J7601 HCPCS code: Ensifentrine, inhalation suspension, fda approved final product, non-compounded, administered through dme, unit dose form, 3 mg
J7601 is the HCPCS Level II code for ensifentrine, inhalation suspension, fda approved final product, non-compounded, administered through dme, unit dose form, 3 mg. Its Medicare coverage code is C (Carrier judgment): Coverage is decided by the Medicare contractor (MAC) case by case. The NCCI unit limit is 2 per day on practitioner claims.
Code details
| Field | Value |
|---|---|
| Section | J codes — Drugs administered other than oral method |
| Coverage code | C — Carrier judgment |
| Pricing indicator | 51 — Drug or biological (priced per ASP/average sales price rules) |
| BETOS category | D1G — Drugs administered through DME |
| Added | 2025-01-01 |
| Last action effective | 2025-01-01 |
NCCI unit limits (MUE)
| Claim type | Max units per day | Rationale |
|---|---|---|
| practitioner claims | 2 | Prescribing Information |
Medicare policy articles for this code
- A52466: Nebulizers - Policy Article (CGS Administrators, LLC (DME MAC) Noridian Healthcare Solutions, LLC (DME MAC)) — mentions this code in its coding guidance
Covered diagnoses (215 ICD-10-CM codes)
The diagnoses most often listed as covered in the policy articles above:
| ICD-10-CM | Diagnosis | Articles listing it |
|---|---|---|
| A15.0 | Tuberculosis of lung | 1 |
| A22.1 | Pulmonary anthrax | 1 |
| A37.01 | Whooping cough due to Bordetella pertussis with pneumonia | 1 |
| A37.11 | Whooping cough due to Bordetella parapertussis with pneumonia | 1 |
| A37.81 | Whooping cough due to other Bordetella species with pneumonia | 1 |
| A37.91 | Whooping cough, unspecified species with pneumonia | 1 |
| A48.1 | Legionnaires' disease | 1 |
| B20 | Human immunodeficiency virus [HIV] disease | 1 |
| B25.0 | Cytomegaloviral pneumonitis | 1 |
| B44.0 | Invasive pulmonary aspergillosis | 1 |
Showing 10 of 215. The full list, non-covered diagnoses and CSV export are in Caduvo.
What changed for J7601
- 2025-01-01: J7601 added to HCPCS Level II
- Next scheduled CMS quarterly update (HCPCS and DMEPOS fee schedule): 2027-01-01
Frequently asked questions
What is HCPCS code J7601?
J7601 is the HCPCS Level II code for ensifentrine, inhalation suspension, fda approved final product, non-compounded, administered through dme, unit dose form, 3 mg. Short descriptor: "Ensifentrine inh 3 mg".
Does Medicare cover J7601?
Coverage code C — Carrier judgment. Coverage is decided by the Medicare contractor (MAC) case by case.
Which diagnoses support coverage for J7601?
Medicare policy articles that cite J7601 list 215 covered ICD-10-CM diagnosis codes across 1 article. The most cited include A15.0 (Tuberculosis of lung), A22.1 (Pulmonary anthrax), A37.01 (Whooping cough due to Bordetella pertussis with pneumonia). A listed diagnosis is necessary but not sufficient; the policy's other criteria still apply.
How many units of J7601 can be billed per day?
2 on practitioner claims (NCCI medically unlikely edits).
Related J76 codes
- J7604 — Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, per gram
- J7605 — Arformoterol, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 15 micrograms
- J7606 — Formoterol fumarate, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 20 micrograms
- J7607 — Levalbuterol, inhalation solution, compounded product, administered through dme, concentrated form, 0.5 mg
- J7608 — Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram
- 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
- J7611 — Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, 1 mg
- J7612 — Levalbuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, 0.5 mg
- J7613 — Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 1 mg
- J7614 — Levalbuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 0.5 mg
- J7615 — Levalbuterol, inhalation solution, compounded product, administered through dme, unit dose, 0.5 mg
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Next steps
- Run a reimbursement report for a device billed under J7601
- Watch J7601 for fee, coverage and descriptor changes
- Build a full Medicare revenue model for J7601
Sources: CMS HCPCS Level II release October 2025; CMS DMEPOS fee schedule; CMS NCCI MUE tables; CMS Medicare utilization (physician and DME supplier files); CMS Medicare Coverage Database articles. Fees are Medicare allowables, not commercial rates. Not billing or legal advice.