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CurrentAetnaPolicy 0691

Exhaled Breath Tests

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Clinical policy governing medical necessity and investigational status of exhaled breath tests (e.g., hydrogen breath testing, exhaled nitric oxide, breath condensate pH, gastric emptying breath test) for Aetna members.

Policy Summary

PayerAetna

PolicyExhaled Breath Tests

Policy CodePolicy 0691

Change TypeNo material clinical or coverage changes

Effective DateAug 13, 2004

Last ReviewSep 15, 2023

Next Review DateJul 25, 2024

Key ActionFor HBT and FeNO, document that selection criteria are met (e.g., 2‑week lactose‑free diet trial before HBT; FeNO used for asthma evaluation/monitoring in members aged ≥5 years).

SourceLink

2medically necessary tests

7+investigational tests

95012,91065example covered CPT codes

09/15/2023Policy last reviewed

Coverage Criteria for Exhaled Breath Tests

Medically Necessary

Aetna considers the following exhaled breath tests medically necessary when criteria is met:

Hydrogen breath testing (HBT): HBT for evaluation of suspected lactose intolerance/deficiency after a 2-week trial of a lactose-free diet and symptoms of lactose intolerance persistafter 2-week lactose-free diet

HBT covered only for lactose intolerance per policy

Exhaled nitric oxide (FeNO): Measurement of exhaled nitric oxide for evaluation of asthma and for monitoring response to long-term control therapy in members aged 5 years and olderage >= 5 years

FeNO covered for asthma evaluation and monitoring when criteria met

Experimental and Investigational

The following exhaled breath tests are considered experimental and investigational because effectiveness has not been established:

Coding and Test Thresholds

Covered CPT Codes (when selection criteria met) - Hydrogen breath testingCPTCovered

91065

Breath hydrogen or methane test (eg, for detection of lactase deficiency, fructose intolerance, bacterial overgrowth, or oro-cecal gastrointestinal transit).

Covered CPT Codes (when selection criteria met) - Exhaled nitric oxideCPTCovered

95012

Nitric oxide expired gas determination.

CPT Codes Not Covered (for indications listed)CPTNot Covered

83987	pH; exhaled breath condensate.
Gastric emptying breath test (GEBT)	No specific CPT code listed; GEBT is identified in the policy as not covered for indications listed.
Exhaled breath temperature (EBT)	No specific CPT code listed; EBT is identified in the policy as not covered for indications listed.
Exhaled volatile organic compounds	No specific CPT code listed; exhaled volatile organic compounds testing is identified as not covered for indications listed.

Other related CPT codes referencedCPT

44388-44408	Colonoscopy through stoma.
45378-45398	Colonoscopy, flexible.

Covered ICD-10 Codes (when selection criteria met)ICD-10Covered

E73.0-E73.9	Lactose intolerance.
J45.20-J45.998	Asthma.

ICD-10 Codes Not Covered for indications listed (not all-inclusive)ICD-10Not Covered

C34.00-C34.92	Malignant neoplasm of bronchus and lung [screening or diagnosing lung cancer].
K31.84	Gastroparesis [small bowel transit time].
Z12.2	Encounter for screening for malignant neoplasm of respiratory organs.

Additional ICD-10 Codes Not Covered (examples)ICD-10Not Covered

G47.33	Obstructive sleep apnea (adult) (pediatric).
D86.0-D86.89	Sarcoidosis.

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior authorization applies to covered CPT codes when criteria are met

Prior authorization/coverage applies to CPT 91065 (breath hydrogen or methane test) and CPT 95012 (nitric oxide expired gas determination) only when the policy’s selection criteria are met (e.g., HBT after a 2‑week lactose‑free diet with persistent symptoms; FeNO for evaluation/monitoring of asthma in members ≥5 years).

91065 covered when HBT selection criteria met (after 2‑week lactose‑free diet with persistent symptoms).
95012 covered when FeNO selection criteria met (evaluation or monitoring of asthma in members aged ≥5 years).

Prior Authorization

If PA is requested for diagnostic/management uncertainty, document indication and rationale

When ordering FeNO or other exhaled tests to resolve diagnostic or management uncertainty, include the clinical indication and supporting rationale with prior‑authorization requests (for example: diagnostic uncertainty, suspected steroid responsiveness, or reason FeNO measurement is needed beyond routine care).

State the indication (e.g., diagnostic uncertainty, suspected steroid responsiveness).

Background and Scope

Background: Exhaled breath tests are noninvasive markers of airway or digestive tract processes and have been applied in clinical contexts such as asthma management (e.g., fractional exhaled nitric oxide, FeNO) and gastrointestinal disorders (e.g., hydrogen breath testing, HBT). The policy summarizes that FeNO correlates with eosinophilic airway inflammation but evidence that routine FeNO-guided management improves broad clinical outcomes is mixed; HBT is medically necessary for lactose intolerance assessment when selection criteria are met.

