Bloomington, Ind., July 6, 2010 – Hospitals nationwide will receive 6 percent higher reimbursement payments for outpatient repair of anal fistulas using Cook Medical's Biodesign® Fistula Plug, a device designed specifically to treat this painful and embarrassing disorder of the lower GI tract. According to new Medicare payment schedules effective January 1^st, hospital outpatient surgery departments will receive approximately $2,200 per procedure, while freestanding ambulatory surgery centers will be paid about $1,300 on average¹. The new fee levels come at an opportune time, as fistulas continue to affect tens of thousands of patients each year in North America alone.

The Centers for Medicare and Medicaid Services (CMS) regularly review charge data from health care providers to determine future facility reimbursement rates. New Medicare fee schedules, published annually, reflect CMS' goal of establishing appropriate payment rates without creating disincentives that could deprive patients of effective treatment. The actual amount of facility reimbursement depends on a number of factors, including the provider and/or site of service (whether a physician, hospital, or ambulatory service, whether inpatient or outpatient) and the facilities' geographic location. Unlike Medicare, commercial insurance plans do not have a consistent national payment methodology, and fee arrangements between these insurers and health care providers vary considerably.

Since Cook introduced the Biodesign Fistula Plug in 2005, health care providers have increasingly recognized the strong performance of biologic grafts for fistula repair. A fistula is an abnormal channel that develops between body organs or an organ and the skin, often in the intestinal tract. Anal fistulas can develop because of mechanical stress caused by Crohn's disease, colitis, diverticulitis and other inflammatory bowel diseases.² They leak fluid, interfere with bowel movements and cause discomfort during sitting and moving. Many can be repaired with a simple procedure called a fistulotomy, but approximately 30 percent of anal fistulas are considered complex and require alternative treatments less likely to prevent anal incontinence.

The Biodesign Fistula Plug is the first device designed and FDA cleared specifically for closing anal fistulas. Unlike other forms of treatment, the Biodesign Fistula Plug does not have a risk of sphincter muscle damage, a potential complication of fistulotomy that can cause incontinence. To further optimize procedural outcomes, Cook recently introduced the Biodesign Fistula Plug Set, a collection of accessory tools designed to help physicians achieve best outcomes in use of the Biodesign Fistula Plug. Available now, the Biodesign Fistula Plug Set includes the Biodesign Fistula Plug itself, brush, irrigation catheters, syringe and sutures.

Biodesign communicates with the body, signaling surrounding tissue to grow throughout the biologic scaffold to close the fistula, allowing the body to restore itself. It combines the best attributes of biologic grafts–resistance to infection and complete remodeling–with the added benefits of moderate price, ease of use and widespread availability.

"In thousands of fistula repair procedures around the world, the Biodesign Fistula Plug has achieved significant success rates in treating the most painful and complex fistulas," said Andy Cron, vice president and global business unit leader of Cook Medical's Surgery strategic business unit. "We hope these new reimbursement rates will advance awareness of this important procedure so that more patients suffering from debilitating fistulas can return to an improved quality of life."

For additional information on the Biodesign Fistula Plug, visit CookBiodesign.com, the first-ever informational microsite for Cook Medical's Biodesign Advanced Tissue Repair Products. Follow updates on Biodesign on Twitter at twitter.com/cooksurgery.

About Biodesign
Biodesign is a whole new category in the evolution of soft tissue repair, addressing physicians' needs for an advanced biologic graft. Once implanted, Biodesign communicates with the body, signaling surrounding tissue to grow across the acellular scaffold, allowing the body to restore itself. Biodesign completely remodels into fully vascularized tissue that becomes stronger over time, providing a permanent repair without a permanent material. Biodesign combines the best attributes of biologic grafts–resistant to infection and complete remodelling–with the added benefits of moderate price, ease of use and widespread availability. Introduced by Cook in 1995 and manufactured in the Cook Biotech facility in West Lafayette, Ind., the grafts have a proven track record in treating a range of conditions including hernias, fistulas, stress urinary incontinence, pelvic organ prolapse and Peyronie's disease, as well as in staple-line reinforcement for bariatric surgery and plastic and reconstructive surgery. To date, nearly 750 clinical articles have been published on the technology behind Biodesign.

About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter at twitter.com/CookMedicalPR and twitter.com/CookSurgery.