Monitoring for Relapse

    Covered when ALL of the following are met

    Population: Patient with Crohn disease or ulcerative colitis who is currently in clinical remission and is being monitored for potential relapse.

    Monitoring aims to detect biochemical changes that may precede clinical relapse

    inv-07: FC/Lactoferrin monitoring and relapse prediction

    Covered when evidence supports use to inform management decisions as an adjunct to clinical assessment and other monitoring methods:

    General use: Fecal calprotectin or lactoferrin is used as an adjunct to clinical assessment and standard monitoring (symptoms, ESR/CRP, CBC) or when endoscopy is not immediately indicated.

    Studies show moderate sensitivity/specificity for predicting relapse but thresholds vary

    inv-08: Contexts with inferred clinical utility

    Covered when ALL of the following are met

    Suspected IBD to decide on endoscopy: Fecal calprotectin or lactoferrin testing is used in individuals with suspected IBD when endoscopy with biopsy is being considered to help decide whether to refer for endoscopy; a negative result can be used to exclude IBD and avoid endoscopy in appropriate pre-test probability contexts.manufacturer/guideline cutoffs (e.g., ~50 μg/g; AGA context: 150 μg/g for some decisions)

    Clinical input and guidelines support this use, particularly in pediatric populations

    Monitoring diagnosed IBD: Fecal calprotectin may be used to monitor disease activity and guide therapeutic decision-making in patients with diagnosed IBD, including prediction of relapse while in remission.context-dependent thresholds (e.g., <150 μg/g to rule out active inflammation; >150 μg/g to suggest active inflammation per some guidelines)

    Indirect evidence supports clinical usefulness though high-quality RCTs are limited

    inv-09: Uncertain clinical utility

    Not clearly supported / investigational:

    Management-changing use without evidence: Routine use of fecal lactoferrin or fecal calprotectin to change management when there is no evidence that such changes improve patient outcomes is considered investigational or of uncertain utility.N/A

    Policy highlights need for randomized trials demonstrating outcome benefit

    inv-10: Society recommendations for biomarker use

    Professional society recommendations and monitoring thresholds:

    AGA biomarker-guided statements: AGA guidance: in UC and CD, fecal calprotectin thresholds (commonly >150 µg/g) and CRP values (e.g., >5 mg/L) are used in conditional recommendations to inform whether to perform endoscopic assessment or consider treatment adjustment; AGA also suggests fecal calprotectin <50 µg/g may be used to avoid endoscopy within 12 months postoperatively in low-risk patients.examples: <50 µg/g to avoid postoperative endoscopy; >150 µg/g to suggest active inflammation

    Recommendations are conditional with low-to-moderate certainty

    ECCO-ESGAR and STRIDE-II: ECCO-ESGAR: use fecal calprotectin with clinical parameters and endoscopy for response assessment; STRIDE-II: normalization of fecal calprotectin to ~100-250 mg/g is an intermediate target and lack of target achievement should prompt consideration of therapy change.STRIDE-II: 100-250 mg/g intermediate target

    Consensus-based targets; lower thresholds may be used for deeper healing

    NICE and ACG positions: NICE recommends fecal calprotectin as an option to support differential diagnosis of IBD vs IBS in adults and children (when cancer not suspected); ACG endorses fecal calprotectin to help differentiate IBD from IBS and recognizes an adjunctive role in monitoring disease activity.varies by guideline; many cite ~50 µg/g for diagnosis/triage

    Guideline statements support appropriate clinical use

    inv-11: FCP-guided endoscopy triage

    Use of FCP to guide need for endoscopy is supported when the following clinical logic is applied:

    Primary clinical logic: Fecal calprotectin testing is used as a triage tool to identify patients likely to have intestinal inflammation who should proceed to endoscopy (elevated FCP) and to identify patients at low risk where endoscopy may be deferred (normal FCP).See thresholds module (commonly ~50 µg/g for triage)

    Evidence and clinical input indicate FCP adds diagnostic value to symptoms and blood markers

    Clinical exceptions: Patients with acute or bloody diarrhea, older patients where cancer/polyps must be excluded, or those with other red-flag features (iron deficiency, overt GI bleeding, unexplained weight loss, strong family history) should proceed to endoscopy regardless of FCP result.

