Medical Policy: 07.03.04
Original Effective Date: November 2009
Reviewed: November 2017
Revised: November 2017
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
A small bowel (intestinal) transplant may be performed as an isolated procedure. An isolated small bowel (intestinal)transplant has evolved into an established therapeutic modality in the management of the patient with irreversible intestinal failure. It is performed mainly in patients with short bowel syndrome (SBS) and those who develop severe complications due to total parenteral nutrition (TPN). The goal of transplantation is to eliminate the need for TPN and to reverse or prevent TPN associated liver disease.
Some conditions are more closely associated with pediatric intestinal failure while others are more common with intestinal failure in adults.
The following are pediatric conditions causing intestinal failure:
The following are adult conditions causing intestinal failure:
The small intestine, particularly the ileum, does have the capacity to adapt to some functions of the diseased or removed portion over a period of 1 to 2 years. Prognosis for recovery depends on the degree and location of the small intestine damage. Therapy is focused on achieving adequate macro and micro nutrient uptake in the remaining small bowel. Pharmacologic agents have been studied to increase villous proliferation and slow transit times, and surgical techniques have been advocated to optimize remaining small bowel. However, some patients with short bowel syndrome are unable to obtain adequate nutrition from enteral feeding and become chronically dependent on TPN. Patients with complications from TPN may be considered candidates for small bowel transplant.
Total parenteral nutrition (TPN) is the current standard of care for patients with intestinal failure. The chronic use of TPN is often associated with life-threatening complications including:
Small bowel (intestinal) transplant should be recommended in patients with the following conditions:
Small bowel transplant may be considered a means to avoid end stage liver failure, thus avoiding a multivisceral organ transplant.
Cadaveric small bowel (intestinal) transplant have been most commonly used, but recently there has been interest in using a portion of intestine harvested from a living related donor. Potential advantages of living donor include the ability to plan transplantation electively and better antigen matching, leading to improved management of rejection.
The number of patients who undergo an intestinal transplant is much lower than other forms of organ transplantation, and there are fewer centers that perform it. The outcomes in patients undergoing intestinal transplant has improved significantly compared with early efforts, with improvements in the immunosuppression protocols and early detection and treatment of rejection. Graft survival in adult and pediatric patients is similar.
The most common causes of graft loss in small bowel transplant are infection, rejection (acute and chronic) and technical or clinical complications. Careful patient selection, post-transplant immunosuppression and patient management are essential for successful long term outcomes. Individuals undergoing repeat small bowel transplantation should meet all eligibility criteria and should not have contraindications to transplantation.
For individuals who have intestinal failure who receive a small bowel transplant, the evidence includes case series. Risks after small bowel transplant are high, particularly related to infection, but may be balanced against the need to avoid the long-term complications of total parenteral nutrition dependence. In addition, early small bowel transplant may prevent the need for a later combined liver/small bowel transplant. The evidence is sufficient to determine that small bowel transplantation results in meaningful improvement in net health outcomes.
For individuals who have failed small bowel transplant without contraindications for retransplant, the evidence for retransplant includes case series. The data from a small number of patients undergoing retransplantation are available, although limited in quantity, the available data have suggested a reasonably high survival rate after small bowel retransplantation in patients who continue to meet criteria for transplantation. The evidence is sufficient to determine that small bowel retransplantation results in meaningful improvement in net health outcomes.
Small bowel transplantation using a living donor may be considered medically necessary only when a cadaveric intestinal transplant is not available. Routine use of living donor intestinal transplants is considered not medically necessary because the net health outcome associated with this procedure is reduced (compared with cadaveric transplant) due to donor-related morbidity.
In 2003, the American Gastroenterological Association produced a medical position statement on short bowel syndrome and intestinal transplantation. It recommends dietary, medical and surgical solutions. Indications for intestinal transplant mirror those of Medicare in patients who fail TPN therapy for one of the following reasons:
Until better data become available, these parameters are likely to be widely recognized as the indications for intestinal transplantation.
In 2001, the American Society of Transplantation issued a position paper on indications for pediatric intestinal transplantation. The position paper included the following:
“Parenteral nutrition represents standard therapy for children with short bowel syndrome and other causes of intestinal failure. Most infants with short bowel syndrome eventually wean from parenteral nutrition, and most of those who do not wean tolerate parenteral nutrition for protracted periods. However, a subset of children with intestinal failure remaining dependent on parenteral nutrition will develop life-threatening complications arising from therapy. Intestinal transplantation can now be recommended for this select group. Life-threatening complications warranting consideration of intestinal transplantation include parenteral nutrition-associated liver disease, recurrent sepsis, and threatened loss of central venous access. Children with liver dysfunction should be considered for isolated intestinal transplantation before irreversible, advanced bridging fibrosis or cirrhosis supervenes, for which a combined liver and intestinal transplant is necessary. Irreversible liver disease is suggested by hyperbilirubinemia persisting beyond 3-4 months of age combined with features of portal hypertension such as splenomegaly, thrombocytopenia, or prominent superficial abdominal veins; esophageal varices, ascites, and impaired synthetic function are not always present.”
As of February 2013, the United Network for Organ Sharing (UNOS) policy on HIV-positive transplant candidates states “A potential candidate for organ transplantation whose test for HIV is positive should not be excluded from candidacy for organ transplantation unless there is a documented contraindication in transplantation based on local policy.”
As of October 2016, the Organ Procurement and Transplantation Network policy states “ To be eligible for an organ transplant, potential candidates must be tested for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C, unless the testing would violate state or federal laws. Potential candidates who test positive for HIV, hepatitis B, or hepatitis C must be offered appropriate counseling.
OPTN permits HIV test positive individuals as organ candidates if permitted by the transplant hospital. Care of HIV positive organ candidate and recipients must not deviate from general medical practice.
Prior approval is required.
See also medical policy 07.03.05 Small Bowel/Liver and Nultivisceral Transplant
A small bowel transplant using a cadaveric intestine may be considered medically necessary in adult and pediatric patients with intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte or micronutrient balance), who have established long-term dependency on TPN and are developing or have developed severe complications due to TPN (see criteria above under Description).
Small bowel transplant would be considered not medically necessary in adult or pediatric patients who are able to tolerate TPN.
Small bowel transplant using a living donor intestine may be considered medically necessary only when a cadaveric intestine is not available for transplantation in a patient who meets the above criteria for a cadaveric intestinal transplant.
Small bowel transplant using living donor is considered not medically necessary in all other situations.
Retransplantation in individuals with graft failure of an initial small bowel (intestinal) transplant due to technical reasons, hyperacute or chronic rejection, or return of disease may be considered medically necessary if the criteria for small bowel transplantation above have been met.
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 one case of intestinal failure.
Patients who are developing or have developed severe complications due to 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 > 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.
Potential contraindications to solid organ transplant (subject to judgement of the transplant center):
The Organ Procurement Transplant Network (OPTN) policy 15.2 permits HIV test positive individuals as organ candidates if permitted by the transplant hospital. Care of the HIV test positive organ candidate and recipients should not deviate from general medical practice.
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