Heartsbreath Test Rejected

The Centers for Medicare & Medicaid Services (CMS) has determined there is insufficient evidence the Heartsbreath Test for predicting heart transplant rejection improves health outcomes and says it is not covered.

CMS issued a decision memorandum (260.10) for a National Coverage Determination (NCD) on Dec. 8, 2008 and notified contractors in Transmittal 99, Change Request (CR) 6366, issued Feb. 13, that the Heartsbreath Test is nationally non-covered.

Menssana Research, Inc. requested in April 2008 that CMS consider national coverage of the Heartsbreath Test as an adjunct to a heart biopsy to detect grade 3 heart transplant rejection in patients who have had a heart transplant within the last year and an endomyocardial biopsy in the prior month.

The Heartsbreath Test is a humanitarian device approved by the Food and Drug Administration (FDA). The test involves collecting breath samples from the patient and analyzing 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.

CMS concluded the test is not reasonable or necessary; the Heartsbreath Test remains a non-covered service, identified by CPT® Category III code 0085T Breath test for heart transplant rejection.

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