Clinical UM Guideline


Subject:Home Enteral Nutrition
Guideline #:  CG-MED-08Current Effective Date:  01/13/2015
Status:RevisedLast Review Date:  11/13/2014

Description

This document addresses "medical food" or commercially available processed enteral products (please see the Definitions section for further information regarding medical food) when used in the home to meet basic metabolic needs in a variety of conditions affecting either the mechanical or metabolic process of digestion.  Enteral nutrition consists of nutritional support given via the gastrointestinal (GI) tract, either directly or through any of a variety of tubes used in specific medical circumstances.  This includes oral feeding, sip feeding, and tube feeding using nasogastric, gastrostomy, jejunostomy, or other tubes.  This document does not address standard food (not for medical purposes), although it is technically an enteral nutritional product.

Note: Some benefit plans exclude products available without prescription, sometimes referred to as 'over the counter,' even when prescribed by a physician or other healthcare provider.  Enteral food products are often available without prescription.  Please see the text in the footnote of this document regarding Federal and State mandates and contract language, as these documents often specifically address the topic of enteral nutrition.

Note: Please see the following related documents for additional information:

Clinical Indications

I.       Oral Enteral Nutrition

Medically Necessary:

  1. Oral enteral nutrition (oral feeding) is considered medically necessary when all of the following criteria are met:
    1. The product must be a medical food for oral feeding; and
    2. The product is the primary source of nutrition (that is, constitutes more than 50 percent of the intake for the individual); and
    3. The product must be labeled and used for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements to avert the development of serious physical or mental disabilities or to promote normal development or function as listed in a. or b. below:
      1. Conditions associated with an in-born error of metabolism that interfere with the metabolism of specific nutrients, including, but not limited to:
        1. Phenylketonuria (PKU); or
        2. Homocystinuria; or
        3. Methylmalonic acidemia; or
      2. Conditions that interfere with nutrient absorption and assimilation, including, but not limited to:
        1. Allergy or hypersensitivity to cow or soy milk diagnosed through a formal food challenge; or
        2. Allergy to specific foods including food-induced anaphylaxis; or
        3. Allergic or eosinophilic enteritis (colitis/proctitis, esophagitis, gastroenteritis); or
        4. Cystic fibrosis with malabsorption; or
        5. Diarrhea or vomiting resulting in clinically significant dehydration requiring treatment by a medical provider; or
        6. Malabsorption unresponsive to standard age appropriate interventions when associated with failure to gain weight or meet established growth expectations; or
        7. Failure to thrive unresponsive to standard age appropriate interventions (for example, nutritionally complete liquid meal supplements ) when associated with weight loss, failure to gain weight or to meet established growth expectations, including but not limited to:
          1. Premature infants who have not achieved the 25th percentile for weight based on their corrected age; or
          2. Individuals with end-stage renal disease and an albumin less than 4 gm/dl; and
    4. The product must be used under the supervision of a physician or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments.
  2. Oral enteral nutrition is considered medically necessary when the diet consists of less than 50 percent enteral nutrition and more than 50 percent standard diet for age when:
    1. The enteral product is used as part of a defined and limited plan of care in transition from a diet of more than 50 percent enteral products to standard diet for age; or
    2. Medical records document a medical basis for the inability to maintain appropriate body weight and nutritional status prior to initiating or after discontinuing use of an enteral supplement as well as ongoing evidence of response to the enteral nutrition.

Not Medically Necessary:

Oral enteral nutrition is considered not medically necessary when the criteria above have not been met.

Oral enteral nutrition is considered not medically necessary when use of a product is based on the convenience or preference of the individual or provider.

II.     Enteral Nutrition Via Tube

Medically Necessary:

  1. Enteral nutrition via tube feeding is considered medically necessary when all of the following criteria are met:
    1. Enteral nutrition comprises the majority (greater than 50 percent) of the diet; and
    2. The product is used under the supervision of a physician or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments; and
    3. Nutrients cannot be ingested orally due to a medical condition which either:
      1. Interferes with swallowing (for example, dysphagia from a neurological condition, severe chronic anorexia nervosa unable to maintain weight and nutritional status with oral nutrition); or
      2. Is associated with obstruction of the proximal GI tract (for example, tumor of the esophagus).
  2. Enteral nutrition via tube is considered medically necessary when the diet consists of less than 50 percent enteral nutrition and more than 50 percent standard diet for age when all of the following criteria are met:
    1. The product is used under the supervision of a physician or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments; and
    2. The enteral product is used, as part of a defined and limited plan of care in transition from a diet of more than 50 percent enteral products to standard diet for age; and
    3. Medical records document a medical basis for the inability to maintain appropriate body weight and nutritional status prior to initiating or after discontinuing use of an enteral supplement as well as ongoing evidence of response to the enteral nutrition.

