National Coverage Analysis (NCA) Tracking Sheet

Pelvic Floor Electrical Stimulation for Urinary Incontinence



Pelvic Floor Electrical Stimulation (PFES) for urinary incontinence refers to the use of a non-implantable electrical device that delivers variable rates of current through the pelvic floor with the intent of strengthening pelvic floor musculature.

Currently, §65-9 (C) of the Coverage Issues Manual states that the effectiveness of these devices is unproven, and therefore cannot be covered under §1862(a)(1) of the Social Security Act as a "reasonable and necessary" treatment. HCFA is currently evaluating this issue to determine whether sufficient scientific evidence exists to allow for a reconsideration of this national policy.

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
HCFA internally generated request N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
03/01/2000 - 03/31/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released


Lead Analysts
Perry Bridger, MHS
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

February 24, 2000

Referred to MCAC Medical and Surgical Procedures Panel, scheduled to meet on April 12 and 13, 2000.

Referred to the Center for Health Plans and Providers (CHPP) for final benefit category determination.

March 27, 2000

Technology assessment  and exclusion tables posted.

April 12, 2000

Benefit category determination made by CHPP.

April 13, 2000

The Medical and Surgical Procedures panel of the MCAC met in Baltimore, Maryland. (See Meeting Information.) The panel concluded that for patients with stress, urge, and post-prostatectomy incontinence, the evidence was not adequate to draw conclusions about the effectiveness of PFES compared to placebo, PFES compared to pelvic muscle exercises (PME) or alternative non-surgical techniques, and PFES and PME compared to PME alone.

June 6, 2000

The Executive Committee  of the MCAC met in Baltimore, Maryland. (See Meeting Information.) They reviewed and ratified the findings of the Medical and Surgical Procedures Panel.

July 25, 2000

Formal MCAC Executive Committee recommendation received by HCFA. Current due date amended.

October 6, 2000

Decision made. Please see Decision Memorandum.