Measurement of Exhaled Nitric Oxide and Exhaled Breath Condensate in the Diagnosis and Management of Asthma and Other Respiratory Disorders
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This policy governs coverage stance for measurement of fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) when used in the diagnosis and management of asthma and other respiratory disorders for members of certain Capital Blue Cross programs.
Measurement of exhaled nitric oxide is now investigational.
Benefit Variations Section was removed.
Language revised under Product Variation, Benefit Variation and Disclaimer sections during a 05/15/2020 consensus review.
Coverage Criteria — FeNO and EBC
FeNO - Investigational
Covered when ALL of the following are met
Supported by policy statement
EBC - Investigational
Covered when ALL of the following are met
Supported by policy statement
Coverage status
Policy coverage statement revised
Effective from major review dated 02/27/2025
This policy applies only to certain Capital Blue Cross programs and products and is subject to program-specific benefit variations. Providers should verify member coverage and any applicable prior authorization requirements with the member's specific plan before ordering FeNO or EBC testing.
The following procedure codes are designated investigational and are not covered under this policy: 83987 and 95012.
Following a major review dated 02/27/2025, the measurement of fractional exhaled nitric oxide (FeNO) was reclassified as investigational. Investigational services are excluded from coverage unless otherwise specified by the member’s benefit terms.
The available evidence is insufficient to conclude that FeNO- or EBC-guided diagnosis or management improves net health outcomes. Randomized trials and systematic reviews have not consistently demonstrated improved symptoms, functional outcomes, or reductions in clinically important events when management is directed by FeNO; evidence for EBC is limited and heterogeneous. Therefore, these tests are considered not proven to improve outcomes for suspected or confirmed asthma or other respiratory disorders.
The Global Initiative for Asthma (GINA) states that FeNO has not been established as useful for ruling in or ruling out a diagnosis of asthma. GINA notes FeNO may support the decision to start inhaled corticosteroids in some patients (e.g., FeNO >50 ppb associated with short-term response) but should not be used alone to exclude treatment decisions.
As of the policy major review on 02/27/2025, measurement of exhaled nitric oxide is explicitly designated investigational in the diagnosis and management of asthma and related respiratory disorders; claims for investigational services are at risk of denial unless the member’s benefit permits otherwise.
Regulatory, Device and Procedure Codes
| FDA product code MXA | Product code for FeNO measurement devices cleared by the FDA |
| 510(k) De novo DEN 030001 / K02113 / K072816 / KI101034 / K133898 / K182874 | 510(k)/de novo identifiers associated with listed FeNO devices (NIOX, NIOX MINO, NIOX VERO, Fenom Pro) |
| Class I registration | RTube™ and ECoScreen EBC collection systems registered as FDA class I devices to collect expired gas |
| No codes listed |
Provider Actions, Billing and Documentation
Program applicability / Prior authorization
This policy applies only to certain programs and products administered by Capital Blue Cross and is subject to benefit variations and program-specific rules. Providers should verify whether the member’s benefit plan is subject to this medical policy before ordering tests or submitting claims. FEP PPO members should refer to the FEP Medical Policy Manual.
- Applicable programs and products may vary — verify member program prior to testing.
- FEP PPO: Refer to FEP Medical Policy Manual (https://www.fepblue.org/benefit-plans/medical-policies-and-utilization-managementguidelines/medical-policies).
Verify coverage / Prior authorization
Prior authorization requirements vary by product and program. Providers should verify coverage and any prior authorization requirements with Capital Blue Cross prior to performing FeNO or exhaled breath condensate testing. Identification of a code in the coding section does not denote coverage.
- Verify benefits and any prior authorization with the member’s plan before testing.
- The presence of a code in the policy’s coding section is not a guarantee of coverage.
Prior authorization requirement
Prior authorization may be required per the member’s benefit program. Administrative or major review notes in the policy do not substitute for program-level prior authorization requirements; check the member’s contract and Capital Blue Cross prior authorization resources.
- Administrative updates and policy revisions do not remove program-level PA requirements.
- Contact Provider Services for plan-specific prior authorization guidance.
Investigational codes — potential denial risk
Use of investigational procedure codes for FeNO or exhaled breath condensate testing may result in claim denials. Coding listed as investigational should be treated as not covered unless otherwise allowed by the member’s benefit terms.
Investigational coverage change
Coverage was updated on 02/27/2025: measurement of exhaled nitric oxide is now classified as investigational. Providers should expect claims for FeNO or exhaled breath condensate testing to be subject to denial under this policy effective that revision date unless a specific program or contract allows coverage.
- Policy change date: 02/27/2025 — measurement of exhaled nitric oxide reclassified to investigational.
- Claims for these services after the effective revision may be denied in accordance with this policy.
Claims and documentation
Payment of claims is subject to the member’s benefit terms, eligibility on the date of service, and a determination that the service is medically necessary and appropriate. Claims for investigational services may be denied. Providers must submit documentation that supports medical necessity when requesting prior authorization or submitting claims.
- Claims are processed per the member’s contract, including limitations and exclusions.
- Document clinical rationale, relevant diagnostics, treatment history, and any prior authorization approval to support medical necessity.
- Expect denial for services coded as investigational unless an exception exists in the member’s benefits.
Documentation note
When submitting prior authorization requests or claims, reference policy MP 4.038 and include supporting clinical documentation and references as appropriate. Retain records that demonstrate that guideline-directed asthma management and conventional monitoring were used to guide care.
- Reference: Capital Blue Cross policy MP 4.038 when applicable.
- Include supporting documentation: clinical notes, FEV1/peak flow results, medication trials, blood eosinophils/FeNO results (if obtained), and rationale for testing.
- Document attempts at guideline-directed management prior to investigational testing.
Management of asthma typically relies on
Management of asthma typically relies on guideline-directed therapy and conventional monitoring of respiratory parameters (e.g., FEV1 and peak flow) and long-term suppression of inflammation with inhaled corticosteroids, leukotriene inhibitors, or other anti-inflammatory agents. Noninvasive inflammatory measurements such as FeNO or exhaled breath condensate are considered investigational per this policy and may not alter management unless supported by covered indications or benefit terms.
- Continue standard asthma management: symptom assessment, FEV1, peak flow monitoring, and guideline-directed pharmacologic therapy.
- Consider repeating blood eosinophils and FeNO up to three times in severe asthma scenarios before concluding non–type 2 inflammation (e.g., when asthma worsens, after OCS, or on lowest OCS dose).
Investigational use — provider expectations
Investigational applications of FeNO and exhaled breath condensate testing may be denied. Providers should anticipate possible denials and verify benefit coverage before ordering; appeals should include comprehensive clinical documentation and reference to MP 4.038 and current supporting literature.
- Expect possible denials for investigational use of FeNO/EBC.
- If pursuing an appeal, include detailed clinical documentation and cite MP 4.038 and relevant references.
Background and Rationale
Asthma is an inflammatory airway disease characterized by wheeze, dyspnea, cough, and chest tightness. Standard monitoring relies on clinical assessment and conventional physiologic testing such as spirometry, forced expiratory volume in 1 second (FEV1), and peak expiratory flow. Noninvasive biomarkers like FeNO and EBC have been studied to assess airway inflammation, but their routine use for diagnosis or management is not supported by sufficient evidence.
Definitions and Terminology
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