Notification

Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk


Notification Issue Date: 10/01/2018

This version of the policy will become effective 01/01/2019.

The following updates have been made to this policy:

  • RELiZORB® device for digestive enzyme supplementation was added to this policy as experimental/investigational
  • The Company's Benefit Language was updated for the non-coverage of the following products: NeoSure, Scandishake, and probiotics.
  • Clarification was made on the coverage of enteral supplies (including pump, tubing, feeding supply kits)
  • Coverage criteria for donated human breast milk has been added, per New Jersey Mandate

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Note: On 12/19/2018, this policy was updated to include a HCPCS code update, effective 01/01/2019.

The following HCPCS code has been removed from this policy:
Q9994 In-line cartridge containing digestive enzyme(s) for enteral feeding, each

The following HCPCS code has been added to this policy:
B4105 In-line cartridge containing digestive enzyme(s) for enteral feeding, each



Medical Policy Bulletin


Title:Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk

Policy #:08.00.18m

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups, but may be included or excluded at the option of the group; therefore, individual group benefits must be verified.

MEDICALLY NECESSARY

NUTRITIONAL FORMULAS AND ENTERAL NUTRITION
Administration Through a Tube

Commercially available nutritional formulas (including enteral nutrition) and associated enteral supplies (including pump, tubing, feeding supply kits) are considered medically necessary and, therefore, covered for individuals of all ages when all of the following criteria AND the subsequent Mandate criteria are met:
  • The commercially available nutritional formula requires administration via a tube (e.g., percutaneous endoscopic gastrostomy [PEG] tube, jejunostomy tube [J-tube], percutaneous endoscopic jejunostomy [PEJ], nasogastric [NG] tube) into the alimentary canal.
  • The tube feeding does not have to be the sole source of nutrition (i.e., more than 75 percent of estimated basal caloric requirements).
  • Examples of nutritional formulas and enteral nutrition that can be administered through a tube include, but are not limited to Boost, Elecare Infant or Jr, Glucerna, Isosource, Jevity, Nutren, Osmolite, PediaSure, Peptamen, Tolerex, Vivonex.

For Pennsylvania infant and child members, see Attachment A for PA Mandate Information.
For New Jersey members 12 months and under, see Attachment B for NJ Mandate Information.
For information regarding caloric requirements, see Attachment C.

Administration Orally
Infants and Children

Commercially available nutritional formulas are considered medically necessary and, therefore, covered for infants and children who require oral administration of an elemental formula (e.g., Elecare Infant or Jr., Neocate Splash, PurAmino, Neocate Junior or Infant, Tolerex, Vivonex) as the sole source of nutrition (i.e., the formula provides more than 75 percent of estimated basal caloric requirements) and who meet one or more of the following criteria AND meet the subsequent Mandate criteria:
  • The individual suffers from severe systemic protein hypersensitivity (e.g., IgE mediated: eosinophilic esophagitis, eosinophilic gastritis, eosinophilic gastroenteritis; non–IgE-mediated: food protein–induced entities such as enterocolitis) that is refractory to dietary and other treatments. Infants younger than 1 year of age must be shown to be refractory to treatment with standard milk or soy protein formulas (e.g., Enfamil A.R., Similac with Iron, Similac Expert Care for Diarrhea, Enfamil Prosobee), and refractory to treatment with non-standard, extensively hydrolyzed formulas (e.g., Nutramigen, Pregestimil, Similac Alimentum).
  • The individual has a disorder(s) of gross anatomy impeding or obstructing passage of nutrition through the alimentary canal (e.g., stricture, tumor, blind pouches).

For Pennsylvania infant and child members, see Attachment A for PA Mandate Information.
    NOTE: Members enrolled in a Pennsylvania Product are not required to meet the Company's definition of sole source of nutrition (i.e., the formula provides more than 75 percent of estimated basal caloric requirements); therefore, an estimated basal caloric requirement is not required.

For New Jersey members 12 months and under, see Attachment B for NJ Mandate Information.
For information regarding caloric requirements, see Attachment C.

