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

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 jejuno​​stomy [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% of estimated ba​sal 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 N​J 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% 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 for at least 2 weeks with standard milk or soy protein formulas (e.g., Enfamil A.R., Similac with Iron, Similac for Diarrhea, Enfamil Prosobee), and refractory to treatment for at least 2 weeks​ with nonstandard, 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% 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 or​al administration of nutritional formulas as the sole source of nutrition (i.e., the formula provides more than 75% 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% 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 IEM 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.

NOT COVERED​

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 polymeric formulas (e.g., Boost, Enfamil EnfaCare, Ensure, NeoSure, PediaSure, Scandishake) for infants and children ​​
  • Oral polymeric formulas (e.g., Boost, Ensure, NeoSure, PediaSure, Scandishake) ​​for adults with a diagnosis of malnutrition due to anorexia or failure to thrive ​​
  • Oral polymeric or oligomeric (hydrolyzed) formulas to support a low ketogenic diet (e.g., KetoVie 4:1) 
  • Oral organic formulas (e.g., ​Kate Farms Organic formula, Similac 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 semisolid 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. 

Medical foods for non-IEM​ (e.g., Encala) are not covered by the Company because they are a benefit contract exclusion. Therefore, they are 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 IEM.
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 durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The 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 7 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 5 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 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%​ 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 for inborn errors of metabolism 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. 

Subject to the terms and conditions of the applicable benefit contract, the RELiZORB device for digestive enzyme supplementation​ is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.
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 percutaneo​us endoscopic gastrostomy (P​​EG) tube, jejunostomy (J-tube) tube, percutaneous endoscopic jejunostomy (PEJ) tube, nasogastric (NG) tube.
​​
Enteral nutrition is used for individuals with a functioning​​ gastrointestinal 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, Nutren, Osmolite, PediaSure, and Resource 2.0.
  • Oligomeric (or semielemental) nonstandard 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% 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 in which the 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."

RELiZORB​  

The FDA approved the RELiZORB single-use device to hydrolyze (digest) fats in enteral formulas for adults and pediatric individuals ages 5 years and older. Preclinical studies were performed in exocrine pancreatic insufficiency porcine subjects to measure fat absorption. Additionally, two small human clinical studies investigated the absorption of fat in individuals aged 4 years and older with cystic fibrosis (CF) who require enteral nutrition (Freedman et al., 2017; Stevens et al., 2018); but limitations in study designs for these investigations preclude derivations of any definitive conclusions from them. These small trials suggest an improvement in symptoms for some individuals, but larger studies with longer duration are still needed to confirm any positive results. For this device, the CF Foundation stated that "additional data needs to be generated" and that "evaluation of its benefits and limits should be considered before use" (Schwarzenberg et al. 2016, 2019). In 2021, Sathe et al. investigated the increase in body mass index (BMI) in individuals with CF who were utilizing RELiZORB during enteral feeds; the results from these individuals were compared with historical controls. Hendrix et al. (2022) was a small case series (n=15) with no control group in individuals with CF and exocrine pancreatic insufficiency who were utilizing RELiZORB during enteral feeds. The improvement in anthropometrics​ was unable to be sustained; furthermore, there was no statistical analysis for the gastrointestinal symptom improvement results. Regarding Sathe et al. (2021) and Hendrix et al. (2022), because a control group was not simultaneously recruited and evaluated, the improvement in BMI cannot be solely attributed to the use of RELiZORB. ​Future investigations require prospective controlled studies in individuals with CF/exocrine pancreatic insufficiency where the primary outcomes such as a decrease in gastrointestinal symptoms or increased weight gain/BMI can be solely attributed to the use of RELiZORB. Based on the limited available evidence to date, the sustained effectiveness of this device cannot be established. The insufficiency of overall evidence to determine that this technology results in a meaningful improvement in the net health outcome for any indications is supported by publications such as that of Freeman et al. (2021) in the Journal of Pediatric Gastroenterology and Nutrition. The authors state: “Although this report provides guidance on the medical management of CP based on existing literature, it also recognizes directions of much needed future investigation into concepts and controversies that require further elucidation and resolution. These include but are not limited to the following: Prospective controlled studies to investigate the role of an organized lipid matrix and the efficacy of enteral in-line feeding cartridges in the management of EPI (exocrine pancreatic insufficiency)."

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

The FDA d​efines 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]. 2022. Available at: https://abbottnutrition.com/therapeutic. Accessed June 21, 2022.​

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

American Society for Parenteral and Enteral Nutrition (ASPEN). Enteral Nutrition Practice Recommendations. JPEN . ​2009;33(2):122-167. Available at: http://www.nutritioncare.org/Guidelines_and_Clinical_Resources/Clinical_Guidelines/. Accessed June 21, 2022.​

Barrett JS, Shepherd SJ, Gibson PR. Strategies to manage gastrointestinal symptoms complicating enteral feeding. JPEN J Parenter Enteral Nutr. 2009 Jan-Feb;33(1):21-6.