Definitions and Test Descriptions

inv-79: FeNO — Fractional exhaled nitric oxide (FeNO): measurement of nitric oxide concentration in exhaled air as a noninvasive marker of eosinophilic ...

Definition — FeNOFractional exhaled nitric oxide (FeNO): measurement of nitric oxide concentration in exhaled air as a noninvasive marker of eosinophilic airway inflammation

Measurement methodSingle‑breath exhalation into device (commonly collected at 50 ml/s) using chemiluminescence or approved analyzers (e.g., NIOX systems)

Clinical implicationElevated FeNO correlates with eosinophilic inflammation and potential steroid responsiveness but is not specific for asthma

inv-80: HBT — Hydrogen breath testing (HBT): breath hydrogen or methane testing used to detect lactase deficiency (lactose intolerance) and other GI co...

Definition — HBTHydrogen breath testing (HBT): measurement of breath hydrogen (and/or methane) at baseline and timed intervals after ingestion of lactose or other carbohydrates to detect malabsorption or bacterial fermentation

Revision History

2023-09-15policy_reviewLatest

Policy last reviewed on 09/15/2023; document remains current with next review scheduled.

2004-08-13policy_effective

Policy originally became effective on 08/13/2004.

Policy Summary

PayerAetna

PolicyExhaled Breath Tests

Policy CodePolicy 0691

Change TypeNo material clinical or coverage changes

Effective DateAug 13, 2004

Last ReviewSep 15, 2023

Next Review DateJul 25, 2024

Key ActionFor HBT and FeNO, document that selection criteria are met (e.g., 2‑week lactose‑free diet trial before HBT; FeNO used for asthma evaluation/monitoring in members aged ≥5 years).

SourceLink

On This Page

Experimental/Investigational Tests: Exhaled breath temperature for lung diseases and other indications; exhaled breath tests for diagnosis of diabetes mellitus or detection/screening of gastric cancer; gastric emptying breath test (GEBT) for gastroparesis and other indications; HBT for indications other than lactose intolerance (examples: IBS, prediction of bowel preparation adequacy prior to colonoscopy, SIBO, small bowel transit time); measurement of exhaled breath condensate (EBC) pH for multiple indications (eg, airway inflammation from bioaerosols, asthma, IBD, lung cancer, OSA, pulmonary diseases, SARS‑CoV‑2); measurement of exhaled volatile organic compounds for cancer detection and other indications; measurement of exhaled nitric oxide for indications not listed as medically necessary (eg, acute mountain sickness, biomarker for pulmonary hypertension, systemic sclerosis lung disease).

List is not all-inclusive

Coverage stance and clinical criteria

FeNO may be considered in specific clinical scenarios but is not routinely supported for serial monitoring in most patients:

Potential appropriate uses: Use of FeNO to identify eosinophilic airway inflammation or to support diagnosis when objective evidence is needed (identification of eosinophilic inflammation supported by strong consensus/moderate evidence; use to support diagnosis is a weaker recommendation).

ATS ad hoc committee (Dweik et al, 2011) conclusions

Situations with limited/uncertain benefit: Routine serial FeNO monitoring to titrate inhaled corticosteroids has not consistently demonstrated improved clinical outcomes in children or adults; evidence from randomized trials and meta-analyses is mixed and guideline groups generally do not endorse routine use.

Meta-analyses and guideline statements (Petsky et al, Cochrane; GINA; Canadian Thoracic Society)

Specific scenarios with positive findings: FeNO-guided algorithms reduced exacerbations in selected populations (for example, children/young adults in some analyses or pregnant women in isolated trials), but external validity and broad guideline endorsement remain limited.

Selected RCTs and subgroup analyses; evidence not conclusive for broad implementation

Evidence-based coverage stance (informational)

Summary clinical conclusions from cited evidence and guidelines

FeNO for routine serial asthma management: Routine serial measurements of FeNO for clinical asthma management do not appear warranted based on meta-analyses of randomized trials; evidence is equivocal for routine use.

Petsky et al and related reviews; trial heterogeneity and bias noted

FeNO to tailor ICS dose: Evidence is insufficient to recommend FeNO to tailor inhaled corticosteroid dosing over titration based on clinical symptoms alone (Canadian Thoracic Society conclusion).

Lougheed et al (2012)

FeNO as diagnostic/management option: NICE guidance states FeNO testing is an option to help diagnose asthma and to support management in symptomatic people on ICS, but the evidence and cost-effectiveness remain inconclusive per systematic review.

Harnan et al (NICE HTA)

FeNO as single surrogate for airway eosinophilia: FeNO, blood eosinophils, and IgE have moderate diagnostic accuracy for sputum eosinophilia but none is sufficiently accurate alone to be definitive; use as a single surrogate will produce false positives/negatives.

