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Radiofrequency (RF) energy is a commonly used surgical tool that has been used for tissue ablation and more recently for tissue remodeling. For example, radiofrequency energy has been investigated as a treatment of gastroesophageal reflux disease, i.e., the Stretta® procedure, in which radiofrequency lesions are designed to alter the biomechanics of the lower esophageal sphincter; in orthopedic procedures to remodel the joint capsule; or in an intradiscal electrothermal annuloplasty procedure, in which the treatment is intended in part to modify and strengthen the disc annulus. In all of these procedures, nonablative levels of radiofrequency thermal energy are used to alter collagen fibrils, which results in a healing response characterized by fibrosis. Recently, radiofrequency energy has been explored as a minimally invasive treatment option for fecal incontinence.
Fecal Incontinence is the involuntary leakage of stool from the rectum and anal canal. Fecal continence depends on a complex interplay of anal sphincter function, pelvic floor function, stool transit time, rectal capacity, and sensation. Etiologies vary and include injury from vaginal delivery, anal surgery, neurologic disease and the normal aging process. Estimated prevalence is 8% of the adult population. Medical management includes dietary measures, such as the addition of bulk producing agents to the diet and elimination of foods associated with diarrhea; antidiarrheal drugs for mild incontinence; bowel management programs, commonly used in patients with spinal cord injuries; and biofeedback. Surgical approaches primarily include a sphincteroplasty, although more novel approaches, such as sacral neuromodulation or creation of an artificial anal sphincter, may be attempted in patients whose only other treatment option is the creation of a stoma. Radiofrequency energy has also been investigated as a minimally invasive treatment of fecal incontinence, referred to as the Secca procedure. In this outpatient procedure using conscious sedation, radiofrequency energy is delivered to the sphincteric complex of the anal canal to create discrete thermal lesions. Over several months, these lesions heal and the tissue contracts, changing the tone of the tissue and potentially improving continence.
In 2002, the SeccaTM System (Mederi Therapeutics) received U.S. Food and Drug Administration clearance through the 510(k) process with the following labeled indication:
"The SeccaTM System is intended for general use in the electrosurgical coagulation of tissue and is intended for use specifically in the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy."
POLICYTransanal radiofrequency therapy is considered investigational as a treatment of fecal incontinence.
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 HISTORY5/18/2006: Approved by Medical Policy Advisory Committee (MPAC)
3/30/2009: Policy reviewed, no changes
04/26/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
04/20/2011: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes to policy statement. Added CPT 0288T to the Code Reference section.
11/15/2013: Policy reviewed; no changes.
10/20/2014: Policy reviewed; no changes.
12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 0377T.
07/23/2015: Code Reference section updated for ICD-10.
01/19/2016: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.01.58
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.