Medical Policy: 02.01.51 

Original Effective Date: September 2013 

Reviewed: June 2020 

Revised: June 2020 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

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.

 

Description:

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.

 

Bulking Agents

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 geno typical male and geno typical 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.

 

Vaginal Insert for Bowel Control

The Eclipse™ Vaginal Insert system (Pelvalon, Inc.) is an inflatable vaginal insert designed to exert pressure on the rectal vault to treat fecal incontinence. According to the manufacturer, the Eclipse™ system consists of a vaginal insert and a pressure-regulated pump. The insert, consisting of a silicone-covered stainless steel base and a posteriorly directed balloon, is placed in the vaginal vault and inflated. The balloon is deflated via the pump when the user needs to have a bowel movement.

 

At Home Voice Guided Exercise Program

InToneMV provides a 12 minute voice-guided therapy session, completed in the of the members home. The session instructs the member to complete both short (3 second) and long (10 second) voluntary contractions. The lighted visual biofeedback graph encourages slow contractions, maintain the lights then release at end of contraction timer. The variation ensures both fast and slow twitch muscle fibers are recruited.

 

Anal Sling

Anal sling is a mesh implant with minimally invasive delivery, to provide support to the anorectum and reduce the incidence of fecal incontinence episodes in women. For example the TOPAS system is comprised of a knitted, Type 1 polypropylene monofilament mesh, which is covered by removable insertion sheaths, and two insertion needles. Implantation is through a transobturator approach via two small incisions in both the thighs and buttocks, requiring about 30 minutes for implantation and a short period for recovery. The implanted mesh is self-fixating and permanent with tissue in-growth providing additional anatomical support to the anorectum. Surgical placement of a perianal sling designed to enhance the anorectal angle may be a potential option for patients, but additional studies are needed.

 

Magnetic Anal Sphincter

The device, known as the Fenix® Continence Restoration System is comprised of an annular series of connected titanium beads. Each bead contains a magnetic core which is magnetically attracted to adjacent beads. Collectively, this attraction augments the native anal sphincter providing needed resistance to involuntary opening of the anal canal. The Fenix implant is supplied sterile and placed through a perineal incision. The available studies on use of the magnetic anal sphincter includes studies that found surgical implantation resulted in a reduction of fecal incontinence in some individuals. Studies also revealed that implantation has been associated with complications including but not limited to infection, erosion of the device, injury during the surgical procedure, pain, constipation and incontinence.

 

Practice Gudielines and Position Statements

National Institute for Health and Clinical Excellence

National Institute for Health and Clinical Excellence concluded "Current evidence on the safety and efficacy of injectable bulking agents for fecal 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.

 

The Agency for Healthcare Research and Quality (AHRQ) published a systematic review on treatments for fecal incontinence. The authors found a lack of comparative studies on Secca and concluded that the evidence for the procedure was insufficient.

 

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.

 

Prior Approval:

Not applicable.

 

Policy:

Refer to policy 02.01.04 for information regarding Biofeedback for fecal incontinence.

Refer to policy 08.01.21 for information regarding Sacral Stimulation for fecal incontinence.

  1. 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.
  2. Perianal electrical stimulation is considered investigational because its effectiveness has not been established.
  3. 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.
  4. Posterior tibial nerve stimulation for fecal incontinence is considered not medically necessary.
  5. The use of the vaginal bowel control vaginal insert, electrical continence aids (i.e Eclipse) are considered investigational.
  6. The use of bowel control anal insert (e.g. Renew Anal Insert) is considered investigational.
  7. At home treatment/exercise programs for fecal incontinence (i.e InToneMV) are considered investigational.
  8. Injection of mesenchymal stem cells/autologous cell therapy for fecal incontinence treatment is considered investigational.
  9. The use of a magnetic anal sphincter (eg, Fenix Continence Restoration System) is considered investigational
  10. Surgical placement of an anal or pubo-rectal sling (i.e. TOPAS™ treatment) 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.

