Heartsbreath Test for Heart Transplant Rejection Form
Procedure is not covered
Background for this Policy
A. General
The Heartsbreath test is a Food and Drug Administration-approved Humanitarian Use Device for use only as an adjunct to the endomyocardial biopsy to detect grade 3 heart transplant rejection in patients who have had a heart transplant within the last year and an endomyocardial biopsy within the prior month. The test involves collecting breath samples from the patient and analysis of the samples performed in a laboratory. These test results are then compared to endomyocardial biopsy findings and the results are provided to the clinician shortly thereafter.
B. Nationally Covered Indications
N/A
C. Nationally Non-Covered Indications
Effective for services performed on or after December 8, 2008, the Centers for Medicare & Medicaid Services has determined that the evidence does not adequately define the technical characteristics of the test nor demonstrate that Heartsbreath testing to predict heart transplant rejection improves health outcomes in Medicare beneficiaries. Thus, we conclude that the Heartsbreath test is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act and is non-covered.
D. Other
N/A
(This NCD last reviewed December 2008.)
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