Nutritional Support

Number: 0061

(Replaces CPB 144)

Policy

Notes:

1. For members with such a plan benefit, specific nutritional support is considered to be a medical item only when it is administered enterally (i.e., by feeding tube) or parenterally (i.e., by intravenous administration) where the member has either (a) a permanent Footnotes^* non-function or disease of the structures that normally permit food to reach the small bowel; or (b) disease of the small bowel that impairs digestion and absorption of an oral diet, either of which requires enteral or parenteral feedings to provide sufficient nutrients to maintain weight and strength commensurate with the member's overall health status.  Note: Not all benefit plans cover nutritional support even in the circumstances stated above.  Please check benefit plan descriptions.

2. Aetna does not cover nutritional support that is taken orally (i.e., by mouth), unless mandated by state law.  Oral nutrition is not considered a medical item.  See section on Special Medical Foods below.

3. Regular food products are not considered medical items.  Regular food products include food thickeners, baby food, gluten-free food products, high protein powders and mixes, low carbohydrate diets, normal grocery items, nutritional supplement puddings, weight-loss foods and formula (products to aid weight loss), or other regular grocery products that can be mixed in blenders and used with an enteral system regardless of whether these regular food products are taken orally or parenterally.  

Determinants of the route of administration of nutritional support include the functional status of the gastrointestinal tract and the anticipated duration of therapy.

1. Enteral Tube Feedings

   Enteral nutrition is the provision of nutritional requirements through a tube into the stomach or small intestine.

   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.

   Aetna considers enteral tube feedings medically necessary when the member has either (a) permanent Footnotes^* non-function or disease of the structures that normally permit food to reach the small bowel; or (b) disease of the small bowel that impairs digestion and absorption of an oral diet, either of which requires tube feedings to provide sufficient nutrients to maintain weight and strength commensurate with the member's overall health status.

   The member's condition could be either an anatomic abnormality (e.g., obstruction due to head and neck cancer or reconstructive surgery, etc.) or a motility disorder (e.g., severe dysphagia following a stroke, neuromuscular or disease of the central nervous system that interferes with the ability to chew or swallow, etc.).  Enteral nutrition is not considered medically necessary for members with a functioning gastrointestinal tract whose need for enteral nutrition is due to reasons such as anorexia or nausea associated with mood disorder, end-stage disease, etc.

   The member must require tube feedings to maintain weight and strength commensurate with the member's overall health status.  Adequate nutrition must not be possible by dietary adjustment and/or oral supplements.  Enteral nutrition may be considered medically necessary for members with partial impairments (e.g., a member with dysphagia who can swallow small amounts of food or a member with Crohn's disease who requires prolonged infusion of enteral nutrients to overcome a problem with absorption).

   Note: Enteral nutrition products that are administered orally and related supplies are not covered.

   Footnotes^* Note: The member must have a permanent impairment.  Permanence does not require a determination that there is no possibility that the member's condition may improve sometime in the future.  If the judgment of the doctor, substantiated in the medical record, is that the impairment can reasonably be expected to exceed 3 months (90 days), the test of permanence is considered met.  This is consistent with Center for Medicare and Medicaid Services (CMS) guidelines.

   Formulas consisting of semi-synthetic intact proteins or protein isolates (e.g., Enrich, Ensure, Ensure HN, Ensure Powder, Isocal, Lonalac Powder, Meritene, Meritene Powder, Osmolite, Osmolite HN, Portagen Powder, Renu, Sustacal, Sustagen Powder, Travasorb) are considered medically necessary for enteral feeding of the majority of older members who meet criteria for enteral feeding.  Formulas consisting of natural intact proteins or protein isolates (e.g., Compleat B, Compleat B Modified, Vitaneed) are considered medically necessary for enteral feeding of members with an allergy or intolerance to semi-synthetic formulas.  Calorically dense formulas are also considered medically necessary for enteral feedings if they are indicated.  The medical necessity for special formulas for enteral feedings must be justified in each member.

   Infant Formula

   Note: Infant formulas  are only covered if administered via the tube-feeding route and the criteria for coverage of enteral feedings are met.  Infant formulas given orally are not covered.  In addition, breast milk additive to prevent necrotizing enterocolitis in premature infants is only covered if administered via the tube-feeding route and the criteria for coverage of enteral feedings are met.