Korevaar et al systematic review summary AUCs

Evidence-based coverage considerations

Evidence synthesis and guideline conclusions from the cited reviews and guidelines:

Adults with asthma - FeNO guidance: Meta-analyses in adults show FeNO-guided adjustment reduced exacerbations (eg, OR ~0.60; rate ratio ~0.59; NNTB ≈12 over 52 weeks) but did not consistently improve symptoms, FEV1, or ICS dose across trials.study-level

Cochrane and related adult RCT meta-analyses

Children with asthma - FeNO guidance: Pediatric trials and meta-analyses show mixed results: some analyses report reduced exacerbations in subsets, but overall results are inconsistent and universal recommendation is not supported.study-level

Cochrane, Gomersal et al and other pediatric reviews

FeNO for diagnosis and monitoring: FeNO has moderate accuracy to diagnose asthma (age ≥5) and performs better in steroid-naïve patients, children, and nonsmokers; it can support starting ICS but cannot rule out asthma or universally justify withholding ICS.age >= 5 years

AHRQ and GINA summaries (Wang et al 2017; GINA 2017/2018)

Special populations and other uses: FeNO and extended NO measurements have been explored in COPD, chronic cough, pulmonary hypertension, systemic sclerosis, and other conditions, but evidence is preliminary and not validated for routine clinical use.evidence-availability

Multiple small studies and meta-analyses cited

FeNO: covered with clinical criteria and caveats

Summary of evidence-based utility of FeNO by clinical scenario

FeNO to support ICS initiation in suspected/diagnosed asthma: FeNO measurement can support the decision to start inhaled corticosteroids in patients with diagnosed or suspected asthma, particularly in adult steroid-naïve patients where FeNO > 50 ppb was associated with good short-term ICS response; FeNO should not be used alone to withhold ICS.FeNO > 50 ppb

GINA guidance and referenced studies

FeNO-guided management effect by age: In children and young adults, FeNO-guided treatment reduced exacerbation rates in some analyses (Evidence A), whereas adults did not show consistent benefit; further research needed to define optimal populations and monitoring frequency.age stratified evidence

GINA 2018 update; pediatric meta-analyses

FeNO diagnostic accuracy: FeNO has moderate accuracy to diagnose asthma in people 5 years and older; performance is better in steroid-naïve asthmatics, children, and nonsmokers; insufficient evidence for children under age 5.age >= 5 years

AHRQ comparative effectiveness review (Wang et al 2017)

FeNO in chronic cough: High FeNO is associated with higher likelihood of ICS response in chronic cough (pooled sensitivity ~68.5%, specificity ~81.9%); subgroup analyses favored a cut-off > 25 ppb, but heterogeneity limits certainty.>25 ppb recommended in subgroup analyses

Ambrosino et al 2021 meta-analysis

EBC and other exhaled biomarkers: investigational / not established

EBC pH and other exhaled breath condensate markers

EBC pH and biomarkers: EBC pH, hydrogen peroxide, cytokines, volatile organic compounds, and other EBC biomarkers have been studied in asthma, COPD, lung cancer, cystic fibrosis and other conditions, but methodological pitfalls, lack of standardization, variable dilution and uncertainty about condensate origins limit clinical applicability; further standardization and validation are needed before routine use.no standardized, validated methodology

ATS/ERS Task Force and multiple reviews caution methods are research-stage

Non-asthma uses: investigational or unproven

Evidence in non-asthma conditions

COPD: FeNO levels are mildly elevated in COPD versus controls per pooled analyses, but clinical usefulness in COPD management is uncertain and requires more high-quality studies.meta-analysis findings

Lu et al 2018 systematic review

Pulmonary hypertension: Preliminary studies evaluated FeNO, CANO and exhaled breath temperature in pulmonary hypertension cohorts and reported correlations with physiologic measures (eg, inverse correlation between EBT and mean pulmonary artery pressure) but evidence is limited and not validated for routine monitoring.small cohort studies

Carpagnano et al and related studies

Systemic sclerosis lung disease: Multi-flow FeNO techniques (eg, CANO, CMAD modeling) may discriminate SSc-PAH and SSc-ILD from controls, but multi-flow FeNO measurement is experimental and suitable only in specialized centers pending validation.experimental multi-flow FeNO

Kozij et al 2017

Other conditions: Various EBC biomarkers and VOC panels have shown differences between disease and control groups (eg, lung cancer, IBD, OSA), but these findings are preliminary and lack standardization and external validation for clinical use.research-stage evidence

Multiple systematic reviews and small studies

Clinical contexts and evidence summaries

Tests and contexts described in the evidence where exhaled breath modalities were investigated:

EBC biomarkers for OSA: Systematic reviews identified candidate blood and EBC biomarkers for OSA but overall validity is unclear and diagnostic accuracy is inconsistent across studies.

De Luca Canto et al 2015

EBC pepsin for pulmonary microaspiration: Pepsin is detectable in EBC in bronchiectasis and COPD and moderately correlates with sputum pepsin, but concentrations did not correlate with esophageal pH monitoring in small studies.

