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    v1.0.28
    OpenPayerPolicy UpdatesGastroenterologyAmeriHealth Caritas Peristeen Coverage Update | Op…
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    CurrentAmeriHealth CaritasPolicy CCP.1246

    Peristeen® anal irrigation system

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    Medical necessity and coverage criteria for the Peristeen transanal irrigation system for bowel management, governing AmeriHealth Caritas benefit determinations for covered members.

    Policy Summary
    PayerAmeriHealth Caritas
    PolicyPeristeen® anal irrigation system
    Policy CodePolicy CCP.1246
    Change TypeAdded indicationevidence and reference updates
    Effective DateAug 1, 2025
    Last ReviewAug 1, 2025
    Next Review DateDec 1, 202639d
    Key ActionObtain prior authorization and document diagnosis, age (>=2 years), symptoms, and failed conservative management.
    SourceLink
    POLICY UPDATE CHANGES

    An indication for members with low anterior resection syndrome was added based on new literature.

    Findings section was rewritten; older references prior to 2014 were deleted and a new systematic review and meta-analysis (Bolia, 2024) was added.

    FDA regulation updated: Peristeen is a Class 2 device indicated for persons ages two years and older with neurogenic bowel dysfunction.

    2 yrsminimum indicated age per FDA and policy
    6 morequired medical review interval
    40–73%reported guideline success

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    62%pooled pediatric success
    35–55%reported discontinuation

    Coverage Criteria for Peristeen Anal Irrigation

    Initial coverage criteria (neurogenic bowel)

    Covered when ALL of the following are met

    Primary neurogenic bowel indication: The system is used for the management of neurogenic bowel dysfunction.
    Age: Member is age two years or older.>= 2 years

    FDA-regulated indication and policy minimum age.

    Symptoms: Member experiences fecal incontinence, chronic constipation, or time-consuming bowel management procedures.
    Failed conservative management: Initial management involving diet, bowel habit, laxatives, or constipating medications has failed.

    Peristeen is considered after failure of initial conservative measures.

    Coverage criteria (low anterior resection syndrome)

    Also covered when ALL of the following are met

    Low anterior resection syndrome: Member has symptoms of low anterior resection syndrome and Peristeen is being used to manage those symptoms.

    Policy cites evidence supporting short-term symptom improvement and trials showing reduced LARS scores with transanal irrigation.

    Pediatric non-neurogenic bowel dysfunction (surgical candidate)

    Covered in pediatric non-neurogenic cases when ALL of the following are met

    Age and diagnosis: Member is up to 21 years of age and has non-neurogenic bowel dysfunction.<= 21 years

    Per policy allowance for pediatric non-neurogenic cases.

    Failed conservative management: Member has failed initial conservative management (dietary, behavioral, or medical measures).

    Reference to required prior conservative therapy before Peristeen.

    Surgical candidate: Member is considered a candidate for surgical intervention.

    Policy follows NICE guidance allowing Peristeen prior to surgery for eligible pediatric patients.

    All other uses of the Peristeen anal irrigation system that are not explicitly listed in this policy’s covered indications are considered investigational and not medically necessary. Requests for devices or supplies intended for indications outside those specified may be denied as they lack sufficient clinical evidence to support coverage.

    Uses that are not specified in the policy indications — that is, indications outside neurogenic bowel dysfunction, low anterior resection syndrome (LARS), or the defined pediatric non‑neurogenic surgical‑candidate subgroup — are considered not medically necessary. Such requests should be evaluated against the policy criteria; if the clinical circumstances do not meet the stated indications and documentation requirements, coverage will not be approved.

    Coding and Age / Review Key Values

    No explicit billing or CPT/ICD codes provided in policymixed
    No codes listed
    inv-07: Minimum age — >= 2 years
    Minimum age>= 2 years
    Source of age criterionPolicy and FDA indication specify use in persons age two years and older
    Applies toAll covered indications (neurogenic bowel, LARS, eligible pediatric non‑neurogenic cases)
    inv-08: Continued approval review interval — every 6 months
    Continued approval review intervalEvery 6 months
    PurposeMedical review to establish compliance and ongoing need for treatment
    Documentation requirement

    Provider Requirements and Authorization

    Prior Authorization

    Prior authorization and ongoing review

    Prior authorization is required to verify that all policy clinical criteria are met, including indication (e.g., neurogenic bowel dysfunction or LARS), member age (≥ 2 years), presence of symptoms (fecal incontinence, chronic constipation, or time‑consuming bowel management), and documentation of failed initial conservative management. Continued authorization requires medical review every six months to confirm ongoing need.

