A small bowel transplant may be performed as an isolated procedure. Isolated small bowel transplant is commonly performed in individuals with short bowel syndrome.

Multivisceral transplantation/retransplantation may be performed as an intestinal allograft in combination with a liver allograft, either alone or in combination with one or more of the following organs: stomach, duodenum, jejunum, ileum, pancreas, or colon.

Small Bowel Transplant

A small bowel transplant using cadaveric intestine may be considered medically necessary in adult and pediatric individuals with ALL the following:

• Intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micro-nutrient balance); and
• Who have established long-term dependence on total parenteral nutrition; and
• Who are developing or have developed severe complications due to total parenteral nutrition.

A small bowel transplant using a living donor may be considered medically necessary only when a cadaveric intestine is not available for transplantation in an individual who meets the criteria noted above for a cadaveric intestinal transplant.

A small bowel re-transplant meeting the criteria indicated in this policy may be considered medically necessary after a failed primary small bowel transplant.

A small bowel transplant using cadaveric or living donors not meeting the criteria as indicated in this policy is considered not medically necessary.

A small bowel transplant is considered experimental/investigational for adult and pediatric individuals with intestinal failure who can tolerate total parenteral nutrition and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

In addition to the above criteria and subject to the discretion of the transplant center, a Hepatitis C Virus (HCV) positive donor organ may be considered medically necessary as an acceptable organ option for an HCV negative adult recipient 18 years of age or older.

Multivisceral Transplant

Transplants, such as a multi-visceral transplant and a small bowel and liver transplant, may be considered medically necessary for pediatric and adult individuals with ALL the following:

• Intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance); and
• Have been managed with long-term total parenteral nutrition; and
• Have developed evidence of impending end-stage liver failure.

Multi-visceral or a small bowel and liver re-transplant may be considered medically necessary after a failed primary small bowel and liver transplant or multi-visceral transplant.

A multi-visceral or small bowel and liver transplant not meeting the criteria as indicated in this policy is considered not medically necessary.

General Criteria

Potential contraindications for solid organ transplant subject to the judgment of the transplant center may include the following:

• Known current malignancy, including metastatic cancer; or
• Recent malignancy with high risk of recurrence; or
• Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
• Other irreversible end-stage diseases not attributed to intestinal failure; or
• History of cancer with a moderate risk of recurrence; or
• Systemic disease that could be exacerbated by immunosuppression; or
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Intestinal failure results from surgical resection, congenital defect, or disease-associated loss of absorption, and is characterized by the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance. Short bowel syndrome is an example of intestinal failure.

Candidates should meet the following criteria:

• Adequate cardiopulmonary status
• Documentation of individuals compliance with medical management.

Small Bowel-Specific Criteria

Individuals who are developing or have developed severe complications due to total parenteral nutrition (TPN) include, but are not limited to, the following: multiple and prolonged hospitalizations to treat TPN-related complications (especially repeated episodes of catheter-related sepsis) or the development of progressive liver failure. In the setting of progressive liver failure, small bowel transplant may be considered a technique to avoid end-stage liver failure related to chronic TPN, thus avoiding the necessity of a multivisceral transplant. In those receiving TPN, liver disease with jaundice (total bilirubin greater than three (3) mg/dL) is often associated with development of irreversible, progressive liver disease. The inability to maintain venous access is another reason to consider small bowel transplant in those who are dependent on TPN.

Small Bowel/Liver-Specific Criteria

Evidence of intolerance of total parenteral nutrition (TPN) includes, but is not limited to, multiple and prolonged hospitalizations to treat TPN-related complications or the development of progressive but reversible liver failure. In the setting of progressive liver failure, small bowel transplant may be considered a technique to avoid end-stage liver failure related to chronic TPN and would thus avoid the necessity of a multi-visceral transplant.