About this policy
CMS National Coverage Determination | ncd_id=325 | manual_section=260.10 | coverage_level_code=3 | national_coverage_type=True | under_review=True | lab_ncd=False
Coverage indications
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.)
Documentation requirements
Item/Service Description: 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. Revision History: 02/2009 - CMS determines 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. Effective Date: 12/08/2008 Implementation Date: 04/06/2009 ( TN 99 ) (CR6366). Benefit Categories: 20 - Diagnostic Tests (other) Transmittal: transmittal_number=99 | transmittal_issue_date=2009-02-13 | change_request_number=6366
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.
Backwork has no codes on record for this policy. Check the source.