CMS Approves Pass-Through Payment for Lutonix DCB for Outpatient Use
February 19 2015 - 11:52AM
Business Wire
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—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.
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.
C. R. Bard, Inc.Investor Relations:Todd W.
Garner, 908-277-8065Vice President, Investor
RelationsorMedia Relations:Scott T. Lowry,
908-277-8365Vice President and Treasurer
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