Lee et al 2015

EBC oxidative markers in asthma: EBC 8-isoprostane and hydrogen peroxide show associations with asthma and oxidative stress in some studies but results are inconsistent and heterogenous; standardization needed before clinical application.

Peel et al; Teng et al; Shoman et al

EBC RT-PCR for SARS-CoV-2: EBC RT-PCR has shown promising detection rates in small studies (eg, up to 93.5% with 4-gene assays) and higher detection early in illness (≈86% at 2 days), but variability by assay, timing, and severity limits routine recommendation; EBC may be adjunctive to NPS RT-PCR.

Ryan et al; Sawano et al

Gastric emptying breath testing (GEBT): GEBT measures 13C-CO2 over a 4-hour protocol after a standardized 13C-enriched test meal to assess gastric emptying, but gastric scintigraphy remains the reference standard.4 hours test duration

Background GEBT description

Hydrogen breath testing (HBT) protocols and limits: HBT protocols commonly sample every 15 minutes over 2 hours after carbohydrate ingestion; suggested H2 thresholds to predict inadequate bowel preparation ranged 3–10 ppm in reviewed studies, but heterogeneity limits generalizability.2-hour sampling; 3–10 ppm thresholds

Pimentel; Sondhi et al

Evidence summaries (informational)

Evidence summaries and study conclusions (informational):

EBT asthma monitoring: EBT measurement was feasible in most pediatric patients but did not correlate with clinician treatment decisions or asthma control in a prospective study of 159 children; routine intermittent EBT monitoring to adjust ICS therapy is not supported by that study.

Hamill et al 2016

EBT reference values and variability: Adult reference EBT values derived in 298 healthy never-smokers were strongly influenced by ambient temperature and to a lesser extent by sex, indicating external conditions affect measurements.

Carpagnano et al 2017

VOCs and breathomics evidence: Systematic reviews found promising discriminatory VOC signals for diseases (eg, sarcoidosis, asthma, cancers, diabetes) with pooled diagnostic metrics in some analyses, but small sample sizes, heterogeneity, and lack of standardization or external validation limit clinical application.

Azim et al; Wang et al; Yang et al

Diabetes breath tests pooled performance: Meta-analysis of breath tests for type 2 diabetes reported high pooled sensitivity (~91.8%), specificity (~92.1%) and AUC (~0.96), but standardization and blinded validation are required prior to clinical adoption.

Wang et al 2021

Electronic nose pooled performance: Pooled analyses of electronic nose studies reported sensitivity ~90% and specificity ~88.4% with AUC ~0.93, yet lack of standardized reporting and external validation limit generalizability.

Yang et al 2021

Specific CPT and ICD-10 codes and example indications are identified in the policy as not covered for the indications listed in this Clinical Policy Bulletin. Examples called out include CPT 83987 (pH; exhaled breath condensate) as a CPT code not covered for CPB-listed indications. The policy also lists a set of ICD-10 codes (e.g., malignant neoplasms C34.00–C34.92, gastroparesis K31.84, obstructive sleep apnea G47.33) and other CPT entries that are related but not covered for the CPB indications; providers should consult the CPB code tables when submitting claims to ensure tests are billed only under covered codes and appropriate indications.

FeNO measurements are not routinely recommended for evaluation of cough due to gastroesophageal reflux disease (GERD) per ATS guidance and related reviews; the policy states FENO does not appear helpful for diagnosing cough due to GERD. Similarly, guideline statements note that a normal exhaled nitric oxide fraction cannot be used to exclude occupational asthma and that FeNO has not been fully validated as an effective diagnostic test for work-related asthma. Use of FeNO outside the medically necessary asthma indications should be supported by clinical rationale and documented evidence.

Measurement of nasal nitric oxide is not supported as a clinically useful measure for sino-nasal disease based on the reviewed literature. Systematic reviews and narrative syntheses identified heterogeneous methods, multiple confounding factors, and insufficient homogeneity across studies, leading the policy authors to conclude that nasal NO currently lacks consistent evidence for routine clinical application in sino-nasal disorders.

FeNO-guided treatment is not recommended for the general asthma population. Multiple guideline statements (GINA, ATS/ERS) and randomized trials/meta-analyses summarized in the policy found that routine sputum- or FeNO-guided treatment strategies have not consistently demonstrated superiority over guideline- or symptom-based management across adults and children; therefore, routine use for broad population management is not endorsed and should be limited to specific clinical scenarios where evidence supports benefit.

Exhaled breath condensate (EBC) testing and many multi-flow or experimental exhaled biomarkers (including hydrogen peroxide, cytokines, volatile organic compounds and other candidate markers) are presented in the policy as research or experimental methods. The policy emphasizes methodological pitfalls, lack of standardized collection and analysis, and insufficient external validation, and therefore these approaches are not established for routine clinical practice outside of research settings.

