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CMS Approves Pass-Through Payment for Lutonix DCB for Outpatient Use
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Lutonix Drug-Coated Balloon |
February 19, 2015 -- Murray Hill, New Jersey -- C. R. Bard, Inc. (NYSE:BCR) today 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 FDA's Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk.
The Lutonix® 035 DCB -- he 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).
Timothy M. Ring, chairman and chief executive officer of C. R. Bard, commented, "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, Inc. (www.crbard.com), headquartered in Murray Hill, N.J., 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.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current expectations, the accuracy of which is necessarily subject to risks and uncertainties. These statements are not historical in nature and use words such as "anticipate", "estimate", "expect", "project", "intend", "forecast", "plan", "believe", and other words of similar meaning in connection with any discussion of future operating or financial performance. Many factors may cause actual results to differ materially from anticipated results including product developments, sales efforts, income tax matters, the outcomes of contingencies such as legal proceedings, and other economic, business, competitive and regulatory factors. The company undertakes no obligation to update its forward-looking statements. Please refer to the Cautionary Statement Regarding Forward-Looking Information in our 2014 Form 10-K for more detailed information about these and other factors that may cause actual results to differ materially from those expressed or implied.
Source: C. R. Bard, Inc. |
