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Nebulizers and Inhalation Solutions
MA05.007g

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.​

PNEUMATIC NEBULIZERS

MEDICALLY NECESSARY
A small-volume, nonfiltered nebulizer with compressor is considered medically necessary and, therefore, covered when used for the administration of any of the following medications:
  • Albuterol, arformoterol,​ budesonide, cromolyn, formoterol,​ ipratropium, levalbuterol, or revefenacin for individuals with chronic obstructive pulmonary disease (COPD; e.g., asthma, emphysema, and chronic bronchitis)
  • Tobramycin for individuals with cystic fibrosis (CF) or bronchiectasis
  • Dornase alfa for individuals with CF
  • Acetylcysteine for individuals with persistent thick or tenacious pulmonary secretions
  • Pentamidine for individuals with any of the following conditions:
    • Human immunodeficiency virus (HIV)
    • Post-organ transplantation with complications
    • Pneumocystosis
  • ​​Hypertonic saline for individuals with CF, bronchiectasis, or ciliary dyskinesia
  • Ensifentrine as an add-on therapy for the management of COPD (e.g. asthma, emphysema, and chronic bronchitis) in individuals who are on dual long-acting beta-agonist (LABA) and long-acting muscarinic-agonist (LAMA) therapy, or triple LABA+LAMA and inhaled corticosteroid (ICS) therapy, and experience one of the following:
    • ​​​​Continued COPD exacerbations
    • Persistent dyspnea
A small-volume, filtered nebulizer with compressor is considered medically necessary and, therefore, covered for the administration of pentamidine to an individual with any of the following conditions:
  • HIV
  • Post-organ transplantation with complications
  • Pneumocystosis
A large-volume unfilled nebulizer with compressor or a nebulizer with compressor and heater is considered medically necessary and, therefore, covered when both of the following criteria are met:
  • There is clinical presentation of at least one of the following:
    • Bronchiectasis
    • CF
    • Tracheobronchial stent
    • Tracheostomy
  • Humidity is required for tenacious pulmonary secretions
NOT MEDICALLY NECESSARY
All other uses for pneumatic nebulizers are considered not medically necessary and, therefore, not covered.

ULTRASONIC NEBULIZERS AND CONTROLLED-DOSE INHALATION DRUG-DELIVERY SYSTEM

MEDICALLY NECESSARY
A small-volume ultrasonic nebulizer for the administration of treprostinil inhalation solution is considered medically necessary and, therefore, covered for individuals with pulmonary hypertension who meet either of the following criteria: 
  • The individual meets all of the following criteria:
    • The individual has a diagnosis of pulmonary artery hypertension and the pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left-sided atrial or ventricular disease, left-sided valvular heart disease) or disorders of the respiratory system other than interstitial lung disease (see below) (e.g., COPD, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders).
    • The individual has primary pulmonary hypertension or pulmonary hypertension, which is secondary to conditions that include, but are not limited to, the following: connective tissue disease, HIV infection, cirrhosis, anorexigens (i.e., diet drugs), or congenital left-to-right shunts. If these conditions are present, all of the following criteria must be met:
      • The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition
      • The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion
      • The individual has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope)
      • Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out
  • The individual has a diagnosis of pulmonary hypertension associated with interstitial lung disease and all of the following criteria are met:
    • The presence of interstitial lung disease has been confirmed by a high-resolution computed topography (CT) scan of the chest
    • The mean pulmonary artery pressure is 25 mm Hg or greater
    • The pulmonary capillary wedge pressure or left ventricular end-diastolic pressure is 15 mm Hg or less
    • The pulmonary vascular resistance is 3 Wood units or greater at rest
    • The individual has significant symptoms of pulmonary hypertension (e.g., dyspnea on exertion, fatigability)
 A controlled-dose inhalation drug-delivery system for the administration of iloprost is considered medically necessary and, therefore, covered for individuals with pulmonary hypertension who meet all of the following criteria: 
  • The individual has a diagnosis of pulmonary artery hypertension and the pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left-sided atrial or ventricular disease, left-sided valvular heart disease) or disorders of the respiratory system (e.g., COPD, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders)
  • The individual has primary pulmonary hypertension or pulmonary hypertension, which is secondary to conditions that include, but are not limited to, the following: connective tissue disease, HIV infection, cirrhosis, anorexigens (i.e., diet drugs), or congenital left-to-right shunts. If these conditions are present, all of the following criteria must be met:
    • The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition
    • The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion
    • The individual has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope)
    • Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out
NOT MEDICALLY NECESSARY
The use of small-volume ultrasonic nebulizers for the delivery of any medication other than treprostinil inhalation solution, or that does not meet the medical necessity criteria, is considered not medically necessary and, therefore, not covered.

