DraftCapital BluecrossPolicy MP 2.015

Enteral Nutrition (including enteral formulas, medical foods, and digestive enzyme cartridges)

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Defines medical necessity and coverage stance for enteral nutrition products (oral and tube-fed), related equipment and supplies, and in-line digestive enzyme cartridges (e.g., Relizorb) for applicable Capital BlueCross products.

Policy Summary

PayerCapital Bluecross

PolicyEnteral Nutrition (including enteral formulas, medical foods, and digestive enzyme cartridges)

Policy CodePolicy MP 2.015

Change TypeCoverage status revised for Relizorbcoding additions

Effective Date9/1/2025

Last ReviewJul 10, 2025

Next Review Date

Key ActionWhen requesting authorization, use the HCPCS codes listed in the policy (e.g., B4105, B4148) and document that patient meets age and clinical criteria for Relizorb.

SourceLink

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DraftCapital BluecrossPolicy MP 2.015

Enteral Nutrition (including enteral formulas, medical foods, and digestive enzyme cartridges)

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Sign up for Capital Bluecross Policy MP 2.015 alerts

Get alerted when Policy MP 2.015 changes without checking for updates manually.

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Policy Summary

PayerCapital Bluecross

PolicyEnteral Nutrition (including enteral formulas, medical foods, and digestive enzyme cartridges)

Policy CodePolicy MP 2.015

Change TypeCoverage status revised for Relizorbcoding additions

Effective Date9/1/2025

Last ReviewJul 10, 2025

Next Review Date

Key ActionWhen requesting authorization, use the HCPCS codes listed in the policy (e.g., B4105, B4148) and document that patient meets age and clinical criteria for Relizorb.

SourceLink

POLICY UPDATE CHANGES

Changed Relizorb (digestive enzyme cartridge) coverage stance from not medically necessary to medically necessary with criteria.

Added new HCPCS code B4148 (effective 10/01/2023) and updated coding tables.

Changed age criterion for Relizorb from 2 years to 1 year.

Benefit Variations Section was removed in an administrative update.

9/1/2025Effective date

Act 191 & 158State statutes referenced

1 yr+Minimum age for Relizorb

multipleHCPCS codes referenced

Coverage Criteria for Enteral Nutrition and Digestive Enzyme Cartridges

Non-Mandated Enteral Nutrition / Relizorb

Covered when ALL of the following are met

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

Relizorb for cystic fibrosis: Digestive enzyme cartridges (e.g., Relizorb) that connect to enteral feeding tubes for hydrolysis of fats are 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 Enteral Nutrition

Mandated coverage under Act 191-1997 and Act 158-2014

Hereditary genetic disorders (Act 191-1997): Enteral formulas administered by mouth or through a feeding tube are considered medically necessary for treatment of branched-chain ketonuria, galactosemia, homocystinuria, or phenylketonuria (PKU).

Amino acid-based elemental formulas (Act 158-2014): Amino acid–based elemental medical formulas (100% free amino acids) may be 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.

Medically Necessary: Digestive enzyme cartridge (Relizorb)

Relizorb (digestive enzyme cartridge) is considered medically necessary when ALL of the following are met:

Relizorb MN criteria: Patient has a diagnosis associated with fat malabsorption such as cystic fibrosis (ICD-10 codes listed in policy) AND is receiving enteral tube feeding; patient meets minimum age requirement of >= 1 year; clinical documentation supports need for an inline digestive enzyme cartridge due to inability to tolerate or absorb enteral fats with standard therapy (e.g., persistent malabsorption despite pancreatic enzyme replacement therapy).age >= 1 year

Policy history: Relizorb coverage stance changed from not medically necessary to medically necessary with clinical criteria; age criterion lowered to >=1 year.

