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Nutritional Support
Policy History
Last Review
03/19/2021
Effective: 10/20/1995
Next
Review: 01/13/2022
Review History
Definitions
Additional Information
Clinical Policy Bulletin
Notes
Number: 0061
(Replaces CPB 144)
Policy *Please see amendment for PennsylvaniaMedicaid at the end of this CPB.
Notes: I. 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 * 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.
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II. 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.
III. 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.
I. 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 *
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
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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.
* 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.
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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
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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.
II. Relizorb
Aetna considers digestive enzyme cartridges (e.g. Relizorb,
Alcresta Pharmaceuticals) which connect to enteral feeding tubes
for hydrolysis (digestion) of fats in enteral formula, medically
necessary for persons with cystic fibrosis on enteral feedings.
III. 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:
A. 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 than 6 g/dL or serum albumin
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less than 3.4 g/dL;
B. A condition in which it is necessary for the
gastrointestinal tract to be totally non-functioning for a
period of time;
C. Evidence of structural or functional bowel disease that
makes oral and tube feedings inappropriate;
D. Hyperemesis gravidarum (only in cases of failed
medical management or when used in a step-therapy
program);
E. 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:
A. A physical disorder impairing food intake such as the
dyspnea of severe pulmonary or cardiac disease;
B. A psychological disorder impairing food intake such as
depression;
C. A side effect of a medication;
D. A swallowing disorder;
E. A temporary defect in gastric emptying such as a
metabolic or electrolyte disorder;
F. Disorders inducing anorexia such as cancer;
G. Renal failure and/or dialysis. *
*Members receiving intra-dialytic parenteral nutrition
must meet the criteria for total parenteral nutrition set
forth above.
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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:
A. Inability to administer or tolerate adequate oral
protein nutrition, including food supplements, or
enteral tube feeding; and
B. The combination of some oral or enteral intake that,
when combined with IPAA, will meet the individual's
nutritional goals; and
C. 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.
IV. 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).
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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.
V. Enteral Nutrition/Enteral Feeding
Aetna considers enteral nutrition for induction and maintenance
of remission in adults with Crohn's disease experimental and
investigational because of insufficient evidence in the peer-
reviewed literature.
Aetna considers enteral nutrition for the treatment of eating
disorders (except in life-saving cases of severe cases of anorexia
nervosa) experimental and investigational because of insufficient
evidence in the peer-reviewed literature.
Aetna considers enteral lactoferrin supplementation for
prevention of sepsis and necrotizing enterocolitis in preterm
infants experimental and investigational because of insufficient
evidence in the peer-reviewed literature.
Background
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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.
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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.
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
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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
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Fat malabsorption is most common in individuals who cannot
produce or secrete adequate amounts of digestive enzymes
because of compromised pancreatic function. According to
current United European Gastroenterology guidelines (Lohr, et
al., 2018), "enteral nutrition is indicated with PERT [pancreatic
enzyme replacement therapy] administered alongside where
necessary (GRADE 2C, strong agreement)" in persons with
pancreatic insufficiency who are unable to achieve adequate
intake with oral nutrition.
There is little evidence to support how PERT is best
administered and optimised in people with CF receiving
enteral nutrition (van der Haak & Kench, 2017). In the absence
of sufficient evidence, a number of techniques have been
described including oral administration, PERT suspended in
juice, PERT dissolved in bicarbonate and administered via an
enteral feeding tube, and administration of crushed
microspheres via an enteral feeding tube.
According to the manufacturer, 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). Relizorb is an enzyme packed
cartridge indicated for use in adults to hydrolyze fats in entral
formula. The cartridge fits in line with enteral feeding systems,
and is connected between the infusion pump and the feeding
tube. The active ingredient is the digestive enzyme lipase,
attached to polymetric carriers together called iLipase. As the
formula passes through Relizorb, it makes contact with the
iLipase, and fats in the formula are modified to more
absorbable forms prior to ingestion. It was cleared for
marketing by the Food and Drug Administration (FDA) for this
indication. However, efficacy data are limited and Relizorb has
not been compared to other methods of administration of
PERT. Therefore, there is an insufficient evidence base to
support its use at this time.
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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 800ml, yet had a mean body
mass index (BMI) of only 17.5kg/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
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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 of this manufacturer-sponsored study 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. The authors stated that
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
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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
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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. The author stated that
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.
Freedman and colleagues (2018) noted that PI and
malabsorption of fats lead to reduced caloric intake, inability to
maintain weight, and increased GI symptoms; thus, EN is used
in patients with CF and poor nutritional status. In an industry-
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sponsored study, these researchers evaluated safety,
tolerability and improvement of FA status in red blood cell
(RBC) membranes, a marker of long-term FA absorption, with
an in-line digestive cartridge (Relizorb) that hydrolyzes fat in
enteral formula. Patients with CF receiving EN participated in
a multi-center, 90-day open-label study during which Relizorb
was used with overnight EN. The primary end-point was
change over time in RBC uptake of docosahexaenoic acid
(DHA) and eicosapentaenoic acid (EPA); GI symptoms were
collected to evaluate safety and tolerability. Several clinical
and anthropometric parameters were also assessed
throughout the study. A total of 36 subjects completed the
study with a mean age of 13.6 years, BMI of 17.7 and 6.2
years mean use of over-night EN. Fat absorption significantly
improved as shown by increased RBC levels of DHA+EPA,
improved ω-6/ω-3 ratio, and increased plasma levels of
DHA+EPA; Relizorb use was not associated with any
unanticipated adverse events (AEs). The authors concluded
that this study established the safety and tolerability of
Relizorb and showed its potential to normalize fat absorption,
improve symptoms commonly associated with fat mal-
absorption and enhance nutritional status in patients with CF
receiving EN feedings. They stated that this was the 1st
prospective study to show EN can improve FA abnormalities in
CF. Since improvement in omega-3 levels has been shown to
help pulmonary and inflammatory status as well as
anthropometric parameters in CF, Relizorb may have
important long-term therapeutic benefits in patients with CF.
Moreover, these investigators stated that it is not possible to
draw definitive conclusions from the current and previous
Relizorb studies regarding the influence of Relizorb use on
changes in patient anthropometric measurements.
The authors stated that this study had several drawbacks. It
was a relatively small study (n = 36). In addition, the study
was strictly open-label and was not intended to compare
outcomes between participants who did and did not use
Relizorb. Furthermore, other than enteral nutrition, dietary
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intake was not recorded during the study, limiting the ability to
determine if oral caloric intake was adequate to lead to weight
gain. Additionally, the study may not have been long enough
to observe an increase in body weight or BMI for patients in a
relatively fat-starved condition. Furthermore, because the
current study did not measure body tissue composition, it is
unknown whether subjects improved their tissue composition
without changing body weight or size. It may turn out that
nutritional health may be more accurately measured using
biomarkers other than the traditional body weight and BMI.
Body tissue composition, including fat mass, fat-free mass,
and lean body mass may be more important to overall health
than body size or mass. It is likely that body tissue
composition is an indirect measure of important cellular and
molecular processes that may be directly measured using
molecules such as long-chain polyunsaturated FAs
(LCPUFAs), which are essential building blocks of cell
membranes and play important roles in cell and tissue function
throughout the body.
