Small Bowel, Liver, and Multivisceral Transplant
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Policy governs medical necessity and coverage criteria for initial and retransplantation of combined small bowel and liver or multivisceral transplants (including living-donor) for pediatric and adult members, and identifies investigational/uncovered indications.
No material clinical or coverage changes in this revision.
Coverage Criteria for Combined Small Bowel and Liver / Multivisceral Transplant
Initial Combined Cadaveric Small Bowel and Liver or Multivisceral Transplant
Covered when ALL of the following are met:
See Policy Guidelines for definition and examples (eg, short bowel syndrome).
Evidence of intolerance to TPN is discussed in Small Bowel/Liver‑Specific Criteria (eg, multiple/prolonged hospitalizations or progressive but reversible liver failure).
See Policy Guidelines for full list of severe complications.
Initial Living Donor Combined Small Bowel and Liver Transplant
Retransplant
Retransplantation is considered medically necessary when the general initial criteria are met and one of the following is present:
Reasons for retransplant are listed in case series and registry reports.
Investigational/Not Covered Indications
Considered investigational because evidence is insufficient to determine improvement in net health outcomes.
Initial transplant candidate criteria
Covered when ALL of the following are met
Population and PICO used in evidence review support this indication.
Multivisceral transplant is indicated when anatomic or other medical problems preclude a small bowel/liver transplant.
See Severe Complications and Small Bowel/Liver‑Specific Criteria for examples and documentation guidance.
Comparators were defined in the evidence review.
Retransplantation coverage criteria
Covered when ALL of the following are met
Based on stated population and intent in retransplant evidence review.
Retransplantation considered as an alternative to continued medical management and TPN.
See case series and UNOS/registry data for common reasons and outcomes.
Retransplantation coverage criteria
Covered when ALL of the following are met
See society indications (AGA, AST) and transplant society guidance for accepted indications and contraindications.
Transplantation for indications not explicitly listed as medically necessary in this policy is considered investigational and will be excluded from coverage. Examples include any combined small bowel and liver or multivisceral transplant performed for conditions beyond those specified in the policy, because the evidence is insufficient to demonstrate improvement in net health outcomes.
Transplants performed when one or more contraindications to solid-organ transplantation are present (see policy contraindications) will also be excluded or considered investigational; examples of such contraindications include active or recent high‑risk malignancy, untreated systemic infection that makes immunosuppression unsafe, other irreversible end‑stage disease unrelated to intestinal failure, or psychosocial/behavioral factors that impair adherence.
Poor expected patient or graft survival and other prohibitive perioperative risks may limit candidacy for combined small bowel–liver or multivisceral transplantation. A prior TEC assessment and subsequent registry/case‑series literature have reported relatively low 2‑ and 5‑year survival (approximately 33%–50% in earlier reports) for some multivisceral cases, though outcomes have improved in more recent series.
These historical data should be balanced against the natural history without transplant (often uniformly fatal); candidacy decisions should consider contemporary center outcomes, patient comorbidities, and likelihood of meaningful benefit.
Lack of adequate control of HIV infection can exclude a candidate unless criteria addressing virologic and immunologic control are met. Extrapolating from British HIV Association/British Transplantation Society guidance, acceptable candidates are typically adherent with antiretroviral therapy, with a sustained CD4 count >100 cells/µL (ideally >200) for ≥3 months, undetectable HIV RNA (<50 copies/mL) for ≥6 months, no recent opportunistic infections for ≥6 months, and no history of certain progressive opportunistic conditions.
Contraindications to combined small bowel–liver or multivisceral transplant are similar to those for other solid‑organ transplants and should be assessed by the transplant center. Typical contraindications include known current malignancy (including metastatic disease), recent malignancy with high risk of recurrence, untreated systemic infection that would make immunosuppression unsafe, and other irreversible end‑stage diseases not related to intestinal failure.
Pediatric guidance from the American Society of Transplantation echoes these principles and further lists contraindications such as profound neurologic disability, life‑threatening comorbidities, severe immunologic deficiencies, nonresectable malignancies, autoimmune diseases, and insufficient vascular patency.
Any combined small bowel and liver or multivisceral transplant performed for indications not specifically listed as medically necessary in this policy is considered investigational and therefore not medically necessary for coverage purposes due to insufficient evidence of benefit.
No additional investigational exclusions are explicitly stated in this segment beyond the general investigational statement that transplants for unlisted indications are considered investigational.
Transplantation or retransplantation should not be performed in patients who no longer meet standard transplant candidacy criteria or who lack documented indications consistent with accepted guidelines. Retransplantation coverage is supported only when the patient continues to meet transplant criteria and a clear, documented indication (for example, acute or chronic rejection, graft nonfunction, CMV‑related graft failure, or progressive liver failure) is present and supported by the submitted clinical evidence.
