Nebulizers & Related Drugs

Affected Providers

Physicians and non-physician practitioners who write prescriptions for nebulizers and related drugs.

HCPCS & CPT Codes

Local Coverage Determination (LCD): Nebulizers (L33370) and Article: Nebulizers (A52466) have the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for nebulizers and related drugs is 7.1%, with a projected improper payment amount of $42.2 million.

You must meet reasonable and necessary requirements. We outline other policy requirements in LCD L33370 and Article A52466.

Denial Reasons

Insufficient documentation accounted for 53.9% of improper payments for nebulizers and related drugs during the 2024 reporting period, while medical necessity (19.1%), no documentation (2.9%), incorrect coding (0.1%), and other errors (24.1%) also caused improper payments. “Other” errors include duplicate payment, non-covered or unallowable service, or ineligible Medicare patient errors.

Preventing Denials

We consider small-volume nebulizers (HCPCS codes A7003, A7004, and A7005) and their related compressor (HCPCS code E0570) for coverage when they’re reasonable and necessary for administering these FDA-approved inhalation solutions:

• Albuterol (HCPCS codes J7611 and J7613), arformoterol (HCPCS code J7605), budesonide (HCPCS code J7626), cromolyn (HCPCS code J7631), formoterol (HCPCS code J7606), ipratropium (HCPCS code J7644), levalbuterol (HCPCS codes J7612 and J7614), metaproterenol (HCPCS code J7669), or revefenacin (HCPCS code J7677) — to manage obstructive pulmonary disease (see Group 8 codes in Article A52466 for applicable diagnoses)
• Dornase alfa (HCPCS code J7639) — for a patient with cystic fibrosis (see Group 9 codes in Article A52466 for applicable diagnoses)
• Tobramycin (HCPCS code J7682) — for a patient with cystic fibrosis or bronchiectasis (see Group 10 codes in Article A52466 for applicable diagnoses)
• Pentamidine (HCPCS code J2545) — for a patient with HIV, pneumocystosis, or complications of organ transplants (see Group 4 codes in Article A52466 for applicable diagnoses)
• Acetylcysteine (HCPCS code J7608) — for persistent thick or tenacious pulmonary secretions (see Group 7 codes in Article A52466 for applicable diagnoses)

We deny these compounded inhalation solutions as not reasonable and necessary: HCPCS codes 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.

If we don’t cover any of the drugs used with a nebulizer, we deny the compressor, nebulizer, and other related accessories and supplies as not reasonable and necessary.

We cover a large-volume nebulizer (HCPCS code A7007 or A7017), related compressor (HCPCS code E0565 or E0572), and water or saline (HCPCS code A4217 or A7018) when it’s reasonable and necessary for delivering humidity to a patient with thick, tenacious secretions who has cystic fibrosis, bronchiectasis, a tracheostomy, or a tracheobronchial stent (see Group 5 codes in Article A52466 for applicable diagnoses). We cover combination HCPCS code E0585 for the same indications.

We cover an E0565 or E0572 compressor and filtered nebulizer (HCPCS code A7006) when it’s reasonable and necessary for administering pentamidine to patients with HIV, pneumocystosis, or organ transplant complications (see Group 1 codes in Article A52466 for applicable diagnoses).

We cover a small-volume ultrasonic nebulizer (HCPCS code E0574) and related accessories when it’s reasonable and necessary for administering treprostinil inhalation solution to patients with pulmonary hypertension only (see Group 11 codes in Article A52466 for applicable diagnoses). We deny claims for E0574 used with other inhalation solutions as not reasonable and necessary.

