CurrentAetnaPolicy 0611

Fecal Incontinence

Defines Aetna's medical necessity, experimental/investigational determinations, and covered procedures and devices for evaluation and management of fecal incontinence for eligible members.

Policy Summary

PayerAetna

PolicyFecal Incontinence

Policy CodePolicy 0611

Change TypeNo material change

Effective DateApr 30, 2002

Next Review DateJun 27, 2024

Key ActionObtain prior authorization and document failure of conservative therapies before requesting implantation procedures or device-based treatments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=50%sacral neuromodulation trial success threshold

weekly+severe FI frequency threshold

50-52%NASHA Dx mid-term improvement

31%Acticon Neosphincter infection rate

21%Acticon Neosphincter erosion rate

Coverage Criteria and Clinical Indications

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Billing Codes and Coding Guidance

Covered CPT Codes (neurostimulation) if selection criteria are metCPTCovered

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 (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming.

CPT codes (posterior tibial nerve / integrated systems)CPT

0587T	Percutaneous implantation or replacement of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve.
0588T	Revision or removal of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve.
0589T	Electronic analysis with simple programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 1-3 parameters.
0590T	Electronic analysis with complex programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 4 or more parameters.
64566	Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming.

Other related CPT codesCPT

11950	Subcutaneous injection of filling material (e.g., collagen).
11954	Subcutaneous injection of filling material (example range).
46750	Sphincteroplasty, anal, for incontinence or prolapse; adult.
46751	Sphincteroplasty, anal, for incontinence or prolapse; child.
46760	Sphincteroplasty, anal, for incontinence, adult; muscle transplant; levator muscle imbrication (Park posterior anal repair); or implantation artificial sphincter.
46761	Sphincteroplasty, anal, for incontinence, adult (additional listed).
90912	Biofeedback training, perineal muscles, anorectal or urethral sphincter, initial 15 minutes.
90913	Each additional 15 minutes of biofeedback training.
97110	Therapeutic procedure, therapeutic exercises, each 15 minutes.
97530	Therapeutic activities, direct (one-on-one), each 15 minutes.

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Covered HCPCS/Device Codes if selection criteria are metHCPCSCovered

C1820	Generator, neurostimulator (implantable), with rechargeable battery and charging system.
C1883	Adaptor/extension, pacing lead or neurostimulator lead (implantable).
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.

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HCPCS codes listed as not covered for indications in the CPBHCPCSNot Covered

A4563	Rectal control system for vaginal insertion, for long term use, includes pump and all supplies and accessories.
L8605	Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies.

ICD-10 diagnosis codesICD-10Covered

R15.0	Fecal incontinence, unspecified
R15.9	Full range: Fecal incontinence codes R15.0 - R15.9

Codes referenced for stem-cell related procedures (listed but not routinely covered)CPT

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38206	Hematopoietic progenitor cell harvesting for transplantation, per collection; autologous.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.
38241	Hematopoietic progenitor cell (HPC); autologous transplantation.

No CPT/HCPCS/ICD-10 codes listed in this excerptmixed

No codes listed

inv-32: Sacral neuromodulation trial success — >= 50 percent improvement threshold

Threshold>= 50% improvement in incontinence symptoms during the temporary percutaneous peripheral nerve stimulation trial (2–3 weeks)

Trial durationTemporary percutaneous peripheral nerve electrode testing over a 2- to 3-week period

Permanent implant criterionPermanent implantable pulse generator may be placed only if patient achieves >=50% improvement during trial

inv-33: Severe fecal incontinence frequency threshold — weekly or more

DefinitionInvoluntary loss of solid stool or liquid stool on a weekly or more frequent basis

ContextUsed to define 'severe' fecal incontinence for eligibility for sphincter repair, colostomy, Acticon Neosphincter

Policy useApplied as an entry criterion for advanced surgical/device interventions in this policy

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended — Bulking / Regenerative Therapies

Prior authorization is recommended for bulking and regenerative therapies (e.g., injectable bulking agents such as NASHA Dx/Solesta, autologous myoblast or stem-cell injections, and other regenerative medicine procedures). Providers should obtain prior authorization when planning these procedures and verify member benefits and any plan-specific requirements prior to scheduling.

Affected therapies: injectable bulking agents (e.g., NASHA Dx/Solesta), autologous myoblast injections, mesenchymal stem cell therapies, other regenerative injections.
Verify member eligibility and plan-specific prior authorization rules before procedure.

Note

Counsel on Long-Term Complication Risks

Document and counsel patients about long-term complication risks for surgical and device-based interventions. Examples include high rates of complications and re-operations with more invasive procedures (e.g., artificial bowel sphincter, graciloplasty), and stoma-related complications (stenosis, leakage, need for revision) after ACE/INA procedures.

Artificial bowel sphincter: substantial complication and re-operation rates reported (major complications sometimes requiring re-operation; some series report very high complication rates).
ACE / INA: stomal stenosis rates reported up to ~50%; leakage and revision/reversal commonly required; long-term failure rates reported.
Graciloplasty / more invasive procedures: higher morbidity and risk of re-operation vs less invasive options.

