Anthem Blue Cross Connecticut TRANS.00013 Small Bowel, Small Bowel/Liver and Multivisceral Transplantation Form

This document addresses small bowel, small bowel/liver and multivisceral transplantation. A small bowel transplant, also known as intestinal transplant, is typically performed on individuals with short bowel syndrome or intestinal failure. In some instances, short bowel syndrome is associated with liver failure, often due to the long-term complications of total parenteral nutrition (TPN). These individuals may be candidates for a small bowel/liver transplant, or a multivisceral transplant.

Note: Please see the following for additional information:

• TRANS.00008 Liver Transplantation

Position Statement

Medically Necessary:

A small bowel transplant using cadaveric intestine is considered medically necessary for adults and children with short bowel syndrome or irreversible intestinal failure who have failed total parenteral nutrition (TPN) and meet the general individual selection criteria listed below.

TPN failure is defined when any one of the following is met:

1. Impending or overt liver failure due to TPN induced liver injury. (Clinical indicators include: increased serum bilirubin or liver enzyme levels, splenomegaly, thrombocytopenia, gastroesophageal varices, coagulopathy, stomal bleeding, hepatic fibrosis, or cirrhosis); or
2. Thrombosis of two or more major central venous channels (subclavian, jugular, or femoral veins). Thrombosis of two or more of these vessels is considered a life-threatening complication and TPN failure; or
3. Frequent central line-related sepsis. Two or more episodes of line-induced systemic sepsis per year that require hospitalization are considered TPN failure. A single episode of line-related fungemia, septic shock, or acute respiratory distress syndrome is considered TPN failure; or
4. Frequent episodes of severe dehydration despite TPN and intravenous fluid supplement. Under certain medical conditions such as secretory diarrhea and non-constructable gastrointestinal tract, the loss of combined gastrointestinal and pancreatobiliary secretions exceed the maximum intravenous infusion rates that can be tolerated by the cardiopulmonary system.

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.

Combined small bowel/liver transplants from deceased donors are considered medically necessary for adults and children who meet criteria for intestinal transplant and have overt or imminent liver failure or anatomical abnormalities which preclude an isolated small bowel transplant.

Multivisceral transplants from deceased donors are considered medically necessary for adults and children who meet criteria for the combined small bowel/liver transplant and require one or more abdominal visceral organs to be transplanted due to concomitant organ failure or anatomical abnormalities which preclude a small bowel/liver transplant.

Retransplantation in individuals with graft failure of an initial small bowel, small bowel/liver, or multivisceral transplant, due to either technical reasons or hyperacute rejection is considered medically necessary.

Retransplantation in individuals with chronic rejection or recurrent disease is considered medically necessary when the individual meets general selection criteria as defined below.

Not Medically Necessary:

A small bowel transplant in adults or children is considered not medically necessary for those who can tolerate TPN.

A small bowel transplant using a living donor in adults or children is considered not medically necessary when a cadaveric intestine is available for transplantation.

Investigational and Not Medically Necessary:

All other indications for small bowel or multivisceral transplants in adults or children, including but not limited to treatment of pseudotumor peritonei, are considered investigational and not medically necessary.

Living donor multivisceral transplants in adults or children are considered investigational and not medically necessary.

General Individual Selection Criteria

In addition to having one of the clinical indications above, the individual must not have a contraindication as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.

Absolute Contraindications for Transplant Recipients include, but are not limited to, the following:

1. Metastatic cancer
2. Ongoing or recurring infections that are not effectively treated
3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery
4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured
5. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations
6. Potential complications from immunosuppressive medications are unacceptable to the patient
7. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention (CDC) definition of CD4 count, 200cells/mm³) unless the following are noted:
   1. CD4 count greater than 200cells/mm³ for greater than 6 months
   2. HIV-1 RNA undetectable
   3. On stable anti-retroviral therapy greater than 3 months
   4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioide-mycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm)
   5. Meeting all other criteria for small bowel or multivisceral transplantation

Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. Vol. 71, 1189-1204, No. 9, May 15, 2001.