    Do not rely on negative FCP alone to rule out need for endoscopy in these contexts

    inv-12: Initial diagnostic testing with FCP

    Covered when ALL of the following are met

    Test performance: When using commonly referenced cutoffs (e.g., ~50 µg/g), pooled sensitivity and specificity are high and negative predictive value can be sufficient to avoid endoscopy in many patients.cutoff ~50 µg/g

    Performance varies by prevalence and cutoff; studies report pooled sensitivity ~93% and high NPV in some cohorts

    Clinical context exceptions: Even with negative FCP, proceed to endoscopy in patients with clinical or laboratory features suggesting alternative indications (e.g., iron deficiency, overt bleeding, unexplained weight loss, suspicion for isolated ileal Crohn's), family history of IBD, or other cancer risk factors.clinical features as listed

    Negative FCP should not replace endoscopy when red-flag features exist

    inv-13: Monitoring disease activity

    Covered when ALL of the following are met

    Disease monitoring: Fecal calprotectin can be used as a noninvasive marker to monitor mucosal healing and disease activity as part of a composite assessment including clinical scores and serum markers (e.g., CRP); serial trending is recommended rather than isolated measurements.serial trending preferred

    Particularly useful in pediatric patients and those with colonic disease to reduce invasive procedures

    Elevated fecal calprotectin or fecal lactoferrin are markers of neutrophil-associated mucosal inflammation but are not specific to inflammatory bowel disease (IBD). Levels can be increased with other causes of mucosal inflammation — for example, gastrointestinal infection, colorectal polyps or cancer — and can be affected by medications (eg, NSAIDs, proton pump inhibitors), age, diet, and exercise. Interpret test results in the clinical context and consider alternative causes of elevation before attributing findings to IBD.

    Fecal calprotectin or lactoferrin should not be used to avoid endoscopy in patients who have other independent indications for colonoscopy. Examples include rectal bleeding, iron deficiency, unexplained weight loss, or age- or family-related cancer risk factors. Use of fecal biomarkers to triage endoscopy applies only when endoscopy with biopsy is being considered to evaluate suspected IBD and alternative causes of symptoms have been evaluated.

    There are no randomized controlled trials that evaluate fecal calprotectin testing specifically for diagnosing suspected IBD. While diagnostic accuracy studies and systematic reviews support high sensitivity and negative predictive value at commonly used thresholds, randomized trial evidence demonstrating improved patient outcomes from using FCP for initial diagnosis is lacking.

    Home-based fecal calprotectin tests evaluated in some trials (for example, the Östlund study) used devices not available in the United States, limiting applicability of those trial results to US clinical practice. Low adherence to home-testing in the reported RCT (about 29%) further reduces generalizability for routine implementation.

    For predicting recurrence in patients with IBD in remission, pooled analyses show moderate performance for fecal calprotectin (pooled sensitivity ~0.72, specificity ~0.73), but radiologic modalities such as magnetic resonance enterography (MRE) and ultrasound have performed better in some reviews. FCP should not be used to replace imaging when cross-sectional assessment is indicated.

    Some clinical input and guideline reviews characterize the use of fecal calprotectin or lactoferrin for management decisions as investigational or of uncertain utility when results do not clearly lead to a defined management change. Manufacturer cutoffs and test characteristics are referenced in guidance, but clinicians noted the need for higher-quality trials to confirm clinical benefit when tests are used to guide therapy.

    The American Gastroenterological Association (AGA) did not make a recommendation in favor of, or against, a biomarker-based monitoring strategy over an endoscopy-based monitoring strategy to improve long-term outcomes in Crohn disease, citing a knowledge gap and conditional recommendations.

    Do not rely on fecal calprotectin to exclude the need for endoscopy in patients presenting with acute or bloody diarrhea, or in older patients where ruling out polyps or colorectal cancer mandates colonoscopy. In these clinical situations, colonoscopic evaluation should proceed regardless of biomarker results.

    A negative fecal calprotectin result alone should not be used to rule out IBD when other red‑flag indications for endoscopy are present — for example iron deficiency anemia, overt gastrointestinal bleeding, or unexplained weight loss. Documented clinical concerns should override a negative biomarker when deciding on endoscopic evaluation.

    Fecal calprotectin or lactoferrin testing performed outside the described diagnostic or monitoring contexts — that is, when criteria for diagnosis, active disease management, or relapse monitoring are not met — is considered investigational and may be denied. Ensure testing aligns with the policy's medical necessity criteria before ordering.

    Use of fecal calprotectin or lactoferrin without documentation of suspected IBD or outside the intended diagnostic context (for example, routine screening in populations not described by the criteria) is not supported. Orders should document clinical indication and prior evaluation steps to justify testing.

