CurrentUnitedHealthcarePolicy CS136TN.P

Enteral Nutrition (Oral and Tube Feeding) (for Tennessee Only)

This policy governs coverage and medical necessity criteria for enteral nutrition products (oral and tube feeding), including standard and specialized nutrient formulas, for Tennessee Medicaid and CoverKids members. It addresses age-specific rules, applicable codes, definitions, and benefit limitations.

Policy Summary

PayerUnitedHealthcare

PolicyEnteral Nutrition (Oral and Tube Feeding) (for Tennessee Only)

Policy CodePolicy CS136TN.P

Change TypeClarification/administrative update

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain and include prior authorization with clinical indication, prior formula trials and responses, growth/nutritional status, and a physician or dietitian order when requesting specialized nutrient formulas for members under 21.

SourceLink

POLICY UPDATE CHANGES

Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information.

B41xx, S943xApplicable codes listed

TennCareAdult criteria reference

InterQual CPPediatric criteria reference

ExamplesInborn errors enumerated

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EoE elemental diet efficacy

Coverage Criteria for Enteral Nutrition

inv-01: Oral Specialized Nutrient Formula — Individuals under 21

Specialized Nutrient Formula (oral) is considered medically necessary for individuals under 21 when ALL of the following are met:

Oral Specialized Nutrient Formula criteria (individuals <21): 1) Prescription by a physician, advanced practitioner, or registered dietitian; 2) The condition is chronic and expected to last an undetermined or prolonged period; 3) Adequate nutrition is not possible by dietary adjustment; 4) The formula used is a Medical Food specially formulated for a specific condition; 5) The individual has one of the following qualifying conditions: inborn errors of metabolism (examples: phenylketonuria, maple syrup urine disease, homocystinuria, methylmalonic acidemia, propionic acidemia, isovaleric acidemia, glutaric aciduria type I, tyrosinemia types I and II, urea cycle disorders); chronic kidney disease stages 2–5 (or on dialysis) for individuals aged <24 months; Crohn disease; severe malabsorption syndromes (e.g., cystic fibrosis, short bowel syndrome, intestinal failure); malnutrition or risk of severe malnutrition or severe disorders (physical disability, intellectual disability) that would result in malnourishment or death without therapy; severe food allergies including eosinophilic esophagitis and other eosinophilic gastrointestinal diseases, FPIES, FPIAP when untreated would cause life-threatening reactions, malnourishment, or death (note: mild/moderate food allergies/food intolerance are not covered by specialized formulas); or gastroesophageal reflux with failure to thrive (in children).

Direct lift from policy criteria (pediatric oral Specialized Nutrient Formula).

inv-02: Adult coverage — defer to TennCare rules

Adults (age 21 and older):

Adult criteria reference: Medical necessity clinical coverage criteria for adults are governed by TennCare Medicaid Chapter 1200-13.13-.10; see that regulation for exclusions and state-specific rules for oral and tube-administered enteral nutrition.

Policy defers to TennCare for adult coverage determinations.

inv-03: Covered clinical scenarios with required documentation

Coverage supported when documentation shows guideline- or evidence-based indication and prior trials as applicable. Examples below reflect groups of indications and supporting evidence.

PKU - medical foods and dietary management: ALL of the following must be documented: (1) diagnosis of phenylalanine hydroxylase deficiency/PKU; (2) initiation or maintenance of a low-phenylalanine diet with specified medical food (amino-acid medical food or glycomacropeptide medical food) to meet protein and nutrient needs; (3) a monitoring plan including anthropometrics and laboratory indexes of metabolic control (blood PHE concentrations) and nutrition adequacy per ACMG and SERN/GMDI guidelines; (4) clinical rationale for the chosen medical food and prescribed protein equivalent (higher doses of protein substitute associated with better PHE control in children).n/a

Supported by systematic reviews, RCTs, and PKU nutrition guidelines.