   Equipment

   Appropriate nutrients, administration supplies, and equipment are considered medically necessary for persons who meet criteria for enteral feedings.  Tube feedings are usually given by gravity feedings or syringe.  Pumps are considered medically necessary durable medical equipment (DME) only where gravity feedings or syringe feedings have caused complications or are otherwise not indicated (e.g., gravity feeding is not satisfactory due to reflux and/or aspiration, severe diarrhea, dumping syndrome, administration rate less than 100 ml/hr, blood glucose fluctuations, circulatory overload, gastrostomy/jejunostomy tube used for feeding).  More than 3 nasogastric tubes or 1 gastrostomy/jejunostomy tube every 3 months is rarely considered medically necessary.

   Note: Some Aetna plans exclude coverage of DME and supplies.  Please check benefit plan descriptions.

2. Relizorb

   Relizorb is considered experimental and investigational for use with enteral tube feedings due to insufficient evidence in the peer-reviewed literature.

3. Parenteral Nutrition/Total Parenteral Nutrition (TPN)

   Parenteral nutrition involves the delivery of micronutrients and macronutrients through catheters in central or peripheral veins.  In most instances, the central venous route is utilized; for long-term total parenteral nutrition (TPN), a central catheter (e.g., Hickman, Broviac, PIC) is burrowed through a subcutaneous tunnel on the anterior chest.

   Generally, the parenteral approach is considered medically necessary only if adequate nutritional intake is not possible via the oral or tube-feeding route.

   Aetna considers parenteral nutrition medically necessary for members who meet any of the following criteria:

   1. Documentation of a failure of enteral (i.e., oral or tube feeding) nutrition, as defined by either of the following:

      1. A non-edematous or post-dialysis documented loss of greater than 10 % of body weight over a 3-month period; or

      2. Total protein less then 6 g/dL or serum albumin less than 3.4 g/dL;

   2. A condition in which it is necessary for the gastrointestinal tract to be totally non-functioning for a period of time;
   3. Evidence of structural or functional bowel disease that makes oral and tube feedings inappropriate;
   4. Hyperemesis gravidarum (only in cases of failed medical management or when used in a step-therapy program);
   5. Member is peri-operative (regardless of disease state) and unable to tolerate oral or tube feedings.

   Parenteral nutrition may be either “self-mixed” (i.e., the member or family caregiver is taught to prepare the nutrient solution aseptically) or “pre-mixed”.  The doctor must justify the need for pre-mixed parenteral nutritional solutions.

   Parenteral nutrition is not considered medically necessary for members with a functioning gastrointestinal tract whose need for parenteral nutrition is only due to:

   1. A physical disorder impairing food intake such as the dyspnea of severe pulmonary or cardiac disease;
   2. A psychological disorder impairing food intake such as depression;
   3. A side effect of a medication;
   4. A swallowing disorder;
   5. A temporary defect in gastric emptying such as a metabolic or electrolyte disorder;
   6. Disorders inducing anorexia such as cancer;
   7. Renal failure and/or dialysis. Footnotes^*

   Footnotes^*Members receiving intra-dialytic parenteral nutrition must meet the criteria for total parenteral nutrition set forth above.

   Aetna considers intra-peritoneal nutrition experimental and investigational.  Aetna considers intra-peritoneal amino acid (IPAA) supplementation medically necessary for members on peritoneal dialysis when all of the following criteria are met:

   1. Inability to administer or tolerate adequate oral protein nutrition, including food supplements, or enteral tube feeding; and
   2. The combination of some oral or enteral intake that, when combined with IPAA, will meet the individual's nutritional goals; and
   3. There is evidence of inadequate dietary protein intake and protein malnutrition.

   Equipment

   If the criteria for parenteral nutrition are met, medically necessary nutrients, administration supplies, and equipment are considered medically necessary.

4. Special Medical Foods Taken Orally

   Note: Aetna covers special medical foods only when mandated by state law.

   Special medical foods are used for the treatment of inborn errors of metabolism (histidinemia, homocystinuria, maple syrup urine disease [MSUD], phenylketonuria [PKU], and tyrosinemia).  The special oral formulas are designed to restrict intake of one or more amino acids.  Some states now have mandates requiring coverage of these dietary formulas.

   Aetna does not cover banked breast milk, food supplements, specialized infant formulas, vitamins and/or minerals taken orally (i.e., by mouth).

