FACT SHEET

Overview: The Health Care Financing Administration, recognizing that urinary incontinence is a major problem for Medicare beneficiaries, decided to review Medicare coverage policy for pelvic floor electrical stimulation and biofeedback for this medical condition. HCFA also received inquiries from professional societies, manufacturers and beneficiaries. The review resulted in new National Coverage Decisions issued today.

Pelvic floor electrical stimulation uses a non-implantable electrical device (placed in the vagina or rectum) to deliver variable rates of electrical current through the pelvic floor with the intent of strengthening the pelvic floor muscles. Biofeedback is a technique intended to teach patients to bring certain physiologic processes under voluntary control using various electrical or mechanical monitoring devices to measure the effectiveness of the patient's actions. The standard primary therapy for urinary incontinence is pelvic muscle exercises aimed at increasing the tone of the pelvic floor muscles.

New National Coverage Decisions provide that Medicare will cover the use of pelvic floor electrical stimulation and biofeedback for Medicare patients with stress and/or urge incontinence for whom pelvic muscle exercise has not worked. The use of biofeedback as a primary therapy for urinary incontinence will remain at the discretion of the private contractors that process and pay Medicare claims. The use of pelvic floor electrical stimulation as a primary therapy remains excluded under a national non-covered decision.

Medicare has covered biofeedback when reasonable and necessary for the individual patient for muscle re-education of specific muscle groups. Since this policy is not specific to urinary incontinence, coverage of biofeedback for urinary incontinence as primary therapy remains at contractor discretion. A national non-coverage policy for pelvic floor electrical stimulation has existed since 1994, and remains in effect for pelvic floor electrical stimulation as a primary therapy.

In reaching its new National Coverage Decisions, HCFA evaluated the scientific evidence, professional society testimony and statements, and clinician statements, as well as hearing from beneficiaries and their support groups.

The Medicare Coverage Advisory Committee (MCAC), a panel of top private sector experts, was asked to determine whether pelvic floor electrical stimulation was better than alternative treatments, including no treatment at all (placebo) for patients with urinary incontinence. MCAC also was asked to determine whether biofeedback to pelvic muscle exercises was better than pelvic muscle exercises alone for patients with various types of urinary incontinence. In both cases the panel concluded that the scientific evidence was not adequate to make these determinations for patients who had used these modalities as primary therapy. However, HCFA will now cover both therapies for beneficiaries who failed trials of pelvic muscle therapy.

These National Coverage Decisions will be effective no later than April 2001. Medicare will define what a "trial of pelvic muscle exercises" is in further instructions to its contractors and in provider education. The national coverage for both therapies affects only for patients for whom traditional initial therapy has not worked, that is, who have failed a "trial of pelvic muscle exercises."

The National Coverage Decisions on Pelvic Floor Electrical Stimulation and Biofeedback can be found on HCFA's web site at: www.hcfa.gov/quality/8b.htm.