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 addresses coverage and medical necessity 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 change

Effective DateN/A

Next Review DateN/A

Key ActionDo not submit claims for FeNO (95012) or EBC pH (83987) as these services are designated not covered / not medically necessary; verify member benefits for plan-specific coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2CPT/HCPCS codes listed as not covered / not medically necessary

Not coveredCoverage stance for FeNO and EBC (commercial and MA)

InsufficientEvidence judged insufficient

2015 / 09/08/2022Policy maintenance

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Coverage determinations and policy scope

Coverage determinations as stated in policy

Covered when ALL of the following are met:

Commercial Products - FeNO and EBC: Measurement of exhaled nitric oxide (FeNO) and measurement of exhaled breath condensate (EBC) are considered not medically necessary in the diagnosis and management of asthma, eosinophilic asthma, and other respiratory disorders (including but not limited to chronic obstructive pulmonary disease and chronic cough) because the evidence is insufficient to determine that the technology results in an improvement in net health outcome.

Supported by diagnostic accuracy studies, RCTs, and systematic reviews that found inconsistent effects on clinical outcomes (see chunks 13,15).

Medicare Advantage Plans - EBC: Measurement of exhaled breath condensate is not covered in the diagnosis and management of asthma and other respiratory disorders because the evidence is insufficient to demonstrate improvement in net health outcome.

Explicit Medicare Advantage noncoverage statement in policy (chunk 5).

Medicare Advantage Plans - FeNO: Measurement of exhaled nitric oxide is not covered in the diagnosis and management of asthma, eosinophilic asthma, and other respiratory disorders for Medicare Advantage members (see general policy statement).

Policy statement indicates noncoverage; see chunks 4 and 6.

Benefits and coverage may vary by contract. Refer to the member’s applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for plan-specific benefits, exclusions, and limitations that apply to measurement of exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC).

Services determined to be not medically necessary or otherwise designated as non-covered benefits under the member’s subscriber agreement or employer agreement are excluded from coverage. Providers may not bill the member for such services unless the member was informed and provided prior written agreement to pay as described in the member’s contractual documents.

Measurement of fractional exhaled nitric oxide (FeNO) and measurement of exhaled breath condensate (EBC) are considered not medically necessary for the diagnosis and management of asthma and other respiratory disorders. Accordingly, CPT codes 95012 (Nitric oxide expired gas determination) and 83987 (pH; exhaled breath condensate) are designated as not covered / not medically necessary for the products referenced in this policy because the evidence is insufficient to demonstrate an improvement in net health outcome.

When services are determined not to be medically necessary (or are medically necessary but are non-covered benefits under the member’s plan), those services may be denied and the provider may not bill the member unless the member provided written agreement to pay in advance. Benefits and eligibility are governed by the member’s subscriber agreement or employer agreement, which supersede this policy.

CPT/HCPCS coding and coverage status

Not covered / Not medically necessary (EBC)CPTNot Covered

83987

pH; exhaled breath condensate

Not covered / Not medically necessary (FeNO)CPTNot Covered

95012

Nitric oxide expired gas determination

Prior authorization, benefit verification, and billing guidance

Prior Authorization

Prior authorization and member-specific coverage

Prior authorization is not applicable for these tests. Coverage and medical necessity are determined by the member's benefit documents and subscriber agreement; contact the provider call center for member-specific benefits and coverage determinations.

Prior authorization: Not applicable
For member-specific coverage and benefit verification, contact the provider call center or refer to the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement

Denial Risk

Denial triggers — codes and services not covered

Claims for measurement of exhaled nitric oxide (CPT 95012) and exhaled breath condensate pH (CPT 83987) are identified as not covered / not medically necessary per this policy.