    • Initial PA must document indication, age ≥ 2 years, symptoms, and prior failed conservative measures (diet, bowel habit changes, laxatives, or constipating medications).
    • Ongoing approval requires medical review every 6 months.
    Step Therapy

    Step therapy requirement

    Peristeen is considered only after failure of initial conservative management such as dietary modification, bowel habit training, laxatives, suppositories, or behavioral measures; alternative covered services (e.g., multifaceted bowel programs, biofeedback, medications, or surgical options) should be considered prior to approval.

    Background and Context

    Fecal incontinence and chronic constipation can result from a range of organic (including neurogenic) and functional causes. The goals of bowel management are to modulate stool consistency, promote regular transit, and achieve predictable evacuation to reduce incontinence and the burden of time‑consuming bowel care. Transanal irrigation (Peristeen) is a manual pump enema system that uses a rectal catheter with an inflatable balloon to evacuate the colon at scheduled times and may reduce symptoms of incontinence and constipation when used according to the indications in this policy. Continued use requires clinical review every 6 months to confirm ongoing need.

    Definitions

    inv-14: Transanal irrigation / Peristeen — device description and components
    Device descriptionPeristeen is a transanal irrigation system: a manual pump enema method using a control unit with pump and a water bag to irrigate the colon
    Catheter componentRectal catheter with a soft inflatable balloon that is secured inside the bowel to create a watertight seal during irrigation
    User operationCan be administered independently or with assistance; designed to permit hands‑free irrigation while the balloon is secured
    Regulatory statusU.S. FDA Class 2 device indicated for persons age two years and older with neurogenic bowel dysfunction
    inv-15: Low anterior resection syndrome (LARS) — definition and clinical characteristics
    DefinitionLow anterior resection syndrome (LARS) is postoperative bowel dysfunction following low anterior resection for rectal cancer, characterized by frequent bowel movements, urgency, incontinence, and incomplete evacuation
    Policy Summary
    PayerAmeriHealth Caritas
    PolicyPeristeen® anal irrigation system
    Policy CodePolicy CCP.1246
    Change TypeAdded indicationevidence and reference updates
    Effective DateAug 1, 2025
    Last ReviewAug 1, 2025
    Next Review DateDec 1, 202639d
    Key ActionObtain prior authorization and document diagnosis, age (>=2 years), symptoms, and failed conservative management.
    SourceLink
    On This Page
    Coverage Criteria for Peristeen Anal IrrigationCoding and Age / Review Key ValuesProvider Requirements and AuthorizationBackground and ContextDefinitions
    Continued requests must include medical review documentation every six months
    • Document attempts at diet/bowel habit modification and trials of laxatives or rectal stimulants (suppositories).
    • Consider listed alternative covered services before Peristeen.
    Documentation Required

    Required documentation

    Provide documentation that supports the covered indication (neurogenic bowel dysfunction, low anterior resection syndrome, or eligible pediatric non‑neurogenic bowel dysfunction), verifies member age (≥ 2 years or ≤ 21 years for the pediatric subgroup), describes symptoms (fecal incontinence, chronic constipation, or time‑consuming bowel management), and records prior failed conservative management. Continued requests must include medical review documentation every six months.

    • Diagnosis and age verification (≥ 2 years; ≤ 21 years for pediatric non‑neurogenic subgroup).
    • Clinical symptom documentation (incontinence, constipation, or time‑consuming management).
    • Records of failed conservative therapies and periodic 6‑month review notes for continued approval.
    Denial Risk

    Not covered uses

    Requests for Peristeen for indications other than neurogenic bowel dysfunction, low anterior resection syndrome, or the specified pediatric non‑neurogenic subgroup are considered investigational/not clinically proven and may be denied as not medically necessary.

    • All other uses are investigational and not medically necessary per policy limitations.
    Clinical characteristicsSymptoms include increased stool frequency (day and night), urgency, incontinence, and sensation of incomplete evacuation
    Treatment role of PeristeenTransanal irrigation (Peristeen) may significantly improve short‑term bowel function and reduce symptom severity, particularly for patients with incomplete evacuation
    Risks and outcomesAssociated with notable dropout rates; rectal perforation is a rare but reported concern; long‑term outcomes remain limited