TL;DR: The Centers for Medicare & Medicaid Services modified NCD 325 governing the Heartsbreath test for heart transplant rejection, with an updated effective date of January 9, 2026. The bottom line hasn't changed — this test is non-covered under Medicare — but billing teams need to know exactly why and what to do when these claims land on your desk.
CMS Heartsbreath test coverage policy under NCD 325 in the Medicare system has been nationally non-covered since December 8, 2008. This 2026 administrative update doesn't restore coverage or add new indications. It confirms the existing non-covered status under section 1862(a)(1)(A) of the Social Security Act, citing insufficient evidence that the test improves health outcomes in Medicare beneficiaries. The policy lists no specific CPT or HCPCS codes — a detail that creates its own billing headaches, covered below.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Heartsbreath Test for Heart Transplant Rejection |
| Policy Code | NCD 325 |
| Change Type | Modified |
| Effective Date | 2026-01-09 |
| Impact Level | Low — no coverage change, but denial risk is real if claims are submitted |
| Specialties Affected | Cardiothoracic surgery, transplant cardiology, clinical laboratory |
| Key Action | Flag any Heartsbreath test charges before submission — these claims will deny under Medicare |
CMS Heartsbreath Test Coverage Criteria and Medical Necessity Requirements 2026
The short version: there are no covered indications under NCD 325. None.
CMS made this determination effective December 8, 2008. The agency concluded that the evidence does not adequately define the technical characteristics of the Heartsbreath test. More directly, CMS found no demonstration that the test improves health outcomes in Medicare beneficiaries. That combination kills medical necessity under section 1862(a)(1)(A) of the Social Security Act — the foundational "reasonable and necessary" standard that governs Medicare coverage decisions.
The Heartsbreath test is a Food and Drug Administration-approved Humanitarian Use Device. That FDA designation matters clinically but does nothing for Medicare reimbursement. FDA approval and CMS coverage are two separate determinations. Your clinical team may point to the FDA status and expect coverage. They're wrong about how Medicare works, and this is a conversation worth having before a claim goes out.
The test itself works as an adjunct to endomyocardial biopsy. It collects breath samples, analyzes them in a laboratory, and compares results to biopsy findings to detect grade 3 heart transplant rejection. The clinical target population is narrow: patients who received a heart transplant within the last year and had an endomyocardial biopsy within the prior month. Even within that narrow window, CMS says no. The CMS Heartsbreath test coverage policy is a categorical exclusion with no exceptions.
Prior authorization is not the issue here. You won't get prior authorization for a nationally non-covered service. Submitting a prior auth request for Heartsbreath testing under Medicare is a waste of time. The denial comes from the NCD itself, not from a prior auth gap.
CMS Heartsbreath Test Exclusions and Non-Covered Indications
NCD 325 in the Medicare system is a clean non-coverage determination. There are no covered subpopulations, no nuanced exceptions, and no pathway to coverage based on clinical circumstances.
The specific exclusion: Heartsbreath testing to predict or detect heart transplant rejection is not covered for services performed on or after December 8, 2008. CMS cited two problems — insufficient evidence defining the test's technical characteristics, and no demonstrated improvement in health outcomes for Medicare beneficiaries. Both failures have to be resolved for CMS to reverse this determination, and the NCD was last reviewed in December 2008. Nothing has changed since.
This isn't a local coverage determination situation. This is a national coverage determination, which means no Medicare Administrative Contractor can override it at the local level. A MAC can't create a local policy that covers what an NCD excludes. If your team is hoping a regional LCD might open a door here, it won't. The NCD takes precedence.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Heartsbreath testing as adjunct to endomyocardial biopsy for grade 3 heart transplant rejection detection — patient with transplant within last year and biopsy within prior month | Not Covered | No specific codes listed in NCD 325 | National non-coverage effective December 8, 2008. No exceptions or covered subgroups. |
CMS Heartsbreath Test Billing Guidelines and Action Items 2026
The January 9, 2026 effective date on this modification is administrative. The non-coverage itself dates to 2008. But the update means your team needs to treat this as an active policy review, not an old determination you can ignore.
Here are your action items:
| # | Action Item |
|---|---|
| 1 | Audit your charge capture now. Pull any charges associated with breath testing, breath analysis, or adjunct cardiac transplant diagnostics. Confirm none are Heartsbreath-related. If your facility performs cardiac transplants, this audit is not optional. Do it before January 9, 2026. |
| 2 | Brief your transplant cardiology and cardiothoracic surgery teams. Physicians ordering this test may not know it's non-covered under Medicare. Give them a one-page summary of NCD 325. The FDA Humanitarian Use Device designation does not equal Medicare coverage. Make that explicit. |
| 3 | Set a hard stop in your billing system. NCD 325 lists no specific CPT or HCPCS codes, which means your denial prevention can't rely on a code-level edit alone. Build a clinical description or charge description master flag for Heartsbreath testing so your billing team catches it before submission. |
| 4 | Expect claim denial if any claims go out. If a Heartsbreath test claim reaches Medicare, it will deny. The denial reason will cite NCD 325 and the "reasonable and necessary" standard under section 1862(a)(1)(A). Don't waste time on appeals — there's no coverage pathway to argue toward. |
| 5 | Document patient financial responsibility conversations. If a patient or physician insists on the Heartsbreath test after Medicare denial, your team needs an Advance Beneficiary Notice of Noncoverage (ABN) on file before the service is performed. Without an ABN, you can't bill the patient for a non-covered service under Medicare billing guidelines. This is where Heartsbreath testing creates real financial exposure for practices. |
| 6 | Don't confuse this with the endomyocardial biopsy itself. The biopsy is separately billable and follows its own coverage rules. NCD 325 applies only to the Heartsbreath breath analysis component. Don't let a Heartsbreath denial contaminate a correctly coded biopsy claim. |
If your facility handles a high volume of cardiac transplants and you're uncertain how this NCD interacts with your specific billing situation, talk to your compliance officer before the January 9, 2026 effective date. The financial exposure is low for most practices, but it's not zero — especially if ABNs aren't in place.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Heartsbreath Testing Under NCD 325
This is a real limitation of this policy: NCD 325 does not list specific CPT, HCPCS, or ICD-10 codes. The Centers for Medicare & Medicaid Services published the national non-coverage determination without tying it to a billing code set. That's not unusual for older NCDs, but it creates a practical problem for Heartsbreath billing teams trying to build automated denial prevention.
No Specific Codes Listed in NCD 325
| Field | Detail |
|---|---|
| CPT Codes | None listed in the policy |
| HCPCS Codes | None listed in the policy |
| ICD-10-CM Codes | None listed in the policy |
The absence of codes doesn't limit the scope of the non-coverage. NCD 325 applies to the Heartsbreath test as a service, regardless of what code your team uses to bill it. If the test is the Heartsbreath breath analysis device, it's non-covered.
For claims processing guidance, CMS references Transmittal 1683 and Transmittal 1697 in the Medicare Claims Processing instructions tied to this NCD. If you need code-level mapping for denial prevention or charge master setup, those transmittals are your best starting point. Your Medicare Administrative Contractor may also have guidance on how they process claims for this service.
This is one of those situations where the absence of a code list forces you to build a clinical description-based edit rather than a code-based edit. That's harder to maintain and easier to miss. Put it on your next charge description master review agenda.
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