Aetna Intestinal Transplant Coverage Update

Coverage Criteria for Intestinal and Multivisceral Transplantation

Initial transplant medical necessity

Covered when ALL of the following are met for persons with clinical indicators of failed TPN:

Clinical indicators of failed TPN (ONE or more required): One or more of: frequent severe dehydration despite IV fluid supplementation; 2 or more episodes per year of systemic sepsis due to line infection (or a single episode of line-related fungemia, septic shock, or ARDS); impending or overt TPN-induced liver failure (e.g., elevated bilirubin or liver enzymes, splenomegaly, thrombocytopenia, coagulopathy, hepatic fibrosis/cirrhosis); loss of vascular access; thrombosis of 2 or more major central venous channels (jugular, subclavian, femoral).

Selection criteria for transplant (ALL required unless transplanting institution protocol applies): Absence of acute or chronic active infections not effectively treated; adequate cardiovascular function (left ventricular ejection fraction >= 40%); adequate liver and kidney function (total bilirubin < 2.5 mg/dL and creatinine clearance > 50 ml/min/kg); no uncontrolled or untreated psychiatric disorders that interfere with compliance; controlled HIV/AIDS defined as CD4 > 200 cells/mm3 for > 6 months, undetectable HIV-1 RNA, and on stable antiretroviral therapy for > 3 months.

Combined intestinal and liver transplant

Combined transplant

Combined intestinal and liver transplant: Considered medically necessary for persons with advanced liver disease necessitating liver transplantation who meet the medical necessity criteria above except the requirement for adequate native liver function (bilirubin < 2.5 mg/dL is not required); renal function should be assessed with measured GFR in candidates for combined transplants.

Multi-visceral transplant coverage

Multi-visceral transplant

Multi-visceral transplant indications: Medically necessary for adults and children who meet criteria for combined small bowel/liver transplant and require one or more additional abdominal visceral organs to be transplanted due to concomitant organ failure or anatomical abnormalities that preclude a small bowel/liver transplant.

Experimental indication exclusion: Multi-visceral transplants are considered experimental and investigational for individuals with neuroendocrine pancreatic tumors.

Indications / Candidate scenarios

Candidate consideration described in referenced studies (examples of clinical scenarios where transplant is performed):

Indications for transplant: Intestinal failure refractory to intestinal rehabilitation/parenteral nutrition; intestinal failure with PN-associated liver disease requiring simultaneous liver-intestine transplant; surgical abdominal catastrophes or frozen abdomen; slow-growing or neuroendocrine tumors not amenable to resection; complete porto-mesenteric thrombosis with cirrhosis; non-resectable recurrent pseudomyxoma peritonei causing nutritional failure.

Sources: Mangus et al. 2013; Varkey et al. 2013; Kubal et al. 2015a

Monitoring and surveillance

Monitoring and risk considerations:

Immunologic monitoring: Consider pre- and post-transplant surveillance for donor-specific anti-HLA antibodies (DSA) because preformed DSAs are present in nearly one-third of ITx recipients and de-novo DSAs develop in up to 40%, and DSAs have been associated with rejection and allograft loss.

Non-invasive rejection surveillance: Fecal calprotectin has been investigated as a non-invasive screening test for intestinal allograft rejection with a proposed positive cutoff of 100 ng/mg, but prospective validation is needed; measurement is considered investigational by the policy.100 ng/mg

Post-transplant surveillance intervals (example): Serial DSA screening has been performed in studies at intervals such as 1, 3, 6, 9, 12, 18, 24, and 36 months after transplantation; monitoring strategies vary by center.

Intestinal transplantation is not medically necessary for persons who have listed contraindications. Contraindications include advanced neurological disorders (for example, neuroaxonal dystrophy, Tay‑Sachs disease, Niemann‑Pick disease and variants, neuronal ceroid lipofuscinosis, Huntington disease), congestive heart failure with refractory symptoms and left ventricular ejection fraction <40%, malignancy not effectively treated with substantial risk of recurrence, multi‑organ failure, presence of other significant gastrointestinal diseases (e.g., bleeding peptic ulcer, diverticulitis, chronic hepatitis), sepsis, and unstable alcohol or substance use disorder (exceptions allowed with documentation of ≥3 months stability). Specific ICD‑10 diagnoses and substance‑use codes are listed in the coding section as contraindicated for this policy.

