A Victory for Children Who Cath
In the past, children who required intermittent catheterization had to reuse their catheters over and over, sometimes as many as 50 times, since Medicaid and Medicare paid for only one catheter per week. In a long-awaited policy revision, Medicare finally approved the use of 200 catheters and packages of lubricant per month beginning April 1, 2008. This rule is strictly a Medicare coverage decision; however, Medicaid and private insurance companies typically follow the lead of Medicare when creating coverage guidelines. This policy will likely apply to most children in the United States within the near future.
For many years, there has been a shocking disconnect on this issue between the FDA [US Food and Drug Administration], who designates catheters as "Single Use Only," and the Centers for Medicaid and Medicare Services, who forced patients to reuse catheters multiple times. While Medicare did allow single-use catheters for patients with two or more documented urinary tract infections, it was often an arduous process to obtain approval for these additional catheters. Children were stuck using catheters again and again, in direct contradiction to the labels on those catheters, which were marked as single use medical devices.
Catheter makers, as well as the Spina Bifida Association, the National Multiple Sclerosis Society, and other medical groups, also advocated for a change to this outdated and hypocritical reuse policy.1
While studies have not necessarily shown an increase in urinary tract infections due to reuse of catheters, some have reported a higher amount of asymptomatic bacteria in the urine.2 Cleaning methods can also influence the rates of infection. A common way to disinfect catheters is to microwave or boil them, but even microwaving for 12 minutes left bacteria on the catheter.3 While further studies are needed to determine the ultimate impact of reuse, using sterile catheters seems like a logical solution to reduce bacteria in the urinary tract and limit infections.
In addition, most studies were conducted on relatively healthy patients with spinal cord injuries or spina bifida, and not on children with multiple other issues such as immune problems, central lines, or a history of repeated infections. Hopefully this new rule will improve the health of many children with complex medical issues throughout the United States, preventing urinary tract infections, kidney infections and damage, sepsis, and other consequences of catheter-related infections. The increased costs of providing extra catheters will likely be offset by the reduction in costs for diagnosing and treating urinary tract infections and their complications.
The language from the new coverage regulation appears below:4
Intermittent catheterization is covered when basic coverage criteria are met and the patient or caregiver can perform the procedure.
For each episode of covered catheterization, Medicare will cover:
1. One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or
2. One sterile intermittent catheter kit (A4353) if additional coverage criteria...are met.
The following table represents the usual maximum number of supplies:
A4332 (200) [lubricant]
A4351 (200) [straight cath]
A4352 (200) [coude tip cath]
A4353 (200) [cath with insertion supplies]
1See this statement from the Spina Bifida Association and this statement from the catheter manufacturer Hollister.
2Kathryn Getliffe, et al. "Current Evidence on Intermittent Catheterization: Sterile Single-Use Catheters or Clean Reused Catheters and the Incidence of UTI." The Journal of Wound, Ostomy and Continence Nursing 2007; 34(3):289-96.
3Guy A. Bogaert, et al. "The Physical and Antimicrobial Effects of Microwave Heating and Alcohol Immersion on Catheters that are Reused for Clean Intermittent Catheterisation." European Urology 2004;46(5):641-6.