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Transanal Radiofrequency Treatment of Fecal Incontinence

Policy Number: MP-163

Latest Review Date: December 2024

Category: Medical                                                    

POLICY:

Transanal radiofrequency treatment of fecal incontinence is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 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. 

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.

Treatment

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 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. RF energy also 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 potentially improving continence.

Radiofrequency (RF) energy is a 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 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 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.

KEY POINTS:

The most recent literature review was updated through December 6, 2024.

Summary of Evidence

For individuals who have fecal incontinence who receive transanal radiofrequency treatment, the evidence includes 8 nonrandomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Studies include a small number of patients, and estimates of treatment differences are very imprecise. Study follow-up periods vary and need to be considerably longer and involve larger numbers of patients to evaluate long-term outcomes properly. Three-year follow-up of a small cohort showed decrement in response over time. Multicenter randomized controlled trials with sufficient power are required to evaluate the continuing use of this procedure as an alternative to other surgical interventions, physical therapies, or as an adjunctive treatment option for fecal incontinence. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence (NICE)

NICE issued guidance on RF treatment for fecal incontinence in 2011. 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.”

In 2016, NICE published a Medtech innovation briefing (MIB) on the Secca system for fecal incontinence.  The aim of an MIB is to aid in the decision-making process by providing a description of the technology, its role in the treatment pathway, a review of relevant published evidence, and cost information. MIBs do not contain recommendations. The MIB notes that “Secca therapy is a minimally invasive treatment option available for people with incontinence of solid or liquid stool at least once a week, in which conservative management options have not controlled symptoms.

American Society of Colon and Rectal Surgeons

The American Society of Colon and Rectal Surgeons, in their 2015 clinical practice guideline notes, “Application of temperature-controlled radiofrequency energy to the sphincter complex may be used to treat fecal incontinence. Grade of Recommendation: Weak recommendation based on moderate-quality evidence, 2B.”  The guidelines also state “Because of the limitations in the available data, alternative treatments should be pursued before considering radiofrequency energy delivery.”

American College of Gastroenterology

The American College of Gastroenterology (ACG) published guidelines on the management of benign anorectal disorders in 2014.  The guideline indicated that there is insufficient evidence to recommend radiofrequency ablation to the anal sphincter as treatment for fecal incontinence. ACG also asserted that the biological rationale for this type of treatment is unproven.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Transanal radiofrequency therapy, radiofrequency energy, fecal incontinence, the Secca System

APPROVED BY GOVERNING BODIES:

In 2002, the Secca™ System (Mederi Therapeutics) received FDA clearance through the 510(k) process 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.”

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

Effective in 2017, there is no specific CPT code for this procedure.  It would be reported with the following unlisted code:

46999

Unlisted procedure, anus

   

REFERENCES:

