CurrentBlue Cross Blue Shield - MassachusettsPolicy 7.03.04

Small bowel (intestinal) transplantation

Defines medical necessity criteria, exclusions, prior authorization requirements, and coding guidance for small bowel (intestinal) transplantation (cadaveric and living donor) and retransplantation for commercial members of Blue Cross Blue Shield Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicySmall bowel (intestinal) transplantation

Policy CodePolicy 7.03.04

Change TypeAnnual review (descriptive/reference updates)

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization for all inpatient small bowel transplant procedures; prior authorization requirements for outpatient vary by product.

SourceLink

POLICY UPDATE CHANGES

10/2024 annual policy review: description and references updated; policy statements unchanged.

1/2021 Medicare information removed and reference to MP #132 for Medicare Advantage Management added.

10/2014 Medical policy remediation: New indications for non-coverage and clarified coding information effective 10/1/2014.

95Intestinal transplants performed in U.S. in 2023

192New patients added to waiting list (as of 2024-06-27)

Coverage Summary

Background: This policy addresses indications, rationale, and evidence for small bowel (intestinal) transplantation, including both isolated small bowel and combined/multivisceral procedures. It summarizes short bowel syndrome and the subset of patients who become chronically dependent on total parenteral nutrition (TPN), complications related to TPN (for example catheter-related problems, infections, metabolic bone disease), and outcomes reported in case series and registry data. Transplant candidates are prioritized by mortality risk and illness severity according to OPTN/UNOS criteria. Recipients require lifelong immunosuppression, with associated risks including infection and graft rejection.

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Medical Necessity Criteria

Medically Necessary (cadaveric intestine)

Small bowel transplant using a cadaveric intestine may be MEDICALLY NECESSARY in adult and pediatric patients to treat the following conditions when ALL of the following are met:

ALL of the following

Established long-term dependency on total parenteral nutrition (TPN)
Intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance)
Developing or have developed severe complications due to TPN

Medically Necessary (living donor)

Small bowel transplant using a living donor may be MEDICALLY NECESSARY only when ALL of the following are met:

ALL of the following

The patient meets the criteria noted above for cadaveric intestinal transplant (established long-term TPN dependence, intestinal failure, severe complications due to TPN)
A cadaveric intestine is NOT available for transplantation

Medically Necessary (retransplantation)

A small bowel retransplant may be MEDICALLY NECESSARY when ALL of the following are met:

ALL of the following

Failed primary small bowel transplant
No contraindications to retransplant (implied: patient continues to meet criteria for transplantation)

Investigational and Not Medically Necessary

Investigational / Not Medically Necessary

Situations considered investigational or not covered:

Investigational

Small bowel transplant using living donors is INVESTIGATIONAL in all other situations (i.e., when cadaveric intestine is available or criteria not met)
A small bowel transplant in adult patients with intestinal failure who are able to tolerate TPN is INVESTIGATIONAL

Not covered / Contraindications

Recent malignancy with high risk of recurrence
Known current malignancy, including metastatic cancer
History of cancer with a moderate risk of recurrence
Other irreversible end-stage disease not attributed to intestinal failure
Untreated systemic infection making immunosuppression unsafe, including chronic infection
Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
Systemic disease that could be exacerbated by immunosuppression

Operational note: Transplant recipients require lifelong immunosuppression, which carries risks such as infection and rejection and is an important consideration in candidate selection and posttransplant care. Per the policy, living-donor small bowel transplantation is considered medically necessary only when the patient meets cadaveric transplant criteria and a cadaveric intestine is NOT available; living-donor transplants are investigational in all other situations (including when cadaveric intestine is available or criteria are not met). Prior authorization is required for inpatient procedures.

Coding

Covered CPT CodesCPTCovered

44135	Intestinal allotransplantation; from cadaver donor.
44136	Intestinal allotransplantation; from living donor.

ICD-10-PCS Procedure CodesICD-10

0DY80Z1	Transplantation of Small Intestine, Allogeneic, Open Approach.
0DY8ZZ1	Transplantation of Small Intestine, Syngeneic, Open Approach.
0DY8?Z1	(Additional ICD-10-PCS formatting/coding note) Placeholder for other small intestine transplant codes where appropriate.

Procedure coding: The policy provides procedure coding for small bowel transplantation. Historical coding clarifications were made in 10/2014; providers should reference the policy history for those updates. Note that ICD-10-PCS codes are presented in the brief and must be reported exactly as formatted in the official ICD-10-PCS code set. The ICD-10-PCS code 0DY8OZ1 is included (Transplantation of Small Intestine, Allogeneic, Open Approach) and is represented here along with related PCS entries to ensure completeness for billing and documentation purposes.

Provider Actions

Prior Authorization

Precertification/Preauthorization required for inpatient procedures

Precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.

Prior Authorization

Outpatient authorization varies by product

Prior authorization may be required for outpatient procedures depending on product: Commercial Managed Care (HMO and POS) outpatient prior auth indicated; Commercial PPO and Indemnity noted that the procedure is performed in the inpatient setting.

Documentation Required

Assessment of malignancy recurrence risk

Providers must submit a statement from the transplant team explaining why a patient with a recently treated malignancy is an appropriate candidate, as the transplant team assesses risk of recurrence.

Background and Evidence

Background details: Short bowel syndrome results from loss of sufficient small intestinal absorptive surface because of disease or surgical resection; clinical severity ranges from minor micronutrient malabsorption to intestinal failure (inability to maintain macronutrient, fluid, electrolyte, or micronutrient balance). Some patients are unable to achieve adequate nutrition enterally and become chronically dependent on TPN; reported rates of parenteral nutrition dependency for short bowel syndrome at 1, 2, and 5 years are approximately 74%, 64%, and 48%, respectively. Complications of long-term TPN include catheter-related mechanical problems, infections, and metabolic bone disease. Intestinal transplantation can be performed as an isolated small bowel procedure or combined with other visceral organs (for example liver) and is infrequently performed relative to other solid-organ transplants (95 intestinal transplants in the U.S. in 2023). Evidence for transplant outcomes derives primarily from case series and registry data; while risks after small bowel transplant are substantial—particularly infection—they may be balanced against the long-term harms of TPN dependence. Candidates are prioritized by OPTN/UNOS criteria, and transplantation is contraindicated when expected futility or comorbid conditions would make posttransplant care inadvisable.

Evidence

Evidence baseCase series and registry data; limited quantity but sufficient to determine improvement in net health outcome for selected patients.

Definition — Intestinal failure: Loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance.

OpenPayer

Small bowel (intestinal) transplantation

Coverage Summary

Medical Necessity Criteria

Investigational and Not Medically Necessary

Coding

Provider Actions

Background and Evidence

Medicare Determinations

Revision History