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Modifiedpriority healthPolicy NO. 91278

ENTERAL NUTRITIONAL THERAPY

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Governs coverage and medical necessity criteria for enteral nutrition delivered via tube (nasogastric, gastrostomy, jejunostomy) including formulas, supplies, pumps, and accessory devices for Priority Health members.

Policy Summary

Payerpriority health

PolicyENTERAL NUTRITIONAL THERAPY

Policy CodePolicy NO. 91278

Change TypeLabeling expansion — age limitation removed for RELiZORB

Effective DateJun 1, 2026

Last ReviewMay 13, 2026

Next Review DateMay 13, 2026

Key ActionObtain prior authorization with clinical documentation when coverage depends on medical necessity or for use of digestive enzyme cartridges.

SourceLink

POLICY UPDATE CHANGES

Labeling for digestive enzyme (lipase) cartridges (e.g., RELiZORB) has expanded to include neonates and infants and the prior 1 year age limitation has been removed.

I.Medical necessity defined

B. SuppliesSupplies/DME covered

RELiZORBRELiZORB criteria

A.Exclusions listed

Multiple B-codesCodes listed

Coverage and Medical Necessity Criteria

Enteral nutritional therapy via tube

Covered when ALL of the following are met:

Primary medical necessity: 1. The member has a functioning gastrointestinal tract AND, due to pathology or dysfunction of the structures that normally permit food to reach the digestive tract, cannot maintain weight and strength commensurate with the patient's general condition; 2. The solution/formula being administered is the primary source of nutrition.

Supplies and pump criteria

Supplies, equipment, and pump coverage:

Supplies: All supplies, equipment, and accessories (durable medical equipment, DME) required for enteral nutritional therapy delivered via a tube (e.g., nasogastric, gastrostomy, jejunostomy), including syringes and tubing, are medically necessary.

Excludes storage units such as refrigerators or freezers per exclusions.

Policy Summary

Payerpriority health

PolicyENTERAL NUTRITIONAL THERAPY

Policy CodePolicy NO. 91278

Change TypeLabeling expansion — age limitation removed for RELiZORB

Effective DateJun 1, 2026

Last ReviewMay 13, 2026

Next Review DateMay 13, 2026

Key ActionObtain prior authorization with clinical documentation when coverage depends on medical necessity or for use of digestive enzyme cartridges.

SourceLink

On This Page

Pump: A pump is considered medically necessary provided the member is experiencing complications associated with bolus feedings OR meets medical necessity criteria for and is utilizing an in-line digestive enzyme cartridge (e.g., RELiZORB).

Pumps must meet applicable device requirements and are reimbursed per coding/capitated rental rules.

Food thickeners

Commercial or prescription food thickeners covered when ALL of the following apply:

Thickeners: i. A clinical feeding/swallowing evaluation of the member has been conducted by a specialist (e.g., speech-language pathologist, occupational therapist); ii. Ongoing complicated feeding issues (e.g., dysphagia, swallowing dysfunction); iii. Non-commercial means of thickening food (e.g., cereals, fruit or vegetable purees) have proven unsuccessful, are contraindicated (e.g., allergy, intolerance, sensitivity), or are inappropriate.

Note exclusions for Medicare members (see coding/exclusions).

Amino acid-based infant formulas

Covered when ALL of the following apply:

Amino acid formulas (infant): Member is 24 months of age or younger; AND documented allergy to cow's milk; AND documented soy formula intolerance; AND documented multiple protein intolerance; AND the 100% hydrolyzed amino acids nutritional formula being administered is the primary source of nutrition; AND formula is recommended by a Pediatric Allergist, Pediatric Pulmonologist or Pediatric Gastroenterologist.

Formulas for inborn errors of metabolism

Formulas to treat specific inborn errors of metabolism are covered when ALL of the following apply:

IEM formulas: a. The formula is a medical food labeled and used for the dietary management of an inborn error of metabolism (IEM) that interferes with the metabolism of specific nutrients (e.g., PKU, Homocystinuria, Maple Syrup Urine Disease); AND b. Nutrition is ordered and managed by a team including a board-certified clinical or medical biochemical geneticist and a metabolic dietician.

When criteria are met, medical necessity for IEM formulas is not limited by age, weight, or laboratory values; select OTC metabolic products may be used when prescription products are unavailable if formulated solely for the IEM.

In-line digestive enzyme cartridge (RELiZORB)

Digestive enzyme cartridges (RELiZORB) are medically necessary when ALL of the following apply:

RELiZORB criteria: a. Criteria for enteral nutritional therapy via a tube have been met; b. Member has a clinical diagnosis characterized by inability to absorb and/or properly digest/metabolize/hydrolyze fats (examples: exocrine pancreatic insufficiency, cystic fibrosis); c. RELiZORB is to be used in conjunction with enteral feeding; d. RELiZORB is NOT being used with incompatible formulas containing insoluble fiber or food particulates (examples: Nutren 1.0 with Fiber; Jevity; Glucerna; Compleat/Compleat Pediatric; PediaSure Harvest); e. RELiZORB is NOT being used with a gravity feed system; f. RELiZORB is being used with an enteral tube feeding pump that has a low flow/no flow alarm (examples listed in policy).Single cartridge up to 500 mL; two cartridges may be used in tandem for >500 mL up to 1000 mL; up to two cartridges per 24-hour period.

Medical necessity and prior authorization

Coverage is determined based on medical necessity and member-specific benefits; prior authorization required when specified.

General coverage logic: Coverage requires that the service/item be medically necessary and within the member's specific benefits. Prior authorization documentation must demonstrate medical necessity when required; experimental or investigational items require review by a Priority Health medical director or clinical pharmacist and may be allowed only in specified severe/terminal circumstances.

See coding section for eligible HCPCS; ICD-10 codes not specified in this section.

Labeling expansion

Coverage implications related to labeling change:

Labeling-based coverage: Device labeling for digestive enzyme (lipase) cartridges has expanded to include neonates and infants; coverage determinations should consider the labeled population.none

Document patient age and clinical indication when requesting coverage; no additional age threshold provided in this section.

The policy excludes coverage for certain non‑medical foods and equipment. Specifically, storage units (for example, refrigerators and freezers) are excluded. Also considered not medically necessary — whether taken orally or via tube — are routine infant formulas typically fed to healthy full‑term infants (e.g., Similac Advance, Enfamil Infant), partially hydrolyzed infant formulas, lactose‑free formulas, formulas or supplements used for ketogenic diets (e.g., KetoCal, RCF) except when standard enteral therapy criteria are met, non‑prescription nutritional supplements (e.g., Ensure), and baby food or other grocery products blenderized for enteral use.

For Priority Health Medicare members, the HCPCS code B4100 (food thickener, administered orally, per oz) is specifically listed as not covered and does not require prior authorization.

This portion of the document does not add any additional exclusions beyond those already enumerated elsewhere in the policy.

The policy identifies multiple specific formulas and products as not medically necessary because they are considered food rather than a medical therapy. Examples include routine infant formulas for healthy full‑term infants (cow’s milk, goat’s milk, or soy‑based products), partially hydrolyzed infant formulas intended to be easier to digest, lactose‑free infant formulas, ketogenic diet formulas or supplements used outside of established enteral therapy criteria, over‑the‑counter nutritional supplements (e.g., Ensure), and blenderized grocery baby foods prepared for enteral use.

Experimental, investigational, or unproven treatments and products are excluded from coverage unless an individual case review by a Priority Health medical director or clinical pharmacist grants an exception. Such exception review may be considered when the condition is terminal, chronic and life‑threatening, severely disabling, or causing serious clinical deterioration; prior plan approval is required for individual consideration.

No additional statements declaring items 'not medically necessary' are provided in this section of the document.

Codes, Billing Units, and Regulatory Listings

Regulatory device 510(k)/PMA numbers listedmixed

K232205	Vesco Q™ Enteral Feeding Pump (510(k)/PMA/De Novo number as listed)
K221603	Kangaroo™ OMNI Enteral Feeding Pump (510(k)/PMA/De Novo number as listed)
K220230	AMSure® Enteral Feeding Pump (510(k)/PMA/De Novo number as listed)

CPT/HCPCS CodesHCPCS

B4034	Enteral feeding supply kit; syringe, per day
B4035	Enteral feeding supply kit; pump fed, per day
B4036	Enteral feeding supply kit; gravity fed, per day
B4081	Nasogastric tubing with stylet (No PA required)
B4082	Nasogastric tubing without stylet (No PA required)
B4087	Gastrostomy/jejunostomy tube, standard, any material, any type, each (No PA required)
B4088	Gastrostomy/jejunostomy tube, low profile, any material, any type, each (No PA required)
B9998	NOC for enteral supplies
B9002	Enteral nutrition infusion pump - with alarm (Pumps are reimbursed as capped rental items)

