Clinical UM Guideline
|Subject:||Home Enteral Nutrition|
|Guideline #:||CG-MED-08||Current Effective Date:||01/05/2016|
|Status:||Reviewed||Last Review Date:||11/05/2015|
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:
I. Oral 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
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:
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.
|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-B4088||Nasogastric, stomach, gastrostomy/jejunostomy tubes [includes codes B4081, B4082, B4083, B4087, B4088]|
|B4100||Food thickener, administered orally, per ounce|
|B4102||Enteral formula, for adults, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit|
|B4103||Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit|
|B4104||Additive for enteral formula (e.g., fiber)|
|B4149-B4162||Enteral formula (administered through an enteral feeding tube) [includes codes B4149, B4150, B4152, B4153, B4154, B4155, B4157, B4158, B4159, B4160, B4161, B4162]|
|B9000-B9002||Enteral nutrition infusion pump [includes codes B9000, B9002]|
|S9340-S9343||Home therapy, enteral nutrition [includes codes S9340, S9341, S9342, S9343]|
|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|
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 enteral nutrition products. 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:
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.
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 October 05, 2015.
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.
Supplemental nutrition: Fewer than 50% of daily calories are supplied by enteral nutrition products.
Total enteral nutrition (TEN): Individual is receiving more than 50% of their daily caloric intake via enteral nutrition products.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Home Enteral Nutrition
|Reviewed||11/05/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion/General Information, Definitions, References and Website sections. Removed ICD-9 codes from Coding section.|
|Revised||11/13/2014||MPTAC review. Clarified Clinical Indications. Updated Description, Discussion/General Information, References and Websites sections.|
|Revised||11/14/2013||MPTAC 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.|
|Reviewed||02/14/2013||MPTAC review. No change to position statement.|
|Reviewed||02/16/2012||MPTAC review. No change to position statement.|
|MPTAC review. No change to position statement. Updated Reference section.|
|01/01/2011||Updated Coding section with 01/01/2011 HCPCS changes.|
|Reviewed||02/25/2010||MPTAC review. No change to position statement. Updated Reference section.|
|Revised||02/26/2009||MPTAC 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.|
|01/01/2009||Updated Coding section with 01/01/2009 HCPCS changes.|
|Revised||08/28/2008||MPTAC 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.|
|Revised||05/15/2008||MPTAC review. Revised age criteria for enteral feeding via tube. Reorganized position statement section. Clarified criteria regarding "inborn error of metabolism."|
|Revised||11/29/2007||MPTAC 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.|
|10/01/2007||Updated coding section with 10/01/2007 ICD-9 changes.|
|Reviewed||12/07/2006||MPTAC review. No change to guideline position statement.|
|Revised||12/01/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|Anthem Virginia||07/29/2002||VA State Memo 1157||Medical Foods For Inborn Errors Of Metabolism And Severe Protein Or Soy Allergies|
|Anthem MidWest||02/11/2005||Anthem Midwest UM Guideline DME-019||Specialized Pediatric Nutrition|
|Anthem Connecticut||11/23/2004||CT State UM Guideline||Specialized Pediatric Nutrition Formula|
|WellPoint Health Networks, Inc.||12/04/2004||9.06.05||Home Enteral Nutrition|