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New U.S. Medicare Policy Encourages Healthier Approach to Bladder Management and Catheter Use

August 11, 2008

People using intermittent catheters no longer need to re-use their catheters due to a new Medicare policy effective April 1, 2008. The change affects nearly 1 million individuals living with spinal cord injury, multiple sclerosis and spina bifida, as well as those who have other permanent conditions requiring bladder management or experience urinary incontinence or retention.

Backed by Coloplast Corp., members of Congress and the incontinence care community, the new policy eliminates mandatory re-use of intermittent catheters for outpatients receiving prescriptions from physicians. The new policy increases reimbursement coverage of sterile catheters from four per month to single-use (each episode of covered catheterization).

New Policy Set to Reduce Exposure to Bacteria and Healthcare Costs

Catheter re-use may be a key contributor to urinary tract infections. With approximately 10 million urinary tract infection-related doctor visits each year(1), the Medicare change is an important step in reducing healthcare costs through preventive care and lowering patient risks related to urinary catheterization:

— Sixty-five percent of intermittent catheter users get urinary tract infections at least once/year, compared to 14 percent in the general Medicare population(2)

— Intermittent catheter users are approximately five times more likely to have at least one urinary tract infection/year(2)

— Medicare-covered per capita cost of treating urinary tract infections was 8-10 times higher for intermittent catheter users ($1,434/spinal cord injury capita and $1,154/spina bifida capita) than the average ($83/capita) (2)

— About $3.5 billion is spent nationally in annual urinary tract infection evaluation and treatment(3)

“This was a vital policy change the industry needed to make,” said Dr. Green, director of Urology at the Shepherd Center in Atlanta, Ga., and published author. “No longer does the patient have to clean his or her catheter after each use. The new policy offers greater patient convenience and reduces the incidence of improper catheterization techniques. It can potentially reduce the cross contamination of bacteria, thus reducing the incidence of urinary tract infections and mitigating significant health care costs associated with urinary tract infections.”

New Policy Reverses Practice of Cleaning and Re-using Catheters

Individuals living with permanent conditions like multiple sclerosis or spinal cord injury can have neurogenic bladders, in which central nervous system damage results in a bladder that cannot empty on its own. As a result, people turn to intermittent catheters, the preferred bladder management tool for greater independence from the alternative, indwelling or foley catheters.

In the 1970s, Clean Intermittent Catheterization (CIC) became the standard protocol, requiring patients and clinicians to clean and re-use catheters despite Food and Drug Administration (FDA) labeling of catheters as single-use medical devices.

In December 2007, the largest hospital network, Veterans Affairs (VA), eliminated the practice of prescribing intermittent catheter re-use for individuals in and outside of the hospital setting. Medicare’s new policy in April 2008 committed the insurance provider to reimbursement of each episode of covered catheterization. Rather than re-using an average of one catheter per week, people depending on intermittent catheters can use a sterile catheter for each catheter insertion.

New Policy Improves Patient Care

This change also lightens the previous cost burden to beneficiaries that narrowed options based on price vs. quality. Clinicians are able to recommend different products based on patient lifestyles and medical needs. They also can more easily change prescriptions when necessary.

“People living with neurogenic bladders tell us their fears of painful health complications, including a high risk of recurring urinary tract infections, resulting from regular re-use of catheters,” said Jan Rolin Frederiksen, president of Coloplast Americas. “Bladder management is very personal and now consumers will be able to better manage their specific needs, solve everyday challenges and live healthier.”

“We’re thrilled to see Coloplast, members of Congress, the Department of Health and Human Services and the continence care community come together to advocate for this change for the benefit of consumers,” said Nancy Muller, executive director of the National Association For Continence. “Access to sterile, single-use supplies is important so at-risk individuals with urinary retention or other chronic medical circumstances requiring intermittent self-catheterization can be better protected against costly, recurrent urinary tract infections.”

Dr. Green added, “It’s reassuring that intermittent catheter users can now experience the product best suited for them and physicians and nurses can spend more time focusing on the patient.”

For more information on Coloplast or the U.S. Medicare coverage policy change for intermittent catheters, please visit the internet press kit at http://www.coloplastmediakit.com/catheterpolicy/. Consumers can contact the Coloplast helpline at 800-525-8161 or visit http://www.continence.us.coloplast.com to ask questions or request product samples.

About Coloplast

Coloplast is a global leader in the development of intimate healthcare products and services to make life easier for people with very personal and private medical concerns. The company’s business areas include continence and urology care, ostomy care and wound and skin care. Its innovative, high-quality brands include Self-Cath(R), SpeediCath, Freedom(R), Titan(R), Aris(R), Biatain(R), SenSura(R), Assura(R) and InterDry(TM). Following the acquisition of Mentor Urology, Coloplast has become the market leader in U.S. continence care. Employing more than 7,000 people, Coloplast is headquartered in Humlebaek, Denmark, with its U.S. subsidiary headquartered in Minneapolis. For more information, visit us.coloplast.com.

1. Litwin, Mark, MD., Christopher Saigal, MD. Urologic Diseases in America. “Introduction.” Table 2, page 5. National Kidney and Urologic Diseases Information Clearinghouse.

2. Direct Research, LLC. “Coloplast Internal Analysis on Record: Medicare Beneficiary Claims.” (2008): 3-5.

3. “Urinary Tract Infection – In-Depth Report.” Review by Harvey Simon, MD, Associate Professor of Medicine, Harvard Medical School. New York Times Health Guide. 2007: Risk Factors.




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