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 states the coverage stance for using FeNO and EBC testing in the diagnosis and management of asthma and other respiratory disorders for Blue Cross Blue Shield - Rhode Island beneficiaries.

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 Date

Key ActionConfirm member coverage and benefits prior to ordering; CPT codes 83987 and 95012 are listed as not covered/not medically necessary and may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2CPT codes listed as not covered

2015-03-03Effective date

insufficient evidenceRationale

24+References cited

Cochrane

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Coverage Criteria

Commercial Products - Not Medically Necessary

Covered when ALL of the following are met:

Commercial coverage stance: Measurement of exhaled nitric oxide and exhaled breath condensate is considered not medically necessary in the diagnosis and management of asthma and other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease and chronic cough as the evidence is insufficient to determine the effect of the technology on health outcomes.

BlueCHiP for Medicare - Not Medically Necessary

Covered when ALL of the following are met:

BlueCHiP for Medicare stance: Measurement of exhaled nitric oxide and exhaled breath condensate is considered not medically necessary for management of asthma and other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease and chronic cough because the evidence is insufficient to determine the effect of the technology on health outcomes.

The policy notes device-specific limitations for NIOX devices. NIOX should not be used in infants or children approximately under age 4 because measurement requires cooperation. Additionally, NIOX devices are not to be used in critical care, emergency care, or anesthesiology settings. (Device variations: some handheld NIOX MINO® models are unsuitable for children younger than age 7 as described in the device summaries.)

Overall, systematic reviews and randomized trials have not consistently demonstrated that routine measurement of FeNO or analyses of exhaled breath condensate (EBC) lead to improved health outcomes. Trials of FeNO-guided medication management showed inconsistent effects on exacerbations and no consistent benefit on day-to-day symptoms or hospitalizations; Cochrane reviews found reduced exacerbations in children but not adults and no consistent impact on other clinical outcomes. Evidence for using FeNO to select biologic therapy or for managing non-asthma respiratory disorders is limited and does not establish improved net health outcomes. Evidence for EBC is limited by heterogeneity in measured biomarkers and a lack of data showing impact on clinical management or outcomes.

If services are determined to be not medically necessary (or are non-covered benefits), providers should confirm member-specific benefits via the provider call center. When a service is deemed not medically necessary, the provider may not charge the member for those services unless the member has been informed and has agreed in writing in advance to accept financial responsibility. Refer to the member’s subscriber agreement, benefit booklet, or participation agreement for applicable terms.

Measurement of fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) described in this policy has been determined to be not medically necessary for diagnosis or management of asthma and other respiratory disorders because the evidence is insufficient to demonstrate an effect on health outcomes. The policy does not list additional explicit conditions or exceptions that would render these services medically necessary in this document; benefit and coverage determinations are governed by the member’s contract and subscriber documents.

Coding

Not Covered / Not Medically Necessary CPT CodesCPTNot Covered

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

Provider Actions & Billing

Prior Authorization

Prior authorization

Not applicable

Note

Benefit verification required

Benefits may vary between groups and contracts. Refer to the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable coverage and benefit details. Provider must verify member-specific benefits and eligibility via the provider call center prior to providing services.

Denial Risk

Not medically necessary / Not covered codes

The following CPT codes are considered not covered / not medically necessary and may result in claim denial or member billing if rendered: 83987 (pH; exhaled breath condensate) and 95012 (Nitric oxide expired gas determination). Providers should confirm coverage prior to billing; services determined to be not medically necessary may result in provider billing to the member only if the member was informed and provided written agreement in advance per participation agreement.

Background

FeNO and EBC are noninvasive respiratory biomarker tests proposed to assess airway inflammation. FeNO measures the fractional concentration of nitric oxide in exhaled breath (commonly measured at an exhalation flow rate of 50 mL/sec and reported in parts per billion) and has been associated with an eosinophilic asthma phenotype. EBC is collected by cooling exhaled air to produce a condensate containing water vapor and aerosolized respiratory fluid droplets with measurable inflammatory mediators (for example, cytokines, leukotrienes, and oxidants). Both types of tests have commercially available collection devices; some FeNO devices received FDA 510(k) clearance for specified adjunctive uses, and EBC collection systems are registered as FDA Class I devices.

Definitions

Fractional Exhaled Nitric Oxide (FeNO) — definition and measurement details

DefinitionFractional exhaled nitric oxide (FeNO) is the measurement of the fractional concentration of nitric oxide in exhaled breath expressed in parts per billion.

Typical measurement methodSingle-breath exhalations after inspiring NO-free air via a mouthpiece followed by exhalation into a measuring device; results are based on the mean of 2–3 values.

Standard flow rateBest measured at an exhalation flow rate of 50 mL per second maintained within ±10% for >6 seconds at an oral pressure between 5 and 20 cm H2O, per ATS/ERS guidance.

Result unitsReported as nitric oxide concentration in parts per billion (ppb).

Device availability/notesDevices measuring FeNO are commercially available in the United States; measurement performed using an oral mouthpiece technique as described above.