Description

Fecal incontinence (FI), also known as bowel incontinence, is the loss of bowel control, which causes stool to leak involuntarily from the rectum. FI can range from the occasional leakage of stool to complete loss of bowel control. FI may also occur only occasionally (e.g., with bouts of diarrhea) or it may be chronic or recurring.

Causes include, but may not be limited to:

• Damage to the anal sphincter (e.g., childbirth, surgery)
• Damage to the pelvic diaphragm
• Diarrhea
• Fecal impaction
• Illnesses that cause the inability to expand and store fecal matter (e.g., inflammatory bowel disease [IBD])
• Injury

Evaluation

Treatment for FI depends on the type of incontinence and the underlying cause; therefore, prior to treatment for FI, an evaluation must be performed. The initial assessment includes obtaining a history and physical, which may consist of an inspection of the perianal area and a digital rectal exam. Other tests include, but may not be limited to, anorectal manometry, endoscopy, endorectal ultrasound or rectal sensory testing.

Treatment

Examples of FI treatments include, but may not be limited to:

• Artificial anal sphincter (e.g., Acticon Neosphincter) is an implantable, fluid filled device that consists of an inflatable silicon cuff, a pressure-regulating balloon and a control pump, which reportedly maintains continence by using the pressure of the fluid filled cuff to occlude the anal canal. When there is a need to defecate (bowel movement), the individual squeezes and releases the pump mechanism, which releases the compressive force around the anal canal. (Refer to Coverage Limitations section)
• Biofeedback is therapy that utilizes sensors to help the individual identify and contract the anal sphincter muscles, which help maintain continence. For information regarding biofeedback, please refer to Biofeedback Medical Coverage Policy.
• Defecation programs (bowel training) are designed to help the individual who has difficulties setting a schedule for sitting on the toilet at a regular time every day after a meal. This training is designed to help incontinence by regularly emptying the bowels.
• Injectable bulking agents (e.g., Solesta) involves the injection of collagen, autologous fat or other materials into the anal sphincter area in order to increase the surface area, which purportedly provides a better seal for the anal canal. (Refer to Coverage Limitations section)
• Nonimplantable muscle stimulators (e.g., Attain, leva Pelvic Health System) are devices that reportedly provide pelvic muscle stimulation and biofeedback without implantation of electrodes to aid in the treatment of fecal incontinence. These devices may be combined with a smartphone app that reportedly transmits real-time data of pelvic floor muscle training.

(Refer to Coverage Limitations section) Percutaneous tibial nerve stimulation (PTNS) (eg, Urgent PC, Nuro Percutaneous Tibial Neuromodulation System [PTNM]), also known as posterior tibial nerve stimulation, involves the use of nonimplanted electrodes which produce stimulation to the tibial nerve that purportedly travels to the sacral nerve plexus to control FI.

(Refer to Coverage Limitations section) Radiofrequency ablation (eg, Secca System) is a minimally invasive procedure that uses alternating electrical current to cause controlled heating of the tissue in the anal sphincter, which reportedly remodels the treated tissue by stimulating the formation of connective tissue.

(Refer to Coverage Limitations section) Rectal catheters and rectal inserts are being investigated for use in a bedridden, immobilized or incontinent individual. Examples of the systems includes, but may not be limited to, include the Qora Stool Management System, which is comprised of a self-expanding indwelling diverter that anchors in the anorectal junction (without a balloon). It is designed to collapse and expand during peristaltic rectal contractions. The Renew Anal Insert is a self-inserted silicone insert that purportedly prevents bowel leakage by resting against the rectum. Another system under study (eg, Contix Fecal Incontinence Management System) is a disposable catheter device that utilizes a balloon that is placed via an injector into the anorectal junction and filled with air. The air is deflated for removal. This device is not currently approved by the US Food & Drug Administration (FDA).

(Refer to Coverage Limitations section)Rectal control system for vaginal insertion (eg, Eclipse system) is a device that includes an inflatable balloon that is placed in the vagina, which upon inflation exerts pressure on the vaginal wall supposedly closing off the rectum. Reportedly, bowel evacuation is completed by deflating the device and re-inflating using an external pump.

(Refer to Coverage Limitations section) Sacral nerve stimulation (eg, Axonics Sacral Neuromodulation System, InterStim II, InterStim Micro, InterStimX) involves the implantation of electrodes at the sacral nerve to improve rectal sensation and anal sphincter muscle control.

Stem cells, specifically adipose tissue-derived stem cells, autologous myoblasts, mesenchymal stem cells are being investigated for the treatment of FI. Purportedly, the injection of stem cells during surgical repair of FI stimulates the formation of granulation tissue, leading to regeneration of the anal sphincter muscles. (Refer to Coverage Limitations section)

Surgical treatment may be performed if there is pelvic floor or anal sphincter muscle injuries.

Procedures include, but may not be limited to:

• Colostomy is the construction of an artificial opening from the colon through the abdominal wall, which bypasses a diseased portion of the lower intestine and permits the passage of stool to a bag outside of the body; typically used as the last attempt to correct FI.
• Muscle transposition is a surgical procedure that uses muscles from another area of the body to encircle and strengthen the anal canal (eg, gluteal or gracilis muscles [dynamic graciloplasty]).
• Sphincteroplasty is utilized to repair a defect in the sphincter muscle in which the two ends of the muscle are cut and overlapped onto one another and then sutured into place to restore the complete circle of muscle.