Formula versus Donor Breast Milk for Feeding Preterm or Low Birth Weight Infants
Quigley and colleagues (2018) noted that when sufficient
maternal breast milk is not available, alternative forms of EN
for preterm or low birth weight (LBW) infants are donor breast
milk or artificial formula. Donor breast milk may retain some of
the non-nutritive benefits of maternal breast milk for preterm or
LBW infants. However, feeding with artificial formula may
ensure more consistent delivery of greater amounts of
nutrients. Uncertainty exists about the balance of risks and
benefits of feeding formula versus donor breast milk for
preterm or LBW infants. In a Cochrane review, these
investigators determined the effect of feeding with formula
compared with donor breast milk on growth and development
in preterm or LBW infants. They used the Cochrane Neonatal
search strategy, including electronic searches of the Cochrane
Central Register of Controlled Trials (CENTRAL; 2017, Issue
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6), Ovid Medline, Embase, and the Cumulative Index to
Nursing and Allied Health Literature (until June 8, 2017), as
well as conference proceedings and previous reviews.
Randomized or quasi-randomized controlled trials (RCTs)
comparing feeding with formula versus donor breast milk in
preterm or LBW infants were selected for analysis. Two
review authors assessed trial eligibility and risk of bias and
extracted data independently. They analyzed treatment
effects as described in the individual trials and reported risk
ratios (RRs) and risk differences (RDs) for dichotomous data,
and mean differences (MDs) for continuous data, with
respective 95 % CIs. These researchers used a fixed-effect
model in meta-analyses and explored potential causes of
heterogeneity in subgroup analyses. They assessed the
quality of evidence for the main comparison at the outcome
level using "Grading of Recommendations Assessment,
Development and Evaluation" (GRADE) methods. A total of
11 trials, in which 1,809 infants participated in total, fulfilled the
inclusion criteria; 4 trials compared standard term formula
versus donor breast milk; and 7 compared nutrient-enriched
preterm formula versus donor breast milk. Only the 4 most
recent trials used nutrient-fortified donor breast milk. The trials
contain various weaknesses in methodological quality,
specifically concerns about allocation concealment in 4 trials
and lack of blinding in most of the trials. Formula-fed infants
had higher in-hospital rates of weight gain (MD 2.51, 95 % CI:
1.93 to 3.08 g/kg/day), linear growth (MD 1.21, 95 % CI: 0.77
to 1.65 mm/week) and head growth (MD 0.85, 95 % CI: 0.47 to
1.23 mm/week). These researchers did not find evidence of
an effect on long-term growth or neurodevelopment. Formula
feeding increased the risk of necrotizing enterocolitis (typical
RR 1.87, 95 % CI: 1.23 to 2.85; RD 0.03, 95 % CI: 0.01 to
0.06). The GRADE quality of evidence was moderate for rates
of weight gain, linear growth, and head growth (down-graded
for high levels of heterogeneity) and was moderate for
neurodevelopmental disability, all-cause mortality, and
necrotizing enterocolitis (down-graded for imprecision). The
authors concluded that in preterm and LBW infants, feeding
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with formula compared with donor breast milk, either as a
supplement to maternal expressed breast milk or as a sole
diet, resulted in higher rates of weight gain, linear growth, and
head growth and a higher risk of developing necrotizing
enterocolitis. The trial data did not show an effect on all-cause
mortality, or on long-term growth or neurodevelopment.
Enteral Nutrition for Induction / Maintenance of Remission in Crohn's Disease
Narula and associates (2018) noted that corticosteroids are
often preferred over EN as induction therapy for Crohn's
disease (CD). Prior meta-analyses suggested that
corticosteroids are superior to EN for induction of remission in
CD. Treatment failures in EN trials are often due to poor
compliance, with drop-outs frequently due to poor acceptance
of a naso-gastric (NG) tube and unpalatable formulations.
This systematic review was an update of a previously
published Cochrane review. These investigators evaluated
the safety and effectiveness of exclusive EN as primary
therapy to induce remission in CD and examined the
importance of formula composition on effectiveness. They
searched Medline, Embase and CENTRAL from inception to
July 5, 2017. They also searched references of retrieved
articles and conference abstracts; RCTs involving patients with
active CD were considered for inclusion. Studies comparing
one type of EN to another type of EN or conventional
corticosteroids were selected for review. Data were extracted
independently by at least 2 authors. The primary outcome
was clinical remission; secondary outcomes included adverse
events (AEs), serious adverse events (SAEs) and withdrawal
due to AEs. For dichotomous outcomes, these researchers
calculated the RR and 95 % CI. A random-effects model was
used to pool data. They performed intention-to-treat (ITT) and
per-protocol analyses for the primary outcome. Heterogeneity
was explored using the Chi-2 and I2 statistics. The studies
were separated into 2 comparisons: one EN formulation
compared to another EN formulation; and EN compared to
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corticosteroids. Subgroup analyses were based on formula
composition and age. Sensitivity analyses included abstract
publications and poor quality studies. These investigators
used the Cochrane risk of bias tool to assess study quality.
They used the GRADE criteria to assess the overall quality of
the evidence supporting the primary outcome and selected
secondary outcomes. A total of 27 studies (1,011 participants)
were included; 3 studies were rated as low risk of bias; 7
studies were rated as high risk of bias, and 17 were rated as
unclear risk of bias due to insufficient information; 17 trials
compared different formulations of EN, 13 studies compared 1
or more elemental formulas to a non-elemental formula, 3
studies compared EN diets of similar protein composition but
different fat composition, and 1 study compared non-elemental
diets differing in glutamine enrichment. Meta-analysis of 11
trials (378 subjects) demonstrated no difference in remission
rates; 64 % (134/210) of patients in the elemental group
achieved remission compared to 62 % (105/168) of patients in
the non-elemental group (RR 1.02, 95 % CI: 0.88 to 1.18;
GRADE very low quality). A per-protocol analysis (346
participants) produced similar results (RR 1.04, 95 % CI: 0.91
to 1.18). Subgroup analyses performed to evaluate the
different types of elemental and non-elemental diets
(elemental, semi-elemental and polymeric) showed no
differences in remission rates. An analysis of 7 trials including
209 patients treated with EN formulas of differing fat content
(low fat: less than 20 g/1,000 kCal versus high fat: greater than
20 g/1,000 kCal) demonstrated no difference in remission
rates (RR 1.03; 95 % CI: 0.85 to 1.26). Very low fat content
(less than 3 g/1,000 kCal) and very low long chain triglycerides
demonstrated higher remission rates than higher content EN
formulas. There was no difference between elemental and non-
elemental diets in AEs rates (RR 1.00, 95 % CI: 0.63 to 1.60;
GRADE very low quality), or withdrawals due to AEs (RR 1.29,
95 % CI: 0.80 to 2.09; GRADE very low quality).
Common AEs included nausea, vomiting, diarrhea and
bloating. A total of 10 trials compared EN to steroid therapy.
Meta-analysis of 8 trials (223 participants) demonstrated no
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difference in remission rates between EN and steroids; 50 %
(111/223) of patients in the EN group achieved remission
compared to 72 % (133/186) of patients in the steroid group
(RR 0.77, 95 % CI: 0.58 to 1.03; GRADE very low quality).