Enteral formula and supply HCPCSHCPCS

B4100	Food thickener, administered orally, per oz (Not covered for Priority Health Medicare; no authorization required)
B4102	Enteral formula, for adults, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit
B4103	Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit
B4104	Additive for enteral formula (e.g., fiber)
B4105	In-line cartridge containing digestive enzyme(s) for enteral feeding, each
B4148	Enteral feeding supply kit; elastomeric control fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape
B4149	Enteral formula, manufactured blenderized natural foods with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit
B4150	Enteral formula, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit
B4152	Enteral formula, nutritionally complete, calorically dense (equal to or greater than 1.5 kcal/ml) with intact nutrients, 100 calories = 1 unit
B4153	Enteral formula, nutritionally complete, hydrolyzed proteins (amino acids and peptide chain), 100 calories = 1 unit

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FDA device listings (examples)mixed

Multiple K and device identifiers

FDA premarket (510(k)/De Novo/PMAs) listings for enteral pumps, feeding sets, PEG kits, extension sets and tubes (examples listed in regulatory section)

Supporting ICD-10ICD-10

ICD-10

ICD-10 codes not specified; see medical necessity criteria

No explicit codes listed in this partmixed

No codes listed

RELiZORB cartridge volume limit — INV-21

Single-cartridge volume limitA single RELiZORB cartridge may be used for up to 500 mL of enteral formula.

Tandem use for larger volumesFor volumes greater than 500 mL and up to 1000 mL, two RELiZORB cartridges may be connected in tandem.

Daily cartridge maximumUp to two RELiZORB cartridges may be used in a 24-hour period; no minimum interval between uses is required.

Enteral formula billing unit — INV-22

Standard enteral formula billing unit100 calories = 1 billing unit for most enteral formulas (per HCPCS B4149, B4150, B4152, etc.).

Clear-fluid formula volume-based unitFor clear-fluid enteral formulas used to replace fluids/electrolytes (adult/pediatric), 500 mL = 1 unit (HCPCS B4102, B4103).

Applies across pediatric and adult formulasThe 100 calories = 1 unit rule is applied to multiple formula categories including nutritionally complete, hydrolyzed, and metabolic formulas as listed in HCPCS group.

Age limitation — INV-23

Prior age limit statusThe previous 1-year minimum age limitation for digestive enzyme (lipase) cartridges has been removed.

Labeling change implicationDevice labeling has expanded to include neonates and infants, informing coverage and authorization decisions.

Operational effectClaims denials based solely on a prior 1-year age minimum may now be inappropriate and should be reconsidered with updated labeling.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required when coverage depends on medical necessity criteria being met. Providers must submit a prior authorization request demonstrating that enteral therapy, digestive enzyme cartridges (e.g., RELiZORB), pumps, or other related devices/services meet the medical necessity criteria in Section I and other applicable sections of this policy. Refer to the Priority Health Provider Manual for submission instructions and plan-specific requirements.

Affected items may include enteral digestive enzyme cartridges (RELiZORB), enteral feeding pumps, and select enteral formulas when coverage is contingent on documented medical necessity.

Documentation Required

Required Documentation for Prior Authorization

Providers must include documentation showing a functioning gastrointestinal tract with inability to maintain weight/strength and that the enteral solution/formula is the primary source of nutrition. For RELiZORB or other lipase cartridges, submit clinical diagnosis demonstrating inability to absorb/digest fats (e.g., exocrine pancreatic insufficiency, cystic fibrosis), confirmation that incompatible formulas or gravity feeds will not be used, and that a pump with low flow/no flow alarm will be used.

Documentation that enteral nutrition criteria (Section I) are met
Clinical diagnosis supporting fat malabsorption or pancreatic insufficiency
Specification of formula to be used and confirmation it is compatible with the cartridge (no insoluble fiber/food particulates)
Confirmation pump (with low/no-flow alarm) will be used and RELiZORB will not be used with gravity feeds
Provider specialty notes where applicable (e.g., pediatric gastroenterologist, metabolic dietician)

Denial Risk

Denial Triggers

Coverage may be denied if required prior authorization and supporting medical necessity documentation are not submitted, or if the item requested falls under exclusions (e.g., routine infant formulas, storage units, grocery foods, non-prescription nutritional supplements, incompatible formulas, or use with gravity feed systems). Requests that do not demonstrate the formula is the primary source of nutrition or that fail to document relevant diagnoses may also be denied.