Routine intermittent monitoring of exhaled breath temperature (EBT) in children prescribed inhaled corticosteroids is not recommended to guide anti-inflammatory therapy. A prospective pediatric study cited in the policy found EBT measurements were feasible but did not correlate with clinician treatment decisions, asthma control assessments, or treatment step, and thus routine EBT monitoring to adjust inhaled corticosteroid therapy cannot be recommended.

Available evidence does not support routine intermittent EBT monitoring to guide inhaled corticosteroid adjustments in children with asthma. The policy references pediatric and adult validation work showing EBT is influenced by ambient conditions and individual factors and lacks demonstrated relationship with clinical control measures necessary to justify therapy changes.

Many diagnostic studies of breath-based sensor arrays and electronic nose platforms lack independent external validation and have small test-set sample sizes. The policy highlights that these methodological limitations constrain generalizability and that pooled diagnostic accuracy estimates from such studies should be interpreted cautiously until external validation and standardized reporting are available.

Hydrogen breath testing (HBT) is considered medically necessary only for evaluation of suspected lactose intolerance/deficiency after a documented 2-week trial of a lactose-free diet with persistent symptoms; use of HBT for other indications (e.g., IBS, SIBO, prediction of bowel preparation adequacy, small-bowel transit time) is considered investigational and not medically necessary.

Routine tailoring of asthma treatment solely based on serial FeNO measurements has not been shown to consistently improve clinically important outcomes (symptoms, exacerbations, lung function) in children or adults. Randomized trials and Cochrane reviews cited in the policy conclude that FeNO-based algorithms did not reliably outperform symptom- or guideline-based management for routine care.

Routine FeNO monitoring may have limited clinical value in certain populations—examples noted in the policy include elderly asthmatics and pregnant women—because FeNO levels can be low, highly variable within subjects, and weakly correlated with control or spirometric measures; these factors reduce the utility of serial FeNO for management in these groups.

Routine use of FeNO to guide therapy in severe asthma and as additional monitoring in children already managed according to guideline-based strategies is unproven. ATS/ERS and specialty statements cited in the policy recommend against routine FeNO-guided management in severe asthma owing to very low-quality or insufficient evidence for benefit.

Use of EBC markers and many exhaled biomarkers for routine diagnosis or management is not medically necessary outside of research settings. The policy underscores lack of reproducible standardized collection and analytic methods, inconsistent study results, and inadequate evidence of clinical benefit as reasons to restrict these tests to investigational contexts.

Use of EBC 8-isoprostane as a quantitative assessment of oxidative stress in asthma is not established for routine clinical decision-making. Systematic reviews and meta-analyses cited in the policy report inconsistent findings, high heterogeneity, and absence of standardized reference ranges, limiting clinical applicability.

Breath-based biomarkers and sensor-array tests that lack methodological standardization, adequate sample size, and external validation should not be used for routine clinical decision-making. The policy notes that such assays and electronic nose studies often differ in sensors, machine-learning methods, and lack independent test-set validation, creating a high risk that reported accuracy will not generalize to other populations.

No explicit billing/coding in this excerptmixed

No codes listed

Referenced FDA 510(k) summariesmixed

510(k) No. K033688	Micro H2 breath monitoring device with Hydra software utility (FDA 510(k) summary)
510(k) No. K072816	Niox Mino breath nitric oxide test system (FDA 510(k) summary)

inv-35: Age threshold for FeNO monitoring — >= 5 years

Age threshold>= 5 years

Applicable testMeasurement of exhaled nitric oxide (FeNO)

Use casesEvaluation of asthma and monitoring response to long-term control therapy

inv-36: FeNO ranges — Population 5th-95th percentiles and cohort ranges

Population percentiles (NHANES 2007-2010)Children <12 y: 5th–95th percentile 3.5–36.5 ppb; Ages 12–80 y: 5th–95th percentile 3.5–39 ppb

COPD cohort distributionIn a COPD pilot study (n=200): 89% had FeNO <25 ppb; 8% had 25–50 ppb; 3% had >50 ppb

Measurement flowFeNO measured at 50 ml/s using online chemiluminescence per ATS/ERS in NHANES analysis

inv-37: FeNO cutoffs — Examples cited include <25 ppb, 25–50 ppb, >50 ppb; trial cutoffs ranged 15–35 ppb; specific predictive cutpoint 31.5 ppb in one chronic ...

Common categorical cutoffsExamples used across studies: <25 ppb (low), 25–50 ppb (intermediate), >50 ppb (high)

Trial cutoffs rangeCutoffs used in randomized trials varied from 15 to 35 ppb

Specific predictive cutpointA chronic cough meta-analysis cited a study identifying a predictive cutpoint of 31.5 ppb

inv-38: FeNO cut-offs referenced — > 50 ppb (adult steroid-naïve associated with short-term ICS response); > 25 ppb referenced as recommended cut-off with better chronic co...

