1

Clinical Policy Bulletin:

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* 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. In general, Aetna Better Health does not consider oral nutrition a medical item.

However, Aetna Better Health covers nutritional support that is taken orally (i.e., by

mouth) in cases of severe diseases such as End Stage Renal Disease (ESRD), cancers

and chronic medical conditions with low Body Mass Index (BMIs). 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

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. However, food thickeners are covered up

to 72 ounces. Amounts exceeding the 72 hours are considered on a case by case basis.

Determinants of the route of administration of nutritional support include the functional status of

the gastrointestinal tract and the anticipated duration of therapy.

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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* 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.

*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-

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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 and breast milk additive to prevent necrotizing enterocolitis in

premature infants 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.

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. 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

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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:

6. A physical disorder impairing food intake such as the dyspnea of severe

pulmonary or cardiac disease;

7. A psychological disorder impairing food intake such as depression;

8. A side effect of a medication;

9. A swallowing disorder;

10. A temporary defect in gastric emptying such as a metabolic or electrolyte

disorder;

11. Disorders inducing anorexia such as cancer;

12. Renal failure and/or dialysis.*

*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:

13. Inability to administer or tolerate adequate oral protein nutrition, including food

supplements, or enteral tube feeding; and

14. The combination of some oral or enteral intake that, when combined with IPAA,

will meet the individual's nutritional goals; and

15. 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.

3. 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.

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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

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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.

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.

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CPT Codes / HCPCS Codes / ICD-9 Codes

CPT codes covered if selection criteria are met:

99507

99601

+ 99602

Other CPT codes related to the CPB:

36555 - 36571

43246

43510

43653

43752

43760

43761

43810 - 43832

+ 44015

44372

44373

44500

49440

49441

49446

49450

49451

49452

74340

HCPCS codes covered if selection criteria are met:

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

B4103 Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g.,

clear liquids), 500 ml = 1 unit

8

B4104 Additive for enteral formula (e.g., fiber)

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

B4034 - B4086,

B4102 - B9999

Enteral and Parenteral Therapy (except food thickener)

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

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

9

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

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)

10

S9124 Nursing care, in the home; by licensed practical nurse, per hour

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-9 codes covered if selection criteria are met (not all inclusive):

140.0 - 154.8 Malignant neoplasm of lip, oral cavity, pharynx, esophagus, stomach, small

intestine including duodenum, colon, rectum, rectosigmoid junction, and

anus

195.0 Malignant neoplasm of head, face, and neck

260, 261, 262 Kwashiorkor, nutritional marasmus or other severe, protein-calorie

malnutrition

263.0 - 263.9 Other and unspecified protein-calorie malnutrition

438.82 Late effect of cerebrovascular disease, dysphagia

530.5 Dyskinesia of esophagus

643.00, 643.01 &

643.03

Mild hyperemesis gravidarum, unspecified as to episode of care, delivered,

with or without mention of antepartum condition, or antepartum condition

or complication

643.10, 643.11 &

643.13

Hyperemesis gravidarum with metabolic disturbance, unspecified as to

episode of care, delivered, with or without mention of antepartum

condition, or antepartum condition or complication

643.20, 643.21 &

643.23

Late vomiting of pregnancy, unspecified as to episode of care, delivered,

with or without mention of antepartum condition, or antepartum condition

or complication

643.80, 643.81 &

643.83

Other vomiting complicating pregnancy, unspecified as to episode of care,

delivered, with or without mention of antepartum condition, or antepartum

condition or complication

643.90, 643.91 &

643.93

Unspecified vomiting of pregnancy, unspecified as to episode of care,

delivered, with or without mention of antepartum condition, or antepartum

condition or complication

787.20 - 787.29 Dysphagia

V44.1 Gastrostomy status

V44.4 Other artificial opening of gastrointestinal tract

11

ICD-9 codes not covered for indications listed in the CPB:

290.0 - 319 Mental disorders

584.5 - 586 Renal failure

V45.1 Renal dialysis status

Other ICD-9 codes related to the CPB:

270.1 - 277.9 Disorders of amino-acid transport and metabolism, carbohydrate transport

and metabolism, lipoid metabolism, plasma protein metabolism, mineral

metabolism, calcium metabolism, fluid, electrolyte, and acid-base balance,

and other and unspecified disorders of metabolism

358.0 - 358.9 Myoneural disorders

536.0 - 536.9 Disorders of function of stomach

555.0 - 564.9 Noninfectious enteritis and colitis, intestinal obstruction without mention of

hernia, diverticula of intestine, and functional digestive disorders, not

elsewhere classified

579.0 - 579.9 Intestinal malabsorption

777.1 - 777.9 Perinatal disorders of digestive system

779.3 Feeding problems in newborn

783.0 Anorexia

783.21, 783.22 Abnormal loss of weight and underweight

783.3 Feeding difficulties and mismanagement

783.41 Failure to thrive

783.7 Adult failure to thrive

786.09 Other dyspnea and respiratory abnormalties

V10.00 - V10.09 Personal history of malignant neoplasm of gastrointestinal tract

The above policy is based on the following references:

1. Centers for Medicare & Medicaid Services (CMS). Enteral and parenteral nutrition

therapy covered as prosthetic device. Medicare Coverage Issues Manual Section 65-10.

Baltimore, MD: CMS; effective July 11, 1984.

2. Tricenturion LLC. 18.2 Parenteral nutrition. Medicare Local Medical Review Policy.

Durable Medical Equipment Regional Carrier (DMERC) Regions A and B. Columbia,

SC: Tricenturion; effective July 1, 1996.

3. Tricenturion LLC. 18.1 Enteral nutrition. Medicare Local Medical Review Policy.

Durable Medical Equipment Regional Carrier (DMERC) Regions A and B. Columbia,

SC: Tricenturion; effective April 1, 2002.

12

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