C.R. Bard (NYSE:BCR) said today that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved a pass-through payment for the Lutonix drug-coated balloon, which won FDA approval earlier this month.
The Lutonix device is the 1st DEB to hit the U.S. market. It’s designed to dilate obstructions in the superficial femoral or popliteal arteries and leave behind a therapeutic dose of paclitaxel, a drug that’s also used to coat drug-eluting stents. FDA granted pre-market approval for the drug-eluting balloon for treating peripheral artery disease earlier this month.
Officials at C.R. Bard said reimbusement provision, which comes under the Medicare hospital outpatient prospective payment system, takes effect April 1. The supplemental reimbursement is to cover additional cost to U.S. hospitals for treating Medicare beneficiaries with the Lutonix balloon in an outpatient setting.
“This CMS 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," C.R. Bard CEO Timothy Ring said in a prepared release.
Earlier this month, C.R. Bard inked a deal with Boston Scientific (NYSE:BSX) for limited U.S. distribution of the device.