Comparative outcomes from cited series indicate that adult patients who are stable on parenteral nutrition/home TPN may have higher survival than adults who undergo intestinal transplantation in some cohorts. This finding supports careful candidate selection and consideration of continued conservative management for adults who are clinically stable on PN rather than routine referral to transplantation.

Measurement of fecal calprotectin for the purpose of detecting intestinal allograft rejection is considered experimental/investigational and not medically necessary, because its clinical value has not been established.

A 2015 UpToDate review of intestinal and multivisceral transplantation did not mention routine monitoring of donor‑specific anti‑HLA antibodies (DSA) as a standard management tool, indicating limited consensus and supporting a lack of routine requirement for DSA surveillance in standard care.

Coding — Covered and Not Covered Codes

Covered CPT/HCPCS related to intestinal transplantationmixedCovered

44132	Donor enterectomy (including cold preservation), open; from cadaver donor.
44133	partial, from living donor.
44135	Intestinal allotransplantation; from cadaver donor.
44136	from living donor.
44137	Removal of transplanted intestinal allograft, complete.
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 anastamosis, each.
44721	arterial anastamosis, each.
36555-36597	Central venous access procedures.
47135	Liver allotransplantation; orthotopic; partial or whole, from cadaver or living donor, any age.

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ICD-10 codes covered if selection criteria are metICD-10Covered

A40.0-A40.9	Streptococcal sepsis.
E86.0-E86.9	Volume depletion.
I82.811-I82.91	Embolism and thrombosis of other specified veins.
K91.2	Postsurgical malabsorption, not elsewhere classified.
Z90.49	Acquired absence of other specified parts of digestive tract.

CPT codes not covered for indications listed in the CPBCPTNot Covered

83993

Calprotectin, fecal.

ICD-10 codes not covered/contraindicatedICD-10Not Covered

B18.0-B18.2	Chronic viral hepatitis B and C codes listed as not covered.
C78.6	Secondary malignant neoplasm of retroperitoneum and peritoneum [recurrent non-resectable pseudomyxoma peritonei].
F10.10-F19.988	Mental and behavioral disorders due to psychoactive substance use (listed as contraindicated).

inv-14: Left ventricular ejection fraction requirement

RequirementLeft ventricular ejection fraction ≥ 40% is required for transplant candidacy (adequate cardiovascular function)

Source contextListed as part of Aetna selection criteria for isolated intestinal transplant; EF threshold cited as 'greater than or equal to 40%'.

Contraindication noteCongestive heart failure with refractory symptoms and EF <40% is listed as a contraindication to transplant.

inv-15: Total bilirubin threshold for isolated intestinal transplant

Maximum total bilirubinTotal bilirubin < 2.5 mg/dL is required for isolated intestinal transplant candidacy

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for intestinal transplant-related procedure codes. Requests must include documentation that the member meets selection criteria and that the transplanting institution's protocol (if any) deems the candidate eligible.

Affected codes include CPT codes such as 44132, 44133, 44135, 44136, 44137, 44715, 44720, 44721 and related transplant procedure codes listed in the policy. Prior authorization is required before scheduling the transplant procedure.

Prior Authorization

Prior Authorization: Candidate Failure of Non‑Transplant Therapy

Prior authorization requests must confirm that the candidate has failed non‑transplant therapies or has specific indications for transplant (for example: parenteral nutrition–associated liver disease, recurrent central line sepsis, threatened loss of central venous access, or other life‑threatening complications of TPN).

Documented failure of intestinal rehabilitation and/or prolonged dependence on TPN despite optimal medical management.
Evidence of complications from TPN such as recurrent line infections (≥2 episodes of systemic sepsis per year), impending or overt TPN‑induced liver failure, loss of central venous access, or thrombosis of major central veins (≥2 vessels).

Background and Definitions

Intestinal failure—most commonly from short bowel syndrome or severe motility disorders—results in inability to maintain adequate nutrition, fluids, and electrolytes via the enteral route. Parenteral nutrition/home TPN is the primary therapy for these patients, but life‑threatening complications of TPN (for example, recurrent central line sepsis, TPN‑associated liver disease, loss of vascular access) can indicate failure of conservative management and consideration of transplant. Outcomes after intestinal and multivisceral transplantation vary, and pediatric candidates may experience different survival benefit compared with adults.

inv-32: Definition — Short bowel syndrome (SBS)

Definition (SBS)Short bowel syndrome (SBS): condition in which the absorbing surface of the small intestine is inadequate due to extensive disease or surgical removal, resulting in inability to obtain adequate nutrition from enteral feeding.

IncludesIncludes causes such as extensive resection, congenital anomalies in infants, and etiologies like Crohn's disease, radiation enteritis, mesenteric thrombosis in adults.

Clinical consequencePatients with SBS are often dependent on parenteral nutrition and may be candidates for intestinal transplantation if TPN fails or causes life‑threatening complications.

Candidate Selection Criteria

Isolated intestinal transplant candidates

Candidates for isolated intestinal transplant

Indication and baseline eligibility: Clinical indicators of failed TPN (see policy) AND either the transplanting institution's protocol eligibility or, if no protocol provided, the Aetna selection criteria: no untreated infections; left ventricular ejection fraction >= 40%; total bilirubin < 2.5 mg/dL; creatinine clearance > 50 ml/min/kg; stable psychiatric/substance use status; and controlled HIV (CD4 >200 cells/mm3 for >6 months, undetectable viral load, on stable antiretroviral therapy >3 months).

Candidate groups

Patient groups more likely to benefit:

Pediatric candidates: Children with irreversible intestinal failure for whom transplantation is often lifesaving; pediatric outcomes and timing considerations may differ from adults and earlier transplantation may be preferred.

Varkey et al. 2013; clinical series

Contraindications to Transplantation

The policy lists both absolute and relative contraindications that should be considered during candidate evaluation. These include advanced neurological disorders (specific neurodegenerative diseases are named), congestive heart failure with refractory symptoms and ejection fraction <40%, active or inadequately treated malignancy with high risk of recurrence, multi‑organ failure, other significant gastrointestinal diseases (e.g., bleeding peptic ulcer, diverticulitis, chronic hepatitis), ongoing sepsis, and unstable alcohol or substance use disorder (with exceptions permitted when documentation shows ≥3 months of stability).

Contraindications and exclusion criteria are summarized in policy text, but a comprehensive, itemized list is not provided in every excerpt of the document. Refer to the full contraindications section and coding lists for the specific diagnoses and codes that are considered exclusions under this policy.

Pre-Transplant Evaluation Requirements

Documentation Required

Perform comprehensive cardiac, hepatic, renal, infectious, psychiatric/substance use and HIV evaluations

Pre‑transplant assessment must include evaluation of cardiac, hepatic, renal, infectious, psychiatric/substance use and HIV status; for combined liver‑intestinal candidates, measured GFR is recommended to assess renal function.

Cardiac: ejection fraction ≥40% per selection criteria.
Hepatic: bilirubin and clinical signs of liver disease; combined candidates may be considered when liver disease necessitates liver transplant.
Renal: creatinine clearance >50 ml/min/kg; for combined transplants, measured GFR recommended.
Infectious and HIV: ensure absence of untreated infection and controlled HIV (CD4 >200 for >6 months, undetectable viral load).
Psychiatric/substance use: documentation of stability and ability to comply with treatment.

Documentation Required

Include clinical function, labs, endoscopy/biopsy, and immunologic testing in evaluation

Transplant Center Requirements

Note

Transplantation considered necessary when transplant center protocol eligibility criteria are met

Aetna considers transplantation medically necessary when the member meets the transplanting institution’s protocol eligibility criteria; if no protocol is provided, the Aetna selection criteria must be documented and met.

Submit the transplant center’s protocol eligibility criteria when available to support medical necessity.

Note

Center experience may be provided but must be supplemented by protocol/selection criteria

Center experience is not specified in this excerpt; referenced studies describe single‑center experiences and protocols that inform outcomes and selection practices.

Clinical and outcome descriptions from single‑center series may be included to support medical necessity but are not substitute for documented candidate criteria.

Post-Transplant Follow-up and Monitoring

inv-44: Long-term follow-up — Management of rejection and infection as per transplant center protocols; graft and patient survival data cited

Management expectationLong-term follow-up should include management of rejection and infection according to transplant center protocols; high rates of rejection and early infection are well documented.

Outcomes citedReported patient and graft survival vary by series (e.g., multi-visceral series report 1- and 3-year survival rates of 72% and 57% respectively in one cohort), underscoring variable long-term outcomes.

Complications to monitorCommon post-transplant complications include high rejection rates (often ≥50% in some series), frequent infections (especially in first year), graft‑versus‑host disease, and PTLD in pediatric recipients; management tailored by center protocols.

inv-45: DSA testing and surveillance biopsies — Post-transplant monitoring should include surveillance for de-novo DSA at serial intervals and periodic biopsies as per center protocols.

DSA surveillance

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Intestinal Transplantation