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    v1.0.28
    OpenPayerPolicy UpdatesGastroenterologyAmeriHealth Caritas RELiZORB Coverage | OpenPayer
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    CurrentAmeriHealth CaritasPolicy CCP.1336

    Digestive enzyme cartridge (RELiZORB) coverage criteria

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    Policy governing medical necessity and coverage of the in-line immobilized lipase digestive enzyme cartridge (RELiZORB) for members with cystic fibrosis and confirmed exocrine pancreatic insufficiency receiving enteral nutrition and pancreatic enzyme replacement therapy.

    Policy Summary
    PayerAmeriHealth Caritas
    PolicyDigestive enzyme cartridge (RELiZORB)
    Policy CodePolicy CCP.1336
    Change TypeNo material changes
    Effective DateMay 2, 2026
    Last ReviewMay 1, 2026
    Next Review DateSep 1, 2027
    Key ActionObtain prior authorization for RELiZORB consistent with coverage criteria (initial up to 6 cartridges/24h for up to 90 days; reauthorization every 180 days requires evidence of weight gain and GI symptom resolution).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    pediatricPopulation covered
    ≤6/24h

    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.

    Qty limit
    ≤90 daysInitial duration
    180 daysReauth interval
    510(k)/De novoRegulatory status
    RCTs + obsEvidence cited

    Coverage Criteria

    Medically necessary use (pediatric cystic fibrosis with EPI)

    Covered when ALL of the following are met:

    Eligibility criteria: Member is pediatric (including neonates and infants in stable health) with cystic fibrosis and confirmed exocrine pancreatic insufficiency AND is receiving ongoing enteral nutrition AND is receiving pancreatic enzyme replacement therapy.

    From coverage policy statement; cartridge intended as adjunct to enteral feeding and PERT

    Authorization limits: Initial authorization: up to six single-use cartridges per 24-hour period for up to 90 days; reauthorization every 180 days thereafter is permitted only with evidence of continued weight gain and gastrointestinal symptom resolution.6 cartridges/24h; initial duration <=90 days; reauth interval = 180 days

    Quantities and reauthorization conditions explicitly stated in limitations

    All uses of an in-line digestive enzyme cartridge other than the covered indication described in this policy are considered investigational and will be reviewed on a case-by-case basis.

    Provider Actions and Requirements

    Prior Authorization

    Prior authorization required for RELiZORB with quantity and duration limits

    Prior authorization is required for RELiZORB and must be consistent with coverage criteria. Initial authorization is limited to up to six single-use cartridges per 24-hour period for up to 90 days; reauthorization is available every 180 days and is contingent on evidence of continued weight gain and resolution of gastrointestinal symptoms.

    • Initial authorization: up to 6 single-use cartridges per 24 hours for up to 90 days.
    • Reauthorization: every 180 days contingent on evidence of continued weight gain and GI symptom resolution.
    Documentation Required

    Cartridge use is individualized; PERT remains standard supportive therapy

    Pancreatic enzyme replacement therapy (PERT) remains the standard supportive therapy; use of the RELiZORB cartridge should be individualized, typically as an adjunct when usual PERT dosing is inadequate or when persistent gastrointestinal issues exist.

    Coding

    Related enteral nutrition HCPCS codesHCPCS
    B4149Blenderized natural foods with intact nutrients, 100 cal = 1 unit
    B4150Nutritionally complete with intact nutrients, 100 cal = 1 unit
    B4152Nutritionally complete, calorically dense (≥1.5 kcal/mL), 100 cal = 1 unit
    B4153Hydrolyzed proteins (amino acids/peptide chain), 100 cal = 1 unit
    B4154Special metabolic needs (excludes inherited diseases), 100 cal = 1 unit
    B4155Nutritionally incomplete/modular nutrients, 100 cal = 1 unit
    B4157Special metabolic needs for inherited disease of metabolism, 100 cal = 1 unit
    B4158Pediatric-specific enteral formulas (various types), 100 cal = 1 unit
    B4159Pediatric-specific enteral formulas (various types), 100 cal = 1 unit
    B4160Pediatric-specific enteral formulas (various types), 100 cal = 1 unit
    1–10 of 12
    1/2

    Definitions

    RELiZORB / in-line immobilized lipase cartridge — device description and interface
    Device descriptionRELiZORB is an in-line cartridge filled with immobilized lipase enzyme covalently bound to polymeric beads that fits between the infusion pump and the feeding tube to hydrolyze fats in enteral formula.
    Purpose / functionIntended to mimic pancreatic lipase function by hydrolyzing fats in enteral formula for patients with lipase deficiency (exocrine pancreatic insufficiency).
    Placement / interfaceDesigned to sit inline between the enteral feeding pump and the patient’s feeding tube during enteral nutrition administration.
    Regulatory statusFDA de novo classification (product code PLQ, regulation 876.5985) with subsequent Class II / 510(k) marketing approval.
    Age indicationIndicated for use in children aged one year and older and adults to hydrolyze fats in enteral formula; FDA review noted expanded use in patients aged one to two years based on retrospective data.