Not Medically Necessary:

Enteral nutrition via tube is considered not medically necessary when used in individuals with normal swallowing and normal proximal GI tract function, except as stated above.

Enteral nutrition via tube is considered not medically necessary when used in individuals able to take the majority of their diet via the oral route except as indicated above.

III.    Other Considerations

Not Medically Necessary:

The use of formulas and other food products is considered not medically necessary when the criteria above have not been met including, but not limited to:

  1. Used primarily for convenience or for features which exceed that which is medically necessary (for example, pre-packaged, liquid vs. powder, etc.).
  2. When used for individuals with disorders of swallowing where non-medical food is tolerated.
Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS  
B4034Enteral feeding supply kit; syringe fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape 
B4035Enteral feeding supply kit; pump fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape 
B4036Enteral feeding supply kit; gravity fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape 
B4081-B4088Nasogastric, stomach, gastrostomy/jejunostomy tubes [includes codes B4081, B4082, B4083, B4087, B4088] 
B4100Food thickener, administered orally, per ounce 
B4102Enteral formula, for adults, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit 
B4103Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit 
B4104Additive for enteral formula (e.g., fiber) 
B4149-B4162Enteral formula (administered through an enteral feeding tube) [includes codes B4149, B4150, B4152, B4153, B4154, B4155, B4157, B4158, B4159, B4160, B4161, B4162] 
B9000-B9002Enteral nutrition infusion pump [includes codes B9000, B9002] 
S9340-S9343Home therapy, enteral nutrition [includes codes S9340, S9341, S9342, S9343] 
S9433Medical food nutritionally complete, administered orally, providing 100% of nutritional intake 
S9434Modified solid food supplements for inborn errors of metabolism 
S9435Medical foods for inborn errors of metabolism 
   
ICD-9 Diagnosis[For dates of service prior to 10/01/2015] 
 All diagnoses 
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2015]
 All diagnoses
  
Discussion/General Information

Enteral nutrition is indicated in order to maintain optimal health status for individuals with diseases or structural defects of the GI tract that interfere with transport, digestion or absorption of nutrients.  Such conditions may include anatomic obstructions due to cancer, motility disorders such as gastroparesis, or metabolic absorptive disorders such as PKU.

The most optimal route of enteral intake is swallowing by mouth.  In conditions where this is not possible, a tube may be placed to facilitate transport of nutrition to the digestive/absorptive sites of the GI tract.  Tube placement and types are governed by individual needs; the least invasive approach being placement of a nasogastric tube.  Enteral tubes may also be placed percutaneously through an abdominal approach; this is most appropriate for long-term needs due to the reduced risk of aspiration and reflux (CMS NCD for Enteral Nutrition, 1984; Simon, 2000).

The term Total Enteral Nutrition (TEN) infers that the individual is receiving more than 50% of their daily caloric intake via tube feedings.  If fewer than 50% of daily calories are supplied by enteral nutrition products, they are considered supplemental.

Oral enteral formula is needed for individuals with inherited metabolic digestive disorders such as:

These diseases are characterized by inborn errors of amino acid metabolism and have distinctive nutritional requirements.  Special formulas are used for the dietary management of these diseases.

The term "medical foods" does not pertain to all foods fed to ill individuals.  Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the individual who is seriously ill or who requires the product as a major treatment modality. Medical foods are intended solely to meet the dietary needs of individuals who have specific metabolic or physiological limitations that restrict their ability to digest regular food.  According to the Food and Drug Administration (FDA), a product must meet all of the following minimum criteria to be considered a medical food:

  1. The product must be a food for oral or tube feeding.
  2. The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements.
  3. The product must be used under the supervision of a physician.