  • A4563 Rectal control system for vaginal insertion, for long term use, includes pump and all supplies and accessories, any type each
  • 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
  • E0740 Non-implanted pelvic floor electrical stimulator, complete system

 

Selected References:

  • National Institute for Health and Clinical Excellence (NICE) 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.
  • 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.
  • 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
  • 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 Gastroenterol 2014 Aug;109(8):1141-57.
  • 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 Jul 2015.
  • Wald, A. (2016). Update on the Management of Fecal Incontinence for the Gastroenterologist. Gastroenterology & Hepatology, 12(3), 155–164.
  • Varma MG, Matthews CA, Muir T, et al. Impact of a Novel Vaginal Bowel Control System on Bowel Function. Diseases of the Colon & Rectum. 2016; 59(2):127-131.
  • Sokol, ER Management of Fecal Incontinence - Focus on a vaginal insert for bowel control. Med Devices. 2016;9:85–91.
  • Takase-Sanchez, MM. A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Adult Women. SOJ Gynecol Obstet Womens Health . 2017;3(1):1-5
  • Forte ML, Andrade KE, Butler M, et al. Treatments for fecal incontinence. Comparative Effectiveness Review No. 165 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 March.
  • Zerbib F, Siproudhis L, Lehur PA, Germain C, Mion F, Leroi AM, et al. Randomized clinical trial of sacral nerve stimulation for refractory constipation. Br J Surg. 2017 Feb;104(3):205-213. doi: 10.1002/bjs.10326. Epub 2016 Oct 25.
  • 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; 60(8):860-865.
  • National Digestive Diseases Information Clearinghouse. Fecal Incontinence. Last updated July 2017.
  • Fenner, D. et al.TOPAS™: A New Modality for the Treatment of Fecal Incontinence in Women, Journal of Minimally Invasive Gynecology , Volume 22 , Issue 3 , S3 - S4
  • Gu P, Kuenzig ME, Kaplan GG, et al. Fecal incontinence in inflammatory bowel disease: A systematic review and meta-analysis. Inflamm Bowel Dis. 2018 Mar 30
  • Sanagapalli S, Neilan L, Lo JYT, et al. Efficacy of percutaneous posterior tibial nerve stimulation for the management of fecal incontinence in multiple sclerosis: A pilot study. Neuromodulation. 2018 Mar 25
  • Danielson J, Karlbom U, Wester T, Graf W. Long-term outcome after dynamic graciloplasty for treatment of persistent fecal incontinence in patients with anorectal malformations. Eur J Pediatr Surg. 2018 Apr 13 [Epub ahead of print].
  • Simillis C, Lal N, Qiu S, et al. Sacral nerve stimulation versus percutaneous tibial nerve stimulation for faecal incontinence: a systematic review and meta-analysis. Int J Colorectal Dis. May 2018;33(5):645-648. PMID 29470730
  • Horrocks EJ, Chadi SA, Stevens NJ, et al. Factors associated with efficacy of percutaneous tibial nerve stimulation for fecal incontinence, based on post-hoc analysis of data from a randomized trial. Clin Gastroenterol Hepatol. Dec 2017;15(12):1915-1921 e1912. PMID 28647458
  • American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 210: Fecal Incontinence. Obstet Gynecol 2019 Apr;133(4):e260-273.
  • Simillis C, Lal N, Qiu S, et al. Sacral nerve stimulation versus percutaneous tibial nerve stimulation for faecal incontinence: a systematic review and meta-analysis. Int J Colorectal Dis. May 2018;33(5):645-648. PMID 29470730
  • Sanagapalli S, Neilan L, Lo JYT, et al. Efficacy of percutaneous posterior tibial nerve stimulation for the management of fecal incontinence in multiple sclerosis: a pilot study. Neuromodulation. Mar 25 2018. PMID 29575432
  • Leo CA, Thomas GP, Hodgkinson JD, et al. The Renew® anal insert for passive faecal incontinence: A retrospective audit of our use of a novel device. Colorectal Dis. 2019 Feb 15 [Epub ahead of print].

 

Policy History:

  • June 2020 - Interim Review, Policy Revised
  • May 2020 - Annual Review, Policy Revised
  • November 2019 - Interim Review, Policy Revised
  • May 2019 - Annual Review, Policy Revised
  • May 2018 - Annual Review, Policy Revised
  • May 2017 - Annual Review, Policy Revised
  • June 2016 - Annual Review, Policy Revised
  • July 2015 - Annual Review, Policy Revised
  • August 2014 - Annual Review, Policy Revised
  • September 2013 - New Medical Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.