Capital Bluecross Enteral Nutrition Coverage Update

Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met

Enteral feeding via tube: When administration of an enteral feeding requires the use of a nasogastric, jejunostomy, or gastrostomy tube, the enteral nutrition product and all related equipment and supplies are considered medically necessary.

Oral enteral feeding proportion: Enteral feedings when administered by mouth are considered medically necessary when the enteral nutrition product provides 50% or more of total nutritional intake.>=50% of total nutritional intake

Relizorb for cystic fibrosis: Digestive enzyme cartridges (e.g., Relizorb) which connect to enteral feeding tubes for hydrolysis of fats in enteral formula are considered medically necessary for individuals who require enteral feedings due to a diagnosis of cystic fibrosis AND are ages 1 year or above.age >= 1 year

Mandated hereditary disorders: Per Act 191-1997, enteral formulas administered by mouth or through the feeding tube are considered medically necessary for any one of: branched-chain ketonuria, galactosemia, homocystinuria, phenylketonuria (PKU).

Amino acid-based elemental formulas for infants/children: As set forth in Act 158 of 2014, amino acid-based elemental medical formulas (100% free amino acids) may be considered medically necessary when ordered by a physician and administered orally or enterally for infants and children for food protein allergies, food protein-induced enterocolitis syndrome, eosinophilic disorders, or short bowel syndrome after both breast milk (if available) AND hydrolyzed formulas have not been tolerated.failure of breast milk and hydrolyzed formulas

Relizorb (digestive enzyme cartridge)

Relizorb (digestive enzyme cartridge) coverage stance and clinical indications

Coverage status and history: Relizorb (in-line digestive enzyme cartridge) was changed from not medically necessary to medically necessary with criteria on 03/28/2024; HCPCS code B4105 was updated from not covered to medically necessary.

Current age threshold: Relizorb is considered medically necessary only for individuals aged 1 year or older (age criterion changed from 2 to 1 year on 03/20/2025).age >= 1 year

Clinical indication: Relizorb is considered medically necessary for individuals who require enteral feedings due to a diagnosis of cystic fibrosis (see ICD-10 codes E84.*) and who require enteral feeding by any route with persistent symptoms despite regular oral pancreatic enzyme replacement therapy when applicable.

Coding:

Mandated Enteral Nutrition and Amino Acid-based Formula Coverage — criteria summary

Mandated and amino acid-based elemental formula coverage

Mandated (Act 191): Per Act 191 (effective June 20, 1997), enteral formulas administered by mouth or through the feeding tube are medically necessary for any one of: branched-chain ketonuria, galactosemia, homocystinuria, or phenylketonuria (PKU).ICD-10 codes listed

Mandated procedure codes: Procedure codes associated with mandated enteral nutrition include B4157 and related codes (policy lists B4162, S9433–S9435, etc.) and procedure codes B4153 and B4161 are listed in the policy procedure code section.

Amino acid-based elemental formulas (Act 158): As set forth in Act 158 of 2014, amino acid-based elemental medical formulas (100% free amino acids) may be considered medically necessary when ordered by a physician and administered orally or enterally for infants and children for conditions such as eosinophilic gastrointestinal disorders, food protein-induced enterocolitis syndrome, postsurgical malabsorption, and specified food allergies (ICD-10 codes enumerated in the policy).ICD-10 codes listed

The presence of a procedure or billing code in the coding section does not by itself indicate that the service is covered. Coverage determinations are made according to the member's benefit plan; therefore, providers must verify eligibility and coverage under the applicable benefit program. In addition, not all services that may be covered are eligible for separate reimbursement.

For non‑mandated enteral nutrition, the policy does not list specific diagnostic requirements. There are no specific diagnoses enumerated as indications for non‑mandated enteral nutrition in this section; coverage for these items should be determined based on member benefits and clinical documentation.

Available evidence for in‑line digestive enzyme cartridges (for example, Relizorb) shows improvements in fat absorption and clinical measures in small studies, including a randomized crossover trial and observational reports; however, the literature is limited by a lack of large randomized controlled trials. Cartridges deliver immobilized lipase and thus may not fully replace oral pancreatic enzyme replacement therapy (PERT), and their benefits should be considered within that context.

Prior to the policy change recorded on 03/28/2024, in‑line digestive enzyme cartridges (Relizorb) were listed as not medically necessary. This prior status is noted in the policy history and may explain earlier prior‑authorization denials before the coverage criteria were revised.

