Immobilized Lipase Cartridges (RELiZORB)
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Medical necessity criteria for use of RELiZORB immobilized lipase cartridges with enteral feeding for members of Ambetter Georgia / Centene-affiliated health plans.
No material clinical or coverage changes in this revision.
Medical Necessity and Coverage Criteria
Initial therapy / Medical necessity criteria
Covered when ALL of the following are met:
Main criteria
Enteral feeding requirement and PERT status
- Member/enrollee requires enteral feeding AND documented failure to achieve or maintain enteral nutrition goals despite optimization of oral pancreatic enzyme replacement therapy (PERT) and nutritional support
- Member/enrollee requires enteral feeding AND documented contraindication to or intolerance of oral PERT during enteral feeding
- Established diagnosis of exocrine pancreatic insufficiency (EPI) confirmed by fecal elastase
Allowed daily cartridge request
- Request is for up to two cartridges per day for member/enrollees ≤ six months of age
- Request is for up to six cartridges per day for member/enrollees > six months of age
Requests that exceed the specified daily cartridge limits are outside the coverage criteria. Specifically, the policy allows up to 2 cartridges per day for members ≤ 6 months of age and up to 6 cartridges per day for members > 6 months of age. Requests for quantities greater than these limits may be denied as not meeting the policy’s allowable cartridge thresholds.
RELiZORB use is covered only when the member has confirmed exocrine pancreatic insufficiency (EPI) by fecal elastase and one of the following applies: the member requires enteral feeding and has either (1) documented failure to achieve or maintain enteral nutrition goals despite optimization of oral pancreatic enzyme replacement therapy (PERT) and nutritional support, or (2) a documented contraindication to or intolerance of oral PERT during enteral feeding. Use of RELiZORB when these conditions are not met (no confirmed EPI, PERT not attempted/optimized without documented contraindication or intolerance, or requested quantities exceeding policy limits) would not meet medical necessity.
Coding and Quantity Limits
| B4105 | In-line cartridge containing digestive enzyme(s) for enteral feeding, each |
Authorization, Documentation, and Provider Requirements
Prior authorization required; medical necessity must be met
Prior authorization is required for requests for immobilized lipase cartridges (RELiZORB). All requests must meet the policy's medical necessity criteria and include supporting documentation as specified in the policy.
Attempt and optimize oral PERT prior to approval
The member must have attempted and had optimization of oral pancreatic enzyme replacement therapy (PERT) before RELiZORB will be approved, unless there is a documented contraindication or intolerance to oral PERT during enteral feeding.
Documentation and coding required (including B4105)
Submit documentation showing the member requires enteral feeding, an established diagnosis of EPI confirmed by fecal elastase, evidence of failure to achieve or maintain enteral nutrition goals despite optimized oral PERT (or documented contraindication/intolerance), and the requested daily cartridge quantity within policy limits. Use HCPCS code B4105 to bill the in-line cartridge.
- Evidence of enteral feeding.
- Fecal elastase result confirming EPI.
- Clinical notes documenting failure to meet/maintain enteral nutrition goals despite optimized oral PERT, or documentation of contraindication/intolerance to oral PERT.
- Requested number of cartridges per day consistent with limits (≤2/day for ≤6 months; ≤6/day for >6 months).
- Billing code: B4105 (In-line cartridge containing digestive enzyme(s) for enteral feeding, each).
Denial triggers — missing criteria or exceeding limits
Requests that fail to meet every element of the medical necessity criteria may be denied. Common denial triggers include lack of enteral feeding, absence of confirmed EPI by fecal elastase, no documented trial/optimization of oral PERT (or no documented contraindication/intolerance), or requests exceeding the allowed daily cartridge limits.
- No documentation that the member requires enteral feeding.
- No fecal elastase confirming EPI.
- No record of attempted/optimized oral PERT and no documented contraindication/intolerance.
- Requested cartridges exceed limits (more than 2/day for members ≤6 months; more than 6/day for members >6 months).
Background
RELiZORB is an FDA‑cleared single‑use in‑line immobilized lipase cartridge intended for use with enteral feeding systems to hydrolyze triglycerides in enteral formulas and improve fat absorption for individuals with exocrine pancreatic insufficiency (EPI). It is intended for members who require enteral feeding and continue to have fat malabsorption despite optimized oral PERT or who cannot tolerate or have contraindications to oral PERT.
Definitions
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