Premera Bluecross oral enteral nutrition Coverage

Coverage Criteria for Oral Enteral Nutrition and Related Devices

inv-01: Medically Necessary Indications

Oral enteral nutrition is considered medically necessary when ALL of the following are met for the listed indications:

Core covered indications: Oral enteral nutrition or supplements for treatment of inborn errors of metabolism (examples: histidinemia, homocystinuria, maple syrup urine disease [MSUD], phenylketonuria [PKU], tyrosinemia)

See ICD-10 examples in coding section

Documentation and ordering: A physician or other licensed healthcare provider must specifically order the product and the manner of administration, and the product must be used under the supervision of that provider

Physician order and supervision required per policy

Washington fully‑insured members - EGID: For WA fully‑insured members, elemental oral enteral formula may be considered medically necessary when ALL: diagnosis of an eosinophilic gastrointestinal disorder (e.g., eosinophilic esophagitis, eosinophilic gastroenteritis, or eosinophilic colitis); ordered by a physician/licensed provider; and use is supervised by that provider

State statute HB 2153 applies

inv-02: Not Covered / Excluded Products

Not covered / Exclusions

General exclusions: Oral enteral nutrition, specialized infant formulas, food and nutritional supplements are NOT covered for common conditions (including but not limited to: cow's milk allergy, food allergies, celiac disease, lactose intolerance, prematurity or low birth weight, protein or fat maldigestion) and non-prescription food/supplement items (e.g., baby food, banked breast milk for non‑hospitalized infants, grocery items, baby food, OTC vitamins, weight‑loss foods and formulas, gluten‑free food products, high protein powders, fluid and electrolyte replacements, fiber additives, food thickeners)

Contract language may vary; see member contract

inv-03: Digestive Enzyme Cartridge (Relizorb)

Special device/formulation coverage

In-line digestive enzyme cartridge (B4105): In-line digestive enzyme cartridge (HCPCS B4105, e.g., Relizorb) is considered medically necessary ONLY for individuals ≥ 5 years with cystic fibrosis and pancreatic insufficiency who have failed pancreatic enzyme replacement therapy (PERT)age >= 5 years

Investigational for all other indications

Other indications: Use of in-line digestive enzyme cartridges is considered investigational for any indication other than the specified cystic fibrosis pancreatic insufficiency population

Policy: investigational for other uses

inv-04: Clinical indications and product-specific stance

Policy documents clinical indications and special considerations for enteral formulas and related devices:

Enteral formula types and indications: Enteral formulas are classified as general (polymeric), semi-elemental, or hydrolyzed/elemental. Indications include malabsorption syndromes, inflammatory bowel disease, pancreatic insufficiency, short bowel syndrome, radiation enteritis, intolerance to normal nutrients, eosinophilic gastrointestinal disorders, and inborn errors of metabolism when specialized exclusion diets or formulas are required.

Elemental or semi-elemental feeds are indicated when polymeric feeds are not tolerated or in malabsorption/short bowel

Relizorb clinical evidence and regulatory stance: Relizorb is an in-line immobilized lipase cartridge intended to hydrolyze fats in enteral formula; it received De Novo classification in 2015 with subsequent 510(k) clearances through 2025. Large-scale adult trials are lacking and evidence is limited; supportive data include the ASSURE study (n=36 in CF) demonstrating improved fat absorption. Policy considers Relizorb medically necessary only in the CF pancreatic insufficiency population (see cartridge criteria) and investigational for other indications.

Not all enteral formulas are compatible with Relizorb; clinical benefit evidence is limited

This policy excludes coverage for routine food products and over-the-counter nutritional supplements that do not require a prescription. Examples of excluded items include baby food, normal grocery items, banked breast milk provided to a non-hospitalized infant, OTC vitamins and minerals, weight-loss foods and formulas, and other listed grocery/food supplements (e.g., gluten-free food products, high protein powders, food thickeners, and fluid and electrolyte replacements).

Physician supervision and a specific prescription are required for enteral medical foods and formulas to be considered for coverage, but a physician order alone does not automatically make a product payable. Contract benefit language may further restrict coverage; check the individual member contract and applicable state mandates (for example, Washington statutes) for exceptions.

Enteral formulas are regulated by the FDA as food supplements, not drugs, and therefore do not undergo the same premarket review as medications. As noted in the policy, many specialized enteral formulas lack prospective, randomized, controlled clinical trials demonstrating clinical benefit.

Because of these regulatory and evidence limitations, requests for specialized enteral products may require detailed physician documentation demonstrating distinctive nutritional requirements and physician supervision consistent with the Medical Food definition; absence of such documentation or robust supporting trials may result in denial.

In-line digestive enzyme cartridges (HCPCS B4105, e.g., Relizorb) are covered only for a limited clinical scenario: individuals aged ≥ 5 years with cystic fibrosis and pancreatic insufficiency who have failed pancreatic enzyme replacement therapy. Use of such cartridges is considered investigational for all other indications.

This policy therefore restricts routine use of cartridge-based digestive enzymes outside the specified cystic fibrosis indication and age threshold; requests for other uses should be expected to be denied as investigational.

Relizorb is an in-line immobilized lipase cartridge intended to mimic pancreatic lipase and hydrolyze fats in enteral formula. The device received FDA classification (De Novo) in 2015 with subsequent clearances, but large-scale randomized trials in adults are lacking.

