Immobilized Lipase Cartridges (RELiZORB)
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Medical necessity criteria and coverage guidance for use of RELiZORB immobilized lipase cartridges with enteral feeding for members of Centene-affiliated health plans.
No material clinical or coverage changes in this revision.
Coverage Criteria for RELiZORB (Immobilized Lipase Cartridges)
Initial coverage criteria
Covered when ALL of the following are met
Main criteria
- PERT response or intolerance: 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
Optimization of oral PERT required unless documented contraindication/intolerance
- EPI confirmation: Established diagnosis of exocrine pancreatic insufficiency (EPI) confirmed by fecal elastasefecal elastase test result per clinician documentation
- Daily cartridge quantity limits: For members ≤ six months of age: up to two cartridges per day; For members > six months of age: up to six cartridges per day≤2 or ≤6 cartridges/day based on age
RELiZORB is intended for use with enteral feeding in individuals who do not secrete sufficient lipase due to exocrine pancreatic insufficiency or related conditions. The policy does not list broad categorical exclusions; rather, coverage is tied to the clinical scenario of insufficient lipase secretion associated with EPI and enteral nutrition. Providers should note that the device is intended to supplement lipase activity during enteral feeding rather than replace standard oral pancreatic enzyme replacement therapy (PERT).
Requests for RELiZORB for members without documented exocrine pancreatic insufficiency (EPI) confirmed by fecal elastase, or for members who have not had documented failure of or intolerance to optimized oral PERT during enteral feeding, do not meet the medical necessity criteria in this policy. Prior authorization must demonstrate an established EPI diagnosis by fecal elastase and either documented failure to achieve or maintain enteral nutrition goals despite optimized oral PERT and nutritional support, or a documented contraindication/intolerance to oral PERT.
Coding and Billing
| B4105 | In-line cartridge containing digestive enzyme(s) for enteral feeding, each |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required. Requests must demonstrate the member meets all medical necessity criteria, including a confirmed diagnosis of exocrine pancreatic insufficiency (EPI) by fecal elastase, evidence of enteral feeding, and that the requested quantity aligns with age-based limits.
- Affected code: B4105 — In-line cartridge containing digestive enzyme(s) for enteral feeding, each
- Age-based limits: ≤ 6 months: up to 2 cartridges/day; > 6 months: up to 6 cartridges/day
Step Therapy / PERT Optimization
Prior to approval, documentation must show optimization of oral pancreatic enzyme replacement therapy (PERT) during enteral feeding, or a documented contraindication/intolerance to oral PERT. Optimization means the member has received adequate dosing and administration of oral PERT with continued failure to achieve or maintain enteral nutrition goals despite nutritional support.
- Optimization must be clearly documented in clinical notes (doses, duration, response)
- If oral PERT is contraindicated or not tolerated, provide clinical rationale and supporting records
Required Clinical Documentation
Documentation must include evidence the member is receiving enteral feeding, confirmation of EPI by fecal elastase testing, records showing PERT optimization or documented contraindication/intolerance, and the requested cartridge quantity with member age to verify dosing limits.
- Enteral feeding orders or nursing/feeding records
- Fecal elastase test result confirming EPI
- Clinical notes detailing PERT trials (dosing, duration, clinical response) or documentation of intolerance/contraindication
- Requested quantity and member age to confirm ≤2/day if ≤6 months or ≤6/day if >6 months
Denial Triggers
Requests missing any required medical necessity elements (for example: no documented EPI by fecal elastase, no evidence of enteral feeding, or no documentation of PERT optimization/contraindication) are subject to denial.
- Common denial reasons: absent fecal elastase confirmation, lack of enteral feeding documentation, no PERT optimization trial or documented contraindication, requested quantity exceeds age-based limits
Background
RELiZORB is a single-use, point-of-care, FDA-cleared in-line digestive enzyme cartridge that contains immobilized lipase. The cartridge hydrolyzes triglycerides in enteral formulas into absorbable fatty acids and monoglycerides prior to entry into the gastrointestinal tract, effectively mimicking pancreatic lipase release to enhance fat absorption and utilization in patients with insufficient endogenous lipase secretion.
Definitions
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