Subgroup analysis by age showed a difference in remission
rates for adults but not for children. In adults, 45 % (87/194) of
EN patients achieved remission compared to 73 % (116/158)
of steroid patients (RR 0.65, 95 % CI: 0.52 to 0.82; GRADE
very low quality). In children, 83 % (24/29) of EN patients
achieved remission compared to 61 % (17/28) of steroid
patients (RR 1.35, 95 % CI: 0.92 to 1.97; GRADE very low
quality). A per-protocol analysis produced similar results (RR
0.93, 95 % CI: 0.75 to 1.14). The per-protocol subgroup
analysis showed a difference in remission rates for both adults
(RR 0.82, 95 % CI: 0.70 to 0.95) and children (RR 1.43, 95 %
CI: 1.03 to 1.97). There was no difference in AEs rates (RR
1.39, 95 % CI: 0.62 to 3.11; GRADE very low quality).
However, patients on EN were more likely to withdraw due to
AEs than those on steroid therapy (RR 2.95, 95 % CI: 1.02 to
8.48; GRADE very low quality). Common AEs reported in the
EN group included heartburn, flatulence, diarrhea and
vomiting, and for steroid therapy acne, moon facies,
hyperglycemia, muscle weakness and hypoglycemia. The
most common reason for withdrawal was inability to tolerate
the EN diet.
The authors concluded that very low quality evidence
suggested that corticosteroid therapy may be more effective
than EN for induction of clinical remission in adults with active
CD. Very low quality evidence also suggested that EN may be
more effective than steroids for induction of remission in
children with active CD. Protein composition did not appear to
influence the effectiveness of EN for the treatment of active
CD. EN should be considered in pediatric CD patients or in
adult patients who can comply with NG tube feeding or
perceive the formulations to be palatable, or when steroid side
effects are not tolerated or better avoided. These researchers
stated that further research is needed to confirm the
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superiority of corticosteroids over EN in adults; and further
research is needed to confirm the benefit of EN in children.
Furthermore, they stated that more effort from industry should
be taken to develop palatable polymeric formulations that can
be delivered without use of a NG tube as this may lead to
increased patient adherence with this therapy.
Akobeng and colleagues (2018) stated that prevention of
relapse is a major issue in the management of quiescent CD.
Current therapies (e.g., methotrexate, biologics,
6-mercaptopurine and azathioprine) may be effective for
maintaining remission in CD, but these drugs may cause
significant AEs. Interventions that are safe and effective for
maintenance of remission in CD are desirable. These
investigators evaluated the safety and efficacy of EN for the
maintenance of remission in CD and examined the impact of
formula composition on effectiveness. They searched
Medline, Embase, CENTRAL, the Cochrane IBD Group
Specialized Register and clinicaltrials.gov from inception to
July 27, 2018. They also searched references of retrieved
studies and reviews; RCTs including participants of any age
with quiescent CD were considered for inclusion. Studies that
compared EN with no intervention, placebo or any other
intervention were selected for review. Two authors
independently screened studies for inclusion, extracted data
and assessed methodologic al quality using the Cochrane risk
of bias tool. The primary outcome was clinical or endoscopic
relapse as defined by the primary studies. Secondary
outcomes included anthropometric measures (i.e., height and
weight), quality of life (QOL), AEs, serious AEs (SAEs) and
withdrawal due to AEs. These researchers calculated the RR
and 95 % CI for dichotomous outcomes. For continuous
outcomes, they calculated the MD and 95 % CI. A random-
effects model was used for the statistical analysis. These
researchers used the GRADE criteria to assess the overall
certainty of the evidence supporting the primary outcome and
selected secondary outcomes. A total of 4 RCTs (262 adult
participants) met the inclusion criteria; 1 study (n = 33)
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compared an elemental diet to a non-elemental (polymeric)
diet; 1 study (n = 51) compared a half elemental diet to a
regular free diet. Another study (n = 95) compared an
elemental diet to 6-mercaptopurine (6-MP) or a no treatment
control group; 1 study (n = 83) compared a polymeric diet to
mesalamine; 2 studies were rated as high risk of bias due to
lack of blinding or incomplete outcome data. The other 2
studies were judged to have an unclear risk of bias. The
studies were not pooled due to differences in control
interventions and the way outcomes were assessed. The
effect of an elemental diet compared to a polymeric diet on
remission rates or withdrawal due to AEs was uncertain; 58 %
(11/19) of participants in the elemental diet group relapsed at
12 months compared to 57 % (8/14) of participants in the
polymeric diet group (RR 1.01, 95 % CI: 0.56 to 1.84; very low
certainty evidence); 32 % (6/19) of participants in the
elemental diet group were intolerant to the enteral nutritional
formula because of taste or smell and were withdrawn from the
study in the first 2 weeks compared to zero participants (0/14)
in the polymeric diet group (RR 9.75, 95 % CI: 0.59 to 159.93;
low certainty evidence). Anthropometric measures, QOL, AEs
and SAEs were not reported as outcomes. The effect of an
elemental diet (half of total daily calorie requirements)
compared to a normal free diet on relapse rates was uncertain;
35 % (9/26) of participants in the elemental diet group
relapsed at 12 months compared to 64 % (16/25) of
participants in the free diet group (RR 0.54, 95 % CI: 0.30 to
0.99; very low certainty evidence). No AEs were reported.
This study reported no differences in weight change between
the 2 diet groups. Height and QOL were not reported as
outcomes. The effect of an elemental diet compared to 6-MP
on relapse rates or AEs was uncertain; 38 % (12/32) of
participants in the elemental diet group relapsed at 12 months
compared to 23 % (7/30) of participants in the 6-MP group (RR
1.61; 95 % CI: 0.73 to 3.53; very low certainty evidence); 3 %
(1/32) of participants in the elemental diet group had an AE
compared to 13 % (4/30) of participants in the 6-MP group (RR
0.23, 95 % CI: 0.03 to 1.98; low certainty evidence); AEs in the
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elemental diet group included surgery due to worsening CD;
AEs in the 6-MP group included liver injury (n = 2), hair loss (n
= 1) and surgery due to an abscess (n = 1). No SAEs or
withdrawals due to AEs were reported. Weight, height and
QOL were not reported as outcomes. The effect of a
polymeric diet compared to mesalamine on relapse rates and
weight was uncertain; 42 % (18/43) of participants in the
polymeric diet group relapsed at 6 months compared to 55 %
(22/40) of participants in the mesalamine group (RR 0.76; 95
% CI: 0.49 to 1.19; low certainty evidence). The MD in weight
gain over the study period was 1.9 kg higher in the polymeric
diet group compared to mesalamine (95 % CI: -4.62 to 8.42;
low certainty evidence); 2 participants in the polymeric diet
group experienced nausea and 4 had diarrhea. It was unclear
if any participants in the mesalamine group had an AE.
Height, QOL, SAEs and withdrawal due to AEs were not
reported as outcomes.
The authors concluded that the findings of this review were
uncertain and no firm conclusions regarding the safety and
efficacy of EN in quiescent CD could be drawn. They stated
that more research is needed to determine the safety and
efficacy of using EN as maintenance therapy in CD. Currently,
there are 4 ongoing studies (estimated enrolment of 280
participants). This review will be updated when the results of
these studies are available.
