Intestinal and Multi-Visceral Transplantation

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.

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.

Failed TPN

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.

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. More specific criteria can be found at: http://www.cms.hhs.gov/providers/transplant/default.asp.

03/2002 - Reissued TN AB-01-58 with new discard date. Effective date 04/01/2001 and implementation date 07/01/2001. (TN AB-02-040) (CR 1629)

04/2001 - Revised TN AB-00-130 to cover intestinal and multi-visceral transplantation for purpose of restoring intestinal function in patients with irreversible intestinal failure. Effective date 04/01/2001 and implementation date 07/01/2001. (TN AB-01-58) (CR 1629)

12/2000 - Covered intestinal transplantation for purpose of restoring intestinal function in patients with irreversible intestinal failure. Effective and implementation dates 04/01/2001. (TN AB-00-130) (CR 1436)