Intestinal Transplantation
DESCRIPTION
Intestinal transplantation may be performed as an isolated small bowel transplant or in conjunction with other visceral organs, including the liver, duodenum, jejunum, ileum, pancreas, or colon, in individuals with intestinal failure. Intestinal failure is characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance.
Isolated small bowel transplant is typically performed in individuals with short bowel syndrome. This is a condition in which the absorbing surface of the small intestine is inadequate due to extensive disease or surgical removal of a large portion of the small intestine. In adults, etiologies of short bowel syndrome include ischemia, trauma, volvulus, and tumors. In children, gastroschisis, volvulus, necrotizing enterocolitis and congenital atresias are predominant causes. In individuals with progressive liver failure, a complication of long-term TPN use, a small bowel transplant may be considered a technique to avoid end-stage liver failure, thus avoiding the necessity of a multivisceral transplant.
A combined small bowel/liver transplant may be considered for children and adults with intestinal failure who have developed evidence of impending end-stage liver failure after long-term use of TPN. A multivisceral transplant may be considered when anatomic or other medical problems preclude a small bowel/liver transplant.
POLICY
Intestinal transplantation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Intestinal retransplantation after a failed primary transplant is considered medically necessary.
An isolated small bowel transplant using a living donor may be considered medically necessary only when a cadaveric intestine is not available for transplantation if medical appropriateness criteria are met. (See Medical Appropriateness below).
Multiple labs and work-up procedures are considered not medically necessary for the sole purpose of repeat evaluation at multiple transplant centers.
MEDICAL APPROPRIATENESS
Intestinal transplantation is considered medically appropriate if ALL of the following are met:
Type of transplant procedure is ANY ONE of the following:
Small bowel transplant if ALL the following are met:
For the treatment of irreversible intestinal failure
Severe complications from long-term TPN use (for example, frequent infections, impending liver failure, inability to maintain venous access, frequent severe dehydration, thrombosis of major central venous channel)
Adequate cardiopulmonary status
Clinical information submitted for determination of medical appropriateness is dated within the last seven months
Combined small bowel/liver transplant if ALL the following are met:
For the treatment of irreversible intestinal failure
Severe complications from long-term TPN use (for example, frequent infections, inability to maintain venous access, frequent severe dehydration, thrombosis of major central venous channel)
Impending or overt end-stage liver failure with ANY ONE of the following:
Elevated serum bilirubin and/or liver enzymes
Splenomegaly
Thrombocytopenia
Gastroesophageal varices
Coagulopathy
Stomal bleeding
Hepatic fibrosis/cirrhosis
Adequate cardiopulmonary status
Clinical information submitted for determination of medical appropriateness is dated within the last seven months
Multivisceral transplant if ALL the following are met:
For the treatment of irreversible intestinal failure
Severe complications from long-term TPN use (for example, frequent infections, inability to maintain venous access, frequent severe dehydration, thrombosis of major central venous channel)
Impending or overt end-stage liver failure with ANY ONE of the following:
Elevated serum bilirubin and/or liver enzymes
Splenomegaly
Thrombocytopenia
Gastroesophageal varices
Coagulopathy
Stomal bleeding
Hepatic fibrosis/cirrhosis
Documentation indicating a combined small bowel/liver transplant is not an option due to anatomic or other medical problems
Adequate cardiopulmonary status
Clinical information submitted for determination of medical appropriateness is dated within the last seven months
HIV status is ANY ONE of the following:
The individual is negative for human immunodeficiency virus (HIV)
No advancing HIV disease as indicated by ALL the following:
The CD4 count is greater than 200 cells per cubic millimeter for at least 3 months
The HIV-1 RNA level is undetectable
Individual has been stable on anti-retroviral therapy greater than 3 months
No other complications from acquired immune deficiency syndrome (AIDS) (e.g. opportunistic infections, including aspergillus, tuberculosis, coccidiosis mycosis, resistant fungal infections Kaposi’s sarcoma or other neoplasm)
ABSENCE of ALL the following: NOTE: Potential contraindications are subject to the judgment of the transplant center
Known current malignancy
History of malignancy with a moderate to high risk of recurrence
Irreversible end-stage disease not attributed to intestinal failure
Systemic disease or untreated systemic infection making immunosuppression unsafe
Psychosocial conditions or chemical dependence affecting ability to adhere to therapy
IMPORTANT REMINDER
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
SOURCES
American Gastroenterological Association. (2022, October). AGA clinical practice update on management of short bowel syndrome: expert review. Retrieved September 29, 2023 from http://www.gastro.org.
BlueCross BlueShield Association. Evidence Positioning System. (9:2023). Isolated small bowel transplant (7.03.04). Retrieved October 2, 2023 from www.bcbsaoca.com/eps/. (35 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (9:2023). Small bowel/liver and multivisceral transplant (7.03.05). Retrieved October 2, 2023 from www.bcbsaoca.com/eps/. (30 articles and/or guidelines reviewed)
Center for Medicare and Medicaid Services. CMS.gov. National Coverage Determination (NCD) for intestinal and multi-visceral transplantation (260.5). Retrieved March 4, 2016 from https://www.cms.gov.
Ganousse-Mazeron, S., Lacaille, F., Colomb-Jung, V., Talbotec, C., Ruemmele, F., Sauvat, F., et al. (2015). Assessment and outcome of children with intestinal failure referred for intestinal transplantation. Clinical Nutrition, 34 (3), 428-435. Abstract retrieved December 28, 2016 from PubMed database.
ORIGINAL EFFECTIVE DATE: 4/1980
MOST RECENT REVIEW DATE: 11/9/2023
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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