Transanal electrical stimulation utilizes electrical stimulation that is applied to the anal canal to supposedly stimulate muscle contraction. (Refer to Coverage Limitations section)

For information regarding the Peristeen Anal Irrigation System, please refer to Durable Medical Equipment (DME) Medical Coverage Policy.

Fecal Incontinence Evaluation and Treatments

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0570-007
Page: 5 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

For information regarding urinary incontinence, please refer to Urinary Bladder Dysfunction Medical Coverage Policy.

Coverage Determination

Any services for fecal incontinence that are considered primarily educational or training in nature are generally NOT covered under most Humana benefit Plans. Please consult the member’s individual certificate regarding Plan coverage.

Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication for the treatment of fecal incontinence.

Humana members may be eligible under the Plan for diagnostic testing for fecal incontinence, which includes, but may not be limited to:

• Anorectal manometry; OR
• Anorectal ultrasonography; OR
• Rectal sensory testing

Conservative management should include a minimum of 2 therapies over a consecutive 60-day period. Conservative management includes, but may not be limited to:

• Biofeedback (may be excluded by the member’s individual certificate as alternative medicine) (for information regarding coverage determinations/limitations, please refer to Biofeedback Medical Coverage Policy); OR
• Defecation programs/bowel training (may be excluded by the member’s individual certificate as educational therapy); OR
• Diet modification; OR
• Pharmacotherapy

Commercial Plan members: requests for SNS placement require review by a medical director.

Fecal Incontinence Evaluation and Treatments Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0570-007
Page: 6 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for sacral nerve stimulation (eg, Axonics Sacral Neuromodulation System, InterStim II, InterStim Micro and InterStimX) when ALL of the following criteria are met:

• 18 years of age or older; AND
• Absence of contraindications; AND
• Testing confirms a diagnosis of FI; AND
• Failure of, contraindication to or intolerance of conservative management of a minimum of 2 therapies over a consecutive 60-day period; AND
• Trial test stimulation that demonstrates 50% or greater improvement in incontinence symptoms during a 14-day trial period.

Humana members may be eligible for removal of a SNS device when a previously implanted device and/or its associated components cause complications or unintended negative outcomes (eg, adverse change in bowel function, infection, new pain, undesirable stimulation) for the individual.

Commercial Plan members: requests for SNS replacement require review by a medical director.

Humana members may be eligible for a SNS replacement when the following criteria are met:

• Previously implanted device and/or its associated components are no longer functioning appropriately (eg, defective pulse generator, lead migration) and are no longer under warranty; AND
• Absence of contraindications; AND
• FDA-approved device is being utilized as the replacement

Fecal Incontinence Evaluation and Treatments Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0570-007
Page: 7 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Humana members may be eligible under the Plan for the following surgical treatments for FI:

• Anal sphincter repair (eg, sphincteroplasty) for the following indications:
  • Anal sphincter injury; AND
  • Failure of, contraindication to or intolerance of conservative management of a minimum of 2 therapies over a consecutive 60-day period; OR
• Colostomy for the following indications:
  • Failure of, contraindication to or intolerance of conservative management of a minimum of 2 therapies over a consecutive 60-day period; AND
  • Failure of or not a candidate for minimally invasive surgical interventions (eg, sacral nerve stimulation) or sphincteroplasty

Coverage Limitations

Humana members may NOT be eligible under the Plan for the following evaluation and fecal incontinence treatments for any indications other than those listed above including, but may not be limited to:

• Artificial anal sphincter (eg, Acticon Neosphincter); OR
• Adipose tissue-derived stem cells, autologous myoblasts or mesenchymal stem cell injections; OR
• Defecography; OR
• Injectable bulking agents (eg, Solesta); OR
• Percutaneous tibial nerve stimulation (eg, Urgent PC, Nuro PTNM); OR
• Rectal catheters (eg, Contix Fecal Incontinence Management System, Qora Stool Management Kit); OR

Fecal Incontinence Evaluation and Treatments Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0570-007
Page: 8 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Rectal control system for vaginal insertion (eg, Eclipse system); OR
• Sacral nerve stimulation (eg, Axonics Sacral Neuromodulation System, InterStim II, InterStim Micro and InterStimX) if the following contraindications are present:
  • 17 years of age or younger; OR
  • Bilateral stimulation; OR
  • Individual not capable of operating the device: OR
  • Pregnancy; OR
  • Presence of progressive, systemic neurologic diseases (eg, multiple sclerosis, Parkinson’s disease)
• Transanal electrical stimulation; OR
• Transanal radiofrequency therapy (eg, Secca System)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for fecal incontinence equipment (eg, Attain nonimplantable muscle stimulator, leva Pelvic Health System) or supplies for any indication including, but may not be limited to, underpads, incontinence collection systems (eg, perianal fecal collection pouches), incontinence undergarments (briefs, diapers) and rectal inserts (eg, Renew Insert). Although they may be prescribed by a health care practitioner, FI equipment and supplies are also available without a prescription and may be obtained over-the-counter (OTC) and are therefore generally excluded in the certificate. In the absence of a certificate exclusion for OTC items, FI equipment and supplies are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Background Additional information about fecal incontinence may be found from the following websites:

Fecal Incontinence Evaluation and Treatments Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0570-007
Page: 9 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• American College of Gastroenterology
• American Society of Colon and Rectal Surgeons
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.