We cover treprostinil inhalation solution (HCPCS code J7686) when the patient meets either criteria 1–3 or criterion 4:

1. The patient has pulmonary artery hypertension (see Group 11 codes in Article A52466 for applicable diagnoses).
2. Pulmonary hypertension isn’t secondary to pulmonary venous hypertension (for example, left-sided atrial or ventricular disease, left-sided valvular heart disease) or respiratory system disorders other than interstitial lung disease (see criterion 4) (for example, chronic obstructive pulmonary disease, obstructive sleep apnea or other sleep-disordered breathing, alveolar hypoventilation disorders).
3. The patient has primary pulmonary hypertension or pulmonary hypertension that’s secondary to 1 of these conditions: connective tissue disease, HIV infection, cirrhosis, anorexigens, or congenital left to right shunts. If these conditions are present, the patient must meet these criteria (3.a. – 3.d.):
   1. Pulmonary hypertension has progressed despite maximal medical or surgical treatment of the identified condition
   2. Mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion
   3. The patient has significant symptoms from the pulmonary hypertension (for example, severe dyspnea on exertion and fatigability, angina, or syncope)
   4. The patient tried and failed treatment with oral calcium channel blocking agents, or the provider considered and ruled it out
4. The patient has a diagnosis of pulmonary hypertension associated with interstitial lung disease (see Group 11 Codes in Article A52466 for applicable diagnoses) and meets these criteria (4a–4e):
   1. The presence of interstitial lung disease has been confirmed by a high-resolution computed tomography (CT) chest scan
   2. Mean pulmonary artery pressure is greater than or equal to 25 mm Hg
   3. Pulmonary capillary wedge pressure or left ventricular end-diastolic pressure is less than or equal to 15 mm Hg
   4. Pulmonary vascular resistance is greater than or equal to 3 Wood Units at rest
   5. The patient has significant symptoms of pulmonary hypertension (for example, dyspnea on exertion, fatigability)

If you don’t meet these criteria, we deny E0574 and the related drug treprostinil (J7686) as not reasonable and necessary.

We consider covering a controlled dose inhalation drug delivery system (HCPCS code K0730) when it’s reasonable and necessary for administering iloprost (HCPCS code Q4074) to patients with pulmonary hypertension only (see Group 14 codes in Article A52466 for applicable diagnoses). We deny claims for K0730 for use with other inhalation solutions as not reasonable and necessary.

We cover iloprost (Q4074) when the patient meets all these criteria (1–3):

1. The patient has a diagnosis of pulmonary artery hypertension (see Group 14 Codes in Article A52466 for applicable diagnoses).
2. Pulmonary hypertension isn’t secondary to pulmonary venous hypertension (for example, left-sided atrial or ventricular disease, left-sided valvular heart disease) or respiratory system disorders (for example, chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep-disordered breathing, alveolar hypoventilation disorders).
3. The patient has primary pulmonary hypertension or pulmonary hypertension secondary to 1 of these conditions: connective tissue disease, HIV infection, cirrhosis, anorexigens, or congenital left to right shunts. If these conditions are present, the patient must meet these criteria (3.a. – 3.d.):
   1. Pulmonary hypertension has progressed despite maximal medical or surgical treatment of the identified condition
   2. Mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion
   3. The patient has significant symptoms from the pulmonary hypertension (for example, severe dyspnea on exertion and fatigability, angina, or syncope)
   4. The patient tried and failed treatment with oral calcium channel blocking agents, or the provider considered and ruled it out

If the patient doesn’t meet these criteria, we deny K0730 and the related drug iloprost (Q4074) as not reasonable and necessary.

A large-volume ultrasonic nebulizer (HCPCS code E0575) offers no proven clinical advantage over a pneumatic compressor and nebulizer, and we deny it as not reasonable and necessary.

Refill Requirements

For DMEPOS items and supplies provided on a recurring basis, base your billing on prospective, not retrospective use.

LCD L33370 has more information on accessories, inhalation drugs and solutions, and refill requirements.

Documentation Requirements

To justify payment, you must meet specific requirements when ordering DMEPOS.

For nebulizers and related drugs, we require a face-to-face encounter before you deliver the items to the patient.