The purpose of the reimbursement is to help cover additional cost to U.S. hospitals for treating Medicare beneficiaries with the Lutonix DCB in the inpatient setting.
CMS determined the amount of the add-on payment to be a maximum of $1,036 when DCBs are used for inpatient peripheral procedures and the total device costs exceed the allowance for existing DRG reimbursement. The add-on payment is effective October 1, 2015.
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.
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 the Lutonix DCB in the inpatient setting, which demonstrates the benefit to patients from this breakthrough technology."
C. R. Bard, headquartered in Murray Hill, is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.