CurrentMeridian Health Plan of MichiganPolicy MI.CP.MP.504

RELiZORB (digestive enzyme cartridge) — coverage criteria for enteral feeding

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This policy governs medical necessity review and coverage guidance for RELiZORB, a single-use digestive enzyme cartridge used inline with enteral tube feeding for patients (adults and children ≥5 years) who have difficulty breaking down and absorbing fats. It applies to Meridian Health Plan of Michigan Michigan Medicaid line of business.

Policy Summary

PayerMeridian Health Plan of Michigan

PolicyRELiZORB (digestive enzyme cartridge) — coverage criteria for enteral feeding

Policy CodePolicy MI.CP.MP.504

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJun 25, 2021

Next Review DateJun 25, 2021

Key ActionSubmit requests for Relizorb for case-by-case review by a Meridian Medical Director and include recent clinical notes documenting failed alternative treatments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approvedRegulatory status

Medical Director reviewAuthorization pathway

Clinical notes ≤12moDocumentation

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CurrentMeridian Health Plan of MichiganPolicy MI.CP.MP.504

RELiZORB (digestive enzyme cartridge) — coverage criteria for enteral feeding

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Sign up for meridian_health_plan_of_michigan Policy MI.CP.MP.504 alerts

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Policy Summary

PayerMeridian Health Plan of Michigan

PolicyRELiZORB (digestive enzyme cartridge) — coverage criteria for enteral feeding

Policy CodePolicy MI.CP.MP.504

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJun 25, 2021

Next Review DateJun 25, 2021

Key ActionSubmit requests for Relizorb for case-by-case review by a Meridian Medical Director and include recent clinical notes documenting failed alternative treatments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approvedRegulatory status

Medical Director reviewAuthorization pathway

Clinical notes ≤12moDocumentation

Coverage Criteria for RELiZORB

Case-by-case medical necessity review

Covered when ALL of the following are met (subject to Medical Director review):

FDA indication: Patient is receiving enteral tube feeding and has difficulty breaking down and/or absorbing fats; RELiZORB (a single-use in-line iLipase cartridge) is intended to hydrolyze fats in enteral formulas prior to ingestion.

RELiZORB is FDA-approved for adults and for children age 5 and older.

Documentation: Recent clinical notes (within the last 12 months) must be provided and must document alternative treatment(s) that were trialed and failed.

All requests will be reviewed by a Meridian Medical Director on a case-by-case basis.

Administrative: Submitted procedure/billing codes must be included on the Michigan Medicaid Fee Schedule and medical necessity criteria must be met.

Coverage is contingent on meeting medical necessity and fee schedule inclusion; requests not reviewed and approved by a Meridian Medical Director may be denied.

Evidence considerations: There is limited published evidence; no peer-reviewed, randomized, placebo-controlled literature demonstrates superiority of RELiZORB over current therapy, and evidence is insufficient for some patient populations with conditions affecting fat breakdown/absorption. Such cases will be reviewed case-by-case and may be excluded from coverage depending on evidence.

Insufficient published evidence may affect determination of medical necessity.

The policy notes that insufficient published evidence exists regarding use of RELiZORB in certain patients receiving enteral nutrition who have underlying conditions that impair fat breakdown and absorption. Such situations are not automatically covered; instead, requests will undergo case-by-case review by a Meridian Medical Director and coverage decisions may depend on available evidence and the individual clinical context.

The document states there is no evidence in peer-reviewed, randomized, placebo-controlled literature demonstrating therapeutic efficacy or safety of RELiZORB compared with current therapy. Because randomized, placebo-controlled trials are lacking for some indications and populations, the policy identifies an evidence gap that may lead to determinations of not medically necessary for certain uses.

Coding

Provider Actions and Authorization Requirements

Prior Authorization

Medical Director review and fee schedule check

All requests for Relizorb will be reviewed by a Meridian Medical Director on a case-by-case basis; coverage is contingent on meeting medical necessity criteria and inclusion of the submitted codes on the Michigan Medicaid Fee Schedule.

Step Therapy

Failure of alternatives required

Provide documentation of alternative treatment(s) that were trialed and failed prior to Relizorb; this demonstrates a stepwise approach is required.

Documentation Required

Required clinical documentation

Background

RELiZORB is described as a single-use, in-line digestive enzyme cartridge that contains immobilized pancreatic lipase (iLipase). It connects inline with enteral pump feed sets to hydrolyze fats in enteral formulas into absorbable fatty acids and monoglycerides prior to ingestion. The immobilized enzyme remains within the cartridge and is intended for patients on enteral tube feeding who have difficulty breaking down and absorbing dietary fats; the device has FDA approval for adults and children age 5 and older, but the policy emphasizes limited large-scale human studies and specific evidence gaps.

Definitions

RELiZORB — key details (inv-12)

Product typeSingle-use, point-of-care digestive enzyme cartridge

Intended useConnects inline with existing enteral pump feed sets and pump extension sets to hydrolyze fats in enteral tube feeding formulas

Patient populationAdults and pediatric patients age 5 years and above receiving enteral tube feedings

Regulatory statusFDA-approved for adults; FDA approval extended to children ages 5–18 (July 2017)

Clinical effectDesigned to mimic pancreatic lipase to break down triglycerides into absorbable fatty acids and monoglycerides prior to ingestion

iLipase — definition (inv-13)