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
LCD L39711: MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy — WPS
Policy LCD-L39711 • Pulmonology
HighThe finalized LCD L39711 pertains to the use of molecular biomarkers for risk stratification of indeterminate pulmonary nodules following bronchoscopy. This LCD is active and will be effective startin
LCD 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
FDA 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%.
Proposed LCD DL33370: Nebulizers — CGS
Policy LCD-DL33370 • Pulmonology
RoutineThe 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
LCD L34541: Transtelephonic Spirometry — CGS
Policy LCD-L34541 • Pulmonology
HighThe implementation of the LCD for Transtelephonic Spirometry will ensure that relevant billing practices align with the latest guidelines. This requires billing team review
LCD L34149: Respiratory Care — Noridian
Policy LCD-L34149 • Pulmonology
HighThe new LCD for Respiratory Care by Noridian is set to take effect on 10/16/2025. This could impact billing processes for related services, requiring providers to stay updated on the specific codes an
LCD L37293: Respiratory Care — Noridian
Policy LCD-L37293 • Pulmonology
HighThe new Local Coverage Determination (LCD) for Respiratory Care by Noridian may impact reimbursement rates and coding requirements for respiratory-related services. Providers should ensure compliance
LCD L38310: Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea — Noridian
Policy LCD-L38310 • Pulmonology
HighThe upcoming LCD on Hypoglossal Nerve Stimulation for treating obstructive sleep apnea will impact billing by establishing clear guidelines and reimbursement rates for this therapy. Providers should p
LCD L33800: Respiratory Assist Devices — CGS
Policy LCD-L33800 • Pulmonology
HighThe new LCD from CGS on Respiratory Assist Devices may lead to adjustments in billing for related equipment and services. Providers should prepare to update their billing practices to ensure complianc
LCD L37887: MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test — Noridian
Policy LCD-L37887 • Pulmonology
HighThe introduction of the Envisia™ test for Idiopathic Pulmonary Fibrosis could enhance diagnostic accuracy and potentially increase testing frequency, impacting overall billing. This could lead to a ri
LCD L39678: MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy — Noridian
Policy LCD-L39678 • Pulmonology
HighThe introduction of MolDX for stratifying pulmonary nodules may significantly impact billing practices by necessitating new documentation and coding for marker tests. Facilities will need to ensure co
LCD L39680: MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy — Noridian
Policy LCD-L39680 • Pulmonology
HighThe implementation of MolDX for molecular biomarkers in risk stratification will likely supports compliance with updated rates for procedures related to pulmonary nodules by ensuring proper reimbursement for molecular testi
LCD L37891: MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test — Noridian
Policy LCD-L37891 • Pulmonology
HighThe update to the MolDX policy for Envisia™ and Veracyte™ tests will enable more accurate billing for idiopathic pulmonary fibrosis diagnostic services. This will likely supports compliance with updated rates fo
LCD L33370: Nebulizers — CGS
Policy LCD-L33370 • Pulmonology
HighThe upcoming LCD on nebulizers effective February 1, 2026, may impact billing by introducing new guidelines for coverage and documentation requirements. Providers need to be aware of these changes, as
LCD L37905: MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test — CGS Administrators
Policy LCD-L37905 • Pulmonology
HighThis Local Coverage Determination (LCD) addresses the Envisia™ and Veracyte™ diagnostic tests for Idiopathic Pulmonary Fibrosis (IPF). It impacts billing for these specific tests under Medicare, sugge