BlueCross and BlueShield of Montana Medical Policy/Codes
Transanal Radiofrequency Treatment of Fecal Incontinence
Chapter: Medicine: Treatments
Current Effective Date: September 24, 2013
Original Effective Date: October 13, 2011
Publish Date: September 24, 2013
Revised Dates: February 1, 2012; July 29, 2013
Description

Radiofrequency (RF) energy is a commonly used surgical tool that has been used for tissue ablation and more recently for tissue remodeling. For example, RF energy has been investigated as a treatment of gastroesophageal reflux disease (GERD), i.e., the Stretta procedure, in which RF 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 (IDET) procedure, in which the treatment is intended in part to modify and strengthen the disc annulus. In all of these procedures, nonablative levels of RF thermal energy are used to alter collagen fibrils, which results in a healing response characterized by fibrosis. Recently, RF 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 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. Anti-diarrheal 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, although more novel approaches may be attempted in those patients whose only other treatment option is the creation of a stoma. These novel approaches include an artificial anal sphincter or sacral neuromodulation. RF energy has also been investigated as a minimally invasive treatment of fecal incontinence, a procedure referred to as the Secca procedure. In this outpatient procedure using conscious sedation, RF 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.

Regulatory Status

In 2002, the Secca™ System received U.S. Food and Drug Administration (FDA) clearance through the 510(k) process with the following labeled indication:

“The Secca™ 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.” (1)

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross Blue Shield of Montana (BCBSMT) considers transanal radiofrequency therapy experimental, investigational and unproven as a treatment of fecal incontinence.

Rationale

This policy was originally created in 2011 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period of September 2011 through September 2012. Following is the summary of the key literature to date.

As of September 2012, no trials allowing comparison of outcomes of transanal radiofrequency (RF) treatment of fecal incontinence to available alternative treatments have been identified. The literature search to date has identified 8 nonrandomized studies on this procedure; 7 studies published between 2003 and 2010, and 1 study published in 2012 identified in the updated literature search.

Abbas et al. (2012) published results of their retrospective review of 27 patients who underwent the Secca™ procedure over a 6-year period (2004-2010) at Kaiser Permanente Los Angeles Medical Center. (2) Thirty-one procedures were performed for moderate to severe fecal incontinence. The majority of study patients were women with a mean age of 64 years, and the most common cause of the incontinence was obstetrical injury. Median length of symptoms was 3 years. Biofeedback had failed in more than half of patients, and more than 20% of patients had previous surgical intervention to treat the incontinence. No major complications occurred following the Secca™ procedure, and minor complications were observed in 5 patients (19%; anal bleeding in 4 and swelling of the vulva in 1). A treatment response was noted in 21 patients (78%) (mean Cleveland Clinic Florida Fecal Incontinence [CCF-FI] Score: 16 [baseline] and 10.9 [3 months postoperatively]). Previous studies have suggested that a CCF-FI of greater than 9 indicates a significant impairment of quality of life. (3) However in the study by Abbas et al. only 6 patients (22%) had a sustained long-term response without any additional intervention, and 14 patients (52%) underwent or are awaiting additional intervention for persistent or recurrent incontinence over a mean follow-up period of 40 months.

A published study of the Secca procedure by Efron et al. in 2003 (4) consists of an open-label, single-arm, nonrandomized clinical study that included 50 subjects who were treated and followed up for 6 months. Patients served as their own controls. The study assessed changes in fecal incontinence symptom scores and quality of life between the baseline and follow-up intervals. Fecal incontinence was assessed with the CCF-FI score, and quality of life was assessed with the Fecal Incontinence Quality of Life (FIQL) score. Both the CCF-FI and FIQL scores improved in a steady gradual manner over a 6-month period, from 14.6 to 11.1 for the CCF-FI and 2.5 to 3.1 for the FIQL. Of the 44 patients with an initial baseline CCF-FI score greater than 9, a total of 15 (34%) achieved a CCF-FI less than 10 at 6 months. Improvement was also assessed using the Medical Outcomes Study Short Form-36 (SF-36), focusing on mental and social parameters. The mean social function subscore improved from 64.3 to 34.4, while the mental health subscore improved from 65.8 to 73.8. Fourteen-day diary data demonstrated significant improvement in all 9 parameters; for example, the days with any fecal incontinence dropped from 10 in a 14-day period to 7. In contrast, there were no differences in objective measures of anal sphincter, i.e., there were no differences based on manometry measures, rectal sensation volumes, pudendal nerve motor latency, or internal or external sphincter defects, as noted on endoanal ultrasound. The authors noted that determining the mechanism of action for the procedure was not an objective of the study. Three significant procedure-related complications occurred during the trial. Two patients developed anal ulceration, and 1 developed bleeding from a hemorrhoidal vein. Twenty-six minor adverse events occurred, including minor bleeding in 5 patients, transient worsening of incontinence in 4 patients, and anal pain in 5 patients.

Felt-Bersma et al. (2007) published the results of an uncontrolled study on the Secca procedure in 11 women with fecal incontinence who underwent baseline and post-treatment testing. (5) Six (55%) patients reported improvement; Vaizey scores decreased 13%, and no changes were observed in anal manometry, rectal compliance measurement, or 3-dimensional anal ultrasound. Postoperative pain was reported to be slight in 8 (73%), moderate in 2, and severe in 1 patient. The investigators suggested that this procedure merited further testing and noted that a randomized, controlled trial was underway.

