J7601 — Ensifentrine, inhalation suspension, fda approved final product, non-compounded, administered through dme, unit dose form, 3 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted; for DMEPOS base items requiring WOPD, a signed WOPD must be received before delivery.
- Suppliers must maintain and produce Proof of Delivery (POD) documentation upon request; lack of POD will result in denial.
- For treprostinil (J7686) and iloprost (Q4074) coverage, documentation must include diagnosis of pulmonary arterial hypertension, hemodynamic measurements (mean pulmonary artery pressure, PCWP or LVEDP, pulmonary vascular resistance), symptom severity, prior maximal treatment, and documentation of trial/failure or contraindication to oral calcium channel blockers; HRCT chest is required when coverage is sought for PH associated with interstitial lung disease.
- Suppliers must follow LCD-related Standard Documentation Requirements Article, the LCD-related Policy Article, Supplier Manual, and applicable DME MAC publications and retain all supporting medical records for claims.
Key Coverage Criteria
- Small-volume nebulizers (A7003, A7004, A7005) and related compressor E0570 are covered when used to administer FDA‑approved inhalation solutions (albuterol, arformoterol, budesonide, cromolyn, formoterol, ipratropium, levalbuterol, metaproterenol, revefenacin) for management of obstructive pulmonary disease.
- Dornase alfa (J7639) delivered via a nebulizer is covered for beneficiaries with cystic fibrosis.
- Tobramycin inhalation (J7682) delivered via a nebulizer is covered for beneficiaries with cystic fibrosis or bronchiectasis.
- Pentamidine (J2545) delivered via an E0565 or E0572 compressor with filtered nebulizer A7006 is covered for beneficiaries with HIV, pneumocystosis, or complications of organ transplant.
- Acetylcysteine (J7608) delivered via nebulizer is covered for persistent thick or tenacious pulmonary secretions.
- Hypertonic saline (J7131) delivered via nebulizer is covered for beneficiaries with cystic fibrosis, bronchiectasis, or ciliary dyskinesia.
2 Active Policies
L33370 — Nebulizers
J19
L40269 — Nebulizers
J19
Related Codes
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