Common denial triggers: missing prior authorization request or incomplete medical necessity documentation
Use of excluded products (routine infant formulas, baby food, grocery items, non-prescription supplements)
Requests to use RELiZORB with incompatible formulas (e.g., Nutren® 1.0 with Fiber, Jevity®, Compleat®) or with gravity feed systems

Denial Risk

Age-based Denial Risk — Updated Labeling for Lipase Cartridges

Labeling for digestive enzyme (lipase) cartridges has expanded to include neonates and infants; Priority Health removed the previous 1-year minimum age limitation accordingly. Do not deny coverage solely on the basis of age when the request documents the clinical indication and meets medical necessity criteria. When requesting coverage for lipase cartridges for neonates/infants, explicitly document patient age and the clinical indication tied to fat malabsorption.

Document patient age and clinical indication when requesting coverage for lipase cartridges
Do not apply a 1-year minimum age exclusion for RELiZORB — coverage decisions must reflect updated labeling
If age-based denials are encountered, request reconsideration with documentation of labeling change and clinical necessity

Background and Rationale

Enteral nutrition delivers nutrients via a tube into the stomach or small intestine (for example, nasogastric or gastrostomy tubes). When feasible, enteral nutrition is preferred over parenteral nutrition because it preserves gut integrity and function and is associated with fewer complications; the enteral solution or formula must be the member’s primary source of nutrition and the member must have a functioning gastrointestinal tract but be unable to maintain weight and strength by oral intake alone.

Key Definitions

Enteral nutrition — INV-37

DefinitionEnteral nutrition: nutrition provided through a tube (e.g., nasogastric, gastrostomy, jejunostomy) into the stomach or small intestine.

Clinical preferenceEnteral feeding is preferred over parenteral feeding when feasible due to fewer serious complications and preservation of gut integrity.

Common delivery routesTypical delivery routes include nasogastric, gastrostomy and jejunostomy tubes.

RELiZORB — INV-38

Device descriptionRELiZORB is a single-use, point-of-care in-line immobilized lipase cartridge that connects with enteral feeding pump tubing and patient extension sets or enteral feeding tubes to hydrolyze fats in enteral formulas.

Intended functionDesigned to mimic pancreatic lipase by hydrolyzing fats to allow delivery of absorbable fatty acids and monoglycerides during enteral feeding.

Use constraintsNot intended for use with gravity feed systems and must be used with enteral pumps that have low flow/no flow alarms; incompatible with formulas containing insoluble fiber or particulates as listed.

Enteral nutrition practice guidelines — INV-39

ASPEN guidanceAmerican Society for Parenteral and Enteral Nutrition (ASPEN) enteral nutrition practice recommendations and safe practices for enteral nutrition therapy are referenced.

ESPEN guidanceEuropean Society for Parenteral and Enteral Nutrition (ESPEN) practical and home enteral nutrition guidelines are cited for practice recommendations.

ESPNIC guidanceEuropean Society of Pediatric and Neonatal Intensive Care (ESPNIC) position statement on nutritional support for children during critical illness is cited.

Lipase cartridge — INV-40

General definitionLipase cartridge: a single-use digestive enzyme cartridge (example: RELiZORB) that hydrolyzes fats in enteral formulas during pump-assisted feeding.

Example productRELiZORB (Alcresta Therapeutics) is provided as the illustrative example of an immobilized lipase cartridge in this policy.

Compatibility noteThese cartridges are incompatible with certain formulas containing insoluble fiber or particulates and are not for gravity feeds.

Policy Revision History and Changes

2026-06-01effective_dateLatest

Policy effective date reflecting updated coverage language and removal of the prior 1-year age limitation for digestive enzyme (lipase) cartridges following labeling expansion.

2025-05-13committee_review

Policy reviewed by committee (listed among past committee review dates) as of May 2025.

2024-05-13committee_review

Policy reviewed by committee (listed among past committee review dates) as of May 2024.

2023-05-13committee_review

Policy reviewed by committee (listed among past committee review dates) as of May 2023.

2020-08-01committee_review

Policy reviewed by committee (listed among past committee review dates) as of August 2020.

1993-01-01committee_review

One of the earliest recorded committee review dates listed (January 1993).

2025-05-13material_change

Labeling for digestive enzyme (lipase) cartridges (e.g., RELiZORB) expanded to include neonates and infants and the prior 1-year age limitation was removed, constituting a material change to coverage determinations.