NCD 260.1

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.)

Revision History

08/2026 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. (TN 13903) (CR14570)

09/2025 - Transmittal 13383 issued August 26, 2025, is being rescinded and replaced by Transmittal 13401, dated September 9, 2025, to add a new attachment to ensure the functionality of the NCD zip URL is working properly and to update the Policy section. All other information remains the same.

The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). (TN 13401) (CR14194)

01/2024 - Transmittal 12350 issued November 03, 2023, is being rescinded and replaced by Transmittal 12440 dated January 3, 2024, to make changes to NCD 90.2, Next Generation Sequencing, spreadsheet to align with revisions being made to CR 13278. All other information remains the same. (TN 12440) (CR13391)

11/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates.(TN 12350) (CR13391)

10/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. (TN 12319) (CR13391)

10/2022 - Transmittal 11546, dated August 4, 2022, is being rescinded and replaced by Transmittal 11636, dated, October 5, 2022, to remove ICD-10 dx codes added in error to NCD 150.3, business requirement 12842.4, and restore ICD-10 dx C91.92 removed in error to NCD 110.23, business requirement 12842.3. All other information remains the same. (TN 11636) (CR12842)

08/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 11546) (CR12842)

01/2021 - Transmittal 10515, dated December 10, 2020, is being rescinded and replaced by Transmittal 10566, dated, January 14, 2021 to remove FISS Reason Codes (RCs) 59041, 59042, 59209, and 59210 from the spreadsheet for NCD 160.18. All other information remains the same. (TN 10566) (CR12027)

12/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10515) (CR12027)

10/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. (TN 10432) (CR12027)

11/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2200) (CR10859)

09/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2138) (CR10859)

08/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding to feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2122) (CR10859)

01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10)

conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result

of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2005) (CR10318)

11/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 1975) (CR10318)

11/2016 - This change request (CR) is the 9th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, and CR9631. Some are the result of revisions required to other NCD-related CRs released separately.

Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1753) (CR9751)

08/2016 - This change request (CR) is the 9th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, and CR9631. Some are the result of revisions required to other NCD-related CRs released separately.

Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1708) (CR9751)

04/2016 - Transmittal 1630, dated February 26, 2016, is being rescinded and replaced by Transmittal 1658 to (1) remove duplicate spreadsheet NCD210.3, (2) add missing spreadsheet NCD20.33, (3) add B/MAC to requirement 3 at request of WPS/B, (4) rename the spreadsheet titles, and, (5) provide a link to the attached spreadsheets for more efficient ease of reference and accessibility. All other information remains the same. (TN 1658) (CR9540)

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1580 ) (CR9252)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding.

These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1537) (CR 9252)

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: 10/1/2015. (TN 1199) (TN 1199) (CR 8197)

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: 10/1/2015. (TN 1165) (CR 8109)

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)

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

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)

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)

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

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

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