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).
No material clinical or coverage changes in this revision.
Coverage Criteria for RELiZORB (immobilized lipase cartridges)
Medical necessity criteria
Covered when ALL of the following are met:
As stated in policy I.A
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
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
| B4105 | In-line cartridge containing digestive enzyme(s) for enteral feeding, each |
Provider Requirements, Prior Authorization, and Denial Risk
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
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)
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 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
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
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