ModifiedFidelis CarePolicy CP MP.58

Intestinal and Multivisceral Transplant

Medical necessity criteria and coding guidance for intestinal, combined intestine-liver, and multivisceral transplantation for pediatric and adult members/enrollees with irreversible intestinal failure; describes indications, contraindications, and procedural codes used for authorization and claims review.

Policy Summary

PayerFidelis Care

PolicyIntestinal and Multivisceral Transplant

Policy CodePolicy CP MP.58

Change TypeCriteria revisions and removals

Effective Date

Next Review Date

Key ActionObtain prior authorization for intestinal, combined intestinal-liver, and multivisceral transplant procedures and submit documentation demonstrating the specific indication and contraindication assessment.

SourceLink

POLICY UPDATE CHANGES

Updated glomerular filtration rate threshold from 30 mL/min/1.73m2 to 40 mL/min/1.73m2 as a contraindication unless considered for multi-organ transplant.

Added clarifying language that TPN-induced liver injury is an indication and clarified stomal wording and hospitalization requirement for certain sepsis criteria.

Expanded and reworded contraindications including addition of HIV with detectable viral load, stroke/acute coronary syndrome/MI within 30 days, septic shock, progressive cognitive impairment, and acute renal failure.

Replaced prior phrasing about nonadherence and psychosocial issues with 'Inability to adhere to the regimen necessary to preserve the transplant; even with caregiver support.'

Removed Criteria II.B.6. for acute liver failure or cirrhosis.

Removed Criteria II.B.12. contraindication regarding absence of an adequate support system.

Background updated with no impact on criteria.

Reviewed codes and descriptions.

References reviewed and updated.

MultipleCovered procedures

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Coverage and Medical Necessity Criteria

Initial transplant coverage criteria

Covered when ALL of the following are met for candidates with irreversible intestinal failure:

Primary coverage prerequisites: 1) Member has irreversible intestinal failure and is a candidate for one of the following transplant types: isolated intestinal transplant (isolated intestinal failure without liver disease), combined intestinal‑and‑liver transplant (intestinal failure with end‑stage liver disease), or multivisceral transplant (intestinal failure with severe gastrointestinal motility disorder or extensive mesenteric thrombosis).

Based on transplant type indications.

Failure of TPN or equivalent indications (one or more required): 2) Evidence of failure of total parenteral nutrition (TPN) demonstrated by one or more of the following: impending or overt TPN‑induced liver injury/ liver failure (e.g., elevated bilirubin or liver enzymes, splenomegaly, thrombocytopenia, varices, coagulopathy, stomal bleeding, hepatic fibrosis/cirrhosis); two or more episodes per year of systemic sepsis due to central line infection requiring hospitalization; thrombosis of two or more central veins (e.g., jugular, subclavian, femoral); one episode of septic shock, ARDS, or line‑related fungemia; loss of vascular access from other complications; frequent severe dehydration despite IV supplementation in addition to TPN; frequent hospitalizations for complications directly related to intestinal failure; or high risk of death without transplant.

TPN failure criteria and related complications.

Anatomic/functional indications: 3) Anatomy or function consistent with transplant indication such as severe short bowel syndrome (e.g., residual small bowel <10 cm in infants or <20 cm in adults), gastrostomy/duodenostomy with inability to sustain enteral nutrition, significant hepatic cirrhosis associated with diffuse portomesenteric thrombosis, or other listed indications (mesenteric ischemia, motility disorders, selected pediatric conditions).

Anatomic thresholds and example conditions referenced in policy.

Contraindications

Not eligible when ANY of the following contraindications are present:

Absolute or relative contraindications: Malignancy with high risk of recurrence or death; other severe uncontrolled medical condition expected to limit survival after transplant; glomerular filtration rate <40 mL/min/1.73 m2 unless being considered for multi‑organ transplant; septic shock; progressive cognitive impairment; stroke, acute coronary syndrome, or myocardial infarction within 30 days; chronic infection with highly virulent or resistant organisms poorly controlled pre‑transplant; inability to adhere to the regimen necessary to preserve the transplant even with caregiver support; active substance use or dependence (including current tobacco, vaping, non‑prescribed marijuana, or IV drug use) without convincing evidence of risk‑reduction behaviors unless urgent timelines allow conditional consideration; HIV infection with detectable viral load unless all of the following are met: CD4 >200 cells/mm3, absence of active AIDS‑defining opportunistic infection or malignancy, and currently on effective antiretroviral therapy (ART).GFR <40 mL/min/1.73 m2; HIV CD4 >200 cells/mm3 when applicable

Contraindications and special HIV criteria are specified in the policy; GFR threshold updated per revision.