CPT 95012 — Nitric oxide, expired gas determination: Not covered / Not medically necessary

Clinical background and rationale

Background: Fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) are noninvasive approaches proposed to assess airway inflammation in patients with suspected or confirmed asthma and other respiratory conditions. FeNO reflects nitric oxide concentration in exhaled breath and correlates with eosinophilic airway inflammation and response to corticosteroids; EBC is condensate collected from cooled exhaled air that can contain nonvolatile inflammatory mediators (for example, pH, cytokines, and oxidative markers). Available studies are heterogeneous, and systematic reviews and clinical trials have not demonstrated consistent improvements in patient health outcomes when management is guided by these measurements, leading to the policy determination of insufficient evidence to support routine clinical use.

Key definitions

inv-17: FeNO — Fractional exhaled nitric oxide definition

TermFractional exhaled nitric oxide (FeNO)

DefinitionThe concentration of nitric oxide in exhaled breath, typically measured at an exhalation rate of 50 mL/sec and expressed in parts per billion.

Clinical relevanceFeNO is elevated in patients with asthma and decreases with corticosteroid treatment; used as a noninvasive marker of eosinophilic airway inflammation.

inv-18: EBC — Exhaled breath condensate definition

TermExhaled breath condensate (EBC)

DefinitionCondensate collected by passing exhaled air through a cooling or condensing apparatus; primarily water vapor but includes aerosolized respiratory droplets containing nonvolatile inflammatory mediators (e.g., cytokines, leukotrienes, oxidants).

Policy updates and references

2015policy_origin

Policy originally established addressing measurement of FeNO and EBC for asthma and other respiratory disorders.

2022-09-08last_review

Policy last reviewed and updated (document last review date 2022-09-08).

2022-09-08coverage_statement_updateLatest

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 change

Effective DateN/A

Next Review DateN/A

Key ActionDo not submit claims for FeNO (95012) or EBC pH (83987) as these services are designated not covered / not medically necessary; verify member benefits for plan-specific coverage.

SourceLink

On This Page

CPT 83987 — pH; exhaled breath condensate: Not covered / Not medically necessary

Denial Risk

Denial risk for non-medically necessary or non-covered services

If services are determined to be not medically necessary or are non-covered benefits, providers may be unable to bill the member unless the member was informed in advance and agreed in writing to accept financial responsibility. Refer to your participation agreement for applicable provisions.

Providers should obtain written member agreement before providing services known to be non-covered or not medically necessary if they intend to bill the member
Verify and document member notification and agreement per participation agreement and plan rules

Note

Benefit verification

Verify benefits and eligibility prior to providing services. Benefits may vary between groups and contracts; refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for plan-specific coverage details.

Benefit verification: Check the member's Benefit Booklet/Evidence of Coverage/Subscriber Agreement
For member-specific determinations or questions, contact the provider call center

Analytic methodsComponents of EBC can be measured by simple tests (pH) or advanced techniques (gas chromatography, mass spectrometry, high-performance liquid chromatography).

inv-19: FeNO shorthand — FeNO (fractional exhaled nitric oxide)

ShorthandFeNO

Expanded formFractional exhaled nitric oxide

Units / measurementReported as nitric oxide concentration in parts per billion based on the mean of 2–3 values at a standardized exhalation flow rate.

inv-20: Exhaled breath condensate — EBC sampling method for airway markers including nitric oxide and pH

MethodEBC is collected by passing exhaled air through a cooling or condensing apparatus to accumulate condensate for analysis.

Contents sampledPrimarily water vapor plus aerosolized respiratory droplets that contain nonvolatile inflammatory mediators (cytokines, leukotrienes, oxidants) and markers such as pH.

Laboratory analysis optionsSimple measurements (pH) to advanced assays (gas chromatography, mass spectrometry, HPLC) depending on target analyte.

Reaffirmed coverage stance: measurement of fractional exhaled nitric oxide (FeNO) and exhaled breath condensate (EBC) are considered not covered / not medically necessary; CPT codes 95012 and 83987 listed as not covered/not medically necessary.

References and guideline sources: Key citations include international and specialty society guidance and systematic reviews, for example the ERS/ATS guideline on severe asthma and ATS clinical practice guidance on interpretation of FeNO, as well as multiple systematic reviews and primary studies on FeNO and EBC (see the policy reference list for full details).