Fecal Incontinence Management (devices and procedures)

Coverage Summary

This policy reviews a range of devices and procedures proposed for the treatment of fecal incontinence (FI) — including anal/rectal inserts (e.g., Renew Anal Insert), injectable perianal bulking agents (e.g., NASHA Dx/Solesta or autologous fat), electrical and magnetic pelvic floor stimulation (e.g., InTone MV, TNT), percutaneous tibial nerve stimulation (PTNS), surgically placed slings for bowel control (e.g., TOPAS System), transanal radiofrequency (SECCA), and vaginal bowel-control systems (e.g., Eclipse System).

Key numeric thresholds and trial-derived criteria

Solesta (NASHA Dx) trial entry - episode frequency>= 4 documented incontinence episodes in 2 weeks

Solesta trial entry - symptom durationSymptoms >= 12 months

Solesta trial entry - severityCCFIS (Cleveland Clinic Florida Fecal Incontinence Score) >= 10

Solesta responder definition (trial primary)>= 50% reduction in number of incontinence episodes

Solesta 6-month RCT result (Graf 2011)Response: 52% active vs 31% sham (OR 2.36; 95% CI 1.24-4.47; p=0.009)

Solesta longer-term follow-upSustained response reported ~12 months (57.4%) and 36 months (52.2%) in uncontrolled follow-up

PTNS recommended initial courseInitial series of 12 weekly office-based treatments (30-minute sessions in major trials)

PTNS common trial responder definition>= 50% reduction in mean number of FI episodes per week

PTNS CONFIDeNT trial dosing/result12 weekly, 30-minute sessions; responder: 38% PTNS vs 31% sham (not statistically significant), but absolute weekly episodes decreased more with PTNS

Vaginal insert study minimum entryMinimum 4 FI episodes over 2 weeks required for some vaginal insert trials/fitting

Medical-Necessity / Investigational Criteria

Investigational Therapies (policy statement)

The following therapies and devices are considered investigational because the evidence is insufficient to determine that they improve net health outcomes for treatment of fecal incontinence.

ALL of the following

Anal inserts for bowel control (e.g., Renew Anal Insert).
Electrical pelvic floor stimulation (e.g., InToneMV).
Injectable bulking agents (e.g., NASHA Dx/Solesta or autologous fat).
Magnetic pelvic floor stimulation (e.g., Translumbosacral Neuromodulation Therapy [TNT]).

Coding

Category III codesmixedNot Covered

No codes listed

FDA-cleared / FDA-approved devices referenced (informational)mixed

Eclipse System (510(k) 2015)	Vaginal insert for bowel control (Eclipse System) - FDA cleared 2015
InTone MV (510(k) 2014)	Non-implantable device providing electrical stimulation and/or biofeedback
NASHA Dx / Solesta (PMA 2011)	Injectable dextranomer in hyaluronic acid approved for FI in adults
Secca System (510(k) 2002)	Radiofrequency system cleared for treatment of fecal incontinence
TOPAS System (510(k) 2016)	Trans-Obturator Posterior Anal Sling System for FI
Urgent PC (510(k) 2005)	Neuromodulation system cleared for other indications
ZIDA Wearable Neuromodulation System (510(k) 2021)	Device cleared for other indications

No procedure or billing codes listed in this partmixed

No codes listed

Unlisted CPT procedures (may be indicated for listed treatments)CPT

46999	Unlisted procedure, anus (may be indicated for bulking agents using Solesta or autologous fat; Eclipse System, anal sling TOPAS system or transanal radiofrequency therapy)
58999	Unlisted procedure, female genital system (nonobstetrical) (when indicated for Eclipse system or Vaginal Insert)

Procedure CPT and related codesCPT

64566	Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming
97014	Application of a modality to 1 or more areas; electrical stimulation (unattended) (when indicated for pelvic floor stimulation [PFS])
97032	Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes (when indicated for pelvic floor stimulation [PFS])
1001T	Autologous muscle cell therapy, injection of muscle progenitor cells into the external anal sphincter, including ultrasound guidance, when performed

HCPCS / Supply / Device codesHCPCS

A4337	Incontinence supply rectal insert, any type each (when indicated for Renew Anal Insert)
A4563	Rectal control system for vaginal insertion, for long term use, includes pump and all supplies and accessories, any type each (when indicated for Eclipse System)
E0740	Incontinence treatment system, pelvic floor stimulator, monitor, sensor, and/or trainer
L8605	Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies

Type / Place of Servicemixed

Type of Service	Surgery
Place of Service	Inpatient/Outpatient

Provider Actions & Documentation Requirements

Documentation Required

Evaluation prior to treatment

Prior to initiating treatment for fecal incontinence document a clinical evaluation including a history and physical, basic office tests and laboratory testing. When indicated, document results of anorectal manometry, anorectal ultrasonography, and rectal sensory testing.

Documentation Required

Trial inclusion criteria documentation for Solesta

When requesting coverage for Solesta document: baseline Cleveland Clinic Florida Fecal Incontinence Score (CCFIS), a baseline bowel diary demonstrating at least 4 incontinence episodes over 2 weeks, symptom duration of at least 12 months, and prior failure of at least one medically supervised conservative therapy.

Background and Definitions

Fecal incontinence is the involuntary leakage of stool with multifactorial causes; initial management is conservative and includes dietary changes, pharmacotherapy (eg, antidiarrheals), pelvic floor muscle training/biofeedback, and bowel training. Multiple devices and procedures have been investigated for patients who fail conservative measures, but the evidence across these therapies is limited or inconsistent and does not clearly demonstrate improved net health outcomes or durable benefit.

Term	Definition
Fecal Incontinence (FI)
The involuntary loss of flatus, liquid, or stool.
NASHA Dx / Solesta
Non-animal-stabilized hyaluronic acid/dextranomer injectable bulking agent FDA-approved for treatment of FI in adults who have failed conservative therapy.
PTNS
Percutaneous tibial nerve stimulation with needle electrode above medial malleolus delivering low-voltage stimulation typically in a series of 12 weekly sessions.
PFS
Pelvic floor stimulation (electrical or magnetic) intended to activate pelvic floor musculature to reduce fecal incontinence.
St. Mark's Score
A validated fecal incontinence severity scoring system ranging 0 (perfect continence) to 24 (maximal incontinence).
CCFIS
A scoring instrument to assess fecal incontinence severity; higher scores indicate worse incontinence (Cleveland Clinic Florida Fecal Incontinence Score).
SECCA
Temperature-controlled radiofrequency energy delivery to the anal canal (transanal radiofrequency procedure).
Vaginal bowel-control system / Eclipse
Intravaginal balloon device inflated to occlude the rectum and reduce fecal incontinence episodes; includes an insert and pump with initial clinician fitting and trial period.
NASHA Dx
Dextranomer in stabilized hyaluronic acid perianal injectable bulking agent (same as Solesta).

Evidence Summary

The evidence base includes systematic reviews, randomized controlled trials, and noncomparative series. Overall, evidence is heterogeneous with generally insufficient durable benefit across therapies. Notably, the Solesta (NASHA Dx) randomized, sham-controlled trial showed a short-term advantage at 6 months (52% response with active vs 31% with sham for ≥50% reduction in episodes), but questions remain about long-term durability and safety; other therapies (anal/vaginal inserts, PFS, PTNS, slings, transanal RF) have limited, inconsistent, or noncomparative data.

Study / Source	Key Finding
Solesta RCT (Graf et al. 2011)
Randomized, sham-controlled trial (N=206): ≥50% reduction in episodes at 6 months 52% with NASHA Dx vs 31% sham (OR 2.36; 95% CI 1.24–4.47; p=0.009); mixed secondary outcomes; more adverse events in active group including proctalgia, rectal hemorrhage; 2 serious AEs (abscesses).
Solesta long-term (Mellgren et al. 2014)
Long-term follow-up of treated patients: sustained response at 12 months (57.4%) and 36 months (52.2%); mean CCFIS decreased from 14.3 to 10.5 at 36 months; additional treatment-related AEs reported.
PTNS CONFIDeNT (Knowles et al. 2015)
Large double-blind multicenter RCT (N=227): primary endpoint (≥50% reduction) not significantly different (38% PTNS vs 31% sham; p=.396), but PTNS showed a significantly greater absolute decrease in weekly episodes (MD -2.26; 95% CI -4.18 to -0.35; p=.021).
NOTABLe trial (Zyczynski et al. 2022)
Sham-controlled RCT in women (N=166): no significant difference in change in St. Mark score or weekly episodes between PTNS and sham; primary outcome not met (adjusted difference in St. Mark score -1.3; 95% CI -2.8 to 0.2).
TOPAS (Mellgren et al. 2016)
Single-arm prospective multicenter study (N=152): 69.1% achieved >50% reduction at 12 months; 19% complete continence; FI episodes/week and CCFIS improved; 104 procedure/device-related AEs in 66 subjects (pelvic pain, infection most common).
Transanal RF evidence summary
Evidence limited to small case series and noncomparative studies; systematic/AHRQ and ASCRS reviews conclude insufficient evidence to support use; RCTs lacking and long-term durability inconsistent.
Richter vaginal insert studies (2015)
Prospective single-arm study: 61 of 110 (55.5%) successfully fit; 1-month ITT success 78.7%; per-protocol success ~85%; common adverse events during fitting (pelvic cramping); no serious AEs reported.
Richter vaginal insert studies (2019)
Prospective open-label durability study (N=73 treated): 3-month success 72.6% ITT; significant improvements in FIQL and St Mark scores; high satisfaction (≈92% at 3 months); many AEs occurred during fitting and some patients could not be fit.
Selected meta-analyses/guidelines (Luo 2024; ASCRS 2023)
Luo 2024 meta-analysis of PTNS vs sham (4 RCTs, N=439) found PTNS reduced weekly episodes (MD -1.6; 95% CI -2.94 to -0.26; p=.02) and higher proportion achieving >50% reduction (RR 0.73; 95% CI 0.57–0.94); ASCRS 2023 guideline: injectable bulking agents, RF, and mechanical/vaginal inserts are not routinely recommended due to low/very-low quality evidence and limited/diminishing benefits.

Revision History

2013-09-01original_effective_date

Original Effective Date September 2013

2023-05-01policy_revised

Policy revised May 2023; review date updated December 2025

2014-08-01policy_renewal

Policy renewed at annual reviews (multiple years documented), including renewals in 2014–2024 as part of annual review cycle