CMS approves add-on payment for Lutonix drug-coated balloon for inpatient use


The US Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment for Bard’s Lutonix drug-coated balloon under the Medicare hospital inpatient prospective payment system.

The purpose of the reimbursement is to help cover additional cost to US hospitals for treating Medicare beneficiaries with Lutonix in the inpatient setting. CMS determined the amount of the add-on payment to be a maximum of US$1,036 when drug-coated balloons are used for inpatient peripheral procedures and the total device costs exceed the allowance for existing DRG reimbursement. The add-on payment is effective from 1 October 2015.

The Lutonix 035 drug-coated balloon—the first Food and Drug-approved drug-coated balloon—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.

Timothy M Ring, chairman and chief executive officer, commented, “After providing reimbursement in the outpatient setting earlier this year, CMS has now provided additional reimbursement for Lutonix in the inpatient setting, which demonstrates the benefit to patients from this breakthrough technology.”