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.

Borowitz DS, Grant RJ Durie PR, the Consensus Committee. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. J Pediatr. 1995; 127:681-84.​

Boullata JI, Carrera AL, Harvey L, et al.; ASPEN Safe Practices for Enteral Nutrition Therapy Task Force, American Society for Parenteral and Enteral Nutrition. ASPEN Safe Practices for Enteral Nutrition Therapy [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jan;41(1):15-103. 

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 20, 2022. 

Company Benefit Contracts.

Coulston A, Boushey CJ, Ferruzzi MG, eds. Nutrition in the Prevention and Treatment of Disease, 3rd edn. Philadelphia: Academic Press; 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: Lippincott, Williams & Wilkins;1998:1003-55.

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

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

Freedman S, Orenstein D, Black P, et al. Increased fat absorption from enteral formula through an in-line digestive cartridge in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101.

Freeman AJ, Maqbool A, Bellin MD, et al. Medical management of chronic pancreatitis in children: a position paper by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Pancreas Committee. J Pediatr Gastroenterol Nutr. 2021;72(2):324-40. 

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: WB Saunders;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. Pediatr Allergy Immunol. 2000;11(3):149-61.

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

Hendrix SJ, Flume PA, First ER, et al. Improvements in anthropometric measures and gastrointestinal tolerance in patients with cystic fibrosis by using a digestive enzyme cartridge with overnight enteral nutrition. Nutr Clin Pract. 2022 Apr;37(2):344-350.  

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.

Koletzko S, Niggemann B, Arato A, et al.; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9.

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

Limketkai BN, Shah ND, Sheikh GN, Allen K. Classifying enteral nutrition: tailored for clinical practice. Curr Gastroenterol Rep. 2019;21(9):47.

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

Mead Johnson. Product Information. 2021. [MJ Web site]. Available at: https://www.hcp.meadjohnson.com/. Accessed June 21, 2022.​​​

Meyer R, Groetch M, Venter C. When should infants with cow's milk protein allergy use an amino acid formula? A practical guide. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):383-99.

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 21, 2022.​

Nestle. Products. [Nestle Web site]. 2021. Available at: https://www.nestlehealthscience.us/brands. Accessed June 21, 2022.​

NJ Law:
    New Jersey Senate Bill S1839, dated JANUARY 22, 2001. Available at: https://www.njleg.state.nj.us/bill-search/2000/S1839. Accessed June 21, 2022. ​

    An Act concerning coverage of certain infant formulas, supplementing Titles 17 and 26 of the Revised Statutes and Title 17B of the New Jersey Statutes, and amending P.L.1992, c.161 and P.L.1992, c.162. Chapter 361. Approved January 6, 2002. Available at: http://www.njleg.state.nj.us/2000/Bills/PL01/361_.HTM . Accessed June 21, 2022. 

    An Act concerning coverage for foods and food products for inherited metabolic diseases. Chapter 338. Approved January 12, 1998. Available at: http://www.njleg.state.nj.us/9697/Bills/PL97/338_.HTM. Accessed June 21, 2022.​​

    An Act concerning health benefits coverage for donated human breast milk. Public Law 2017, c 301; Approved January 16, 2018. Effective January 1, 2019. Available at: http://www.njleg.state.nj.us/2016/Bills/PL17/309_.PDF. Accessed June 21, 2022.​
Noridian Medicare Local Coverage Determination (LCD): Enteral Nutrition (L38955). Original Effective Date 09/05/2021. Revision Effective date 01/01/2022​. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38955 . Accessed June 21, 2022.

Noridian Medicare Local Coverage Article (LCA): Enteral Nutrition (A58833). Original Effective Date 09/05/2021. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58833 . Accessed June 21, 2022.​
​
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PA Law:RELiZORB®. Prescribing information. Alcresta Therapeutics, Inc. 2022. Available at: https://www.relizorb.com/hcp#. Accessed June 21, 2022.​
 
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Sampson HA. Food allergy. Part 2: diagnosis and management. J Allergy Clin Immunol. 1999;103(6):981-9.

Sathe MN, Patel D, Stone A, First E. Evaluation of the effectiveness of in-line iLipase cartridge in enterally fed patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2021; 72(1):18-23. 