High FeNO associated with ICS response>50 ppb — in adult steroid‑naïve patients associated with good short‑term response to inhaled corticosteroids (ICS)

Recommended cut-off for chronic cough subgroup>25 ppb — subgroup analyses in chronic cough found improved predictive performance with >25 ppb

inv-39: Hydrogen breath test cut-off — Suggested absolute hydrogen levels to distinguish adequate from inadequate bowel preparation: 3 to 10 ppm

Suggested H2 thresholdsAbsolute hydrogen levels suggested to distinguish inadequate from adequate bowel preparation: 3 to 10 ppm

Study scopeDerived from systematic review of 6 studies with sample sizes 61–127 and heterogeneous protocols

Performance rangeReported sensitivity ranged 71%–100% and specificity 87%–100% depending on cut-off

inv-40: EBC SARS‑CoV‑2 detection timing — Highest EBC detection within 2 days of symptom onset (detection rate reported 86%)

Peak detection timingHighest EBC SARS‑CoV‑2 detection within 2 days of symptom onset

Reported detection rateDetection rate in EBC samples at 2 days since onset reported as 86% in one study

Factors affecting detectionDetection and viral load in EBC varied by need for oxygen/mechanical ventilation, days since onset, and presence of cough/fever

inv-41: FeNO reference ranges / thresholds — Document references studies on normal values and clinical thresholds but no numeric thresholds are provided in this excerpt

Document references normal values but not in excerptPolicy references studies on normal FeNO values and clinical thresholds but does not provide additional numeric thresholds in this excerpt

Supporting statementMultiple referenced studies and reviews (See KC & Christiani NHANES analysis; Korevaar diagnostic accuracy review) provide context for FeNO interpretation

Interpretation caveatLarge inter-individual variation and covariates (age, sex, ethnicity, BMI, smoking, atopy) limit single-point interpretation

Provide supporting clinical rationale and context for how the result will change management.

Prior Authorization

No explicit prior‑authorization requirement stated for FeNO in this policy excerpt

The policy excerpt does not establish payer‑level prior authorization rules for FeNO or other exhaled breath tests; local plan prior‑auth requirements should be confirmed separately.

No explicit PA requirement for FeNO is specified in this document.
Check the member’s benefit plan for any local prior‑authorization rules.

Prior Authorization

Policy excerpt does not specify payer PA for FeNO

This section does not state any payer‑level prior authorization requirements for FeNO testing; providers should not assume uniform PA rules across plans and must verify benefit‑specific authorization policies.

Policy text does not specify payer PA triggers for FeNO.
Confirm authorization requirements with the member’s plan.

Prior Authorization

Prior authorization likely for experimental or nonstandard exhaled tests

Because many exhaled breath condensate (EBC) methods and multi‑flow or other nonstandard exhaled techniques are described as experimental or research‑only, prior authorization or explicit documentation of medical necessity may be required when these nonstandard tests are ordered.

EBC and many multi‑flow FeNO techniques are described as research/experimental and not established for routine clinical use.
Payers may require PA or additional justification for investigational/nonstandard exhaled tests.

Documentation Required

Document procedural protocol elements for breath tests in the record

Document the test protocol in the medical record for breath tests: for GEBT include overnight fast, baseline breath test, standardized 13C‑enriched protein test meal, and serial breath collections over four hours; for HBT document timed breath samples (every 15 minutes over a 2‑hour period) after the challenge carbohydrate.

GEBT: overnight fast, baseline test, standardized 13C protein meal, serial collections over 4 hours.
HBT: timed breath samples every 15 minutes during a 2‑hour testing period after ingestion of the challenge carbohydrate.

Prior Authorization

Provide validation evidence and external validation to justify coverage for investigational tests

When breath‑based diagnostic devices or test methods lack standardized reporting, external validation, or are investigational, provide independent validation evidence and methodologic details to justify coverage (e.g., validation studies, external cohorts, standardized cutpoints and analytic methods).

Submit evidence of standardized reporting and external validation if available.
Document that the device/method has been validated in appropriate populations or provide rationale for clinical use.

Prior Authorization

No PA requirements specified in these excerpts

This excerpt does not define any specific prior authorization requirements for exhaled breath tests; absence of specified PA in the policy does not preclude plan‑level authorization rules elsewhere—confirm with the payer.

No PA requirements are specified in these excerpts.
Verify plan‑specific authorization policies.

Step Therapy

Consider standard symptom/spirometry‑based approaches before FeNO‑guided therapy

The document notes FeNO‑based adjustment of inhaled corticosteroids was not superior to symptom‑ or physician‑based adjustment in BASALT; consider standard symptom/spirometry‑based approaches before implementing FeNO‑guided algorithms.

BASALT trial found no superiority of FeNO‑based adjustment versus physician or symptom‑based strategies for time to treatment failure.
Consider established clinical monitoring before FeNO‑guided therapy.