Mandated Coverage (Act 191)

Enteral nutrition items mandated by Pennsylvania Act 191 are covered for specified diagnoses:

Act 191 mandated diagnoses: Enteral formulas are medically necessary for any one of the following hereditary metabolic disorders as enumerated in Act 191: branched-chain ketonuria, galactosemia, homocystinuria, or phenylketonuria (PKU) — specific ICD-10-CM codes are listed in the policy (e.g., E70.0; E71.x series; E72.11; E74.x series).ICD-10 specific codes listed

Medically Necessary: Amino acid–based elemental formulas (Act 158)

Amino acid–based elemental formulas (Act 158) are covered when the member has one of the listed indications:

Act 158 indications: Amino acid–based elemental medical formulas (100% free amino acids) are medically necessary when ordered by a physician and administered orally or enterally for diagnoses including eosinophilic gastrointestinal diseases, food protein–induced enterocolitis syndrome, postsurgical malabsorption (short bowel), or documented food allergies (ICD-10-CM codes listed in the policy).ICD-10 specific codes listed

Procedure codes B4153 and B4161 are used to report amino acid–based elemental formulas.

The presence of a procedure or HCPCS code in this policys coding tables does not by itself guarantee coverage or payment. Final claim adjudication is subject to the members specific benefit plan, eligibility on the date of service, and any applicable limitations or exclusions in the members contract. Providers should verify benefits and prior authorization requirements for the members product before delivering or billing for enteral nutrition products and related supplies.

For the listed non-mandated enteral nutrition HCPCS codes, this policy does not require a specific diagnosis code for coverage determination. The policy explicitly states that "There are no specific diagnoses" required for the non-mandated enteral nutrition codes identified in the coding section.

Available randomized controlled trial data for in-line digestive enzyme cartridges (e.g., Relizorb) are limited. The ASSURE study and a 2017 randomized crossover trial demonstrated improved fatty acid absorption and some symptom benefits, but the evidence base lacks large RCTs. Because cartridges deliver only immobilized lipase, they may not completely eliminate the need for oral pancreatic enzyme replacement therapy (PERT) in affected patients.

Policy history shows that earlier versions classified in-line digestive enzyme cartridges (Relizorb) as not medically necessary. The historical entry for 02/11/2022 documents a policy change at that time listing in-line digestive enzyme cartridges as not medically necessary prior to subsequent revisions.

Coding: HCPCS, CPT, and Diagnosis Codes

Covered when Medically Necessary (enteral supplies and home therapy services)HCPCSCovered

B4148
B4035
B9002
B4036
B9998
B4081
S9340
B4082
S9341
B4083

1–10 of 14

1/2

Covered when Medically Necessary (enteral supplies and home therapy services) - alternate mapping styleHCPCSCovered

B4148
B4035
B9002
B4036
B9998
B4081
S9340
B4082
S9341
B4083

1–10 of 14

1/2

Digestive enzyme cartridge (Relizorb)HCPCSCovered

B4105

Digestive enzyme cartridge (Relizorb)HCPCSCovered

B4105

General enteral nutrition HCPCS mappingsHCPCS

B4148	HCPCS code listed in policy (new code added 10/01/2023)
B4035	Mapped in table
B9002	Mapped in table
B4036	Mapped in table
B9998	Mapped in table
B4081	Mapped in table / S9340
B4082	Mapped in table / S9341
B4083	Mapped in table / S9342
B4087	Mapped in table / S9343
B4088	Mapped in table

General enteral nutrition HCPCS mappingsHCPCS

B4148	HCPCS code listed in policy (new code added 10/01/2023)
B4035	Mapped in table
B9002	Mapped in table
B4036	Mapped in table
B9998	Mapped in table
B4081	Mapped in table / S9340
B4082	Mapped in table / S9341
B4083	Mapped in table / S9342
B4087	Mapped in table / S9343
B4088	Mapped in table

Relizorb / digestive enzyme cartridgeHCPCSCovered

B4105

Digestive enzyme cartridge (Relizorb) — code historically not covered, later changed to medically necessary with criteria

Relizorb / digestive enzyme cartridgeHCPCSCovered

B4105

Digestive enzyme cartridge (Relizorb) — code historically not covered, later changed to medically necessary with criteria