Schwarzenberg SJ, Borowitz D, et al. Challenging barriers to an option for improved provision of enteral nutrition. J Cyst Fibros. 2019;18(4):447-9.​


Schwarzenberg SJ, Hempstead SE, McDonald CM, et al. Enteral tube feeding for individuals with cystic fibrosis: Cystic Fibrosis Foundation evidence-informed guidelines. J Cyst Fibros. 2016;15(6):724-35.


Shike M. Enteral feeding. In: Shils ME, Olson JA, Shike M, Ross AC, eds. Modern Nutrition in Health and Disease. 9th ed. Philadelphia: 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.

Stevens J, Wyatt C, Brown P, et al. Absorption and safety with sustained use of RELiZORB evaluation (ASSURE) study in patients with cystic fibrosis receiving enteral feeding. J Pediatr Gastroenterol Nutr. 2018;67(4):527-32.  

Terheggen-Lagro SW, Khouw IM, Schaafsma A, Wauters EA. Safety of a new extensively hydrolysed formula in children with cow's milk protein allergy: a double blind crossover study. BMC Pediatr. 2002;14(2):10.

Turck D, Braegger CP, Colombo C, et al. ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis. Clin Nutr. 2016 Jun;35(3):557-77.

Ulshen M. Food allergy (Food hypersensitivity). In: Behrman RE, Kliegman RM, Jenson HB, eds. Nelson Textbook of Pediatrics. 16th ed. Philadelphia: WB Saunders; 2000:1158-9.

US Food and Drug Administration (FDA). 510(k) Premarket Notification for Relizorb. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed June 21, 2022.​

US Food and Drug Administration (FDA). Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition. May 2007. Updated 05/13/2007. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-frequently-asked-questions-about-medical-foods-second-edition. Accessed June 21, 2022.​

US Food and Drug Administration (FDA). Guidance for industry: Frequently Asked Questions about FDA's Regulation of Infant Formula. March 2006. [FDA Web site]. Page Last Updated 09/20/2018. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-frequently-asked-questions-about-fdas-regulation-infant-formula​. Accessed June 21, 2022.

US Food and Drug Administration (FDA). Medical Foods Guidance Documents & Regulatory Information. [FDA Web site]. Page Last Updated 01/25/2022. Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/. Accessed June 21, 2022.​​

US Food and Drug Administration (FDA) Rules and regulations. Nutrient requirements for infant formulas. Fed Regist. 1985;50:45106-8.

US Food and Drug Administration (FDA) infant formulas, regulatory information, Sec. 412. [21 USC §350a]. Requirements for Infant Formulas. Updated 05/16/2022. Available at: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm136118.htm#manufacture. Accessed June 21, 2022.​​​

Weinstein DS, Furman J. Enteral formulas. Nurs Clin North Am. 1997;32(4):669-83.

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

Zeiger RS. Dietary aspects of food allergy prevention in infants and children. J Pediatr Gastroenterol Nutr. 2000;30 Suppl:S77-S86.​

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
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

B4148 Enteral feeding supply kit; elastomeric control fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape
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

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)

S9432 Medical foods for non-inborn errors of metabolism​​
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

Policy History

Revisions From 08.00.18p:
10/01/2023This version of the policy will become effective 10/01/2023.

The following HCPCS code has been added to this policy:
B4148 Enteral feeding supply kit; elastomeric control fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape

Revisions From 08.00.18o:
​10/19/2022
​The policy has been reviewed and reissued to communicate the Company’s continuing position on Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk.​
12/20/2021
This version of the policy will become effective 12/20/2021​. ​

This policy was revised to communicate the Company's coverage position for  Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk.

The following critieria have been revised:

For infants younger than 1 year of age with severe systemic protein hypersensitivity who require oral administration of an elemental formula, a two-week trial of both standard milk or soy protein formulas AND non-standard, extensively hydrolyzed must be tried before coverage of elemental formula​ is Medically Necessary. 

The list and examples of non-covered formulas, products, and supplies have been expanded. ​

Revisions From 08.00.18n:
10/01/2021

This version of the policy will become effective 10/01/2021.​


The following HCPCS code has been added to this policy as noncovered, since it is a Benefit Contract Exclusion: 

S9432 Medical foods for non-inborn errors of metabolism​


Additionally, the following language was added to the Noncovered section of the Policy:
Medical foods for non-inborn errors of metabolism​ (e.g., Encala) are not covered by the Company because they are a benefit contract exclusion. Therefore, they are not eligible for reimbursement consideration.​

Guidelines Section was updated to align with the Company's Benefit Contract Language.​​

 Revisions From 08.00.18m:
10/23/2019This policy has been reissued in accordance with the Company's annual review process.

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

Revisions From 08.00.18l:
11/22/2017This 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.
10/1/2023
9/29/2023
08.00.18
Medical Policy Bulletin
Commercial
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No
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.