ModifiedCentenePolicy CP MP.137

Clinical Policy: Fecal Incontinence Treatments

Medical necessity and coding policy for procedures and devices used to treat fecal incontinence for members/enrollees of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyFecal Incontinence Treatments

Policy CodePolicy CP MP.137

Change TypeAnnual clinical criteria revision and coding updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and document severe chronic fecal incontinence, failed conservative therapy, effective test stimulation (≥50% improvement >1 week) and ability of member/caregiver to operate the device.

SourceLink

POLICY UPDATE CHANGES

Added criterion that member/enrollee demonstrates the ability to operate the device or has a supportive caregiver.

Removed criterion requiring inadequate response to test stimulation.

Removed previous criteria for sphincteroplasty listed as I.B.2.

Updated coding tables to add CPT 44320 and HCPCS C1767, C1778.

Added criteria I.B.1.d. 'Member/enrollee demonstrates the ability' and removed criteria referencing inadequate response to test stimulation and absence of any physical or mental illness.

Removed age '24 years' criterion and removed 'more than twelve months after vaginal childbirth' from definition of severe, chronic fecal incontinence.

>=50%effective stimulation threshold

>2episodes/week threshold

3 months

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Coverage Criteria for Fecal Incontinence Treatments

Initial therapy — Sacral neuromodulation

Covered when ALL of the following are met:

Sacral neuromodulation initial criteria: 1) Severe, chronic fecal incontinence defined as greater than two incontinent episodes on average per week with duration greater than six months in a member/enrollee who previously achieved bowel control; 2) Inadequate response to conservative treatments (e.g., pharmacotherapy, dietary management, strengthening exercises); 3) Requested procedure meets one of the following: a percutaneous test stimulation was effective, defined as at least 50% sustained improvement in symptoms lasting more than one week; 4) Condition is not related to anorectal malformation (including congenital anorectal malformation, external anal sphincter defects >60 degrees), visible sequelae of pelvic radiation, active anal abscesses or fistulae, or chronic inflammatory bowel disease; 5) Member/enrollee demonstrates the ability to operate the device or has a supportive caregiver to provide assistance; 6) Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury; 7) No contraindications such as mechanical outlet obstruction or diathermy use (shortwave, microwave, ultrasound).

From policy section I and latest revision

Surgical options

Covered when ALL of the following are met:

Artificial bowel sphincter (Acticon Neosphincter): Member is ≥18 years old; incontinence is not complicated by an irreversibly obstructed proximal segment of bowel; failure of, or not a candidate for, medical interventions or sphincter repair; other device-specific surgical candidacy considerations apply.

From policy I.B.2

Colostomy: Considered as a last resort when all other treatments have failed or are contraindicated.

From policy I.B.3

Not proven effective / investigational

The following procedures have not been proven effective for the treatment of fecal incontinence:

Not proven effective: Injectable bulking agents (e.g., dextranomer/hyaluronic acid – Solesta/NASHA Dx), transanal radiofrequency therapy (SECCA), anal electrical stimulation, posterior tibial nerve stimulation, Eclipse vaginal bowel control system, and sacral nerve stimulation for the treatment of chronic constipation or chronic pelvic pain.

Policy section II

Revised clinical criteria (selection)

Policy criteria were revised during annual review with additions and removals affecting eligibility and prerequisites for certain interventions.

Selected revisions (annual review): Added criterion I.B.1.d requiring that the member/enrollee demonstrates the ability to operate the device or has a supportive caregiver; removed prior criterion requiring inadequate response to test stimulation and removed prior sphincteroplasty-specific criteria; removed age '24 years' and the 'more than twelve months after vaginal childbirth' timing restriction from definitions where noted.

See revision history (05/25 annual review)

This policy addresses medical necessity and coding for procedures and devices used to treat fecal incontinence. Procedures considered in policy Section II as not proven effective for the treatment of fecal incontinence include injectable bulking agents (e.g., dextranomer/hyaluronic acid — Solesta/NASHA Dx), transanal radiofrequency therapy (SECCA), anal electrical stimulation, posterior tibial nerve stimulation, and the Eclipse vaginal bowel control system. Surgical options and advanced interventions referenced elsewhere in the policy include sacral neuromodulation (sacral nerve stimulation), artificial bowel sphincter (Acticon Neosphincter), and colostomy as a last-resort treatment when other therapies have failed or are contraindicated.

During the most recent annual review the policy removed specific timing and age restrictions from the clinical criteria. Language requiring an age of 24 years and the timing phrase 'more than twelve months after vaginal childbirth' were deleted from the definition and eligibility sections to avoid those prior limitations.

