Enteral Nutrition (including Relizorb™)
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This policy governs coverage of enteral nutrition products and the Relizorb™ in-line lipase cartridge for Blue Cross Blue Shield - North Carolina members; it specifies when enteral nutrients and Relizorb are medically necessary and when they are not covered.
Relizorb™ is covered when used to hydrolyze fats in enteral formula for members meeting specific clinical criteria, including cystic fibrosis and failure of PERT.
Expanded FDA clearance history for Relizorb (adult, pediatric 5+, and pediatric 2+ approvals) reflected in description.
Coverage Criteria
Relizorb (medical necessity)
Relizorb is considered medically necessary when ALL of the following are met:
Requirement to trial PERT prior to Relizorb coverage.
Prescription enteral nutrients (medical necessity)
Enteral nutrients that require a prescription are eligible when ANY of the following diagnoses are present:
A prescription is required and member benefit language should be reviewed.
A prescription is required and member benefit language should be reviewed.
A prescription is required and member benefit language should be reviewed.
A prescription is required and member benefit language should be reviewed.
Most enteral food products available without a prescription or sold over-the-counter are not eligible for coverage. BCBSNC treats these non-prescription enteral nutrition products as ineligible benefits unless specific medical criteria and a prescription are documented and the member’s benefit booklet allows coverage. This limit reflects that many enteral formulas are classified as medical foods and are routinely available without a prescription, and therefore are not covered under the plan except when explicit clinical criteria are met.
Relizorb™ is addressed separately and may be covered only when the specific medical necessity requirements in this policy are satisfied. Uses of Relizorb outside those stated criteria are considered investigational and not covered, and claims will be denied when the policy-required documentation and indications are not met. This positions Relizorb as a medically necessary, covered treatment only for the limited, defined indications described in the criteria.
When the coverage criteria for Relizorb are not satisfied, Relizorb is considered investigational and not covered and claims for its use will be denied. Coverage is limited to the specific clinical scenarios and documentation requirements described elsewhere in this policy.
Similarly, most enteral food products that are available without a prescription/OTC remain not covered under BCBSNC. These non-prescription enteral foods will be denied unless a prescription and the applicable medical criteria are documented and the member’s benefits permit coverage.
Coding and Billing
Provider Actions and Requirements
Prior authorization required; list of applicable codes
Follow the member's benefit booklet and BCBSNC prior authorization processes for enteral nutrition and Relizorb claims; applicable HCPCS/related codes are B4102, B4103, B4104, B4105, B4149, B4150, B4152, B4153, B4154, B4155, B4157, B4158, B4159, B4160, B4161, B4162, and S9433. BCBSNC may request records to determine medical necessity.
- Review member benefit booklet before applying policy.
- Submit prior authorization per BCBSNC procedures using the applicable HCPCS codes listed.
- Be prepared to provide medical records if requested to support medical necessity.
Trial of PERT required before Relizorb
Relizorb will be covered only after the individual has failed to achieve enteral feeding goals while receiving pancreatic enzyme replacement therapy (PERT) in conjunction with enteral feedings.
- Document trial of PERT with enteral feedings and evidence that feeding goals were not met.
Provide full medical records on request; letters alone insufficient
BCBSNC may request medical records to determine medical necessity; letters of support can be helpful but are not sufficient unless they include all specific information needed for the determination.
- Provide complete medical records when requested, including documentation of diagnosis, symptoms, feeding regimen, PERT trial, and target BMI data.
OTC enteral products ineligible and subject to denial
Most enteral food products available without a prescription (over-the-counter) are not eligible for coverage and claims will be denied unless a prescription and applicable medical criteria are documented; Relizorb is investigational and will be denied when coverage criteria are not met.
- Ensure enteral products are prescription-only and meet the policy's clinical criteria before submitting claims.
Definitions
Background
Enteral Nutrition (EN) delivers nutrients directly into the gastrointestinal tract via a tube, catheter, or stoma for patients who cannot meet nutritional needs orally. Enteral formulas are typically classified as medical foods and may be provided for conditions that impair oral intake or digestion.
Fat malabsorption in enteral-fed patients can lead to inadequate weight gain or loss, gastrointestinal symptoms (for example, diarrhea, steatorrhea, abdominal pain, bloating, nausea, flatulence, vomiting), and can negatively affect respiratory status and bone health. Relizorb™ is an in-line immobilized lipase cartridge designed to hydrolyze triglycerides in enteral formulas to improve fat absorption; BCBSNC provides coverage for Relizorb when the specific medical necessity criteria in this policy are met.
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