Commercial

Medical Policy

Title:

Nebulizers and Inhalation Solutions

Policy #:

05.00.15t

Policy

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 (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

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

If the medical necessity criteria for one of the small-volume or large-volume nebulizers listed above are met, the individual can obtain either a standard or a portable nebulizer. A portable nebulizer can be battery-operated or connected to an alternate power source.

EXPERIMENTAL/INVESTIGATIONAL
All other uses for pneumatic nebulizers are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

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 (please refer to the Treatment of Pulmonary Artery Hypertension with Intravenous, Subcutaneous, and Inhaled Pharmacologic Agents policy for dosing and frequency requirements):

The individual has a confirmed diagnosis of pulmonary arterial hypertension (PAH), in accordance with the WHO Group 1 classification and all of the following criteria are met:

The diagnosis of PAH has been confirmed by a catheterization (right heart or Swan-Ganz) or echocardiography.
Documentation that the individual's mean pulmonary arterial pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg during exercise/exertion.
The individual meets the NYHA Functional Classification requirements Class III.

The individual has a confirmed diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (PH-ILD) WHO Group 3 when all of the following criteria are met:

The individual has a confirmed diagnosis of WHO Group 3 PH based on CT imaging, which demonstrates evidence of diffuse parenchymal lung disease performed within six months.
The individual may have any form of ILD or combined pulmonary fibrosis and emphysema (CPFE).
The individual has a right heart catheterization (RHC) within one year with the following documented parameters:

Pulmonary vascular resistance (PVR) greater than 3 Wood Units (WU)
A pulmonary capillary wedge pressure (PCWP) of 15 mmHg or less
A mean pulmonary arterial pressure (mPAP) of 25 mmHg or greater

The individual has a baseline six-minute walk distance (6MWD) of 100 meters or greater
For the individual receiving chronic medication for underlying lung disease (e. g., pirfenidone, nintedanib, etc.), the dose must be stable and optimized for 30 days or longer prior to treatment.
For the individual with connective tissue disease (CTD) the baseline forced vital capacity (FVC) must be less than 70 percent.

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 (please refer to the Treatment of Pulmonary Artery Hypertension with Intravenous, Subcutaneous, and Inhaled Pharmacologic Agents policy for dosing and frequency requirements):

The individual has a confirmed diagnosis of PAH, in accordance with the WHO Group 1 classification.

The diagnosis of PAH has been confirmed by a catheterization (right heart or Swan-Ganz) or echocardiography.

Documentation that the individual's mean pulmonary arterial pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg during exercise/exertion.
The individual meets the NYHA Functional Classification requirements of Class III-IV.

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 because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

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 because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

NOT COVERED
A large-volume ultrasonic nebulizer does not meet the definition of durable medical equipment (DME) because it is considered a device that has features of a medical nature that are not required by the individual's condition, and, therefore, 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 two months:

Corrugated tubing, disposable, used with large-volume nebulizer, 100 feet

The following accessories have a maximum replacement of one per three 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 six months:

Administration set, with small-volume nonfiltered pneumatic nebulizer, nondisposable

The following accessories have a maximum replacement of one per three 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 an 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 equipment for a device that does not meet the definition of DME because it has features of a medical nature that are not required by the individual's condition and, therefore, 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 because commercially manufactured products are available.

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 because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of illness or injury. 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 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 does not meet the definition of DME because it has features of a medical nature that are not required by the individual’s condition (an unfilled nebulizer filled with water or saline is an acceptable alternative) and, therefore, not covered and not eligible for reimbursement consideration by the Company because it is considered a convenience item.

A spacer does not meet the definition of DME because it is non-reusable by another individual and is not a rental-type item and, therefore, not covered and not eligible for reimbursement consideration by the Company because the item is not required for the individual’s condition.

A duplicate small-volume or large-volume nebulizer (e.g., for use when traveling, for an additional residence, work, school) is a benefit contract exclusion and, therefore, not covered and not eligible for reimbursement consideration by the Company because it is considered a convenience item.

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.

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 REQUIREMENT
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 seven 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 five 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

The World Health Organization (WHO) Group 1 Classification

Pulmonary arterial hypertension (PAH) represents Group 1 within the Pulmonary Hypertension World Health Organization (WHO) clinical classification system and is one of five such groups. The groups are divided based on etiology.

