Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Measurement of Exhaled Nitric Oxide and Breath Condensate in the Diagnosis and Management of Asthma and Other Respiratory Disorders

Policy #:07.11.02f

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

EXHALED NITRIC OXIDE

Measurement of exhaled nitric oxide (i.e., eNO, FeNO) is considered medically necessary and, therefore, covered when used as an adjunctive test to aid in the diagnosis of asthma using spirometry and, if necessary, provocation for individuals with suspected asthma.

Measurement of exhaled nitric oxide (i.e., eNO, FeNO) in individuals with an established diagnosis of asthma is considered medically necessary and, therefore, covered when used for any of the following purposes:
  • Evaluation of response to anti-inflammatory treatment
  • Monitoring compliance with anti-inflammatory treatment
  • Detection of steroid resistance
  • Prediction of exacerbation of asthma
  • Dose optimization

A maximum of five exhaled nitric oxide tests in a 12-month period is considered medically necessary and, therefore, covered.

Measurement of exhaled nitric oxide (i.e., eNO, FeNO) for the diagnosis and management of other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease (COPD) and chronic cough, is considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of these services cannot be established by review of the available published peer-reviewed literature.

EXHALED BREATH CONDENSATE

The collection and analysis of exhaled breath condensate (EBC) for the diagnosis and management of asthma or other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease (COPD) and chronic cough, is considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of these services cannot be established by review of the available published peer-reviewed literature.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the measurement of exhaled nitric oxide (i.e., eNO, FeNO) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Subject to the terms and conditions of the applicable benefit contract, the measurement of exhaled nitric oxide (i.e., eNO, FeNO) for the diagnosis and management of other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease (COPD) and chronic cough, is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Subject to the terms and conditions of the applicable benefit contract, the measurement of exhaled breath condensate (EBC) in the diagnosis and management of asthma and other respiratory disorders including, but not limited to, chronic obstructive pulmonary disease (COPD) and chronic cough, is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA that measure exhaled nitric oxide (NO) in expired human breath as a marker for inflammation in individuals with asthma.

In April 2003, the NIOX Breath Nitric Oxide Test System® (NIOX®) received FDA approval as a Class II device through the 510(k) process. The device is intended to aid in evaluating an asthma patient’s response to anti-inflammatory therapy by measuring changes in fractional exhaled nitric oxide concentration as an adjunct to established clinical and laboratory assessments of asthma.

In March 2008, the NIOX MINO®, a hand-held device designed to measure fractional exhaled nitric oxide in human breath, received FDA approval through the 510(k) process. The device was approved for the following indication:
    "FENO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. NIOX MINO® should only be used as directed in the NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists or laboratory technicians. NIOX MINO® cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO® should not be used in critical care, emergency care or in anaesthesiology."

In 2008, the Apieron INSIGHT™ eNO System received FDA approval through the 510(k) process. The intended use is to quantitatively measure exhaled nitric oxide in expired breath as a maker of inflammation for persons with asthma. The system is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. The system can be used by trained operators in a physician’s office laboratory setting, and should not be used in critical care, emergency care, or in anesthesiology.

RTube® Exhaled Breath Condensate collection system (Respiratory Research, Inc.; Charlottesville, VA) and the ECoScreen EBC collection system (CareFusion, Germany) are registered with the FDA as Class I devices for the collection of expired gas and are, therefore, exempt from the premarket notification requirement.

Description

Asthma is a chronic inflammatory disorder of the airways that affects millions of individuals worldwide. This disease causes the lungs to become constricted and inflamed, which limits airflow and makes it difficult to breathe. Long-term suppression of inflammation through the use of steroids, leukotriene inhibitors, or other anti-inflammatory drugs is critical in the management of persistent asthma.

The most accurate techniques for monitoring the status of underlying inflammation associated with asthma include bronchoscopy with lavage and biopsy, and analysis of induced sputum. Although these tests are reliable, they are invasive and too cumbersome to use for routine monitoring. Routine surveillance of asthma has focused more on respiratory parameters, such as the one-second forced expiratory volume and peak flow values, which measure the volume of rapidly exhaled air rather than assess underlying inflammation.

There has been intense interest in developing noninvasive techniques to assess the underlying pathogenic chronic inflammation associated with asthma through the measurement of inflammatory mediators. Two strategies are currently being investigated: the measurement of fractional exhaled nitric oxide (FeNO) and the evaluation of exhaled breath condensate (EBC).

The measurement of FeNO is a noninvasive test that calculates the concentration of nitric oxide (NO) in human air exhaled from the nasal or oral cavity. NO is an endogenous messenger that regulates peripheral blood flow, platelet function, immune reactions, and neurotransmission; it is also a mediator of inflammation. In biologic tissues, NO is unstable; however, in the gas phase it is fairly stable and can be measured in exhaled air. The concentration of NO molecules is measured by a chemiluminescence gas analyzer using integrated software. This analyzer is operated by a trained physician, nurse, or laboratory technician. A plastic shield is placed over the individual's nose or mouth, and a breathing tube connects the shield to the analyzer. Once the shield is in place, NO-free air is inhaled to total lung capacity, followed by a slow exhalation back into the tube. The reading of NO concentration is immediately displayed on the analyzer's screen. Exhaled NO is usually measured during single-breath exhalations. A decrease in the measurement of exhaled NO suggests that lung inflammation is reduced; an increase suggests that lung inflammation is increased.

EBC is a technique that involves collecting cool exhaled air and EBC droplets. The collection can be obtained in a commercially available system, called the RTube® (Respiratory Research, Inc.; Charlottesville, VA). This system contains a disposable polypropylene condensation chamber that is cooled by an overlying aluminum cooling sleeve. There are various laboratory methods used to measure the components of EBC, which range from simple techniques, such as PH measurement, to the more sophisticated gas chromatography/mass spectrometry or high performance liquid chromatography, depending on what component is needed.

The measurement of NO and EBC in individuals with asthma has been investigated for the following purposes:
  • Diagnosis of asthma
  • Evaluation of response to anti-inflammatory treatment
  • Monitoring compliance with anti-inflammatory treatment
  • Detection of steroid resistance
  • Prediction of exacerbation of asthma
  • Dose optimization

Aside from asthma, measurement of NO has been proposed to diagnose and/or assess the following conditions:
  • Chronic cough
  • Cystic fibrosis
  • Rhinitis
  • Primary ciliary dyskinesia
  • Chronic obstructive pulmonary disease (COPD)

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Szefler SJ, Martin RJ, King TS, et al. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol. 2002;109(3):410-418.

Szefler SJ, Mitchell H, Sorkness CA, et al. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomized controlled trial. Lancet. 2008;372(9643):1065-1072.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY
95012

EXPERIMENTAL/INVESTIGATIONAL
83987


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

For Exhaled Nitric Oxide, report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.


For Exhaled Breath Condensate, all diagnoses are considered Experimental/Investigational.



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Revisions from 07.11.02f:
03/26/2018The coverage position for the use of Exhaled Nitric Oxide was changed from Experimental/Investigational to Medically Necessary for the following indications:
  • When used as an adjunctive test to aid in the diagnosis of asthma using spirometry and if necessary provocation for individuals with suspected asthma
  • When used in individuals with an established diagnosis of asthma for the following purposes:
    • Evaluation of response to anti-inflammatory treatment
    • Monitoring compliance with anti-inflammatory treatment
    • Detection of steroid resistance
    • Prediction of exacerbation of asthma
    • Dose optimization
  • A maximum of five exhaled nitric oxide tests in a 12-month period is covered.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 03/26/2018
Version Issued Date: 03/26/2018
Version Reissued Date: N/A

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