Policy Coding and Diagnosis Codes

Covered when Medically Necessary: enteral supplies and home therapy servicesmixedCovered

B4148	Enteral supplies/home therapy services (listed as covered when medically necessary in policy)
B4035	Procedure code referenced in coding list
B4036	Procedure code referenced in coding list
B4081	Procedure code referenced in coding list
B4082	Procedure code referenced in coding list
B4083	Procedure code referenced in coding list
B4087	Procedure code referenced in coding list
B4088	Procedure code referenced in coding list

Digestive enzyme cartridge (Relizorb)ProcedureCovered

B4105

Digestive enzyme cartridge (Relizorb)

Covered / listed procedure codes (policy coding tables)HCPCS

B4148	Procedure code listed in policy (new code added 10/01/2023)
B4105	Relizorb digestive enzyme cartridge

Non-mandated Enteral NutritionHCPCS

B4149

Non-mandated enteral nutrition procedure code (includes B4150, B4152, B4154, B4155, B4158, B4159, B4160)

Mandated Enteral Nutrition / Amino acid-based formula codesHCPCS

B4157	Mandated Enteral Nutrition (Act 191) code (includes B4162, S9433, S9434, S9435)
B4153	Amino acid-based elemental medical formula code
B4161	Amino acid-based elemental medical formula code

ICD-10 IndicationsICD-10

E84.0	Cystic fibrosis with pulmonary manifestations
E84.1	Cystic fibrosis with intestinal manifestations
E84.11	Meconium ileus in cystic fibrosis
E84.19	Cystic fibrosis with other intestinal manifestations
E84.8	Cystic fibrosis with other manifestations
E84.9	Cystic fibrosis, unspecified
E71.0	Maple-syrup-urine disease
E71.110	Isovaleric acidemia
E71.120	Methylmalonic acidemia
K20.0	Eosinophilic esophagitis

1–10 of 12

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Minimum age for Relizorb use

Minimum age for Relizorb use>= 1 year

Policy change date to MNRelizorb changed from not medically necessary to medically necessary on 03/28/2024

Age criterion historyAge criterion lowered from 2 years to 1 year on 03/20/2025

Provider Actions, Prior Authorization & Documentation

Documentation Required

Coverage subject to benefit program

Coverage under this policy is subject to member benefit program variations. Identification of codes or services in this section does not guarantee coverage — benefits, prior authorization requirements, and reimbursement eligibility are determined by the member's specific Capital BlueCross product and benefit plan.

Coverage may vary by product/program (see Section VI/Product Variations historically; note: Product Variations language was removed 07/10/2025 administrative update — confirm current member benefits).

Denial Risk

Denial risk for Relizorb prior to 03/28/2024

Relizorb (digestive enzyme cartridge) had a historical denial risk prior to 03/28/2024 when it was classified as not medically necessary. Claims or prior authorization requests dated before 03/28/2024 for Relizorb may have been denied under the prior policy position.

Background and Context

Enteral nutrition provides specialized formulas and medical foods by mouth or directly into the gastrointestinal tract when oral intake is inadequate or not possible. It is used for conditions that require tailored nutritional management — for example, certain hereditary metabolic disorders and disorders causing malabsorption such as cystic fibrosis or exocrine pancreatic insufficiency. In‑line digestive enzyme cartridges (e.g., Relizorb) are designed to deliver immobilized lipase into the enteral feeding circuit to aid fat hydrolysis during tube feeding.

Key Definitions

Enteral feeding

DefinitionProvision of nutrition using special enteral formula administered by mouth or through a gastrointestinal tube (short-term: nasogastric, nasoduodenal, nasojejunal; long-term: percutaneous gastrostomy or jejunostomy).

Short-term vs Long-termShort-term enteral tube feedings: nasogastric, nasoduodenal, nasojejunal; Long-term: percutaneous gastrostomy or jejunostomy.

Administration routesCan be provided orally or via tubes placed into the gastrointestinal tract.

Medical Food

FDA definition (Orphan Drug Act)A food formulated to be consumed or administered enterally under physician supervision for dietary management of a disease with distinctive nutritional requirements (21 U.S.C. 360ee(b)(3)).

Minimum product criteria

Policy Changes and Revision History

2025-07-10administrative_updateLatest

Removed Benefit Variations section and updated Disclaimer (administrative).

2025-03-20policy_change

Lowered minimum age criterion for Relizorb from 2 years to 1 year and updated rationale and coding tables.

2024-03-28policy_change

Changed Relizorb status from not medically necessary to medically necessary with clinical criteria; updated rationale and references and changed B4105 from not covered to medically necessary.