Liver transplantation or hepatic transplantation is the replacement of a diseased liver with a healthy liver or split organ from a living or cadaveric donor.To initiate the prior authorization process, it is necessary to complete and submit the Liver 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 Tuft’s Health One Care plan Members the following criteria is used:

• Adult Liver Transplant NCD 206.1
• MassHealth Medical Necessity Determinations for Organ Transplant Procedures

The Plan may authorize coverage of a liver transplantation for Members who have satisfactory psychosocial and support systems in place and ONE of the following:

1. Acute liver failure from any cause; or
2. Decompensated chronic liver disease leading to liver failure due to portal hypertension as manifested by ONE ofthe following:
   1. Variceal hemorrhage; or
   2. Recurrent ascites; or
   3. Recurrent encephalopathy; or
   4. Hepatorenal syndrome; or
3. Hepatocellular carcinoma when no lesion > 5 cm OR no more than 3 lesions the largest < 3 cm or when exceeding these parameters, and the transplant center believes the benefit of transplant outweighs the risk of post- transplant recurrence

Note: Members with polycystic liver disease and massive hepatomegaly associated with obstruction or impaired function may be appropriate for liver transplant when alternative interventions have failed.

Limitations

The Plan will not authorize the coverage of a liver transplant for Members with ONE of the following:

1. Active or uncontrolled alcohol use disorder or substance use disorder (Evidence for alcohol abstinence may vary among liver transplant programs, but generally a minimum of 3 months is required)
2. Any unresolved psychosocial concerns or history of noncompliance with medical management
3. Extrahepatic malignancy within the past 5 years (excluding superficial skin cancers) or those not meeting oncologiccriteria for cure
4. Hepatic malignancy not meeting indication criteria above
5. Hepatocellular carcinoma that has extended beyond the liver
6. Members with human immunodeficiency virus (HIV) disease unless ALL of the following are met:
   1. Pre-transplant evaluation by an infectious disease specialist with expertise in HIV and transplantation as well as confirmation of plans for continued follow-up after transplantation with an infectious disease specialist of same expertise
   2. CD4 count greater than 200 cells/mm3 during 3 months prior to transplantation
   3. Undetectable HIV-1 ribonucleic acid (RNA)
   4. Stable anti-retroviral therapy for > three months
   5. 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, and/or other neoplasm)
7. Neuroendocrine tumors metastatic to the liver
8. Uncontrolled sepsis
9. Untreated/unstable cardiopulmonary disease

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.

Codes