Note

Not Applicable / Administrative Notice

No additional documentation requirements or clinical criteria are specified in this content window beyond the general requirements elsewhere in the policy. Providers must still confirm any plan-specific forms, prior authorization pathways, and documentation checklists with the member's payer.

Providers remain responsible for verifying benefits and prior authorization requirements with Aetna prior to performing procedures.
Clinical Policy Bulletins (CPBs) do not guarantee coverage; check member-specific plan documents.

Documentation Required

Documentation Required to Support Medical Necessity

Maintain thorough clinical documentation to support medical necessity for device- and procedure-based treatments. Documentation should demonstrate failure of conservative therapies, objective assessments of sphincter integrity/function, and results of any staged testing (trial stimulation) prior to permanent implantation.

Conservative therapy: record attempts and inadequate response to biofeedback, bowel training, diet modification, pharmacotherapy, and strengthening exercises.
Objective testing: anorectal manometry, endoanal ultrasound, rectal sensory testing as applicable to document sphincter structure/function.
For sacral neuromodulation: document temporary percutaneous peripheral nerve electrode trial over 2–3 weeks and ≥50% improvement in incontinence symptoms prior to permanent IPG implantation.
For bulking/regenerative therapies: include prior conservative therapy failure and any trial or staged-treatment response data.

Step Therapy

Surgical Treatment After Conservative Therapy — Devices as Alternatives

Surgical options are generally considered after failure of conservative therapies; device-based approaches (e.g., sacral neuromodulation, injectable bulking agents, or Fenix system) may be alternatives to more invasive surgery depending on patient factors and documented response to prior treatments.

Step-wise approach: conservative management first; consider less invasive device-based therapies for patients refractory to conservative measures before proceeding to major reconstructive surgery.
Examples: sacral neuromodulation may be used in patients with weak but structurally intact sphincter who fail conservative care; injectable bulking agents or Fenix system may be options for selected patients.
Record rationale for choosing device-based vs surgical reconstruction in the medical record.

Note

Guidance — Newer Surgical/Device Options Supersede Older Procedures

Note that newer, less-invasive surgical and device options (e.g., sacral neuromodulation, Fenix system, approved injectable agents) have largely supplanted older, more morbid procedures (e.g., dynamic graciloplasty, some augmentation surgeries) in many practice settings; document the clinical reasoning when considering legacy procedures.

Guideline context: multiple societies note sacral neuromodulation has largely replaced several older augmentation procedures.
If considering older techniques (dynamic graciloplasty, ABS), document why newer options were not appropriate for the patient.

Background, Definitions, and Evidence Context

Fecal incontinence is the involuntary leakage of flatus, liquid, or solid stool and can result from sphincter damage, diarrhea, fecal impaction, or diseases such as inflammatory bowel disease. Initial evaluation typically includes history and physical examination, basic office testing and laboratory studies, and may include anorectal manometry, endoanal ultrasonography, and rectal sensory testing. Most cases are mild‑to‑moderate and are initially managed with conservative treatments including dietary modification, fiber, anti‑motility medications, bowel training programs, biofeedback, and pelvic floor strengthening; invasive procedures are reserved for patients who have failed or are not candidates for conservative management.

inv-67: Severe fecal incontinence definition (frequency threshold)

TermSevere fecal incontinence

Frequency thresholdInvoluntary loss of solid stool or liquid stool on a weekly or more frequent basis

Use in policyDetermines candidacy for anal sphincter repair, colostomy, Acticon Neosphincter

inv-68: Acticon Neosphincter definition

DeviceActicon Neosphincter (artificial anal sphincter)

ComponentsOcclusive inflatable silicone cuff; pressure-regulating balloon; control pump

FunctionCuff occludes anal canal; patient squeezes pump to move fluid to balloon to deflate cuff for defecation

inv-69: Sacral nerve stimulation (sacral neuromodulation) definition

TermSacral nerve stimulation (sacral neuromodulation)

DescriptionImplantation of electrodes at the sacral nerve to improve anal sphincter control and rectal sensation; often preceded by a temporary percutaneous trial

Policy notesTemporary percutaneous peripheral nerve electrode trial (2–3 weeks); permanent implant considered if >=50% improvement

inv-70: Injectable bulking agents definition

TermInjectable bulking agents

DescriptionInjection of materials (e.g., collagen, autologous fat, dextranomer/hyaluronic acid, silicone, microbeads) into the anal sphincter/submucosa to increase surface area and improve anal canal seal

Example / FDA statusSolesta (dextranomer in hyaluronic acid) FDA-approved for adults who failed conservative therapies; typically delivered as 4 injections per visit, up to two treatments in pivotal trial

inv-71: Perianal electrical stimulation / TENS definition

TermPerianal electrical stimulation / TENS

DescriptionNon-implanted electrical stimulation applied transanally or transcutaneously (or stimulation of posterior tibial nerve) aiming to stimulate sphincter contraction or neuromodulation

Evidence noteCochrane review and trials report insufficient data and mixed results; therapeutic effect suggested but not certain

inv-72: NASHA Dx / Solesta definition and indication

TermNASHA Dx / Solesta

DescriptionDextranomer in stabilized hyaluronic acid gel injected into submucosal tissue beneath the anal lining to bulk tissue and narrow the anal opening

IndicationFDA-approved for adults (≥18) with fecal incontinence who have failed conservative therapies; typical regimen in pivotal study: 2 treatments, 4 injections each

inv-73: Passive fecal incontinence (definition)

TermPassive fecal incontinence

DescriptionIncontinence characterized by leakage without awareness; hypothesized to respond better to bulking agents that augment resting anal tone

Clinical relevanceIdentified as a subgroup potentially more likely to benefit from peri-anal bulking injections

inv-74: CC‑FIS (Cleveland Clinic Fecal Incontinence Score) definition

TermCC‑FIS (Cleveland Clinic Fecal Incontinence Score)

DescriptionA validated fecal incontinence severity score used to quantify symptom burden and change following interventions

Use in studiesUsed in most bulking agent studies; pooled mean pre-op CC‑FIS and change reported in meta-analysis

inv-75: PTNS definition

TermPTNS (posterior tibial nerve stimulation)

DescriptionPeripheral neuromodulation applying stimulation to the posterior tibial nerve to modulate sacral nerve pathways for incontinence control

Evidence noteLimited evidence with heterogeneous small studies; a multi-center RCT did not show significant benefit over sham for primary endpoint

inv-76: Autologous myoblast injection definition

TermAutologous myoblast injection

DescriptionInjection of cultured muscle-derived (autologous myoblast) cells into the external anal sphincter to promote regeneration and improve continence

Evidence notePilot studies (n=10) reported symptom improvement and safety but require validation in larger trials

inv-77: PNTML definition

TermPudendal Nerve Terminal Motor Latency (PNTML)

DescriptionMeasurement of time after stimulating the pudendal nerve to induce contraction of external anal sphincter; normal ~2.0 msec; prolongation suggests nerve damage

LimitationsOperator-dependent with poor correlation to clinical symptoms; guidelines do not recommend routine use

inv-78: MiniACE (Balloon Button) definition

TermMiniACE (Balloon Button)

DescriptionLow-profile percutaneous antegrade continence enema device inserted into the cecum (via cecostomy or Malone appendicostomy) held by an internal balloon and external bolster to facilitate antegrade enemas

IndicationUsed for patients with non-functioning colon who have not responded to conservative treatments; evidence insufficient to support use for FI

inv-79: Malone ACE (appendicostomy) definition

TermMalone ACE (appendicostomy)

DescriptionSurgically-created appendicostomy to deliver antegrade colonic enemas; historically used in children and sometimes adults for refractory constipation or fecal incontinence

Outcomes noteHigher success in children vs adults; associated with stoma stenosis and need for revision

inv-80: Cecostomy / MiniACE Balloon Button definition

TermCecostomy / MiniACE Balloon Button

DescriptionIndwelling low-profile balloon button tube inserted percutaneously or via colonoscopy into the cecum to permit antegrade enemas

Comparative noteProposed to have lower stomal stenosis than Malone ACE in some series; used for antegrade enemas in refractory cases

inv-81: Ileal Neoappendicostomy (INA) definition

TermIleal Neoappendicostomy (INA)

DescriptionSurgical creation of a neoappendicostomy using ileum when appendix is absent to enable antegrade continence enemas (ACE)

Evidence noteSystematic reviews report improved bowel function and QOL but also notable stoma-related and post-operative complications

inv-82: Vaginal Bowel Control (VBC) device definition

TermVaginal Bowel Control (VBC) device

DescriptionIntra-vaginal insert with an inflatable balloon and pump that occludes the rectum posteriorly to reduce fecal incontinence episodes (example: Eclipse system)

Study noteClinical studies used fitting and trial response (>=50% reduction) to select long-term users; fitting success variable

inv-83: Fecal incontinence (FI) general prevalence definition

TermFecal incontinence (FI)

DefinitionThe involuntary leakage of solid or loose stool; prevalence estimated at 7–15% of community-dwelling women

Clinical relevanceAssociated with reduced quality of life; many women do not report symptoms

inv-84: Dynamic graciloplasty definition

TermDynamic graciloplasty

DescriptionSurgical transposition of the gracilis muscle around the anal canal with continuous electrical stimulation to increase resting tone

Outcomes / availabilityAssociated with considerable morbidity and high long-term complication rates; implantable pulse generator may not be available in the U.S.

OpenPayer

Fecal Incontinence

Coverage Criteria and Clinical Indications

Billing Codes and Coding Guidance

Provider Requirements, Prior Authorization, and Documentation

Background, Definitions, and Evidence Context

Policy Revision History