Levalbuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, 0.5 mg
Medicare coverage: Special coverage instructions apply
Status: active (October 2026 file)
Medically Unlikely Edits (effective October 1, 2026)
Practitioner: max 10 units per day (clinical), rationale: Prescribing Information
Outpatient hospital: max 0 units per day (clinical), rationale: CMS Policy
DME supplier: max 900 units per day (clinical), rationale: Clinical: Data
Medicare pricing for J7612
Medicare Part B drug payment limit (ASP, October 2026)
J7612 payment limit: $0.304 per 0.5 MG, effective October 1, 2026 through December 31, 2026, based on 2Q26 ASP data. Coinsurance 20%.
NDCs that bill under J7612 (CMS ASP NDC-HCPCS crosswalk, October 2026)
00378-6993-93 Levalbuterol Inhalation Solution Concentrated, Mylan Pharmaceuticals Inc.: 75 billing units per package (30 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / .5 mL in 1 VIAL)
From payers' published prior-auth lists, coverage policies and state Medicaid fee schedules, updated Oct 16, 2026. The role is what the policy's own code table or text says about the code. Not a guarantee of coverage or payment; verify with the payer. CPT® is a registered trademark of the American Medical Association.