Medical Policy: 02.01.51
Original Effective Date: September 2013
Reviewed: November 2019
Revised: November 2019
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 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.
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.
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.
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.
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.
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 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.
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.
The Peristeen Anal Irrigation System (Coloplast Corp) is designed to minimize the likelihood of involuntary bowel leakage or constipation. The device introduces water into the colon via a rectal catheter. Within the rectal catheter, an incorporated inflatable balloon is intended to assist in holding the catheter in place, thereby promoting adequate evacuation of the contents of the lower colon. The water stimulates the bowel and flushes out the stool over approximately 10 to 30 minutes. The device is designed to be used routinely (daily or every other day). The manufacturer suggests that it may take 4 to 12 weeks to establish a regular routine of use. Parameters that may be adjusted for individuals include the volume of water used, the frequency of irrigation, and the amount of air pumped into the balloon.
"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.
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.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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.