ModifiedCapital BluecrossPolicy MP 4.038

Measurement of exhaled nitric oxide and exhaled breath condensate in the diagnosis and management of asthma and other respiratory disorders

This policy governs Capital BlueCross coverage determinations for measuring fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) in the diagnosis and management of asthma and other respiratory disorders for applicable Capital BlueCross products.

Policy Summary

PayerCapital Bluecross

PolicyMeasurement of exhaled nitric oxide and exhaled breath condensate in the diagnosis and management of asthma and other respiratory disorders

Policy CodePolicy MP 4.038

Change TypeMajor review (investigational designation) + administrative update

Effective DateOct 1, 2025

Next Review Date

Key ActionExpect investigational/non-covered determinations for FeNO and EBC; verify member benefits and prior authorization requirements before ordering.

SourceLink

POLICY UPDATE CHANGES

02/27/2025 Major Review. Measurement of exhaled nitric oxide is now investigational. Updated background, rationale and references.

07/10/2025 Administrative Update. Removed Benefit Variations Section and updated Disclaimer.

InvestigationalFeNO for diagnosis/management

InvestigationalEBC for diagnosis/management

ListedFDA-cleared devices

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Most recent major revision

Coverage Criteria and Policy Stance

Not medically necessary / Investigational

Coverage stance:

Overall policy conclusion: Measurement of exhaled nitric oxide (FeNO) is considered investigational for the diagnosis and management of asthma, eosinophilic asthma, and other respiratory disorders including but not limited to chronic obstructive pulmonary disease and chronic cough due to insufficient evidence of health outcome benefit.

EBC conclusion: Measurement of exhaled breath condensate (EBC) is considered investigational for the diagnosis and management of asthma and other respiratory disorders including but not limited to chronic obstructive pulmonary disease and chronic cough due to insufficient evidence of benefit.

Guideline-derived clinical criteria and thresholds

Guideline-based considerations and suggested thresholds from major respiratory organizations informing potential clinical use of FeNO

ERS/ATS anti-IgE guidance: ERS/ATS suggested using a FeNO cut-off ≥19.5 ppb to identify adolescents (>12 years) and adults with severe allergic asthma more likely to benefit from anti-IgE (omalizumab) (conditional, low quality)>=19.5 ppb

Guideline recommendation is conditional and based on low-quality evidence; most anti-IL-5 guidance focused on blood eosinophils rather than FeNO

GINA — diagnosis and ICS initiation: GINA states FeNO has not been established to rule in or rule out a diagnosis of asthma; FeNO >50 ppb has been associated with a good short-term response to inhaled corticosteroids but cannot be used to decide against ICS treatment.>50 ppb

Studies mainly in non-smokers; effect on longer-term exacerbation risk is unclear

GINA — management and monitoring: GINA notes mixed evidence for FeNO-guided adjustment of treatment; some trials and meta-analyses showed reduced exacerbations while other high-quality trials did not; further studies are needed to define populations most likely to benefit and optimal monitoring frequency.clinical context dependent

Single-point FeNO measurements should be interpreted with caution

GINA — refractory type 2 inflammation criteria: GINA short guide suggests considering refractory type 2 inflammation if on high-dose ICS or daily OCS and any of: blood eosinophils ≥150/µL, FeNO ≥20 ppb, sputum eosinophils ≥2%, or clinically allergen-driven asthma; these are initial assessment suggestions, not eligibility criteria for biologic therapy.>=20 ppb

Consider repeating blood eosinophils and FeNO up to 3 times before assuming non-type 2 inflammation

Not covered / Investigational

Policy coverage stance and criteria (as revised):

Investigational designation: Measurement of exhaled nitric oxide is now investigational as of 02/27/2025 major review.

Providers should expect investigational/non-covered determinations unless other policy language (not present in this extract) specifies exceptions.

This policy is applicable only to certain programs and products administered by Capital Blue Cross and is subject to product-specific benefit variations. Providers should verify member benefits and consult program guidance (for example, FEP PPO members should refer to the FEP Medical Policy Manual) to determine whether the policy applies to a given patient and whether prior authorization or alternate coverage rules apply.

The following procedure codes are identified in the policy as investigational and therefore not covered: 83987 and 95012. Claims submitted with these codes may be denied.

As of the major policy review on 02/27/2025, measurement of fractional exhaled nitric oxide (FeNO) has been designated investigational for the diagnosis and management of asthma and other respiratory disorders.

The available evidence is insufficient to demonstrate that FeNO- or exhaled breath condensate (EBC)-directed diagnosis or management improves net health outcomes for asthma or other respiratory disorders. Studies report variable diagnostic cutoffs, heterogeneous designs, and inconsistent impacts of FeNO-guided treatment on clinical outcomes; similarly, evidence for EBC is limited by variability in measured components and lack of standardized methods. Consequently, these tests are considered investigational for routine diagnosis or management.