Guidelines on clinical nutrition in inflammatory bowel disease
from the European Society for Parentaral and Enteral Nutrition
(Forbes, et al., 2017) state that "there is no 'IBD diet' that can
be generally recommended to promote remission in IBD
patients with active disease." The guidelines noted that, due to
strong concerns over corticosteroid use and aiming for optimal
growth in children, enteral nutrition is often first-line therapy for
pediatric patients with active Crohn's disease. The guidelines
noted that, although enteral nutrition as primary therapy in
adults with Crohn's disease has also repeatedly been
considered to be effective "the data are not robust." The
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guidelines note that "meta-analyses do not support the use of
EN as primary treatment for acute exacerbations of CD in
adults. Patchy clinical conviction and the data, which appear
better than might be expected with placebo, ensure continuing
controversy over its role in adults."
Early Enteral Nutrition for Individuals Who Have Severe Head Injury
Yi and colleagues (2019) noted that the role of early enteral
nutrition (EEN) supplemented with probiotics (less than 48
hours) in improving clinical outcomes of patients with severe
head injury (SHI) remains controversial. In a meta-analysis,
these investigators examined the efficacy of EEN
supplemented with probiotics on clinical outcomes in these
patients. Systematic searches were performed in PubMed,
Cochrane Central Register of Controlled Trials, China National
Knowledge Infrastructure, Wanfang database, and Chinese
Biomedical Literature to identify potential studies; 2
investigators checked citations, extracted data, appraised risk
of bias, and then STATA 12.0 was used to perform statistical
analysis. A total of 18 trials were eventually included in the
present study. Meta-analysis indicated that EEN
supplemented with probiotics was associated with decreased
risk of infection (RR, 0.53; 95 % CI: 0.44 to 0.65), decreased
risk of mortality (RR, 0.56; 95 % CI: 0.38 to 0.82), decreased
risk of GI complications (RR, 0.19; 95 % CI: 0.13 to 0.25), and
shortened stays in ICU (MD, -4.55; 96 % CI: -5.91 to -3.19).
The authors concluded that EEN supplemented with probiotics
may be a promising alternative for patients with SHI because it
decreased the risk of infection, mortality, and GI complications,
as well as shortened the stays in ICU. These researches
stated that further large-scale and well-designed studies are
needed to establish this conclusion.
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Enteral Nutrition in the Treatment of Eating Disorders
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Hale and Logomarsino (2019) stated that EN is frequently
used in the treatment of anorexia nervosa (AN), and less
commonly, bulimia nervosa (BN); yet, no standardized
guidelines for treatment exist at this time. These investigators
examined the efficacy of EN in the treatment of eating
disorders and made recommendations for clinical practice and
future research. They carried out a literature search of 7
databases. The search strategy combined key terms anorexia
nervosa, bulimia, and eating disorders with terms associated
with EN. There were no restrictions on publication date or
language. Studies that assessed the effect of EN on weight
restoration, refeeding syndrome, and binge/purge behaviors in
the treatment of AN and BN were included. Of 73 full-text
articles reviewed, 22 met inclusion criteria; 19 studies reported
that significant short-term weight gain was achieved when EN
was used for re-feeding malnourished AN patients; however,
results varied for the 6 studies reporting on long-term weight
gain, maintenance, and recovery. In studies with a
comparator, no significant differences were found between the
EN and oral re-feeding cohorts regarding GI disturbance, re-
feeding syndrome, or electrolyte abnormalities; 5 studies
examined the effect of EN on binge/purge behaviors,
suggesting that temporary exclusive EN decreased the
frequency and severity of binge/purge episodes. The authors
concluded that although EN is an essential life-saving
treatment in severe cases of AN, it does not guarantee long-
term success or recovery. The results of this systematic
review highlighted the need for prospective controlled trials
with adequate sample sizes to make comparisons between
specific feeding methods, formulations, and defined short- and
long-term outcomes. These researchers stated that evidence-
based standards for clinical practice are needed with specific
guidelines for best results for AN and BN treatment. Level of
Evidence = I.
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Early Enteral Nutrition Following Gastrointestinal Surgery
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In a Cochrane review, Herbert and colleagues (2019)
examined if early commencement of post-operative enteral
nutrition (within 24 hours), oral intake and any kind of tube
feeding (gastric, duodenal or jejunal), compared with
traditional management (delayed nutritional supply) is
associated with a shorter length of hospital stay (LOS), fewer
complications, mortality and AEs in patients undergoing lower
gastro-intestinal (GI) surgery (distal to the ligament of Treitz).
These investigators searched the Cochrane Central Register
of Controlled Trials (CENTRAL, the Cochrane Library 2017,
issue 10), Ovid Medline (1950 to November 15, 2017), Ovid
Embase (1974 to November 15, 2017). They also searched
for ongoing trials in ClinicalTrials.gov and World Health
Organization International Clinical Trials Registry Platform
(November 15, 2017), and hand-searched reference lists of
identified studies and previous systematic reviews. These
researchers included RCTs comparing early commencement
of enteral nutrition (within 24 hours) with no feeding in adult
patients undergoing lower GI surgery. Two review authors
independently assessed study quality using the Cochrane
'Risk of bias' tool tailored to this review and extracted data.
Data analyses were conducted according to the Cochrane
recommendations. They rated the quality of evidence
according to GRADE. Primary outcomes were LOS and post-
operative complications (wound infections, intra-abdominal
abscesses, anastomotic dehiscence, pneumonia). Secondary
outcomes were: mortality, AEs (nausea, vomiting), and QOL;
LOS was estimated using MD (presented as mean +/- SD).
For other outcomes, these researchers estimated the common
RR and calculated the associated 95 % CIs. For analysis,
these investigators used an inverse-variance random-effects
model for the primary outcome (LOS) and Mantel-Haenszel
random-effects models for the secondary outcomes. They
also performed Trial Sequential Analyses (TSA). These
researchers identified 17 RCTs with 1,437 patients undergoing
lower GI surgery. Most studies were at high or unclear risk of
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bias in 2 or more domains; 6 studies were judged as having
low risk of selection bias for random sequence generation and
insufficient details were provided for judgement on allocation
concealment in all 17 studies. With regards to performance
and deception bias; 14 studies reported no attempt to blind
subjects and blinding of personnel was not discussed either.
Only 1 study was judged as low risk of bias for blinding of
outcome assessor. With regards to incomplete outcome data,
3 studies were judged to be at high risk because they had
more than 10 % difference in missing data between groups.