Idiopathic (IPAH): a rare form of PAH characterized by elevated pulmonary artery pressure with no apparent cause.
Heritable (HPAH): a form of PAH caused by predisposing genes or from a familial context.

Bone morphogenetic protein receptor type 2 (BMPR2)

Activin receptor-like kinase 1 gene (ALK1), endoglin (with or without haemorrhagic telangiectasia)

Unknown

Drug- and toxin-induced
Associated with (APAH)

Connective tissue diseases

Human immunodeficiency virus (HIV) infection

Portal hypertension

Congenital heart disease (CHD)

Schistosomiasis

Chronic haemolytic anemia

Persistent pulmonary hypertension of the newborn (PPHN)

Unique class 1 (Group 1)

Pulmonary veno-occlusive disease (PVOD) and/or pulmonary capillary hemangiomatosis (PCH)

The New York Heart Association (NYHA) Functional Classifications are summarized as follows:

Class I: Individuals with no limitation of physical activity and no symptoms. Ordinary physical activity does not cause undue fatigue, palpitations, or dyspnea (shortness of breath).

Class II: Individuals with slight limitation of physical activity and mild symptoms. Comfortable at rest. Ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.

Class III: Individuals with marked limitation of physical activity due to symptoms. Comfortable at rest, but less than ordinary activity causes fatigue, palpitations, dyspnea, or anginal pain.

Class IV: Individuals with severe limitations experience symptoms of heart failure or the anginal syndrome that may be present even while at rest. If any physical activity is undertaken, discomfort is increased.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, nebulizers and their accessories are covered under the medical benefits of the Company's products when the medical necessity criteria listed in the medical policy are met. However, nebulizers and their accessories that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

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).

While 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 respirable 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 Association of Respiratory Care (AARC). AARC Clinical Practice Guideline. Aerosol Delivery Device Selection for Spontaneously Breathing Patients: 2012; 57(4):613-626. Also available on the AARC Web site at: https://www.aarc.org/wp-content/uploads/2014/08/aerosol_delivery_2012.pdf. Accessed July 20, 2023.

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 29, 2023.

American Heart Association. Heart failure classification. [American Heart Association Web site]. 06/07/2023. Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure. Accessed August 15, 2023.

Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013;Sep 13(9):CD000052.

Cates CJ, Crilly JA, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2006; Apr 19(2):CD000052.

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 04/17/2023). Available at: https://www.cms.gov/files/document/required-face-face-encounter-and-written-order-prior-delivery-list.pdf. Accessed June 29, 2023.

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 29, 2023.

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 29, 2023.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) 280.1: Durable Medical Equipment Reference List. Original 04/01/2003 (Revised: 05/05/2005). Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=190&ncdver=2&keywordtype=starts&keyword=durable&bc=0. Accessed June 29, 2023.

Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention 2022. [GINA Web site]. 04/30/2022. Available at: https://ginasthma.org/gina-reports/. Accessed July 20, 2023.

Lexi-Drugs Compendium. Metaproterenol. [Lexicomp Online Web site]. 07/18/23. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 25, 2023.

Noridian Healthcare Solutions, LLC., Local Coverage Article (LCA). A52466: Nebulizers. [Noridian Healthcare Solutions Web site]. Original 10/01/2015 (Revised: 01/01/2023). Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52466&ver=53&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 29, 2023.

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). Availble at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52514&ver=57&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 29, 2023.

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&ver=44&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 29, 2023.

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: 01/01/2023). Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426. Accessed June 29, 2023.

Noridian Healthcare Solutions, LLC., Local Coverage Determination (LCD). L33370: Nebulizers. [Noridian Healthcare Solutions Web site]. Original: 10/01/15. (Revised: 01/01/2023). Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33370&ver=45&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 29, 2023.

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 29, 2023.

Prins KW, Thenappan T. World Health Organization Group I Pulmonary Hypertension: Epidemiology and Pathophysiology. Cardiol Clin. 2016 Aug;34(3):363-74.

Rose-Jones LJ, Mclaughlin VV. Pulmonary hypertension: types and treatments. Curr Cardiol Rev. 2015;11(1):73-9.

Smith LJ. Aerosols. In: Baum GL, Crapo JD, Celli BR, Karlinsky JB, eds. Textbook of Pulmonary Diseases: Volume 1. 6th ed. Philadelphia, PA: Lippincott-Raven;1998:316.

Waxman A, Restrepo-Jaramillo R, Thenappan T, et al. Inhaled Treprostinil in Pulmonary Hypertension Due to Interstitial Lung Disease. N Engl J Med. 2021;384(4):325-334.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Iloprost. Prescribing information. [FDA Web site]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021779s021lbl.pdf. 03/02/2022. Accessed July 25, 2023.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Metaproterenol sulfate. Prescribing information. [FDA Web site]. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. 08/08/2022. Accessed July 25, 2023.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Treprostinil. Prescribing information. [FDA Web site]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022387s020lbl.pdf. 05/20/2022. Accessed on August 15, 2023.

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:

A4619

Face tent

A7003

Administration set, with small volume nonfiltered pneumatic nebulizer, disposable

A7004

Small volume nonfiltered pneumatic nebulizer, disposable

A7005

Administration set, with small volume nonfiltered pneumatic nebulizer, non-disposable

A7006

Administration set, with small volume filtered pneumatic nebulizer

A7007

Large volume nebulizer, disposable, unfilled, used with aerosol compressor

A7010

Corrugated tubing, disposable, used with large volume nebulizer, 100 feet

A7012

Water collection device, used with large volume nebulizer

A7013

Filter, disposable, used with aerosol compressor or ultrasonic generator

A7014

Filter, non-disposable, used with aerosol compressor or ultrasonic generator

A7015

Aerosol mask, used with DME nebulizer

A7016

Dome and mouthpiece, used with small volume ultrasonic nebulizer

A7017

Nebulizer, durable, glass or autoclavable plastic, bottle type, not used with oxygen

A7525

Tracheostomy mask, each

E0565

Compressor, air power source for equipment which is not self-contained or cylinder driven

E0570

Nebulizer, with compressor

E0572

Aerosol compressor, adjustable pressure, light duty for intermittent use

E0574

Ultrasonic/electronic aerosol generator with small volume nebulizer

E0580

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

E0585

Nebulizer, with compressor and heater

E1372

Immersion external heater for nebulizer

K0730

Controlled dose inhalation drug delivery system

THE FOLLOWING CODES ARE USED TO REPRESENT INHALATION DRUGS AND SOLUTIONS:

A4216

Sterile water, saline and/or dextrose, diluent/flush, 10 ml

A4217

Sterile water/saline, 500 ml

A4218

Sterile saline or water, metered dose dispenser, 10 ml

A7018

Water, distilled, used with large volume nebulizer, 1000 ml

J2545

Pentamidine isethionate, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per 300 mg

J7605

Arformoterol, inhalation solution, FDA approved final product, noncompounded, administered through DME, unit dose form, 15 mcg

J7606

Formoterol fumarate, inhalation solution, FDA approved final product, noncompounded, administered through DME, unit dose form, 20 mcg

J7608

Acetylcysteine, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per g

J7611

Albuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, 1 mg

J7612

Levalbuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, 0.5 mg

J7613

Albuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose, 1 mg

J7614

Levalbuterol, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose, 0.5 mg

J7620

Albuterol, up to 2.5 mg and ipratropium bromide, up to 0.5 mg, FDA-approved final product, noncompounded, administered through DME

J7626

Budesonide, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, up to 0.5 mg

J7631

Cromolyn sodium, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per 10 mg

J7639

Dornase alfa, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per mg

J7644

Ipratropium bromide, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per mg

J7677

Revefenacin inhalation solution, FDA-approved final product, noncompounded, administered through DME, 1 microgram

J7682

Tobramycin, inhalation solution, FDA-approved final product, noncompounded, unit dose form, administered through DME, per 300 mg

J7686

Treprostinil, 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:

J7604

Acetylcysteine, inhalation solution, compounded product, administered through DME, unit dose form, per g

J7607

Levalbuterol, inhalation solution, compounded product, administered through DME, concentrated form, 0.5 mg

J7609

Albuterol, inhalation solution, compounded product, administered through DME, unit dose, 1 mg

J7610

Albuterol, inhalation solution, compounded product, administered through DME, concentrated form, 1 mg

J7615

Levalbuterol, inhalation solution, compounded product, administered through DME, unit dose, 0.5 mg

J7622

Beclomethasone, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7624

Betamethasone, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7627

Budesonide, inhalation solution, compounded product, administered through DME, unit dose form, up to 0.5 mg

J7628

Bitolterol mesylate, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7629

Bitolterol mesylate, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7632

Cromolyn sodium, inhalation solution, compounded product, administered through DME, unit dose form, per 10 mg

J7634

Budesonide, inhalation solution, compounded product, administered through DME, concentrated form, per 0.25 mg

J7635

Atropine, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7636

Atropine, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7637

Dexamethasone, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7638

Dexamethasone, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7640

Formoterol, inhalation solution, compounded product, administered through DME, unit dose form, 12 mcg

J7641

Flunisolide, inhalation solution, compounded product, administered through DME, unit dose, per mg

J7642

Glycopyrrolate, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7643

Glycopyrrolate, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7645

Ipratropium bromide, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7647

Isoetharine HCl, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7650

Isoetharine HCl, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7657

Isoproterenol HCl, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7660

Isoproterenol HCl, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7667

Metaproterenol sulfate, inhalation solution, compounded product, concentrated form, per 10 mg

J7670

Metaproterenol sulfate, inhalation solution, compounded product, administered through DME, unit dose form, per 10 mg

J7676

Pentamidine isethionate, inhalation solution, compounded product, administered through DME, unit dose form, per 300 mg

J7680

Terbutaline sulfate, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7681

Terbutaline sulfate, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7683

Triamcinolone, inhalation solution, compounded product, administered through DME, concentrated form, per mg

J7684

Triamcinolone, inhalation solution, compounded product, administered through DME, unit dose form, per mg

J7685

Tobramycin, 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
A7009	Reservoir bottle, nondisposable, used with large volume ultrasonic nebulizer
E0575	Nebulizer, Ultrasonic, Large volume
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

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 05.00.15t:

01/01/2024

This version of the policy will become effective 01/01/2024.

Face-to-face language and documentation requirements have been removed for HCPCS code K0730.

The following updates have been made:

Criteria revised for use of a small-volume ultrasonic nebulizer for treprostonil administration
Criteria revised for use a controlled-dose inhalation drug-delivery system for iloprost administration
Coverage position revised to not eligible for reimbursement for metaproterenol solution administration because it has been withdrawn from the market
Guidelines revised to include WHO Group 1 Classification and NYHA Functional Classifications

The following codes have been revised to not eligible for reimbursement:

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

Revisions From 05.00.15s:

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
Not covered: spacer device in alignment with the Company 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
Criteria for the use of controlled-dose inhalation drug-delivery system for the administration of iloprost

The following codes have been been revised from covered to non-covered in alignment with the Company definition of DME:

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 05.00.15r:

03/24/2021

This 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 criteria have 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 is added for the specified HCPCS code:
K0730 Controlled dose inhalation drug delivery system

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 05.00.15q:

12/16/2019

This version of the policy will become effective 12/16/2019.

The following HCPCS code was added to this policy as Medically Necessary:

A7018 Water, distilled, used with large volume nebulizer, 1000 ml

The following HCPCS codes in this policy were added to the coding table as Not Covered:

A7008 Large volume nebulizer, disposable, prefilled, used with aerosol compressor

A7009 Reservoir bottle, nondisposable, used with large volume ultrasonic nebulizer

E0575 Nebulizer, Ultrasonic, Large volume

Revisions From 05.00.15p:

08/15/2018

This policy has been reissued in accordance with the Company's annual review process.

01/26/2018

This version of the policy will become effective 01/26/2018. The intent of this policy has not changed, although it has been modified to incorporate compounded inhalation solutions as not medically necessary.

The following HCPCS codes for compounded inhalation solutions have been added to this policy as not medically necessary:

J7604, J7607, J7609, J7610, J7615, J7622, J7624, J7627, J7628, J7629,J7632, J7634, J7635, J7636, J7637, J7638, J7640, J7641, J7642, J7643, J7645, J7647, J7650, J7657, J7660,J7667, J7670, J7676, J7680, J7681, J7683, J7684, J7685, J7699.

The following HCPCS codes for inhalation drugs and solutions have been added to this policy as medically necessary:
A4216, A4217, A4218, J2545, J7605, J7606, J7608, J7611, J7612, J7613, J7614, J7620, J7626, J7631, J7639, J7644, J7669, J7682, J7686, J7699, Q4074

The following policy criteria has been revised for a small-volume, nonfiltered nebulizer with compressor and is considered medically necessary when used for the administration of:

Albuterol for individuals with asthma/obstructive pulmonary disease when a metered dose inhaler (MDI) with a spacer device was considered inappropriate or was insufficient for the administration of the medication

Version Effective Date:

1/1/2024

Version Issued Date: