CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

This policy governs coverage and medical necessity determinations for measurement of fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) in the diagnosis and management of asthma and other respiratory disorders for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

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

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 3, 2015

Next Review DateN/A

Key ActionDo not submit claims for FeNO (95012) or EBC (83987) as these tests are stated as not covered or not medically necessary; verify member benefits and eligibility before providing services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2technologies addressed

2CPT codes not covered

Not coveredCoverage stance

0Related payer policies

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Coverage Determinations

General Noncoverage / Not Medically Necessary

Covered when ALL of the following are met:

Overall coverage stance: Measurement of exhaled nitric oxide (FeNO) and measurement of exhaled breath condensate (EBC) are considered not covered or not medically necessary for the diagnosis and management of asthma and other respiratory disorders due to insufficient evidence of improvement in net health outcome.

Applies to Medicare Advantage Plans and Commercial Products as specified in policy.

Measurement of exhaled nitric oxide (FeNO) and measurement of exhaled breath condensate (EBC) are excluded from coverage for the diagnosis and management of asthma and other respiratory disorders (including but not limited to eosinophilic asthma, chronic obstructive pulmonary disease, and chronic cough). The policy states these technologies are not covered or are considered not medically necessary because the available evidence is insufficient to demonstrate an improvement in net health outcome.

Coverage and payment for services are determined by the member's subscriber agreement, member certificate, or employer agreement, which take precedence over this medical policy. Providers should verify member-specific benefits and any prior authorization requirements through the provider call center or eligibility systems before delivering services. If a service is determined to be not medically necessary or is a non-covered benefit under the member's contract, the provider may not bill the member unless the member has been informed and provided written agreement in advance to accept financial responsibility.

For Commercial Products, measurement of FeNO and EBC is considered not medically necessary for the diagnosis and management of asthma and other respiratory disorders. For Medicare Advantage Plans, measurement of FeNO and measurement of EBC are stated as not covered for the diagnosis and management of asthma and other respiratory disorders. The corresponding CPT codes listed as not covered / not medically necessary are 95012 (Nitric oxide expired gas determination) and 83987 (pH; exhaled breath condensate).

Provider Responsibilities and Billing Impact

Prior Authorization

Not applicable

Documentation Required

Benefit Verification

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

Denial Risk

Denial Risk for FeNO and EBC Testing

Measurement of exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) testing is considered not medically necessary or not covered for the diagnosis and management of asthma, eosinophilic asthma, chronic obstructive pulmonary disease, chronic cough, and other respiratory disorders as described in the policy statement. Claims submitted for these services (including CPT codes 95012 and 83987) may be denied as not medically necessary.

Affected codes may include: 95012, 83987

Note

Verify Member Eligibility and Prior Authorization

Verify member eligibility and benefit coverage prior to providing services. For member-specific benefit questions or to confirm prior authorization requirements (if any), contact the provider call center or use BCBSRI online provider tools.

Documentation Required

Coverage and Documentation Guidance

Subscriber and employer agreements govern coverage and supersede this medical policy. This document is informational and is not a guarantee of payment. Providers may bill members for services that are determined to be not medically necessary or are non-covered only if the member was informed and provided written agreement in advance per participation agreements and applicable rules.

Clinical Background

Asthma is an inflammatory airway disease characterized by symptoms such as wheeze, dyspnea, cough, and chest tightness. Fractional exhaled nitric oxide (FeNO) is a noninvasive marker associated with eosinophilic airway inflammation and may decrease with corticosteroid treatment; exhaled breath condensate (EBC) samples airway lining fluid and can contain biomarkers such as pH and oxidative stress markers. Despite their potential to reflect airway inflammation, current evidence for routine clinical use of FeNO and EBC in diagnosis or management is limited and heterogeneous, which underlies the policy's noncoverage stance.

Key Terms

inv-15: FeNO definition — fractional exhaled nitric oxide explanation

DefinitionFractional exhaled nitric oxide (FeNO) is the concentration of nitric oxide in exhaled air, measured during single-breath exhalations (typically at a flow rate of 50 mL/s) and reported in parts per billion.

Physiologic relevanceNO is an endogenous messenger and inflammatory mediator found throughout the body; FeNO is elevated in patients with asthma and decreases with corticosteroid treatment.

Measurement techniqueMeasured by inspiring NO-free air to total lung capacity then exhaling at a controlled flow into a measuring device; results are the mean of 2–3 values.

StandardizationATS/ERS guidance recommends measurement at an exhalation rate of 50 mL/s maintained within 10% for >6 seconds at an oral pressure between 5 and 20 cm H2O.

Clinical roleProposed as a noninvasive marker to assess airway and eosinophilic inflammation and to inform corticosteroid responsiveness, though evidence for routine clinical use is limited.

inv-16: EBC definition — exhaled breath condensate explanation

DefinitionExhaled breath condensate (EBC) is the fluid collected by passing exhaled air through a cooling or condensing apparatus, yielding condensate derived primarily from water vapor plus aerosolized respiratory droplets.

ContentsEBC contains nonvolatile inflammatory mediators and markers such as cytokines, leukotrienes, oxidants, antioxidants, and other oxidative stress markers.

Analytic methodsComponents of EBC can be measured by techniques ranging from simple pH measurement to gas chromatography, mass spectrometry, or high-performance liquid chromatography depending on the analyte.

Research vs clinical useEBC has been used to sample airway biomarkers for research; clinical utility remains under study due to variability in collection and analysis methods.

inv-17: FeNO (alternate/reference) definition

Alternate phrasingFeNO — a noninvasive marker measured in exhaled breath to assess airway inflammation and eosinophilic inflammation in asthma.

Measurement unitsReported as nitric oxide concentration in parts per billion (ppb), typically using the mean of multiple exhalations.

Guideline referencesInterpreting FeNO and its use in guiding asthma treatment is addressed in ATS and other clinical practice guidelines cited in the policy references.

inv-18: Exhaled Breath Condensate (EBC) — alternate/reference definition

Alternate phrasingExhaled breath condensate (EBC) — condensate of exhaled air used to sample airway biomarkers (e.g., pH, oxidative stress markers, nitric oxide–related compounds) for research and potential clinical assessment.

Primary source materialEBC is primarily water vapor-derived but includes aerosolized respiratory droplets containing airway lining fluid constituents.

Analytical variabilityA variety of laboratory techniques exist to analyze EBC components, contributing to heterogeneity in results and limiting routine clinical application.