CMS Pub. 100-03, ch. 1, § 260.10

December 8, 2008)

(Rev.99, Issued: 02-13-09, Effective: 12-08-08, Implementation: 04-06-09)

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.)

270 - Wound Treatment

(Rev 7, 03-19-04)