Adults
Commercially available nutritional formulas (e.g., Boost, Ensure, Glucerna, Jevity, Osmolite) are considered medically necessary and, therefore, covered for adults who require oral administration of nutritional formulas as the sole source of nutrition (i.e., the formula provides more than 75 percent of estimated basal caloric requirements) when the individual has a disorder(s) of gross anatomy impeding or obstructing the passage of nutrition through the alimentary canal (e.g., stricture, tumor, blind pouches).

For information regarding caloric requirements, see Attachment C.

MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM ADMINISTERED ORALLY OR THROUGH A TUBE
Prescription medical foods administered orally or via a tube into the alimentary canal for individuals diagnosed with genetic (inherited) inborn errors of metabolism (IEM), such as phenylketonuria (PKU), homocystinuria, branched-chain ketonuria, galactosemia, and maple syrup urine disease, are covered for individuals of all ages who need administration of a formula that is manufactured for individuals with IEMs.
  • Medical foods are not required to meet the Company's definition of sole source of nutrition (i.e., the formula provides more than 75 percent of estimated basal caloric requirements); therefore, an estimated basal caloric requirement is not required for IEMs.
  • Examples of medical foods for individuals diagnosed with IEM include, but are not limited to, BCAD 1 or 2, OA 1 or 2, PFD 2 or Toddler, PhenylAde, Phenyl-Free 1 or 2 or 2HP, Ketonex 1 or 2.

For Pennsylvania members, see Attachment A for PA Mandate Information.
For New Jersey members, see Attachment B for NJ Mandate Information.
For information regarding caloric requirements, see Attachment C.

LOW-PROTEIN MODIFIED FOODS FOR INBORN ERRORS OF METABOLISM
New Jersey Products

Low-protein modified food products are covered by the Company in accordance with the state mandates for individuals enrolled in a New Jersey product subject to New Jersey's insurance law who are diagnosed with an inherited error of metabolism and the treatment is determined to be medically necessary by the individual's physician.

For New Jersey members, see Attachment B for NJ Mandate Information.

Pennsylvania Products

Low-protein modified food products are not covered by the Company for individuals enrolled in Pennsylvania products for inherited errors of metabolism because they do not meet the Company's definition of medical foods or nutritional formulas. Therefore, they are not eligible for reimbursement consideration.

For Pennsylvania members, see Attachment A for PA Mandate Information.

NONCOVERED: OTHER FORMULAS, PRODUCTS, AND SUPPLIES

Infant, child, or adult nutritional formulas or enteral nutrition that do not meet The Company's coverage criteria are not covered by the Company, and are therefore, not eligible for reimbursement consideration. Examples include the following:
  • Oral formulas (e.g. Boost, Ensure, NeoSure, PediaSure, Scandishake) for those with a diagnosis of malnutrition due to anorexia or failure to thrive
  • Oral organic formulas (e.g. Similac Advance Organic formula)

Banked breast milk is not covered by the Company, and is therefore, not eligible for reimbursement consideration. For members enrolled in NJ Products, donated banked breast milk may be covered through a NJ Mandate. Individual benefits must be verified. For New Jersey members, see Attachment B for NJ Mandate Information.

Elemental semi-solid foods (e.g. Neocate Nutra) are not covered by the Company, and are therefore, not eligible for reimbursement consideration.

Products that are used to replace fluids and electrolytes (e.g., Electrolyte Gastro, Pedialyte), for adults and children, are not covered by the Company, and are therefore, not eligible for reimbursement consideration.

Oral additives (e.g., Duocal, fiber, probiotics, or vitamins) and food thickeners (e.g., Thick-It, Resource ThickenUp) for adults and children, are not covered by the Company, and are therefore, not eligible for reimbursement consideration.
  • Most prescribed enteral formulas are nutritionally complete (i.e., they contain all vital nutrients, including vitamins and fiber). Therefore, additives and food thickeners are not eligible for separate reimbursement.
    • Nutritional formulas that are incomplete are described as such because they consist of specific nutrients to meet the nutritional needs of individuals with inborn errors of metabolism.

Supplies associated with the oral administration of formula (e.g., bottles, nipples) are not covered by the Company, and are therefore, not eligible for reimbursement consideration.

EXPERIMENTAL/INVESTIGATIONAL

Although the US Food and Drug Administration (FDA) has approved the RELiZORB® device for digestive enzyme supplementation, the Company has determined that the safety and/or effectiveness of this device cannot be established by review of the available published peer-reviewed literature. Therefore, RELiZORB® is considered experimental/investigational by the Company and not covered.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Guidelines

The Company utilizes the following two methods to calculate whether the nutritional formulas being requested meet 75 percent of the individual's total caloric needs:
  • The individual's food log is submitted and evaluated in relation to the individual's average caloric intake requirements based on age, weight, diagnosis, and clinical information.
  • The caloric content of liquid supplements ordered is evaluated in relation to the individual's average caloric intake requirements.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, medical foods (i.e., enteral nutrition and nutritional formulas) and low-protein modified food products are covered under the medical benefits of the Company’s products when the medical necessity criteria in this medical policy are met.

For legislated mandate determinations, read the specific attachment information for the state or commonwealth in which the member's benefits are issued.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state where the group benefit contract is issued determine the mandated coverage.

Description

NUTRITIONAL FORMULAS AND ENTERAL NUTRITION

Nutritional formulas are over-the-counter or prescription liquid nutritional products formulated to supplement or replace normal food products. The nutritional formulas are formulated for use in infants, children, or adults, based on the specific formula's content. An infant formula is further defined by the US Food and Drug Administration (FDA) as "a food that purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk."

In addition to age group, the nutritional formulas differ in their administration route, either oral or enteral.

Note: For the purposes of this policy, the term "enteral nutrition" will refer to nutrients administered into the alimentary canal through a tube, such as percutaneous endoscopic gastrostomy (PEG) tube, jejunostomy (J-tube) tube, percutaneous endoscopic jejunostomy (PEJ) tube, nasogastric (NG) tube.

Enteral nutrition is used for individuals with a functioning GI tract who have a disorder that prevents them from masticating and swallowing food.

Nutritional formulas and enteral nutrition are classified as polymeric, oligomeric, or monomeric, and are described below:
  • Polymeric (standard) formula consists of semisynthetic intact proteins or protein isolates. Examples include Boost, Ensure, Glucerna, Isosource, Jevity, Meritene, Nutren, Osmolite, PediaSure, and Resource 2.0.
  • Oligomeric (or semi-elemental) non-standard formula contains peptides that are broken-down (hydrolyzed) into varying chain lengths. Examples include Enfamil Gentlease, Gerber Good Start, Nutramigen, Peptamen, Portagen, Pregestimil, Similac Alimentum, Similac Total Comfort). Some of these products are used when an individual has a protein hypersensitivity.
  • Monomeric (or elemental) formula is completely amino acid--based (i.e., the nitrogen content of an elemental formula is 100 percent provided by amino acids). Examples of elemental formulas include, Elecare Infant or Jr., Neocate Splash, PurAmino, Neocate Junior or Infant, Tolerex, Vivonex.

Note: A formula whose nitrogen content is derived from protein hydrolysates, such as Nutramigen, is not considered an elemental formula, even when the labeling and/or product information identifies such a formula as "elemental."

The FDA approved the RELiZORB® device to hydrolyze fats in enteral formulas for adults and pediatric individuals ages 5 years and older. Based on available evidence to date, the safety and effectiveness cannot be established.

MEDICAL FOODS AND LOW-PROTEIN MODIFIED FOOD PRODUCTS TO SUPPLEMENT INDIVIDUALS WITH INBORN ERRORS OF METABOLISM (IEM)

The US Food and Drug Administration (FDA) defines a medical food as a "food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." FDA section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)). The FDA further defines medical foods as "foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition’s specific dietary management." Medical foods are "intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone." They also "provide nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation."

Inborn errors of metabolism (IEM) are genetic disorders that affect the ability of an individual to digest foods and metabolize nutrients. IEMs are caused by genetic defects that usually result in the absence of an enzyme that is necessary to process specific nutrients. The enzyme deficiency results in malnourishment or toxic accrual of substances that are harmful to the body and result in organ damage. Without treatment, these disorders may lead to mental retardation, developmental delay, seizures, coma, and death.

There are three major categories of IEMs: protein disorders, fatty acid oxidation disorders, and carbohydrate disorders. IEM treatment varies depending on the type and severity of disorder, but typically includes the following nutritional strategies:
  • Special formulas that do not contain the “offending” nutrients the individual cannot metabolize
  • Special food products such as low-protein foods formulated with less protein than conventional foods
  • Vitamin supplements
  • Amino acid and enzyme supplements
  • Prescription drugs
  • Nutritional supplements that help to normalize the otherwise disturbed metabolism

A common example of an IEM is phenylketonuria (PKU), which prevents an individual from processing the substrate phenylalanine, an essential amino acid commonly present in foods. Consumption of a typical diet for an individual with PKU would cause toxic build-up of phenylalanine within the body. Thus, treatment of PKU requires a diet with very low, to absent, phenylalanine. Other examples of IEM include branched-chain ketonuria, galactosemia, and homocystinuria.

Individuals with IEM require "exempt" specialized metabolic nutritional formulas. The FDA has requirements for the minimum and maximum amount of nutrients in nutritional formulas; if these requirements are not met, the nutritional formula may be "exempt" from these nutrient requirements. Exempt amino acid-based metabolic formulas require a prescription. Examples include, BCAD 1 or 2, OA 1 or 2, PFD 2 or Toddler, PhenylAde, Phenyl-Free 1 or 2 or 2HP, Ketonex 1 or 2.

LOW-PROTEIN MODIFIED FOOD PRODUCTS
Low-protein modified food products are specially formulated to have less than 1 gram of protein per serving. Low-protein modified food products are intended for use under the direction of a physician for the dietary treatment of hereditary metabolic diseases, but does not include a natural food that is naturally low in protein. Some examples of low-protein food products that are commercially available for purchase are breads, pasta, pastry shells, and rice pizza shells.
References


Abbott Nutrition. Products - Therapeutic. [Abbott Nutrition Web site]. 2018. Available at: https://abbottnutrition.com/therapeutic . Accessed June 27, 2018.

American Academy of Pediatrics. Committee on Nutrition. Hypoallergenic infant formulas. Pediatrics. 2000;106(2 Pt 1):346-9.

American Society for Parenteral & Enteral Nutrition (ASPEN). Enteral Nutrition Practice Recommendations. Journal of Parenteral and Enteral Nutrition. January 26, 2009. Available at: http://www.nutritioncare.org/Guidelines_and_Clinical_Resources/Clinical_Guidelines/ . Accessed July 11, 2018.

Bines J, Francis D, Hill D. Reducing parenteral requirement in children with short bowel syndrome: impact of an amino acid-based complete infant formula. J Pediatr Gastroenterol Nutr. 1998;26(2):123-8.

Braga M, Gianotti L, Radaelli G, et al. Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. Arch Surg. 1999;134(4):428-33.

Camp KM, Lloyd-Puryear MA, Huntington KL. Nutritional Treatment for Inborn Errors of Metabolism: Indications, Regulations, and Availability of Medical Foods and Dietary Supplements Using Phenylketonuria as an Example. Mol Genet Metab. 2012;107(1-2): 3–9.

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual.Chapter 15: Covered medical and other health services. 120 - Prosthetic Devices (Rev. 1, 10-01-03). [CMS Web site]. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-Ioms-Items/Cms012673.html . Accessed June 21, 2018.

Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD). 180.2: Enteral and parenteral nutrition therapy. [CMS Web site]. 07/11/84. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=242&ncdver=1&DocID=180.2&ncd_id=180.2&ncd_version=1&basket=ncd%25253A180%25252E2%25253A1%25253AEnteral+and+Parenteral+Nutritional+Therapy&bc=gAAAAAgAAAAAAA%3d%3d& . Accessed June 21, 2018.

Company Benefit Contracts.

Coulston A, Boushey CJ, Ferruzzi MG. Nutrition in the Prevention and Treatment of Disease, 3rd Ed. 2013.

de Boissieu D, Dupont C. Time course of allergy to extensively hydrolysed cow's milk proteins in infants. J Pediatr. 2000;136(1):119-20.

Dennis M. Nutrition after stroke. Br Med Bull. 2000;56(2):466-75.

D'Netto MA, Herson VC, Hussain N, et al. Allergic gastroenteropathy in preterm infants. J Pediatr. 2000;137(4):480-6.

Elsas L, Acosta P. Nutritional support of inherited metabolic disease. In: Shils ME, Olson JA, Shike M, Ross AC, eds. Modern Nutrition in Health and Disease. 9th ed. Philadelphia, PA: Lippincott, Williams & Wilkins;1998:1003-55.

Engorn B, Flerlage J. The Harriet Lane Handbook. 20th ed. Philadelphia, PA: Elsevier Saunders; 2015.

Escott-Stump S. Nutrition and Diagnosis - Related Care, 7th Ed. 2012. Wolters Kluwer/Lippincott Williams & Wilkins. Philadelphia, PA.

Garcia-Careaga M Jr, Kerner JA Jr. Gastrointestinal manifestations of food allergies in pediatric patients. Nutr Clin Pract. 2005;20(5):526-35.

Gottschlich MM, Shronts EP, Hutchins AM. Defined formula diets. In: Rombeau JL, Rolandelli RH, eds. Clinical Nutrition: Enteral and Tube Feedings. 3rd ed. Philadelphia, PA: WB Saunders Co;1997:222-36.

Halken S, Hansen KS, Jacobsen HP, et al. Comparison of a partially hydrolyzed infant formula with two extensively hydrolyzed formulas for allergy prevention: a prospective, randomized study. Pediatric Allergy Immunol. 2000;11(3):149-61.

Harris JA, Benedict FG. A Biometric Study of Basal Metabolism in Man. Washington, DC: Carnegie Institution, 1919.

Høst A, Koletzko B, Dreborg S, et al. Dietary products used in infants for treatment and prevention of food allergy. Joint Statement of the European Society for Paediatric Allergology and Clinic Immunology (ESPACI) Committee on Hypoallergenic Formulas and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child. 1999;81(1):80-4.

Kulick D, Deen D. Specialized nutrition support. Am Fam Physician. 201115;83(2):173-83.

Makola D. Elemental and semi-elemental formulas: are they superior to polymeric formulas? Practical Gastroenterology. 2005;34:59-72.

Mead Johnson. Product Information. 2018. [MJ Web site]. Available at: https://www.meadjohnson.com/pediatrics/us-en/product-information/products . Accessed July 11, 2018.

Mifflin MD, St Jeor ST, Hill LA, et al. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990 Feb;51(2):241-7.

National Institutes of Health (NIH). Report of the NIH Consensus Development Conference on Phenylketonuria (PKU): Screening & Management: Chapter III. updated 12/21/11. Available at: https://www.nichd.nih.gov/publications/pubs/pku/Pages/sub31.aspx. Accessed June 25, 2018.
Nestle. Products. [Nestle Web site]. 2017. Available at: https://www.nestlehealthscience.us/brands . Accessed June 27, 2018.

NJ Law: Noridian Medicare Local Coverage Determination (LCD): L33783 & A52493: Enteral nutrition. Original: 10/01/2015. Revised 01/01/2017. Available at: https://med.noridianmedicare.com/web/jadme/policies/lcd/active . Accessed June 25, 2018.

Otten JJ, Hellwig JP, Meyers LD, eds. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements . Washington, DC: National Academies Press, 2006.

PA Law:
RELiZORB®. Prescribing information. Alcresta Therapeutics, Inc. 2018. Available at: http://relizorb.com/hcp . Accessed July 10, 2018.

Rezvani I. Defects in metabolism of amino acids. In: Behrman RE, Kliegman RM, Jenson HB, eds. Nelson Textbook of Pediatrics. 16th ed. Philadelphia, PA: WB Saunders Co;2000:374-5.

Sampson HA. Food allergy. Part 1: immunopathogenesis and clinical disorders. J Allergy Clin Immunol. 1999;103(5 Pt 1):717-28.

