Summary Of Evidence

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Analysis of Evidence

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History/Background and/or General Information

Aerosol or vapor inhalation involves the administration of drugs or solution of drugs by the nasal or oral respiratory route for local or systemic effect. The drugs or solution of drugs commonly administered via a nebulizer or aerosol include distilled water, hypertonic saline, and bronchodilators such as anticholinergics and B-Agonists.

Inhalation therapy is used in the therapeutic treatment of patients with known lung disease, as well as for producing bronchodilation, mobilizing sputum, and inducing sputum production for diagnostic purposes.

This policy addresses the use of aerosol or vapor inhalation for sputum mobilization, bronchodilation, and sputum induction for diagnostic purposes.

If a patient is unable to produce sputum, inhalation of a nebulized solution of 3 or 4 ml of distilled water or hypertonic sodium chloride results in the induction of an adequate specimen for examination. Any type of nebulizer may be used; however, ultrasonic nebulizers, which produce a concentrated mist, are preferred. The procedure is terminated when an adequate specimen is obtained, the nebulizer solution is exhausted, or after a maximum of 15-20 minutes. The procedure is most often used for patients suspected of having tuberculosis or a lung malignancy, and to search for Pneumocystis carinii infection in patients with the acquired immunodeficiency syndrome (AIDS).

Covered Indications

The use of an aerosol or vapor inhalation for diagnostic purposes will be considered medically reasonable and necessary for the following indications:

• For the induction/mobilization of sputum in a patient who presents with signs and symptoms of a respiratory infection (e.g., fever, dyspnea, chest congestion, cough) or suspected lung malignancy, and who is unable to produce an adequate sputum specimen for examination by conventional methods;
• For the induction/mobilization of sputum in a patient who continues to demonstrate signs and symptoms of a respiratory infection (e.g., fever, dyspnea, chest congestion, cough) despite antibiotic treatment, and who is unable to produce an adequate sputum specimen for follow-up examination by conventional methods; and/or
• To produce bronchodilation prior to a pulmonary function test (PFT), when the patient’s functional ability to perform the test is decreased and would otherwise result in an inconclusive finding.

Limitations

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.