February 23, 2015 — C. R. Bard Inc. announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved a pass-through payment for the Lutonix drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favorable recommendation from the U.S. Food and Drug Administration’s (FDA) Circulatory Systems Devices Advisory Panel.
The Lutonix 035 DCB—the first FDA-approved DCB— is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.
This supplemental reimbursement provision takes effect on April 1, 2015. The purpose of the supplemental reimbursement is to cover additional cost to U.S. hospitals for treating Medicare beneficiaries with the Lutonix DCB in the outpatient setting. The Healthcare Common Procedure Coding System (HCPCS) code for this new device category will be C2623 (catheter, transluminal angioplasty, drug-coated, non-laser).
For more information: www.crbard.com
June 13, 2024 