The use of the controlled-dose inhalation drug-delivery system for the delivery of any medication other than iloprost inhalation solution, or that does not meet the medical necessity criteria, is considered not medically necessary and, therefore, not covered.

NOT COVERED
A large-volume ultrasonic nebulizer is an item not covered by Medicare because it offers no proven clinical advantage over a pneumatic compressor and nebulizer, and, therefore, is not covered and not eligible for reimbursement consideration by the Company because it is considered a convenience item.

ACCESSORIES FOR PNEUMATIC NEBULIZERS

MEDICALLY NECESSARY
Accessories for pneumatic nebulizers are separately reimbursable if the related aerosol compressor is considered medically necessary and the accessories are used in accordance with the time frames specified below.

The following accessories have a maximum replacement of one per month:
  • Face tent 
  • Administration set, with a small-volume filtered pneumatic nebulizer
  • Aerosol mask, used with a DME nebulizer 
  • Tracheostomy mask
The following accessories have a maximum replacement of two per month:
  • Administration set, with a small-volume nonfiltered pneumatic nebulizer, disposable 
  • Small-volume, nonfiltered pneumatic nebulizer, disposable, in addition to administration set, with small-volume, nonfiltered pneumatic nebulizer, disposable
  • Water collection device, used with large-volume nebulizer 
  • Filter, disposable, used with aerosol compressor 
  • Large-volume nebulizer, disposable, unfilled, used with aerosol compressor 
The following accessory has a maximum replacement of one unit (100 feet) per 2 months:
  • Corrugated tubing, disposable, used with large-volume nebulizer, 100 feet 
The following accessories have a maximum replacement of one per 3 months:
  • Administration set, with small-volume nonfiltered pneumatic nebulizer, nondisposable only when used with controlled-dose inhalation drug-delivery system 
  • Filter, nondisposable, used with aerosol compressor or ultrasonic generator 
The following accessory has a maximum replacement of one per 6 months:
  • Administration set, with small-volume nonfiltered pneumatic nebulizer, nondisposable 
The following accessories have a maximum replacement of one per 3 years:
  • Nebulizer, durable, glass or autoclavable plastic, bottle type, not used with oxygen 
  • Immersion external heater for nebulizer 
NOT MEDICALLY NECESSARY
Kits and concentrates used to clean respiratory equipment are considered not medically necessary and, therefore, not covered.

ACCESSORIES FOR ULTRASONIC NEBULIZERS

MEDICALLY NECESSARY
Accessories for ultrasonic nebulizer are separately reimbursable if the related small-volume ultrasonic generator nebulizer is considered medically necessary and the accessories are used in accordance with the time frame specified below.

The following accessory has a maximum replacement of two per year:
  • Dome and mouthpiece, used for small-volume ultrasonic nebulizer 
NOT COVERED
A reservoir bottle, nondisposable, used with a large-volume ultrasonic nebulizer is a device that is excluded from coverage by Medicare and, therefore, is not covered and not eligible for reimbursement consideration by the Company because it is considered a convenience item.

COMPOUNDED INHALATION SOLUTIONS

NOT MEDICALLY NECESSARY
Compounded inhalation solutions are considered not medically necessary, and therefore, not covered.

NONCOMPOUNDED INHALATION SOLUTIONS
 

NOT ELIGIBLE FOR REIMBURSEMENT 
Noncompounded metaproterenol solution is no longer manufactured and has been withdrawn from market; therefore, it is not eligible for reimbursement.​

OTHER NEBULIZATION DEVICES AND ACCESSORIES

MEDICALLY NECESSARY
A disposable, unfilled nebulizer that can be filled with water or saline by the individual or a caregiver is an acceptable alternative and considered medically necessary and, therefore, covered if the medical necessity criteria listed above for a large-volume nebulizer with compressor are met.

NOT MEDICALLY NECESSARY
A large-volume nebulizer, related compressor or generator, and water or saline when used predominantly to provide room humidification are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of illness or injury. 

Technological advancements or newly released upgrades to equipment, when the original equipment still functions properly and/or there are no significant changes in the individual's condition, are considered not medically necessary and, therefore, not covered. Refer to the policy addressing the repair and replacement of durable medical equipment (DME) for more information.

