Healthcare Industry News: neuromodulation
News Release - December 8, 2010
Uroplasty Updates National Government Services Coverage Decision for Posterior Tibial Nerve Stimulation (PTNS)MINNEAPOLIS, Dec. 8, 2010 -- (Healthcare Sales & Marketing Network) -- Uroplasty, Inc. (Nasdaq:UPI ), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced that, after the close of market on Tuesday, December 7, 2010, it became aware that National Government Services (NGS), a regional Medicare carrier, had issued a future negative coverage decision on PTNS therapy that will be effective in four states after January 3, 2011. NGS covers Connecticut, Indiana, Kentucky and New York.
"This is the first negative coverage decision we have received since the publication of our SUmiT study and the announcement that the American Medical Association (AMA) would issue a CPT® Category I Code to be effective January 1, 2011," said David Kaysen, Uroplasty President and CEO. "We are disappointed and plan to address this with NGS to work toward a reversal of this decision. Importantly, we do not expect this decision to impact the positive coverage decisions we have already received. Each Medicare jurisdiction has its own reimbursement contractor making its own coverage decisions independently."
Uroplasty has previously announced positive coverage decisions by six regional Medicare carriers covering Arizona, Arkansas, California, Hawaii, Idaho, Louisiana, Montana, Nevada, North Carolina, North Dakota, Ohio, South Carolina, South Dakota, Utah, Washington, Wyoming and West Virginia. The Company estimates the total number of Medicare covered lives for which it has received positive coverage decisions is approximately at 12 million. This NGS negative decision has no impact on these positive decisions. NGS covers less than 10% of total Medicare covered lives.
"We plan to meet soon with the medical director of NGS to understand the basis for the decision and work with the carrier to reverse it," continued Mr. Kaysen. "We believe this decision is contrary to the strong clinical data that supports PTNS that led to the positive CPT coding decision and the coverage decisions in other jurisdictions. We will continue to present the growing body of clinical data to NGS and other medical directors of Medicare carriers, and private payers to ensure they understand the patient benefits and encourage them to cover and reimburse PTNS."
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions. Our focus is the continued commercialization of our Urgent PC neuromodulation System, the only FDA-cleared system that delivers posterior tibial nerve stimulation (PTNS) for the office-based treatment of overactive bladder and associated symptoms of urgency, frequency and urge incontinence. We also offer Macroplastique® Implants, an injectable urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. For more information on the company and its products, please visit Uroplasty, Inc. at www.uroplasty.com.
This press release contains forward-looking statements that reflect our best estimates regarding future events. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our anticipated results. We discuss in detail the factors that may affect the achievement of our forward-looking statements in our Annual Report on Form 10-K filed with the SEC. In particular, we cannot be certain that the rate of reimbursement for PTNS treatments will be adequate to justify the cost of our product, that other Medicare carriers or private payers will provide coverage for this treatment, or that any of the other risks identified in our 10-K will not adversely affect our expectations as described in these forward-looking statements.
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