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| Press Release November 9, 2004 | |
LAKE FOREST, Calif.--(BUSINESS WIRE)--Nov. 9, 2004--
I-Flow Views Decision as Initial Step toward Widespread Medicare
Policy and Broader Private Insurance Coverage
I-Flow Corporation (NASDAQ: IFLO) today announced the first coverage by Medicare for ON-Q(R) PainBuster(R), related to a specific case when the device was used for a patient following hernia surgery. The decision that ON-Q was medically necessary and therefore payable was made by an administrative law judge based upon the law and clinical evidence submitted by I-Flow. The appeal featured highlights of ON-Q's recently cleared enhanced labeling as well as clinical data demonstrating the benefits of the ON-Q Soaker(TM) Catheter. "We believe that providing non-narcotic pain relief and helping promote faster return to normal is an essential part of any surgical procedure and Medicare coverage is another step toward making ON-Q the gold standard for post-surgical pain relief," said Donald M. Earhart, President and CEO of I-Flow Corporation. "This breakthrough paves the way for I-Flow to use the decision as a supporting point for both Medicare and private insurance companies to encourage widespread policies that include payment for ON-Q so that the therapy will be available to even more surgeons and patients." Historically, all of Medicare's contractors, or DMERCs, have adopted policies that resulted in denied payments for ON-Q PainBuster. However, based on the law and evidence that included compelling clinical findings presented during an appeal to an administrative law judge assigned to hear Medicare cases, it was determined that ON-Q was payable. With this decision, I-Flow will now request that each Medicare contractor revise its coverage policy and begin providing payment for ON-Q when used to treat post-operative pain. Additionally, private payer systems commonly establish coverage decisions based upon Medicare policy. I-Flow plans to leverage this coverage decision with private insurers as well. About ON-Q PainBuster ON-Q is now labeled to significantly reduce pain and narcotics intake after surgery. ON-Q PainBuster is a simple yet elegant device that consists of a small balloon pump that holds a local anesthetic (a pain-numbing medicine) and delivers it through a tiny, specially-designed tube (catheter) directly into the surgical site. The proprietary ON-Q Soaker(TM) Catheter is designed to provide more even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities. ON-Q PainBuster delivers narcotic-free pain relief for many surgeries, including: cesarean section, hysterectomy, knee replacement, mastectomy, cardio-vascular/thoracic, foot and ankle and many cosmetic procedures. ON-Q PainBuster helps patients avoid the side effects of narcotics so they can get back to their normal lives faster. Currently, 39 studies on the use of ON-Q have been completed and published and more are underway to demonstrate the benefits of ON-Q in additional areas such as pediatrics and wound healing. For more information about ON-Q, visit AskYourSurgeon.com or call 800-448-3569. About I-Flow Corporation I-Flow Corporation (iflo.com) designs, develops and markets technically advanced, low-cost drug delivery systems and services that are redefining the standard of care by providing life-enhancing, cost-effective solutions for pain relief. Certain disclosures made by the Company in this press release and in other reports and statements released by the Company are and will be forward-looking in nature, such as comments that express the Company's opinions about trends and factors that may impact future operating results. Disclosures that use words such as the Company "believes," "anticipates," or "expects" or use similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ from those expected, and readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to republish revised forward-looking statements to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures made by the Company in this release which seek to advise interested parties of the risks and other factors that affect the Company's business, as well as in the Company's periodic reports on Forms 10-K, 10-Q, and 8-K filed with the Securities and Exchange Commission. The risks affecting the Company's business include, among others: implementation of our direct sales strategy; dependence on our suppliers and distributors; reliance on the success of the home health care industry; our continuing compliance with applicable laws and regulations, such as the Food Drug and Cosmetics Act, and the FDA's concurrence with our management's subjective judgment on compliance issues; the reimbursement system currently in place and future changes to that system; competition in the industry; economic and political conditions in foreign countries; currency exchange rates; inadequacy of booked reserves; technological changes and product availability and acceptance. All such forward-looking statements, whether made in this release or elsewhere, should be considered in context with the various disclosures made by the Company about its business.
CONTACT: Schwartz Communications
Wendy Williams/Brian Bogie, 781-684-0770
iflo@schwartz-pr.com
or
I-Flow Corporation
Orlando Rodrigues, 949-206-2619
orlandorodrigues@iflo.com
SOURCE: I-Flow Corporation
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| SITEMAP | SALES INFOCENTER HEALTHCARE COMPLIANCE PROGRAM | HIPAA PRIVACY NOTICE © 2004-2010 I-FLOW CORPORATION. All Rights Reserved There are inherent risks in all medical devices, please refer to the product labeling for Indications, Cautions, Warnings and Contraindications.For example, failure to follow the product labeling regarding filling, flow rate selection and placement of the pump and/or catheter could directly impact patient safety. Physician is responsible for prescribing and administering medications per instructions provided by the drug manufacturer. |