Step Therapy

No formal step‑therapy requirements specified for FeNO

No formal step‑therapy protocol is provided in this excerpt; FeNO may inform ICS initiation or titration but the policy does not require or specify step‑therapy sequencing or mandatory FeNO‑first steps.

Policy states FeNO may guide ICS decisions but provides no formal step‑therapy protocol.
No step therapy requirements are specified in the excerpt.

Step Therapy

Do not substitute unvalidated EBT‑based adjustments for guideline‑directed monitoring

For asthma monitoring, do not substitute unvalidated exhaled breath temperature (EBT)‑based adjustments for established clinical assessments and guideline‑directed therapy without supporting validation.

EBT measurement did not correlate with clinician treatment decisions or asthma control in a pediatric study; routine intermittent EBT monitoring to adjust ICS is not recommended.
Use validated clinical assessments and guideline‑directed therapy for monitoring.

Documentation Required

Required clinical documentation: show selection criteria are met for HBT and FeNO

Support HBT and FeNO claims with documentation that selection criteria are met: for HBT record that symptoms persisted after a 2‑week lactose‑free diet; for FeNO document patient age (≥5 years) and the asthma evaluation/monitoring indication.

HBT: document a 2‑week trial of lactose avoidance with persistent symptoms prior to testing.
FeNO: document age (≥5 years) and indication (evaluation or monitoring of asthma).

Documentation Required

When FeNO is part of a multi‑component program, document FeNO’s specific role

When FeNO is used within a multi‑component asthma program, clearly document the specific role of FeNO versus other program components so outcomes attributable to FeNO can be evaluated (policy notes the contribution of FeNO could not be determined in multi‑component programs).

Describe how FeNO results informed clinical decisions distinct from other program elements.
Clarify FeNO frequency, thresholds used, and linkage to treatment changes.

Documentation Required

Record FeNO measurement method and patient covariates when reporting results

Report FeNO measurement details and patient covariates used for interpretation (e.g., device/method — 50 ml/s online chemiluminescence per NHANES, age, sex, ethnicity, height, BMI, smoke exposure, allergic history) because population reference percentiles and prediction equations depend on these factors.

Document testing method (flow rate, device type) and relevant covariates (age, sex, ethnicity, height, BMI, smoke exposure, hay fever).
Reference population percentiles/prediction equations when applicable.

Documentation Required

Report numeric FeNO value (ppb) and the cut‑points used for interpretation

Report FeNO values in parts per billion (ppb) and document the cut‑points or trial cutoffs used (examples cited include <25 ppb, 25–50 ppb, >50 ppb; trial cutoffs ranged 15–35 ppb) when results are used to support diagnostic or treatment decisions.

Document the numeric FeNO value in ppb and the cut‑points used to interpret it.
When used to support ICS initiation/titration, include whether patient was steroid‑naïve and the guideline comparator algorithm.

Documentation Required

When using FeNO to guide ICS decisions, document value, context, comparator algorithm and treatment decisions

When FeNO is used to support initiation or titration of inhaled corticosteroids, document the FeNO value, clinical context (e.g., steroid‑naïve status), which guideline‑based comparator algorithm was used, and the treatment decision tied to the measurement.

Include FeNO numeric value, patient steroid exposure status, comparator algorithm, and the specific treatment action taken.
Tie the clinical decision directly to the measurement in the record.

Documentation Required

Include test‑method details (device, ambient conditions, sampling/analysis) in reports

When reporting breath test results, document device type, ambient conditions (e.g., ambient temperature for EBT), sampling and analytical methods, and whether validated reference values or external validation cohorts were used.

Document device model and analytic method.
For EBT, record ambient temperature; for other tests, document sampling methods and any external validation used.

Denial Risk

Denial trigger: billing codes for investigational/non‑covered exhaled tests may be denied

Use CPT codes only as specified by the policy: use CPT 83987 (EBC pH) or CPTs for tests labeled experimental/investigational only with caution — use of CPT codes not listed as covered (e.g., 83987) or codes for tests identified as experimental/investigational may trigger claim denial.

Claims for EBC pH (CPT 83987) or other tests listed as investigational may be denied.
Submit justification and evidence when billing for methods not listed as covered.

Denial Risk

Denial risk: routine serial FeNO monitoring for management may be challenged

Claims that rely on routine serial FeNO monitoring for management may be challenged or denied because several randomized trials and meta-analyses did not show consistent improvement in clinical outcomes with routine FeNO‑based monitoring.

Szefler et al. (2008) and BASALT (Calhoun et al., 2012) found no improvement in key outcomes with routine FeNO monitoring in some trials.
Meta‑analyses show mixed results; routine serial FeNO monitoring is not consistently supported.

