A small bowel transplant is the transplantation of an intestinal allograft to an individual with irreversible intestinal failure.

The purpose of this transplant is to restore intestinal function. An allograft refers to when transplanted cells, tissues or organs are sourced from a genetically non-identical member of the same species.

To initiate the prior authorization process, it is necessary to complete and submit the Intestinal and Multivisceral Transplant Request for Coverage Form.

Clinical Guideline Coverage Criteria

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth for coverage determinations for its Dual Product Eligible plan Members. MassHealth Medical Necessity Determinations and CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) and documentation included in the Medicare manuals are the basis for coverage determinations where available. For Tufts Health One Care plan Members the following criteria is used:

• Intestinal and Multi-Visceral Transplant NCD 260.5
• MassHealth Medical Necessity Determinations for Organ Transplant Procedures

Small Bowel Transplant:

Transplant: Point32Health companies 2111627

Solid Organ Transplant: Intestinal (Small Bowel, Simultaneous Small Bowel-Liver) and Multivisceral

1. The plan may authorize a small bowel transplant for a pediatric or adult Member meeting ALL of the following criteria:
1. Adult Members with iatrogenic, traumatic, or vascular thrombosis and loss of small bowel; and
2. Satisfactory psychosocial and support systems in place; and
3. Total parenteral nutrition (TPN) dependency established for a minimum of 2 years, or implementation of this requirement puts the Member at an unacceptably increased risk for a catastrophic event.
1. Liver dysfunction
2. Repeated infection
3. Thrombosis
4. Venous access difficulty with TPN, defined as more than one-half of the sites typically used for TPN (e.g., jugular, subclavian, and iliac veins) becoming inaccessible due to thrombosis
2. Simultaneous Small Bowel-Liver Transplant: The plan may authorize a simultaneous small bowel/liver transplant in all Members with Short Bowel Syndrome (SBS) when ALL of the following criteria are met:
1. Evidence of impending liver failure, including BOTH of the following:
1. Prolonged prothrombin time
2. Decreasing albumin level
2. Satisfactory psychosocial and support systems in place
3. Severe complications of TPN including at least ONE of the following:
1. Liver dysfunction
2. Repeated infections
3. Thrombosis
4. Venous access difficulty with TPN
4. TPN dependency established minimum of 2 years
3. Multivisceral Transplants: The plan may authorize multivisceral transplants in all Members with SBS when long term TPN results in impending liver failure complications (e.g., pancreatic failure, thrombosis of the celiac axis and superior mesenteric artery and/or pseudo-obstruction affecting the entire GI tract).

Limitations

The plan will not authorize the coverage of a small bowel, simultaneous small bowel and liver, or multivisceral transplant for Members with ANY of the following:

1. Active or uncontrolled alcohol use disorder or substance use disorder
2. Any unresolved psychosocial concerns or history of noncompliance with medical management
3. Human immunodeficiency virus (HIV) infection unless ALL of the following are met:
1. CD4 count greater than 200 cells/mm³ during 3 months prior to transplantation
2. Undetectable HIV-1 ribonucleic acid (RNA)
3. Stable anti-retroviral therapy for > 3 months
4. Absence of serious complications associated with or secondary to HIV disease (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections; Kaposi’s sarcoma; or other neoplasm)

5. Serious health condition that creates the inability to tolerate the transplant surgery or post-transplant medical regimen adherence, such as multisystem organ failure, cerebral edema, and/or severe cardiopulmonary disease
6. Systemic disease affecting multiple body systems, including but not limited to scleroderma, amyloidosis, diffuse atheromatous disease, and/or aggressive malignancies
7. Uncontrolled or untreatable infection, any source

Note: Smoking has been strongly correlated to adverse health and surgical outcomes. There is evidence to show that smoking, both by donors and by recipients, has a major impact on outcomes after organ transplantation. Smoking cessation is strongly recommended for both donors and recipients prior to transplantation.

Solid Organ Transplant: Intestinal (Small Bowel, Simultaneous Small Bowel-Liver) and Multivisceral

Codes