Non-mandated Enteral NutritionHCPCS

B4149	Non-mandated enteral nutrition
B4150	Non-mandated enteral nutrition
B4152	Non-mandated enteral nutrition
B4154	Non-mandated enteral nutrition
B4155	Non-mandated enteral nutrition
B4158	Non-mandated enteral nutrition
B4159	Non-mandated enteral nutrition
B4160	Non-mandated enteral nutrition

Non-mandated Enteral NutritionHCPCS

B4149	Non-mandated enteral nutrition
B4150	Non-mandated enteral nutrition
B4152	Non-mandated enteral nutrition
B4154	Non-mandated enteral nutrition
B4155	Non-mandated enteral nutrition
B4158	Non-mandated enteral nutrition
B4159	Non-mandated enteral nutrition
B4160	Non-mandated enteral nutrition

Amino acid-based / elemental formula codesHCPCSCovered

B4153	Amino acid–based elemental medical formula reporting (Act 158)
B4161	Amino acid–based elemental medical formula reporting

Amino acid-based / elemental formula codesHCPCSCovered

B4153	Amino acid–based elemental medical formula reporting (Act 158)
B4161	Amino acid–based elemental medical formula reporting

ICD-10-CM diagnosis codes (Relizorb, Act 191/158, and amino-acid formula indications)ICD-10Covered

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
E70.0	Classical phenylketonuria
E71.0	Maple-syrup-urine disease
E71.110	Isovaleric acidemia
E71.111	3-methylglutaconic aciduria

1–10 of 30

1/3

ICD-10-CM diagnosis codes (Relizorb, Act 191/158, and amino-acid formula indications)ICD-10Covered

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
E70.0	Classical phenylketonuria
E71.0	Maple-syrup-urine disease
E71.110	Isovaleric acidemia
E71.111	3-methylglutaconic aciduria

1–10 of 30

1/3

Minimum patient age for Relizorb

Minimum patient age>= 1 year

Policy change historyAge criterion changed from 2 to 1 year (03/20/2025).

Applicable deviceRelizorb (digestive enzyme cartridge) — see HCPCS mappings and coding tables.

Provider Actions, Authorization, and Billing Guidance

Prior Authorization

Check product-specific benefit variations and prior authorization rules

This policy applies only to certain Capital Blue Cross programs and products; benefit variations may exist and members/providers should consult product-specific manuals (for example, FEP PPO refers to the FEP Medical Policy Manual) to determine prior authorization requirements and coverage rules.

See product-specific manuals (e.g., FEP Medical Policy Manual) for program-specific prior authorization rules.

Billing Rule

Use the policy-listed HCPCS codes when requesting authorization

When requesting authorization or submitting claims, use the HCPCS procedure codes listed in the policy for the specific enteral nutrition items or devices; the policy maps Relizorb and enteral supply codes (e.g., B4105, B4148, B4153, B4159, B4161) and these codes should be billed as indicated.

Definitions

Enteral feeding

DefinitionProvision of nutrition via special enteral formula either by mouth or through a tube placed into the gastrointestinal tract, including short-term nasogastric, nasoduodenal, nasojejunal and long-term percutaneous gastrostomy or jejunostomy.

Routes of administrationOral or tube (nasogastric, nasoduodenal, nasojejunal, percutaneous gastrostomy/jejunostomy).

Indications (general)Used when patients cannot meet nutritional needs by regular diet or require supplemental/sole source nutrition.

Medical Food

Definition (FDA)Food formulated to be consumed or administered enterally under physician supervision for the dietary management of a disease or condition with distinctive nutritional requirements (per 21 U.S.C. 360ee(b)(3)).

Use setting

Background

Enteral nutrition provides specialized formulas or medical foods administered orally or via a feeding tube when patients cannot meet nutritional needs by regular diet. These products are used to support caloric and nutrient requirements in conditions such as rare hereditary metabolic disorders, exocrine pancreatic insufficiency (including cystic fibrosis), and other disorders where oral intake is inadequate or absorption is impaired.

