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MP 2.01.58 Transanal Radiofrequency Treatment of Fecal Incontinence

Medical Policy    
Section
Medicine 
Original Policy Date
7/17/03
Last Review Status/Date
Reviewed with literature search/9:2013
Issue
9:2013
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Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

Radiofrequency (RF) energy has 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 improving continence. This procedure is very similar in concept to the Stretta® procedure for treatment of gastroesophageal reflux disease (GERD).

Background

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), ie, 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. 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, 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

Transanal radiofrequency therapy is considered investigational as a treatment of fecal incontinence.

Policy Guidelines

The Secca procedure may be performed on an outpatient basis using conscious sedation and a local anesthetic.

Effective in 2012, there is a specific CPT category III code for this procedure:

0288T: Anoscopy, with delivery of thermal energy to the muscle of the anal canal (eg, for fecal incontinence)

Prior to 2012, there were no specific CPT codes describing this procedure. It was likely that CPT code 46999 (unlisted procedure, anus) would have been used.

Between 2004 and 2012, the Centers for Medicare and Medicaid (CMS) created a specific HCPCS code for this procedure when performed on Medicare patients in outpatient facilities – C9716 (Creation of thermal anal lesions by radiofrequency energy).


Benefit Application 
BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.


Rationale

This policy was originally created in 2003 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period of September 2012 through August 1, 2013. Following is the summary of the key literature to date.

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 one study published in 2012.

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 posttreatment 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 August 23, 2013 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. No new studies on this procedure have 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 investigational.

Practice Guidelines and Position Statements

The United Kingdom’s National Institute for Health and Care 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.

 References:

  1. Food and Drug Administration (FDA). 510(k) Summary. Attachment 14. 2002. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf/k014216.pdf. Last accessed August 2013.
  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/nicemedia/live/13047/54501/54501.pdf. Last accessed August 2013.
  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. 

Codes

Number

Description

CPT  0288T Anoscopy, with delivery of thermal energy to the muscle of the anal canal (eg, for fecal incontinence)
  46999 Unlisted procedure, anus
ICD-9 Diagnosis  787.6  Incontinence of feces 
HCPCS  C9716  Creation of thermal anal lesions by radiofrequency energy (code deleted 12/31/11)
ICD-10-CM (effective 10/1/14)   Investigational for all diagnoses
  R15 Fecal incontinence
ICD-10-PCS (effective 10/1/14)    ICD-10-PCS codes are only for use on inpatient services. There is no specific ICD-10-PCS code for this procedure. One of the following codes might be used.
   0D5R3ZZ Surgical, gastrointestinal system, destruction, anal sphincter, percutaneous
   0DQR3ZZ Surgical, gastrointestinal system, repair, anal sphincter, percutaneous

Index
Fecal Incontinence, Radiofrequency Treatment
Radiofrequency Treatment, Fecal Incontinence
Secca Procedure

Policy History

Date Action Reason
07/17/03 Add policy to Medicine section New policy
04/16/04 Replace policy Policy updated with literature review; no change in policy statement
03/15/05 Replace policy Policy updated with literature review; no change in policy statement
12/14/05 Replace policy Policy updated with literature review; no change in policy statement
12/12/06 Replace policy Policy updated with literature review; no change in policy statement
02/14/08 Replace policy Policy updated with literature review; reference 4 added; no change in policy statement
3/12/09 Replace policy  Policy updated with literature review; reference numbers 5-7 added; no change in policy statement 
03/11/10 Replace policy Policy updated with literature review; no change in policy statement
3/10/11 Replace policy Policy updated with literature review, reference number 8 added, no change in policy statement
11/10/11 Replace policy Policy updated with literature review through August 2011; references reordered; no change in policy statement
11/08/12 Replace Policy Policy updated with literature review through September 2012; references 2, 10 and 11 added; references reordered; no change in policy statement
9/12/13 Replace policy Policy updated with literature review through August 1, 2013; no new references added; no change in policy statement
11/14/13 Replace policy- correction only Language that should have been deleted in the September update was removed from the Summary