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DESCRIPTIONRadiofrequency energy is a commonly used surgical tool that has been used for tissue ablation and more recently for tissue remodeling. Radiofrequency energy (via the SeccaTM System) has been investigated as a treatment of gastroesophageal reflux disease (GERD), i.e. the Stretta procedure, in which radiofrequency lesions are designed to alter the biomechanics of the lower esophageal sphincter. Other treatments include orthopedic procedures to remodel the joint capsule, or in an intradiscal electrothermal annuloplasty (IDET) procedure, where the treatment is intended in part to modify and strengthen the disc annulus. In these procedures, nonablative levels of radiofrequency thermal energy are used to alter collagen fibrils, which result 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. There are a variety of etiologies, including injury from vaginal delivery, anal surgery, neurologic disease and the normal aging process. It is estimated that the disorder affects some 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 can be used for mild degrees of incontinence. Bowel management programs, commonly used in patients with spinal cord injuries, may also be effective in patients with fecal incontinence. Biofeedback has been investigated as well. Surgical approaches primarily include a sphincteroplasty. Other approaches may be attempted in those whose only other treatment option is the creation of a stoma. These approaches include an artificial anal sphincter or sacral neuromodulation. Radiofrequency energy has also been investigated as a minimally invasive treatment of fecal incontinence, referred to as the Secca procedure. In this 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 improving continence. This procedure is very similar in concept to the Stretta procedure for treatment of gastroesophageal reflux disease.
In 2002, the SeccaTM System 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 service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
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.
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.