Immobilized Lipase Cartridges (RELiZORB)
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Medical necessity criteria and coverage guidance for RELiZORB immobilized lipase cartridges used with enteral feeding for members/enrollees of Ambetter Nevada (Centene-affiliated health plans). Affects providers requesting coverage for RELiZORB cartridges.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Medical necessity — RELiZORB
Covered when ALL of the following are met
Age-based limits: ≤6 months = up to 2/day; >6 months = up to 6/day
The list of procedure and billing codes included in this policy is provided for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage; providers must reference current, authoritative coding guidance and payor-specific rules when preparing claims and authorizations.
Coding and Quantity Limits
| B4105 | In-line cartridge containing digestive enzyme(s) for enteral feeding, each |
Provider Requirements, Prior Authorization, and Billing
Prior authorization required; bill with HCPCS B4105
Prior authorization is required. Claims/claims submissions should reference HCPCS code B4105 (In-line cartridge containing digestive enzyme(s) for enteral feeding, each).
- HCPCS: B4105 — In-line cartridge containing digestive enzyme(s) for enteral feeding, each
Document PERT optimization or contraindication/intolerance
Provider must document that oral pancreatic enzyme replacement therapy (PERT) and nutritional support have been optimized prior to RELiZORB approval, or document a contraindication or intolerance to oral PERT during enteral feeding.
- 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
Provide enteral feeding evidence, fecal elastase, and clinical records
Submit clinical documentation showing the member requires enteral feeding, fecal elastase test confirming exocrine pancreatic insufficiency (EPI), and medical records demonstrating failure to achieve/maintain enteral nutrition goals despite optimized oral PERT and nutritional support or a documented contraindication/intolerance to oral PERT.
- Evidence of enteral feeding
- Fecal elastase confirming EPI
- Clinical records showing failure to achieve/maintain enteral nutrition goals despite optimized oral PERT and nutritional support, or documentation of contraindication/intolerance to oral PERT
Denial risk if required criteria or PERT optimization not documented
Requests lacking documentation of EPI confirmed by fecal elastase, lacking evidence of enteral feeding, or lacking documentation of failed/intolerant optimization of oral PERT may be denied.
- No documented EPI confirmed by fecal elastase
- No evidence of enteral feeding
- No documentation of failed optimization of oral PERT or documented contraindication/intolerance
Background
RELiZORB is an FDA-cleared, single-use immobilized lipase cartridge designed to hydrolyze triglycerides in enteral formulas into absorbable fatty acids and monoglycerides prior to delivery to the gastrointestinal tract, intended to enhance fat absorption for patients with exocrine pancreatic insufficiency (EPI).
Definitions
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