CurrentCignaPolicy 0136

Infant Nutritional Formula

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This policy governs coverage of oral and enteral nutritional formula for infants 12 months of age or younger. Coverage varies by benefit plan, and medically necessary coverage is limited to formula specifically formulated to treat an inborn error of metabolism.

Policy Summary

PayerCigna

PolicyInfant Nutritional Formula

Policy CodePolicy 0136

Change TypeAnnual administrative reviewno clinical changes

Effective DateSeptember 15, 2026

Next Review DateSeptember 15, 2027

Key ActionSubmit the appropriate covered HCPCS code with documentation supporting that the patient is 12 months of age or younger and that the formula treats an inborn error of metabolism.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤12 monthsInfant age limit

5Covered HCPCS codes

No clinical changes2026 annual review outcome

Medical Necessity and Coverage Rules

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentCignaPolicy 0136

Infant Nutritional Formula

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Sign up for Cigna Policy 0136 alerts

Get alerted when Policy 0136 changes without checking for updates manually.

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Policy Summary

PayerCigna

PolicyInfant Nutritional Formula

Policy CodePolicy 0136

Change TypeAnnual administrative reviewno clinical changes

Effective DateSeptember 15, 2026

Next Review DateSeptember 15, 2027

Key ActionSubmit the appropriate covered HCPCS code with documentation supporting that the patient is 12 months of age or younger and that the formula treats an inborn error of metabolism.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤12 monthsInfant age limit

5Covered HCPCS codes

No clinical changes2026 annual review outcome

Medical Necessity and Coverage Rules

HCPCS codes marked with a dagger (†) are generally excluded from coverage when used to treat conditions other than infant inborn errors of metabolism. The exclusion applies based on the condition being treated; formula coverage is considered medically necessary when the formula is reported for treatment of an infant inborn error of metabolism, subject to the applicable benefit plan.

Covered Codes and Billing Parameters

Covered HCPCS CodesHCPCSCovered

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.

Covered ICD-10-CM Diagnosis CodesICD-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.
E70.29	Other disorder of tyrosine metabolism.
E70.40-	Disorders of histidine metabolism.
E70.49	Other disorders of histidine metabolism.
E70.5	Disorders of tryptophan metabolism.
E70.81	Aromatic L-amino acid decarboxylase deficiency.

1–10 of 67

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Infant Age

Coverage age limit12 months or younger

Covered populationInfants

Applicable formulaOral and enteral nutritional formula

Enteral Formula Billing Unit

Billing conversion100 calories = 1 unit

Billing contextEnteral formula

Measurement basisCalories

Submission and Denial Prevention

Documentation Required

Support Age, Indication, and Covered Code

Document that the patient is an infant (≤ 12 months of age), that the formula is specifically formulated to treat an inborn error of metabolism, and that the submitted code accurately describes the covered formula and service. Coverage varies by benefit plan, so verify the customer's plan document before submitting.

Include clinical documentation supporting infant age and the inborn error of metabolism, such as a disorder of amino acid or organic acid metabolism.
Use the most appropriate HCPCS code effective on the date of service: B4154, B4155, B4157, B4162, or S9435.
Check code validity at the time of service; deleted or not-yet-effective codes may not be reimbursed.

Denial Risk

Noncovered Diagnosis, Code, or Indication

Claims may be denied when the diagnosis, procedure code, or formula indication is not covered under this policy. Infant nutritional formula is generally excluded when used for conditions other than an infant inborn error of metabolism, and services submitted without a covered code are not covered.

Do not submit this coverage request for a noncovered diagnosis or for formula that is not specifically formulated to treat an inborn error of metabolism.
Use only covered, active HCPCS codes appropriate to the service and date of submission; claims lacking a covered code may be denied.
Codes marked † are generally excluded when used for conditions other than infant inborn errors of metabolism; S9435 (††) is medically necessary when reported for infant nutritional formula treating an inborn error of metabolism.

Clinical Context

Inborn errors of metabolism are inherited disorders caused by defects in enzymes or transport systems that disrupt normal metabolic pathways. In infants, these disorders may cause poor feeding, vomiting, lethargy, seizures, metabolic acidosis, hyperammonemia, or encephalopathy and may progress rapidly to metabolic crisis, organ dysfunction, or death. Specialized oral or enteral formulas support treatment by restricting nutrients the infant cannot metabolize while providing calories, protein equivalents, vitamins, and minerals needed for growth and neurodevelopment. Early dietary treatment is a cornerstone of management for conditions such as phenylketonuria, organic acidemias, and urea cycle disorders.

Key Terms

Definitions

TermInfant

DefinitionA child 12 months of age or younger

Policy applicationOral and enteral nutritional formula for infants is addressed by this policy

Definitions

TermInborn error of metabolism

DefinitionAn inherited disorder caused by defects in enzymes or transport systems that disrupt normal metabolic pathways

Related conditionsIncludes disorders of amino acid metabolism, organic acidemias, urea cycle disorders, and related metabolic conditions

Policy Summary

PayerCigna

PolicyInfant Nutritional Formula

Policy CodePolicy 0136

Change TypeAnnual administrative reviewno clinical changes

Effective DateSeptember 15, 2026

Next Review DateSeptember 15, 2027

Key ActionSubmit the appropriate covered HCPCS code with documentation supporting that the patient is 12 months of age or younger and that the formula treats an inborn error of metabolism.

SourceLink

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