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    v1.0.30
    OpenPayerPolicy UpdatesGastroenterologyArizona Complete Health RELiZORB Coverage Prior Au…
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    CurrentArizona Complete HealthPolicy CP.MP.252

    Immobilized Lipase Cartridges (RELiZORB)

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    Defines medical necessity criteria for use of RELiZORB immobilized lipase cartridges with enteral feeding for members/enrollees of the health plan; applies to requests for cartridge coverage when treating exocrine pancreatic insufficiency (EPI).

    Policy Summary
    PayerArizona Complete Health
    PolicyImmobilized Lipase Cartridges (RELiZORB)
    Policy CodePolicy CP.MP.252
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization with documentation of enteral feeding, fecal elastase–confirmed EPI, and prior optimization of oral PERT or documented intolerance.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Up to 2/day≤ 6 months
    Up to 6/day> 6 months
    B4105

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    HCPCS
    Fecal elastaseDiagnostic

    Coverage Criteria for RELiZORB (immobilized lipase cartridges)

    Medical necessity criteria

    Covered when ALL of the following are met:

    Overall coverage criteria: Member requires enteral feeding AND one of the PERT-related conditions (documented failure to achieve or maintain enteral nutrition goals despite optimization of oral pancreatic enzyme replacement therapy (PERT) and nutritional support OR documented contraindication to or intolerance of oral PERT during enteral feeding)

    As stated in policy I.A

    Diagnostic confirmation of EPI: Member has an established diagnosis of exocrine pancreatic insufficiency (EPI) confirmed by fecal elastase

    As stated in policy I.B

    Cartridge quantity limits

    • Age-based options: Up to two cartridges per day for member/enrollees ≤ six months of age OR up to six cartridges per day for members/enrollees > six months of age

      Policy I.C.1–2

    PERT optimization or intolerance (nested OR): Documented failure to achieve or maintain enteral nutrition goals despite optimization of oral PERT and nutritional support OR documented contraindication to or intolerance of oral PERT during enteral feeding

    This clause is an OR condition referenced under overall coverage criteria I.A

    Requests that exceed the age-based per-day cartridge limits specified in the coverage criteria are not supported. The policy allows up to 2 cartridges per day for members ≤ six months of age and up to 6 cartridges per day for members > six months of age; requests for quantities above these thresholds do not meet the stated coverage criteria.

    Use of RELiZORB cartridges is not considered medically necessary when there is no documentation of exocrine pancreatic insufficiency (EPI) confirmed by fecal elastase, or when there is no documentation of either failure to achieve or maintain enteral nutrition goals despite optimization of oral pancreatic enzyme replacement therapy (PERT) and nutritional support, or a documented contraindication/intolerance to oral PERT during enteral feeding. Additionally, requests that exceed the stated daily cartridge limits for the member's age are excluded from coverage. Providers should also follow coding and billing guidance, including referencing HCPCS B4105 where applicable.

    Coding and Quantity Limits

    Referenced HCPCS CodesHCPCS
    B4105In-line cartridge containing digestive enzyme(s) for enteral feeding, each
    Cartridge daily limit by age
    Maximum cartridges - ≤ 6 monthsUp to 2 cartridges per day for members ≤ six months of age
    Maximum cartridges - > 6 monthsUp to 6 cartridges per day for members > six months of age
    Policy applicationRequests exceeding the specified per-day cartridge limits for the member's age are not supported by the coverage criteria

    Provider Requirements, Prior Authorization, and Denial Risk

    Prior Authorization

    Prior Authorization Required

    Prior authorization is REQUIRED for RELiZORB (immobilized lipase cartridges). Submit prior authorization requests per Arizona Complete Health procedures. Billing reference: HCPCS B4105 — In-line cartridge containing digestive enzyme(s) for enteral feeding, each.

    • HCPCS: B4105
    Documentation Required

    Required Clinical Documentation

    Document confirmation of exocrine pancreatic insufficiency (EPI) — e.g., fecal elastase result — and that the member requires enteral feeding. Include clinical notes showing enteral feeding regimen and indication for enzyme cartridge.

    • Fecal elastase results confirming EPI
    • Documentation of enteral feeding (orders, nursing notes, formula)

    Background

    RELiZORB is a single-use, point-of-care immobilized lipase cartridge that is used in-line with enteral feeding systems to hydrolyze triglycerides in enteral formulas prior to reaching the gastrointestinal tract, with the goal of improving fat absorption for patients with exocrine pancreatic insufficiency (EPI). It is an FDA-cleared digestive enzyme cartridge intended for use when enteral feeding is required and when oral PERT is ineffective, not tolerated, or contraindicated.

    Definitions

    RELiZORB definition
    Device nameRELiZORB (immobilized lipase cartridge)
    FDA statusOnly U.S. Food and Drug Administration (FDA)-cleared digestive enzyme cartridge indicated for use with enteral feeding systems to hydrolyze fats
    MechanismSingle-use, point-of-care cartridge containing immobilized lipase that hydrolyzes triglycerides in enteral formulas into absorbable fatty acids and monoglycerides prior to entering the gastrointestinal tract
    Intended effectDesigned to mimic pancreatic lipase release to enhance fat absorption and improve nutritional outcomes in patients with insufficient pancreatic lipase
    Exocrine pancreatic insufficiency (EPI) definition
    DefinitionExocrine pancreatic insufficiency (EPI) is a disorder caused by the pancreas failing to deliver a minimum threshold level of pancreatic digestive enzymes to the intestine, leading to maldigestion and malabsorption of nutrients, often confirmed by low fecal elastase
    Policy Summary
    PayerArizona Complete Health
    PolicyImmobilized Lipase Cartridges (RELiZORB)
    Policy CodePolicy CP.MP.252
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization with documentation of enteral feeding, fecal elastase–confirmed EPI, and prior optimization of oral PERT or documented intolerance.
    SourceLink
    On This Page
    Coverage Criteria for RELiZORB (immobilized lipase cartridges)Coding and Quantity LimitsProvider Requirements, Prior Authorization, and Denial RiskBackgroundDefinitions
    Step Therapy

    Step Therapy / Prior Trial Requirement

    Provide documentation of prior optimization of oral pancreatic enzyme replacement therapy (PERT) and nutrition management, unless there is a documented contraindication or intolerance to oral PERT. If oral PERT was contraindicated or not tolerated, include clinical rationale.

    • Records of PERT dosing, duration, and response
    • Nutrition support documentation showing continued malabsorption or failure to meet goals
    • If applicable, documented contraindication or intolerance to oral PERT
    Denial Risk

    Denial Risk for Unmet Criteria

    Requests lacking the required prior authorization, HCPCS coding, confirmation of EPI, enteral feeding documentation, or evidence of PERT optimization/contraindication are at risk for denial. Ensure all supporting clinical and billing documentation is included with the request.

    • Missing fecal elastase or enteral feeding documentation may result in denial
    • Absence of prior PERT optimization documentation (or documented contraindication) may result in denial
    Common causesCommon in individuals with cystic fibrosis, chronic pancreatitis, and other disorders that impair pancreatic function
    Clinical consequenceLeads to malabsorption of macronutrients and deficiencies of fat-soluble vitamins (A, D, E, K), decreased caloric absorption, and possible gastrointestinal symptoms