Measurement of Exhaled Nitric Oxide and Exhaled Breath Condensate in the Diagnosis and Management of Asthma and Other Respiratory Disorders
DESCRIPTION
There is an interest in the measurement of exhaled nitric oxide (ENO) and exhaled breath condensate (EBC) in the research community. How these measurements may be related to the diagnosis and management of respiratory disorders are being studied.
Measurement of ENO is being investigated as a noninvasive marker of airway inflammation. ENO is typically measured during single breath exhalations. First, the individual inspires nitric oxide-free air via a mouthpiece until total lung capacity is achieved. This is followed immediately by exhalation through the mouthpiece into the measuring device. Researchers have raised concerns regarding the lack of a standardized protocol for monitoring ENO, which creates difficulties for use of ENO levels for monitoring.
Examples of devices used for the measurement of ENO include: the Nitric Oxide Monitoring System (NIOX) which is FDA approved and the Breathmeter which has not yet received FDA approval.
Measurement of EBC is being investigated as a noninvasive method for studying the composition/inflammation of the fluid lining the airway. There are a variety of laboratory techniques to measure EBC. These techniques include pH measurement, gas chromatography/mass spectrometry and high performance liquid chromatography. It is not known if EBC pH measurements provide accurate estimates of airway pH. Researchers have raised concerns regarding the standardization of EBC collection and measurement methods.
An example of a device used for the measurement of EBC is the RTube.
POLICY
Measurement of exhaled nitric oxide for the diagnosis and management of respiratory disorders, including, but not limited to the following: asthma, chronic cough, cystic fibrosis, and primary ciliary dyskinesia is considered investigational.
Measurement of exhaled breath condensate for the diagnosis and management of respiratory disorders, including, but not limited to the following: asthma, chronic cough, cystic fibrosis, and primary ciliary dyskinesia is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed, long-term studies in peer-reviewed journals that evaluate whether the addition of exhaled nitric oxide and exhaled breath condensate measurements to clinical and lung function assessment results in improved control of respiratory disorders are not available.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2008). Measurement of exhaled nitric oxide and exhaled breath condensate in the diagnosis and management of asthma and other respiratory disorders (2.01.61). Retrieved December 28, 2009 from BlueWeb. (43 articles and/or guidelines reviewed)
Global Initiative for Asthma. (2006). Global strategy for asthma management and prevention. Retrieved April 7, 2008 from http://www.ginasthma.org. http://www.ginasthma.org/Guidelineitem.asp??l1=2&l2=1&intId=1561 (59 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2007, August; 2009, October update search). Nitric oxide breath analysis for the diagnosis and management of asthma. Retrieved December 28, 2009 from http://www.Hayesinc.com/subscribers. (47 articles and/or studies reviewed)
Malinovschi, A., Janson, C., Holmkvist, T., Norback, D., Merilainen, P., & Hogman, M. (2006). IgE sensitization in relation to flow-independent nitric oxide exchnage parameters. Respiratory Research, 7 (1), 92.
Menzies, D., Nair, A., & Lipworth, B. J. (2007). Portable exhaled nitric oxide measurement: Comparison with the gold standard technique. Chest, 2007 (131), 410-414.
Szefler, S. J., Mitchell, H., Sorkness, C. A., Gergen, P. J., O'Connor, G. T., Morgan, W. J., et al. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: A randomised controlled trial. Lancet 2008; 372 (9643), 1065-1072. Abstract retrieved December 20, 2009 from PubMed database.
The Technology Evaluation Center (2006, February). Exhaled nitric oxide monitoring as a guide to treatment decisions in chronic asthma (Vol.20, No. 17). Chicago: BlueCross BlueCross Association. (23 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 11/11/2006
MOST RECENT REVIEW DATE: 2/11/2010
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.