Covered for a patient with permanent (expected to last at least three months), severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient's general condition.

The patient must have:

1. A condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients, or
2. A disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through the GI system. There must be objective evidence supporting the clinical diagnosis.

The ordering physician is expected to see the patient within 30 days prior to the initial certification. If the physician does not see the patient within this time frame, he/she must document the reason why and describe what other monitoring methods were used to evaluate the patient's parenteral nutrition needs.

When nutritional support other than the oral route is needed, tube enteral nutrition is usually preferable to parenteral nutrition for the following reasons:

1. In a fluid restricted patient, tube enteral nutrition permits delivery of all necessary nutrients in a more concentrated volume than parenteral nutrition, and
2. Tube enteral nutrition allows for safer home delivery of nutrients.

Parenteral nutrition is non-covered for the patient with a functioning gastrointestinal tract whose need for parenteral nutrition is only due to:

• A swallowing disorder
• A temporary defect in gastric emptying, i.e. a metabolic or electrolyte disorder
• A psychological disorder impairing food intake, i.e. depression
• A metabolic disorder inducing anorexia, i.e. cancer
• A physical disorder impairing food intake, i.e. the dyspnea of severe pulmonary or cardiac disease
• A side effect of medication
• Renal failure and/or dialysis

Diagnoses A-F are covered for parenteral nutrition as they are deemed to be severe enough that the patient would not be able to maintain weight and strength on only oral intake or tube enteral nutrition:

1. Massive small bowel resection (within the past 3 months)
   • Resection must have left ≤ 5 feet of small bowel beyond the ligament of Treitz
2. Short bowel syndrome
   • Severe enough that the patient has net gastrointestinal fluid and electrolyte malabsorption such that on an oral intake of 2.5-3 liters/day the enteral losses exceed 50% of the oral/enteral intake
   • Urine output is < 1 liter/day
3. Bowel rest
   • Required for at least three months, and
   • Receiving TPN for treatment of symptomatic pancreatitis with or without pancreatic pseudocyst, or
   • Severe exacerbation of regional enteritis, or
   • Proximal enterocutaneous fistula where tube feeding distal to the fistula isn't possible.
4. Complete mechanical small bowel obstruction
   • Surgery is not an option
5. Significantly malnourished and severe fat malabsorption
   • 10% weight loss over 3 months or less
   • Serum albumin < 3.4 gm/DL
   • Fecal fat exceeds 50% of oral/enteral intake on a diet of at least 50 gm of fat/day as measured by a standard 72 hour fecal fat test
6. Significantly malnourished and has severe motility disturbance of small intestine and/or stomach
   • Motility disturbance is unresponsive to prokinetic medication* demonstrated either:
   • Scintigraphically (solid meal gastric emptying study demonstrating that the isotope fails to reach the right colon by 6 hours post ingestion).
   • Radiographically (barium or radiopaque pellets fail to reach the right colon by 6 hours following administration).
   • These studies must be performed when the patient is not acutely ill or on any medication that would decrease bowel motility.
   • 10% weight loss over 3 months or less
   • serum albumin ≤ 3.4 gm/DL
   • *Unresponsiveness defined as presence of daily symptoms of nausea and vomiting while taking maximal doses. This should be recorded in the patient's medical record.
     
     

   Patients who do not meet the criteria for the diagnoses listed in A-F, must meet criteria 1-2 below plus criteria G and H. Maintenance of weight and strength commensurate with the patients overall health status must require intravenous nutrition and must not be possible utilizing all of the following approaches:
   
   

   1. Modifying the nutrient composition of the enteral diet (e.g. lactose free, gluten free, low in long chain triglycerides, substitution with medium chain triglycerides, provision of protein as peptides or amino acids, etc), and
   2. Utilizing pharmacologic means to treat the etiology of the malabsorption (e.g. pancreatic enzymes or bile salts, broad-spectrum antibiotics for bacterial overgrowth, prokinetic medication for reduced motility, etc).
      
      
7. 10% weight loss over 30 months or less and serum albumin ≤ 3.4 gm/DL, and
8. A disease and clinical condition has been documented as being present and it has not responded to altering the manner of delivery of appropriate nutrients (e.g., slow infusion through a tube with the tip located in the stomach or jejunum).

Renal failure and/or dialysis: In order to cover intradialytic parenteral nutrition (IDPN - parenteral nutrition delivered during hemodialysis) documentation must be clear and precise to verify that the patient suffers from a permanently impaired gastrointestinal tract and that there is insufficient absorption of nutrients to maintain adequate strength and weight. Records should document that the patient cannot be maintained on oral or enteral feedings and that due to severe pathology of the alimentary tract, the patient must be intravenously infused with nutrients. Infusions must be vital to the nutritional stability of the patient and not supplemental to a deficient diet or deficiencies caused by dialysis. Physical signs, symptoms, and test results indicating severe pathology of the alimentary tract must be clearly evident in any documentation submitted. Patients receiving IDPN must meet the parenteral coverage criteria listed in #1 and #2 above.