    Background

    Exocrine pancreatic insufficiency results from inadequate production of pancreatic enzymes — primarily lipase, amylase, and proteases — which impairs digestion, particularly fat hydrolysis, and leads to malabsorption. Clinical consequences include steatorrhea, weight loss or failure to thrive, bloating, and deficiencies of fat-soluble vitamins, often necessitating pancreatic enzyme replacement therapy or specialized enteral nutrition to meet nutritional goals.

    Policy Summary
    PayerAmeriHealth Caritas
    PolicyDigestive enzyme cartridge (RELiZORB)
    Policy CodePolicy CCP.1336
    Change TypeNo material changes
    Effective DateMay 2, 2026
    Last ReviewMay 1, 2026
    Next Review DateSep 1, 2027
    Key ActionObtain prior authorization for RELiZORB consistent with coverage criteria (initial up to 6 cartridges/24h for up to 90 days; reauthorization every 180 days requires evidence of weight gain and GI symptom resolution).
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and RequirementsCodingDefinitionsBackground
    • RELiZORB contains only lipase and does not replace protease or amylase; supplemental PERT may still be required.
    • Consider cartridge use when oral PERT dosing is inadequate or GI symptoms persist; assess cost and individual circumstances.
    Documentation Required

    Required clinical documentation for initial authorization and reauthorization

    Clinical documentation submitted with authorization requests must demonstrate a diagnosis of cystic fibrosis with confirmed exocrine pancreatic insufficiency, evidence of ongoing enteral nutrition, and concurrent pancreatic enzyme replacement therapy; for reauthorization include objective evidence of continued weight gain and resolution of gastrointestinal symptoms.

    • Diagnosis: cystic fibrosis with confirmed exocrine pancreatic insufficiency.
    • Therapy: documentation of ongoing enteral nutrition and concurrent PERT.
    • Reauthorization evidence: objective weight gain and GI symptom resolution.
    Denial Risk

    Denial risk for requests exceeding quantity/duration limits or lacking reauthorization evidence

    Requests that exceed six single-use cartridges within a 24-hour period or request an initial authorization duration beyond 90 days may be denied; reauthorization requires documentation of continued weight gain and gastrointestinal symptom resolution to avoid denial.

    • Do not request more than 6 cartridges per 24 hours for initial authorization.
    • Initial authorization beyond 90 days is outside policy limits and may be denied.
    • Provide objective evidence of benefit (weight gain, symptom resolution) for reauthorization.
    Denial Risk

    Noncovered/investigational uses may be denied or reviewed case-by-case

    Use of the digestive enzyme cartridge for indications other than pediatric cystic fibrosis with confirmed exocrine pancreatic insufficiency receiving enteral nutrition and PERT is considered investigational and may be denied or subject to case-by-case review.

    • All other uses of a digestive enzyme cartridge are investigational and will be reviewed case-by-case.
    • Policy coverage is limited to pediatric members (including neonates and infants in stable health) with CF and confirmed EPI on enteral nutrition plus PERT.
    Exocrine pancreatic insufficiency — definition and clinical implications
    DefinitionExocrine pancreatic insufficiency is a clinical syndrome characterized by inadequate pancreatic enzyme production (lipase, amylase, protease) leading to impaired digestion and malabsorption, particularly of fats.
    Common etiologiesPancreatic causes include chronic pancreatitis, cystic fibrosis (most common in children), pancreatic duct obstruction, pancreatic surgery, and Shwachman-Diamond syndrome; non‑pancreatic causes include celiac disease, Crohn’s disease, Zollinger‑Ellison syndrome, and motility disorders.
    Clinical indicatorsSteatorrhea, ongoing weight loss, abdominal discomfort/bloating, loss of appetite, and low circulating levels of micronutrients, lipoproteins, and fat‑soluble vitamins.
    Diagnostic testsFecal fat quantification and 13C‑mixed triglyceride breath test are among the most accurate; fecal elastase-1, imaging, direct pancreatic function tests, and macro/micronutrient blood tests may also be used.
    Therapeutic implicationsPatients often require pancreatic enzyme replacement therapy or enteral nutrition to meet nutritional goals; lipase deficiency can lead to clinically significant fat malabsorption affecting growth and nutrient status.