For selective reporting, 9 studies were judged as unclear as
protocols were not provided and 8 studies had issues with
either missing data or incomplete reporting of results. LOS
was reported in 16 studies (1,346 subjects). The mean LOS
ranged from 4 to 16 days in the early feeding groups and from
6.6 to 23.5 days in the control groups. Mean difference in LOS
was 1.95 (95 % CI: -2.99 to -0.91, p < 0.001) days shorter in
the early feeding group. However, there was substantial
heterogeneity between included studies (I2 = 81 %, Chi2 =
78.98, p < 0.00001), thus the overall quality of evidence for
LOS was low. These results were confirmed by the TSA
showing that the cumulative Z-curve crossed the trial
sequential monitoring boundary for benefit. These
investigators found no differences in the incidence of post-
operative complications: wound infection (12 studies, 1,181
subjects, RR 0.99, 95 % CI: 0.64 to 1.52, very low-quality
evidence), intra-abdominal abscesses (6 studies, 554
subjects, RR 1.00, 95 % CI: 0.26 to 3.80, low-quality
evidence), anastomotic leakage/dehiscence (13 studies, 1,232
subjects, RR 0.78, 95 % CI: 0.38 to 1.61, low-quality e vidence;
number needed to treat for an additional beneficial outcome
(NNTB) = 100), and pneumonia (10 studies, 954 subjects, RR
0.88, 95 % CI: 0.32 to 2.42, low-quality evidence; NNTB =
333). Mortality was reported in 12 studies (1,179 subjects),
and showed no between-group differences (RR = 0.56, 95 %
CI: 0.21 to 1.52, p = 0.26, I2 = 0 %, Chi2 = 3.08, p = 0.96, low-
quality evidence). The most commonly reported cause of
death was anastomotic leakage, sepsis and acute myocardial
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infarction (MI); 7 studies (613 subjects) reported vomiting (RR
1.23, 95 % CI: 0.96 to 1.58, p = 0.10, I2 = 0 %, Chi2 = 4.98, p
= 0.55, low-quality evidence; number needed to treat for an
additional harmful outcome (NNTH) = 19), and 2 studies (118
subjects) reported nausea (RR 0.95, 0.71 to 1.26, low-quality
evidence); 4 studies reported combined nausea and vomiting
(RR 0.94, 95 % CI: 0.51 to 1.74, very low-quality evidence); 1
study reported QOL assessment; the scores did not differ
between groups at 30 days after discharge on either QOL
scale EORTC QLQ-C30 or EORTC QlQ-OV28 (very low-
quality evidence). The authors concluded that the findings of
this review suggested that early enteral feeding may lead to a
reduced post-operative LOS, however cautious interpretation
must be taken due to substantial heterogeneity and low-quality
evidence. For all other outcomes (post-operative
complications, mortality, AEs, and QOL) the findings were
inconclusive, and further studies are needed to enhance the
understanding of early feeding for these. In this updated
review, only a few additional studies have been included, and
these were small and of poor quality. To improve the
evidence, future trials should address quality issues and focus
on clearly defining and measuring post-operative
complications to allow for better comparison between studies.
However due to the introduction of fast track protocols that
already include an early feeding component, future trials may
be challenging. A more feasible trial may be to examine the
effect of differing post-operative energy intake regimens on
relevant outcomes.
Braungart and Siminas (2020) noted that prolonged post-
operative fasting has been the traditional model of care
following pediatric GI surgery. In contrast, early feeding has
become well established in the adult population, where meta-
analyses have shown early introduction of enteral feeding to
be beneficial to hospital stay and patient outcomes. In a
systematic review, these researchers examined the safety and
effectiveness of early enteral feeding versus traditional enteral
feeding after GI anastomosis in children in the pediatric
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literature. They carried out a comprehensive literature search
of the English literature (PubMed, Ovid, Embase data-bases)
from inception to present according to the PRISMA guidelines.
Included studies were evaluated according to the MINORS
criteria. Outcomes for time to 1st feed and full feeds, and
discharge, and risk of major complications were synthesized.
A total of 10 studies comprising 451 patients were included in
the analysis. All studies aimed at examining the safety of early
feeding in pediatric GI surgery, with or without a fast-track
program. Only 4 studies compared the study group to a
control group in which patients were fed in a traditional way
(traditional feeding). Most studies defined early feeding as
feeds commenced less than or equal to 24 hours post-
operatively (range of 2 to 72 hours). Mean time to 1st feed
was significantly lower in the early feeding group, but not
significantly lower for the mean time to full feeds and mean
hospital stay. Bowel obstruction and anastomotic breakdown
were classed as major complications. There was no
significant difference in their occurrence in both groups. The
authors concluded that although the studies identified were
few and heterogeneous, they showed that there was no clear
advantage of keeping children "nil by mouth" and no clear
disadvantage of providing early enteral nutrition following
elective GI surgery. Moreover, these researchers stated that
larger RCTs are needed to examine the true impact on post-
operative complications, healthcare-associated costs, and to
examine patient-reported outcome measures.
Enteral Lactoferrin Supplementation for Prevention of Sepsis and Necrotizing Enterocolitis in Preterm Infants
Pammi and Suresh (2020) stated that lactoferrin could
enhance host defenses and may be effective for prevention of
sepsis and necrotizing enterocolitis (NEC) in preterm
neonates. In a Cochrane review, these researchers examined
the safety and effectiveness of lactoferrin supplementation to
enteral feeds for prevention of sepsis and NEC in preterm
neonates. In addition, they evaluated the effects of lactoferrin
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supplementation to enteral feeds on the duration of positive-
pressure ventilation, development of chronic lung disease
(CLD) or peri-ventricular leukomalacia (PVL), length of hospital
stay to discharge among survivors, and adverse neurological
outcomes at 2 years of age or later. These investigators used
the standard search strategy of Cochrane Neonatal to update
their search. They searched the Cochrane Central Register of
Controlled Trials (CENTRAL 2019, Issue 9), Medline via
PubMed (1966 to January 20, 2020), PREMEDLINE (1996 to
January 20, 2020), Embase (1980 to January 20, 2020), and
CINAHL (1982 to January 20, 2020). These researchers also
searched clinical trials data-bases, conference proceedings,
and the reference lists of retrieved articles for RCTs and quasi-
randomized trials. They included RCTs evaluating enteral
lactoferrin supplementation at any dose or duration to prevent
sepsis or NEC in preterm neonates; and used the standard
methods of Cochrane Neonatal and the GRADE approach to
examine the certainty of evidence. Meta-analysis of data from
12 RCTs showed that lactoferrin supplementation to enteral
feeds decreased late-onset sepsis (typical RR 0.82, 95 % CI:
0.74 to 0.91; typical RD -0.04, 95 % CI: -0.06, -0.02; NNTB 25,
95 % CI: 17 to 50; 12 studies, 5,425 participants, low-certainty
evidence) and decreased LOS (MD -2.38, 95 % CI: -4.67,
-0.09; 3 studies, 1,079 participants, low-certainty evidence).
