Small Bowel/Liver and Multivisceral Transplant

POLICY NUMBER

A.7.03.05

DESCRIPTION

This policy addresses transplantation and retransplantation of an intestinal allograft in combination with a liver allograft, either alone or in combination with one or more of the following organs: stomach, duodenum, jejunum, ileum, pancreas, or colon.

Solid organ transplantation offers a treatment option for patients with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Patients are prioritized for transplant by mortality risk and severity of illness criteria developed by Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Small Bowel/Liver and Multivisceral Transplant

In 2023, 46,629 transplants were performed in the United States procured from 39,679 deceased donors and 6,950 living donors. Intestinal transplants occur less frequently than other organ transplants, with 10 or fewer patients receiving liver-intestine transplant each year from 2008 to 2019. Small bowel and liver or multivisceral transplant is usually considered in adults and children who develop serious complications related to parenteral nutrition, including inaccessibility (eg, due to thrombosis) of access sites, catheter-related sepsis, and cholestatic liver disease.

Short Bowel Syndrome

Short bowel syndrome is defined as an inadequate absorbing surface of the small intestine due to extensive disease or surgical removal of a large portion of the small intestine. In some instances, short bowel syndrome is associated with liver failure, often due to the long-term complications of total parenteral nutrition.

TreatmentA small bowel/liver transplant or a multivisceral transplant includes the small bowel and liver with one or more of the following organs: stomach, duodenum, jejunum, ileum, pancreas, and/or colon. The type of transplantation depends on the underlying etiology of intestinal failure, quality of native organs, presence or severity of liver disease, and history of prior abdominal surgeries. A multivisceral transplant is indicated when anatomic or other medical problems preclude a small bowel/liver transplant. Complications following small bowel/liver and multivisceral transplants include acute or chronic rejection, donor-specific antibodies, infection, lymphoproliferative disorder, graft-versus-host disease, and renal dysfunction.

Small bowel/liver and multivisceral transplantation are surgical procedures and, as such, are not subject to regulation by the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

Isolated Small Bowel Transplants  are addressed in a separate policy.

POLICY

No benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorization through case management from Blue Cross & Blue Shield ofMississippi.

A small bowel/liver transplant or multivisceral transplant may be considered medically necessary for pediatric and adult individuals with intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance), who have been managed with long-term total parental nutrition (TPN) and who have developed evidence of impending end-stage liver failure.

A small bowel/liver retransplant or multivisceral retransplant may be considered medically necessary after a failed primary small bowel/liver transplant or multivisceral transplant.

A small bowel/liver transplant or multivisceral transplant is considered investigational in individuals with the following absolute contraindications:

• Known current malignancy, including metastatic cancer;

• Recent malignancy with a high risk of recurrence;

• Untreated systemic infection making immunosuppression unsafe, including chronic infection; or

• Other irreversible end-stage disease not attributed to intestinal failure.

Coverage is not provided for:

• Services for which the cost is covered/funded by governmental, foundation, or charitable grants

• Organs sold rather than donated to the recipient

• An artificial organ.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

General

Potential contraindications for solid organ transplant that are subject to the judgment of the transplant center include the following:

• Known current malignancy, including metastatic cancer

• Recent malignancy with high risk of recurrence

• History of cancer with a moderate risk of recurrence

• Systemic disease that could be exacerbated by immunosuppression

• Untreated systemic infection making immunosuppression unsafe, including chronic infection

• Other irreversible end-stage disease not attributed to intestinal failure

• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Intestinal failure results from surgical resection, congenital defect, or disease-associated loss of absorption and is characterized by the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance. Short bowel syndrome is an example of intestinal failure.

Candidates should meet the following criteria:

• Adequate cardiopulmonary status

• Documentation of individual compliance with medical management.

HIV-positive patients who meet the following criteria, as stated in the 2001 guidelines of the American Society of Transplantation, could be considered candidates for small bowel/liver or multivisceral transplantation under the following conditions:

• CD4 count >200 cells per cubic millimeter for >6 months

• HIV-1 RNA undetectable

• On stable anti-retroviral therapy >3 months

• No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm), and meeting all other criteria for transplantation.

Small Bowel/Liver-Specific Criteria

Evidence of intolerance of total parenteral nutrition (TPN) includes, but is not limited to, multiple and prolonged hospitalizations to treat TPN-related complications, or the development of progressive but reversible liver failure. In the setting of progressive liver failure, small bowel transplant may be considered a technique to avoid end-stage liver failure related to chronic TPN, thus avoiding the necessity of a multivisceral transplant.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

8/1998: Approved by Medical Policy Advisory Committee (MPAC).

8/2001: Reviewed by MPAC.

2/15/2002: Investigational definition added.

5/7/2002: Type of Service and Place of Service deleted.

7/21/2005: Reviewed by MPAC; "HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients."

10/19/2005: Code Reference table updated: Non-Covered Codes table added; CPT codes 44132, 44135, 44137, 44715, 44720, 44721, 47140, 47141, 47142, 47143, 47144, 47145, 47146, 47147 added to covered table, 44133, 44136 added to non-covered table, 44120, 44121, 44799, 47134 deleted; ICD-9 procedure codes 00.91, 00.92, 00.93, 46.97, 50.22, 50.4, 50.51 added, 50.5 deleted; HCPCS codes S2053, S2152 added to covered table, S2054, S2055 added to non-covered table; diagnosis codes 996.82, 886.89, V42.07, V42.8 deleted.

3/24/2006: Coding updated. CPT4 2006 revisions added to policy.

11/10/2006: Multivisceral transplant changed from "investigational" to "medically necessary." Policy name changed from Small Bowel, Liver and Mutivisceral Transplant to Multivisceral Transplant. Code reference table updated: HCPCS code S2054 and S2055 added to covered codes.

12/07/2009: Policy Title revised to add "Small Bowel/Liver and." Policy Description Section revised with link to related policy, Small Bowel Transplants. Policy Statement Section revised as follows: Replaced medically necessary verbiage "short bowel syndrome" with "intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance)." Patient Selection Criteria Guideline added. Non-coverage information added. Coding Section revised as follows: CPT4 codes 44133 and 44136 moved from Non-Covered Codes Table to Covered Codes Table, ICD9 procedure code 45.62 added to Covered Codes Table, ICD9 diagnosis code 570 added to Covered Codes Table. CPT4 code 44137 removed from Covered Codes Table. Removed deleted CPT4 code 47134 from Covered Codes Table. Removed incorrect ICD9 procedure code 50.5 from Covered Codes Table. Removed Non-Covered Codes Table.

08/23/2011: Policy description updated. Policy statement revised to add a not medically necessary statement. Deleted outdated references from the Sources section. Policy guidelines updated regarding patient selection criteria. Moved HIV-positive patient selection criteria from the Policy section to the Policy Guidelines section.

07/17/2012: Policy reviewed; no changes.

11/15/2013: Policy statement updated to add the following: A small bowel/liver retransplant or multivisceral retransplant may be considered medically necessary after a failed primary small bowel/liver transplant or multivisceral transplant.

09/01/2015: Code Reference section updated for ICD-10.

12/31/2015: Code Reference section updated to add CPT code 47399.

06/01/2016: Policy number A.7.03.05 added. Policy Guidelines updated to add medically necessary definition.

01/19/2017: Policy description updated regarding FDA regulation. Policy statements unchanged.

09/19/2017: Policy description updated regarding treatment of short bowel syndrome. Policy statements unchanged. Code Reference section updated to remove deleted CPT code 47136.

08/27/2018: Policy description updated regarding FDA regulation of human cells and tissues. Policy statements unchanged. Code Reference section updated to remove ICD-9 diagnosis code 570 and deleted ICD-10 diagnosis code K55.0.

09/12/2019: Policy reviewed; no changes.

09/11/2020: Policy description updated regarding solid organ transplantation and data for small bowel/liver and multivisceral transplant. Policy statements unchanged.

12/20/2021: Policy description updated regarding new data for transplants performed in the United States. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

11/01/2022: Policy description updated regarding new data for transplants. Policy statements updated to change "patients" to "individuals." Policy Guidelines updated regarding potential contraindications.

10/06/2023: Policy description updated regarding new data for transplants. Policy statements updated to change "not medically necessary" to "investigational" and "high incidence" to "high risk."

10/22/2024: Policy description updated regarding new transplant data. Policy statements unchanged.

SOURCE(S)

1. Blue Cross Blue Shield Association policy #7.03.04

2. Blue Cross Blue Shield Association policy #7.03.05

3. Blue Cross Blue Shield Association policy #7.03.06

4. United Network for Organ Sharing

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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