Fecal Incontinence Treatments
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Defines medical necessity and non-covered procedures for treatments of fecal incontinence for members/enrollees of Arizona Complete Health (Centene-affiliated health plans). Applies to providers requesting authorization for procedural interventions.
Added criterion that member/enrollee demonstrates the ability to operate the device or has a supportive caregiver.
Removed previous criterion requiring inadequate response to test stimulation (I.B.1.e.iii).
Added CPT 44320 and HCPCS C1767, C1778 to coding tables.
Removed '≥ 4 years age' criteria.
Added requirement 'in a member/enrollee that has previously achieved bowel control' to I.A.
Removed 'more than twelve months after vaginal childbirth' from the definition of severe, chronic fecal incontinence in I.A.
Added criteria I.B.1.d. Member/enrollee demonstrates the ability…
Removed previous criteria I.B.2. for sphincteroplasty.
Added CPT 44320 and HCPCS C1767, C1778 to coding tables.
Coverage Criteria and Procedural Indications
Initial procedural coverage
Covered when ALL of the following are met:
From I.A
From I.B
Sacral nerve stimulation (sacral neuromodulation)
SNS is medically necessary when ALL of the following are met
I.B.1 with additions per revision history
Artificial bowel sphincter (Acticon Neosphincter)
Acticon Neosphincter is medically necessary when ALL of the following are met
I.B.2
Colostomy
Colostomy coverage
I.B.3
Revised eligibility and definition criteria (I.A)
Policy revisions affecting existing criteria include:
Changes documented in revision history.
Procedural criteria updates (I.B)
Procedure-specific criteria changes:
See revision history for exact wording.
The policy identifies specific procedures that are considered not proven effective for the treatment of fecal incontinence and therefore excluded from coverage. These include transanal radiofrequency therapy (Secca), injectable bulking agents (for example, dextranomer/hyaluronic acid [Solesta]), anal electrical stimulation, posterior tibial nerve stimulation, vaginal bowel control systems (e.g., the Eclipse system), and sacral nerve stimulation when used for chronic constipation or chronic pelvic pain. The background discussion notes limited, small, or short-to-mid term evidence for several of these modalities, supporting their listing as not proven effective.
The policy calls out specific CPT and HCPCS codes that do not support coverage criteria and may be excluded or require additional justification. Examples listed explicitly are CPT 46760, CPT 46761, CPT 64581, CPT 64590 and HCPCS L8683. The revisions section also notes the addition of codes to the coding tables (for example, CPT 44320 and HCPCS C1767, C1778), underscoring the need to verify codes submitted for prior authorization against the current coding tables.
The policy explicitly states that the procedures listed have not been proven effective for the treatment of fecal incontinence and therefore are considered not medically necessary under this policy when used for that indication. The document cites limited or low-quality evidence for injectable bulking agents and transanal radiofrequency, and notes small, short- or mid-term studies for devices such as the Eclipse system, supporting the determination that these procedures are not proven.
The revision history documents that certain criteria and related items were removed from the policy and are no longer supported. Notably, the policy removed the previous sphincteroplasty criteria I.B.2, and revisions removed criteria related to inadequate response to test stimulation (I.B.1.e.iii). These removals mean sphincteroplasty-specific coverage logic present in prior versions is no longer part of the current criteria set, and billing or authorization requests relying on those removed criteria should be reassessed against the updated policy requirements and coding tables.
Coding Tables and Stated Code Lists
| 44320 | Colostomy or skin level cecostomy. |
| 46750 | Sphincteroplasty, anal, for incontinence or prolapse; adult. |
| 46751 | Sphincteroplasty, anal, for incontinence or prolapse; child. |
| 46760 | Sphincteroplasty, anal, for incontinence, adult; muscle transplant. |
| 46761 | Sphincteroplasty, anal, for incontinence, adult; levator muscle imbrication (Park posterior anal repair). |
| 46999 | Unlisted procedure, anus. |
| 64561 | Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed. |
| 64581 | Open implantation of neurostimulator electrode array; sacral nerve (transforaminal placement). |
| 64585 | Revision or removal of peripheral neurostimulator electrode array. |
| 64590 | Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver. |
| A4290 | Sacral nerve stimulation test lead, each. |
| A4335 | Incontinence supply; miscellaneous. |
| C1767 | Generator, neurostimulator (implantable), non-rechargeable. |
| C1778 | Lead, neurostimulator (implantable). |
| E0745 | Neuromuscular stimulator, electronic shock unit. |
| L8680 | Implantable neurostimulator electrode, each. |
| L8681 | Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only. |
| 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. |
| 64566 | Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming |
| L8605 | Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies |
| 46760 | CPT code listed as not supported in HCPCS codes that do not support coverage criteria |
| 46761 | CPT code listed as not supported in HCPCS codes that do not support coverage criteria |
| 64581 | CPT code listed as not supported in HCPCS codes that do not support coverage criteria |
| 64590 | CPT code listed as not supported in HCPCS codes that do not support coverage criteria |
| L8683 | HCPCS code listed as not supporting coverage criteria |
| 44320 | CPT code added to coding tables per revision |
| C1767 | HCPCS code added to coding tables per revision |
| C1778 | HCPCS code added to coding tables per revision |
Provider Requirements, Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for procedural and device codes that support coverage criteria. Prior authorization requests must include the specific procedure and device codes and clinical rationale demonstrating that the member meets policy criteria for severe, chronic fecal incontinence and prior conservative management.
