CMS Pub. 100-03, ch. 1, § 260.9

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.)