Elemental/amino acid formula for severe food allergies and EoE: Any ONE of the following indications: (1) failure to resolve symptoms on extensively hydrolyzed formula; (2) faltering growth/failure to thrive attributable to food allergy; (3) multiple food eliminations or severe complex gastrointestinal food allergies (e.g., FPIES, FPIAP) where elemental formula is clinically indicated; (4) eosinophilic esophagitis when an elemental diet is chosen (pooled efficacy ~90.8%); document prior trials and response where applicable.n/a

inv-04: Covered when guideline-based indications met

Clinical guideline–based indications and relative effectiveness summarized from cited evidence and society guidance:

Eosinophilic esophagitis (EoE): Elemental (amino acid–based) diets and empiric six-food elimination diets are effective options to induce histologic remission in EoE: pooled studies report ~90.8% remission with amino acid–based elemental formulas and ~72.1% combined efficacy for six-food elimination diets. AGA/JTF suggests elemental diet over no treatment (conditional/moderate evidence) and empiric six-food elimination diet over no treatment (conditional/low-quality evidence).

Per Arias et al. 2014 meta-analysis and AGA/JTF guideline (Hirano 2020).

Children with EoE - ESPGHAN position: ESPGHAN recommends empiric elimination diets as first-line dietary treatment in childhood EoE, considering cow’s milk, wheat, and eggs first in a step-up approach; reserve amino acid–based formulas for multiple food allergies, failure to thrive, severe disease, or when adherence/palatability limit strict diets.

Per ESPGHAN position statement (Amil-Dias 2023).

Cystic fibrosis and severe malabsorption: Use nutritional supplements (oral and enteral) in children and adults with growth or weight deficits to improve rate of weight gain; follow pancreatic enzyme dosing guidance where applicable (e.g., 500–2,500 lipase units/kg/meal).

Requests for provision of enteral products should distinguish between commercially produced medical foods/specialized nutrient formulas and caregiver-prepared self‑blenderized formulas. This policy identifies self‑blenderized formulas for oral intake, commercial food thickeners, and enteral formula additives for oral intake as items not routinely covered. The brief also notes electrolyte-containing oral fluids and high‑dose vitamin/mineral regimens are handled as benefit exclusions when they are not part of a documented, guideline‑based nutrition plan.

Within the Coverage Criteria segment the document states there are no additional, explicit exclusion conditions beyond the listed benefit considerations; reviewers should apply the enumerated not‑covered items and the written medical necessity criteria when assessing requests.

Regulatory status alone does not determine coverage. The document explicitly states that FDA approval alone is not a basis for coverage and clarifies that medical foods are regulated as foods, not drugs; coverage decisions depend on benefit rules and documented medical necessity under physician supervision.

When deciding between a specialized nutrient formula (medical food/elemental or amino‑acid formula) and a standard formula for oral intake, the policy directs use of specialized products only when the Coverage Rationale criteria are met (for example: inborn errors of metabolism, severe food allergy not responsive to extensively hydrolyzed formula, eosinophilic esophagitis requiring an elemental diet, or malnutrition where standard diet cannot meet needs). If criteria are not met, the request for either specialized or standard oral formula is generally not covered and reviewers should apply step‑therapy guidance (e.g., trial of extensively hydrolyzed formula) and documentation requirements first.

The evidence base for phenylketonuria (PKU) nutrition management has limitations. Systematic reviews identified few randomized controlled trials and the authors concluded that due to the paucity of high‑quality RCTs no firm conclusions can be drawn about exact thresholds or timing for relaxing dietary PHE restriction. Current practice supports early initiation and continued monitoring of a low‑PHE diet, but the precise level or timing for relaxation of PHE restriction remains uncertain and would require larger, adequately powered RCTs to define.