EACH OF THE DIAGNOSES OR CONDITIONS LISTED IN A-H HAVE SPECIFIC COVERAGE QUALIFICATION THAT MUST BE MET AND REQUIRES EXTENSIVE ADDITIONAL DOCUMENTATION TO BE SUBMITTED WITH THE FIRST CLAIM SUBMITTED TO MEDICARE. PLEASE REFER TO THE MEDICAL POLICY FOR MORE DETAIL. THIS DOCUMENTATION COULD INCLUDE, BUT IS NOT LIMITED TO THE FOLLOWING:

Copies of operative reports, discharge summaries, x-ray reports, physician letters, serum albumin tests, nutritional assessments, caloric intake history, weight history, caloric losses, dietary modifications or supplements tried, detailed description of tube trials on enteral nutrition, prokinetic medications used, etc. The tests required are specific to the patient's diagnosis.

The following are moderate abnormalities which would require a failed trial of tube enteral nutrition (criteria 1 and 2 above) before parenteral nutrition would be covered:

(Documentation of the failed trial of enteral nutrition would need to be submitted with the claim and available on request.)

• Moderate fat malabsorption - fecal fat exceeds 25% of oral/enteral intake on a diet of at least 50 gm of fat/day as measured by a standard 72 hour fecal fat test
• Diagnosis of malabsorption with objective confirmation by methods other than 72 hour fecal fat test (e.g. Sudan stain of stool d-xylose test, etc.)
• Gastroparesis which has been demonstrated (a) radiographically or scintigraphically as described in criterion F, above, with the isotope or pellets failing to reach the jejunum in 3-6 hours, or (b) by manometric motility studies with results consistent with an abnormal gastric emptying, and a small bowel motility disturbance which is unresponsive to prokinetic medication, demonstrated with a gastric to right colon transit time between 3-6 hours
• Small resection leaving > 5 feet of small bowel beyond the ligament of Treitz
• Short bowel syndrome which is not severe (as defined in B, above)
• Mild to moderate exacerbation of regional enteritis, or an enterocutaneous fistula
• Partial mechanical small bowel obstruction where surgery is not an option

Definition of a Tube Trial:
A concerted effort must be made to place a tube. For gastroparesis, tube placement must be post-pylorus, preferably in the jejunum. Use of a double lumen tube should be considered. Placement of the tube in the jejunum must be objectively verified by radiographic studies or fluoroscopy. Placement via endoscopy or open surgical procedure would also verify location of the tube, however they are not required.

A trial with enteral nutrition must be made, with appropriate attention to dilution, rate, and alternative formulas to address side effects of diarrhea.

Examples of a failed tube trial would be:

• A person who has had a documented placement of a tube in the post-pyloric area continues to have problems with vomiting and on radiographic recheck the tube has returned to the stomach.
• After an attempt of sufficient time (5-6 hours) to get a tube into the jejunum, the tube does not progress and remains in the stomach or duodenum. An attempt of enteral tube feeding with a very slow drip was made. It was initially tolerated well but vomiting occurred when the rate was increased.
• After placement of the tube in the jejunum and 1-2 days of enteral tube feeding, the person has vomiting and distension.
• A tube is placed appropriately and remains in place. Enteral nutrition is initiated and the concentration and rate are increased gradually. Over the course of 3-4 weeks, attempts to increase the rate and/or concentration and/or alter the formula to reach the targeted intake are unsuccessful, with increase in diarrhea, bloating or other limiting symptoms, and the person is unable to meet the needed nutritional goals (stabilize at desired weight or gain weight as needed).

Parenteral nutrition can be covered in a patient with the ability to obtain partial nutrition from oral intake or a combination of oral/enteral (or even oral/enteral/parenteral) intake as long as the following criteria are met:

1. a.	A permanent condition of the alimentary tract is present which has been deemed to require parenteral therapy because of its severity (criteria A-F); or
   b.	A permanent condition of the alimentary tract is present which is unresponsive to standard medical management (criterion H); and

2. The person is unable to maintain weight and strength (criterion G).

The ordering physician must document the medical necessity for protein orders outside the range of 0.8-1.5 gm/kg/day, dextrose concentration less than 10%, or lipid use greater than 15 units of a 20% solution or 30 units of a 10% solution per month.

Parenteral nutrition solutions containing little or no amino acids and/or carbohydrates would be covered only in situations A, B or D (above).

Special parenteral formulas (B5000-B5200) are rarely medically necessary. If the medical necessity for these formulas is not substantiated, payment will be made for the medically appropriate formula.

Recertification after the first six months of therapy is required for continued coverage by the Medicare program. Recertification must include:

• Recertification CMN
• Physician statement describing the continued need for parenteral nutrition
• Including any changes to the therapeutic regimen in the event of malnutrition
• Situations E-H
• Results of the most recent serum albumin (within 2 weeks of recertification)
• Patient's most recent weight (and date of weight measurement)

Equipment and Supplies:

Infusion pumps are covered for patients covered for parenteral nutrition. Only one pump (stationary or portable) will be covered at any one time. Additional pumps will be denied as not medically necessary.

If the coverage requirements for parenteral nutrition are met, medically necessary nutrients, supply and administration kits (one each kit per day) will also be covered.