Nebulizers, pneumatic or ultrasonic, are devices which use either compressed gas or high-frequency electric oscillations to aerosolize liquid medication into a fine mist for inhalation into the lower-respiratory tract. The medications are delivered either continuously or intermittently via a facemask or mouthpiece.

Pneumatic Nebulizers

A small volume, non-filtered nebulizer with compressor may be considered medically necessary for the administration for inhaled medications, as per The U.S. Food and Drug Administration (FDA) indications for ANY of the following conditions listed below. The medications for these conditions may include but are not limited to those listed.

• Pulmonary disease, including, but not limited to:
  • Chronic bronchitis, or;
  • Chronic Obstructive Pulmonary Disease (COPD), or;
  • Emphysema, or;
  • Asthma.or;
  • COVID-19 (Coronavirus Disease 2019), or;
    • Beta-adrenergics (albuterol), or;
    • Isoproterenol,or;
    • Isoetharine, or;
    • Levalbuteral, or;
    • Metaproterenol),or;
    • Anticholinergics (ipratropium), or;
    • Corticosteroids (budesonide), or;
    • Cromolyn, or;
    • Formoterol (Perforomist), or ;
    • Arformoterol (Brovana)
• Bronchiectasis
  • Antibiotics such as, Tobramycin
• Persistent thick or tenacious secretions
  • Acetylcysteine
• Croup
  • Epinephrine
• Multi-drug resistant P. aeruginosa pneumonia failing to improve with IV therapy
  • Colistin
• Mycobacertium Avium Complex (MAC) with complex pulmonary disease not responsive to conventional three drug treatment of macrolide, rifampin and ethambutol.
  • Amikacin liposome inhalation suspension (Arikayce), 

A small volume, nonfiltered nebulizer with compressor may be considered medically necessary for the administration of inhaled medications ONLY when the medical necessity requirements for the medications, that are found in HMK Medical Policy  I-143 Inhalation Products for the Management of Cystic Fibrosis,  have been met:

All other uses of small volume, nonfiltered nebulizer with compressor are considered not medically necessary.

A small volume, filtered nebulizer with compressor may be considered medically necessary for the administration of pentamidine for individuals with ANY of the following conditions:

• Human immunodeficiency virus (HIV); or
• Post-organ transplantation with complications; or
• Pneumocystosis.

All other uses of small volume, filtered nebulizer with compressor are considered not medically necessary. 

A large volume nebulizer, with compressor, or a nebulizer with compressor and heater, may be considered medically necessary to deliver humidity to a person with thick, tenacious secretions, with ANY of the following indications:

• Bronchiectasis; or
• Cystic Fibrosis (CF); or
• Tracheobronchial stent; or
• Tracheostomy

A non-disposable reservoir bottle when used with large volume nebulizers is considered not medically necessary.

A prefilled disposable large volume nebulizer is non-covered.

An unfilled disposable large volume nebulizer is non-covered.

All other uses of a large volume nebulizer, with compressor, or a nebulizer with compressor and heater are considered not medically necessary.

Ultrasonic Nebulizers

Ultrasonic nebulizers may be considered medically necessary for delivery of tobramycin (Tobi) for individuals with CF ONLY when the medical necessity requirements for the medication, found in HMK Medical Policy I-143 Inhalation Products for the Management of Cystic Fibrosis, have been met AND when ALL of the following indications are met:

• The individual meets the criteria for a standard nebulizer; and
• The primary care physician and specialist indicate that the individual has been compliant with other nebulizer and medication therapy; and
• The use of a standard nebulizer has failed to control the individual's disease and prevent the individual from utilizing the hospital or emergency room.

All other uses of ultrasonic nebulizers are considered not medically necessary.

A large volume ultrasonic nebulizer has no proven clinical advantage over a pneumatic compressor and nebulizer and is considered not medically necessary.

Accessories may be considered medically necessary when the nebulizer, compressor, and medications are medically necessary. 

The following table lists the usual maximum frequency of replacement for accessories. Claims for more than the usual maximum replacement amount are considered not medically necessary:

The use of nebulizers is typically an outpatient service which is only eligible for coverage as an inpatient service in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.