The use of weight for a given age is a common metric used to determine if an individual meets criteria for failure to thrive (FTT).  However, the threshold for weight for age is not standardized.  Cole and colleagues (2011) use "weight less than 75 percent of median weight for age," while the Agency for Healthcare Research and Quality (AHRQ) report states that the U.S. Social Security Administration (SSA) considers FTT to be present "when there is a fall in weight to below the 3rd percentile or to less than 75% of median weight-for-height or age in children under two years old" (Perrin, 2003). The current SSA language says growth retardation should be documented by 3 measurements over a 6 month period showing "less than the third percentile on the CDC's [Center for Disease Control's] most recent weight-for-length charts" for children under the age of 2, and "less than the 3rd percentile on the CDC's most recent BMI for age growth charts" for children 2 years old and older (SSA, 105.08B1, 24598.002). Cole and colleagues (2011) further illustrate the lack of consensus on this issue by stating:

Other definitions are used commonly in the professional literature such as height-for-weight <3rd percentile; weight-for-age less than 3rd or 5th percentile or less than 80 percent of median for age; weight-for-height <10th percentile; and weight-for-age more than 2 standard deviations below the mean for age.   

Both the terms "corrected" age and "chronological" age appear frequently in the literature regarding the measurement of age in children diagnosed with FTT. The use of the term "corrected" allows for greater accuracy in the estimation of expected growth in children, specifically those born premature, who may have a significant discrepancy between their gestational and chronological ages.  However, the use of this convention is not uniform in either the literature or guidelines addressing this issue. In accordance with Cole and colleagues (2011), this guideline uses the term "corrected" when referring to the measurement of premature infants.

Definitions

Dysphagia: The term that describes difficulty swallowing due to abnormal swallowing reflex.

Food allergy or hypersensitivity: A clinically abnormal response believed to be caused by an immunologic reaction resulting from the ingestion of a food or food additive.

Food anaphylaxis: A classic allergic hypersensitivity reaction to food or food additives involving IgE antibody that occurs rapidly and may be life threatening.

Food challenge: This is an evaluation technique that may be used to assist in the diagnosis of food or eating-related disorders.  After an adequate time with the exclusion of suspected foods (usually a week or two), the suspected food or foods are administered under close supervision in a dose escalation manner with proper observation periods between doses. Food challenges may be done in an open manner with the subject aware of what they are being given, with the subject unaware, or with both the subject and physician unaware.

Medical food: As defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3) 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.*

* U.S. Food and Drug Administration. Regulatory Information. Section 5 of Orphan Drug Act. Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/default.htm.  Accessed on August 21, 2014.

Proximal gastrointestinal tract: The section of the GI tract from the mouth to the small bowel.

Standard food:This is regular grocery products including typical (not specially formulated) infant formulas.

References

Peer Reviewed Publications:

