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National Coverage Determination (NCD)

Heartsbreath Test for Heart Transplant Rejection

260.10

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Tracking Information

Publication Number
100-3
Manual Section Number
260.10
Manual Section Title
Heartsbreath Test for Heart Transplant Rejection
Version Number
1
Effective Date of this Version
12/08/2008
Ending Effective Date of this Version
Implementation Date
04/06/2009
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Tests (other)


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

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.
Indications and Limitations of Coverage

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.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
99
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R99NCD.pdf
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).
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Heartsbreath Test for Heart Transplant Rejection 1 12/08/2008 - N/A You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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