CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

fecal_calprotectin_testing_policy

Defines medical necessity and noncoverage positions for fecal calprotectin testing for Medicare Advantage and commercial products, including clinical indications (differential diagnosis when endoscopy with biopsy is being considered) and excluded uses (monitoring active IBD and surveillance for relapse). Lists applicable HCPCS and supporting ICD-10 codes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyfecal_calprotectin_testing_policy

Policy CodePolicy N/A

Change Typeclarified

Effective DateApr 1, 2020

Next Review Date

Key ActionDocument that the test is being used to evaluate a differential diagnosis of IBD versus noninflammatory bowel disease and that endoscopy with biopsy is being considered; only when these conditions are documented is testing considered medically necessary.

SourceLink

POLICY UPDATE CHANGES

Policy expresses medically necessary use for differential diagnosis when endoscopy with biopsy is being considered, and not medically necessary/not covered for management and surveillance of IBD.

1Covered indication category

2Not covered uses (management, surveillance)

1Covered HCPCS code listed

Coverage Summary

Fecal calprotectin testing is supported as a noninvasive diagnostic tool to help distinguish inflammatory bowel disease (IBD) from noninflammatory conditions (e.g., IBS) when endoscopy with biopsy is being considered. It is considered medically necessary for this differential diagnosis for both Medicare Advantage and Commercial products. The policy states that fecal calprotectin is not supported for use in monitoring disease activity or for predicting/surveillance of relapse, as the evidence is insufficient to determine effects on health outcomes. Effective date: 04/01/2020; Last review: 02/03/2021.

Policy metadata

Policy title (subject)Fecal calprotectin testing

PayerBlue Cross Blue Shield - Rhode Island

Coverage stancemixed (medically necessary for differential diagnosis when endoscopy with biopsy is being considered; not medically necessary/not covered for management or surveillance of IBD)

Effective date04/01/2020

Last review date02/03/2021

StatusCURRENT

93-99%Diagnostic sensitivity at 50 μg/g (negative predictive value 73–100%)

~49/100Estimated invasive tests avoided per 100 suspected IBD cases (≈1 case missed)

Medical-Necessity Criteria

Medically Necessary Indication

Fecal calprotectin testing is considered medically necessary when ALL of the following are met:

ALL of the following

Patient evaluation is for differential diagnosis of inflammatory bowel disease (IBD) versus noninflammatory bowel disease (including irritable bowel syndrome)
Endoscopy with biopsy is being considered to evaluate the patient

Not Medically Necessary / Not Covered Indications

Fecal calprotectin testing is considered not medically necessary / not covered for the following uses:

ANY of the following

Management of inflammatory bowel disease, including management of active inflammatory bowel disease
Surveillance for relapse of disease in remission (predicting relapse / routine monitoring)

Coding

Covered HCPCSHCPCSCovered

83993

Calprotectin, fecal

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

K50.00-K50.919	Crohn disease codes (range provided in policy)
K51.00-K51.019	Ulcerative colitis codes (range provided in policy)
K51.50-K51.919	Ulcerative colitis codes (additional range provided in policy)
K52.3	Pseudomembranous colitis
R19.8	Other specified symptoms and signs involving the digestive system and abdomen

Provider Actions

Documentation Required

Indication documentation for medical necessity

Document that the fecal calprotectin test is being used to evaluate a differential diagnosis of inflammatory bowel disease (IBD) versus noninflammatory bowel disease (including irritable bowel syndrome) and that endoscopy with biopsy is being considered. Testing is considered medically necessary only when these conditions are documented.

83993
K50.00-K50.919
K51.00-K51.019
K51.50-K51.919
K52.3
R19.8

Denial Risk

Denied/Not covered uses

Claims for fecal calprotectin testing when used to monitor active IBD or for surveillance/prediction of relapse in patients in remission are considered not medically necessary/not covered and may be denied.

83993

Background and Evidence

Fecal calprotectin is a stool biomarker — a calcium- and zinc-binding protein — proposed as a noninvasive test to distinguish IBD from noninflammatory conditions, to evaluate response to treatment, and to predict relapse. Evidence supports diagnostic accuracy for selecting patients who may forgo endoscopy (studies most commonly used a 50 μg/g cutoff with sensitivity ~93%–99% and negative predictive value ~73%–100%, and an estimated ~49 invasive tests avoided per 100 suspected IBD cases with ~1 case missed). The evidence is insufficient to support routine use for monitoring disease activity or predicting relapse.

Definitions

TermFecal calprotectin

DefinitionA calcium- and zinc-binding protein measured in stool as a marker of intestinal inflammation.

Evidence item	Value
Diagnostic sensitivity at 50 μg/g threshold	93% to 99% (negative predictive value 73% to 100%)
Estimated avoided invasive tests	Out of 100 suspected IBD cases, ~49 invasive tests avoided with 1 case missed

Revision History

2020-04-01clarified

Policy expresses medically necessary use for differential diagnosis when endoscopy with biopsy is being considered for individuals suspected of IBD; applies to Medicare Advantage Plans.

2020-04-01clarified

Policy expresses medically necessary use for differential diagnosis when endoscopy with biopsy is being considered for individuals suspected of IBD; applies to Commercial Products.

2021-02-03clarifiedLatest

Policy clarifies that fecal calprotectin testing is not medically necessary / not covered for management of inflammatory bowel disease, including management of active IBD and surveillance for relapse of disease in remission; applies to both Medicare Advantage and Commercial Products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyfecal_calprotectin_testing_policy

Policy CodePolicy N/A

Change Typeclarified

Effective DateApr 1, 2020

Next Review Date

SourceLink

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