Sensitivity analysis including only good methodological
certainty studies suggested a decrease in late-onset sepsis
with enteral lactoferrin supplementation (typical RR 0.87, 95 %
CI: 0.78 to 0.97; typical RD -0.03, 95 % CI: -0.05 to -0.0; 9
studies, 4,702 participants, low-certainty evidence). There
were no differences in NEC stage II or III (typical RR 1.10, 95
% CI: 0.86 to 1.41; typical RD -0.00, 95 % CI: -0.02 to 0.01; 7
studies, 4,874 participants; low-certainty evidence) or “all-
cause mortality” (typical RR 0.90, 95 % CI: 0.69 to 1.17; typical
RD -0.00, 95 % CI: -0.01 to 0.01; 11 studies, 5,510
participants; moderate-certainty evidence). One study
reported no differences in neurodevelopmental testing by
Mullen's or Bayley III at 24 months of age after enteral
lactoferrin supplementation (1 study, 292 participants, low-
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certainty evidence). Lactoferrin supplementation to enteral
feeds with probiotics decreased late-onset sepsis (RR 0.25, 95
% CI: 0.14 to 0.46; RD -0.13, 95 % CI: -0.18 to -0.08; NNTB 8,
95 % CI: 6 to 13; 3 studies, 564 participants; low-certainty
evidence) and NEC stage II or III (RR 0.04, 95 % CI: 0.00 to
0.62; RD -0.05, 95 % CI: -0.08 to -0.03; NNTB 20, 95 % CI:
12.5 to 33.3; 1 study, 496 participants; very low-certainty
evidence), but not “all-cause mortality” (very low-certainty
evidence). Lactoferrin supplementation to enteral feeds with
or without probiotics had no effect on CLD, duration of
mechanical ventilation or threshold retinopathy of prematurity
(low-certainty evidence). Investigators reported no adverse
effects in the included studies. The authors found low-
certainty evidence from studies of good methodological quality
that lactoferrin supplementation of enteral feeds decreased
late-onset sepsis but not NEC of greater than or equal to stage
II or “all-cause mortality” or neurodevelopmental outcomes at
24 months of age in preterm infants without adverse effects.
Low-to-very low certainty evidence suggested that lactoferrin
supplementation of enteral feeds in combination with
probiotics decreased late-onset sepsis and NEC of greater
than or equal to stage II in preterm infants without adverse
effects, however, there were few included studies of poor
methodological quality. These researchers stated that the
presence of publication bias and small studies of poor
methodology that may inflate the effect size made
recommendations for clinical practice difficult.
In a RCT, Pehlevan and colleagues (2020) examined the
effect of Lactobacillus and Bifidobacterium together with
oligosaccharides and lactoferrin on the development of NEC or
sepsis in very low birth weight neonates. Neonates with a
gestational age of less than or equal to 32 weeks and birth
weight of less than or equal to 1,500 g were enrolled. The
study group received a combination of synbiotics and
lactoferrin, whereas the control group received 1 ml of distilled
water as placebo starting with the 1st feed until discharge.
The outcome measures were the incidence of NEC stage of
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greater than or equal to 2 or late-onset culture-proven sepsis
and NEC stage of greater than or equal to 2 or death. Mean
birth weight and gestational age of the study (n = 104) and the
control (n = 104) groups were 1,197 ± 235 g versus 1,151 ±
269 g and 29 ± 1.9 versus 28 ± 2.2 weeks, respectively (p >
0.05). Neither the incidence of NEC stage greater than or
equal to 2 or death, nor the incidence of NEC stage greater
than or equal to 2 or late-onset culture-proven sepsis differed
between the study and control groups (5.8 % versus 5.9 %, p
= 1; 26 % versus 21.2 %, p = 0.51). The only significant
difference was the incidence of all stages of NEC (1.9 %
versus 10.6 %, p = 0.019). The authors concluded that the
combination of synbiotics and lactoferrin did not reduce NEC
severity, sepsis, or mortality.
Home Enteral Nutrition After Esophagectomy for Esophageal Cancer
Liu and colleagues (2020) stated that not only has the
placement rate of enteral feeding tubes during operations for
esophageal cancer increased, but also has number of patients
who choose to continue enteral feeding at home instead of
removing the feeding tube at discharge. In a systematic
review, these researchers examined the impacts of home
enteral nutrition (HEN) after esophagectomy in esophageal
cancer patients. This systematic review was carried out in
accordance with PRISMA and Cochrane guidelines. English
and Chinese data-bases, including PubMed, Embase, Web of
Science, the Cochrane Library, Scopus, CBM, CNKI, and Wan
Fang were searched from inception to December 7, 2019;
RCTs evaluating the short-term outcomes of HEN following
esophagectomy in cancer patients were included. The risk of
bias of the included studies was appraised according to the
Cochrane risk of bias tool. The summary of relative risk (RR) /
weighted mean difference (WMD) estimates and
corresponding 95 % CI were calculated using fixed- and
random-effects models. A total of 9 RCTs involving 757
patients were included in the meta-analysis. Compared with
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oral diet, HEN was associated with significantly increased
body weight (WMD 3 kg, 95 % CI: 2.36 to 3.63, p < 0.001),
BMI (WMD 0.97 kg/m, 95 % CI: 0.74 to 1.21, p < 0.001),
albumin (WMD 3.43 g/L, 95 % CI: 2.35 to 4.52, p < 0.001),
hemoglobin (WMD 7.23 g/L, 95 % CI: 5.87 to 8.59, p < 0.001),
and total protein (WMD 5.13 g/L, 95 % CI: 3.7 to 6.56, p <
0.001). No significant differences were observed in pre-
albumin and GI adverse reactions. Physical (WMD 8.82, 95 %
CI: 6.69 to 10.95, p < 0.001) and role function (WMD 12.23, 95
% CI: 2.72 to 21.74, p = 0.01) were also significantly better in
the HEN group. The nausea/vomiting (WMD -5.43, 95 % CI:
-8.29 to -2.57, p = 0.002) and fatigue symptoms (WMD -11.76,
95 % CI: -16.21 to -7.32, p < 0.001) were significantly
reduced. Appetite loss (WMD -8.48, 95 % CI: -14.27 to -4.88,
p = 0.001), diarrhea (WMD -3.9, 95 % CI: -7.37 to -0.43, p =
0.03) , and sleep disturbance (WMD -7.64, 95 % CI: -12.79 to
-2.5, p = 0.004) in the HEN group were also significantly less
than the control group. The authors concluded that HEN
improved nutrition status, physical and role function, and
reduced nausea/vomiting, fatigue, appetite loss, diarrhea, and
sleep disturbance compared with an oral diet in esophageal
cancer patients post-surgery; and HEN did not increase
adverse reactions.
The authors stated that a major drawback of this study was
that HEN after an esophagectomy for cancer is mainly used in
China; thus, the current evidence is mainly based on studies
performed in Chinese populations, so it is unclear how
applicable these findings are to other regions. These
researchers stated that multi-center studies with better
methodological quality are needed to examine the effects of
long-term HEN and provide more data and evidence to
reinforce these findings.
