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National Coverage Determination (NCD) for Adult Liver Transplantation (260.1)

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Benefit Category
Inpatient Hospital Services

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

Liver transplantation, which is in situ replacement of a patient’s liver with a donor liver, in certain circumstances, may be an accepted treatment for patients with end-stage liver disease due to a variety of causes. The procedure is used in selected patients as a treatment for malignancies, including primary liver tumors and certain metastatic tumors, which are typically rare but lethal with very limited treatment options. It has also been used in the treatment of patients with extrahepatic perihilar malignancies. Examples of malignancies include extrahepatic unresectable cholangiocarcinoma (CCA), liver metastases due to a neuroendocrine tumor (NET), and, hemangioendothelioma (HAE). Despite potential short- and long-term complications, transplantation may offer the only chance of cure for selected patients while providing meaningful palliation for some others.


Indications and Limitations of Coverage

B. Nationally Covered Indications

Effective July 15, 1996, adult liver transplantation when performed on beneficiaries with end- stage liver disease other than hepatitis B or malignancies is covered under Medicare when performed in a facility which is approved by the Centers for Medicare & Medicaid Services (CMS) as meeting institutional coverage criteria.

Effective December 10, 1999, adult liver transplantation when performed on beneficiaries with end-stage liver disease other than malignancies is covered under Medicare when performed in a facility which is approved by CMS as meeting institutional coverage criteria.

Effective September 1, 2001, Medicare covers adult liver transplantation for hepatocellular carcinoma when the following conditions are met:

  • The patient is not a candidate for subtotal liver resection;
  • The patient’s tumor(s) is less than or equal to 5 cm in diameter;
  • There is no macrovascular involvement;
  • There is no identifiable extrahepatic spread of tumor to surrounding lymph nodes, lungs, abdominal organs or bone; and,
  • The transplant is furnished in a facility that is approved by CMS as meeting institutional coverage criteria for liver transplants (see 65 FR 15006).

Effective June 21, 2012, Medicare Adminstrative Contractors acting within their respective jurisdictions may determine coverage of adult liver transplantation for the following malignancies: (1) extrahepatic unresectable cholangiocarcinoma (CCA); (2) liver metastases due to a neuroendocrine tumor (NET); and, (3) hemangioendothelioma (HAE).

1. Follow-Up Care

Follow-up care or re-transplantation required as a result of a covered liver transplant is covered, provided such services are otherwise reasonable and necessary. Follow-up care is also covered for patients who have been discharged from a hospital after receiving non-covered liver transplant. Coverage for follow-up care is for items and services that are reasonable and necessary as determined by Medicare guidelines.

2. Immunosuppressive Drugs

See the Medicare Benefit Policy Manual, Chapter 15, “Covered Medical and Other Health Services,” §50.5.1 and the Medicare Claims Processing Manual, Chapter 17, “Drugs and Biologicals,” §80.3.

C. Nationally Non-Covered Indications

Adult liver transplantation for other malignancies remains excluded from coverage.

D. Other

Coverage of adult liver transplantation is effective as of the date of the facility’s approval, but for applications received before July 13, 1991, can be effective as early as March 8, 1990. (See 56 FR 15006 dated April 12, 1991.)

(This NCD last reviewed June 2012.)


Claims Processing Instructions
Revision History

1991 - Renamed and revised to extend coverage to adults with specific conditions. Effective date 03/08/1990. (TN 52)

08/1992 - Revised to add ICD-9-CM codes not included in previous revision. Effective date NA. (TN 60)

06/1996 - Revised to expand coverage to all ESLD diagnoses except hepatitis B or malignancies. Effective 07/15/1996. (TN 87)

12/1999 - Revised to remove hepatitis B as a noncovered condition. Effective date 12/10/1999 and implementation date 01/17/2000. (TN 121) (CR 1071)

07/17/2001 - Revised to provide coverage for patients with hepatocellular carcinoma under certain circumstances. Liver transplantation for other forms of malignancies remains noncovered. Effective and implementation dates 09/01/2001. (TN 142) (CR 1738)

03/2006 - Delete coding information. Effective/Implementation date 06/19/2006. (TN 48) (CR4278)

08/2012 - Effective for claims with dates of service June 21, 2012 and later, contractors may, at their discretion cover adult liver transplantation for patients with extrahepatic unresectable cholangiocarcinoma (CCA), (2) liver metastases due to a neuroendocrine tumor (NET) or (3) hemangioendothelimo (HAE) when furnished in an approved Liver Transplant Center. All other nationally non-covered malignancies continue to remain nationally non-covered. (TN 146) (CR7908)

01/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy.Implementation date: 04/01/2013 Effective date: 10/1/2014. (TN 1165) (CR 8109)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2014. (TN 1199) (TN 1199) (CR 8197)


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