CMS Pub. 100-03, ch. 1, § 260.5

A. General

Medicare covers intestinal and multi-visceral transplantation for the purpose of restoring

intestinal function in patients with irreversible intestinal failure. Intestinal failure is defined as

the loss of absorptive capacity of the small bowel secondary to severe primary gastrointestinal

disease or surgically induced short bowel syndrome. It may be associated with both mortality

and profound morbidity. Multi-visceral transplantation includes organs in the digestive system

(stomach, duodenum, pancreas, liver and intestine).

The evidence supports the fact that aged patients generally do not survive as well as younger

patients receiving intestinal transplantation. Nonetheless, some older patients who are free from

other contraindications have received the procedure and are progressing well, as evidenced by

the United Network for Organ Sharing (UNOS) data. Thus, it is not appropriate to include

specific exclusions from coverage, such as an age limitation, in the national coverage policy.

B. Nationally Covered Indications

Effective for services performed on or after April 1, 2001, this procedure is covered only when

performed for patients who have failed total parenteral nutrition (TPN) and only when performed

in centers that meet approval criteria.

1. Failed TPN

The TPN delivers nutrients intravenously, avoiding the need for absorption through the small

bowel. TPN failure includes the following:

• Impending or overt liver failure due to TPN induced liver injury. The clinical

manifestations include elevated serum bilirubin and/or liver enzymes, splenomegaly,

thrombocytopenia, gastroesophageal varices, coagulopathy, stomal bleeding or hepatic

fibrosis/cirrhosis.

• Thrombosis of the major central venous channels; jugular, subclavian, and femoral

veins. Thrombosis of two or more of these vessels is considered a life threatening complication

and failure of TPN therapy. The sequelae of central venous thrombosis are lack of access for

TPN infusion, fatal sepsis due to infected thrombi, pulmonary embolism, Superior Vena Cava

syndrome, or chronic venous insufficiency.

• Frequent line infection and sepsis. The development of two or more episodes of

systemic sepsis secondary to line infection per year that requires hospitalization indicates failure

of TPN therapy. A single episode of line related fungemia, septic shock and/or Acute

Respiratory Distress Syndrome are considered indicators of TPN failure.

• Frequent episodes of severe dehydration despite intravenous fluid supplement in

addition to TPN. Under certain medical conditions such as secretory diarrhea and non-constructable gastrointestinal tract, the loss of the gastrointestinal and pancreatobiliary secretions

exceeds the maximum intravenous infusion rates that can be tolerated by the cardiopulmonary

system. Frequent episodes of dehydration are deleterious to all body organs particularly kidneys

and the central nervous system with the development of multiple kidney stones, renal failure, and

permanent brain damage.

2. Approved Transplant Facilities

Intestinal transplantation is covered by Medicare if performed in an approved facility. The

criteria for approval of centers will be based on a volume of 10 intestinal transplants per year

with a 1-year actuarial survival of 65 percent using the Kaplan-Meier technique.

C. Nationally Non-covered Indications

All other indications remain non-covered.

D. Other

NA.

(This NCD last reviewed May 2006.)