Policy Summary

PayerCapital Bluecross

PolicyEnteral Nutrition (including enteral formulas, medical foods, and digestive enzyme cartridges)

Policy CodePolicy MP 2.015

Change TypeCoverage status revised for Relizorbcoding additions

Effective Date9/1/2025

Last ReviewJul 10, 2025

Next Review Date

Key ActionWhen requesting authorization, use the HCPCS codes listed in the policy (e.g., B4105, B4148) and document that patient meets age and clinical criteria for Relizorb.

SourceLink

On This Page

Bill Relizorb and related enteral supplies using the HCPCS codes enumerated in the coding section.
Ensure the code used matches the device or supply per the policy mapping.

Step Therapy

Sequence therapy after documented trial of oral PERT

Relizorb may be considered only for patients who require enteral feeding and continue to have persistent symptoms despite regular oral pancreatic enzyme replacement therapy (PERT); document prior use of and response to oral PERT when seeking authorization.

Document that the patient requires enteral feeding by any route and has persistent symptoms despite regular oral PERT.
Provide clinical evidence (e.g., fecal elastase testing) supporting exocrine pancreatic insufficiency when available.

Note

Digestive enzyme cartridge coverage indications

(No additional provider action specified in source)

Documentation Required

Verify eligibility, benefits, and medical necessity before treatment

Verify the member’s eligibility, specific benefit plan, and medical necessity prior to providing services; final claim payment is determined by the member’s benefit program, eligibility on the date of service, and medical necessity determination.

Confirm benefits and prior authorization requirements with the member’s product prior to service.
Final claim processing is subject to the terms and contract that apply to the member’s benefit program.

Billing Rule

Apply the policy’s HCPCS coding and map to documented indication

Use the appropriate HCPCS procedure code(s) from the policy’s coding table on claims (examples include B4105, B4148, B4153, B4159, B4161) and ensure the code maps to the applicable indication per the policy.

Select HCPCS codes that correspond to the item or formula provided as listed in the coding section.
Map the billed code to the documented diagnosis/indication in the medical record.

Denial Risk

Risk of denial if services fall outside member benefits or eligibility

Coverage and payment may be denied if the service is not covered under the member’s benefit plan, if the member is not eligible on the date of service, or if the service is not determined to be medically necessary.

Presence of a code in the policy’s coding section does not guarantee coverage; check member-specific benefits.
Claims may be denied if medical necessity is not supported by documentation.

Denial Risk

Denial risk for codes previously listed as not covered (e.g., Relizorb/B4105)

Codes that were previously listed as not covered (for example, Relizorb mapping B4105 historically placed in a non-covered table) may still be denied unless the claim meets the updated medical necessity criteria in this policy; ensure documentation meets the current MN criteria before billing.

If billing a code previously listed as not covered, include documentation demonstrating the patient meets the policy’s current medical necessity criteria.
Review policy history—Relizorb and B4105 were moved from not covered to medically necessary with criteria in the policy updates.

Administered orally or via enteral tube as part of medical management under physician order.

ExamplesMedical foods used when standard diet or formulas do not meet disease-specific nutritional needs.

Relizorb / digestive enzyme cartridge

Device descriptionAn inline digestive enzyme cartridge (Relizorb) intended to hydrolyze fats in enteral formula to improve fat absorption for patients with exocrine pancreatic insufficiency or other fat malabsorption conditions.

Clinical useUsed inline with enteral tube feeds for individuals receiving enteral nutrition, with coverage criteria tied to diagnoses (e.g., cystic fibrosis) and age thresholds.

Coding noteRelizorb historically mapped to HCPCS B4105 (updated to MN) and administrative addition of B4148 occurred 10/01/2023; see coding tables for current mappings.

Amino acid–based elemental formula

DefinitionAmino acid–based elemental medical formula: a specialized formula composed of free amino acids (100% amino acids) used for dietary management of conditions such as eosinophilic gastrointestinal diseases, food protein–induced enterocolitis syndrome, short bowel syndrome when breast milk/hydrolyzed formulas are not tolerated, and certain inborn errors of metabolism.

Mandated coverageThese formulas are included in Act 158 and may be medically necessary for infants and children when ordered by a physician for specified indications.

Reporting codesProcedure codes B4153 and B4161 are used to report amino acid–based elemental medical formulas (Act 158).