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What Does FeNO Testing Coverage and Reimbursement Look Like in the US?

Fractional exhaled nitric oxide (FeNO) testing, the simple and non-invasive way to measure the amount of nitric oxide (NO) that is exhaled from the lungs, has emerged as an important test to help identify airway inflammation.1,2 As a result, US health insurance companies, also known as payers, are beginning to realize the importance and benefits of FeNO testing for asthma patients.

Many studies have shown that FeNO testing is cost-effective and can assist in asthma diagnosis, predict response to inhaled corticosteroids (ICS), optimize therapy, monitor adherence and reduce exacerbations by up to 50%.3-8 This is great news to payers as the potential downstream cost-savings from this align with the goal of ensuring the patient receives quality asthma care. Additionally, the implementation of FeNO testing has the potential to deliver more good news for all stakeholders:

  • For the patient: FeNO testing currently has broad payer coverage, improving access to the care they need9
  • For the healthcare provider (HCP): FeNO testing can help improve the diagnosis and management of asthma patients with one quick test, right at the point-of-care5,7,10
  • For the payer: The reimbursement rate for FeNO testing is nominal. The US national payer average is $20 per test9,11

The Past and Exciting Present of the Payer and Coverage Landscape

Approximately 84% of all US insured lives are covered for FeNO testing when positive and silent coverage are considered.12 This is for the approximately 325 million trackable covered and insured lives in the US across private (commercial), government payer (Medicaid and Medicare) and Veterans Administration (VA)12

This is a marked improvement for asthma patients. With the advent of new asthma drug approvals, specifically novel biologics, FeNO testing was often included in the clinical studies’ protocols for the development of these novel drugs.13-17 This has piqued the clinical education interest of HCPs, and even some payers, who might previously have had low awareness of FeNO testing.

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Payers often partner with a third-party company to handle prior authorization requests on a per-case basis. When faced with increased amounts of prior authorizations, payers will look closer at their non-covered medical policies that are generating above-average prior authorization requests. These increased prior authorization requests ultimately raise the payers’ third-party administrative fees. FeNO testing reimbursement rates for a payer are often less than the fee a payer gives to the third-party to review the prior authorization.18

In 2019, the third largest national payer, Aetna (~23 million covered lives), changed its FeNO testing medical coverage policy to positive.19 More recently, in 2023, Blue Cross Blue Shield’s largest single state plan, Blue Cross Blue Shield of Michigan (~5 million lives covered) followed suit with a switch to positive.20

UnitedHealthcare (~47 million covered lives) has effectively retired its FeNO testing policy (no longer having a published medical coverage reimbursement policy for this service). “Retiring” a medical coverage policy will often be referred to as “silent” after this switch. Most often in cases where a payer has retired their FeNO testing medical coverage policy, or the payer has never had a FeNO policy, claim submissions are typically approved for coverage and reimbursement by the payer. Silent coverage does not guarantee coverage or reimbursement.

For FeNO testing, often the payer requirement is simply that the FeNO test is for a diagnosis and/or management of asthma only and that the HCP deems FeNO testing medically necessary.

FeNO testing coverage in the US has increased from 40% to approximately 84% of all insured lives.12 With this greater coverage and reimbursement, access to FeNO testing could provide asthma patients and HCPs with more opportunities to help improve asthma diagnosis and management.4,5,7,21

To see how FeNO testing could help improve your asthma patient outcomes, learn more at niox.com.

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References

1. Khatri SB et al. An official American Thoracic Society clinical practice guideline: use of fraction-al exhaled nitric oxide to guide the treatment of asthma. Am J Respir Crit Care Med. 2021;204(10):e97-e109. 2. Busse WW et al. Baseline FeNO as a prognostic biomarker for subsequent severe asthma exacerbations in patients with uncontrolled, moderate-to-severe asthma receiving placebo in the LIBERTY ASTHMA QUEST study: a post-hoc analysis. Lancet Respir Med. 2021;9(10):1165-1173. 3. Barry LE et al. Cost-Effectiveness of Fractional Exhaled Nitric Oxide Suppression Testing as an Adherence Screening Tool Among Patients With Difficult-to-Control Asthma. The Journal of Allergy and Clinical Immunology: In Practice. 2023. 4. Sabatelli L et al. Cost-effectiveness and budget impact of routine use of fractional exhaled nitric oxide monitoring for the management of adult asthma patients in Spain. J Investig Allergol Clin Immunol. 2017;27(2):89-97. 5. Menzies-Gow A et al. Clinical utility of fractional exhaled nitric oxide in severe asthma management. Eur Respir J. 2020;55(3):1901633. 6. Porsbjerg C et al. Asthma. The Lancet. 2023. 7. Hanania NA et al. Measurement of fractional exhaled nitric oxide in real-world clinical practice alters asthma treatment decisions. Ann Allergy Asthma Immunol. 2018;120(4):414-418. 8. Petsky HL et al. Exhaled nitric oxide levels to guide treatment for adults with asthma. Cochrane Database Syst Rev. 2016;9(9):CD011440. 9. NIOX®. Data on File; MKT-DOF-008. 2023. 10. Alving K et al. Validation of a new portable exhaled nitric oxide analyzer, NIOX VERO®: randomized studies in asthma. Pulm Ther. 2017;3:207-218. 11. Kaiser Family Foundation (KFF). How Much More Than Medicare Do Private Insurers Pay? A Review of the Literature. Available at; https://www.kff.org/medicare/issue-brief/how-much-more-than-medicare-do-private-insurers-pay-a-review-of-the-literature/. Accessed; January 2024. 12. NIOX®. Data on File; MKT-DOF-009. 2023. 13. ClinicalTrials.gov. Search results for; asthma, FeNO, dupilumab. Available at; https://clinicaltrials.gov/search?cond=Asthma&term=dupilumab,%20feno. Accessed; January 2024. 14. ClinicalTrials.gov. Search results for; asthma, FeNO, tezepelumab. Available at; https://clinicaltrials.gov/search?cond=Asthma&term=tezepelumab,%20feno. Accessed; January 2024. 15. ClinicalTrials.gov. Search results for; asthma, FeNO, omalizumab. Available at; https://clinicaltrials.gov/search?cond=Asthma&term=omalizumab,%20feno. Accessed; January 2024. 16. ClinicalTrials.gov. Search results for; asthma, FeNO, mepolizumab. Available at; https://clinicaltrials.gov/search?cond=Asthma&term=mepolizumab,%20feno. Accessed; January 2024. 17. ClinicalTrials.gov. Search results for; asthma, FeNO, benralizumab. Available at; https://clinicaltrials.gov/search?cond=Asthma&term=benralizumab,%20feno. Accessed; January 2024. 18. Nalashaa Healthcare Solutions. Why prior-authorization automation is more than a trivial need for health plans. Available at; https://blog.nalashaahealth.com/prior-authorization-automation-for-healthplans/. Accessed; January 2024. 19. Asthma and Allergy Foundation of America. Aetna Decides FeNO Testing Is Medically Necessary for Its Members With Asthma. Available at; https://community.aafa.org/blog/aetna-decides-feno-testing-is-medically-necessary-for-its-members-with-asthma. Accessed; January 2024. 20. Blue Cross Blue Shield Blue Care Network Medical Policy. Exhaled nitric oxide and exhaled breath condensate in the diagnosis and management of respiratory disorders. Available at; https://www.bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/87127.pdf. Accessed; January 2024. 21. Price DB et al. Fractional exhaled nitric oxide as a predictor of response to inhaled corticosteroids in patients with non-specific respiratory symptoms and insignificant bronchodilator reversibility: a randomised controlled trial. Lancet Respir Med. 2017;6(1):29-39.