FDAnews Device Daily Bulletin

ARIZONA LAWMAKERS SEEK MEDICARE POLICY SHIFT ON URINARY CATHETER REUSE

July 7, 2006
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Two House lawmakers are challenging a Medicare policy they say forces patients suffering from bladder dysfunctions to reuse urinary catheters.

Catheters are narrow tubes inserted through the urethra to drain the bladder. Infection risks increase with reuse of the devices, which are labeled for single use only by the FDA, according to a letter drafted by Reps. Rick Renzi (R.-Ariz.) and J.D. Hayworth (R-Ariz.) to Mark McClellan, administrator of the Centers for Medicare and Medicaid (CMS).

Medicare currently pays for only one catheter per week for outpatients, "except under very limited circumstances" for nursing home patients, those with systems that are immunosuppressed and pregnant women with spinal cord injuries, the congressmen noted.

The current policy is the result of a local coverage decision (LCD) and not a national coverage decision, a CMS spokewoman said. "This LCD is not an absolute bar to single use, but there has to be some reason medically having do with a particular patient" to change the policy on an individual basis.

A review of CMS literature shows that "clean, intermittent catheterization has been accepted as safe for over 24 years," she added.