Sampson HA. Food allergy. Part 2: diagnosis and management. J Allergy Clin Immunol. 1999;103(6):981-9.

Shike M. Enteral feeding. In: Shils ME, Olson JA, Shike M, Ross AC, eds. Modern Nutrition in Health and Disease. 9th ed. Philadelphia, PA: Lippincott, Williams & Wilkins;1998:1643-8.

Sicherer SH, Eigenmann PA, Sampson HA. Clinical features of food protein-induced enterocolitis syndrome. J Pediatr. 1998;133(2):214-19.

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Zachos M, Tondeur M, Griffiths AM. Enteral nutritional therapy for induction of remission in Crohn's disease. 01/24/07. The Cochrane Database of Systematic Reviews. 2007, Issue 1. Art. No.: CD000542. DOI: 10.1002/14651858.CD000542.pub2.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medical necessity as listed in the policy


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT ENTERAL SUPPLIES AND DME:

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

B9002 Enteral nutrition infusion pump, any type

B9998 NOC for enteral supplies

E0776 IV pole


THE FOLLOWING CODES ARE USED TO REPRESENT NUTRITIONAL FORMULAS AND ENTERAL NUTRITION:

B4149 Enteral formula, blendarized 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, included 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 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 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 (eg, glucose polymers, proteins/amino acids (eg, glutamine, arginine), fat, (eg, medium chain triglycerides) or combination, administered through an enteral feeding tube, 100 calories= 1 unit.

B4158 Enteral formula, for pediatrics, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber and/or iron, administered through an enteral feeding tube, 100 calories = 1 unit.

B4159 Enteral formula, for pediatrics, nutritionally complete soy based with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber and/or iron, administered through an enteral feeding tube, 100 calories = 1 unit.

B4160 Enteral formula, for pediatrics, nutritionally complete calorically dense (equal to or greater than 0.7 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.

B4161 Enteral formula, for pediatrics, hydrolyzed amino acids and peptide chain proteins, includes, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories= 1 unit.


THE FOLLOWING CODES ARE USED TO REPRESENT MEDICAL FOODS FOR INBORN ERRORS OF METABOLISM ADMINISTERED ORALLY OR THROUGH A TUBE:

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.

S9433 Medical food nutritionally complete, administered orally, providing 100% of nutritional intake

S9434 Modified solid food supplements for inborn errors of metabolism

S9435 Medical foods for inborn errors of metabolism


NOT COVERED

THE FOLLOWING CODES ARE USED TO REPRESENT OTHER FORMULAS, PRODUCTS, AND SUPPLIES:

B4100 Food thickener, administered orally, per ounce

B4102 Enteral formula, for adults, used to replace fluids and electrolytes (eg, clear liquids), 500 ml= 1 unit

B4103 Enteral formula for pediatrics, used to replace fluids and electrolytes (eg, clear liquids), 500 ml= 1 unit

B4104 Additive for enteral formula (eg, fiber)

THE FOLLOWING CODE IS NOT COVERED EXCEPT FOR MEMBERS ENROLLED IN NJ PRODUCTS SUBJECT TO THE NJ MANDATE, OR WHO HAVE A BENEFIT FOR THIS SERVICE:

T2101 Human breast milk processing, storage and distribution only


EXPERIMENTAL/INVESTIGATIONAL

B4105 In-line cartridge containing digestive enzyme(s) for enteral feeding, each



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk
Description: PA Mandates

Attachment B: Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk
Description: NJ Mandates

Attachment C: Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk
Description: Caloric Requirements




Policy History

08.00.18m

01/01/2019

The following updates have been made to this policy:
  • RELiZORB® device for digestive enzyme supplementation was added to this policy as experimental/investigational
  • The Company's Benefit Language was updated for the non-coverage of the following products: NeoSure, Scandishake, and probiotics.
  • Clarification was made on the coverage of enteral supplies (including pump, tubing, feeding supply kits)
  • Coverage criteria for donated human breast milk has been added, per New Jersey Mandate


08.00.18l

11/22/2017

This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 12/31/2018
Version Reissued Date: N/A

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