Ruiz et al. (2010) published a paper reporting on 1-year quality-of-life and continence outcomes for a series of 24 patients treated with RF energy for fecal incontinence in 2003 to 2004. (6)Twelve-month results were available for 16 of the 24 patients (67%). The mean CCF-FI score improved from 15.6 at baseline to 12.9 at 12 months (p=0.035). The mean FIQL Questionnaire score improved in all subsets except for the depression subscore. The authors comment that the actual clinical significance of this improvement needs to be determined.

Three additional very small case series (n=15, 19, 8) were performed outside the U.S. (7-9) In 2 of these small trials, no clear benefit was noted for the procedure. Given the small number of studies that have been conducted and the limitations of those trials (i.e., small number of patients, lack of control arm and randomization, inconsistencies with inclusion and exclusion criteria, and short-term follow-up, the efficacy of RF therapy for fecal incontinence is not supported in the literature.

A search of online site ClinicalTrials.gov in October 2012 did not identify any clinical trials of RF treatment of fecal incontinence.

Summary

The trials described in this policy include a small number of patients, and the estimates of treatment differences are very imprecise. The study follow-up periods are variable and need to be considerably longer for a proper evaluation of long-term success. Only one new retrospective study on this procedure has been published since the last update. Multicenter randomized controlled trials with sufficient power are required to evaluate the continuing use of this procedure as an alternative to other surgical interventions or physical therapies or as an adjunct treatment option for fecal incontinence. Given the insufficient evidence available to evaluate the impact of the technology on net health outcome, this surgical procedure is considered experimental, investigational and unproven.

Practice Guidelines and Position Statements

The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued guidance on radiofrequency treatment for fecal incontinence in 2011. (10) NICE concluded that “evidence on endoscopic radiofrequency therapy of the anal sphincter for [fecal] incontinence raises no major safety concerns. There is evidence of efficacy in the short term, but in a limited number of patients. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.” (10)

The American Society of Colon and Rectal Surgeons, in their 2007 practice parameters for the treatment of fecal incontinence, classified the Secca™ procedure as a potentially useful treatment intervention for selected patients with moderate fecal incontinence. (11) This statement was based on level IV evidence (grade of recommendation C) because of the limited data available on this treatment modality.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

Rationale for Benefit Administration
 
ICD-9 Codes
787.60
ICD-10 Codes
R15.9, 0D5R3ZZ, 0DQR3ZZ
Procedural Codes: 46999, 0288T
References
  1. Food and Drug Administration (FDA). 510(k) Summary. Attachment 14. 2002. Available online at: http://www.accessdata.fda.gov . Last accessed September, 2012.
  2. Abbas MA, Tam MS, Chun LJ. Radiofrequency treatment for fecal incontinence: is it effective long-term? Dis Colon Rectum 2012; 55(5):605-10.
  3. Rothbarth J, Bemelman WA, Meijerick WJ et al. What is the impact of fecal incontinence on the quality of life. Dis Colon Rectum 2001; 44(1):67-71.
  4. Efron JE, Corman ML, Fleshman J et al. Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence. Dis Colon Rectum 2003; 46(12):1606-18.
  5. Felt-Bersma RJ, Szojda MM, Mulder CJ. Temperature-controlled radiofrequency energy (SECCA) to the anal canal for the treatment of faecal incontinence offers moderate improvement. Eur J Gastroenterol Hepatol 2007; 19(7):575-80.
  6. Ruiz D, Pinto RA, Hull TL et al. Does the radiofrequency procedure for fecal incontinence improve quality of life and incontinence at 1-year follow-up? Dis Colon Rectum 2010; 53(7):1041-6.
  7. Lefebure B, Tuech JJ, Bridoux V et al. Temperature-controlled radiofrequency energy delivery (Secca procedure) for the treatment of fecal incontinence: results of a prospective study. Int J Colorectal Dis 2008; 23(10):993-7.
  8. Takahashi-Monroy T, Morales M, Garcia-Osogobio S et al. SECCA procedure for the treatment of fecal incontinence: results of five-year follow-up. Dis Colon Rectum 2008; 51(3):355-9.
  9. Kim DW, Yoon HM, Park JS et al. Radiofrequency energy delivery to the anal canal: is it a promising new approach to the treatment of fecal incontinence? Am J Surg 2009; 197(1):14-8.
  10. National Institute for Health and Clinical Excellence (NICE). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence (2011). Available online at: http://www.nice.org.uk . Last accessed October 2012.
  11. Tjandra JJ, Dykes SL, Kumar RR et al. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum 2007; 50(10):1497-507.
  12. Transanal Radiofrequency Treatment of Fecal Incontinence. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference manual (2012 November) Medicine 2.01.58.
History
October 2011 New Policy: Ivestigational
February 2012 Policy updated with literature review through August 2011; references reordered; no change in policy statement
July 2013 Policy formatting and language revised.  Policy statement unchanged.  Removed code C9716 and added 0288T.
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Transanal Radiofrequency Treatment of Fecal Incontinence