CurrentBlue Cross Blue Shield - MassachusettsPolicy 524

Measurement of Exhaled Nitric Oxide (FeNO) and Exhaled Breath Condensate (EBC)

Defines BCBS Massachusetts coverage stance on measuring fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) for diagnosis and management of asthma and other respiratory disorders for commercial and Medicare members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMeasurement of Exhaled Nitric Oxide (FeNO) and Exhaled Breath Condensate (EBC)

Policy CodePolicy 524

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionDo not submit outpatient claims for FeNO or EBC testing for commercial or Medicare outpatient products because these services are not covered; obtain precertification for related inpatient services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalFeNO for respiratory disorders

InvestigationalEBC for respiratory disorders

95012, 83987Investigational codes

Not coveredOutpatient coverage

Multiple

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Major guideline sources

Coverage Criteria

Investigational — FeNO

Covered when ALL of the following are met:

Investigational uses: 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.

From policy statements.

Investigational — EBC

Covered when ALL of the following are met:

Investigational uses: 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.

From policy statements.

Outpatient measurement of fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) is not a covered outpatient service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, and Medicare outpatient products. Claims for these outpatient services may be denied when submitted for these product types.

Evidence and cited references indicate that FeNO cannot universally replace methacholine challenge testing for diagnosis; studies and reviews report variable performance across settings and cutoffs. Exhaled biomarkers, including FeNO and components measured in EBC, demonstrate variable utility across diseases and diagnostic contexts and have not been shown to be a reliable substitute for established provocation or functional testing in all clinical scenarios.

The body of evidence is insufficient to demonstrate that measurement of FeNO or EBC improves net health outcomes for diagnosis, management, or treatment selection in asthma or other respiratory disorders. Systematic reviews, diagnostic accuracy studies, randomized trials, and observational data are limited by heterogeneity in methods, variable biomarker cutoffs, and lack of data showing incremental benefit when added to existing diagnostic or management algorithms.

Randomized trials and systematic reviews report inconsistent clinical benefit from FeNO-guided management. Several RCTs and two Cochrane reviews found mixed results—some pediatric trials reported reductions in exacerbations while adult trials often showed no improvement in day-to-day symptoms or hospitalizations—and overall FeNO monitoring has not consistently reduced exacerbation frequency or inhaled corticosteroid exposure across all studied populations.

Coding

Investigational CPT CodesCPTNot Covered

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

Provider Actions and Billing Guidance

Prior Authorization

Inpatient prior authorization required

Precertification/preauthorization is required for inpatient procedures described in this policy. Lack of required precertification may result in claim denials.

Applies to all products when the procedure is performed inpatient.

Denial Risk

Outpatient noncoverage

Outpatient measurement of fractional exhaled nitric oxide (FeNO) or exhaled breath condensate (EBC) is not a covered outpatient service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, and Medicare products.

Background

Asthma is an inflammatory airway disease characterized by wheeze, cough, and dyspnea; routine monitoring typically uses spirometry and peak expiratory flow to assess airflow limitation. FeNO is a noninvasive measure of airway nitric oxide that can reflect eosinophilic airway inflammation and often decreases with corticosteroid therapy. Exhaled breath condensate (EBC) samples airway lining fluid components (for example, pH and cytokines), but measurement techniques and interpretation are variable, and clinical utility for guiding diagnosis or therapy remains unproven.

Definitions

Fractional exhaled nitric oxide (FeNO) — measurement definition and method

DefinitionFractional exhaled nitric oxide (FeNO) — the concentration of nitric oxide in exhaled breath measured during single-breath exhalations, expressed in parts per billion.

Standardized measurementMeasured during single-breath exhalations after inhalation of NO‑free air to total lung capacity, then exhaled at a target flow rate of 50 mL/s maintained within ±10% for >6 seconds and oral pressure 5–20 cm H2O.

Biologic rationaleNO is an endogenous inflammatory mediator; FeNO is elevated in many patients with asthma and decreases with corticosteroid treatment.

DevicesCommercially available FeNO measuring devices are used in clinical settings to record exhaled NO concentrations.

Exhaled breath condensate (EBC) — sampling description

Definition

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMeasurement of Exhaled Nitric Oxide (FeNO) and Exhaled Breath Condensate (EBC)

Policy CodePolicy 524

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

Billing Rule

Coding and documentation guidance

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. The code lists in the policy are informational only and inclusion does not guarantee coverage or reimbursement; verify member benefits at the time of service.

Documentation Required

Provider documentation

No additional provider documentation requirements are specified in the reference content for this policy beyond standard medical record documentation to support medical necessity.

Step Therapy

Step therapy

No step therapy requirements are specified in the reference content for this policy.

Note

References: trials and systematic reviews

References include randomized controlled trials and systematic reviews/meta-analyses evaluating FeNO-guided management versus symptom- or guideline-based approaches; examples include Cochrane reviews (Petsky et al. 2016 for adults and children), systematic reviews and meta-analyses (e.g., Korevaar et al. 2023; Wang et al. 2018), and RCTs such as Szefler et al. 2008 and Turner et al. (RAACENO) 2022.

Exhaled breath condensate (EBC) — fluid collected by passing exhaled air through a condensing or cooling apparatus, yielding an accumulated sample derived largely from water vapor and aerosolized respiratory droplets.

Sample compositionContains nonvolatile inflammatory mediators such as cytokines, leukotrienes, oxidants, antioxidants, and other markers of oxidative stress.

Collection methodExhaled air is cooled/condensed in a collection device to accumulate condensate for laboratory analysis.

Analytic variabilityLaboratory techniques vary widely depending on the analyte of interest (eg, pH measurement, gas chromatography–mass spectrometry, or high-performance liquid chromatography).

FeNO — noninvasive biomarker definition and clinical use

Role as biomarkerFeNO is a noninvasive biomarker used to assess airway eosinophilic inflammation and has been evaluated to guide asthma management.

Clinical associationsElevated FeNO is observed in many patients with asthma and may predict corticosteroid responsiveness in some populations.

LimitationsEvidence does not support universal replacement of established diagnostic tests (eg, methacholine challenge); randomized trials show inconsistent effects on exacerbation reduction and inhaled corticosteroid dosing across populations.

Guideline contextFeNO measurement and interpretation are discussed across ATS/ERS and other guideline and clinical trial literature as a potential adjunctive tool rather than a standalone diagnostic test.

Exhaled breath condensate — sampling method and biomarkers discussed

Sampling methodEBC is obtained by cooling exhaled air in a condensing apparatus to collect airway lining fluid components for analysis.

Analytes evaluatedMeasured biomarkers include pH, cytokines, leukotrienes, oxidants/antioxidants, and other markers of oxidative stress; assays range from simple pH to advanced mass spectrometry techniques.

Clinical utilityEBC has been investigated as a noninvasive sampling method for airway biomarkers in asthma, COPD, interstitial lung disease and other respiratory disorders, but techniques and interpretation are variable across studies.

Evidence overviewReviews and systematic evaluations highlight methodological heterogeneity and limited standardization of EBC collection and assays, restricting clinical applicability.