  1. Haddad RY, Thomas DR. Enteral nutrition and enteral tube feeding. Review of the evidence. Clin Geriatr Med. 2002; 18(4):867-881.
  2. Høst A, Koletzko B, Dreborg S, et al. Dietary products used in infants for treatment & prevention of food allergy. Joint Statement of the European Society for Paediatric Allergology and Clinical 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):80-84.
  3. Joly F, Dray X, Corcos O, et al. Tube feeding improves intestinal absorption in short bowel syndrome patients. Gastroenterology. 2009; 136(3):824-831.
  4. Klek S, Hermanowicz A, Dziwiszek G, et al. Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study. Am J Clin Nutr. 2014; 100(2):609-615.
  5. Nakajoh K, Nakagawa T, Sekizawa K, et al. Relation between incidence of pneumonia and protective reflexes in post-stroke patients with oral or tube feeding. J Intern Med. 2000; 247(1):39-42.
  6. Riva E, Fiocchi A, Fiori L, Giovannini M. Prevention and treatment of cow's milk allergy. Arch Dis Child. 2001; 84(1):91.
  7. Schwenk WF 2nd. Specialized nutrition support: the pediatric perspective. JPEN J Parenter Enteral Nutr. 2003; 27(3):160-167, viii.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Society for Parenteral and Enteral Nutrition (ASPEN). Administration of specialized nutrition support. JPEN J Parenter Enteral Nutr. 2002; 26(1 Suppl):18SA-21SA.
  2. 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. Accessed on August 21, 2014.
  3. Centers for Medicare and Medicaid Services. National Coverage Determination: Enteral and Parenteral Nutritional Therapy. NCD #180.2. Effective July 11, 1984. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on August 21, 2014.
  4. Cole SZ, Lanham JS. Failure to thrive: an update. Am Fam Physician. 2011; 83(7):829-834.
  5. Druyan ME, Compher C, Boullata JI, et al. Clinical Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients: applying the GRADE system to development of A.S.P.E.N. clinical guidelines. JPEN J Parenter Enteral Nutr. 2012; 36(1):77-80. Available at: http://pen.sagepub.com/content/36/1/77.full.pdf+html. Accessed on September 2, 2014.
  6. Durfee SM, Adams SC, Arthur E, et al. A.S.P.E.N. Standards for nutrition support: home and alternate site care. Nutr Clin Pract. 2014; 29(4):542-555. Available at: http://ncp.sagepub.com/content/29/4/542.full.pdf+html. Accessed on September 2, 2014.
  7. Good P, Cavenagh J, Mather M, Ravenscroft P. Medically assisted nutrition for palliative care in adult patients. Cochrane Database Syst Rev. 2008;(4):CD006274.
  8. Good P, Richard R, Syrmis W, et al. Medically assisted nutrition for adult palliative care patients. Cochrane Database Syst Rev. 2014;(4):CD006274.
  9. Koretz RL, Avenell A, Lipman TO. Nutritional support for liver disease. Cochrane Database Syst Rev. 2012;(5):CD008344.
  10. Langer G, GroBmann K, Fleischer S, et al. Nutritional interventions for liver-transplanted patients. Cochrane Database Syst Rev. 2012;(8):CD007605.
  11. Marchand V, Motil KJ.; NASPGHAN Committee on Nutrition. Nutrition support for neurologically impaired children: a clinical report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2006; 43(1):123-135.
  12. Mills RJ, Davies MW. Enteral iron supplementation in preterm and low birth weight infants. Cochrane Database Syst Rev. 2012;(3):CD005095.
  13. Morgan J, Bombell S, McGuire W. Early trophic feeding versus enteral fasting for very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2013a;(3):CD000504.
  14. Morgan J, Young L, McGuire W. Delayed introduction of progressive enteral feeds to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2013b;(5):CD001970.
  15. National Institute for Health and Clinical Excellence (NICE). Quality Standard for Nutrition Support in Adults. NICE quality standards [QS24]. November 2012. Available at: http://www.nice.org.uk/guidance/QS24/chapter/introduction-and-overview. Accessed on September 2, 2014.
  16. Payne C, Wiffen PJ, Martin S. Interventions for fatigue and weight loss in adults with advanced progressive illness. Cochrane Database Syst Rev. 2012;(1):CD008427.
  17. Perrin EC, Cole CH, Frank CH, et al. Criteria for determining disability in infants and children: failure to thrive. Evid Rep Technol Assess (Summ). 2003; (72):1-5. Available at: http://www.ncbi.nlm.nih.gov/books/NBK36834/. Accessed on August 21, 2014.
  18. Poropat G, Giljaca V, Hauser G, Stimac D. Enteral nutrition formulations for acute pancreatitis (Protocol). Cochrane Database Syst Rev. 2013;(6):CD010605.
  19. Sampson EL, Candy B, Jones L. Enteral tube feeding for older people with advanced dementia. Cochrane Database Syst Rev. 2009;(2):CD007209.
  20. Tan-Dy C, Ohlsson A. Lactase treated feeds to promote growth and feeding tolerance in preterm infants. Cochrane Database Syst Rev. 2013;(3):CD004591.
  21. Quigley M, McGuire W. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database Syst Rev. 2014;(4):CD002971.
  22. U.S. Food and Drug Administration (FDA). Center for Food Safety and Applied Nutrition. Office of Nutritional Products, Labeling, and Dietary Supplements. Draft Guidance for Industry: Frequently Asked Questions about Medical Foods. Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/ucm054048.htm. Accessed on August 21, 2014.
  23. U.S. Food and Drug Administration (FDA). Regulatory Information. Section 5 of Orphan Drug Act. Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/default.htm. Accessed on August 21, 2014.
  24. U.S. Social Security Administration (SSA). Disability Evaluation under Social Security. 105.08 Digestive System – Childhood. Available at: http://www.ssa.gov/disability/professionals/bluebook/105.00-Digestive-Childhood.htm#105_08. Accessed on August 21, 2014.
  25. U.S. Social Security Administration (SSA). Program Operations Manual System (POMS). DI 24598.002. Failure to Thrive. Effective 12/21/2007. Available at: https://secure.ssa.gov/poms.nsf/lnx/0424598002. Accessed on August 21, 2014.
  26. Watson J, McGuire W. Nasal versus oral route for placing feeding tubes in preterm or low birth weight infants. Cochrane Database Syst Rev. 2013;(2):CD003952.
  27. Watson J, McGuire W. Transpyloric versus gastric tube feeding for preterm infants. Cochrane Database Syst Rev. 2013;(2):CD003487.
Index

