The US Centers for Medicare and Medicaid Services has approved a pass-through payment for Bard’s Lutonix drug-coated balloon under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favourable recommendation from the Food and Drug Administration (FDA)’s Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk.
The Lutonix 035 is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilises standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease 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 US hospitals for treating Medicare beneficiaries with Lutonix in the outpatient setting. The Healthcare Common Procedure Coding System code for this new device category will be C2623 (catheter, transluminal angioplasty, drug-coated, non-laser).
Timothy M Ring, chairman and chief executive officer of Bard, commented, “This approval is another positive step in the global progression of our drug-coated balloon program, which aims to benefit patients and clinicians who struggle with the debilitating problem of peripheral artery disease.”