HCFA panel gives InterStim thumbs up
HCFA panel gives InterStim thumbs up
HCFA will rule on coverage before end of year
Nearly 17 million Americans suffer from urinary incontinence, and this embarrassing and sometimes disabling condition often is the trigger that moves older patients out of their homes and into nursing homes. Now, an implantable treatment that provides excellent urinary control may receive Medicare coverage before the end of the year and prevent many premature nursing home admissions.
The InterStim Therapy for urinary control developed by Minneapolis-based Medtronic recently received a unanimous thumbs-up from the Medical and Surgical Procedures Panel of the Health Care Financing Administration’s Medicare Coverage Advisory Committee in Baltimore. That approval is likely to result in a national Medicare coverage policy for sacral nerve stimulation.
The panel affirmed the effectiveness of the InterStim Therapy, which uses sacral nerve stimulation to treat patients with refractory urinary urge incontinence and urgency-frequency. The device is indicated for the treatment of urinary urge incontinence, nonobstructive urinary retention, and significant symptoms of urgency-frequency when drugs prove inadequate or cause intolerable side effects.
In InterStim therapy, an implantable neurostimulator delivers mild electrical stimulation to the sacral nerves, which are located in the lower back and influence bladder function.
In a clinical study, InterStim showed sustained clinical benefit in implanted patients. At the 12-month follow-up exam, researchers found:
• 73% of patients with urinary urge incontinence achieved a reduction in leaking episodes per day of 50% of more.
• 55% of patients with urgency-frequency experienced an increase in volume eliminated per void of 50% or more.
• There were no reports of permanent injury associated with the devices or use of sacral nerve stimulation.
• Roughly 30% of patients who received InterStim underwent subsequent surgery to reposition or replace elements of their systems.
InterStim Therapy costs about $10,000, including the neurostimulator and lead. Physician and hospital fees vary regionally but range between $15,000 and $20,000.
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