Applicable Codes

Applicable HCPCS/CodesHCPCS

B4100	Food thickener, administered orally, per oz.
B4102	Enteral formula, for adults, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit.
B4103	Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit.
B4104	Additive for enteral formula (e.g., fiber).
B4149	Enteral formula, manufactured blenderized natural foods with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit.
B4150	Enteral formula, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit.
B4152	Enteral formula, nutritionally complete, calorically dense (equal to or greater than 1.5 kcal/ml) with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit.
B4153	Enteral formula, nutritionally complete, hydrolyzed proteins (amino acids and peptide chain), includes fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit.
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.

1–10 of 20

1/2

Phenylalanine (PHE) target

Phenylalanine (PHE) target≤ 360 μmol/L

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization and Affected Codes

Prior Authorization Required. Prior authorization (PA) is required for specialized nutrient formulas and certain enteral nutrition services; check the member’s benefit, federal/state/contractual requirements, and TennCare rules where applicable before submission. UnitedHealthcare may reference InterQual for individuals under age 21 to determine medical necessity for tube-administered enteral nutrition.

Affected codes: include enteral formula and supply HCPCS/NDCs and tube-feeding procedure codes — verify current code list in the policy coding section.
TennCare/State-specific: follow TennCare Medicaid rules where specified; state/federal terms supersede policy.

Prior Authorization

Prior Authorization: Required Clinical Information

Information to include with a prior authorization request: provide a clear clinical indication, duration/expected chronicity of the condition, and documentation of why standard nutrition is inadequate. Include prior trials and outcomes (e.g., diet modifications, standard formulas, extensively hydrolyzed formulas), intolerance or adverse reactions, and multidisciplinary care involvement when applicable.

Medical Necessity Criteria

inv-32: Pediatric Specialized Nutrient Formula medical necessity

Medical necessity for Specialized Nutrient Formula (oral) for individuals under 21 requires:

DME medical necessity nodes for pediatric oral Specialized Nutrient Formula: Prescriber order from a physician, advanced practitioner, or registered dietitian; documentation that the condition is chronic and expected to last an undetermined or prolonged period; evidence that adequate nutrition cannot be achieved by dietary adjustment alone; confirmation that the formula is a Medical Food formulated for a specific condition; and documentation that the patient meets one of the enumerated qualifying conditions (inborn errors of metabolism; CKD stages 2–5 or on dialysis if aged <24 months; Crohn disease; severe malabsorption syndrome; malnutrition or at risk of severe malnutrition or severe disorders leading to malnourishment; severe food allergies including EoE, FPIES, FPIAP when untreated would cause life-threatening reactions or malnourishment; or gastroesophageal reflux with failure to thrive).

Direct lift from policy pediatric medical necessity criteria.

inv-33: Indications for elemental/amino acid formulas

Medical necessity for specialized formulas is supported when documentation shows:

Required Documentation and Orders

Documentation Required

Prescriber order and clinical justification required

Obtain a prescription or order from an appropriate clinician (physician, advanced practitioner, or registered dietitian) that documents the chronic condition, inability to meet nutrition needs via diet, and justification for ongoing use of a specialized formula as medical necessity.

Order must identify treating prescriber and clinical justification for chronic therapy.
State that dietary adjustment is insufficient and medical food is required.

Documentation Required

Physician/dietitian order and nutrition plan with monitoring schedule

Provide a physician- or dietitian-authored nutrition plan that includes the diagnosis, prescribed formula/medical food and dosing (protein equivalent where applicable), and a monitoring schedule for growth and laboratory indices (e.g., anthropometrics and blood PHE for PKU).

Diagnosis and prescribed formula with dosing/prescribed protein equivalent.
Monitoring schedule for growth (anthropometrics) and labs (e.g., blood PHE).

Items Not Covered / Limitations

Not covered items specifically called out include: self‑blenderized formulas for oral intake, commercial food thickeners, and enteral formula additives for oral intake. The policy lists these as generally not covered benefit considerations because they are not recognized as medically necessary enteral products under the Coverage Rationale when criteria are unmet.

The document segment reviewed does not add further DME or formula items to the not‑covered list beyond the enumerated exclusions; apply the listed benefit considerations and medical necessity criteria when evaluating coverage.

The policy emphasizes that medical foods are not drugs and that their FDA/regulatory description is informational only. Coverage determination is driven by the member’s benefit plan and documented medical necessity—FDA clearance or the label of a product does not by itself establish coverage under UnitedHealthcare.

Definitions

Medical Food

Regulatory definitionA Medical Food is a specially formulated product for enteral feeding under physician supervision for specific dietary management when normal diet modification is insufficient

Key characteristicsFormulated/processed product intended for partial or exclusive feeding, used under medical supervision, provides nutrition modified for a disease's unique needs

Coverage noteFDA status is informational; medical foods are regulated as foods not drugs and FDA approval alone is not a basis for coverage

Specialized Nutrient Formula

DefinitionSpecialized Nutrient Formula: formula produced to meet unique nutrient needs for specific disease conditions

Use contextUsed when ordinary diet modification cannot meet distinctive nutritional requirements and provided under medical supervision

Background

Enteral nutrition delivers nutrition via the gastrointestinal tract by oral intake, liquid supplements, or tube feeding. Formulas are categorized as standard formulas with intact nutrients or Specialized Nutrient Formulas (medical foods) produced to meet distinctive nutritional requirements for specific diseases. Medical Foods are intended to be consumed or administered enterally under physician supervision for dietary management of conditions with established, distinctive nutrient needs.

Policy Summary

PayerUnitedHealthcare

PolicyEnteral Nutrition (Oral and Tube Feeding) (for Tennessee Only)

Policy CodePolicy CS136TN.P

Change TypeClarification/administrative update

Effective DateJun 1, 2026

Next Review DateN/A

SourceLink

On This Page

Guideline-based and systematic review evidence support use.

Crohn disease - enteral nutrition approaches: ALL of the following for coverage of partial or exclusive enteral nutrition: (1) diagnosis of active Crohn disease; (2) documented treatment plan using exclusive enteral nutrition (EEN) or Crohn disease exclusion diet (CDED) with partial enteral nutrition as per trial protocols; (3) monitoring and tolerance documentation, including formula type and percent of caloric intake when used as partial enteral nutrition; pediatric RCT evidence supports CDED plus partial enteral nutrition for remission at 12 weeks.n/a

Specify formula type and percent of caloric intake when used as partial enteral nutrition.

Pediatric chronic kidney disease - specialized nutrition/enteral support: ALL of the following: (1) diagnosis of CKD stages 2–5D in a pediatric patient requiring modified energy/protein prescription; (2) nutrition plan referencing KDOQI/PRNT recommendations for energy and protein to support growth; (3) documentation for supplemental enteral nutrition or specialized formulas when indicated to meet growth targets.n/a

Guideline-based nutrition targets required.

Per Cystic Fibrosis Foundation guidance (Stallings 2008).

Malnutrition support: Initiate nutrition support (oral, enteral, or parenteral) in patients who are malnourished or at risk per NICE criteria (BMI and weight-loss thresholds, inadequate intake >5 days, or poor absorptive capacity/high losses/increased needs) and per ASPEN/Academy diagnostic indicators; consider oral supplements when swallowing is safe.

Per NICE 2017 and Academy/ASPEN consensus.

Pediatric reflux with failure to thrive: Consider a 2–4 week trial of extensively hydrolyzed formula (or amino acid–based formula) in formula-fed infants with suspected reflux after optimal nonpharmacologic treatment has failed; reserve amino acid formulas for severe symptoms or failure of hydrolysate formula.

Per NASPGHAN/ESPGHAN guidance (Rosen 2018).

Required clinical info: diagnosis and relevant history, indication for medical food or specialized formula, expected duration (chronic vs temporary).
Prior trials: documentation of dietary adjustments and specific standard formula trials and responses (dates, products used, duration).
Intolerance details: description of intolerance or failure to respond (symptoms, weight faltering, lab abnormalities).

Denial Risk

Coverage Exclusions and Likely Denial Triggers

Coverage exclusions that commonly trigger denials: requests for specialized formulas when criteria are not met; standard formulas for oral intake when state criteria are not met; self-blenderized formulas; commercial food thickeners; formula additives for oral intake; electrolyte fluids for routine replacement; nutrition/cosmetic high-dose supplements; formulas for mild/moderate food allergies; oral nutrition for lack of appetite or cognitive causes.

Common denial triggers: missing evidence that standard formulas/dietary adjustments were insufficient; no documentation of chronic or medically complex condition; requests for products explicitly listed as non-covered.
Administrative denial risk: requests inconsistent with federal/state/contractual coverage terms.

Documentation Required

Documentation-Related Denial Risks

Documentation-related denial risks: incomplete nutritional assessment (missing anthropometrics, intake records, weight trajectory), absent or outdated laboratory data, lack of specified monitoring plan, and insufficient evidence of medical supervision. Omissions increase likelihood of denial or request for additional information.

Nutrition assessment elements to include: height/length, weight, growth percentiles or z-scores, recent weight change, dietary intake records.
Laboratory/monitoring data: relevant metabolic labs, nutrient markers, and planned interval monitoring.
Operational note: clearly state the supervising clinician and frequency of follow-up visits and monitoring.

Documentation Required

Physician Supervision and Documentation

Physician supervision and documentation expectations: medical foods and specialized enteral nutrition must be used under medical supervision. PA requests should identify the prescribing provider (physician, advanced practitioner, or registered dietitian when authorized), include the treatment plan, frequency of follow-up, and documentation that the member is receiving ongoing medical oversight.

Who may prescribe: physician, advanced practitioner (NP, CNS, PA), or registered dietitian per policy criteria.
Documentation: signed prescription or order, care plan, evidence of recurring medical follow-up and supervision.

Step Therapy

Therapeutic Sequencing Preference

Therapeutic sequencing preference: prefer standard formulas and diet modification first where clinically appropriate. Specialized nutrient formulas and medical foods should be reserved for individuals with documented distinctive nutritional requirements that cannot be met by standard products or diet change.

Sequence: attempt dietary adjustment and standard/nutritionally complete formulas before specialized formulas unless contraindicated.
Exceptions: immediate use of amino acid–based or other specialized formulas is acceptable in severe cases (e.g., inborn errors of metabolism, severe malabsorption, severe food allergy with failure to thrive).

Step Therapy

Recommended Step-Up Approach and Clinical Step Approaches

Recommended step-up approach for infant formula and clinical step approaches: for severe food allergies and related conditions, trial extensively hydrolyzed formula for approximately 2 weeks first; if symptoms persist or for failure to thrive/more severe presentations, escalate to an amino acid–based formula. For gastroesophageal reflux with failure to thrive, consider a 2–4 week trial of extensively hydrolyzed formula (or amino acid formula if severe) after nonpharmacologic measures fail.

Infant formula step-up: extensively hydrolyzed formula → if inadequate after trial → amino acid (elemental) formula.
Clinical step approach: trial less-restrictive strategies (diet modification, standard formulas, hydrolyzed formulas) before more restrictive or elemental therapies, except in urgent/severe cases.

Indications for amino-acid/elemental formulas:

(1) Severe non-IgE-mediated food allergy (e.g., FPIES, FPIAP) or other severe complex gastrointestinal food allergies where elemental formula is indicated; (2) eosinophilic esophagitis when an elemental diet is chosen to induce histologic remission; (3) symptoms not resolved on an extensively hydrolyzed formula; (4) faltering growth/failure to thrive attributable to allergy/intolerance requiring elemental formula to restore growth. Document prior formula trials and clinical response where applicable.