The policy identifies certain treatments and codes as not supporting coverage. Specifically, posterior tibial nerve stimulation (CPT 64566) is listed as a CPT code that does not support coverage, and the injectable bulking agent (HCPCS L8605) — dextranomer/hyaluronic acid implant (anal canal) — is listed as a HCPCS code that does not support coverage. These items are noted in the policy Section II as procedures that have not been proven effective for fecal incontinence and may be denied when requested.

Wording in the policy was revised to reflect ongoing evaluation of several interventions. Rather than using the term 'experimental/investigational,' the policy now states these interventions 'have not been proven effective for the treatment of fecal incontinence, although continue to be evaluated in clinical studies,' signaling continued review of the evidence while maintaining that current data do not support routine coverage.

Coding Tables and Definitions

Covered CPT CodesCPTCovered

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 generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver

1–10 of 13

1/2

Covered HCPCS CodesHCPCSCovered

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

1–10 of 15

1/2

CPT codes that do NOT support coverage criteriaCPTNot Covered

64566

Posterior tibial neurostimulation, percutaneous needle electrode, single treatment; includes programming

HCPCS codes that do NOT support coverage criteriaHCPCSNot Covered

L8605

Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant; anal canal, 1 ml, includes shipping and necessary supplies

Added CPT Codes (recent revisions)CPT

44320

Colostomy or skin level cecostomy

Added HCPCS Codes (recent revisions)HCPCS

C1767	Generator; neurostimulator (implantable), non-rechargeable
C1778	Lead, neurostimulator (implantable)

Previously updated HCPCS CodesHCPCS

L8683

Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

Previously updated CPT CodesCPT

46760	Sphincteroplasty, anal, for incontinence, adult; muscle transplant
46761	Sphincteroplasty, anal, for incontinence, adult; levator muscle imbrication (Park posterior anal repair)
64581	Open implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
64590	Insertion or replacement of peripheral, sacral, or gastric neurostimulator generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver

Key definitions

Clinical response to test stimulationEffective percutaneous stimulation defined as >= 50% sustained improvement for >1 week

Severity thresholdSevere, chronic fecal incontinence defined as >2 incontinent episodes per week and duration >6 months

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for implantation, revision, removal and programming related to neurostimulation procedures and implantable neurostimulator devices (including sacral neuromodulation leads and generators). Providers should obtain PA before scheduling procedures to avoid denial of payment.

Affected services include implantation/programming of neurostimulators, lead placement/revision/removal, generator implantation/replacement, and related HCPCS/CPT supplies and testing.
Providers must follow evidence of coverage/contract terms; this policy is a guide to medical necessity and does not guarantee payment. Coverage decisions remain subject to the member's coverage documents and applicable state/federal rules.

Billing Rule

Coding Updates — Include on PA Requests

Background and Scope

Fecal incontinence is the uncontrolled passage of feces and is typically defined by duration and impact on bowel control; it can substantially impair quality of life. Treatment selection depends on the underlying cause, anal sphincter anatomy, and the degree to which symptoms affect daily functioning. Initial management usually includes conservative measures such as dietary modification, pharmacotherapy, and pelvic floor strengthening exercises; advanced options including sacral neuromodulation, sphincter repair or artificial bowel sphincter, and colostomy are considered when conservative therapy fails or is inadequate.

Key Definitions Used in This Policy

inv-29: Severe, chronic fecal incontinence — definition

Episode criterion>2 incontinent episodes on average per week.

Duration criterionDuration greater than six months.

Prior statusIndividual previously achieved bowel control (prior continence).

inv-30: Effective percutaneous stimulation (test)

Effectiveness thresholdDefined as at least 50% sustained improvement lasting more than one week during test stimulation.

PurposeServes as the criterion for determining a successful percutaneous test prior to sacral neuromodulation implantation.

Policy Revision History and Notable Changes

2025-05-25clinical_criteria_revisionLatest

Annual review added criterion I.B.1.d requiring the member/enrollee demonstrate the ability to operate the device or have a supportive caregiver, removed prior criterion I.B.1.e.iii requiring inadequate response to test stimulation, and removed I.B.2 sphincteroplasty-specific criteria; policy statement II was reworded and references were updated.

2025-05-25coding_updateLatest

Coding tables were updated to add CPT 44320 and HCPCS codes C1767 and C1778, which were incorporated into the policy's coding sections and may affect prior authorization and billing.

The policy's annual review removed two prior criteria: the specific age requirement of 24 years and the timing limitation of 'more than twelve months after vaginal childbirth.' These deletions were made to the definition and eligibility phrasing during the revision noted in the policy history.