Billing Rule

No explicit procedural or billing authorization rules stated in this excerpt — verify with payer

This document segment does not state explicit procedural or billing authorization requirements; however, clinical utility is described as limited or inconclusive in multiple contexts — verify local payer billing/authorization rules before ordering.

No explicit PA or billing instructions are provided in these chunks.
Verify plan‑specific authorization and billing policies.

Billing Rule

No payer billing/authorization instructions in this excerpt — confirm with plan

No explicit payer authorization or billing instructions are present in these chunks; providers should confirm authorization and coding with the member’s plan since the policy focuses on clinical utility rather than plan‑specific PA triggers.

Policy text does not supply payer PA triggers or billing instructions.
Confirm authorization and coding with the plan prior to testing.

Denial Risk

Nonstandardized EBC methods risk noncoverage

Methods and measurements for exhaled breath condensate are not standardized and lack validated clinical utility; ordering or billing for EBC methods without standardized methodology or validation may result in noncoverage.

EBC collection and analysis lack standardization and reproducibility per ATS/ERS and reviews.
Lack of validated clinical utility increases risk of noncoverage for EBC tests.

Denial Risk

HBT protocol variability and cut‑off heterogeneity may affect coverage and interpretation

Hydrogen breath testing protocols and analyzers are heterogeneous and reported cut‑offs vary (suggested H2 thresholds 3–10 ppm to predict inadequate bowel prep); document local method and validation because variability could affect interpretation and lead to denials if the local method is not validated.

HBT protocols vary; suggested hydrogen cut‑offs to distinguish adequate vs inadequate bowel prep ranged from 3–10 ppm.
Document the protocol and analyzer used and any local validation data.

Denial Risk

Validation and generalizability risk for unvalidated breath diagnostics

Tests and sensor‑array breath diagnostics without independent external validation, standardized reporting, or adequate sample sizes may have limited generalizability; provide validation data and standardized reporting when requesting coverage to mitigate denial risk.

Electronic nose and breathomics studies often lack independent external validation and have small test‑set sample sizes limiting generalizability.
Supply external validation and standardized accuracy reporting when available.

Note

No explicit authorization/denial triggers in these chunks — verify plan rules and document medical necessity

The policy notes no explicit authorization or denial triggers in these chunks and clarifies that Clinical Policy Bulletins assist plan benefit administration; providers remain responsible for medical advice and treatment—confirm any required authorizations with the plan and ensure clinical documentation supports medical necessity.

Clinical Policy Bulletins do not substitute for plan authorization processes.
Providers should verify authorization and document medical necessity in the record.

Typical protocolBreath samples commonly every 15 minutes over a 2‑hour testing period after carbohydrate load; used after a 2‑week lactose‑free diet trial if symptoms persist

Covered indicationCovered for evaluation of suspected lactose intolerance when symptoms persist after a 2‑week lactose‑free diet

inv-81: FeNO — Fractional exhaled nitric oxide — a noninvasive biomarker reflecting airway eosinophilic inflammation and potential steroid responsiveness.

FeNO as biomarkerFeNO reflects airway eosinophilic inflammation and has moderate diagnostic accuracy for sputum eosinophilia (adult AUC ~0.75; pediatric AUC ~0.81)

LimitationsModerate sensitivity and specificity mean FeNO alone will yield false positives/negatives; interpretation should consider clinical context

UnitsReported in parts per billion (ppb)

inv-82: FeNO (fractional exhaled nitric oxide) — Measurement description including common collection flow (50 ml/s).

Measurement flow rateCommon collection flow for FeNO is 50 ml/s using online chemiluminescence devices per ATS/ERS guidance

Procedure summaryPatient inhales NO‑free air to total lung capacity then slowly exhales into mouthpiece while device records NO concentration

Example devicesExamples include NIOX Breath and NIOX MINO systems

inv-83: Diagnostic accuracy AUC — Area under the receiver operator curve used to summarize test accuracy (e.g., FeNO AUC ~0.75 in adults for detecting sputum eosinophilia).

Diagnostic accuracy metricArea under the receiver operator curve (AUC) used to summarize test accuracy; FeNO AUC ~0.75 in adults for detecting sputum eosinophilia

Evidence baseMeta-analysis included 32 studies (24 adult, 8 pediatric) with varying risk of bias

ImplicationModerate diagnostic accuracy supports FeNO as adjunctive, not definitive, test for airway eosinophilia

inv-84: FeNO definition (ppb) — Fractional exhaled nitric oxide, measured in parts per billion (ppb), a noninvasive biomarker that correlates with eosinophilic airway in...

Reported categorical rangesStudy examples report FeNO categories: <25 ppb (low), 25–50 ppb (intermediate), >50 ppb (high)

COPD cohort exampleIn a COPD pilot (n=200): mean FeNO 15.3 ppb; 89% <25 ppb; 8% 25–50 ppb; 3% >50 ppb

Trial variabilityRandomized trials used cutoffs ranging 15–35 ppb when adjusting therapy