NOT COVERED
If there are no nebulizable drugs that are covered and eligible for reimbursement by Medicare under either part B or part D for the individual​, then the compressor, the nebulizer, and other related accessories/supplies are, therefore, not covered and not eligible for reimbursement consideration by the Company because the items are not required for the individual’s condition.  

A prefilled disposable large-volume nebulizer is an item not covered by Medicare because it is not considered to be DME and, therefore, not covered and not eligible for reimbursement consideration by the Company because it is considered a convenience item.

A spacer is not covered by Medicare because it is not considered to be DME and, therefore, not covered and not eligible for reimbursement consideration by the Company because the item is not required for the individual’s condition. ​ ​

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation.

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES ​(WHEN APPLICABLE)
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.

For specified DME items, documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.

Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, nebulizers are categorized as durable medical equipment (DME) and are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

 The FDA has approved numerous nebulizer devices.

Description

Nebulizers are devices used to quickly convert liquid medication (e.g., bronchodilators, steroids) into a fine mist or aerosol for inhalation into the lower respiratory tract. The medications are delivered either continuously or intermittently via a face mask or mouthpiece. Nebulizers are commonly used by individuals with chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, bronchiolitis, and cystic fibrosis (CF).

Although metered-dose inhalers (MDIs) are the most common form of delivery for aerosol medications, nebulizers are indicated when the medication is only available as a solution, or if a high dose is required. Nebulizers are especially effective when treating infants, young children, individuals with impaired cognition, the acutely ill, and others who cannot master the correct MDI inhalation technique. The major advantages of nebulizers are that they are effective even in individuals with very low inspiratory flow rates and when coordination with the respiratory cycle is not required.

The nebulizer is a chamber (small cup with a lid) where the liquid medication is aerosolized prior to inhalation. There are two types of nebulizers currently available: pneumatic (jet) nebulizers and ultrasonic (generator) nebulizers.

Pneumatic nebulizers (also known as jet nebulizers or atomizers) use compressed gas (air or oxygen) to convert liquid medication into an aerosol. When the gas hits the liquid, atomization occurs, and small droplets are formed. The distribution of the particles generated by the nebulizer and the deposition in the lungs depend on the design of the nebulizer, the type of baffle (a small plastic piece that causes the liquid medication to convert into droplets), the length of the nebulization, the volume of the drug solution, and the existing temperature, humidity, and surface tension of the liquid.

Ultrasonic nebulizers use electricity to convert liquid medication into resp​irable​ droplets. With the use of a piezoelectric crystal, high-frequency electric oscillations are transformed into mechanical oscillations, which provide the energy to produce an aerosol.

Ultrasonic nebulizers tend to deliver a higher rate of drug output in a shorter nebulization time than pneumatic nebulizers. However, the droplets produced by ultrasonic nebulizers can be larger than those formed by pneumatic nebulizers, which may cause the medication to not nebulize properly or uniformly. Although modifications have been made to ultrasonic nebulizers that allow them to produce smaller droplets, the use of pneumatic nebulizers continues to be the standard of care.

References

American College of Allergy, Asthma & Immunology. Asthma-COPD overlap. [ACAAI Web site]. 2014. Available at: https://acaai.org/asthma/types-asthma/asthma-copd-overlap. Accessed June 13, 2025.

Centers for Medicare & Medicaid Services (CMS). Required Face-to-Face Encounter and Written Order Prior to Delivery List. [CMS Web site]. 11/16/2012 (Revised 08/12/2024). Available at: https://www.cms.gov/files/document/required-face-face-encounter-and-written-order-prior-delivery-list.pdf. Accessed June 13, 2025.

Centers for Medicare & Medicaid Services (CMS). Federal Register. Medicare Program; End-stage renal disease prospective payment system, payment for renal dialysis services furnished to individuals with acute kidney injury, end-stage renal disease quality incentive program, durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) fee schedule amounts, DMEPOS competitive bidding program (CBP) amendments, standard elements for a DMEPOS order, and master list of DMEPOS items potentially subject to a face-to-face encounter and written order prior to delivery and/or prior authorization requirements for calendar year (CY) 2020; Final Rule. [Federal Register Web site]. 11/08/2019. Available at: https://www.federalregister.gov/documents/2019/11/08/2019-24063/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis. Accessed June 13, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) 200.2: Nebulized Beta Adrenergic Agonist Therapy for Lung Disease. Original 09/10/2007 (Revised: 01/22/2008). Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=321&ncdver=1&keyword=nebulizer&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed June 13, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) 280.1: Durable Medical Equipment Reference List. Original 04/01/2003 (Revised: 05/16/2023). Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=190&ncdver=3&keywordtype=starts&keyword=durable&bc=0. Accessed June 13, 2025.