  1. Abbas MA, Tam MS, Chun LJ. Radiofrequency treatment for fecal incontinence: is it effective long-term? Dis Colon Rectum 2012; 55(5):605-10.
  2. Assmann SL, Keszthelyi D, Kleijnen J, et al. Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration. United European Gastroenterol J. 2022 Apr;10(3):251-286.
  3. Bharucha AE, Knowles CH, Mack I, et al. Faecal incontinence in adults. Nat Rev Dis Primers 2022 Aug 10; 8(1):53.
  4. Bordeianou LG, Thorsen AJ, Keller DS, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence. Dis Colon Rectum 2023; 66(5):647-661.
  5. Efron JE, et al. Safety and effectiveness of temperature-controlled radio-frequency energy delivered to the anal canal (Secca procedure) for the treatment of fecal incontinence. Diseases of the Colon and Rectum, December 2003; 46(12): 1606-16.
  6. Felt-Bersma RJ. Temperature-controlled radiofrequency energy in patients with anal incontinence: an interim analysis of worldwide data. Gastroenterol Rep (Oxf). 2014 May;2(2):121-5.
  7. Felt-Bersma RJ, Szojda MM and 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): 575-580.
  8. Food and Drug Administration (FDA). 510(k) Summary. Attachment 14. 2002. Available at: www.accessdata.fda.gov/cdrh_docs/pdf/k014216.pdf.
  9. Food and Drug Administration (FDA). Attachment 14: 510(k) Summary. Curon Medical, Inc.'s SeccaTM System. 2002; http://www.accessdata.fda.gov/cdrh_docs/pdf/k014216.pdf. Accessed August 29, 2020.
  10. Forte ML, Andrade KE, Butler M, et al. Treatments for fecal incontinence. Rockville (MD) Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF.
  11. Frascio M, Stabilini C, Casaccia M, et al F. Radiofrequency Procedure (SECCA®) for Fecal Incontinence: One-Year Experience. Surg Technol Int. 2017 Jul 25;30:97-101.
  12. Frascio M, Mandolfino F, Imperatore M, et al. The SECCA procedure for faecal incontinence: a review. Colorectal Dis. 2014 Mar;16(3):167-72.
  13. Hinninghofen H and Ench P. Fecal incontinence: evaluation and treatment. Gastroenterol Clin North Am. 2003 Jun, 32(2): 685-706.
  14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  15. 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, January 2009; 197(1): 14-18.
  16. Lam TJ, Visscher AP, Meurs-Szojda MM, Felt-Bersma RJ. Clinical response and sustainability of treatment with temperature-controlled radiofrequency energy (Secca) in patients with faecal incontinence: 3 years follow-up. Int J Colorectal Dis 2014; 29(6):755-761.
  17. Lefebure B, Tuech JJ, Bridoux V, et al. Temperature-controlled radio frequency energy delivery (Secca procedure) for the treatment of fecal incontinence: Results of a prospective study. Int J Colorectal Dis 2008; 23(10): 993-997.
  18. National Institute for Health and Care Excellence (NICE). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence [IPG393]. 2011; www.nice.org.uk/guidance/ipg393. 
  19. National Institute for Health and Care Excellence (NICE). Secca System for faecal incontinence [MIB66]. 2016; www.nice.org.uk/advice/mib66/chapter/summary. 
  20. Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the treatment of fecal incontinence. Dis Colon Rectum. Jul 2015; 58(7):623-636.
  21. Rosenblatt P. New developments in therapies for fecal incontinence. Curr Opin Obstet Gynecol. 2015 Oct;27(5):353-8. 
  22. Rothbarth J, Bemelman WA, Meijerink WJ, et al. What is the impact of fecal incontinence on quality of life? Dis Colon Rectum, January 2001; 44(1): 67-71.
  23. Ruiz D, Pinto RA, Hull TL et al. Does the radiofrequency procedure for fecal incontinence improve quality of life and incontinence a 1-year follow-up? Dis Colon Rectum 2010; 53(7):1041-6.
  24. Secca Datasheet.  Curon Medical, Inc. www.curonmedical.com/products/secca_datasheet.html.
  25. Simillis C, Lal N, Pellino G, et al. A systematic review and network meta-analysis comparing treatments for faecal incontinence. Int J Surg. 2019 Jun;66:37-47.
  26. Takahashi T, et al. Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca Procedure). Diseases of the Colon and Rectum, June 2003; 46(6): 711-15.
  27. Takahashi-Monroy T, Morales M, et al. SECCA procedure for the treatment of fecal incontinence:  Results of five-year follow-up. Dis Colon Rectum 2008; 51(3): 355-359.
  28. Tariq S, et al.  Fecal incontinence in the elderly patient. American Journal of Medicine, August 2003, Vol. 115, No. 3.
  29. Tjandra JJ, Dykes SL, Kumar RR, et al. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum 2007; 50(10):1497-1507.
  30. Tuteja AK and Rao SS. Review article: recent trends in diagnosis and treatment of fecal incontinence.  Alimentary Pharmacology and Therapeutics, April 2004; 19(8): 829-40.
  31. U.S. Food and Drug Administration. 510(k) Summary K104216. Curon Medical Inc.'s Secca™ System. March 21, 2002. Rockville, MD.
  32. Vergara-Fernandez O, Arciniega-Hernández JA, Trejo-Avila M. Long-term outcomes of radiofrequency treatment for fecal incontinence: are the results maintainable? Int J Colorectal Dis. 2020 Jan;35(1):173-176.
  33. Visscher AP, Lam TJ, Meurs-Szojda MM, Felt-Bersma RJF. Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial. Dis Colon Rectum. 2017 Aug;60(8):860-865.
  34. Wald A, Bharucha AE, Limketkai B, et al. ACG Clinical Guidelines: Management of Benign Anorectal Disorders. Am J Gastroenterol 2021; 116(10):1987-2008.
  35. Wald A, Bharucha AE, Cosman BC, et al. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. Aug 2014; 109(8):1141-1157; (Quiz) 1058.
  36. Wexner S and Sands D.  What’s new in colon and rectal surgery?  Journal of the American College of Surgeons, 2003 Jan, 196(1): 95-103.

POLICY HISTORY:

Medical Policy Group, May 2004 (1)

Medical Policy Administration Committee May 2004

Available for comment June 1-July 15, 2004

Medical Policy Group, May 2006 (1)

Medical Policy Group, May 2008 (1)

Medical Policy Group, May 2010 (1): Key Points updated, no policy change

Medical Policy Group, November 2011 (3): Code 0288T added

Medical Policy Group, January 2012 (2): Updated Key Points 2011 Update & References

Medical Policy Panel, November 2012

Medical Policy Group, November (2): No change in policy statement.  Approved by Governing Bodies, Key Points, References updated with new information from 2012 literature search HCPCS code C9716 added

Medical Policy Panel, September 2013

Medical Policy Group, October 2013 (2): No new literature identified.   No change to policy statement

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, December 2015

Medical Policy Group, December 2015 (4): Update to Key Points, Approved Governing Bodies and References.  No change to policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (4): Update to Key Points, Coding, and References. No change to policy statement.

Medical Policy Panel, November 2017

Medical Policy Group, December 2017 (4): Updates to Key Points and References.  No change in policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (4): Updates to Key Points. No change to policy statement.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Key Points. No change to Policy Statement.

Medical Policy Panel, November 2020

Medical Policy Group, December 2020 (5): Updates to Key Points, and References. No change to Policy Statement. Policy retired effective December 14, 2020.

Medical Policy Group, January 2022 (5): Reviewed by consensus. Update to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, December 2022 (5):  Reviewed by consensus. Update to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, December 2023 (11):  Reviewed by consensus. Update to Key Points, Benefit Application, Current Coding and References. Removed previous coding section. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, December 2024 (11):  Reviewed by consensus. Update to Key Points, and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.