Medical Policy: 07.03.04
Original Effective Date: November 2009
Reviewed: November 2015
Revised: November 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
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.
Small bowel 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.
Intestinal Failure results from obstruction, dysmotility, 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 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 balances when on a conventionally accepted normal diet.
Leading causes of intestinal failure differ between adult and pediatric populations. In children, the following are the leading causes of intestinal failure:
The following are the leading causes of intestinal failure in adults:
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 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 transplant is the most commonly performed transplant, there has been recent interest in using living donors. Living donor transplantation has been proposed as a means to increase the pool of donor organs and thereby reduce waiting time and wait list morbidity and mortality.
Retransplantation
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.
Summary
Small bowel 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.
Practice Guidelines or Position Statements
American Gastroenterological Association
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.
Prior approval is required. Submit a prior approval now.
See also medical policy 07.03.05 Small Bowel/Liver and Nultivisceral Transplant
Cadaveric Small Bowel 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.
Living Donor Small Bowel Transplant
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 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. However, small bowel transplant using a living donor does have a role in select cases where a cadaveric intestine is not available, see above.
Small Bowel Retransplant
Small bowel retransplant may be considered medically necessary in individuals with graft failure of an initial small bowel transplant who meet criteria for small bowel transplantation above.
Except as defined above, candidates for small bowel transplant should meet the following general criteria:
The evaluation of a transplant candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.
The United Network for Organ Sharing (UNOS) believes that asymptomatic HIV-positive patients should not necessarily be excluded for candidacy for organ transplantation, stating, “A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy.” In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that the presence of AIDS could be considered a contraindication to kidney transplant unless the following criteria were present. These criteria may be extrapolated to other potential organ transplants:
It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.