Because evidence for retransplantation is limited primarily to single‑center series and registry data, documentation must demonstrate continued candidacy, absence of contraindications, and justification that retransplantation is the appropriate therapeutic alternative to medical management or parenteral nutrition.
Coding and Billing
| No codes listed |
| 44135 | Intestinal allotransplantation; from cadaver donor. |
| 44136 | Intestinal allotransplantation; from living donor. |
| 47135 | Liver allotransplantation; orthotopic, partial or whole, from cadaver or living donor, any age. |
| 47399 | Unlisted procedure liver (if used to represent liver allotransplantation, heterotopic, partial or whole, from cadaver or living donor, any age when performed in conjunction with small intestinal transplant or multivisceral transplant). |
Provider Actions, Prior Authorization and Documentation
Prior Authorization Required
Prior approval is required for initial combined cadaveric or living-donor small bowel and liver or multivisceral transplants and for retransplantation requests. Submit clinical documentation to the medical director or prior authorization contact as specified by the plan.
- Prior authorization required for initial combined cadaveric small bowel and liver or multivisceral transplants and for initial living-donor combined small bowel and liver transplants.
- Prior authorization required for retransplantation of combined small bowel and liver or multivisceral transplants.
Required Clinical Documentation
Approval for initial combined transplants requires documentation that the individual has intestinal failure with loss of absorptive function, has been managed with long-term total parenteral nutrition (TPN), and is developing or has developed severe TPN-related complications or impending end-stage liver failure. Approval for retransplantation requires documentation that the candidate continues to meet standard transplant criteria and that the prior graft has failed for an approved reason (e.g., acute rejection, chronic rejection, non-function, or return of disease).
- Document intestinal failure (loss of absorption and inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance).
- Document history of long-term TPN and intolerance or failure of medical management.
- Document development of severe TPN-related complications (e.g., thrombosis of two or more major central venous channels; ≥2 episodes line-related systemic sepsis per year; one episode of line-related fungemia, septic shock, or ARDS; frequent dehydration despite TPN).
- For retransplant: document reason for retransplant (acute rejection, chronic rejection, non-function, CMV, liver failure, lymphoproliferative disorder, graft dysfunction, or return of disease) and evidence the patient still meets transplant candidacy.
- Provide evidence of adequate cardiopulmonary status, compliance with medical management, and absence of contraindications to transplant (see policy contraindications).
Denial Triggers
Requests may be denied if the transplant is sought for indications not meeting the policy's medical necessity criteria, if required documentation is incomplete or absent, or if contraindications to transplant are present (e.g., active or high‑risk malignancy, uncontrolled infection, irreversible non–intestinal end‑stage disease, severe psychosocial issues or substance abuse that impair adherence).
- Transplants performed for conditions not listed as medically necessary will be considered investigational and denied.
- Lack of documentation of intestinal failure, long-term TPN, severe TPN‑related complications or impending liver failure may trigger denial.
- Retransplantation requests lacking clear documentation that patient continues to meet transplant criteria or lacking a documented appropriate indication for retransplant may be denied.
Post-Transplant Complications and Coverage
Post-transplant complications such as acute or chronic rejection, development of donor-specific antibodies, infection, lymphoproliferative disorder, graft-versus-host disease, and renal dysfunction are recognized complications; coverage for management of these complications follows standard benefit provisions. Documentation of such complications should be provided when relevant to requests for retransplantation or additional services.
- Examples of post-transplant complications: acute/chronic rejection, donor-specific antibodies, infection, lymphoproliferative disorders, graft‑versus‑host disease, renal dysfunction.
- Document complications and clinical course if they form the basis for retransplantation requests.
Retransplant Prior Authorization and Documentation Risk
Retransplantation evidence is limited primarily to single-center case series; therefore, prior authorization should confirm the candidate is an individual with a failed small bowel and liver or multivisceral transplant without contraindications and that non-surgical comparators (continued medical management and parenteral nutrition) have been considered. Failure to document ongoing eligibility and lack of alternative management consideration increases risk of denial.
- Recognize limited evidence base (single-center case series, some UNOS database analyses).
- Ensure documentation demonstrates continued eligibility and that medical management/parenteral nutrition were considered as comparators prior to retransplantation.
- Retransplantation authorization requires clear rationale (e.g., acute/chronic rejection, graft non-function, CMV, liver failure, lymphoproliferative disorder).
Conservative Management and Comparative Therapy Consideration
Before listing for transplant, conservative management options should have been attempted or considered, including continued medical management and parenteral nutrition. Referral for transplant evaluation is appropriate for patients with life-threatening complications of intestinal failure or long-term TPN who meet guideline indications.
- Comparators to transplantation include medical management and parenteral nutrition (TPN).
- Candidates should have been evaluated/managed with long-term TPN and shown intolerance or failure of medical management when indicated.
- Referral/consideration for intestinal transplant is intended for patients with life‑threatening TPN‑related complications or impending liver failure.
Candidate Selection and Indications
Candidate Criteria
Candidate selection requires documentation of intestinal failure and TPN‑related complications plus adequate cardiopulmonary status and compliance.
Short bowel syndrome is an example (see Policy Definitions).
Evidence of TPN intolerance or complications supports candidacy (see Severe Complications).
Specific thresholds and examples are listed in Policy Guidelines.
Required for transplant candidacy per Policy Definitions.
Underlying diagnoses supporting transplant evaluation
Conditions and factors supporting candidacy for intestinal/visceral transplantation
From pediatric conditions list.
Chronic TPN is often associated with life‑threatening complications such as catheter‑related sepsis, catheter‑related thrombosis, severe dehydration, and PN‑associated liver disease.
Retransplant candidate criteria
Candidate population described in evidence review
PICO population used in selection of literature.
See case series summaries and UNOS/registry analyses for supporting data.
Candidate criteria
Indications and candidate considerations from society statements
Per American Gastroenterological Association position statement and update.
Per American Society of Transplantation position paper.
Contraindications
Known current malignancy, including metastatic cancer, is a potential contraindication to solid‑organ transplantation and is typically considered during candidate evaluation.
Recent malignancy with a high risk of recurrence should be regarded as a contraindication until the risk of recurrence is acceptably low and the malignancy is managed according to oncology guidance.
A history of cancer with a moderate risk of recurrence is also noted as a potential contraindication; assessment of recurrence risk should inform transplant candidacy decisions.
Untreated systemic infection that would render immunosuppression unsafe is a contraindication to transplantation until the infection is controlled.
Other irreversible end‑stage diseases unrelated to intestinal failure are potential contraindications and should be considered in the overall assessment of transplant benefit and risk.
Systemic diseases that are likely to be exacerbated by immunosuppression (for example, certain autoimmune conditions) may contraindicate transplantation.
Psychosocial conditions or active chemical dependency that impair a patient’s ability to adhere to lifelong therapy and follow‑up are considered contraindications until adequately addressed.
Absolute or relative contraindications are subject to transplant center judgment; the list above is illustrative rather than exhaustive and must be interpreted in the context of individual patient assessment.
The transplant center should evaluate the overall oncologic risk profile, including tumor biology and timing since therapy, when considering candidates with prior malignancy.
Chronic infections that cannot be controlled or would be aggravated by immunosuppression are contraindications to transplantation until effectively treated.
Other irreversible comorbid conditions that substantially limit life expectancy independent of intestinal failure may preclude transplantation.
Pre-Transplant Evaluation Requirements
Evaluation must document cause of intestinal failure and TPN history
Evaluation must document the cause of intestinal failure, prior management with long‑term TPN, evidence of TPN intolerance or progressive liver failure, and adequate cardiopulmonary status and compliance with therapy.
- Include cause of intestinal failure, TPN history, TPN complications, cardiopulmonary assessment, and adherence documentation
Document evaluation of liver disease and transplant type selection
Pre‑transplant evaluation should document intestinal failure with impending end‑stage liver disease, attempts or consideration of medical management/TPN, and rationale for selecting small bowel/liver versus multivisceral transplant.
- Document how transplant type was chosen based on anatomy, organ quality, liver disease severity, and prior surgeries
Include full transplant workup in pre‑approval package
Pre‑approval evaluation should include a complete transplant workup including prior transplant history (if applicable), cause of graft failure, infection history (eg, CMV, bloodstream infections), immunologic evaluation (donor‑specific antibodies), and assessment of comorbidities and nutritional status.
- Provide immunologic testing, infection history, and comorbidity assessment in pre‑approval package
Document TPN complications, listed indications, and absence of contraindications
Pre‑transplant evaluation should document prior management of intestinal failure, complications of TPN, and presence of listed indications (eg, impending liver failure, vascular thrombosis, recurrent line sepsis); explicitly document absence of contraindications per society guidance.
- Reference AGA/AST indications and contraindications in documentation when applicable
Transplant Center Requirements
Center capabilities and evaluation expected
Transplant center judgment is required; standard transplant center evaluation and capability are implicitly required and documentation should reflect that the procedure will be performed at an experienced center.
- Document center capability and that the transplant will occur at an experienced/credentialed center
Definitions and Background
Intestinal failure results from surgical resection, congenital defect, or disease‑associated loss of absorptive surface leading to inability to maintain protein‑energy, fluid, electrolyte, or micronutrient balance. Short bowel syndrome is a common example and may be associated with progressive liver disease from long‑term TPN.
Combined small bowel and liver or multivisceral transplantation is indicated for patients with intestinal failure and impending or established liver failure due to prolonged TPN and for patients with life‑threatening complications of intestinal failure; transplantation requires lifelong immunosuppression and is prioritized according to disease severity and candidate suitability.
Post-Transplant Care and Follow-Up
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