Lexi-Drugs Compendium. Metaproterenol. [Lexicomp Online Web site]. 07/18/23. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed June 13, 2025.

Noridian Healthcare Solutions, LLC., Local Coverage Article (LCA). A52466: Nebulizers. [Noridian Healthcare Solutions Web site]. Original 10/01/2015 (Revised: 01/01/2024). Available at:  https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52466&ver=67&bc=0. Accessed June 13, 2025.

Noridian Healthcare Solutions, LLC. Local Coverage Article (LCA). A52514: Oxygen and Oxygen Equipment. [Noridian Healthcare Solutions Web site]. Original: 10/01/2015 (Revised: 04/01/2023). Available at:  https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52514&ver=61&bc=0. Accessed June 13, 2025.

Noridian Healthcare Solutions, LLC. Local Coverage Article (LCA). A52517: Respiratory Assist Devices. [Noridian Healthcare Solutions Web site]. Original: 10/01/2015 (Revised 08/08/2021). Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52517. Accessed June 13, 2025.

Noridian Healthcare Solutions, LLC., Local Coverage Article (LCA). A55426: Standard Documentation Requirements for All Claims Submitted to DME MACs. [Noridian Healthcare Solutions Web site]. Original: 01/01/2017 (Revised: 01/01/2024). Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426. Accessed June 13, 2025.

Noridian Healthcare Solutions, LLC., Local Coverage Determination (LCD). L33370: Nebulizers. [Noridian Healthcare Solutions Web site]. Original: 10/01/15. (Revised: 01/01/2024). Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33370&ver=49&keyword=nebulizer&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed June 13, 2025.

Noridian Healthcare Solutions, LLC., Local Coverage Determination (LCD). L33797: Oxygen and Oxygen Equipment. [Noridian Healthcare Solutions Web site]. Original: 10/01/2015 (Revised:04/01/2023). Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33797&ver=50&keyword=nebulizer&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed June 13, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Metaproterenol sulfate. Prescribing information. [FDA Web site]. 08/08/2022. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed June 13, 2025.​

