Measurement of Exhaled Nitric Oxide (FeNO) in the Diagnosis and Management of Respiratory Disorders
Customize your policy alerts
Sign up for Capital Bluecross Policy MP 4.038 alerts
Get alerted when Policy MP 4.038 changes without checking for updates manually.
Monitor payer policy activity
This policy governs the use of exhaled nitric oxide (FeNO) testing in the diagnosis and management of asthma, eosinophilic asthma, and other respiratory disorders for Capital Bluecross products subject to benefit variations.
No material clinical or coverage changes in this revision.
Coverage Criteria
Overall coverage stance
Covered only under specific, limited circumstances; otherwise investigational.
Based on available diagnostic accuracy studies, RCTs, and systematic reviews showing inconsistent impact on clinical outcomes; FeNO may have adjunctive roles in select situations but is not established as broadly beneficial.
Guideline-based recommendations and thresholds (informational)
Guideline statements and conditional recommendations regarding FeNO use (informational):
Conditional recommendation; panel noted low-quality evidence and resource considerations.
Suggested cut-off specific to anti-IgE (omalizumab) consideration; evidence limited.
FeNO may support but does not replace clinical judgment or established diagnostic testing.
Used as assessment guidance prior to consideration of type 2-targeted biologics; not equivalent to treatment eligibility criteria.
Policy statement history and status
Policy statement history and current status summary:
Providers should note the investigational designation implemented 02/27/2025 and recent administrative edits.
Claims inconsistent with the investigational determination may be denied; verify product/program variations and benefit terms.
Measurement of fractional exhaled nitric oxide (FeNO) has been studied primarily in asthma. Evidence for use of FeNO in respiratory disorders other than asthma (for example, COPD, cystic fibrosis, allergic rhinitis, pulmonary hypertension, primary ciliary dyskinesia, and chronic cough) is limited and heterogeneous, and how FeNO would be integrated into established clinical management pathways for these conditions is unclear. Clinical input and available studies do not support that FeNO measurement improves net health outcomes in non‑asthma respiratory disorders; therefore FeNO is not supported for routine use in these indications.
Procedure code 95012 (FeNO testing) is designated as investigational and not covered under this policy.
Criteria for exhaled breath condensate testing and the associated CPT 83987 have been removed from this policy and the management of that testing has been delegated to Evicore for prior authorization and review.
Although FeNO is a noninvasive biomarker associated with eosinophilic airway inflammation and corticosteroid responsiveness, randomized trials and systematic reviews have not consistently demonstrated improved clinical outcomes when FeNO is used to guide routine asthma medication management (step‑up/step‑down therapy). Subgroup and diagnostic studies examining FeNO to select biologic therapies (for example, anti‑IL‑5, anti‑IL‑4/13, or anti‑IgE agents) show possible quantitative associations but do not establish that baseline FeNO alone reliably identifies patients who will or will not benefit. Accordingly, FeNO should not be used as the sole basis for routine medication adjustment or biologic selection.
Policy history: on 02/27/2025 (Major Review) the measurement of exhaled nitric oxide was designated investigational and the background, rationale, and references were updated.
Coding and Devices
| FDA product code MXA | FeNO measurement devices cleared by FDA |
| NIOX / NIOX MINO / NIOX VERO / Fenom Pro / Pro TM Nitric Oxide Test | Specific FDA-cleared FeNO devices listed in Table 1 (see device entries K02113, K072816, KI101034, K133898, K182874) |
| 95012 | Procedure code listed for FeNO testing (identified as investigational; therefore, not covered) |
| 83987 | Exhaled breath condensate testing (referenced as removed from this policy and delegated to Evicore) |
Provider Actions and Billing Guidance
Benefit/program verification required
Verify that this policy applies to the member’s specific Capital BlueCross product and program prior to ordering or performing FeNO testing, because the policy is applicable only to certain programs and products and is subject to benefit variations.
- Confirm member eligibility and benefit limitations on date of service.
- Refer to product-specific guidance (e.g., FEP PPO: FEP medical policy manual).
FeNO coding and coverage note (CPT 95012)
Procedure code 95012 for FeNO testing is listed in the coding section as investigational and not covered; verify member benefits and any payer-specific memos before billing or ordering the test.
- Identification of a code in the coding section does not denote coverage; codes are subject to change.
- Confirm coverage status with member benefit information and prior authorization requirements per product terms.
Prior authorization and delegation — check current pathway
Check current prior authorization processes and delegated vendors before requesting authorization; some services and codes (for example, exhaled breath condensate/CPT 83987) have been delegated to Evicore and authorization pathways may have changed.
- When delegated, follow the payer’s delegated vendor (Evicore) prior authorization requirements for the affected codes.
- Review policy history and administrative updates for changes to authorization/delegation.
FeNO is adjunctive to clinical assessment
Use FeNO only as an adjunct to established clinical and laboratory assessments—FeNO measurements support but do not replace standard clinical evaluation and tests when diagnosing or managing asthma.
