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Current techniques for diagnosing and monitoring asthma and predicting exacerbations are suboptimal. Two new strategies, evaluation of exhaled nitric oxide (NO) and exhaled breath condensate (EBC) are proposed. These techniques are also potentially useful in the management of other conditions such as chronic obstructive pulmonary disease (COPD) and chronic cough. There are commercially available devices for measuring nitric oxide in expired breath and various laboratory techniques for evaluating components of exhaled breath condensate.
For example, the National Heart Lung and Blood, in its clinical guidelines regarding the management of asthma, offers the following definition:
“Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role, in particular: mast cells, eosinophils, T lymphocytes, macrophages, neutrophils and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment. The inflammation also causes an associated increase in the existing bronchial hyper responsiveness to a variety of stimuli.”
Guidelines for the management of persistent asthma stress the importance of long-term suppression of inflammation using steroids, leukotriene inhibitors, or other anti-inflammatory drugs. Existing techniques for monitoring the status of underlying inflammation have focused on bronchoscopy with lavage and biopsy, or analysis by induced sputum. Given the cumbersome nature of these techniques, the ongoing assessment of asthma focuses not on the status of the underlying chronic inflammation, but rather on regular assessments of respiratory parameters such as FEV-1 and peak flow. Therefore, there has been interest in measuring exhaled nitric oxide as a non-invasive and convenient technique for assessing the underlying pathogenic chronic inflammation as reflected by measurements of inflammatory mediators. Two new strategies have been investigated, the measurement of exhaled nitric oxide and the evaluation of exhaled breath condensate. Nitric oxide is an important endogenous messenger and inflammatory mediator that is widespread in the human body, functioning, for example, to regulate peripheral blood flow, platelet function, immune reactions, and gas phase, nitric oxide is fairly stable, permitting its measurement in exhaled air. While nitric oxide is a volatile mediator that can be measured in exhaled air, most inflammatory mediators are not volatile and thus cannot be detected in the gas phase. Exhaled breath condensate (EBC) consists of exhaled air passed through a condensing or cooling apparatus, resulting in an accumulation of fluid. Although EBC is primarily derived from water vapor, it also contains aerosol particles or respiratory fluid droplets, which in turn contains various nonvolatile inflammatory mediators, such as cytokines, leukotrienes, oxidants, antioxidants and various other markers of oxidative stress. The pH of EBC can also be measured. Various studies have focused on different components of EBC as inflammatory markers in respiratory disease. The following clinical roles for measurement of NO and EBC have been investigated in the diagnosis and management of asthma:
Aside from asthma, the following clinical applications of NO measurement have been proposed:
Measurement of Nitric Oxide
In 2003, the U.S. Food and Drug Administration (FDA) approved for marketing the Nitric Oxide Monitoring System (NIOX) with the following indication:
“[Measurements of the fractional nitric oxide (NO) concentration in expired breath (FE-NO)] provide the physician with means of evaluating an asthma patient’s response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments in asthma. NIOX should only be used by trained physicians, nurses and laboratory technicians. NIOX cannot be used with infants or by children approximately under the ages of 4, as measurement requires patient cooperation. NIOX should not be used in critical care, emergency care or in anesthesiology.”
The Breathmeter is another device used to measure exhaled nitric oxide using laser spectroscopy. The Breathmeter has not yet received FDA approval for marketing.
Collection and Measurement of Exhaled Breath Condensate (EBC)
The basic technique of collecting EBC consists of a technique to cool exhaled air and collect EBC droplets. One commercially available system, the RTube consists of a disposable polypropylene condensation chamber that is cooled by an overlying aluminum cooling sleeve. There are a variety of laboratory techniques to measure the components of EBC, including such simple techniques as pH measurement, to the more sophisticated gas chromatography/mass spectrometry or high performance liquid chromatography, depending on the component of interest.
POLICYMeasurement of exhaled nitric oxide is considered investigational in the diagnosis and management of asthma and other respiratory disorders including, but not limited to chronic obstructive pulmonary disease and chronic cough.
Measurement of exhaled breath condensate is considered investigational in the diagnosis and management of asthma and other respiratory disorders including, but not limited to chronic obstructive pulmonary disease and chronic cough.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all devices approved for marketing by the FDA may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/25/2004: Approved by Medical Policy Advisory Committee (MPAC)
4/29/2004: Code Reference section completed
3/22/2005: Code Reference section updated, CPT code 0064T added non-covered codes, CPT code 84999 Note: "To report services on or after 1/1/2005, see CPT code 0064T" added
12/22/2005: Collection and Measurement of Exhaled Breath Condensate and coding 0140T added to policy
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
1/3/2007: Policy reviewed, no changes
12/17/2008: Policy reviewed, no changes
05/28/2010: Title updated with "Exhaled Breath Condensate"; Description section updated; Policy Statement section - existing policy statement was divided into two statements: one for exhaled nitric oxide and the other for exhaled breath condensate - both remain investigational; FEP verbiage was added to the Policy Exceptions section; and Code Reference section was updated to add new CPT Code 83987 and CPT Code 94799 to the Non-Covered Codes Table.
02/23/2011: Policy reviewed; no changes.
02/24/2012: The first policy statement was revised to change “exhaled or nasal nitric oxide” to “exhaled nitric oxide.” Intent unchanged. Deleted outdated references from the Sources section. Removed deleted CPT codes 0064T and 0140T from the Code Reference section.
04/04/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.61
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.