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DESCRIPTIONPelvic floor stimulation is proposed as a non-surgical treatment option for women and men with urinary incontinence. This approach involves either electrical stimulation of pelvic floor musculature or extracorporeal pulsed magnetic stimulation. Electrical stimulation of the pelvic floor is also proposed as a treatment of fecal incontinence.
Urinary incontinence (UI) is a common condition defined as an involuntary leakage of urine. Women are twice as likely to be affected as men, and prevalence increases with age. The severity of incontinence affects quality of life and treatment decisions. The types of urinary incontinence include stress, urge, overflow, functional, and post-prostatectomy incontinence. Nonsurgical treatment options may include pharmacologic therapy, pelvic floor muscle exercises (PME), bowel or bladder training exercises, electrical stimulation, and neuromodulation.
Pelvic floor stimulation (PFS) involves the 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. The intent of the intervention is to stimulate the pudendal nerve in order to activate the pelvic floor musculature; it is thought that activation of these muscles will lead to improved urethral closure. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. The 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. Variation in the amplitude and frequency of the electrical pulse is used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the type of etiology of incontinence, i.e., either detrusor instability, stress incontinence, or a mixed pattern. Magnetic pelvic floor stimulation does not require an internal electrode; patients may 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 delivered in the physician’s office.
Several electrical stimulators have been cleared by the FDA. In March 2006, the MyoTrac Infiniti™ (Thought Technology), a non-implanted electrical stimulator for treating urinary incontinence, was cleared for marketing by FDA through the 510(k) process. Predicate devices, also used to treat urinary incontinence, include the Pathway™ CTS 2000 (Prometheus Group) and the InCare® PRS (Hollister). In 2011, the itouch Sure Pelvic Floor Exerciser (TensCare, U.K.) was cleared for marketing. This product is being marketed in the United States as EmbaGYN® by Everett Laboratories (Chatham, NJ).
In June 2000, the NeoControl® Pelvic Floor Therapy System (Neotonus) was approved by the FDA through the premarket approval process for treating urinary incontinence in women. This device, formerly known as the Neotonus Model 1000 Magnetic Stimulator, provides non-invasive electromagnetic stimulation of pelvic floor musculature. The magnetic system is embedded in a chair seat; patients sit on the chair fully clothed and receive the treatment. The magnetic fields are controlled by a separate power unit.
In February 2014, the InTone®MV (InControl Medical, Brookfield, WI), a nonimplantable device that provides electrical stimulation and/or biofeedback via manometry, was cleared by FDA. The device is intended for the treatment of male and female urinary and fecal incontinence.
The following policies address other treatment approaches for urinary incontinence:
POLICYElectrical 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 EXCEPTIONSFederal 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 GUIDELINESInvestigative 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY6/1/2007: 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 added.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 1.01.17
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.