Intestinal and Multivisceral Transplant
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Medical necessity criteria and coding guidance for isolated intestinal, combined intestinal-liver, and multivisceral transplantation for pediatric and adult members/enrollees with irreversible intestinal failure.
Updated contraindications to include GFR threshold changes, HIV with detectable viral load conditions, stroke/ACS/MI timing, septic shock, progressive cognitive impairment, and clarified substance use language.
Added clarifying language to Procedure Criteria II.A.1 to include TPN-induced liver injury and specify hospitalization requirement for recurrent line infections.
Updated CPT and HCPCS code listings for intestinal, liver, and multivisceral transplant procedures and prep/reconstruction codes.
Coverage and Medical Necessity Criteria
inv-01: Medical Necessity Criteria
Covered when ALL of the following are met:
Overall
Indications (II.A)
- TPN failure (II.A.1): Failure of total parenteral nutrition (TPN) as indicated by one or more of: a) impending or overt TPN-induced liver injury (elevated serum bilirubin and/or liver enzymes, splenomegaly, thrombocytopenia, gastro-esophageal varices, coagulopathy, stomal bleeding, or hepatic fibrosis/cirrhosis); b) thrombosis of two or more central veins (including jugular, subclavian, femoral); c) two or more episodes per year of systemic sepsis from line infection requiring hospitalization; d) one episode of septic shock, acute respiratory distress syndrome (ARDS), and/or line-related fungemia; e) frequent severe dehydration despite IV fluid supplementation in addition to TPN; f) other complications leading to loss of vascular access.
TPN failure entries correspond to II.A.1.a-f.
- High risk of death (II.A.2): High risk of death if transplant is not performed.
- Severe short bowel (II.A.3): Severe short bowel syndrome: gastrostomy, duodenostomy, and/or residual small bowel <10 cm in infants and <20 cm in adults.<10 cm infants; <20 cm adults
- Frequent hospitalizations (II.A.4): Frequent hospitalizations for complications directly related to intestinal failure (e.g., opioid dependency for pain management, or pseudoobstruction).
- Hepatic cirrhosis with thrombosis (II.A.5): Significant hepatic cirrhosis associated with diffuse portomesenteric thrombosis.
Contraindications (II.B)
- Malignancy with high risk of recurrence or death related to cancer.
- Severe uncontrolled medical condition: Other severe uncontrolled medical condition expected to limit survival after transplant.
- Renal dysfunction: Glomerular filtration rate < 40 mL/min/1.73m2 unless being considered for multi-organ transplant.GFR < 40 mL/min/1.73m2
- HIV with detectable viral load: HIV infection with detectable viral load is a contraindication unless ALL of the following are met: a) CD4 cell count >200 cells/mm3; b) absence of active AIDS-defining opportunistic infection or malignancy; c) member is currently on effective antiretroviral therapy (ART).
Conditions permit listing in select circumstances per policy.
- Septic shock.
- Cognitive impairment: Progressive cognitive impairment.
- Recent vascular/cardiac event: Stroke, acute coronary syndrome, or myocardial infarction (excluding demand ischemia) within 30 days.within 30 days
- Chronic resistant infection: Chronic infection with highly virulent and/or resistant microbes that are poorly controlled pre-transplant.
- Nonadherence: Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.
- Active substance use or dependence including current tobacco use, vaping, marijuana use (unless prescribed), or IV drug use without convincing evidence of risk reduction behaviors (unless urgent transplant timelines are present, in which case a commitment to reducing behaviors is acceptable). Serial blood and urine testing may be used to verify abstinence.
Policy language has been updated to remove several prior absolute contraindications and to clarify existing items. Specifically, the policy removed prior contraindications such as 'severely limited functional status with poor rehabilitation potential' and the prior wording regarding absence of an adequate support system; these concepts are no longer listed as standalone contraindications. Revision notes document multiple edits to the contraindication list and wording changes across 2022–2024 that replace, refine, or relocate prior exclusions to improve clarity and align with current practice guidance.
These edits also include targeted wording clarifications in procedure criteria (for example, expanding TPN-related liver injury language and separating and clarifying infection-related points) and updates to renal-function and HIV-related language. Where applicable, the policy now specifies GFR thresholds and conditional allowances for HIV with detectable viral load under defined circumstances. Providers should follow the updated list of contraindications in II.B when assessing transplant candidacy.
Transplantation is considered medically necessary only when the member meets the policy’s specified indications and does not have any listed contraindication. If the member does not meet at least one qualifying indication in section II.A or has any contraindication listed in section II.B, intestinal, combined intestinal-liver, or multivisceral transplantation is not covered.
Coverage determinations are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents. In addition, Medicare/Medicaid rules and any applicable state provisions may affect coverage; providers should review applicable Medicare NCDs/LCDs and plan documents when seeking authorization.
Candidate Indications and Requirements
inv-22: Transplant type indications
Candidate must have one qualifying indication and no contraindications.
