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DESCRIPTIONRadiofrequency tissue remodeling with specially designed devices has been explored as a minimally invasive treatment option for urinary stress incontinence. It involves using nonablative levels of radiofrequency energy to shrink and stabilize the endopelvic fascia.
Urinary stress incontinence, defined as the involuntary loss of urine from the urethra due to an increase in intra-abdominal pressure, is a common condition, affecting 6.5 million women in the United States. Conservative therapy usually includes pelvic floor muscle exercises, biofeedback (see Biofeedback policy), pelvic electrical stimulation (see Pelvic Floor Stimulation as a Treatment of Urinary Incontinence policy), or periurethral bulking agents such as collagen (See Periurethral Bulking Agents for the Treatment of Incontinence policy) might also be tried. Various surgical options are considered when conservative therapy fails, including most prominently various different types of bladder suspension procedures, which intends to reduce bladder neck and urethra hypermobility by tautening the endopelvic fascia. For example, for colposuspension (i.e., the Burch procedure), sutures are placed in the endopelvic fascia and fixed to Cooper's ligament or retropubic periosteum, which in turn creates a floor or hammock underneath the bladder neck and urethra. Recently, radiofrequency energy has been investigated as a technique to shrink and stabilize the endopelvic fascia, thus improving the support for the urethra and bladder neck. Two radiofrequency devices have been specifically designed for the treatment of urinary stress incontinence, which may be performed as outpatient procedures under general anesthesia. The SURx Transvaginal System is a radiofrequency device that has been specifically designed as a transvaginal treatment of urinary stress incontinence that can be performed as an outpatient procedure under general anesthesia:
The SURx Transvaginal System received clearance to market through the U.S. Food and Drug Administration (FDA) 510(k) process in 2002. According to the FDA, the device “is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.” As of 2006, the SURx is no longer marketed in the U.S.
Novasys Medical received clearance to market the Renessa® transurethral RF system through the U.S. Food and Drug Administration (FDA) 510(k) process in 2005. The device is indicated for the transurethral treatment of stress urinary incontinence due to hypermobility.
POLICYTransvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence is considered investigational.
Transurethral radiofrequency tissue remodeling as a treatment of urinary stress 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.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY12/13/2006: Policy added.
3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
2/18/2008: Policy reviewed, no changes
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
04/26/2010: Policy description updated regarding status of devices and treatment approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
03/09/2011: Added new CPT code 53860 to the Code Reference section.
04/19/2012: Policy reviewed; no changes to policy statement. Removed deleted CPT code 0193T from the Code Reference section.
07/23/2015: Code Reference section updated for ICD-10.
06/06/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.60
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.