    Direct evidence that fecal calprotectin testing improves health outcomes (from randomized trials showing better clinical outcomes versus usual care) is not available in the diagnostic context; RCT evidence for outcome benefit is lacking in the excerpts reviewed.

    Clinical utility of fecal calprotectin testing for monitoring active IBD has not been definitively established. A chain of evidence linking test performance to improved patient outcomes is incomplete because consistent RCT data demonstrating reduced relapse or improved quality of life are limited.

    Routine escalation of medication based solely on fecal calprotectin (eg, FC‑guided medication escalation to prevent relapse) is not proven to reduce relapse rates in primary analyses of available RCTs. When FCP is used to change therapy, thresholds and treatment algorithms should be predefined and clinicians should recognize limited trial evidence supporting outcome benefit.

    Routine use of fecal lactoferrin or calprotectin for management when there is no pre-specified plan to change management based on results is considered not medically necessary or of uncertain utility. Tests should be ordered when results will directly inform a documented management decision.

    Fecal calprotectin should not be used as a substitute for endoscopy in patients with red‑flag features or a very high pre-test probability of disease. In such patients, endoscopic evaluation with biopsy remains the reference standard and should not be deferred solely based on biomarker results.

    Using fecal calprotectin to rule out disease when the pre-test probability is very high (for example, ≥85% in adults or ≥78% in children) may be inappropriate and cost-ineffective; screening strategies are most useful when pre-test probability is below the stated thresholds.

    Coding

    Regulatory/Product codesmixed
    NXOFDA product code for calprotectin tests (as referenced)
    Covered CPT Codes - LaboratoryCPTCovered
    83630Lactoferrin, fecal; qualitative
    83631Lactoferrin, fecal; quantitative
    83993Calprotectin, fecal
    HCPCSHCPCS
    No code(s)HCPCS: No codes listed
    Fecal calprotectin cutoff
    Cutoff value< 50 µg/g suggests low likelihood of IBD
    Commonly used threshold50 µg/g commonly used as normal/abnormal cutoff for adults and children >4 years
    Age considerationsHigher physiologic values in neonates/infants; moderate increases up to 100 µg/g in individuals >65 years
    Fecal lactoferrin threshold
    Recommended range4.0–7.25 mg/g recommended to optimize sensitivity
    Performance notePooled fecal lactoferrin sensitivity ~0.82 and specificity ~0.95 (area under SROC 0.95)
    InterpretationElevated FL prompts further evaluation for IBD or infection; low/undetectable suggests symptoms unlikely due to inflammation
    Fecal calprotectin cutoff (clinical/lab notes)
    Common cutoff50 µg/g commonly used for adults and children >4 years
    Laboratory-specific rangesFDA-cleared PhiCal interpretive ranges: <50 µg/g normal; 50–120 µg/g indeterminate; >120 µg/g abnormal; some labs use upper thresholds up to 250 µg/g
    Stability/sampleCalprotectin is stable in feces at room temperature for up to one week; small stool sample sufficient
    Fecal lactoferrin baseline cutoff
    Baseline cutoff<7.25 μg/g considered low/undetectable for fecal lactoferrin
    Test formatsFL can be reported qualitatively or quantitatively using ELISA-based assays
    Clinical implicationUndetectable/low FL suggests symptoms unlikely due to neutrophilic intestinal inflammation
    Fecal calprotectin threshold
    Representative threshold50 μg/g frequently cited as an optimal/representative threshold
    Evidence summarySystematic reviews/meta-analyses identify 50 μg/g as optimal threshold for assessing disease activity
    Use in triageAt 50 μg/g, fecal calprotectin used to triage need for endoscopy given high sensitivity
    Fecal calprotectin thresholds discussed
    Range across studiesCutoffs reported across studies range from 6 to 280 μg/g
    Common optimal threshold50 μg/g reported as optimal in multiple reviews/meta-analyses
    Tight-control/clinical trial thresholdsTight-control threshold referenced ≥250 μg/g in CALM study; one monitoring RCT used escalation at ≥300 μg/g and reduction when <200 μg/g
    Fecal calprotectin thresholds seen in studies
    Meta-analysis optimal cut-offOptimal cut-off for predicting relapse identified ~152 µg/g (Shi et al meta-analysis)
    Monitoring RCT triggersOne RCT used escalation when FC ≥300 µg/g and de-escalation when <200 µg/g
    Predictive performanceProspective studies pooled show sensitivity ~0.72 and specificity ~0.74 for predicting relapse
    Common fecal calprotectin thresholds
    Common clinical thresholds50 μg/g commonly cited by manufacturers/clinicians; 150 μg/g cited by AGA to help rule in/out active inflammation
    CRP concordanceAGA references combined thresholds (e.g., fecal calprotectin and CRP) to guide decisions; CRP threshold cited as 5 mg/L
    Postoperative guidanceAGA suggests fecal calprotectin <50 μg/g to avoid endoscopy in selected asymptomatic postoperative CD patients within 12 months

