Latest Review Date: April 2024

Category:Durable Medical Equipment (DME)                                                         

POLICY:

Enteral nutrition with enteral feeding tubes (e.g., NG tubes, NE tubes, G- tubes, J-tubes) is considered medically necessary including, but not limited to, the following functional impairments or conditions:

• Inherited diseases of amino acid or organic acid metabolism (e.g., Phenylketonuria/PKU);
• Branch–chain ketonuria, galactosemia, or homocystinuria;
• Crohn’s disease;
• Gastroesophageal reflux with failure to thrive;
• Disorders of gastrointestinal motility (e.g., chronic intestinal pseudo-obstruction, Ogilvie’s syndrome);
• Malabsorption Syndrome;
• Ulcerative colitis;
• Cognitive neurological disorders that may cause the patient to forget how to swallow, such as: Dementia, Alzheimer’s disease, or Organic brain syndrome;
• Mechanical dysfunction of the gastrointestinal tract in which there is a functional impairment that results in a specific inability to swallow or may prevent food from reaching the stomach (e.g., esophageal obstruction or stricture, cancer of the larynx or tongue);
• Compromised ability for oral intake in patients with a functioning gastrointestinal tract who, due to pathology, disease or non-function of the structures that normally permit food to reach the digestive tract, cannot maintain weight and strength commensurate with his or her general condition;
• Muscular paralysis in which the patient is unable to swallow;
• Physiologic anorexia (such as cancer, sepsis, liver disease, HIV/AIDS).

Enteral nutrition HCPCS coding (B4149-B4162) is covered only if given through a feeding tube.

Blenderized natural foods with intact nutrients (B4149):

Includes products such as Compleat® Pediatric, Nourish, Pediasure Harvest™, Real Food Blends™ and Liquid Hope®.

Blenderized natural foods may be considered medically necessary when ALL of the following criteria is met:

• Prescribed by physician;
• Administered via feeding tube;
• Considered life sustaining primary source of nutrition; 
• Documentation of inability to tolerate 2 other nutritionally complete polymeric/hydrolyzed/elemental enteral formulas that are non-blenderized natural foods.
  • Administration of failed complete polymeric/hydrolyzed/elemental enteral formulas can be either by continuous tube feeding or bolus feeding.
  • Blenderized natural food products must be packaged by a manufacturer registered with the FDA.

Regular food items are not considered medical items and are non-covered.

Examples may include, but are not limited to the following:

• electrolyte replacement (B4102-B4103)
• food/liquid thickener (B4100)
• probiotics, additives such as fiber (B4104)
• baby food
• gluten-free food
• high protein powders and mixes  
• low carbohydrate diets
• normal grocery items
• nutritional supplement puddings
• weight-loss foods and weight loss formulas

All individuals must be monitored in conjunction with a qualified Dietitian, Health care Practitioner certified in nutritional support, Gastroenterologist, or Pediatric Allergist.

All enteral nutrition benefits must be prescribed in a written order by the individual's physician and will be processed in accordance with the member’s benefits.

This medical policy applies to enteral feeding use in the home only. Coverage for inpatient or skilled nursing facility acute care is not included in this policy.

For Nutritional Treatment of Childhood Medical Conditions, see Medical Policy #215

For Enteral Feeding Cartridge for Pancreatic Insufficiency (i.e., Relizorb) see Medical Policy #638

DESCRIPTION OF PROCEDURE OR SERVICE:

Enteral nutrition is the provision of nutritional requirements through a tube into the stomach or small intestine. Enteral nutrition is an option when an individual is unable to maintain a caloric intake sufficient to maintain weight and overall health.

The short-term methods of enteral tube feedings include nasogastric, nasoduodenal and, less frequently, nasojejunal tubes.  Long-term enteral feedings are best administered by a percutaneous gastrostomy or jejunostomy tube.

KEY POINTS:

Literature review performed through April 2024.

Summary of Evidence

The development of techniques to secure an individual’s nutrition has increased the survival of severely ill individuals. Most enteral formulas used for nutritional support (tube feeds) are ready-to-use fluids, in microbial free containers that provide macronutrients, micronutrients, fluids and, in some cases, soluble or insoluble fiber. Feeding by the enteral route is more physiologic than the intravenous route, and therefore has fewer short- and long-term complications. When nutritional support is necessary, tube feedings provide nutrients sufficient to maintain weight and strength commensurate with the individual’s overall health status.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

1.3.1 Nutrition support should be considered in people who are malnourished, as defined by any of the following:

• a BMI of less than 18.5 kg/m²
• unintentional weight loss greater than 10% within the last 3–6 months
• a BMI of less than 20 kg/m² and unintentional weight loss greater than 5% within the last 3–6 months.

1.3.2 Nutrition support should be considered in people at risk of malnutrition who, as defined by any of the following:

• have eaten little or nothing for more than 5 days and/or are likely to eat little or nothing for the next 5 days or longer
• have a poor absorptive capacity, and/or have high nutrient losses and/or have increased nutritional needs from causes such as catabolism.

1.3.3 Healthcare professionals should consider using oral, enteral or parenteral nutrition support, alone or in combination, for people who are either malnourished or at risk of malnutrition, as defined in 1.3.1 and 1.3.2. Potential swallowing problems should be taken into account.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Enteral feeding, tube feeding, formula, compleat pediatric, liquid hope, nutrition, electrolyte replacement (clear liquids), food thickener, liquid thickener, NG tube, nasogastric tube, Naso-enteral (NE), Gastrostomy (G-tube), Jejunostomy (J-tube), blenderized natural foods

APPROVED BY GOVERNING BODIES:

According to the U.S. Food and Drug Administration, “the term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is ‘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.’”

“Medical foods do not have to undergo premarket review or approval by FDA and individual medical food products do not have to be registered with FDA”.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

HCPCS:

REFERENCES:

1. Akobeng AK, Zhang D, Gordon M, MacDonald JK. Enteral nutrition for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev. 2018;8(8):CD005984.
2. American Academy of Pediatrics Committee on Nutrition. Reimbursement for medical foods for inborn errors of metabolism. Pediatrics. 1994;93(5):860.
3. American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Enteral Nutrition Practice Recommendations. JPEN J Parenter Enteral Nutr. 2009; 33(3):122-167. Available at:http://pen.sagepub.com/cgi/reprint/33/2/122.
4. American Society for Parenteral and Enteral Nutrition. Clinical Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, 2009.
5. Food and Drug Administration. Frequently Asked Questions About Medical Foods; Second Edition, Guidance for Industry https://www.fda.gov/files/food/published/Guidance-for-Industry--Frequently-Asked-Questions-About-Medical-Foods--Second-Edition-%28PDF%29.pdf
6. Gopalan S, Khanna S. Enteral nutrition delivery technique. Curr Opin Clin Nutr Metab Care. 2003 May;6(3):313-7. doi: 10.1097/01.mco.0000068968.34812.14.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Makola D. Elemental and Semi-Elemental Formulas: Are They Superior to Polymeric Formulas? Nutrition Issues in Gastroenterology, Series #34. Dec 2005. Available at URL address: https://med.virginia.edu/ginutrition/wp-content/uploads/sites/199/2015/11/MakolaArticle-Dec05.pdf
9. McClave SA, Taylor BE, Martindale RG, et al. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr 2016; 40(2): 159-211.
10. National Institute for Health and Clinical Excellence (NICE). Clinical Guideline 32 Nutrition support in adults: oral nutrition support, enteral tube feeding and parenteral nutrition. February 2006. Available at URL address: http://www.nice.org.uk/guidance/CG32
11. Ojo O, Keaveney E, Wang XH, Feng P. The Effect of Enteral Tube Feeding on Patients' Health-Related Quality of Life: A Systematic Review. Nutrients. 2019 May 10;11(5):1046. doi: 10.3390/nu11051046.
12. Ojo O, Brooke J. Recent Advances in Enteral Nutrition. Nutrients. 2016 Nov 8;8(11):709. doi: 10.3390/nu8110709.
13. U.S. National Library of Medicine. National Institutes of Health. Inborn errors of metabolism. 2020. Bethesda, MD https://medlineplus.gov/ency/article/002438.htm
14. U. S. Food and Drug Administration (FDA). Exempt Infant Formulas Marketed in the United States by Manufacturer and Category. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Infant Formula Guidance Documents & Regulatory Information. 2019. https://www.fda.gov/food/infant-formula-guidance-documents-regulatoryinformation/exempt-infant-formulas-marketed-united-states-manufacturer-and-category
15. U.S. Food and Drug Administration. Medical Foods Guidance Documents & Regulatory Information. https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/medical-foods-guidance-documents-regulatory-information
16. Weissman B et al. Enteral feeding. American Academy of Pediatrics. 2008, Vol. 28, pp. 105-106.

POLICY HISTORY:

Medical Policy Group, April 2021 (6): New medical policy based on current internal processing guidelines. No change to previous coverage and processing guidelines.

Available for comment through June 11, 2021.

MPAC May 2021

Medical Policy Group, April 2022 (6): Updates to Description, Key Points and References.

Medical Policy Group, May 2022 (6): Updates to policy statement to include clarification for B4149, Governing Bodies, Key Words and References.

Medical Policy Group, April 2023 (6): Updates to Description, Key Points, Governing Bodies, Benefit Application, Current Coding (B9002) and References.

Medical Policy Group, April 2024 (6): Updates to Key Points and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent 

therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.