Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence

POLICY NUMBER

A.1.01.17

DESCRIPTION

Pelvic floor stimulation is proposed as a non-surgical treatment option for women and men with urinary or fecal incontinence. This approach involves either electrical stimulation of pelvic floor musculature or extracorporeal pulsed magnetic stimulation.

Pelvic Floor Stimulation

Pelvic floor stimulation (PFS) involves electrical stimulation of pelvic floor muscles using either a probe wired to a device for controlling the electrical stimulation or, more recently, extracorporeal electromagnetic (also called magnetic) pulses. Stimulation of the pudendal nerve to activate the pelvic floor musculature may improve urethral closure. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. Methods of electrical PFS have varied in location (e.g., vaginal, rectal), stimulus frequency, stimulus intensity or amplitude, pulse duration, pulse to rest ratio, treatments per day, number of treatment days per week, length of time for each treatment session, and overall time period for device use between clinical and home settings. Variations in the amplitude and frequency of the electrical pulse are used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the etiology of the incontinence (i.e., either detrusor instability, stress incontinence, or a mixed pattern). Magnetic pelvic floor stimulation does not require an internal electrode; instead, patients sit fully clothed on a specialized chair with an embedded magnet.

Patients receiving electrical PFS may undergo treatment in a physician’s office or physical therapy facility, or patients may undergo initial training in a physician’s office followed by home treatment with a rented or purchased pelvic floor stimulator. Magnetic PFS may be administered in the physician’s office.

Several electrical stimulators have been cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) process, such as nonimplanted electrical stimulators for treating urinary incontinence and predicate devices which are also used to treat urinary incontinence.

The following policies address other treatment approaches for urinary incontinence:

POLICY

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary incontinence is considered investigational.

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for fecal incontinence is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

6/1/2007: Policy added to specifically address pelvic floor stimulation; subject was previously addressed in the "Incontinence Therapy" policy. No change made to policy statement.

7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC).

9/18/2007: Policy reviewed, no changes.

12/31/2008: Deleted HCPC code 0029T.

4/24/2009: Policy reviewed, no changes.

04/27/2010: Policy description updated regarding urinary incontinence treatment approaches and FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. 

06/21/2011: Policy reviewed; no changes.

05/09/2012: Policy reviewed; no changes.

08/07/2013: Policy reviewed; no changes.

07/11/2014: Added "Fecal Incontinence" to the policy title to reflect the expanded scope of the policy. Policy statement revised to state that electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for fecal incontinence is considered investigational.

08/04/2015: Code Reference section updated for ICD-10.

09/10/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines section updated to define investigative.

05/31/2016: Policy number A.1.01.17 added.

12/30/2016: Policy description updated regarding urinary incontinence. Policy statements unchanged. Code Reference section updated to add CPT code 53899. Revised code description for HCPCS code E0740.

08/29/2017: Policy reviewed; no changes.

08/21/2018: Policy description updated with data from the National Center for Health Statistics regarding reported issues with incontinence. Devices updated. Policy statements unchanged.

09/04/2019: Policy description updated to remove information regarding incontinence and treatment. Policy statements unchanged.

09/08/2020: Policy description updated. Policy statements unchanged.

12/07/2021: Policy reviewed; no changes.

04/26/2023: Policy reviewed. Policy statements unchanged. Code Reference section updated to add HCPCS code G0283.

09/08/2023: Policy description updated. Policy statements unchanged.

09/06/2024: Policy description updated. Policy statements unchanged.

09/22/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross & Blue Shield Association Policy # 1.01.17

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.