    Provider Actions and Documentation

    Prior Authorization

    Prior Approval

    Prior approval — No prior approval is applicable for fecal calprotectin or lactoferrin testing per this document.

    Prior Authorization

    Prior Authorization Note

    Prior authorization not specified in provided sections — The policy text and supporting sections do not list explicit prior authorization codes or a formal prior authorization requirement for fecal calprotectin or lactoferrin testing. Laboratories and ordering providers should note, however, that payers may require documentation of medical necessity on claim submission; when testing is used to substitute for or to determine need for endoscopy, confirm payer-specific prior authorization policies for endoscopy or biomarker-guided procedures.

    Documentation Required

    Justify Testing vs Endoscopy and Standard Monitoring

    Justify testing relative to endoscopy and standard monitoring — When fecal calprotectin or lactoferrin testing is used to triage need for endoscopy or as an alternative to repeat endoscopy for monitoring, providers should document how the test result will influence management compared with standard monitoring (symptoms, ESR/CRP, CBC) and whether endoscopy with biopsy would otherwise be planned.

    Prior Authorization

    Prior Authorization for Biomarker-Guided Endoscopy

    Prior authorization for biomarker-guided endoscopy decisions — If fecal biomarker results (FCP or lactoferrin) are being used to determine whether an endoscopy with biopsy will be performed (either to defer or to trigger endoscopy), providers and laboratories should verify whether a payer requires prior authorization for the endoscopic procedure based on biomarker-directed decision-making and submit the clinical rationale accordingly.

    Prior Authorization

    Prior Authorization Considerations

    Prior authorization considerations — The policy emphasizes that use of fecal calprotectin to triage endoscopy may reduce procedures but does not itself specify payer authorization rules. Providers should ensure documentation is available to support medical necessity and check member-specific benefit terms for any prior authorization, step-therapy, or other utilization management requirements.

    Note

    FCP to Triage Endoscopy

    FCP testing to triage endoscopy — Fecal calprotectin testing is intended to inform the decision whether to proceed to endoscopy with biopsy in individuals with suspected IBD. A negative FCP (using the laboratory's stated cutoff) in an appropriate pre-test probability setting may support avoiding or deferring endoscopy; an elevated FCP can justify referral for endoscopy.

    Denial Risk

    Investigational Use and Denial Risk

    Investigational use may lead to denial — Use of fecal calprotectin or lactoferrin testing outside the medically necessary indications described (for example, when not used to diagnose or manage IBD) may be considered investigational and could be denied. Tests performed without appropriate clinical context or without meeting policy criteria are at risk for noncoverage.

    Documentation Required

    Appropriate Clinical Context

    Appropriate clinical context required — Testing is intended for patients in whom endoscopy with biopsy is being considered to evaluate suspected IBD, or for monitoring disease activity in patients with established Crohn's disease or ulcerative colitis. Alternative causes of symptoms should be reasonably excluded and other indications for endoscopy (eg, rectal bleeding, iron deficiency, alarm features, cancer risk) must be considered.

    Note

    Other Provider Actions

    None specified in this excerpt — The source excerpt does not present additional provider actions or step-therapy rules beyond those summarized here.

    Documentation Required

    Reference-Standard Validation

    Documentation linked to reference-standard validation — Studies included in the evidence review required a suitable reference standard (endoscopy with biopsy). Providers should document that testing and clinical decision-making align with reference-standard expectations used in validation studies.

    Documentation Required

    Reference Standard (Endoscopy) Expectations

    Reference standard expectations — Endoscopy with biopsy is the reference standard for diagnosing and monitoring IBD. Reliance solely on fecal biomarkers without appropriate clinical correlation and consideration of the reference standard may be inadequate.

    Denial Risk

    Situations Where Endoscopy Is Required

    Situations where endoscopy remains required — Endoscopy with biopsy remains required in scenarios where colonoscopy is indicated regardless of FCP (eg, acute bloody diarrhea, overt gastrointestinal bleeding, iron deficiency, unexplained weight loss, or older age with cancer risk). A negative fecal biomarker does not obviate endoscopy when other indications exist.