   Food supplements, specialized infant formulas (e.g., Alimentum, Elecare, Neocate, and Nutramigen), lactose-free foods, vitamins and/or minerals may be used to replace intolerable foods, for lactose intolerance, to supplement a deficient diet, or to provide alternative nutrition in the presence of such conditions as allergies, gastrointestinal disorders, hypoglycemia, and obesity.  Food supplements, lactose-free foods, specialized infant formulas, vitamins and/or minerals taken orally are not covered, even if they are required to maintain weight or strength and regardless of whether these are prescribed by a physician.

   Most Aetna plans do not specifically include coverage of infant formulas when taken orally.  In the absence of a specific inclusion or state mandate, specialized infant formulas are not covered.

Background

Parenteral nutrition involves the delivery of micronutrients and macronutrients through catheters in central or peripheral veins.  In most instances, the central venous route is utilized, and for long-term total parenteral nutrition a central catheter (e.g., Hickman, Broviac, PIC) is burrowed through a subcutaneous tunnel on the anterior chest.

Enteral nutrition can be administered via a small catheter placed through the nose into the stomach or by a surgically placed catheter into the stomach or intestines.  Enteral nutrition therapy may supplement protein and calories in a variety of situations where oral nutrition is not adequate, with the intention of providing part or all of the daily requirements.  Specialized diets for specific diseases or pathophysiologic situations may be administered via enteral nutrition.  These specialized diets may involve restricting a particular element of the diet (e.g., fat, lactose), adding a particular nutrient that may be required in larger amounts than are available from a regular diet (e.g., calcium, potassium), or altering the consistency of the diet (e.g., high-fiber, full-liquid).

The need for specialized foods is very common, and for most conditions, the specialized food is needed for the person's entire lifetime.  For example, in Europe and the United States, the prevalence of lactose intolerance is 7 to 20 % in Caucasians, and is as high as 80 to 95 % among Native Americans, 65 to 75 % among Africans and African Americans, and 50 % in Hispanics (Scrimshaw et al, 1988).  The prevalence exceeds 90 % in some populations in eastern Asia.

Another example of a common medical condition requiring a specialized diet is celiac disease (also called gluten-sensitive enteropathy and non-tropical sprue), with a prevalence of almost 1 % of the population (Fasano et al, 2003).  There are many other examples where specialized diets are prescribed, which could extend to specialized diets for hypertension, diabetes, or cardiovascular disease.

Sullivan et al (2010) evaluated the health benefits of an exclusively human milk-based diet compared with a diet of both human milk and bovine milk-based products in extremely premature infants.  Infants fed their own mothers' milk were randomized to 1 of 3 study groups.  Groups HM100 and HM40 received pasteurized donor human milk-based human milk fortifier (HMF) when the enteral intake was 100 and 40 ml/kg/day, respectively, and both groups received pasteurized donor human milk if no mother's milk was available.  Group BOV received bovine milk-based HMF when the enteral intake was 100 ml/kg/day and preterm formula if no mother's milk was available.  Outcomes included duration of parenteral nutrition, morbidity, and growth.  The 3 groups (total n = 207 infants) had similar baseline demographic variables, duration of parenteral nutrition, rates of late-onset sepsis, and growth.  The groups receiving an exclusively human milk diet had significantly lower rates of necrotizing enterocolitis (NEC; p = 0.02) and NEC requiring surgical intervention (p = 0.007).  The authors concluded that for extremely premature infants, an exclusively human milk-based diet is associated with significantly lower rates of NEC and surgical NEC when compared with a mother's milk-based diet that also includes bovine milk-based products.