Transplant type indications
- Isolated intestinal transplant: Indicated for isolated intestinal failure with no liver disease.
(I.A)
- Combined intestinal and liver transplant: Indicated for intestinal failure with end-stage liver disease.
(I.B)
- Multivisceral transplant: Indicated for intestinal failure with gastrointestinal motility disorders (e.g., chronic idiopathic intestinal pseudo-obstruction, visceral myopathy, visceral neuropathy, total intestinal aganglionosis, some mitochondrial disorders that affect GI motor function) or extensive mesenteric thrombosis.
(I.C)
Contraindications
The policy lists the following absolute or relative contraindications. Presence of any single contraindication generally disqualifies the member from transplant candidacy unless the policy explicitly allows conditional exception (for example, specific HIV criteria): malignancy with high risk of recurrence or death related to cancer; other severe uncontrolled medical condition expected to limit survival after transplant; glomerular filtration rate < 40 mL/min/1.73m2 unless being considered for multi-organ transplant; 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 member is on effective antiretroviral therapy); septic shock; progressive cognitive impairment; stroke, acute coronary syndrome, or myocardial infarction within 30 days (excluding demand ischemia); chronic infection with highly virulent and/or resistant microbes poorly controlled pre-transplant; inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support; and active substance use or dependence including current tobacco use, vaping, non-prescribed marijuana, or IV drug use without convincing evidence of risk-reduction behaviors (serial testing may be used to verify abstinence).
The policy revision history documents that several prior contraindications were removed or reworded and that thresholds and conditional allowances (for example, GFR and HIV-related criteria) were updated to improve clarity and align with current clinical practice.
Pre-Transplant Evaluation Requirements
EVALUATION REQUIREMENTS — Document intestinal failure severity, TPN complications, vascular access, sepsis, liver and other organ function
Pre‑transplant evaluation must document the severity of intestinal failure, including measurements of residual small bowel length, history and complications of total parenteral nutrition (TPN), vascular access status (including central vein thromboses and loss of access), history of sepsis/line infections and related hospitalizations, liver disease staging, and assessment of other organ function such as renal GFR.
- Residual small bowel length (report <10 cm in infants; <20 cm in adults when applicable).
- TPN complications: evidence of TPN‑induced liver injury, recurrent line infections, thrombosis of central veins, loss of vascular access.
- Sepsis history: number of systemic sepsis episodes requiring hospitalization, episodes of septic shock/ARDS/line‑related fungemia.
- Vascular access status: thrombosis of two or more central veins or other loss of access events.
- Liver disease staging and portal/mesenteric thrombosis assessment.
- Renal function assessment (GFR) and other organ evaluations.
EVALUATION REQUIREMENTS — Use referenced clinical guidelines and literature for evaluation and indications
The policy explicitly references clinical guidance and peer‑reviewed literature to inform pre‑transplant evaluation and indications; providers should use sources such as UpToDate, ESPEN guidelines, and cited transplant literature when performing workup and determining candidacy.
- UpToDate overview of intestinal and multivisceral transplantation (cited).
- ESPEN guidelines on chronic intestinal failure (cited).
- Peer‑reviewed transplant literature and society position statements (e.g., AST, British Society of Gastroenterology).
Provider Required Actions and Documentation
Prior authorization required — demonstrate medical necessity per policy criteria
Prior authorization is required and must demonstrate the member meets the policy medical necessity criteria for isolated intestinal, combined intestinal‑liver, or multivisceral transplantation as described in Section II.
- Include evidence that one qualifying indication (II.A) is met and that no contraindications (II.B) are present.
- Reference applicable CPT/HCPCS codes when submitting authorization (see coding section).
Review Medicare/Medicaid determinations before authorization
For Medicare members/enrollees, review all applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Coverage Articles prior to applying this policy’s criteria and submitting authorization requests.
- Refer to the CMS website and applicable NCD/LCDs to ensure consistency with Medicare guidance.
Step therapy — not applicable for transplant candidacy
Step therapy is not applicable to transplant candidacy in this policy; no step therapy sequence is specified as a prerequisite to authorization for intestinal or multivisceral transplant.
Required documentation — demonstrate one qualifying indication and absence of contraindications
Include documentation demonstrating medical necessity by showing one qualifying indication (per II.A) and that no contraindications (per II.B) exist; submit clinic notes, hospital records, imaging, laboratory data, operative reports, and relevant procedure codes as applicable.
- Evidence of TPN failure (e.g., labs, imaging for TPN‑induced liver injury, documentation of central vein thromboses, sepsis hospitalizations).
- Measured residual bowel length when claiming severe short bowel.
- Liver disease staging and portal/mesenteric thrombosis documentation.
- Relevant CPT/HCPCS codes to accompany claims/authorization.
Provider documentation and compliance — follow coverage documents and legal requirements
Providers must follow this clinical policy and any applicable coverage documents and legal/regulatory requirements when submitting claims and seeking authorization; professional judgment remains the responsibility of the treating provider.
- Adhere to evidence of coverage, provider agreements, and state/federal regulations when submitting requests.
Triggers for denial — failure to meet indications or presence of contraindications
Requests may be denied if the member does not meet any qualifying indication (II.A) or if any listed contraindication (II.B) is present — examples include failure to document TPN failure criteria, severe short bowel thresholds, GFR below the contraindication threshold, active uncontrolled infection, or inability to adhere to the required regimen.
- Denial triggers include lack of evidence for TPN failure, residual bowel length not meeting thresholds, documented contraindications such as malignancy with high recurrence risk, GFR <40 mL/min/1.73m2 (unless multi‑organ transplant), septic shock, or active substance use without risk‑reduction evidence.
Coverage conditions and legal precedence — subject to plan terms and applicable law
Coverage decisions and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents and to applicable state and federal requirements; where conflicts with state Medicaid provisions occur, state Medicaid rules take precedence.
Provider action — placeholder
Reserve as a policy‑specific provider instruction placeholder for brief advisories or short actionable notes when needed.
Coding Guidance
| 44135 | Intestinal allotransplantation; from cadaver donor |
| 44136 | Intestinal allotransplantation; from living donor |
| 44715 | Backbench standard preparation of cadaver or living donor intestine allograft prior to transplantation, including mobilization and fashioning of the superior mesenteric artery and vein |
| 44720 | Backbench reconstruction of cadaver or living donor intestine allograft prior to transplantation; venous anastomosis, each |
| 44721 | Backbench reconstruction of cadaver or living donor intestine allograft prior to transplantation; arterial anastomosis, each |
| 47135 | Liver allotransplantation, orthotopic, partial or whole, from cadaver or living donor, any age |
| 47143 | Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation; without trisegment or lobe split |
| 47144 | Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation; with trisegment split |
| 47145 | Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation; with lobe split |
| 47146 | Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; venous anastomosis, each |
| 47147 | Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; arterial anastomosis, each |
| 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 living 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 |
Center and Program Requirements
CENTER REQUIREMENTS — guideline‑based recommendations; no explicit payer accreditation stated
The policy references professional guideline recommendations and specialist review for center‑level considerations but does not specify explicit payer center accreditation or certification requirements within this document.
- Follow professional society guidance and specialist consultation for program structure and case selection.
CENTER REQUIREMENTS — follow Medicare NCD/LCD and Health Plan certification/regulatory requirements
For center certification and regulatory compliance, refer to and align with applicable Medicare NCDs/LCDs and the Health Plan’s requirements for facility certification and relevant state regulatory rules.
- Review CMS NCD 260.5 and any relevant LCDs/Coverage Articles when applicable to Medicare members.
Post-Transplant Coverage and Bundling
Definitions
Background and Clinical Context
Intestinal failure is the loss of small-bowel absorptive capacity that results in the need for long-term parenteral nutrition or other interventions to maintain nutrition and fluid balance. Short bowel syndrome (SBS) is a common cause of intestinal failure and often follows extensive small-bowel resection.
The policy references clinical criteria used to identify candidates for transplantation: patients with irreversible intestinal failure who have failed or are unsuitable for intestinal rehabilitation and who meet specific indications such as TPN failure (including TPN-induced liver injury, loss of vascular access, repeated line infections, or septic complications), severe short bowel syndrome (residual small bowel <10 cm in infants or <20 cm in adults), frequent hospitalizations for intestinal-failure complications, or significant hepatic cirrhosis with portomesenteric thrombosis. Transplant types covered include isolated intestinal, combined intestinal-liver, and multivisceral procedures depending on the underlying pathology.
Policy Revision History
Annual review expanded II.A.4 (e.g., opioid dependency, pseudo-obstruction); clarified II.A.1 (added TPN‑induced liver injury, changed 'peristomal' to 'stomal', separated II.A.1.c with hospitalization requirement, clarified II.A.1.d, and updated portomesenteric wording); GFR contraindication standardized to <40 mL/min/1.73m2; HIV-related listing conditions clarified (CD4 >200, absence of active AIDS‑defining infection/malignancy, on effective ART).
Annual review updated active substance use verbiage (II.B.13) to specify tobacco, vaping, marijuana, IV drug use and allowance for commitment to behavior change when urgent; references reviewed and updated.
Annual review edited contraindications and replaced earlier functional/psychological nonadherence language with 'Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.'; references reviewed and specialist reviewed.
Revised contraindications (added GFR restriction, HIV with detectable viral load, recent stroke/ACS/MI, acute renal failure, septic shock, progressive cognitive impairment; removed acute medical instability and uncorrectable bleeding diathesis); updated revision/approval date formatting.
Replaced prior wording about severely limited functional status and nonadherence-related contraindications with consolidated inability-to-adhere statement; changed header 'review date' to 'Date of Last Revision' and revision log header wording.
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