Available clinical data include the ASSURE single-arm prospective study (n=36, mean age 13.8 years) in individuals with cystic fibrosis, which demonstrated improved markers of fat absorption (increased RBC and plasma DHA+EPA). The policy notes that while these results suggest potential benefit in cystic fibrosis, evidence remains limited and Relizorb did not have sufficient peer-reviewed adult data at the time of earlier reviews.

Billing and Diagnosis Codes

HCPCS/Healthcare procedure codesHCPCS

B4100	Food thickener, administered orally, per oz.
B4102	Enteral formula, for adults, used to replace fluids and electrolytes, 500 ml = 1 unit.
B4103	Enteral formula, for pediatrics, used to replace fluids and electrolytes, 500 ml = 1 unit.
B4104	Additive for enteral formula (e.g., fiber).
B4149	Enteral formula, manufactured blenderized natural foods with intact nutrients, 100 calories = 1 unit.
B4150	Enteral formula, nutritionally complete with intact nutrients, 100 calories = 1 unit.
B4152	Enteral formula, nutritionally complete, calorically dense (>=1.5 kcal/ml), 100 calories = 1 unit.
B4153	Enteral formula, nutritionally complete, hydrolyzed proteins, 100 calories = 1 unit.
B4154	Enteral formula, nutritionally complete, for special metabolic needs, excludes inherited disease of metabolism, 100 calories = 1 unit.
B4155	Enteral formula, nutritionally incomplete/modular nutrients, 100 calories = 1 unit.

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Covered diagnosis codes (examples) for metabolic and EGID and CFICD-10Covered

E70.0	Classical phenylketonuria (PKU)
E71.0	Maple syrup urine disease (MSUD)
E70.21	Tyrosinemia
E70.41	Histidinemia
E72.11	Homocystinuria
D81.810	Biotinidase deficiency
K20.0	Eosinophilic esophagitis
K52.81	Eosinophilic gastritis or gastroenteritis
K52.82	Eosinophilic colitis
E84.0	Cystic fibrosis with pulmonary manifestations

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Device product codemixed

PLQ	Product Code for Relizorb (device)

Diagnosis codes added in historyICD-10

E71.111

3-methylglutaconic aciduria (diagnosis code added May 2026)

Enteral formula billing unit — units definitions

Billing unit — standard enteral formulas100 calories = 1 unit for most B41xx HCPCS codes (e.g., B4149, B4150, B4152, B4153, B4154, B4155, B4157, pediatric B4158–B4162)

Billing unit — fluid replacement formulas500 mL = 1 unit for B4102 (adult fluid/electrolyte replacement) and B4103 (pediatric fluid/electrolyte replacement)

Billing unit — food thickenerB4100 billed per ounce as described in HCPCS listing

Billing unit — modular/ingredient productsModular nutrients and incomplete formulas (e.g., B4155) are also reported using 100 calories = 1 unit when applicable

Provider Requirements, Documentation, and Prior Authorization

Documentation Required

Physician order and clinical documentation required

Physician order and clinical documentation are required for enteral nutritional support and cartridge enzyme therapy. A physician (or other licensed prescriber where allowed by contract) must specifically order the product, route, and manner of administration. Physician supervision is defined as periodic assessment of nutritional status by a provider with prescriptive authority. A physician order alone does not guarantee coverage; the medical record must document that medical necessity criteria are met.

Physician must specifically order nutrients and manner of administration
Physician supervision = periodic assessment of nutritional status
Medical records must document that medical necessity criteria are met

Prior Authorization

Relizorb prior authorization and device coding

Prior authorization is required for Relizorb (immobilized lipase cartridge, HCPCS B4105) when used under the plan. Coverage for B4105 is limited: it is considered medically necessary only for individuals with cystic fibrosis meeting the policy criteria; all other indications are investigational. Submit diagnosis codes supporting cystic fibrosis and required clinical documentation with the authorization request. Use appropriate HCPCS and diagnosis coding when billing.

Key Definitions

Enteral nutrition — definition of enteral nutritional support

DefinitionEnteral nutrition: nutritional support delivered via the gastrointestinal tract, including oral feeding, sip feeding, or tube feeding (nasogastric, gastrostomy, jejunostomy)

Routes of administrationOral (by mouth), sip feeding, or enteral tube delivery to stomach or intestines

PurposeUsed when a patient cannot eat/swallow or cannot adequately digest or absorb nutrients from a regular diet

Inborn errors of metabolism — definition and significance for lifelong formula needs

DefinitionInborn errors of metabolism: rare genetic disorders in which the body cannot appropriately convert food into energy due to defects in metabolic enzymes

Clinical significanceUntreated disorders can lead to developmental delays, neurologic injury, and other medical problems; many are identified by newborn screening

Background and Evidence Summary

Enteral nutrition delivers nutrients via the gastrointestinal tract by oral, sip, or tube feeding when patients cannot safely eat, swallow, digest, or absorb ordinary diets. Products range from general (polymeric) feeds for patients with normal digestion to semi-elemental and elemental formulas for malabsorption or short-bowel conditions.

Specialized enteral formulas and medical foods are intended for specific clinical circumstances — for example, inborn errors of metabolism or eosinophilic gastrointestinal disorders (where state mandates may apply). Because many enteral formulas are regulated as food supplements, coverage is limited to clearly defined medical indications and requires physician prescription and supervision.

OpenPayer

Home Enteral (Oral) Nutritional Support and Specialized Formulas — Coverage Criteria

Coverage Criteria for Oral Enteral Nutrition and Related Devices

Billing and Diagnosis Codes

Provider Requirements, Documentation, and Prior Authorization

Key Definitions

Background and Evidence Summary