- Affected procedures and devices require prior authorization before scheduling or implantation.
- Include proposed CPT/HCPCS codes and device model when applicable.
Code Verification and Prior Authorization
Verify CPT and HCPCS codes against the plan’s current coding tables prior to submission. Some codes do not support coverage criteria and their use may lead to denial of the request.
- Codes that do NOT support coverage criteria include CPT 46760, 46761, 64581, 64590 and HCPCS L8683.
- Use the CPT and HCPCS codes listed in the policy’s coding sections (CPT codes such as 44320, 46750, 46751, 46999, 64561, 64585, 64595, 95970–95971; HCPCS codes such as A4290, A4335, C1767, C1778, L8680–L8682, L8684–L8689, etc.) when they apply.
Required Clinical Documentation
Provide complete clinical documentation demonstrating the medical necessity criteria are met. Documentation must show severity, duration, prior therapies tried, and treatment response.
- Document severe, chronic fecal incontinence defined as >2 incontinent episodes per week on average and duration >6 months.
- Document that conservative therapies (e.g., pharmacotherapy, dietary management, strengthening exercises) were attempted and did not produce adequate response.
- For sacral neuromodulation, include results of percutaneous test stimulation showing ≥50% sustained symptom improvement for more than one week.
- Document that the member previously achieved bowel control and can operate the device or has an appropriate caregiver to assist.
Documentation and Applicability Reminders
This policy is a medical necessity guideline and does not guarantee coverage or payment. Providers should align requests with applicable state and federal rules and the member’s benefit contract.
- Clinical policy guides medical necessity determinations but coverage is subject to the member’s benefit plan, contract terms, exclusions and applicable laws.
- Retain and submit supporting records (clinic notes, bowel diaries, prior treatments, test stimulation reports, device operation training) with the authorization request.
Conservative Therapy Prerequisite
Prior to requesting advanced interventions, conservative management must have been tried and failed. Authorization requests should document the nature and duration of conservative therapies.
- Conservative therapies include pharmacologic treatment, dietary modification, pelvic floor strengthening/exercises, and correction of anatomic defects when applicable.
- State the duration and outcomes of conservative therapy and why further conservative care is not appropriate or effective.
Follow Referenced Step Therapy Guidance
Follow referenced step-therapy guidance and specialty guidelines when applicable. Requests should reference relevant guideline recommendations and local coverage determinations used to support the treatment plan.
- Cite applicable clinical guidance (e.g., ACOG, ACG, UpToDate) or local coverage determinations when supporting the treatment sequence.
- When a staged approach is recommended (e.g., conservative care → test stimulation → implant), submit documentation for each completed stage.
Definitions and Key Clinical Thresholds
Fecal incontinence is generally defined in this policy as the uncontrolled passage of feces occurring over a sustained period and significantly impairing quality of life. The policy identifies severe, chronic fecal incontinence as occurring in individuals who previously achieved bowel control and experience an average of greater than two incontinent episodes per week for a duration of more than six months. The background emphasizes that treatment selection depends on etiology and sphincter anatomy, that initial management should include dietary and medical measures, and that many interventional options have modest benefit with limited long-term evidence.
Revision History and Material Changes
Added criterion I.B.1.d requiring member/enrollee demonstrates ability to operate device or has supportive caregiver; removed I.B.1.e.iii (inadequate response to test stimulation), removed I.B.3.d, and removed prior sphincteroplasty criteria I.B.2.
Added criterion I.B.1.d (ability requirement) and removed I.B.1.e.iii (inadequate response to test stimulation) and I.B.3.d; sphincteroplasty criteria I.B.2 removed and CPT 44320 plus HCPCS C1767/C1778 added to coding tables.
Removed '≥ 4 years' age criterion and removed 'more than twelve months after vaginal childbirth' from definition of severe, chronic fecal incontinence; references reviewed and updated.
Identified CPT codes 46760, 46761, 64581, 64590 and HCPCS L8683 as not supporting coverage criteria; references reviewed and updated.
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