Ganapathy et al (2012) evaluated the cost-effectiveness of a 100 % human milk-based diet composed of mother's milk fortified with a donor human milk-based HMF versus mother's milk fortified with bovine milk-based HMF to initiate enteral nutrition among extremely premature infants in the neonatal intensive care unit (NICU).  A net expected costs calculator was developed to compare the total NICU costs among extremely premature infants who were fed either a bovine milk-based HMF-fortified diet or a 100 % human milk-based diet, based on the previously observed risks of overall NEC and surgical NEC in a randomized controlled study that compared outcomes of these 2 feeding strategies among 207 very low birth-weight infants.  The average NICU costs for an extremely premature infant without NEC and the incremental costs due to medical and surgical NEC were derived from a separate analysis of hospital discharges in the state of California in 2007.  The sensitivity of cost-effectiveness results to the risks and costs of NEC and to prices of milk supplements was studied.  The adjusted incremental costs of medical NEC and surgical NEC over and above the average costs incurred for extremely premature infants without NEC, in 2011 US$, were $74,004 (95 % confidence interval [CI]: $47,051 to $100,957) and $198,040 (95 % CI: $159,261 to $236,819) per infant, respectively.  Extremely premature infants fed with 100 % human-milk based products had lower expected NICU length of stay and total expected costs of hospitalization, resulting in net direct savings of 3.9 NICU days and $8,167.17 (95 % CI: $4,405 to $11,930) per extremely premature infant (p < 0.0001).  Costs savings from the donor HMF strategy were sensitive to price and quantity of donor HMF, percentage reduction in risk of overall NEC and surgical NEC achieved, and incremental costs of surgical NEC.  The authors concluded that compared with feeding extremely premature infants with mother's milk fortified with bovine milk-based supplements, a 100 % human milk-based diet that includes mother's milk fortified with donor human milk-based HMF may result in potential net savings on medical care resources by preventing NEC.

Relizorb:

Relizorb is considered a first of it's kind enzyme cartridge.  It is designed to mimic the action of pancreatic lipase for use in adults receiving enteral tube feedings (Medscape, 2015). It was approved by the Food and Drug Administration (FDA) for this indication.  However, large scale studies in human subjects are still lacking.  Therefore, there is an insufficient evidence base to support its use at this time.

Schwarzenberg and associates (2016) stated that nutrition is integral to the care of individuals with cystic fibrosis (CF).  Better nutritional status is associated with improved pulmonary function.  In some individuals with CF, enteral tube feeding can be useful in achieving optimal nutritional status.  Current nutrition guidelines do not include detailed recommendations for enteral tube feeding.  The Cystic Fibrosis Foundation convened an expert panel to develop enteral tube feeding recommendations based on a systematic review of the evidence and expert opinion.  These guidelines addressed when to consider enteral tube feeding, assessment of confounding causes of poor nutrition in CF, preparation of the patient for placement of the enteral feeding tube, management of the tube after placement and education about enteral feeding.  These recommendations are intended to guide the CF care team, individuals with CF, and their families through the enteral tube feeding process.  The guideline stated that an inline cartridge enzyme (lipase) delivery system for enteral feeds was approved by the FDA for adults during the development of these guidelines; evaluation of its benefits and limits should be considered before use.

In a multi-center, randomized, double-blind, cross-over, open-label clinical trial, Freedman and colleagues (2017) evaluated the safety, tolerability, and fat absorption of a new in-line digestive cartridge (Relizorb) that hydrolyzes fat in enteral formula provided to patients with CF.  Plasma omega-3 fatty acid (FA) concentrations were measured and used as markers of fat absorption.  Gastro-intestinal symptoms were recorded to evaluate safety and tolerability.  Information regarding the effect of enteral nutrition (EN) on appetite and breakfast consumption was also collected.  Before study entry, participants had received EN for a mean of 6.6 years at a mean volume of approximately 800 ml, yet had a mean body mass index (BMI) of only 17.5 kg/m and omega-3 FA plasma concentrations were only 60 % of levels found in normal healthy subjects.  Compared with placebo, cartridge use resulted in a statistically significant 2.8-fold increase in plasma omega-3 FA concentrations.  There were no adverse experiences associated with cartridge use, and a decrease in the frequency and severity of most symptoms of malabsorption was observed with cartridge use.  Participants reported increased preservation of appetite and breakfast consumption with cartridge use compared with their pre-study regimen.  The authors concluded that the use of this in-line digestive cartridge was safe and well-tolerated, and resulted in significantly increased levels of plasma omega-3 FA used with enteral formula, suggesting an overall increased fat absorption. 

The authors stated that the main drawback of this study was the small sample size (n = 34).  Despite the relatively small sample size, the study, however, included approximately 1 % of the population of patients with CF who receive EN.  In addition, the age range of the study population is representative of the population of patients with CF in the United States.  Thus, these study results should be generalizable to the larger population of patients with CF and exocrine pancreatic insufficiency who receive supplemental EN.  Only 1 feeding through digestive cartridge was, however, used to measure its effect on fat absorption, and only 7 days of digestive cartridge use were used to measure its safety.  They stated that a longer-term study is currently ongoing to assess the effects of sustained digestive cartridge use, particularly without concomitant pancreatic enzyme replacement therapy.

