Description

Exhaled breath tests are noninvasive methods designed to measure certain gases and compounds found in exhaled breath. The measurement of these gases has been proposed for use as markers for airway inflammation. Though introduced primarily to aid in asthma management, exhaled breath tests have been suggested for use in the evaluation of other respiratory disorders with an inflammatory component, such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary hypertension and are also suggested for gastrointestinal (GI) use. Marker identification is purportedly useful for physicians to verify a diagnosis, monitor adherence to anti-inflammatory therapy or for predicting upcoming exacerbations.

Exhaled breath markers for airway inflammation include the measurement of nitric oxide and/or breath condensate pH. Gastric emptying breath testing (GEBT) and hydrogen breath testing (HBT) are examples of tests used to diagnose certain gastrointestinal conditions.

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Exhaled Breath Tests

Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0325-017
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Exhaled Nitric Oxide Testing

Nitric oxide (NO) is produced by the respiratory tract mucosa (lining) and is supposedly a powerful mediator involved in airway inflammation. It has been suggested that elevated levels of NO in exhaled air, referred to as fractional exhaled NO (FeNO), could serve as markers of airway inflammation. Measurement changes of FeNO in expired breath purportedly aids in evaluating how an individual with asthma is responding to anti-inflammatory therapy and serves as an adjunct (addition) to established clinical and laboratory assessments of asthma.

Exhaled nitric oxide (ENO) testing involves breathing through a mouthpiece that is connected to a computer by a tube. The individual breathes in air to total lung capacity then slowly exhales into the mouthpiece and the computer screen displays the NO concentration. Examples of ENO testing systems include, but may not be limited to, NIOX VERO and NObreath. (Refer to Coverage Limitations section)

Exhaled Breath Condensate pH Testing

Exhaled breath condensate (EBC) pH is being investigated as a biomarker for airway inflammation. Acidic or low pH measurements have been demonstrated in individuals with asthma and COPD.

EBC pH testing involves breathing into a tube that is surrounded by a cold metal sleeve for 10 to 15 minutes. The pH is obtained and measured from the collection of water vapors created by the lungs. (Refer to Coverage Limitations section)

Gastric Emptying Breath Testing

GEBT was developed to aid in the diagnosis of gastroparesis (delayed gastric emptying). This condition is characterized by slow or nonmovement of food from the stomach to the small intestine due to improper contractions of stomach muscles. Gastroparesis may result from conditions such as Parkinson’s disease, diabetes or following intestinal surgery. Gastric scintigraphy is considered the gold standard for diagnosing gastroparesis. For information regarding gastric scintigraphy, please refer to Gastrointestinal Motility Monitoring Medical Coverage Policy.

The ¹³C-Spirulina Gastric Emptying Breath Test (GEBT) is conducted over a four-hour period after an overnight fast and reportedly measures how fast the stomach

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. empties solids by measuring carbon dioxide in an individual’s breath. Baseline breath tests are conducted before the individual eats a specially made protein test meal enriched with carbon-13. This substance is then measured via breath testing at multiple time points after the meal to determine the rate of gastric emptying. (Refer to Coverage Limitations section)

Hydrogen Breath Testing

Lactose intolerance or deficiency is caused by the inability to digest lactose, which is found in milk and other dairy products. This condition typically involves symptoms such as abdominal pain, bloating, diarrhea, gas or nausea. Individuals with suspected lactose intolerance are generally advised to follow a dairy-free diet for a period of time to determine if symptoms will resolve. Further testing, such as HBT, may be indicated if symptoms continue.

HBT involves measuring breath hydrogen (H2) before and at timed intervals after ingesting a solution containing lactose. The individual blows into balloon-like bags from which the exhaled breath is tested for the presence of hydrogen. The exhalations are captured and tested every fifteen minutes during a two-hour testing period. Normally, very little hydrogen is detected in exhaled breath; however, when undigested lactose becomes fermented in the colon, hydrogen is produced. Raised levels of hydrogen found in exhaled breath may aid in diagnosis of lactose intolerance or deficiency.

For information regarding breath tests for transplant rejection (eg, Heartsbreath), please refer to Molecular Diagnostic Assays and Breath Testing for Transplant Rejection Medical Coverage Policy.

Coverage Determination

Humana members may be eligible under the Plan for HBT for evaluation of suspected lactose intolerance/deficiency for persistent symptoms (eg, abdominal pain, bloating, diarrhea, gas, nausea).

Note: The criteria for hydrogen breath testing are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for HBT for any indications other than those listed above including, but may not be limited to, the following:

Exhaled Breath Tests Effective Date: 06/22/2023

Revision Date: 06/22/2023

Review Date: 06/22/2023

Policy Number: HUM-0325-017

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Irritable bowel syndrome (IBS); OR
• Small bowel transit time/gastroparesis; OR
• Small intestinal bacterial overgrowth (SIBO)

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the following types of breath testing:

• EBC pH; OR
• ENO; OR
• GEBT

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about asthma, gastroparesis or lactose intolerance may be found from the following websites:

• American Academy of Allergy, Asthma and Immunology
• American College of Gastroenterology
• American Lung Association
• National Library of Medicine

Alternatives to breath tests for airway inflammation include, but may not be limited to, the following:

Medical Alternatives

• Peak expiratory flow rate (PEFR)
• Spirometry

Alternatives to GEBT include, but may not be limited to, the following:

• Gastric scintigraphy

Physician consultation is advised to make an informed decision based on an individual's health needs.

Exhaled Breath Tests Effective Date: 06/22/2023

Revision Date: 06/22/2023

Review Date: 06/22/2023

Policy Number: HUM-0325-017

Page: 5 of 11

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.