CPT Codes / HCPCS Codes / ICD-10 Codes
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Code Code Description
Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":
CPT codes covered if selection criteria are met:
99507 Home visit for care and maintenance of
catheter(s) (e.g., urinary, drainage, and enteral)
99601 Home infusion/specialty drug administration,
per visit (up to 2 hours)
+ 99602 each additional hour (List separately in
addition to code for primary procedure)
Other CPT codes related to the CPB:
36555 -
36571
Insertion of central venous catheter
43246 Upper gastrointestinal endoscopy including
esophagus, stomach, and either the duodenum
and/or jejunum as appropriate; with directed
placement of percutaneous gastrostomy tube
43510 Gastrotomy; with esophageal dilation and
insertion of permanent intraluminal tube (e.g.,
Celestin or Mousseaux-Barbin)
43653 Laparoscopy, surgical; gastrostomy, without
construction of gastric tube (e.g., Stamm
procedure) (separate procedure)
43752 Naso- or oro-gastric tube placement, requiring
physician's skill and fluoroscopic guidance
(includes fluoroscopy, image documentation
and report)
43762 -
43763
Replacement of gastrostomy tube,
percutaneous, includes removal, when
performed, without imaging or endoscopic
guidance
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Code Code Description
43761 Repositioning of the gastric feeding tube,
through the duodenum for enteric nutrition
43810 -
43832
Gastroduodenostomy, gastrojejunostomy;
without vagotomy, with vagotomy, any type,
gastrostomy, open; without construction of
gastric tube (e.g., Stamm procedure) (separate
procedure), neonatal, for feeding, or with
construction of gastric tube (e.g., Janeway
procedure)
+ 44015 Tube or needle catheter jejunostomy for enteral
alimentation, intraoperative, any method (List
separately in addition to primary procedure)
44372 Small intestinal endoscopy, enteroscopy
beyond second portion of duodenum, not
including ileum; with placement of
percutaneous jejunostomy tube
44373 with conversion of percutaneous gastrostomy
tube to percutaneous jejunostomy tube
44500 Introduction of long gastrointestinal tube (e.g.,
Miller-Abbott) (separate procedure)
49440 Insertion of gastrostomy tube, percutaneous,
under fluoroscopic guidance including contrast
injection(s), image documentation and report
49441 Insertion of duodenostomy or jejunostomy tube,
percutaneous, under fluoroscopic guidance
including contrast injection(s), image
documentation and report
49446 Conversion of gastrostomy tube to gastro-
jejunostomy tube, percutaneous, under
fluoroscopic guidance including contrast
injection(s), image documentation and report
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Code Code Description
49450 Replacement of gastrostomy or cecostomy (or
other colonic) tube, percutaneous, under
fluoroscopic guidance including contrast
injection(s), image documentation and report
49451 Replacement of duodenostomy or jejunostomy
tube, percutaneous, under fluoroscopic
guidance including contrast injection(s), image
documentation and report
49452 Replacement of gastro-jejunostomy tube,
percutaneous, under fluoroscopic guidance
including contrast injection(s), image
documentation and report
74340 Introduction of long gastrointestinal tube (eg,
Miller-Abbott), including multiple fluoroscopies
and images, radiological supervision and
interpretation
HCPCS codes covered if selection criteria are met:
Enteral lactoferrin supplementation – no specific code:
B4034 -
B4083,
B4102 -
B9999
Enteral and Parenteral Therapy (except food
thickener)
B4087 Gastrostomy/jejunostomy tube, standard, any
material, any type, each
B4088 Gastrostomy/jejunostomy tube, low-profile, any
material, any type, each
B4102 Enteral formula, for adults, used to replace
fluids and electrolytes (e.g., clear liquids), 500
ml= 1 unit
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Code Code Description
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)
B4105 In-line cartridge containing digestive enzyme(s)
for enteral feeding, each
B4149 Enteral formula, manufactured blenderized
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
S5497 Home infusion therapy, catheter care/
maintenance, not otherwise classified; includes
administrative services, professional pharmacy
services, care coordination, and all necessary
supplies and equipment (drugs and nursing
visits coded separately), per diem
S5498 Home infusion therapy, catheter care/
maintenance, simple (single lumen), includes
administrative services, professional pharmacy
services, care coordination, and all necessary
supplies and equipment (drugs and nursing
visits coded separately), per diem
S5501 Home infusion therapy, catheter care/
maintenance, complex (more than one lumen),
includes administrative services, professional
pharmacy services, care coordination, and all
necessary supplies and equipment (drugs and
nursing visits coded separately), per diem
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Code Code Description
S5502 Home infusion therapy, catheter care/
maintenance, implanted access device,
includes administrative services, professional
pharmacy services, care coordination, and all
necessary supplies and equipment (drugs and
nursing visits coded separately), per diem (use
this code for interim maintenance of vascular
access not currently in use)
S5517 Home infusion therapy, all supplies necessary
for restoration of catheter patency or declotting
S5518 Home infusion therapy, all supplies necessary
for catheter repair
S5520 Home infusion therapy, all supplies (including
catheter) necessary for a peripherally inserted
central venous catheter (PICC) line insertion
S5521 Home infusion therapy, all supplies (including
catheter) necessary for a midline catheter
insertion
S5522 Home infusion therapy, insertion of peripherally
inserted central venous catheter (PICC),
nursing services only (no supplies or catheter
included)
S5523 Home infusion therapy, insertion of midline
central catheter, nursing services only (no
supplies or catheter included)
S9342 Home therapy; enteral nutrition via pump;
administrative services, professional pharmacy
services, care coordination, and all necessary
supplies and equipment (enteral formula and
nursing visits coded separately), per diem
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Code Code Description
S9343 Home therapy; enteral nutrition via bolus;
administrative services, professional pharmacy
services, care coordination, and all necessary
supplies and equipment (enteral formula and
nursing visits coded separately), per diem
S9364 Home infusion therapy, total parenteral nutrition
(TPN); administrative services, professional
pharmacy services, care coordination, and all
necessary supplies and equipment including
standard TPN formula (lipids, specialty amino
acid formulas, drugs other than in standard
formula and nursing visits coded separately),
per diem
S9365 Home infusion therapy, total parenteral nutrition
(TPN); 1 liter per day, administrative services,
professional pharmacy services, care
coordination, and all necessary supplies and
equipment including standard TPN formula
(lipids, specialty amino acid formulas, drugs
other than in standard formula and nursing
visits coded separately), per diem
S9366 Home infusion therapy, total parenteral nutrition
(TPN); more than 1 liter but no more than 2
liters per day, administrative services,
professional pharmacy services, care
coordination, and all necessary supplies and
equipment including standard TPN formula
(lipids, specialty amino acid formulas, drugs
other than in standard formula and nursing
visits coded separately), per diem
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Code Code Description
S9367 Home infusion therapy, total parenteral nutrition
(TPN); more than 2 liters but no more than 3
liters per day, administrative services,
professional pharmacy services, care
coordination, and all necessary supplies and