Because the procedures and tests listed in this policy are considered investigational, use of the listed investigational procedure codes is treated as not covered under this policy. Providers should expect that claims for these services may be denied unless other coverage language or product-specific benefit rules provide an exception.

The policy history documents a 02/27/2025 major review that changed the coverage stance: measurement of exhaled nitric oxide is now designated investigational. This change reflects the conclusion that current evidence does not establish improved net health outcomes when FeNO measurement is used for diagnosis or management.

Coding, Devices, and Code Status

FDA-cleared devices and 510(k)/product codesmixed

FDA product code MXA	FeNO measurement devices cleared under product code MXA
510(k) K02113 / DEN 030001	NIOX Nitric Oxide Monitoring System
510(k) K072816 / KI101034	NIOX MINO
510(k) K133898	NIOX VERO
510(k) K182874	Fenom Pro Nitric Oxide Test

EBC collection system registrationsmixed

Class I registration

RTube and ECoScreen EBC collection systems registered as class I devices

Investigational; therefore, not coveredmixedNot Covered

83987
95012

Coding updated (see policy for exact codes)mixed

No codes listed

FeNO decision thresholds — ERS/ATS and GINA suggested cut-offs and interpretations

ERS/ATS suggested cut-offFeNO ≥19.5 ppb to identify adolescents (>12 years) and adults with severe allergic asthma more likely to benefit from anti-IgE (omalizumab) — guideline recommendation is conditional (low quality).

GINA — short-term ICS responseFeNO >50 ppb has been associated with a good short-term (weeks) response to inhaled corticosteroids; can support decision to start ICS but not to withhold ICS.

GINA — refractory type 2 inflammation thresholdFeNO ≥20 ppb suggested as one criterion (with blood eosinophils ≥150/µL or sputum eosinophils ≥2% or allergen-driven asthma) when assessing possible refractory type 2 inflammation on high‑dose ICS or daily OCS; repeat testing up to 3 times may be appropriate before assuming non-type 2.

Provider Requirements, Prior Authorization, and Billing Impact

Prior Authorization

Prior authorization may vary by product

Prior authorization requirements vary by Capital Bluecross product and program. Providers must verify member benefits and prior authorization requirements for the specific Capital Bluecross product before performing FeNO or exhaled breath condensate testing.

Check product-specific benefit variations and prior auth rules; FEP PPO: refer to FEP Medical Policy Manual.

Prior Authorization

Investigational codes — prior authorization note

Services and procedure codes designated as investigational in this policy may still require prior determination of coverage or prior authorization depending on the product. Do not assume coverage based on coding alone.

Investigational services require verification of coverage and may need prior authorization prior to service.
Contact Provider Services or Member Services for questions about coverage determinations.

Background and Rationale

Asthma is a chronic inflammatory airway disorder characterized by variable airflow obstruction and bronchial hyperresponsiveness, commonly presenting with wheeze, cough, and dyspnea. Routine monitoring and management emphasize clinical assessment and objective measures such as spirometry (FEV1, peak flow). Noninvasive tests such as FeNO and EBC have been proposed to assess airway inflammation, but available evidence is heterogeneous and does not consistently demonstrate that using these biomarkers to guide therapy improves patient-important outcomes.

Definitions

FeNO — definition

TermFractional exhaled nitric oxide (FeNO)

DefinitionConcentration of nitric oxide in exhaled breath measured during single-breath exhalations at an exhalation flow rate of 50 mL/s, expressed in parts per billion (ppb); results are typically the mean of 2–3 values.

Clinical noteFeNO is a noninvasive biomarker of airway eosinophilic/type 2 inflammation; levels are higher in asthma and decrease with corticosteroid treatment.

Exhaled breath condensate — definition

TermExhaled breath condensate (EBC)

DefinitionFluid collected by passing exhaled air through a condensing or cooling apparatus, accumulating primarily water vapor plus aerosolized respiratory droplets that contain nonvolatile inflammatory mediators (e.g., cytokines, leukotrienes, oxidants).

Policy Revisions and Effective Dates

2025-07-10administrative updateLatest

Administrative update removing Benefit Variations section and updating the Disclaimer.

2025-02-27major review

Major review: measurement of exhaled nitric oxide designated investigational; background, rationale, and references updated.

2024-09-17consensus review

Policy Summary

PayerCapital Bluecross

PolicyMeasurement of exhaled nitric oxide and exhaled breath condensate in the diagnosis and management of asthma and other respiratory disorders

Policy CodePolicy MP 4.038

Change TypeMajor review (investigational designation) + administrative update

Effective DateOct 1, 2025

Next Review Date

Key ActionExpect investigational/non-covered determinations for FeNO and EBC; verify member benefits and prior authorization requirements before ordering.

