NCD 260.9

Indications and Limitations of Coverage

A. General

Cardiac transplantation is covered under Medicare when performed in a facility which is approved by Medicare as meeting institutional coverage criteria. (See CMS Ruling 87-1.)

B. Exceptions

In certain limited cases, exceptions to the criteria may be warranted if there is justification and if the facility ensures our objectives of safety and efficacy. Under no circumstances will exceptions be made for facilities whose transplant programs have been in existence for less than 2 years, and applications from consortia will not be approved.

Although consortium arrangements will not be approved for payment of Medicare heart transplants, consideration will be given to applications from heart transplant facilities that consist of more than one hospital where all of the following conditions exist:

• The hospitals are under the common control or have a formal affiliation arrangement with each other under the auspices of an organization such as a university or a legally constituted medical research institute; and

• The hospitals share resources by routinely using the same personnel or services in their transplant programs. The sharing of resources must be supported by the submission of operative notes or other information that documents the routine use of the same personnel and services in all of the individual hospitals. At a minimum, shared resources means:

• The individual members of the transplant team, consisting of the cardiac transplant surgeons, cardiologists and pathologists, must practice in all the hospitals and it can be documented that they otherwise function as members of the transplant team; and

• The same organ procurement organization, immunology, and tissue-typing services must be used by all the hospitals;

• The hospitals submit, in the manner required (Kaplan-Meier method) their individual and pooled experience and survival data; and

• The hospitals otherwise meet the remaining Medicare criteria for heart transplant facilities; that is, the criteria regarding patient selection, patient management, program commitment, etc.

C. Pediatric Hospitals

Cardiac transplantation is covered for Medicare beneficiaries when performed in a pediatric hospital that performs pediatric heart transplants if the hospital submits an application which CMS approves as documenting that:

• The hospital’s pediatric heart transplant program is operated jointly by the hospital and another facility that has been found by CMS to meet the institutional coverage criteria in CMS Ruling 87-1;

• The unified program shares the same transplant surgeons and quality assurance program (including oversight committee, patient protocol, and patient selection criteria); and

• The hospital is able to provide the specialized facilities, services, and personnel that are required by pediatric heart transplant patients.

D. Follow-Up Care

Follow-up care required as a result of a covered heart 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 a noncovered heart transplant. Coverage for follow-up care would be for items and services that are reasonable and necessary, as determined by Medicare guidelines. (See the Medicare Benefit Policy Manual, Chapter 16, “General Exclusions From Coverage,” §180.)

E. Immunosuppressive Drugs

See the Medicare Claims Processing Manuals, Chapter 17, “Drugs and Biologicals,” §§80.3.1 and, Chapter 8, “Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims,” §120.1.

F. Artificial Hearts

Medicare covers ventricular assist devices (VAD) and artificial hearts when implanted under the coverage criteria stated in §20.9 of this manual (NCD Manual 100-03).

(This NCD last reviewed April 2008.)

Revision History

10/2024 - The purpose of the 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 12904) (CR13828)

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)

10/2021 - 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. (TN 11083) (CR12482)

02/2020 - 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, long-standing NCD process. (TN 2427) (CR11491)

06/2016 - Transmittal 1665, dated May 13, 2016, is being rescinded and replaced by Transmittal 1672 to: (1) 9631.1: Remove FISS responsibility and 1st sentence; (2) 9631.2: Remove additional procedure codes, including 0075T, 0076T; (3) 9631.4: Revise descriptor of dx L59.8; (4) 9631.6: Add deletion of dx C49.10, C65.9, remove deletion of dx C54.9, remove deletion of invalid dx C47.90; (5) 9631.8: Remove deletion of invalid dx C51.29, replace with deletion of dx C50.029; (6) 9631.9: Add deletion of 0V504ZZ, 0V500ZZ, override capability, and contractor discretion verbiage. All other information remains the same. (TN 1672) (CR9631)

05/2016 - This change request (CR) is the 7th 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, and CR9540. 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 1665) (CR9631)

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)

09/2008 - This corrects Transmittal 93, Change Request 6185, dated August 29, 2008. The only change is the implementation date (12/01/2008). All other material remains the same. (TN 95)

08/2008 - Cardiac transplantation is covered under Medicare when performed in a facility which is approved by Medicare as meeting institutional coverage criteria. Effective date 05/01/2008. Implementation date 10/01/2008. (TN 93) (CR6185)

12/2002 - Reflected policy regarding coverage of artificial hearts and ventricular assist devices in §65-15 of the CIM. Effective and implementation dates 04/01/2003. (TN 165) (CR 2481)

05/1989 - Deleted information on immunosuppressive drugs contained in other manuals. Effective date NA. (TN 36)

06/1988 - Covered when performed in pediatric hospitals that meet certain conditions. Effective date 10/17/1986. (TN 25)

10/1987 - Covered when performed in Medicare approved facilities, and routine follow-up care also covered, subject to certain conditions. Effective date 10/17/1986. (TN 20)