Home Enteral Nutrition

History
StatusDateAction
Revised11/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review.  Clarified Clinical Indications. Updated Description, Discussion/General Information, References and Websites sections.
Revised11/14/2013MPTAC review.  Changed "chronological age" to "corrected age" in medically necessary criteria for oral enteral nutrition for children with failure to thrive unresponsive to standard age appropriate interventions.  Updated Rationale and Reference sections.
Reviewed02/14/2013MPTAC review.  No change to position statement.
Reviewed02/16/2012MPTAC review.  No change to position statement.

Reviewed

 

02/17/2011

 

MPTAC review.  No change to position statement. Updated Reference section.
 01/01/2011Updated Coding section with 01/01/2011 HCPCS changes.
Reviewed02/25/2010MPTAC review.  No change to position statement. Updated Reference section.
Revised02/26/2009MPTAC review. Modified note in description regarding benefit issues. Reorganized position statement section. Added requirement for documentation of food challenge to oral nutrition medically necessary statement regarding allergy or hypersensitivity to cow or soy milk. Added criteria to oral nutrition medically necessary statement for malabsorption conditions to include "when associated with failure to gain weight or meet established growth expectations."  Added Failure to Thrive as an oral nutrition medically necessary indication. Added statement for when oral or tube nutrition is medically necessary when it comprises less than 50% of intake. Added medically necessary criteria for tube nutrition requiring that individuals must have a condition that either interferes with swallowing or is associated with obstruction of the proximal gastrointestinal tract.  Added not medically necessary statement for when used in individuals with normal swallowing and normal proximal gastrointestinal tract function.   Updated Discussion, Definitions, and Reference sections.
 01/01/2009Updated Coding section with 01/01/2009 HCPCS changes.
Revised08/28/2008MPTAC review. Added definition of "medical food." Added the term "medical food" to all clinical indication statements. Added "conditions that interfere with the metabolism of specific nutrients" and other clarifying language to the medically necessary statement in section I.  Added "The diagnosis is not failure to thrive" to medically necessary statement in Section II. Added "The diagnosis is not failure to thrive" and "the diagnosis is not allergy to mother's milk", and statement addressing continuation of therapy to medically necessary statement In section III. Added not medically necessary statement to section III addressing re-evaluation of therapy, and "The diagnosis is not failure to thrive" and "the diagnosis is not allergy to mother's milk".  Added "The diagnosis is not failure to thrive" and "the diagnosis is not allergy to mother's milk" to medically necessary section in Section IV.  Added new not medically necessary statement to section IV for when medical food is used primarily for convenience or for individuals with disorders of swallowing where non-medical food is tolerated. Revised Discussion section.  Updated Coding section with 10/01/2008 ICD-9 changes.
Revised05/15/2008MPTAC review. Revised age criteria for enteral feeding via tube. Reorganized position statement section. Clarified criteria regarding "inborn error of metabolism."
Revised11/29/2007MPTAC review. Added "in all situations" to not medically necessary statement regarding over the counter and specialized pediatric formulas.  Updated Reference section.  Updated Coding section with 01/01/2008 HCPCS changes. 
 10/01/2007Updated coding section with 10/01/2007 ICD-9 changes.
Reviewed12/07/2006MPTAC review. No change to guideline position statement.
Revised12/01/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger OrganizationsLast Review DateDocument NumberTitle
Anthem Virginia07/29/2002VA State Memo 1157Medical Foods For Inborn Errors Of Metabolism And Severe Protein Or Soy Allergies
Anthem MidWest02/11/2005Anthem Midwest UM Guideline DME-019Specialized Pediatric Nutrition
Anthem Connecticut11/23/2004CT State UM GuidelineSpecialized Pediatric Nutrition Formula
WellPoint Health Networks, Inc.12/04/20049.06.05Home Enteral Nutrition