Isolated Small Bowel Transplant and Small Bowel/Liver and Multivisceral Transplant
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Defines medical necessity and investigational uses for isolated small bowel, small bowel/liver, and multivisceral transplant for adults and pediatric patients with intestinal failure and TPN-related complications; applies to Capital BlueCross products with benefit variations.
No material clinical or coverage changes in this revision.
Coverage Criteria for Intestinal and Multivisceral Transplantation
Isolated small bowel transplant (cadaveric)
Isolated small bowel transplant is considered medically necessary when ALL of the following are met:
Cadaveric intestine preferred; living donor allowed only when cadaveric not available
Isolated small bowel transplant (living donor)
Living donor isolated small bowel transplant:
Living donor use otherwise considered investigational
Small bowel retransplant
Small bowel retransplant:
Case series evidence suggests reasonable survival in appropriately selected patients
Small bowel/liver and multivisceral transplant
Small bowel/liver and multivisceral transplant are considered medically necessary when ALL of the following are met:
Small bowel/liver transplant may avoid need for multivisceral transplant if liver disease is reversible
Transplant center judgment applies to contraindications and candidacy assessment
Medical necessity criteria — covered when clinical evidence and selection criteria are met
Covered when clinical evidence and selection criteria are met:
Available evidence (case series, registry data) supports a meaningful improvement in net health outcome for appropriately selected patients
Registry and case series data support meaningful improvement in net health outcome
Case series suggest reasonable survival after retransplantation
A small bowel transplant using a living donor is investigational in all situations except when a cadaveric intestine is not available and the individual otherwise meets criteria for a cadaveric transplant. The policy states that living donor isolated small bowel transplant may be considered medically necessary only when a cadaveric intestine is not available and the candidate meets the listed cadaveric transplant criteria; all other uses of living-donor isolated small bowel transplant are investigational due to insufficient evidence of benefit.
Transplantation will be excluded and may be denied when it is expected to be futile due to comorbid disease or when required post-transplant care is expected to significantly worsen comorbid conditions. This includes situations where the overall burden of comorbidity makes the risk of transplant outweigh any potential survival or quality-of-life benefit.
Administrative review and consensus reviews conducted through 05/21/2020 resulted in no changes to policy statements. Reformatting and language revisions were administrative (product/benefit variation and disclaimer updates); no substantive policy criteria were altered.
Small bowel transplant is considered investigational for adult and pediatric individuals with intestinal failure who can tolerate TPN. In other words, patients who are stable on TPN without developing severe TPN-related complications are not candidates for transplant under this policy.
Procedures are not medically necessary when patient comorbidities render the transplant futile or when anticipated post-transplant management will significantly worsen comorbid disease. The policy explicitly notes transplantation is contraindicated in such cases and would be denied.
Consensus reviews documented in the policy history report no change to policy statements; the documented reviews are administrative in nature and do not list additional explicit not medically necessary conditions in the reviewed segments.
Candidate Selection and Eligibility
Candidate criteria for intestinal transplant
Candidate selection considerations include demonstration of TPN-related complications and overall fitness for transplant:
These complications support consideration for isolated small bowel or combined transplants
Transplant center assessment required
Candidate selection
Candidate selection principles described in policy:
Evidence is based on case series and registry data; transplant center judgment and national program policies (OPTN/CMS) guide selection
Pre-Transplant Evaluation Requirements
Document TPN intolerance / TPN-related complications
Provide documentation demonstrating evidence of intolerance to total parenteral nutrition (TPN) or TPN-related complications when requesting evaluation or authorization for intestinal transplant. Examples cited in the policy include multiple or prolonged hospitalizations for TPN complications, catheter-related sepsis, progressive liver disease, and loss of venous access.
- Multiple and prolonged hospitalizations to treat TPN-related complications
- Catheter-related sepsis or recurrent catheter-related infections
- Progressive liver disease attributable to TPN (e.g., elevated bilirubin)
- Inability to maintain venous access for long-term TPN
Provide specific event-level evidence of TPN intolerance
When documenting TPN intolerance for transplant evaluation, include specific examples and objective events that meet the policy’s definition of TPN-related complications (hospitalizations, catheter-related sepsis, progressive liver failure, or loss of venous access) to support medical necessity.
- Cite hospital admissions and reason(s) for admission related to TPN complications
- Provide microbiology and treatment details for catheter-related sepsis episodes
- Document liver dysfunction attributed to TPN (see bilirubin threshold referenced elsewhere)
- Describe attempts and failures to maintain venous access
Cite referenced clinical guidelines and position statements
Reference guideline and position statements used in the policy when planning evaluation and management; the policy cites AGA clinical updates, AST/ASG pediatric position papers, British Transplantation Society guidance, OPTN policies, and the CMS NCD as supporting clinical resources.
- American Gastroenterological Association position statements and clinical updates (AGA)
- American Society of Transplantation pediatric position paper
- British Transplantation Society guidelines
- Organ Procurement and Transplantation Network (OPTN) policies and CMS National Coverage Determination
Contraindications and Conditions That May Preclude Coverage
Potential contraindications that may preclude coverage include known current malignancy or recent malignancy with high risk of recurrence, untreated systemic infection or chronic infection that makes immunosuppression unsafe, and other irreversible end-stage disease not due to intestinal failure. These conditions are assessed by the transplant center and may result in denial of transplantation.
Avoid candidates with listed contraindications
Do not submit transplant requests for individuals with conditions listed as potential contraindications; the policy identifies current malignancy, recent malignancy with high recurrence risk, untreated systemic infection, other irreversible end-stage disease, systemic disease worsened by immunosuppression, and psychosocial or chemical dependency issues.
- Known current malignancy, including metastatic cancer
- Recent malignancy with high risk of recurrence or history of cancer with moderate risk of recurrence
- Untreated systemic infection or chronic infection making immunosuppression unsafe
- Other irreversible end-stage disease not attributed to intestinal failure
- Systemic disease that could be exacerbated by immunosuppression
- Psychosocial conditions or chemical dependency affecting adherence
Futility or inability to manage post-transplant care may trigger denial
Be aware that transplantation will be denied when the procedure is expected to be futile due to comorbid disease or when post-transplant care is expected to significantly worsen comorbid conditions; document assessments that show the patient is not in such a futility category.
- Demonstrate that comorbid conditions do not render transplantation futile
- Show that post-transplant management is not expected to significantly worsen existing comorbidities
Administrative note — policy statements unchanged
Administrative reviews have not changed core policy statements; the policy history documents editorial updates only and does not list additional documentation-related denial risks in these sections.
- Policy history notes multiple consensus reviews with no change to policy intent
- Documentation-related denial risks are not specified in the administrative history
Provider Actions, Authorization, and Documentation
Prior authorization required to establish medical necessity
Obtain prior authorization to establish medical necessity for isolated small bowel transplant, small bowel/liver transplant, multivisceral transplant, and applicable retransplantation; authorization must document intestinal failure with long-term TPN dependence and TPN-related complications or progressive liver failure as applicable.
- Prior authorization required for isolated small bowel, small bowel/liver, multivisceral transplant, and retransplantation
- Must document intestinal failure with long-term TPN dependence and relevant TPN-related complications or progressive liver failure
Prior authorization required for listed procedure codes
Submit prior authorization requests for the specific procedure codes listed in the coding section; coverage determination remains subject to member benefit terms and the prior authorization process.
- Transplant procedure codes listed in the coding section must be used on requests
- Coverage is determined by medical necessity and member benefit provisions
Coding update: CPT 44799 noted (PA details not specified)
Note that the policy’s coding table was updated to include CPT 44799; prior authorization processes reference the coding table but specific PA workflows are not detailed in these chunks.
- Coding table includes CPT 44799 (unlisted intestine procedure)
- Prior authorization requirements are not specifically outlined in the cited coding/authorization notes
Document prior conservative and medical therapies
Document efforts at conservative and medical therapies prior to transplant evaluation; the policy notes nutritional optimization, attempts at enteral feeding, pharmacologic measures, and surgical bowel-preserving procedures as prior treatment considerations.
- Nutritional optimization and attempts at enteral feeding
- Pharmacologic agents to enhance absorption or slow transit
- Surgical bowel-preserving techniques
Provider action (see policy for details)
Reserved for provider-action content from the policy (no specific action text in chunks provided).
Provider action (see policy for details)
Reserved for provider-action content from the policy (no specific action text in chunks provided).
Submit cardiopulmonary status, compliance, and TPN-intolerance evidence
Include documentation demonstrating adequate cardiopulmonary status and patient compliance with medical management when requesting authorization; also provide objective evidence of intolerance to alternatives such as TPN complications, prolonged hospitalizations, catheter-related sepsis, progressive liver disease, or loss of venous access.
- Evidence of adequate cardiopulmonary evaluation
- Documentation of patient compliance with medical therapy
- Clinical records supporting TPN intolerance (hospitalizations, infections, liver dysfunction, venous access issues)
Submit procedure/diagnosis codes and supporting medical necessity documentation
When submitting for authorization, include the applicable procedure and diagnosis codes from the policy’s coding section and supporting clinical documentation to demonstrate medical necessity; presence of a code in the list does not guarantee coverage.
- Use codes listed in the policy (see coding table) for procedures and diagnoses
- Attach documentation supporting medical necessity per member benefit rules
- Code listing does not by itself denote coverage
Policy history: coding table updated (added CPT 44799)
The coding table was updated in the policy history; CPT 44799 (unlisted intestine procedure) was added per the policy history and coding sections.
- CPT 44799 added to the coding table per policy history
- Refer to the coding section for current code listings
Do not authorize transplants for listed contraindications
Do not proceed with transplant authorization for patients with current malignancy, recent malignancy with high recurrence risk, untreated systemic infection, or other irreversible end-stage disease not due to intestinal failure; these are listed as contraindications that may preclude coverage.
- Known current malignancy, including metastatic disease
- Recent malignancy with high risk of recurrence
- Untreated systemic or chronic infection
- Other irreversible end-stage disease not attributed to intestinal failure
Futility and post-transplant management concerns may trigger denial
Be aware that transplantation requests may be denied if judged futile due to comorbid disease or if post-transplant care is expected to significantly worsen comorbid conditions; include assessments showing these risks are not present.
- Document evaluations demonstrating transplant is not expected to be futile
- Address how post-transplant care will not significantly worsen comorbidities
Administrative note — no change to policy statements across reviews
Administrative policy reviews have not altered policy statements; the history records editorial and coding updates only and does not list additional documentation-based denial risks in these administrative notes.
- Multiple consensus reviews with no change to policy statements
- Administrative edits and coding reviews noted in policy history
Procedure and Diagnosis Coding
| 47133 | Procedure code listed under 'Covered when medically necessary' |
| 47135 | Procedure code listed under 'Covered when medically necessary' |
| 47140 | Procedure code listed under 'Covered when medically necessary' |
| 47141 | Procedure code listed under 'Covered when medically necessary' |
| 47142 | Procedure code listed under 'Covered when medically necessary' |
| 47143 | Procedure code listed under 'Covered when medically necessary' |
| 47144 | Procedure code listed under 'Covered when medically necessary' |
| 47145 | Procedure code listed under 'Covered when medically necessary' |
| 47146 | Procedure code listed under 'Covered when medically necessary' |
| 47147 | Procedure code listed under 'Covered when medically necessary' |
| K72.00 | Acute and subacute hepatic failure without coma |
| K72.01 | Acute and subacute hepatic failure with coma |
| K72.10 | Chronic hepatic failure without coma |
| K72.11 | Chronic hepatic failure with coma |
| K90.83 | Intestinal Failure |
| T86.851 | Intestine transplant failure |
| 44799 | Unlisted procedure, intestine |
Transplant Center and Program Requirements
Transplant center assessment required for candidate selection
Transplant center judgment applies for contraindications and candidate selection; the policy explicitly states transplant center assessment is required when applying general criteria and candidate requirements.
- Transplant center assesses and judges contraindications
- Center documents candidate fitness and eligibility
Center judgment applies to contraindications and candidate fitness
Transplant centers must apply their clinical judgment when evaluating candidates, including assessment of cardiopulmonary status, compliance, and whether contraindications exist; the policy defers these determinations to the center.
- Center documents adequate cardiopulmonary status and compliance
- Center determines presence or absence of listed contraindications
Document center-level evaluation and multidisciplinary assessment
Transplant centers should follow standard transplant evaluation and workup processes and document center-level assessments; the policy references candidate criteria and defers specific center requirements to the transplant program judgment.
- Document center-specific evaluation and multidisciplinary assessments
- Provide center rationale when exceptions or complex comorbidities exist
Adhere to OPTN and CMS program requirements and referenced resources
Centers should adhere to national program requirements and referenced resources; the policy cites OPTN policies and the CMS National Coverage Determination as relevant program-level guidance.
- Follow OPTN policies and CMS NCD for intestinal and multivisceral transplantation
- Use referenced national guidelines to inform center practices
Post-Transplant Care and Coverage Considerations
Definitions and Acronyms
Background and Epidemiology
Intestinal failure results from surgical resection, congenital defects, or disease-associated loss of absorptive capacity leading to inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance. Short bowel syndrome is a common cause. Many patients become chronically dependent on total parenteral nutrition (TPN) and may develop TPN-related complications such as catheter-related sepsis and progressive liver disease; these complications drive consideration for intestinal transplant. Intestinal transplants are infrequently performed, carry substantial infection and rejection risks, and require lifelong immunosuppression.
Policy Revision History
Added CPT 44799 (unlisted procedure, intestine) to the coding table and updated ICD-10 table, references, and policy guidelines; editorial refinements to policy statements with no change to intent.
Consensus review with policy statements unchanged; references reviewed and updated and coding reviewed with no coding changes.
Consensus review with policy statements unchanged; references reviewed and updated and coding reviewed.
Consensus review with policy statements unchanged; references and background updated.
Consensus review with policy statement unchanged; background and references updated.
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