Transanal Radiofrequency for Fecal Incontinence Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2019 POLICY LAST REVIEWED: 02|05|2025 OVERVIEW Radiofrequency energy has been investigated as a minimally invasive treatment of fecal incontinence, in a procedure 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 improving continence.
MEDICAL CRITERIA Not applicable
PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Transanal radiofrequency therapy is considered not covered as a treatment of fecal incontinence as the evidence is insufficient to determine the effects of the technology on health outcomes. Commercial Transanal radiofrequency therapy is considered not medically necessary as a treatment of fecal incontinence as the evidence is insufficient to determine the effects of the technology on health outcomes. COVERAGE Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage. BACKGROUND 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 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 (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. 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 for gastroesophageal reflux disease (ie, the Stretta procedure), in which RF lesions are designed to alter the biomechanics of the lower esophageal Medical Coverage Policy | Transanal Radiofrequency for Fecal Incontinence

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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. In 2002, the Secca™ System (Mederi Therapeutics) was cleared for marketing by the U.S. Food and Drug Administration 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.”1,
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. CODING Medicare Advantage Plans and Commercial Products There is no specific CPT code(s) for this procedure. It would be reported with the following unlisted CPT code: 46999 Unlisted procedure, anus

RELATED POLICIES None

PUBLISHED Provider Update, April 2025 Provider Update, April 2024 Provider Update, May 2023 Provider Update, July 2022 Provider Update April 2021

REFERENCES:

1. Food and Drug Administration (FDA). Attachment 14: 510(k) Summary. Curon Medical, Inc.'s Secca™ System. 2002.
2. Forte ML, Andrade KE, Butler M, et al. Treatments for Fecal Incontinence (Comparative Effectiveness Review No. 165). Rockville, MD: Agency for Healthcare Research and Quality; 2016.
3. Abbas MA, Tam MS, Chun LJ. Radiofrequency treatment for fecal incontinence: is it effective long- term? Dis Colon Rectum. May 2012;55(5):605-610. PMID 22513440
4. Rothbarth J, Bemelman WA, Meijerink WJ, et al. What is the impact of fecal incontinence on quality of life? Dis Colon Rectum. Jan 2001;44(1):67-71. PMID 11805565
5. 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. Jul 2010;53(7):1041-1046. PMID 20551757
6. 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. Jul 2007;19(7):575-580. PMID 17556904

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

7. Lam TJ, Visscher AP, Meurs-Szojda MM, et al. 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. Jun 2014;29(6):755-761. PMID 24805249
8. 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. Dec 2003;46(12):1606-1616; discussion 1616-1608. PMID 14668584
9. 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. Oct 2008;23(10):993-997. PMID 18594840
10. 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. Mar 2008;51(3):355-359. PMID 18204954
11. 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. Jan 2009;197(1):14-18. PMID 18614149
12. National Institute for Health and Care Excellence (NICE). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence [IPG393]. 2011.
13. National Institute for Health and Care Excellence (NICE). Secca System for faecal incontinence [MIB66].
15. 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. PMID 26200676

16. 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. PMID 25022811

    i

    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS