CurrentSelectHealthPolicy 95

Enteral Nutrition and Specialized Enteral Formulas Coverage Criteria

Coverage criteria and administrative requirements for oral and tube-delivered enteral formulas, medical foods, and related supplies for SelectHealth commercial, Medicare Advantage, and Medicaid plans; affects members and providers requesting enteral nutrition coverage.

Policy Summary

PayerSelectHealth

PolicyEnteral Nutrition and Specialized Enteral Formulas Coverage Criteria

Policy CodePolicy 95

Change TypeNo material change

Effective DateSep 30, 2013

Next Review Date

Key ActionVerify member eligibility and benefits and obtain prior authorization with required documentation demonstrating medical necessity before providing enteral formula.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24+coding items provided

A-F / condition-specificeligibility paths

Multiplerevision entries

Coverage Criteria for Enteral Nutrition

Initial Coverage criteria

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Primary coverage criteria (choose at least one): One of the following MUST be met: (1) Oral/enteral feeding comprises >50% of total estimated daily caloric needs with qualifying condition; (2) Diagnosis of an inborn error of metabolism treated with a formula specific for that disorder; (3) Diagnosis of cystic fibrosis with documented malabsorption or nutritional compromise; (4) Congenital cardiac condition in a child <18 with documented poor growth; (5) Oral/enteral fat emulsion formula indications (see fat emulsion criteria); or (6) Enteral formula comprises at least 20% of daily caloric needs with qualifying circumstances (e.g., supplement to TPN or tapering from TPN).

See condition-specific criteria nodes and specialized formula sections for detail.

Administrative criteria (must ALL be met): a) Annual assessment by a registered dietitian (exceptions considered case-by-case); b) Requested formula is available only through a pharmacy with a provider prescription; c) Written documentation demonstrating medical necessity including diagnosis and description of functional impairment related to need for enteral nutrition, attending physician's order/prescription updated at least annually, and an annual statement from the attending physician attesting to appropriateness of therapy and that they have personally assessed the individual.

Coverage and reimbursement remain subject to member benefits and eligibility.

Inborn errors of metabolism

Coverage for inherited metabolic disorders:

IEM criteria: Diagnosis of an inborn error of metabolism AND the formula is specifically formulated for treatment of amino acid or urea cycle disorders AND use is under the direction and ongoing supervision of a physician.

Codes specific to inherited metabolic disease (e.g., HCPCS B4157) apply as listed in coding section.

Cystic fibrosis

Coverage for cystic fibrosis (CF):

CF criteria: Diagnosis of cystic fibrosis AND documented malabsorption, nutritional compromise, or caloric deficiency related to CF demonstrated by documented weight loss or lack of weight gain (weight-for-length/height or BMI < 50th percentile is sufficient, or inability to maintain >=50th percentile when supplemental formula is discontinued) AND prior attempts at supplementation (e.g., oral supplements, food thickeners, added fats) AND active follow-up by a gastroenterology or CF specialist and a registered dietitian as indicated.

Documentation of prior conservative measures and specialist follow-up required.

Congenital cardiac conditions

Coverage for congenital cardiac conditions (children <18):

Pediatric congenital heart disease criteria: Member is a child under age 18 with a documented congenital cardiac condition AND documented poor growth as shown by growth charts (weight <=10th percentile for height and age OR weight <25th percentile for height and weight with 3 months of flat or declining weight) AND documentation of reasonable attempts at supplementation with commercially available foods/nutritional supplements AND active follow-up by a cardiovascular specialist for the underlying condition.

Reasonable attempts at supplementation must be documented in the medical record.

Fat emulsion / caloric-proportion criteria

Coverage for fat emulsion formulas:

Fat emulsion indications: Member has at least ONE of the following: for children <8, documented decline in weight percentile despite reasonable trial of standard formulas; documented need for fluid restriction and inability to meet daily nutritional needs with standard enteral formulas; a specific gastrointestinal or metabolic condition addressed by fat emulsion formulas (e.g., lactose intolerance, celiac disease); or refeeding in members with anorexia nervosa who are unable to take adequate oral nutrition and have BMI <18 (adults) or BMI <5th percentile (children/adolescents).

Decline in weight percentile must be measured on standardized growth charts.

Volume/caloric proportion for coverage: Enteral formula comprises at least 20% of the member's daily caloric needs AND documentation demonstrates at least ONE qualifying circumstance such as use to supplement TPN or to taper from TPN, or use while transitioning off long-term enteral formula; coverage of such formula for tapering is reviewed every 90 days.20%

Enteral formula coverage is based on caloric needs not met via oral intake or TPN (e.g., if member receives 70% of caloric needs via TPN, Select Health will cover enough formula to meet the remaining 30%).

Specialized formula criteria

Coverage of specialized enteral formulas:

Hydrolyzed/elemental formula coverage: Hydrolyzed, amino acid, or elemental formulas are covered when the member has at least ONE of the following: weight loss or stall in weight with standard formula; excessive irritability with no other identifiable cause; poor or difficult feeding; documented formula allergy; presence of GI bleeding with no other cause found; OR failure of 2 weeks of ALL specified conservative measures (e.g., change in maternal diet if breast milk is used).2 weeks

Ketogenic diet formulas are covered only if other formula coverage criteria are met; food supplements for the ketogenic diet are not covered.

SelectHealth does not cover routine payment for the following items. These exclusions apply unless state law explicitly mandates coverage: medical foods; regular grocery food products (including baby food) used with enteral systems; weight‑loss foods and formulas (e.g., Slim Fast); mega‑vitamin therapy; gluten‑free and lactose‑free food products; products to aid lactose digestion; over‑the‑counter high‑protein powders and mixes; nutritional supplement puddings; oral rehydration therapy; food thickeners; and enzyme‑packed cartridges (e.g., Relizorb) used with enteral tube feedings.

CPT / HCPCS Codes and Billing Notes

CPT CodesCPT

99507	Home visit for care and maintenance of catheter(s) (e.g,, urinary, drainage, and enteral)
99601	Home infusion/specialty drug administration, per visit (up to 2 hours)
99602	Home infusion/specialty drug administration; per visit (up to 2 hours); each additional hour (List separately in addition to code for primary procedure)

HCPCS codes (supplies & small formula items)HCPCS

B4034	Enteral feeding supply kit; syringe fed, per day; includes but not limited to feeding/flushing syringe, administration set tubing; dressings, tape
B4035	Enteral feeding supply kit; pump fed, per day; includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape
B4036	Enteral feeding supply kit; gravity fed, per day; includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape
B4081	Nasogastric tubing with stylet
B4082	Nasogastric tubing without stylet
B4083	Stomach tube-Levine type
B4087	Gastrostomy/jejunostomy tube, standard, any material, any type, each
B4088	Gastrostomy/jejunostomy tube, low-profile, any material, any type, each
B4100	Food thickener; administered orally, per oz
B4103	Enteral formula; for pediatrics, used to replace fluids and electrolytes (e.g., clear liquids); 500 ml = 1 unit

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HCPCS codes (enteral formulas)HCPCS

B4149	Enteral formula, manufactured blenderized natural foods with intact nutrients; administered through an enteral feeding tube; 100 calories = unit
B4150	Enteral formula, nutritionally complete with intact nutrients; administered through an enteral feeding tube; 100 calories = unit
B4152	Enteral formula, nutritionally complete, calorically dense (>=1.5 kcal/ml) with intact nutrients; administered through an enteral feeding tube; 100 calories = unit
B4153	Enteral formula, nutritionally complete; hydrolyzed proteins (amino acids and peptide chain); administered through an enteral feeding tube; 100 calories = unit
B4154	Enteral formula, nutritionally complete, for special metabolic needs, excludes inherited disease of metabolism; administered through an enteral feeding tube; unit
B4155	Enteral formula, nutritionally complete/modular nutrients; administered through an enteral feeding tube; 100 calories = unit
B4157	Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism; administered through an enteral feeding tube; 100 calories = unit
B4158	Enteral formula, for pediatrics, nutritionally complete with intact nutrients; administered through an enteral feeding tube; 100 calories = unit

Enteral supplies and basic formula codesHCPCS

B4034	Enteral feeding supply kit; syringe fed, per day; includes but not limited to feeding/flushing syringe, administration set tubing; dressings, tape
B4035	Enteral feeding supply kit; pump fed, per day; includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape
B4036	Enteral feeding supply kit; gravity fed, per day; includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape
B4081	Nasogastric tubing with stylet
B4082	Nasogastric tubing without stylet
B4083	Stomach tube—Levine type
B4087	Gastrostomy/jejunostomy tube, standard, any material, any type, each
B4088	Gastrostomy/jejunostomy tube, low-profile, any material, any type, each
B4100	Food thickener; administered orally, per oz
B4102	ml = unit (unit definition present in document)

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Specialty enteral formulas and home infusion HCPCSHCPCS

B4149	Enteral formula, manufactured blenderized natural foods with intact nutrients; administered through an enteral feeding tube; 100 calories = unit
B4150	Enteral formula, nutritionally complete with intact nutrients; administered through an enteral feeding tube; 100 calories = unit
B4152	Enteral formula, nutritionally complete, calorically dense (>=1.5 kcal/ml) with intact nutrients; administered through an enteral feeding tube; 100 calories = unit
B4153	Enteral formula, nutritionally complete; hydrolyzed proteins (amino acids and peptide chain); administered through an enteral feeding tube; 100 calories = unit
B4154	Enteral formula, nutritionally complete, for special metabolic needs, excludes inherited disease of metabolism; administered through an enteral feeding tube; unit
B4155	Enteral formula, nutritionally complete/modular nutrients; administered through an enteral feeding tube; 100 calories = unit
B4157	Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism; administered through an enteral feeding tube; 100 calories = unit
B4158	Enteral formula, for pediatrics, nutritionally complete with intact nutrients; 100 calories = unit
B4159	Enteral formula; includes proteins, fats, carbohydrates, vitamins and minerals; 100 calories = unit
B4160	Enteral formula, for pediatrics, nutritionally complete calorically dense (>=0.7 kcal/ml) with intact nutrients; 100 calories = unit

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Home infusion supplies and insertion codesHCPCS

S5502	Home infusion therapy, implanted access device, includes administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, per diem
S5517	Home infusion therapy, all supplies necessary for restoration of catheter patency or declotting
S5518	Home infusion therapy, all supplies necessary for catheter repair
S5520	Home infusion therapy, all supplies (including catheter) necessary for a peripherally inserted central venous catheter (PICC) line insertion
S5521	Home infusion therapy, all supplies (including catheter) necessary for a midline catheter insertion
S5522	Home infusion therapy, insertion of peripherally inserted central venous catheter (PICC), nursing services only (no supplies or catheter included)
S5523	Home infusion therapy; insertion of midline central catheter, nursing services only (no supplies or catheter included)

Oral/enteral feeding proportion — >50% requirement

ThresholdOral/enteral feeding comprises >50% of total estimated daily caloric need for coverage under certain criteria

ContextThis proportion is one of the primary clinical criteria (A-F) required for coverage when combined with the administrative requirements in section B

ImplicationDocumentation should quantify estimated daily caloric needs and show enteral/oral formula provides >50%

Unintentional weight loss thresholds

1-month thresholdUnintentional weight loss of 5% in one month

3-month thresholdUnintentional weight loss of 7.5% in three months

6-month thresholdUnintentional weight loss of 10% in six months

Unit calorie thresholds and unit definitions

Standard unit definitionMany enteral formulas are billed with 100 calories = 1 unit

Pediatric/volume unit exampleSome pediatric formulas specify 500 ml = 1 unit (e.g., B4103) or use ml = unit conventions (B4102)

Calorically dense formulasCertain calorically dense formulas specify kcal/ml thresholds (e.g., >=1.5 kcal/ml for B4152; >=0.7 kcal/ml for pediatric B4160) with 100 calories = 1 unit

Provider Requirements and Actions

Prior Authorization

Prior Authorization and Renewal

Prior authorization is required for enteral/oral formula coverage. Initial certification documentation and a provider prescription/order must be submitted. After the initial certification period, renewals will usually be for 6 months unless clinical documentation supports a chronic long-term need, in which case renewals may be annual. Shorter renewal periods may be required based on clinical circumstances.

Initial and renewal certifications require a provider prescription/order updated at least annually.
Renewals default to 6 months after initial certification; annual renewal only when chronic long-term need is documented.
Coverage for tapering off TPN or enteral formula is reviewed every 90 days.

Denial Risk

Denial Risk if Criteria or Documentation Not Met

Failure to meet the policy's coverage criteria or to provide required documentation may result in claim denial. Coverage requires meeting at least one of the clinical criteria A–F (as applicable) and all applicable documentation requirements.

Denial risk exists if conservative therapy to increase caloric intake was not attempted and documented when required.
Denial may occur if written documentation does not demonstrate medical necessity (diagnosis, functional impairment, attending physician details).

Note

Coverage Depends on Member Benefits

Coverage and reimbursement depend on the member's individual benefit plan and eligibility at the time services are rendered. Inclusion of codes or policy language does not guarantee coverage for a given member.

Apply the member's contract benefits in effect at time of service to determine coverage.
SelectHealth will base formula coverage on the portion of caloric needs not met via oral intake or TPN (examples in policy).

Documentation Required

Verify Benefits and Contact Information

Providers must verify member eligibility and benefits prior to submitting requests and may contact SelectHealth for questions about coverage or reimbursement.

Members may contact Customer Service at the phone number on their member ID card to discuss benefits.
Providers may call SelectHealth Provider Relations at (801) 442-3692 for questions about this Coverage Policy.

Definitions and Key Terms

Medical foods — definition

DefinitionMedical foods: foods formulated to be consumed or administered enterally under the supervision of a physician for the specific dietary management of a disease or condition with distinctive nutritional requirements

Regulatory referenceTerm referenced to section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)) in the policy text

Use caseIntended for dietary management when distinctive nutritional requirements are established by medical evaluation

Elemental / amino acid formulas — definition

DefinitionElemental / amino acid formulas: formulas in which proteins are broken down to their simplest (amino acid) form to facilitate digestion and absorption

IndicationsPrescribed for infants/children unable to digest or tolerate whole proteins due to allergies or gastrointestinal conditions

ExamplesExamples cited in policy: Neocate, EleCare, PurAmino

HCPCS enteral supply and formula codes — descriptions

Range of HCPCS codesEnteral feeding supplies and formulas described across codes B4034–B4162 and related S/B codes

Supply kit examplesB4034–B4036: enteral feeding supply kits (syringe, pump, gravity) described as per day items

Formula code examplesB4149–B4162: enteral formulas with unit definitions (commonly 100 calories = 1 unit) and special pediatric/calorically dense categories