Alkaade and Vareedayah (2017) stated that exocrine pancreatic insufficiency (EPI) is characterized by a deficiency of exocrine pancreatic enzymes, resulting in deficits in digestion of all macronutrients, with deficiencies in digestion of fats being the most clinically relevant.  The leading cause of EPI is chronic pancreatitis.  However, many other causes and conditions may be implicated, including CF, pancreatic duct obstruction, gastric and pancreatic surgery, diabetes mellitus and other conditions.  Physical and biochemical causes of EPI include decreased production and secretion of lipase, increased lipase destruction, pancreatic duct obstruction, decreased lipase stimulation and degradation, as well as gastro-intestinal (GI) motility disorders.  Exocrine pancreatic insufficiency is largely diagnosed clinically, and is often identified by symptoms such as steatorrhea, weight loss, abdominal discomfort, and abdominal bloating.  Lifestyle modifications (e.g., smoking cessation, limiting or avoiding alcoholic drinks, and reducing dietary fat intake) and exogenous pancreatic enzyme supplements are commonly used to help restore normal digestion and absorption of dietary nutrients in patients with EPI.  The authors noted that approximately 44 % of patients with CF require oral supplemental nutrition, and 11 % require enteral tube feeding.  Nutrient utilization may be improved using semi-elemental or elemental enteral products or dosing pancreatic enzyme replacement therapy (PERT) with enteral feedings.  Additionally, a recently approved in-line medical device with immobilized lipase (Relizorb) has been developed to hydrolyze fats in enteral formula.

Nguyen (2017) noted that EN is preferred over parenteral nutrition (PN) as a result of the greater safety of EN therapy and comparative convenience.  A wide variety of EN products have been developed, including disease-specific products to help manage the nutritional needs of patients with kidney failure, liver failure, lung disease, diabetes, and other conditions.  An assessment of each patient's nutritional needs and digestive function should be conducted prior to initiation of EN therapy.  Other considerations in determining the appropriate route and method of EN administration include the time and nursing involvement required for administration, potential complications of medication administration, and concerns related to pancreatic dysfunction in certain groups.  The author noted that (i) a recently approved in-line medical cartridge with immobilized lipase (Relizorb) hydrolyzes fats in enteral formulas just prior to delivery into the patient with an enteral feeding tube; and (ii) to eliminate the challenges of PERT administration, the Cystic Fibrosis Foundation indicates Relizorb may be used to deliver enteral formula in this population.

Freedman (2017) stated that patients with EPI have suboptimal secretion of pancreatic digestive enzymes and experience a range of clinical symptoms related to the malabsorption of fat.  In patients with EPI unable to meet their nutritional requirements, EN support is used to augment nutritional status.  In addition to protein and carbohydrate, EN formulas contain fats as a calorie source, as well as vitamins and minerals to help prevent nutritional deficiencies related to malabsorption.  Semi-elemental EN formulas are advantageous as they contain hydrolyzed protein, shorter chain carbohydrates, and may contain medium chain triglycerides as a fat source.  However, severely pancreatic insufficient patients may be unable to absorb complex long-chain triglycerides provided by EN formulas due to insufficient pancreatic lipase; replacement pancreatic enzyme products are recommended for these patients.  Currently, none of the FDA-approved PERT products are indicated for use in patients receiving EN and administration of enzymes by mixing into EN formula is not supported by guidelines as this route is associated with risks.  Relizorb (immobilized lipase) is a novel in-line digestive cartridge that has been designed to address the unmet need for PERT in patients receiving EN.  Relizorb efficacy and compatibility with a range of commercially available polymeric and semi-elemental formulas with varying nutrient, caloric content, and triglyceride chain lengths have been demonstrated.  In most formulas, Relizorb efficiently hydrolyzed greater than 90 % of fats within the formula into absorbable FAs and monoglycerides.

Aetna's policy on parenteral and enteral nutrition is similar to Medicare policy.  Medicare provides reimbursement under the part-B prosthetic-device benefit for parenteral and enteral nutrition.  Consistent with its policy of covering supplies necessary for use of prosthetics, Medicare will generally cover medically necessary supplies, equipment, and nutrients associated with parenteral and enteral nutrition if the coverage requirements for enteral or parenteral nutritional therapy are met under the prosthetic device benefit provision.

The above policy is based on the following references: