CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Fecal Calprotectin Testing

Policy governing coverage and medical necessity of fecal calprotectin testing for evaluation and management of suspected or established inflammatory bowel disease (IBD) for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyFecal Calprotectin Testing

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionNo prior authorization is required for fecal calprotectin testing; verify member benefits for coverage specifics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

83993CPT code listed as medically necessary

50 μg/gDiagnostic threshold

93%-99%Sensitivity at ~50 μg/g

66.7%Estimated colonoscopy reduction

27References cited

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Evaluation to distinguish IBD vs non-IBD when endoscopy is being considered

Covered when ALL of the following are met

Indication: Fecal calprotectin testing is medically necessary for the evaluation of patients when the differential diagnosis includes inflammatory bowel disease versus noninflammatory bowel disease (including irritable bowel syndrome) and endoscopy with biopsy is being considered.50 μg/g (commonly used cutoff in diagnostic studies)

Applies to Medicare Advantage and Commercial products; test can inform decision whether to proceed with endoscopy by identifying patients unlikely to have IBD.

Not covered / not medically necessary - Management of established IBD

Exclusion: Fecal calprotectin testing is considered not covered or not medically necessary for the management of established inflammatory bowel disease, including monitoring active disease and surveillance for relapse in remission, because the evidence is insufficient to demonstrate improved health outcomes.

Applies to both Medicare Advantage and Commercial products.

Fecal calprotectin testing is not covered / not medically necessary when used for the management of established inflammatory bowel disease (IBD), including the monitoring of active disease and surveillance for relapse during remission. The policy determination is that evidence is insufficient to demonstrate that fecal calprotectin testing in these management contexts improves health outcomes.

Coverage and payment determinations are governed by the member's subscriber agreement or employer agreement. This medical policy is provided for informational purposes and is not a guarantee of payment; for member-specific benefits or prior authorization requirements, contact the provider call center or refer to the member's benefit documents.

Using fecal calprotectin to guide treatment decisions in patients with active IBD or to predict relapse during remission is considered not medically necessary because current evidence does not demonstrate improved net health outcomes. Systematic reviews and randomized trials have not established that management changes driven by calprotectin measurements reliably reduce relapse rates or improve clinical outcomes.

Coding and Diagnostic Thresholds

Medically necessary CPT codeCPTCovered

83993

Calprotectin, fecal

ICD-10 Diagnosis Codes that may support medical necessityICD-10

K52.3
K52.89
K52.9
K58.0
K58.1
K58.2
K58.3
K58.4
K58.5
K58.6

1–10 of 17

1/2

Fecal calprotectin diagnostic threshold for triage — 50 μg/g

Diagnostic threshold for triage50 μg/g

Clinical application at this thresholdUsed to triage patients for endoscopy when IBD is suspected vs noninflammatory conditions

Reported test performance at ~50 μg/gSensitivity for IBD: 93%–99%; negative predictive value: 73%–100%

Impact on colonoscopy useIncorporation into diagnostic work-up estimated to reduce need for colonoscopy by 66.7%

Actions for Providers and Billing

Note

Prior Authorization

No prior authorization is applicable for fecal calprotectin testing.

Denial Risk

Denial risk for IBD management indications

Fecal calprotectin testing is considered not medically necessary for the management of inflammatory bowel disease, including management of active IBD and surveillance for relapse in remission. Claims for testing performed for IBD management indications may be denied or determined not payable.

Affected CPT: 83993

Billing Rule

Potential denial/charge risk

Services determined to be not medically necessary or non-covered under a member's benefits may not be charged to the member unless the member was informed and provided written agreement to pay in advance. Refer to your provider participation agreement for applicable provisions.

Note

Benefits & eligibility

Benefits and eligibility are determined by the member's subscriber agreement, Evidence of Coverage, or employer agreement and will supersede this policy. For member-specific coverage information, contact the provider call center.

Note

Benefit variability notice

Benefit coverage for laboratory services may vary between groups and contracts. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for specific laboratory coverage details.

Billing Rule

Required coding linkage

CPT 83993 (Calprotectin, fecal) should be supported by an appropriate ICD-10 diagnosis code from the listed set when billing to indicate medical necessity.

Required CPT: 83993
See supported ICD-10 diagnosis codes: K52.3; K52.89; K52.9; K58.0 - K58.9; R19.4; R19.5; R19.7; R19.8

Note

Verify coverage and authorization

Benefits are determined by subscriber/employer agreements; this policy is informational and is not a guarantee of payment. For coverage confirmation, contact the provider call center or verify via member-specific resources.

Background

Calprotectin is a calcium- and zinc-binding protein released from neutrophils during activation or cell death and can be measured in stool as a noninvasive marker of intestinal inflammation. Fecal calprotectin testing has been evaluated to help distinguish inflammatory bowel disease from noninflammatory conditions (for example, to triage patients for endoscopy) and as a potential tool to monitor disease activity or predict relapse, but evidence supporting routine use for guiding therapy or surveillance is insufficient.

Definitions

Definition of Calprotectin

Protein family and originNeutrophil-derived calcium- and zinc-binding protein

Cellular abundanceAccounts for approximately 60% of neutrophil cytoplasmic proteins

Release mechanismReleased from neutrophils during activation or apoptosis/necrosis

Stability in stoolShown to be stable in feces at room temperature for up to 1 week

Definition of Inflammatory Bowel Disease (IBD)

Constituent conditionsCrohn disease and ulcerative colitis

Disease characteristicsChronic conditions characterized by intestinal inflammation with variable clinical and pathologic features

Anatomic distinctionsCrohn can involve entire GI tract and is transmural; ulcerative colitis is mucosal and limited to the colon

Definition of Fecal calprotectin

Biomarker typeStool biomarker indicating intestinal inflammation

Clinical usesUsed to distinguish inflammatory from functional GI disorders and to monitor IBD activity

Rationale vs serologic markersFecal markers are more specific to GI inflammation because they are not elevated in extra-digestive processes

Practical advantageStable in stool allowing home collection and transport to laboratory

OpenPayer

Fecal Calprotectin Testing

Coverage Criteria for Fecal Calprotectin Testing

Coding and Diagnostic Thresholds

Actions for Providers and Billing

Background

Definitions

Revision History