    Denial Risk

    Indications Requiring Endoscopy Despite Negative FCP

    Indications that still require endoscopy despite negative FCP — Patients with alarm features (iron deficiency anemia, overt bleeding, unexplained weight loss), high pre-test probability, or risk factors for neoplasia should undergo endoscopic evaluation even if fecal calprotectin or lactoferrin is negative.

    Documentation Required

    Required Clinical Documentation

    Required clinical documentation — Providers should include documentation supporting the diagnostic evaluation: clinical indication (suspected IBD vs monitoring), presenting symptoms, pre-test probability assessment, results of prior testing (stool pathogen testing, CBC, ESR/CRP), imaging or prior endoscopic findings, and how FCP/lactoferrin results will be used to influence management.

    Documentation Required

    Test Result and Assay Documentation

    Required documentation — Document the fecal calprotectin or lactoferrin result with the assay method and the laboratory cutoff used (eg, many labs use 50 µg/g; some use higher thresholds up to 250 µg/g), the clinical indication (suspected IBD vs monitoring), and whether endoscopy with biopsy is being considered or deferred.

    Documentation Required

    Fecal Calprotectin Result Reporting

    Documentation should include fecal calprotectin result — Record the numeric fecal calprotectin value, the laboratory-specific threshold used to categorize results (normal/indeterminate/abnormal), and any plan for repeat testing or follow-up if results are indeterminate.

    Documentation Required

    Clinical Context for Monitoring

    Required clinical context — For monitoring, document that the patient has established Crohn's disease or ulcerative colitis, disease status (remission vs active), and concurrent use of standard monitoring measures (symptom assessment, ESR/CRP, CBC).

    Documentation Required

    Documentation Elements

    Required documentation elements — Include patient selection criteria, prior or concurrent test results, rationale for testing instead of immediate endoscopy (if applicable), and how results will change management (eg, defer endoscopy, escalate therapy, obtain endoscopy).

    Documentation Required

    Clinical Indication on Record

    Document clinical indication (suspected IBD vs monitoring) — Specify whether the test is ordered to evaluate new-onset symptoms where endoscopy is being considered or to monitor disease activity/relapse risk in diagnosed IBD.

    Documentation Required

    Clinical Rationale

    Clinical rationale — Provide a concise clinical rationale for testing (eg, to exclude IBD in a patient with chronic diarrhea and low pre-test probability, to guide need for endoscopy, or to monitor for relapse in a patient in remission) and cite supporting clinical findings and prior tests.

    Documentation Required

    Document How FCP Informs Decisions

    Document clinical use of FCP in decision-making — Explicitly state how the fecal biomarker result will be used (eg, negative result will defer endoscopy; elevated result will prompt endoscopic evaluation; result will guide medication escalation or surveillance interval).

    Documentation Required

    Recommended Documentation to Support Decisions

    Recommended clinical documentation to support decision-making — Recommended items include pre-test probability assessment, presenting symptoms, family history of IBD, prior inflammatory markers (CRP/ESR), prior imaging or endoscopy reports, numeric fecal biomarker values with lab cutoffs, and planned management actions contingent on results.

    Note

    Place in Diagnostic Workup

    Place in diagnostic workup — Clinical workup typically includes stool pathogen testing and blood tests; fecal calprotectin/lactoferrin are noninvasive adjuncts used to triage patients for endoscopy and to monitor disease activity alongside standard measures.

    Step Therapy

    Step Therapy

    No step therapy requirements specified — The provided sections do not describe any step therapy requirements for fecal calprotectin or lactoferrin testing.

    Documentation Required

    Use With Standard Monitoring

    Use with standard monitoring — When used for monitoring, providers should document concurrent assessment with symptoms and blood inflammatory markers (CRP/ESR) and indicate whether biomarker results prompted endoscopy or treatment changes.

    Documentation Required

    Integration With Other Markers

    Consider integrating fecal calprotectin — Consider integrating fecal calprotectin (and/or lactoferrin) results with blood inflammatory markers (CRP), clinical assessment, and imaging/endoscopy findings before changing therapy or deferring/scheduling endoscopy.

    Note

    Other

    None specified — No additional provider actions are specified in the excerpt beyond documentation, appropriate clinical use, and verification of payer authorization requirements where applicable.

    Definitions and Background