FDA Approval: ARIKAYCE (AMIKACIN) — Type 3 - New Dosage Form
Policy FDA-NDA207356 · Pulmonology
CriticalArikayce (amikacin liposomal inhalation suspension) received FDA approval in September 2018 as an inhaled orphan drug for refractory Mycobacterium avium complex (MAC) lung disease, administered via a
View alertLCD L39658: MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy — CGS
Policy LCD-L39658 · Pulmonology
HighThe final LCD L39658 addresses the use of molecular biomarkers for risk stratification of indeterminate pulmonary nodules following bronchoscopy, effective from June 18, 2026. Healthcare providers in
View alertFDA Approval: PROVOCHOLINE (METHACHOLINE CHLORIDE) — Type 1 - New Molecular Entity
Policy FDA-NDA019193 · Pulmonology
HighProvocholine (Methacholine Chloride) is an injectable drug likely to receive a specific J-code for billing. As a Part B candidate, it may be eligible for pass-through payment or reimbursed at ASP+6%.
View alertProposed LCD DL33370: Nebulizers — CGS
Policy LCD-DL33370 · Pulmonology
HighThe proposed Local Coverage Determination (LCD) for nebulizers may impact billing practices by clarifying coverage guidelines for these devices. This could lead to changes in reimbursement rates or el
View alert