Fecal Incontinence Treatment
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This clinical guideline defines when treatments and procedures for severe fecal incontinence are considered medically necessary or not for EmblemHealth members and describes required documentation for medical review.
Autologous muscle cell therapy (injection of muscle progenitor cells into the external anal sphincter) is listed as investigational / not considered medically necessary, effective 1/1/2026 (code 1001T).
Coverage Criteria for Fecal Incontinence Treatments
Medically necessary treatments for severe fecal incontinence
Covered when ANY of the following are met and conservative interventions have failed:
Contraindications such as irreversibly obstructed proximal bowel or poor surgical/anesthesia candidacy preclude use (see Limitations/Exclusions).
A 2–3-week temporary percutaneous trial must be completed; permanent implantation (e.g., InterStim®) is considered medically necessary only if trial shows ≥50% improvement in incontinence symptoms.
The Acticon Neosphincter artificial bowel sphincter is not considered medically necessary when the specific coverage criteria are not met or when use is contraindicated. Examples of contraindications include incontinence complicated by an irreversibly obstructed proximal segment of bowel or when the member is a poor candidate for surgery or anesthesia. Approval requires documentation that all required clinical and eligibility criteria have been satisfied prior to coverage.
The following interventions are not considered medically necessary due to insufficient evidence of therapeutic value: radiofrequency energy delivery (e.g., Secca Therapy), perianal electrical stimulation, injectable bulking agents (e.g., Solesta®; CPT 0963T), vaginal bowel control systems (e.g., eclipse system™ — note: covered for Medicare members only), injection of autologous myoblast cells, injection of mesenchymal stem cells, topical estrogen, tibial nerve stimulation, pudendal nerve terminal motor latency testing, and the Interna® Dermal Regeneration FENIX™ Continence Restoration System.
Specific interventions listed in the Limitations and Exclusions section are deemed not medically necessary because there is insufficient evidence demonstrating therapeutic benefit; this includes injectable bulking agents (e.g., Solesta®), tibial nerve stimulation, Secca Therapy, autologous/cell-based injections, and other listed devices and biologic therapies (including autologous muscle cell therapy, CPT 1001T, effective 1/1/2026).
Procedure, Supply, and Diagnosis Codes
| 64561 | Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed. |
| 64581 | Incision for implantation of neurostimulator electrodes; sacral nerve (transforaminal placement). |
| 64590 | Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling. |
| 95972 | Electronic analysis of implanted neurostimulator pulse generator system; complex spinal cord, or peripheral neurostimulator pulse generator/transmitter, with programming. |
| L8680 | Implantable neurostimulator electrode, each. |
| L8681 | Patient programmer (external) for use with implantable programmable implantable neurostimulator pulse generator. |
| L8682 | Implantable neurostimulator radiofrequency receiver. |
| L8683 | Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver. |
| L8684 | Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement. |
| L8685 | Implantable neurostimulator pulse generator, single array, rechargeable, includes extension. |
| L8686 | Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension. |
| L8687 | Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension. |
| L8688 | Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension. |
| L8689 | External recharging system for battery (internal) for use with implantable neurostimulator. |
| L8695 | External recharging system for battery (external) for use with implantable neurostimulator. |
| A04.71 | Enterocolitis due to Clostridium difficile, recurrent. |
| A04.72 | Enterocolitis due to Clostridium difficile, not specified as recurrent. |
Provider Requirements and Prior Authorization
Prior authorization required for neuromodulation and implants
Prior authorization review is required before approval of procedures such as sacral neuromodulation and implantation of neurostimulator devices; submit the requested authorization for review along with clinical evidence that the member meets medical necessity criteria.
Document failed conservative care and complete staged neuromodulation trial
Conservative interventions (dietary management, pharmacotherapy, pelvic floor strengthening) must have failed before considering advanced treatments; for sacral neuromodulation, a 2–3 week percutaneous temporary electrode trial demonstrating ≥50% improvement is required prior to permanent implantation.
- Conservative care examples: dietary management, pharmacotherapy, strengthening exercises.
- Temporary percutaneous peripheral nerve electrode trial duration: 2–3 weeks; success threshold: ≥50% improvement in incontinence symptoms.
Submit required clinical evidence with authorization request
The treating physician or primary care provider must submit clinical evidence that the member meets the guideline criteria for the requested treatment or surgical procedure to allow EmblemHealth to properly review the request.
- Include documentation of prior conservative treatments attempted and their outcomes, physical exam findings (e.g., weak but structurally intact sphincter when applicable), and results of any temporary neuromodulation trial.
- For Acticon Neosphincter requests, document member age (≥18 years) and contraindications assessment.
Documentation omission may cause denial
Failure to submit the required clinical evidence and documentation will prevent proper preauthorization or post-payment review and may lead to denial of the request.
- Missing documentation of failed conservative care, temporary trial results (for neuromodulation), or physician verification of guideline criteria increases risk of denial.
Background and Clinical Context
Anal incontinence is defined as the involuntary loss of solid or liquid feces or flatus. Severe fecal incontinence refers to involuntary loss of solid or liquid feces or flatus occurring on a weekly or more frequent basis. Initial management typically comprises conservative medical interventions such as dietary management, pharmacotherapy, and pelvic floor strengthening exercises; advanced surgical or device-based treatments are considered when conservative measures fail.
Definitions
Revision History and Policy Changes
Added autologous muscle cell therapy as investigational (autologous muscle cell therapy; CPT 1001T).
Transferred policy content to individual company branded template.
EmblemHealth ConnectiCare adopted the clinical criteria of parent corporation EmblemHealth.
Added Interna® Dermal Regeneration FENIX™ Continence Restoration System as investigational.
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