Supported by guideline reviews, systematic reviews, and clinical practice guidance.

inv-34: Documentation to support medical necessity for enteral nutrition

Malnutrition and pediatric nutrition diagnostic indicators per authoritative guidance:

Adult malnutrition criteria (NICE): Meet any NICE-defined malnutrition criteria: BMI < 18.5 kg/m2; unintentional weight loss >10% within 3–6 months; BMI <20 kg/m2 with unintentional weight loss >5% within 3–6 months; or inadequate intake for >5 days, poor absorptive capacity, high losses, or increased needs. Nutrition support should be considered in these circumstances.

Per NICE 2017 guidance.

Adult malnutrition diagnosis (ASPEN/Academy): Identification of two or more of the following: insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, fluid accumulation that may mask weight loss, or diminished functional status (e.g., hand grip strength).

Per Academy/ASPEN consensus (White et al. 2012).

Pediatric malnutrition indicators (Academy/ASPEN): Use pediatric primary indicators and thresholds: weight-for-height and BMI-for-age z-scores (mild: -1 to -1.9; moderate: -2 to -2.9; severe: ≤ -3), mid-upper arm circumference z-scores, weight gain velocity (<2 years) thresholds, percent weight loss criteria, and deceleration in z-scores per consensus guidance to classify severity and support medical necessity for enteral nutrition.

Per Academy/ASPEN pediatric indicators (Becker et al. 2015).

Plan for dietitian involvement and follow-up.

Documentation Required

Document physician supervision and medical necessity

Document physician supervision of enteral administration and medical necessity for medical foods; confirm and record adherence to any benefit-specific requirements prior to coverage decisions.

Record that medical foods are provided under physician supervision as defined by regulation.
Document medical necessity and confirm benefit-specific authorization requirements have been met.

Typical formsEnteral nutrition products taken orally or via tube feeding

Inborn Errors of Metabolism

DefinitionInborn Errors of Metabolism are disorders causing blocks in metabolic pathways leading to clinically significant consequences

ExamplesPhenylketonuria (PKU), maple syrup urine disease, methylmalonic acidemia

Clinical relevanceRequire specialized dietary management and medical foods to address distinctive nutrient handling or intolerance

Amino acid medical foods (AA-MFs)

DefinitionAmino acid medical foods (AA-MFs) are formula-based medical foods composed of free amino acids to meet protein needs without intact protein/phenylalanine

Use casesPrimary option for PKU dietary management to avoid intact phenylalanine and to meet protein equivalents; also used when elemental nutrition is required

Evidence noteAA-MFs were compared with GMP-MFs in trials showing effective PHE control; AA-MFs may decrease plasma PHE in some studies

Glycomacropeptide medical foods (GMP-MFs)

DefinitionGlycomacropeptide medical foods (GMP-MFs) are medical foods based on glycomacropeptide used as a lower-phenylalanine protein source in PKU

Clinical contextShown to be acceptable and safe with improved palatability and gastrointestinal tolerability vs AA-MFs and may enhance dietary adherence

Comparative findingsTrials reported similar blood PHE concentrations over short-term crossover periods despite higher PHE intake from GMP-MFs

Elemental (amino acid) diet/formula

DefinitionElemental (amino acid) diet/formula is nutrition composed of free amino acids and minimal intact protein used to induce remission or manage severe non-IgE-mediated food allergies and eosinophilic esophagitis (EoE)

Clinical usesInduction of histologic remission in EoE (amino acid–based formulas ~90.8% efficacy in pooled studies) and management of severe food-allergy cases (FPIES, FPIAP) or failure of hydrolyzed formulas

Guideline contextAGA/JTF and ESPGHAN guidance support elemental diets for selected severe cases and recommend stepwise use based on tolerance and adherence

medical food (regulatory wording)

Statutory phrasingA medical food is 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))

Regulatory implicationMedical foods are not drugs and are subject to food regulations; FDA guidance is informational and does not determine coverage

Practice requirementUse under medical supervision with documented medical necessity and nutrition plan for recurring care and instruction