CurrentBlue Cross Blue Shield - MassachusettsPolicy 524

Measurement of Exhaled Nitric Oxide and Exhaled Breath Condensate in the Diagnosis and Management of Respiratory Disorders prn.pdf

Policy governs coverage for measurement of fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) for diagnosis and management of asthma, eosinophilic asthma, and other respiratory disorders for commercial and Medicare products. It defines investigational status and prior authorization requirements for inpatient services.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMeasurement of Exhaled Nitric Oxide and Exhaled Breath Condensate in the Diagnosis and Management of Respiratory Disorders prn.pdf

Policy CodePolicy 524

Change TypeAnnual reviewreferences updated

Effective DateDec 1, 2025

Next Review Date

Key ActionPrecertification/preauthorization is required for all products if measurement procedures are performed inpatient.

SourceLink

POLICY UPDATE CHANGES

Policy statements unchanged.

8/2024 annual review: references updated; policy statements unchanged.

2/2019 investigational indications clarified to indicate eosinophilic asthma.

2Procedures listed as investigational (FeNO, EBC)

2CPT codes listed

524Policy number

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Coverage Summary

Scope: This policy governs coverage for measurement of fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) for the diagnosis and management of asthma (including eosinophilic asthma) and other respiratory disorders across commercial and Medicare products. FeNO and EBC are noninvasive tests proposed to assess airway inflammation and inflammatory mediators to assist diagnosis and management of asthma and other respiratory diseases.

Overview: Multiple study types have been evaluated, including diagnostic accuracy studies, randomized controlled trials, and systematic reviews. Evidence is insufficient to determine that measurement of FeNO or EBC results in improvement in net health outcome for diagnosis or management of asthma and other respiratory disorders.

Policy key facts

policy_number524

dates.effective2025-12-01

dates.last_review2025-12-01

statusCURRENT

subjectMeasurement of Exhaled Nitric Oxide and Exhaled Breath Condensate

Medical-Necessity and Coverage Determinations

Coverage Determination

Policy statements:

FeNO investigational: Measurement of exhaled or nasal nitric oxide is considered INVESTIGATIONAL in the diagnosis and management of asthma, eosinophilic asthma, and other respiratory disorders including but not limited to chronic obstructive pulmonary disease and chronic cough.
EBC investigational: Measurement of exhaled breath condensate is considered INVESTIGATIONAL in the diagnosis and management of asthma and other respiratory disorders including but not limited to chronic obstructive pulmonary disease and chronic cough.

Precertification / Prior Authorization Requirements

Authorization rules by setting:

Provider Actions

Prior Authorization

Inpatient preauthorization required

Precertification/preauthorization is required for all products if measurement procedures are performed inpatient.

Documentation Required

Outpatient product-specific prior authorization

Outpatient services are not covered for multiple commercial and Medicare products; where outpatient prior authorization might apply, providers must follow product-specific prior authorization requirements and member contract benefits.

Coding

Investigational / Not Covered CPT CodesCPTNot Covered

83987	pH; exhaled breath condensate.
95012	Nitric oxide expired gas determination.

Background and Evidence Summary

FeNO and EBC: Fractional exhaled nitric oxide (FeNO) is the concentration of nitric oxide in exhaled breath (expressed in parts per billion) measured during controlled single-breath exhalations; devices are commercially available. Exhaled breath condensate (EBC) is collected by condensing exhaled air and contains water vapor plus aerosolized respiratory droplets with various inflammatory mediators measured by laboratory techniques (eg, pH, mass spectrometry).

Limitations: Studies use heterogeneous FeNO cutoff values and there is considerable variability in which EBC components are measured and how measurements are standardized. The heterogeneity of thresholds and uncertainty about the incremental impact of FeNO or EBC on clinical decision-making and downstream outcomes limit support for coverage.

Net health outcome conclusion: Evidence is insufficient to determine that FeNO or EBC measurement results in improvement in net health outcome for diagnosis or management of asthma and other respiratory disorders.

FeNO-guided management RCT findings: Randomized trial evidence is mixed. Systematic reviews (Cochrane) and RCTs found reduced exacerbations with FeNO-guided management in children but not adults, and no consistent impact on day-to-day symptoms or hospitalizations.

Definitions

Thresholds / Other items

Revision History

2025-05-01annual_reviewLatest

Annual policy review with literature update through May 1, 2025; references added.

2024-08annual_review

8/2024 annual review: references updated; policy statements unchanged.

2019-02material_clarification

2/2019 investigational indications clarified to indicate eosinophilic asthma.