CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

fecal_calprotectin_testing_policy

Policy describes coverage stance and clinical background for fecal calprotectin testing for diagnosis and management of intestinal conditions including inflammatory bowel disease (IBD) for Blue Cross Blue Shield - Rhode Island commercial and BlueCHiP for Medicare products. It notes prior authorization requirements and coding.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

Policyfecal_calprotectin_testing_policy

Policy CodePolicy N/A

Change Typeclarified

Effective DateOct 1, 2015

Next Review Date

Key ActionPrior authorization is not required for fecal calprotectin testing.

SourceLink

POLICY UPDATE CHANGES

Policy last updated 05/02/2017; prior authorization not required and test considered not medically necessary.

1Primary Test Code Mentioned

Not medically necessaryCoverage Stance

No prior authAuthorization Requirement

Coverage Summary

Background: Fecal calprotectin is a fecal protein marker proposed as a noninvasive test for intestinal inflammation and evaluation of inflammatory bowel disease (IBD), including diagnosis, monitoring treatment response, and predicting relapse. The policy effective date is 10/01/2015 and the last review/update was on 05/02/2017.

Overview: Fecal calprotectin testing has high sensitivity in studies for detecting IBD but there is insufficient evidence that testing improves health outcomes for diagnosis or management of IBD; prior authorization is not required and the test may be considered not medically necessary due to insufficient evidence of effect on health outcomes.

Fecal Calprotectin — Key Coverage Keys

Primary Test Code Mentioned83993 (Calprotectin, fecal)

Coverage StanceConsidered not medically necessary for diagnosis and management of IBD/intestinal conditions

Authorization RequirementPrior authorization is not required

Common diagnostic cutoff (from evidence)50 µg/g used in most studies

Policy effective / last reviewEffective 2015-10-01; Policy last updated 2017-05-02

Medical Criteria / Coverage Determination

Prior authorization is not required.

Fecal calprotectin testing is considered not medically necessary in the diagnosis and management of intestinal conditions, including the diagnosis and management of inflammatory bowel disease (IBD), because the evidence is insufficient to determine the effects of the technology on health outcomes.

Applies to BlueCHiP for Medicare and Commercial Products

Medical Necessity / Decision Criteria

Medical Criteria / Coverage Determination

Fecal calprotectin testing coverage determination:

Prior authorization is not required.

Applies to BlueCHiP for Medicare and Commercial Products

Provider Actions and Billing Impact

Prior Authorization

Prior authorization not required

Prior authorization is not required for fecal calprotectin testing.

83993

Denial Risk

Not medically necessary determination

Claims for fecal calprotectin testing may be considered not medically necessary for diagnosis and management of intestinal conditions including IBD and may be denied based on insufficient evidence of health outcome benefit.

83993

Documentation Required

Benefit verification

Benefits may vary between groups and contracts; providers must refer to the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement to determine coverage specifics.

Background, Evidence, and Definitions

Fecal calprotectin is intended as a noninvasive marker to detect intestinal neutrophilic inflammation and has been proposed to help distinguish IBD from noninflammatory disorders, guide selection of patients for endoscopy, monitor response to therapy, and predict relapse. The marker is a calcium- and zinc-binding protein released from neutrophils and is stable in feces at room temperature for up to one week, which facilitates home collection and laboratory testing.

Sensitivity and cutoffs: Diagnostic studies generally report very high sensitivity for commercially available fecal calprotectin tests, with many studies using a common diagnostic cutoff of 50 µg/g. However, studies vary in the cutoff values used and in their settings, contributing to uncertainty about optimal thresholds and diagnostic accuracy across populations.

Limitations and outcomes: Most studies were conducted in specialty settings with relatively little data on testing in the general population (risk of spectrum effects). Evidence is limited and inconsistent for use in treatment monitoring and relapse prediction, and overall the evidence is considered insufficient to determine effects on health outcomes for diagnosis or management of intestinal conditions including IBD. Prior authorization is not required for the test, but coverage determinations may consider it not medically necessary.

Evidence Item	Value
Common diagnostic cutoff used in studies	50 µg/g
Evidence conclusion	Insufficient to determine effects on health outcomes for diagnosis/management of IBD

Fecal calprotectin: A calcium- and zinc-binding protein released from neutrophils that serves as a marker of intestinal inflammation; it is stable in feces at room temperature for up to one week.

Revision History

2017-05-02policy_updateLatest

Policy last updated 05/02/2017; prior authorization not required and test considered not medically necessary. Document header shows policy effective 10/01/2015 and last update 05/02/2017; no clinical policy statement changes indicated.