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)
MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT NEBULIZATION DEVICES AND ACCESSORIES:
A4619Face tent
A7003Administration set, with small volume nonfiltered pneumatic nebulizer, disposable
A7004Small volume nonfiltered pneumatic nebulizer, disposable
A7005Administration set, with small volume nonfiltered pneumatic nebulizer, non-disposable
A7006Administration set, with small volume filtered pneumatic nebulizer
A7007Large volume nebulizer, disposable, unfilled, used with aerosol compressor
A7010Corrugated tubing, disposable, used with large volume nebulizer, 100 feet
A7012Water collection device, used with large volume nebulizer
A7013Filter, disposable, used with aerosol compressor or ultrasonic generator
A7014Filter, non-disposable, used with aerosol compressor or ultrasonic generator
A7015Aerosol mask, used with DME nebulizer
A7016Dome and mouthpiece, used with small volume ultrasonic nebulizer
A7017Nebulizer, durable, glass or autoclavable plastic, bottle type, not used with oxygen
A7525Tracheostomy mask, each
E0565Compressor, air power source for equipment which is not self-contained or cylinder driven
E0570Nebulizer, with compressor
E0572Aerosol compressor, adjustable pressure, light duty for intermittent use
E0574Ultrasonic/electronic aerosol generator with small volume nebulizer
E0580Nebulizer, durable, glass or autoclavable plastic, bottle type, for use with regulator or flowmeter
E0585Nebulizer, with compressor and heater
E1372Immersion external heater for nebulizer
K0730Controlled dose inhalation drug delivery system
​
THE FOLLOWING CODES ARE USED TO REPRESENT INHALATION DRUGS AND SOLUTIONS:
A4216Sterile water, saline and/or dextrose, diluent/flush, 10 ml
A4217Sterile water/saline, 500 ml
A4218Sterile saline or water, metered dose dispenser, 10 ml
A7018Water, distilled, used with large volume nebulizer, 1000 ml
J2545Pentamidine isethionate, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per 300 mg
​J7131
​Hypertonic saline solution, 1 ml​
​J7601
​Ensifentrine, inhalation solution, FDA approved final product, noncompounded, administered through DME, unit dose form, 3 mg
J7605Arformoterol, inhalation solution, FDA approved final product, noncompounded, administered through DME, unit dose form, 15 mcg
J7606Formoterol fumarate, inhalation solution, FDA approved final product, noncompounded, administered through DME, unit dose form, 20 mcg
J7608Acetylcysteine, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per g
J7611Albuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, 1 mg
J7612Levalbuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, 0.5 mg
J7613Albuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose, 1 mg
J7614Levalbuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose, 0.5 mg
J7620Albuterol, up to 2.5 mg and ipratropium bromide, up to 0.5 mg, FDA-approved final product, noncompounded, administered through DME
J7626Budesonide, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, up to 0.5 mg
J7631Cromolyn sodium, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per 10 mg
J7639Dornase alfa, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per mg
J7644Ipratropium bromide, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per mg
J7677Revefenacin inhalation solution, FDA-approved final product, noncompounded, administered through DME, 1 microgram
J7682Tobramycin, inhalation solution, FDA-approved final product, noncompounded, unit dose form, administered through DME, per 300 mg
J7686Treprostinil, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, 1.74 mg
Q4074 Iloprost, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, up to 20 mcg
THE FOLLOWING CODE IS USED TO REPRESENT A NONCOMPOUNDED INHALATION SOLUTION:
J7699 NOC drugs, inhalation solution administered through DME
NOT MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT COMPOUNDED INHALATION SOLUTIONS:
J7604Acetylcysteine, inhalation solution, compounded product, administered through DME, unit dose form, per g
J7607Levalbuterol, inhalation solution, compounded product, administered through DME, concentrated form, 0.5 mg
J7609Albuterol, inhalation solution, compounded product, administered through DME, unit dose, 1 mg
J7610Albuterol, inhalation solution, compounded product, administered through DME, concentrated form, 1 mg
J7615Levalbuterol, inhalation solution, compounded product, administered through DME, unit dose, 0.5 mg
J7622Beclomethasone, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7624Betamethasone, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7627Budesonide, inhalation solution, compounded product, administered through DME, unit dose form, up to 0.5 mg
J7628Bitolterol mesylate, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7629Bitolterol mesylate, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7632Cromolyn sodium, inhalation solution, compounded product, administered through DME, unit dose form, per 10 mg
J7634Budesonide, inhalation solution, compounded product, administered through DME, concentrated form, per 0.25 mg
J7635Atropine, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7636Atropine, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7637Dexamethasone, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7638Dexamethasone, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7640Formoterol, inhalation solution, compounded product, administered through DME, unit dose form, 12 mcg
J7641Flunisolide, inhalation solution, compounded product, administered through DME, unit dose, per mg
J7642Glycopyrrolate, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7643Glycopyrrolate, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7645Ipratropium bromide, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7647Isoetharine HCl, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7650Isoetharine HCl, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7657Isoproterenol HCl, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7660Isoproterenol HCl, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7667Metaproterenol sulfate, inhalation solution, compounded product, concentrated form, per 10 mg
J7670Metaproterenol sulfate, inhalation solution, compounded product, administered through DME, unit dose form, per 10 mg
J7676Pentamidine isethionate, inhalation solution, compounded product, administered through DME, unit dose form, per 300 mg
J7680Terbutaline sulfate, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7681Terbutaline sulfate, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7683Triamcinolone, inhalation solution, compounded product, administered through DME, concentrated form, per mg
J7684Triamcinolone, inhalation solution, compounded product, administered through DME, unit dose form, per mg
J7685Tobramycin, inhalation solution, compounded product, administered through DME, unit dose form, per 300 mg
THE FOLLOWING CODE IS USED TO REPRESENT A COMPOUNDED INHALATION SOLUTION:
J7699 NOC drugs, inhalation solution administered through DME

NOT ELIGIBLE FOR REIMBURSEMENT

THE FOLLOWING CODES  REPRESENT METAPROTERENOL SULFATE WHICH IS NO LONGER MANUFACTURED AND HAS BEEN WITHDRAWN FROM THE MARKET:

J7668 Metaproterenol sulfate, inhalation solution, FDA- approved final product, noncompounded, administered through DME, concentrated form, per 10 mg

J7669 Metaproterenol sulfate, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per 10 mg​


NOT COVERED
A7008
Large volume nebulizer, disposable, prefilled, used with aerosol compressor
A7009Reservoir bottle, nondisposable, used with large volume ultrasonic nebulizer
E0575 Nebulizer, Ultrasonic, Large volume
S8100Holding chamber or spacer for use with an inhaler or nebulizer; without mask
S8101Holding chamber or spacer for use with an inhaler or nebulizer; with mask
Revenue Code Number(s)
N/A


​

Coding and Billing Requirements

Policy History

Revisions From MA05.007g:
​02/01/2026

This version of the policy will be issued on 06/01/2026 with a retroactive effective date of 02/01/2026.

