Medical Policy: 07.03.04
Original Effective Date: November 2009
Reviewed: November 2016
Revised: November 2016
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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 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. As reported in 2013 Annual Report by the Organ Procurement and Transplantation Network, one year graft survival for all recipients of an intestinal graft (year 2011 to 2012) is approximately 75 percent, which five-year graft survival for patients transplanted between 2007 and 2008 is 52 percent. Patient survival is approximately 80 percent at one year and just over 60 percent at five years. Overall patient survival at 10 and 15 years was only 42 and 35 percent, thus, short and medium term graft and patient survival are good, but the longer term results need to improve.
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.
Isolated small bowel (intestinal) transplant may be considered medically necessary in patients with intestinal failure who are developing severe total parenteral nutrition (TPN) – related complications, to obviate the subsequent need for multi-visceral transplant. Small bowel transplant using a living donor may be considered medically necessary only when a cadaveric intestinal transplant is not available. The available published survival data suggest that small bowel retransplant is reasonable option after a failed primary small bowel transplant; thus, this may be considered medically necessary.
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.
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. Submit a prior approval now.
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 investigational in all other situations.
Based on peer reviewed literature living donors for small bowel (intestinal) transplantation is limited and the number of living donor transplants performed to date has been small. The literature is mostly limited to single center individual case reports and small case series. More large studies are needed to determine impact on net health outcomes to include that patient survival is comparable or better than those patients receiving cadaveric organs. Currently the net health outcome associated with this procedure is reduced compared to cadaveric transplant because of donor related morbidity. However, small bowel (intestinal) transplant using a living donor does have a role in select cases where a cadaveric intestine is not available, as indicated above.
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.
Policy Guidelines (H3)
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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