Does J7601 require prior authorization?

Yes, J7601 requires prior authorization (medium confidence). Conditional coverage; review criteria to confirm PA need.

What is the Medicare reimbursement rate for J7601?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J7601`, Ensifentrine, inhalation suspension, fda approved final product,

HCPCS/CPT

Prior Authorization

Prior Auth Required

Conditional coverage; review criteria to confirm PA need (medium 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.

For refill dispensing, suppliers must document beneficiary contact (affirmative response) made no sooner than 30 days prior to expected end of supply and must document delivery no sooner than 10 days prior to expected end of supply.

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.

5 Active Policies

BCBSLA-00913-4242AFD2DF, 00913 ensifentrine (Ohtuvayre)

POINT32HEALTH-PMNG-17106, Ohtuvayre (ensifentrine)

MULTI

POINT32HEALTH-PMNG-17116, Ohtuvayre (ensifentrine)

MULTI

OSCAR-OHTUVAYRE-ENSIFENTRINE-PG237-VER-3-3D55D98704, Ohtuvayre (ensifentrine) (PG237, Ver. 3)

L33370, Nebulizers

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J7601, Ensifentrine, inhalation suspension, fda approved final product,