equipment including standard TPN formula
(lipids, specialty amino acid formulas, drugs
other than in standard formula and nursing
visits coded separately), per diem
S9368 Home infusion therapy, total parenteral nutrition
(TPN); more than 3 liters per day,
administrative services, professional pharmacy
services, care coordination, and all necessary
supplies and equipment including standard
TPN formula (lipids, specialty amino acid
formulas, drugs other than in standard formula
and nursing visits coded separately), per diem
HCPCS codes not covered for indications listed in the CPB:
A9152 Single vitamin/mineral/trace element, oral, per
dose, not otherwise specified
A9153 Multiple vitamins, with or without minerals and
trace elements, oral, per dose, not otherwise
specified
B4100 Food thickener, administered orally, per oz
Other HCPCS codes related to the CPB:
S9123 Nursing care, in the home; by registered nurse,
per hour (use for general nursing care only, not
to be used when CPT codes 99500-99600 can
be used)
S9124 Nursing care, in the home; by licensed practical
nurse, per hour
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Code Code Description
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
S9810 Home therapy; professional pharmacy services
for provision of infusion, specialty drug
administration, and / or disease state
management, not otherwise classified, per hour
(do not use this code with any per diem code)
ICD-10 codes covered if selection criteria are met (not all inclusive):
C00.0 -
C21.8
Malignant neoplasm of lip, oral cavity, pharynx,
esophagus, stomach, small intestine, colon,
rectosigmoid junction, rectum, anus and anal
canal
C76.0 Malignant neoplasm of head, face and neck
E40, E41,
E42, E43
Kwashiorkor, nutritional marasmus, marasmic
kwashiokor and unspecified severe protein-
calorie malnutrition
E44.0 -
E44.1
Protein-calorie malnutrition of moderate and
mild degree
E45 Retarded development following protein-calorie
malnutrition
E46 Unspecified protein-calorie malnutrition
E84.0 -
E84.9
Cystic fibrosis
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Code Code Description
I69.091
I69.191
I69.291
I69.391
I69.891
I69.991
Sequelae of cerebrovascular disease
[dysphagia]
K22.4 Dyskinesia of esophagus
O21.0 Mild hyperemesis gravidarum
O21.1 Hyperemesis gravidarum with metabolic
disturbance
O21.2 Late vomiting of pregnancy
O21.8 Other vomiting complicating pregnancy
O21.9 Vomiting of pregnancy, unspecified
R13.0 -
R13.19
Aphagia and dysphagia
Z93.1 Gastrostomy status
Z93.4 Other artificial openings of gastrointestinal tract
status
ICD-10 codes not covered for indications listed in the CPB:
A40.0 -
A40.9
Streptococcal sepsis [prevention of sepsis]
A41.9 Sepsis, unspecified organism [prevention of
sepsis]
F01.50 -
F80.2
F80.4 -
F84.0
F84.3 -
F99
Mental and behavioral disorders
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Code Code Description
K50.00 -
K50.919
Crohn's disease
K55.30 Necrotizing enterocolitis, unspecified
[prevention of necrotizing enterocolitis]
K55.31 Stage 1 necrotizing enterocolitis [prevention of
necrotizing enterocolitis]
K55.32 Stage 2 necrotizing enterocolitis [prevention of
necrotizing enterocolitis]
K55.33 Stage 3 necrotizing enterocolitis [prevention of
necrotizing enterocolitis]
N17.0 -
N19
Acute kidney failure and chronic kidney disease
Z99.2 Dependence on renal dialysis
Enteral lactoferrin supplementation:
HCPCS codes covered if selection criteria are met:
Enteral lactoferrin supplementation - no specific code:
ICD-10 codes not covered for indications listed in the CPB:
A40.0 -
A40.9
Streptococcal sepsis [prevention of sepsis]
A41.9 Sepsis, unspecified organism [prevention of
sepsis]
K55.30 Necrotizing enterocolitis, unspecified
[prevention of necrotizing enterocolitis]
K55.31 Stage 1 necrotizing enterocolitis [prevention of
necrotizing enterocolitis]
K55.32 Stage 2 necrotizing enterocolitis [prevention of
necrotizing enterocolitis]
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Code Code Description
K55.33 Stage 3 necrotizing enterocolitis [prevention of
necrotizing enterocolitis]
The above policy is based on the following references:
1. Ainsworth SB, Clerihew L, McGuire W. Percutaneous
central venous catheters versus peripheral cannulae
for delivery of parenteral nutrition in neonates.
Cochrane Database Syst Rev. 2007;(3):CD004219.
2. Akobeng AK, Zhang D, Gordon M, MacDonald JK.
Enteral nutrition for maintenance of remission in
Crohn's disease. Cochrane Database Syst Rev.
2018;8:CD005984.
3. Alkaade S, Vareedayah AA. Primer on exocrine
pancreatic insufficiency, fat malabsorption, and fatty
acid abnormalities. Am J Manag Care. 2017;23(12
Suppl):S203-S209.
4. Al-Omran M, Albalawi ZH, Tashkandi MF, Al-Ansary LA.
Enteral versus parenteral nutrition for acute
pancreatitis. Cochrane Database Syst Rev. 2010;
(1):CD002837.
5. Al-Omran M, Groof A, Wilke D. Enteral versus
parenteral nutrition for acute pancreatitis. Cochrane
Database Syst Rev. 2003;(1):CD002837.
6. American Academy of Pediatrics Committee on
Nutrition. Reimbursement for medical foods for
inborn errors of metabolism. Pediatrics. 1994;93
(5):860.
7. American College of Obstetrics and Gynecology
(ACOG). ACOG Practice Bulletin: Nausea and vomiting
of pregnancy. Obstet Gynecol. 2004;103(4):803-814.
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8. American Gastroenterological Association. American
Gastroenterological Association medical position
statement: Parenteral nutrition. Gastroenterology.
2001;121(4):966-969.
9. Anderson AD, Palmer D, MacFie J. Peripheral
parenteral nutrition. Br J Surg. 2003;90(9):1048-1054.
10. Anderson CF, MacBurney MM. Application of A.S.P.E.N.
clinical guidelines: Parenteral nutrition use at a
university hospital and development of a practice
guideline algorithm. Nutr Clin Pract. 1996;11(2):53-58.
11. Anker SD, John M, Pedersen PU, et al; German Society
for Nutritional Medicine (DGEM); Becker HF, Bohm M,
Brunkhorst FM, Vogelmeier C; European Society for
Parenteral and Enteral Nutrition (ESPEN). ESPEN
Guidelines on Enteral Nutrition: Cardiology and
pulmonology. Clin Nutr. 2006;25(2):311-318.
12. Arends J, Bodoky G, Bozzetti F, et al; German Society
for Nutritional Medicine (DGEM); Zurcher G, Fietkau R,
Aulbert E, et al; European Society for Parenteral and
Enteral Nutrition (ESPEN). ESPEN Guidelines on Enteral
Nutrition: Non-surgical oncology. Clin Nutr. 2006;25
(2):245-259.
13. Avenell A, Handoll HH. Nutritional supplementation for
hip fracture aftercare in the elderly. Cochrane
Database Syst Rev. 2006;(4):CD001880.
14. Bombell S, McGuire W. Early trophic feeding for very
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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan
benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,
general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care
services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors
in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely
responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is
subject to change.
Copyright © 2001-2021 Aetna Inc.
https://aetnet.aetna.com/mpa/cpb/1_99/0061.html 4/12/2021
Page 59
AETNA BETTER HEALTH® OF PENNSYLVANIA
Amendment to Aetna Clinical Policy Bulletin Number: 0061 Nutritional
Support
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. These are covered under the Pennsylvania Medical assistance plan.
Breast milk additive to prevent necrotizing enterocolitis in premature infants is covered under the Pennsylvania Medical assistance plan if administered via the tube‐feeding route or by mouth. Human donor breast milk is covered for the Pennsylvania Medical assistance plan. The following benefit information does not apply to Medicaid. 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.
The Pennsylvania Medical Assistance Program covers most medically necessary services. Please contact Aetna Better Health Member Service at 1‐866‐638‐1232 to determine the member’s benefit plan.
revised 03/19/2021