LCD L33370: Nebulizers

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Payment may be made for supplies that are necessary for the effective use of durable medical equipment. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment or to assure the proper functioning of the equipment. However, the coverage of such drugs or biologicals does not preclude the need for a determination that the drug or biological itself is reasonable and necessary for treatment of the illness or injury or to improve the functioning of a malformed body member.

A small volume nebulizer (A7003, A7004, A7005), and related compressor (E0570) are considered for coverage when it is reasonable and necessary to administer the following FDA-approved inhalation solutions listed below (refer to the Group 3 Codes in the LCD-related Policy Article for applicable diagnoses):

It is reasonable and necessary to administer albuterol (J7611, J7613), arformoterol (J7605), budesonide (J7626), cromolyn (J7631), formoterol (J7606), ipratropium (J7644), levalbuterol (J7612, J7614), metaproterenol (J7669), or revefenacin (J7677) for the management of obstructive pulmonary disease (refer to the Group 8 Codes in the LCD-related Policy Article for applicable diagnoses); or

It is reasonable and necessary to administer dornase alfa (J7639) to a beneficiary with cystic fibrosis (refer to the Group 9 Codes in the LCD-related Policy Article for applicable diagnoses); or

It is reasonable and necessary to administer tobramycin (J7682) to a beneficiary with cystic fibrosis or bronchiectasis (refer to the Group 10 Codes in the LCD-related Policy Article for applicable diagnoses); or

It is reasonable and necessary to administer pentamidine (J2545) to a beneficiary with HIV, pneumocystosis, or complications of organ transplants (refer to the Group 4 Codes in the LCD-related Policy Article for applicable diagnoses); or

It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary secretions (refer to the Group 7 Codes in the LCD-related Policy Article for applicable diagnoses).

It is reasonable and necessary to administer hypertonic saline (J7131) to a beneficiary with cystic fibrosis, bronchiectasis, or ciliary dyskinesia (refer to Group 15 Codes in the LCD-related Policy Article for applicable diagnoses); or

• It is reasonable and necessary to administer ensifentrine (J7601) as an add-on therapy for the management of chronic obstructive pulmonary disease (see Group 16 Codes in the LCD-related Policy Article) in beneficiaries 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 (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS in the LCD-related Policy Article):

• Continued COPD exacerbations; or

• Persistent dyspnea.

Use of ensifentrine (J7601) without either dual LABA/LAMA maintenance therapy or triple LABA/LAMA/ICS maintenance therapy will be considered not reasonable and necessary.

Compounded inhalation solutions (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, and compounded solutions billed with J7699) will be denied as not reasonable and necessary.

If none of the drugs used with a nebulizer are covered, the compressor, the nebulizer, and other related accessories/supplies will be denied as not reasonable and necessary.

A large volume nebulizer (A7007, A7017), related compressor (E0565 or E0572), and water or saline (A4217 or A7018) are considered for coverage when it is reasonable and necessary to deliver humidity to a beneficiary with thick, tenacious secretions, who has cystic fibrosis, bronchiectasis, a tracheostomy, or a tracheobronchial stent (refer to the Group 5 Codes in the LCD-related Policy Article for applicable diagnoses). Combination code E0585 will be covered for the same indications.

An E0565 or E0572 compressor and filtered nebulizer (A7006) are c onsidered for coverage when it is reasonable and necessary to administer pentamidine to beneficiaries with HIV, pneumocystosis, or complications of organ transplants (refer to the Group 1 Codes in the LCD-related Policy Article for applicable diagnoses).

A small volume ultrasonic nebulizer (E0574) and related accessories are considered for coverage when it is reasonable and necessary to administer treprostinil inhalation solution to beneficiaries with pulmonary hypertension only (refer to the Group 11 Codes in the LCD-related Policy Article for applicable diagnoses). Claims for code E0574 used with other inhalation solutions will be denied as not reasonable and necessary.

Treprostinil inhalation solution (J7686) is considered for coverage when either criteria 1-3; or , criterion 4 are met:

The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 11 Codes in the LCD-related Policy Article for applicable diagnoses); 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 criterion 4) (e.g., chronic obstructive pulmonary disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders); and

The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) must be met:

The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and

The mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with exertion; and

The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and

Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.

The beneficiary has a diagnosis of pulmonary hypertension associated with interstitial lung disease (refer to Group 11 Codes in the LCD-related Policy Article for applicable diagnoses) and the following criteria (a-e) are met:

The presence of interstitial lung disease has been confirmed by a high-resolution CT scan of the chest; and

The mean pulmonary artery pressure is ≥ 25 mm Hg; and

The pulmonary capillary wedge pressure or left ventricular end-diastolic pressure is ≤ 15mm Hg; and

The pulmonary vascular resistance is ≥ 3 Wood Units at rest; and

The beneficiary has significant symptoms of pulmonary hypertension (e.g., dyspnea on exertion, fatigability)

If the above criteria are not met, code E0574 and the related drug treprostinil (J7686) will be denied as not reasonable and necessary.

A controlled dose inhalation drug delivery system (K0730) is considered for coverage when it is reasonable and necessary to administer iloprost (Q4074) to beneficiaries with pulmonary hypertension only (refer to the Group 14 Codes in the LCD-related Policy Article for applicable diagnoses). Claims for code K0730 for use with other inhalation solutions will be denied as not reasonable and necessary.

Iloprost (Q4074) is considered for coverage when all of the following criteria 1-3 are met:

The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 14 Codes in the LCD-related Policy Article for applicable diagnoses); 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., chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders); and

The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) must be met:

The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and

The mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with exertion; and

The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and

Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.

If the above criteria are not met, code K0730 and the related drug iloprost (Q4074) will be denied as not reasonable and necessary.

A large volume ultrasonic nebulizer (E0575) offers no proven clinical advantage over a pneumatic compressor and nebulizer and will be denied as not reasonable and necessary.

ACCESSORIES:

Accessories are separately payable if the related aerosol compressor and the individual accessories are reasonable and necessary. The following table lists the compressor/generator, which is related to the accessories described. Other compressor/generator/accessory combinations are considered not reasonable and necessary.

Compressor/Generator

Related Accessories

E0565

A4619, A7006, A7007, A7010, A7012, A7013, A7014, A7015, A7017, A7525, E1372

E0570

A7003, A7004, A7005, A7006, A7013, A7015, A7525

E0572

A7006, A7007, A7014, A7017

E0574

A7013, A7014, A7016

E0585

A4619, A7006, A7010, A7012, A7013, A7014, A7015, A7525

K0730

A7005

This array of accessories represents all possible combinations, but it may not be appropriate to bill any or all of them for one device.

The following table lists the usual maximum frequency of replacement for accessories. Claims for more than the usual maximum replacement amount will be denied as not reasonable and necessary.

Accessory

Usual maximum replacement

A4619

One/month

A7003

Two/month

A7004

Two/month (in addition to A7003)

A7005

One/6 months

A7005

One/3 months only with K0730

A7006

One/month

A7007

Two/month

A7010

One unit (100 ft.)/2 months

A7012

Two/month

A7013

Ensifentrine

Clinical Background

Chronic obstructive pulmonary disease (COPD) is a composite of progressive lung diseases including emphysema and chronic bronchitis. Approximately 12% of adults over the age of 65 have diagnosed COPD. 1 Cigarette smoking is the leading cause of COPD. It may also be caused by chronic marijuana use, 2 vaping, and exposure to air pollutants from traffic, second-hand smoke, or indoor fuels used for heating and cooking. 3,4 Approximately 25-30% of people with COPD have never smoked. 5 Individuals may be predisposed to developing COPD due to biological factors, such as systemic inflammation, or genetic conditions, such as alpha-1 antitrypsin deficiency. 6,7 A family history of COPD is an independent risk factor for the development of COPD, severity of disease, and frequency of exacerbations. 4,8 People who experience more frequent acute exacerbations experience a faster progression of their COPD and worse health status compared with those with few acute exacerbations. 9 Severe COPD is a disability that limits individuals from participating in activities of daily life. 10,11 People with COPD are at higher risk of developing other chronic health conditions, including respiratory tract infections, lung cancer, heart disease, musculoskeletal frailty, and depression. 6,12 Patients with other comorbidities (e.g., pulmonary hypertension, cardiovascular disease, lung cancer) typically have a poorer prognosis. 6

Chronic Obstructive Pulmonary Disease is characterized by inflammation and mucus plugging of the airways and structural changes of the alveoli, resulting in poor gas exchange and airflow obstruction. 6 Pulmonary function testing is the mainstay of diagnosis and longitudinal monitoring for disease progression. Obstruction to airflow limits the volume of air that can be exhaled in one second (FEV 1 ) and results in hyperinflation of the lungs and a decrease in forced vital capacity (FVC). A diagnosis is made when the ratio of the forced expiratory volume in one second compared with the forced vital capacity (FEV 1 /FVC) is less than 0.7. 13 Diffusion of carbon dioxide from the circulation into the alveoli is impaired due to damage of the alveolar basement membranes and obstruction to exhalation, resulting in chronically elevated levels of carbon dioxide. Disease severity is determined by the reduction in FEV 1 , as established by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification system: