National Coverage Determination (NCD)

Heart Transplants


Expand All | Collapse All

Tracking Information

Publication Number
Manual Section Number
Manual Section Title
Heart Transplants
Version Number
Effective Date of this Version
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Inpatient Hospital Services
Physicians' Services

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

Item/Service Description
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 two 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;
    • 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 Manual, 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 does not cover the use of artificial hearts as a permanent replacement for a human heart or as a temporary life-support system until a human heart becomes available for transplant (often referred to as a "bridge to transplant"). Medicare does cover a ventricular assist device (VAD) when used in conjunction with specific criteria listed in §20.9 of the NCD Manual.

Cross Reference

Transmittal Information

Transmittal Number
Revision History

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) 


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Heart Transplants 3 05/01/2008 - N/A View
Heart Transplants 2 04/01/2003 - 05/01/2008 You are here
Heart Transplants 1 10/17/1986 - 04/01/2003 View
CPT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.