Infant Nutritional Formula

Coverage Summary

Scope: Medical Coverage Policy: 0136 defines medical necessity and coverage for oral and enteral infant nutritional formulas for infants (≤12 months) when the formula is specifically formulated for the treatment of inborn errors of metabolism (IEM). It provides coding guidance (HCPCS and ICD-10), exclusions for other indications, and documentation requirements for providers.

Overview: Subject: Infant Nutritional Formula. Status: CURRENT. Policy number: Medical Coverage Policy: 0136. Effective / Last review: 2025-10-15. This policy covers oral and enteral infant formulas when used to treat IEMs and specifies age and other criteria for medical necessity.

Thresholds and key stats

Infant age threshold≤ 12 months (CDC definition)

Enteral formula primary nutrition threshold>= 60% of caloric intake (enteral support indicated when formula is primary source)

Primary covered indicationFormulas specifically formulated for treatment of inborn errors of metabolism (IEM) such as amino acid or organic acid disorders

HCPCS/Procedure Codes Listed5+ (e.g., B4154, B4155, B4157, B4162, S9435)

ICD-10 Codes Listed50+ (multiple IEM diagnosis codes enumerated)

Medical Necessity Criteria

Medically Necessary - Infant (≤ 12 months) Oral/Enteral Nutritional Formula

Considered Medically Necessary when ALL of the following are met:

Medically necessary criteria (infant IEM)

Age: Patient is an infant (defined by CDC as zero to one year of age) i.e., ≤ 12 months of age≤ 12 months
Defined by CDC as zero to one year of age (CDC, 2024).
Indication: Nutritional formula is specifically formulated for the treatment of an inborn error of metabolism (IEM) (e.g., disorders of amino acid or organic acid metabolism)
Examples include PKU, MSUD, urea cycle disorders and other IEMs treatable by dietary modification.

General Enteral Nutrition Indication (contextual/description)

Not Medically Necessary / Exclusions

Not Medically Necessary / Exclusions (removed from policy statements previously)

Policy identifies conditions and items that are not covered (listed historically as removed policy statements):

Exclusions/Not Medically Necessary (historical)

Standard or specialized infant formula for non-IEM conditions: Standard or specialized infant formula for conditions other than inborn errors of metabolism, including but not limited to: food allergies, multiple protein intolerances, lactose intolerances, gluten-free formula for celiac disease, milk allergies, sensitivities to intact protein, protein or fat maldigestion, intolerances to soy formulas or protein hydrolysates, prematurity, or low birth-weight
Historically listed as not medically necessary for these indications.
Home enteral infusion pumps
Historically removed from policy statements.
Home parenteral nutrition

Coding

Covered HCPCS - enteral formulas and pediatric metabolic formulas (when meeting IEM criteria)HCPCSCovered

B4154	Enteral formula, nutritionally complete, for special metabolic needs, excludes inherited disease of metabolism, includes altered composition of proteins, fats, carbohydrates, vitamins and/or minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit
B4155	Enteral formula, nutritionally incomplete/modular nutrients, includes specific nutrients, carbohydrates (e.g. glucose polymers), proteins/amino acids (e.g. glutamine, arginine), fat (e.g. medium chain triglycerides) or combination, administered through an enteral feeding tube, 100 calories = 1 unit
B4157	Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit
B4162	Enteral formula, for pediatrics, special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit
S9435	Medical foods for inborn errors of metabolism

Relevant ICD-10 Diagnosis Codes (IEM indications)ICD-10Covered

D81.810	Biotinidase deficiency
D81.818	Other biotin-dependent carboxylase deficiency
E70.0	Classical phenylketonuria
E70.1	Other hyperphenylalaninemias
E70.20	Disorder of tyrosine metabolism
E70.21	Disorder of tyrosine metabolism
E70.22	Disorder of tyrosine metabolism
E70.23	Disorder of tyrosine metabolism
E70.24	Disorder of tyrosine metabolism
E70.25	Disorder of tyrosine metabolism

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Provider Actions / Billing Guidance

Documentation Required

Document IEM diagnosis and infant age

Providers must submit documentation that the patient is an infant (≤12 months) and that the formula is specifically formulated for treatment of an inborn error of metabolism associated with an applicable ICD-10 diagnosis code.

Document patient age: infant defined as ≤ 12 months (CDC definition).
Document the IEM diagnosis and include the applicable ICD-10 code on the claim.
Document that the formula is specifically formulated for treatment of the IEM.

Billing Rule

Use appropriate HCPCS/ICD-10 codes

When seeking reimbursement, providers must bill using the HCPCS codes B4154, B4155, B4157, B4162 or S9435 as appropriate and include covered ICD-10 diagnosis codes for inborn errors of metabolism; claims submitted without covered codes under this policy will be denied.

Background & Definitions

Background: Specialized oral or enteral nutritional formulas may be required for infants with inborn errors of metabolism to restrict or modify amino acids and other nutrients to prevent severe complications. Enteral nutrition can be oral or tube-fed and major formula types include elemental/amino acid–based, semi-elemental, standard/polymeric, and specialized/disease-specific formulations; infants with IEMs (e.g., phenylketonuria, maple syrup urine disease, urea cycle disorders) often require dietary modification and specialized formulas early in life to prevent intellectual disability, metabolic crises, or death.

Term	Definition
Infant	Defined by CDC as zero to one year of age (≤ 12 months).
Inborn Errors of Metabolism (IEM)	Genetic metabolic disorders (e.g., PKU, MSUD, urea cycle disorders) requiring dietary modifications and specialized formula.

Evidence summary / Regulatory note: The policy references U.S. Food and Drug Administration guidance on infant formula regulatory requirements, noting FDA materials (2024–2025) addressing safety, nutritional adequacy (required nutrients), quality control, labeling, and manufacturer responsibilities for infant formula.

Medicare Local and National Coverage Determinations

Type	Name/Number	Effective Date
LCD	Enteral Nutrition L38955	2024-01-01
NCD	No National Coverage Determination found

Revision History

2025-09-15annual_review

Annual Review on 9/15/2025 revised the benefit plan disclaimer, removed a 'not medically necessary items' statement, and changed the title (administrative/non-clinical revisions; clinical coverage remained that infant formula is medically necessary only for IEM).

2024-09-15annual_review

Annual Review on 9/15/2024 removed numerous prior policy statements and a list of items (e.g., home parenteral nutrition, many formula uses for non-IEM indications); removal clarifies exclusions and was not a clinical expansion of covered indications.