SourceLink

On This Page

Prior Authorization

Consult policy for prior authorization and coding updates

Prior authorization and coverage determinations are subject to change with coding or policy updates. Consult this policy and the payer’s current prior authorization lists and billing guidance before ordering/testing.

Review the policy and current coding before submitting prior authorization requests.
Confirm medical necessity documentation aligns with policy language and member benefit terms.

Denial Risk

Investigational — denial likely

Because FeNO and exhaled breath condensate (EBC) are designated investigational for diagnosis and management of asthma and other respiratory disorders, claims for these services are likely to be denied unless coverage is explicitly determined under a member’s benefit program.

Measurement of exhaled nitric oxide and EBC are considered investigational for asthma and other respiratory disorders.
Investigational designation typically results in denial unless an exception is documented in the member’s benefit plan.

Denial Risk

Investigational procedures — denial risk

Procedures and codes listed as investigational (for example CPT 83987 and 95012) are not covered under this policy and may be denied on claim submission.

Investigational; therefore, not covered: 83987, 95012.
Do not bill these codes as covered services without prior written determination of coverage.

Denial Risk

Investigational designation may lead to denial

The policy’s investigational designation (most recently updated 02/27/2025) may lead to claim denials for services rendered after the effective date. Providers should review the policy history and effective dates when assessing prior claims or future services.

02/27/2025: Measurement of exhaled nitric oxide changed to investigational — coverage stance change may trigger denials.
Check policy history for revisions and effective dates when evaluating coverage.

Note

Context — standard asthma management

Standard management of persistent asthma emphasizes long-term suppression of inflammation and routine monitoring with clinical assessments and measures such as FEV1 and peak flow. FeNO and EBC are not established replacements for routine monitoring or standard management approaches.

Follow established asthma management guidelines (steroids, leukotriene inhibitors, anti-inflammatory drugs) and routine respiratory parameter monitoring.
FeNO/EBC are investigational and should not replace standard monitoring such as FEV1 or peak flow.

Note

Repeat testing before escalation

Before concluding that a patient does not have type 2 inflammation, consider repeating blood eosinophil count and FeNO testing up to three times (for example when asthma worsens, before oral corticosteroid [OCS] use, or at least 1–2 weeks after OCS or on the lowest possible OCS dose) per guideline suggestions.

Consider repeating blood eosinophils and FeNO up to 3 times before assuming non–type 2 asthma.
Timing examples: when asthma worsens, prior to giving OCS, or ≥1–2 weeks after a course of OCS.

UseVarious laboratory techniques (pH measurement, GC/MS, HPLC) can analyze EBC components; primarily used in research contexts to sample airway markers.

FeNO — clinical note (ppb; biomarker of eosinophilic inflammation)

UnitsFeNO is reported in parts per billion (ppb).

Biomarker roleMeasured FeNO is used as a biomarker of airway eosinophilic (type 2) inflammation and may inform response to corticosteroids or biologic therapies in specific contexts.

Measurement contextFeNO interpretation should account for factors such as age (<12 years), allergen exposure, smoking status, and recent corticosteroid use.

FeNO — noninvasive biomarker of eosinophilic airway inflammation (additional reference)

DescriptionFeNO is a noninvasive measurement used as a biomarker of eosinophilic airway inflammation, cited in ATS/ERS and other guideline literature.

Guideline supportOfficial ATS clinical practice guideline and multiple guideline references discuss interpretation and potential clinical applications of FeNO.

Research implicationGuidelines note mixed evidence for FeNO‑guided management and emphasize need for further studies to define populations and monitoring strategies.

Exhaled breath condensate — sampling method for airway markers (research)

MethodEBC sampling collects airway markers by cooling exhaled air to accumulate condensate containing water vapor and respiratory droplets for subsequent laboratory analysis.

AnalytesEBC can contain nitric oxide derivatives and other inflammation-related analytes (cytokines, leukotrienes, oxidants) measurable by techniques such as pH, GC/MS, or HPLC.

Primary useMainly a research tool to sample airway mediators; clinical utility for routine diagnosis or management remains investigational.

Consensus review with no change to policy statement; cross-reference added and references updated.

2023-09-18consensus review

Consensus review with no change to policy statement; ICD-10 added and references updated.

2022-07-12consensus review

Consensus review with no change to policy statement; references reviewed and updated.

2021-11-09consensus review

Consensus review; no criteria changes and references updated; coding reviewed.

2021-09-07administrative update

Administrative update adding new ICD-10 codes (effective 10/01/2021).

2020-11-16major review

Major review revising measurement of exhaled nitric oxide policy statement from investigational to medically necessary with updated coding, references and summary of evidence.

2020-05-15consensus review

Consensus review with language revisions under Product Variation, Benefit Variation and Disclaimer sections and updated references.