The policy revision removed two prior exclusion entries from the coverage criteria: Criterion II.B.6 (acute liver failure or cirrhosis) and Criterion II.B.12 (absence of an adequate support system). These deletions are documented in the revision notes and do not change other medical necessity criteria in the policy.

The policy no longer lists absence of an adequate support system as a contraindication to intestinal or multivisceral transplantation. This specific removal (previously listed as Criterion II.B.12) is noted in the revision history and reflected in the updated contraindications.

Transplantation is not medically necessary when the candidate does not meet the defined criteria for irreversible intestinal failure and the listed indications (isolated intestinal, combined intestinal‑liver, or multivisceral transplant) or when any of the policy’s contraindications are present. Clinical documentation must demonstrate the specific indication and address contraindication domains such as malignancy risk, renal function, infection/HIV status, substance use/adherence, recent cardiovascular events, and cognitive status.

Candidate Selection and Evaluation

Prior Authorization

Prior Authorization Required

Provider action: Prior authorization — Prior authorization is required for all intestinal, combined intestinal-liver, and multivisceral transplant requests. The pre-approval evaluation must document failure of total parenteral nutrition (TPN) using the criteria below, evidence of liver disease when a combined liver transplant is requested, and all relevant clinical documentation supporting indications and absence of contraindications. For Medicare members, ensure review and alignment with applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and CMS Coverage Articles prior to submission.

Prior authorization required for all transplant types listed in policy.
For Medicare members, review applicable NCDs/LCDs/CMS articles to ensure consistency with Medicare coverage rules (see CMS website).
Pre-approval submission must include full evaluation documentation (see Candidate Selection criteria group).

Denial Risk

Denial Triggers

Absolute and Relative Contraindications

Contraindications include conditions expected to meaningfully limit post‑transplant survival or increase risk of recurrence or immediate morbidity. Key items include malignancy with high risk of recurrence or death, severe uncontrolled medical conditions that limit survival, and GFR <40 mL/min/1.73m2 unless the candidate is being considered for a multi‑organ transplant. Other contraindications described in the policy include uncontrolled or highly virulent chronic infection, recent stroke/acute coronary syndrome/myocardial infarction within 30 days, septic shock, progressive cognitive impairment, inability to adhere to the regimen necessary to preserve the transplant, and active substance use or dependence without convincing evidence of risk‑reduction behaviors.

The policy explicitly removed the previous contraindication that listed absence of an adequate support system (Criterion II.B.12). This change is recorded in the revision notes and means lack of an identified support system is no longer enumerated as a reason for ineligibility in this policy.

Procedure and Billing Codes

Covered CPT Codes (intestine-related)CPTCovered

44135	Intestinal allotransplantation;_from cadaver_donor
44136	Intestinal allotransplantation; from living donor
44715	Backbench standard preparation of cadaver Or living donor intestine allograft to transplantation, including mobilization and fashioning of the superior mesenteric artery and vein prior
44720	Backbench reconstruction of cadaver or donor intestine allograft to transplantation;_venous anastomosis,each living prior
44721	Backbench reconstruction of cadaver or donor intestine allograft to transplantation; arterial anastomosis,each living prior

Covered CPT Codes (liver-related)CPTCovered

47135	Liver allotransplantation, orthotopic, partial or whole, from cadaver or living donor,_anyage
47143	Backbench standard preparation of cadaver donor whole liver to allotransplantation; without trisegment or lobe split graft prior
47144	Backbench standard preparation of cadaver donor whole liver to allotransplantation; with trisegment split of whole liver into two partial liver grafts (i.e-, left lateral segment graft prior graft
47145	Backbench standard preparation of cadaver donor whole liver to allotransplantation; with lobe split of whole liver into two partial liver grafts (i.e,, left lobe [segments II, graft prior graft
47146	Backbench reconstruction of cadaver or donor liver prior to allotransplantation;_venous anastomosis_each_ living graft
47147	Backbench reconstruction of cadaver or living donor liver to allotransplantation; arterial anastomosiseach graft prior

HCPCS Codes (transplant and procurement)HCPCSCovered

S2053	Transplantation of small intestine and liver allografts
S2054	Transplantation of multivisceral organs_.
S2055	Harvesting of donor multivisceral organs, with preparation and maintenance of allografts;_from_cadaver_donor_.
S2152	Solid organs(s), complete or segmental, single organ or combination of organs; deceased or donor(s), procurement, transplantation, and related complications; including: drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services, and the number of days of pre- and posttransplant care in the global definition

inv-09: GFR threshold — 40 mL/min/1.73m2

GFR threshold40 mL/min/1.73m2

ContextGFR <40 mL/min/1.73m2 is listed as a contraindication unless the candidate is being considered for multi-organ transplant

Policy change noteThreshold updated from 30 to 40 mL/min/1.73m2 per 05/24 annual review

inv-10: HIV CD4 — >200 cells/mm3

HIV CD4 criterion>200 cells/mm3

Associated HIV requirementsAbsence of active AIDS-defining opportunistic infection or malignancy and currently on effective antiretroviral therapy (ART)

Prior Authorization, Documentation, and Administrative Actions

Prior Authorization

Obtain prior authorization for listed transplant and procurement CPT/HCPCS codes

Prior authorization is required for the intestinal, combined intestinal‑liver, and multivisceral transplant procedures and the associated procurement/preparation HCPCS/CPT codes listed in the policy.

Submit prior authorization for CPT codes such as 44135, 44136, 44715, 44720, 44721, 47135, 47143–47147 and HCPCS S2053, S2054, S2055, S2152 as applicable.
Include clinical documentation that demonstrates the specific indication and criteria met when requesting authorization.

Billing Rule

Ensure prior authorization decisions align with Medicare NCDs/LCDs/CMS guidance

For Medicare members/enrollees, prior authorization and coverage decisions should be consistent with applicable Medicare NCDs, LCDs, and CMS guidance; reviewers must consult those Medicare resources when making coverage determinations.

Transplant Center and Accreditation Notes

Note

No explicit center requirements listed in this policy section

This policy does not specify transplant center accreditation, volume, or other center‑level requirements in this portion of the document; medical necessity review and coding implications are described but explicit center requirements are not listed.

Refer to CMS/NCD/LCD and Health Plan accreditation requirements for center‑level standards as implied by the policy.

Note

Refer to CMS/NCD/LCD and Health Plan accreditation requirements for centers

Refer to applicable CMS/NCD/LCD guidance and Health Plan accreditation requirements for transplant centers, as this policy implies but does not state explicit center requirements in this section.

Consult CMS and Health Plan resources for center accreditation and any volume or credentialing requirements.

Post-Transplant Billing and Bundles

inv-29: Procurement, transplantation, and related complications bundle (S2152)

HCPCS codeS2152

Description (exact)Solid organs(s), complete or segmental, single organ or combination of organs; procurement, transplantation, and related complications; including: drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services, and the number of days of pre- and posttransplant care in the global definition

ScopeInclusive procurement/transplant bundle covering drugs, supplies, hospitalization and outpatient follow-up

inv-30: Post-transplant coverage

Post-transplant specificsNo post-transplant coverage specifics appear in this portion of the document.

Policy note

Clinical Background

Intestinal failure is the loss of absorptive capacity of the small bowel due to underlying disease or surgical short bowel syndrome. Typical small bowel length varies; short bowel syndrome (SBS) is described as occurring when approximately 200 cm of small bowel remain, and intestinal transplantation (including isolated intestinal, combined intestinal‑liver, or multivisceral transplant) is a therapeutic option for patients with irreversible intestinal failure.

Key Definitions

inv-20: Short bowel syndrome (SBS)

DefinitionShort bowel syndrome (SBS) occurs when there is approximately 200 cm of small bowel remaining leading to intestinal failure.

Clinical implicationSBS can result from surgical resection and leads to loss of absorptive capacity warranting consideration for intestinal rehabilitation or transplant depending on severity.

Typical small bowel length rangeTypical small intestine length varies widely (approximately 3 to 8 meters), with SBS defined by marked reduction to ~200 cm remaining.

inv-21: Multivisceral transplant

DefinitionMultivisceral transplant includes the stomach, duodenum, pancreas, liver, small intestine, and large intestine; a modified version may exclude the liver if the recipient's liver is normal.

Occasional inclusion

Document Changes and Review Notes

2024-05annual_review_revisionLatest

Updated GFR threshold from 30 to 40 mL/min/1.73m2 and added clarifying language to policy/criteria, including TPN‑induced liver injury and hospitalization requirements; separated and clarified several subcriteria.

2022-05annual_review

Edited contraindications to add GFR restriction, HIV with detectable viral load, recent stroke/ACS/MI, acute renal failure, septic shock, progressive cognitive impairment; replaced prior wording around malignancy and substance use; removed acute medical instability and uncorrectable bleeding diathesis.