Key facts for NCD 260.10
- Benefit category
- Diagnostic Tests (other)
- Effective date
- 12/08/2008
- Implemented 04/06/2009
- Transmittal
- Transmittal 99
- Versions published
- 1
- Manual chapter
- 260
- NCD Manual (Pub. 100-03)
TL;DR
NCD 260.10 sets Medicare's national policy for heartsbreath test for heart transplant rejection under the benefit category "Diagnostic Tests (other)", effective 12/08/2008 and implemented 04/06/2009. 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… It has been revised once since publication and binds every Medicare Administrative Contractor nationally.
Item or service described
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.)
Text reproduced from the CMS Medicare Coverage Database record for NCD 260.10 version 1. View the original on cms.gov.
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).
How this NCD shows up on remittances
A service denied under a National Coverage Determination returns CARC 50 (not deemed medically necessary) with remark N386 (decision based on an NCD); a denial citing a local policy instead carries N115. Because NCDs bind nationally, the appeal path is documentation that the patient meets the indications above, not a contractor-policy argument.
How QuickIntell applies NCD 260.10
QuickAuth checks the ordered service and diagnosis against NCD and LCD criteria before the encounter, QuickCode validates the diagnosis pairing on the claim, and QuickRCM routes CARC 50 denials with the policy text and the covered-code list attached so the appeal starts with evidence.
Frequently asked questions — NCD 260.10
What does NCD 260.10 cover?
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… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database.
When did NCD 260.10 take effect?
The current version (1) is effective 12/08/2008, implemented 04/06/2009, published in transmittal 99. This is the only published version.
Does a Local Coverage Determination override NCD 260.10?
No. A National Coverage Determination binds all Medicare Administrative Contractors; an LCD can only address services or circumstances the NCD leaves open. Claims denied under this NCD typically return CARC 50 with remark N386 (NCD) rather than N115 (LCD).
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database NCDs via the CMS Coverage APIVersion API snapshot 2026-09-27 · effective 2026-09-20 · file national-coverage-ncd.jsonSHA-256 a90fadfd264b9ef4…
Disclaimer
This page reproduces the CMS National Coverage Determination text and, for laboratory NCDs, the CMS ICD-10 edit lists, as an operational reference. Coverage decisions depend on the full policy, the claim and the contractor; nothing here is legal, clinical or billing advice. CPT codes are shown as numbers only; CPT descriptors are copyright AMA.