Medical Policy: 02.01.51
Original Effective Date: September 2013
Reviewed: June 2016
Revised: June 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Fecal incontinence refers to the involuntary loss of gas or liquid stool (called minor incontinence) or the involuntary loss of solid stool (called major incontinence). Continence requires the normal function of both the lower digestive tract and the nervous system. The anal sphincters, along with the pelvic muscles that surround the end of the digestive tract, ensure controlled movement of digestive tract contents. There are many possible causes of fecal incontinence; in most cases, incontinence results from some combination of damage to the anal sphincters, neurologic causes, decreased distensibility of the rectum, fecal impaction and diarrhea. Treatment includes behavior changes, medication, the use of bulking substances, treatment of impaction, nerve stimulation and surgery.
Several agents (Durasphere, silicone biomaterial, etc) have been studied for the treatment of fecal incontinence. To date, only one bulking agent has been approved by the FDA for treating fecal incontinence. This is a formulation of non-animal stabilized hyaluronic acid/dextranomer in stabilized hyaluronic acid (NASHA Dx) and is marketed by Q-Med as Solesta. Solesta is a sterile gel that is injected into the anal canal. It is composed of naturally made materials, dextranomer and sodium hyaluronate. Solesta is classified as a medical device (injectable bulking agent) and not a drug.
Transanal Radiofrequency Therapy
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.
Perianal Electrical Nerve Stimulation
Electrical stimulation with a non-implantable stimulator is delivered generally by anal probes connected to an external pulse generator. The electrical stimulation is controlled via a probe wired to a device. A variation in the amplitude and frequency of the electrical pulse is used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the type of etiology of incontinence. The Urgent PC Neuromodulation System is not FDA-cleared for the treatment of fecal incontinence. The company’s website states that the treatment can be used for this condition and that the recommended initial course of treatment includes 12 weekly sessions. In February 2014, the InTone®MV (InControl Medical, Brookfield, WI), a nonimplantable device that provides electrical stimulation and/or biofeedback via manometry, was cleared by FDA. The device is intended for the treatment of male and female urinary and fecal incontinence.
Posterior tibial nerve stimulation (PTNS)
The procedure for PTNS consists of the insertion of a needle above the medial malleolus into the posterior tibial nerve followed by the application of low voltage (10mA, 1–10 Hz frequency) electrical stimulation that produces sensory and motor responses (i.e., a tickling sensation and plantar flexion or fanning of all toes). Noninvasive PTNS has also been delivered with surface electrodes.
National Institute for Health and Clinical Excellence concluded: "Current evidence on the safety and efficacy of injectable bulking agents for faecal incontinence does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research, which should take place in the context of a clinical trial or formal audit protocol that includes information on well-defined patient groups."
Note: See the related policy, Anorectal Biofeedback number 02.01.04.
- Transanal radiofrequency therapy for the treatment of fecal incontinence (also known as the Secca procedure) is considered investigational because its effectiveness has not been established.
- Perianal electrical stimulation is considered investigational because its effectiveness has not been established.
- The use of injectable bulking agents (Solesta, autologous myoblast cells, collagen, etc) for the treatment of fecal incontinence is considered investigational because their effectiveness has not been established.
- Posterior tibial nerve stimulation for fecal incontinence is considered investigational.
The above treatments for fecal incontinence lack demonstration of efficacy and long term effects at this time. There remains a lack of information regarding the predictive factors for successful treatment selection at this time.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
L8605 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies
- 46999 Unlisted procedure, anus
64566 Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming
0288T Anoscopy, with delivery of thermal energy to the muscle of the anal canal (eg, for fecal incontinence)
0377T Anoscopy with directed submucosal injection of bulking agent for fecal incontinence
E0740 Incontinence treatment system, pelvic floor stimulator, monitor, sensor, and/or trainer
0438T Transperineal placement of biodegradable material, peri-prostatic (via needle), single or multiple, includes image guidance
National Institute for Health and Clinical Excellence (NICE).External Site Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence (2011).
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.
Dehli T, Stordahl A, Vatten LJ et al. Sphincter training or anal injections of dextranomer for treatment of anal incontinence: a randomized trial. Scand J Gastroenterol 2013
Leung FW. Treatment of fecal incontinence - review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue. J Interv Gastroenterol 2011; 1(4):202-06
Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Feb 28;2:CD007959
a href="http://www.nice.org" target="_blank">National Institute for Health and Clinical Excellence (NICE).External Site. Percutaneous tibial nerve stimulation for faecal incontinence (2011).
Hosker G, Norton C, Brazzelli M. Electrical stimulation for faecal incontinence in adults. Cochrane Database Syst Rev. 2000;(2).
Satish S, Rao M. Diagnosis and management of fecal incontinence. Practice Guidelines. American Journal of Gastroenterology 2004; doi:10.1111/j.1572-0241.2004.40105.x
Nandivada P, Nagle D. Surgical therapies for fecal incontinence. Curr Opin Gastroenterol. 2014;30(1):69-74.
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.
Sood MR. Functional fecal incontinence in infants and children: Definition, clinical manifestations and evaluation. UpToDate Inc. Waltham, MA. Last reviewed April 2015.
Robson K, Lembo AJ. Fecal incontinence in adults: Etiology and evaluation. UpToDate Inc., Waltham, MA. Last reviewed April 2015b
Bharucha AE, Fletcher JG, Melton LJ, 3rd, Zinsmeister AR. Obstetric trauma, pelvic floor injury and fecal incontinence: a population-based case-control study. Am J Gastroenterol. 2012;107:902–911.
National Institute for Clinical Excellence (NICE). Injectable bulking agents for faecal incontinence. Feb 2007.
Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J GastroenterolExternal Site. 2014 Aug;109(8):1141-57.
Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' Clinical External SitePractice Guideline for the Treatment of Fecal Incontinence. Jul 2015.
Alavi K, Chan S, Wise P, et al. Fecal Incontinence: Etiology, Diagnosis, and Management. J Gastrointest Surg. 2015 Oct;19(10):1910-21.
June 2016 - Annual review, Policy revised
July 2015 - Annual review, Policy revised
August 2014 - Annual review, Policy revised
September 2013 - New medical policy
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.