Heartsbreath Test for Heart Transplant Rejection

CMS has determined (effective December 8, 2008) that the Heartsbreath test is not reasonable and necessary and is non-covered for Medicare beneficiaries due to insufficient evidence of technical validity and clinical outcome benefit. This non-coverage applies even though the device has FDA Humanitarian Use Device approval for adjunctive use with endomyocardial biopsy to detect grade 3 rejection within one year post-transplant with a biopsy within the prior month.

"Effective December 8, 2008, the Heartsbreath test is not covered for Medicare beneficiaries because evidence does not adequately define the test's technical characteristics nor demonstrate improved..."

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