- FeNO measurements are described as an adjunct to established clinical and laboratory assessments in asthma.
- Continue routine monitoring with spirometry/FEV1 and clinical assessment rather than relying on FeNO alone.
Testing frequency and therapy monitoring guidance
Follow guidance on repeat testing and corticosteroid tapering: consider repeating blood eosinophils and FeNO up to three times before assuming non–type 2 inflammation, and use FeNO-supported monitoring when tapering oral corticosteroids after response to type 2 targeted therapy.
- Repeat blood eosinophils and FeNO up to 3 times (e.g., when asthma worsens, before giving OCS, or at least 1–2 weeks after a course of OCS).
- When patient responds to type 2 targeted therapy, consider gradual OCS tapering supported by monitoring symptoms and FeNO.
No FeNO-specific step therapy requirements specified
No step therapy requirements are specified in the policy sections referenced; do not assume any FeNO-specific step therapy pathway is required by this policy.
- Documented policy sections do not list step therapy requirements for FeNO testing or related therapies.
Use FDA‑cleared FeNO devices (FDA product code MXA)
When performing FeNO testing, use FDA–cleared devices and heed device-specific indications; devices for FeNO measurement are cleared under FDA product code MXA and are intended as adjuncts to clinical assessment with age/cooperation limitations noted by device labeling.
- Devices cleared for FeNO measurement are listed with FDA product code MXA.
- Device labeling notes age and cooperation limitations (e.g., some devices not for infants; some suitable for children 7 years and older) and that FeNO is to be used as an adjunct to clinical assessment.
Documentation and benefit verification required
Provide documentation and verify benefits at time of service: coverage and payment depend on the member’s benefit program, eligibility on the date of service, and whether the service is deemed medically necessary per contract terms.
- Supply documentation that supports medical necessity consistent with current policy wording.
- Confirm member eligibility and benefit limitations before submitting claims; identification of a code does not imply coverage.
Match documentation to current policy and coding
Ensure submitted clinical documentation matches the currently effective policy and coding because policy history and administrative updates have changed coding and criteria over time; provide records that reflect the current policy requirements.
- Policy history documents multiple revisions and administrative updates; supply documentation consistent with the effective policy.
- Removed criteria (e.g., exhaled breath condensate/CPT 83987) have been delegated—do not submit documentation for removed criteria as if current.
Investigational status — denial risk for diagnostic/management use
Testing of FeNO for diagnosis or management of asthma, eosinophilic asthma, and other respiratory disorders is considered investigational; claims for these indications may be denied on that basis.
- Measurement of exhaled nitric oxide is considered investigational for asthma, eosinophilic asthma, and other respiratory disorders due to insufficient evidence of net health outcome benefit.
- Anticipate denials when services are inconsistent with the policy’s investigational determination.
Investigational / not covered: CPT 95012
Procedure code 95012 is listed as investigational and therefore not covered; billing the code may result in claim denial under this policy.
- 95012 is explicitly listed in the policy’s 'Investigational; therefore, not covered' coding list.
- Verify coverage and consider alternative coding/documentation if applicable.
Policy history: 02/27/2025 major review — stance changed to investigational
Note the 02/27/2025 Major Review that changed the policy to investigational and ensure documentation and claims reflect the current investigational stance rather than prior medically necessary criteria.
- Policy history: 02/27/2025 Major Review — measurement of exhaled nitric oxide is now investigational.
- Do not rely on earlier versions that listed medically necessary criteria; supply documentation consistent with the current policy effective dates.
Background
Asthma is an inflammatory airway disorder characterized by variable airflow obstruction, airway hyperresponsiveness, and symptoms such as wheeze, cough, and shortness of breath. Long‑term management emphasizes suppression of airway inflammation (commonly with inhaled corticosteroids) and objective monitoring (for example, spirometry and peak flow). Because FeNO reflects nitric oxide produced in the airways and correlates with eosinophilic inflammation, it has been investigated as a noninvasive biomarker to assist diagnosis, predict corticosteroid responsiveness, and support management decisions; however, evidence of consistent benefit for routine clinical use is insufficient.
Definitions
Revision History
Removed criteria for exhaled breath condensate and associated CPT 83987 and delegated that testing to Evicore; background updated.
Removed Benefit Variations section and updated the Disclaimer.
Measurement of exhaled nitric oxide was changed to investigational; background, rationale, and references were updated.
No change to policy statement; added cross reference and updated references.
No change to policy statement; added ICD-10 codes and updated references.
Consensus review with no change to the policy statement; references reviewed and updated.
Consensus review with no criteria changes; references and coding reviewed and updated.
Addition of new ICD-10 codes; effective date 2021-10-01.
Revised measurement of exhaled nitric oxide policy statement from investigational to medically necessary with criteria; updated coding, references, and evidence summary.
Language revised under Product Variation, Benefit Variation and Disclaimer sections; references updated.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.