 ​​

The following drugs have been added to the medically necessary section for a small-volume, nonfiltered nebulizer:

  • Hypertonic saline for specific diagnoses
  • Ensifentrine for specific diagnoses.

The following HCCPS codes have been added to the policy:

  • J7131 Hypertonic saline solution, 1 ml
  • J7601 Ensifentrine, inhalation suspension, FDA approved final product, non-compounded, administered through DME, unit dose form, 3 mg.

Revisions From MA05.007f:
​08/06/2025
​This policy has been reviewed and reissued to communicate the Company’s continuing position on nebulizers and inhalation solutions.​​
​10/30/202​4

​This policy has been reviewed and reissued to communicate the Company’s continuing position on nebulizers and inhalation solutions.​​

​01/01/2024

​Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
10/16/2023​​
​This version of the policy will become effective 10/16/2023​. 


Face-to-face language and documentation requirements have been removed for HCPCS code K0730 in accordance with the 2023 CMS New Final Rule on Face-to-Face Encounters.

 

The following updates have been made:

  • Criteria revised for the use of a small-volume ultrasonic nebulizer for the administration of treprostinil
  • Company's coverage position revised to not eligible for reimbursement for the administration of metaproterenol solution because it has been withdrawn from the market​

Revisions From MA05.007e:
09/05/2022
This version of the policy will become effective 09/05/2022. 

The following policy criteria have been added to this policy:
  • Not covered: nebulizer and related accessories if none of the drugs used with the nebulizer are covered in alignment with Noridian
  • Not covered: spacer device in alignment with the CMS definition of durable medical equipment (DME)
The following policy criteria have been revised:​
  • Criteria for the use of a small-volume ultrasonic nebulizer for the administration of treprostinil in alignment with Noridian
  • Criteria for the use of controlled-dose inhalation drug-delivery system for the administration of iloprost in alignment with Noridian
The following codes have been revised in alignment with the CMS definition of DME from covered to non-covered:
  • S8100 Holding chamber or spacer for use with an inhaler or nebulizer; without mask
  • S8101 Holding chamber or spacer for use with an inhaler or nebulizer; with mask​

Revisions From​ MA05.007d:
03/24/2021This policy has been reissued in accordance with the Company's annual review process.
​08/03/2020
​This version of the policy will become effective 08/03/2020.

The following criterion has been added to this policy:
    • Revefenacin to inhalation solutions for the management of obstructive pulmonary disease
In accordance with the Centers for Medicare & Medicaid Services' (CMS) Final Rule 1713 (84 Fed. Reg Vol 217), a face-to-face encounter has been removed for the specified HCPCS codes:
      E0570 Nebulizer, with compressor

      E0580 Nebulizer, durable, glass or autoclavable plastic, bottle type, for use with regulator or flowmeter

      E0585 Nebulizer, with compressor and heater

The following HCPCS code has been added to this policy (Medically Necessary):
J7677 Revefenacin inhalation solution, FDA-approved final product, noncompounded, administered through DME,​ 1 microgram

Revisions From MA05.007c:
12/16/2019This version of the policy will become effective 12/16/2019.

The policy has been reviewed and reissued to communicate the Company’s continuing position on Nebulizers and Inhalation Solutions.

Revisions From MA05.007b:
08/15/2018This policy has been reissued in accordance with the Company's annual review process.
01/2​6/2018This version of the policy will become effective 01/26/2018. This policy was updated to communicate the Company's continuing coverage of nebulizers.

The following HCPCS code has been deleted from this policy:
      J7674 Methacholine chloride administered as inhalation solution through a nebulizer, per 1 mg

Revisions From MA05.007a:
03/30/2016This policy has been reviewed and reissued to communicate the Company's continuing coverage of nebulizers.
01/01/2016This policy will become effective 01/01/2016.

The following HCPCS code has been termed and removed from the policy:
A7011 Corrugated tubing, non-disposable, used with large volume nebulizer, 10 feet

Revisions From MA05.007:
05/13/2015This policy has been reviewed and reissued to communicate the Company's continuing coverage of nebulizers.
01/01/2015This is a new policy.

2/1/2026
6/1/2026
MA05.007
Medical Policy Bulletin
Medicare Advantage
No
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