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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:

1. Diagnosis of Asthma
   The current method of asthma diagnosis focuses on the clinical history and the demonstration of reversible airflow limitation. For example, spirometry measurements may be performed before and after the administration of a short-acting bronchodilator to demonstrate the presence of reversible airflow limitation. Measurement of exhaled nitric oxide levels has been suggested as either an alternative or adjunct to spirometry.

2. Response to Anti-Inflammatory Treatment
   Declining levels of exhaled nitric oxide suggest declining inflammation.

3. Monitoring Compliance of Anti-Inflammatory Treatment
   Persistent elevation of exhaled nitric oxide may suggest poor compliance with long-term therapy.

4. Detection of Steroid Resistance
   Steroid resistance may be reflected by persistently high nitric oxide levels despite corticosteroid treatment. Steroid resistance may be related to poor inhalation technique, inadequate dosage, overwhelming anti-inflammatory technique, or poor compliance.

5. Prediction of Exacerbation of Asthma
   Currently, prediction of exacerbation of asthma is based on self-assessment of peak flow meter measurements. Increasing levels of exhaled nitric oxide may be able to predict exacerbations before the onset of clinical symptoms or changes in peak flow values.

6. Dose Optimisation
   There has been interest in using measurements of exhaled nitric oxide to guide dosing of anti-inflammatory medications.

Aside from asthma, the following clinical applications of NO measurement have been proposed:

1. Assessment of Chronic Cough
   Chronic cough may be related to smoking, postnasal drip, gastroesophageal reflux, COPD, or asthma. Elevation of exhaled nitric oxide may point to asthma as the etiology.

2. Assessment of Cystic Fibrosis
   Exhaled nitric oxide appears to be decreased in patients with cystic fibrosis.

3. Rhinitis
   Nasal nitric oxide (as opposed to exhaled nitric oxide) may be increased in patients with allergic rhinitis.

4. Primary Ciliary Dyskinesia
   Nasal nitric oxide may be decreased in patients with primary ciliary dyskinesia.

Measurement of Nitric Oxide
The most commonly used technique for measurement of exhaled nitric oxide is chemiluminescence after reaction with ozone. Exhaled nitric oxide is typically measured during single breath exhalations. First, the subject inspires nitric oxide-free air via a mouthpiece until total lung capacity is achieved, followed immediately by exhalation through the mouthpiece into the measuring device. The early studies of exhaled nitric oxide showed various levels of nitric oxide in health and disease, attributed to the lack of a standardized technique of measurement. In 1999, the American Thoracic Society published recommendations for the standardized measurement of exhaled 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.

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.

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.

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.

All codes billed for this procedure are considered investigational and not eligible for coverage. 

Non-Covered Codes

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