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I-Flow Announces First Medicare Coverage Of ON-Q PainBuster

11/10/2004

LAKE FOREST, Calif. -- I-Flow Corporation announced the first coverage by Medicare for ON-Q® PainBuster®, 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™ 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™ 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, cardiovascular/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.

About I-Flow Corporation
I-Flow Corporation 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.

Source: BusinessWire


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