Transplant and for Heart Failure
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Defines medical necessity, coverage, and prior authorization requirements for specific laboratory tests used to assess allograft rejection in heart and kidney transplant recipients and biomarkers in heart failure for Medicare Advantage Plans and Commercial Products (partial document: Part 1 of 2).
No material clinical/coverage changes - has_material_change=false
Coverage Summary
This policy (effective 06/01/2021, last reviewed 02/16/2021) provides a focused overview of coverage and medical necessity criteria for laboratory tests used to assess allograft rejection and biomarkers in heart failure. The coverage stance is mixed: AlloMap (gene expression profiling) is covered for Medicare Advantage, AlloSure Heart and AlloSure Kidney have defined Medicare Advantage medical necessity criteria (and require prior authorization), while Heartsbreath, myTAIHEART, and the Presage® ST2 Assay are not covered for Medicare Advantage due to insufficient evidence. For Commercial products listed in this policy, all addressed tests (AlloMap, AlloSure Heart, AlloSure Kidney, Heartsbreath, myTAIHEART, Presage ST2) are considered not medically necessary. The tests specifically addressed are AlloMap, AlloSure Heart, AlloSure Kidney, Heartsbreath, myTAIHEART, and Presage® ST2.
Medical-Necessity Criteria
AlloSure Heart - Medicare Advantage Medical Necessity
AlloSure® Heart may be considered medically necessary when all of the following criteria are met:
AlloSure Heart criteria
- Conjunction with AlloMap: It is used in conjunction with AlloMap®
- Clinical suspicion: To assess the probability of allograft rejection in heart transplant recipients with clinical suspicion of rejection
- Biopsy decision: To inform clinical decision-making about the necessity of a heart biopsy in such patients at least 55 days post-transplant in conjunction with standard clinical assessment>= 55 days post-transplant
AlloSure Kidney - Medicare Advantage Medical Necessity
AlloSure® Kidney may be considered medically necessary when all of the following criteria are met:
AlloSure Kidney criteria
- Clinical use: It is used to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection
- Biopsy decision: To inform clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment>= 2 weeks post-transplant
Prior Authorization Requirements - Medicare Advantage Plans
Tests requiring prior authorization for Medicare Advantage Plans:
PA requirements
- AlloSure Heart PA: AlloSure Heart requires prior authorization
- AlloSure Kidney PA: AlloSure Kidney requires prior authorization
- Unlisted CPT PA: Unlisted CPT codes (eg, 81479 for AlloSure) require prior authorization to determine coverage/medical necessity
Authorization Process Restriction
Restrictions on who may obtain authorization:
Authorization process restriction
- Ordering physician only: Only the ordering physician shall be involved in the authorization, appeal or other administrative processes related to prior authorization/medical necessity
- Laboratory prohibition: Laboratories or laboratory representatives are prohibited from obtaining clinical authorization or participating in the authorization process on behalf of the ordering physician; violations may lead to termination from the BCBSRI provider network and financial liability for unauthorized services
Covered vs Not Covered - Medicare Advantage Plans
Coverage determinations for Medicare Advantage Plans:
Medicare Advantage coverage determinations
- AlloMap covered: AlloMap is covered
- AlloSure Heart conditional: AlloSure Heart may be considered medically necessary when specified criteria are met
- AlloSure Kidney conditional: AlloSure Kidney may be considered medically necessary when specified criteria are met
- Heartsbreath not covered: Heartsbreath is not covered (evidence insufficient)
- myTAIHEART not covered: myTAIHEART is not covered (evidence insufficient)
- Presage ST2 not covered: Presage® ST2 Assay is not covered (evidence insufficient)
Commercial Products Coverage Position
Coverage determinations for Commercial Products (per this document):
Coding
| 81595 | Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes..., algorithm reported as a rejection risk score (AlloMap) |
| 81479 | Unlisted molecular pathology procedure (use for AlloSure Heart and AlloSure Kidney). Requires prior authorization for Medicare Advantage Plans and Commercial Products |
| unlisted_pre2021 | 0085T Breath test for heart transplant rejection (Heartsbreath) - use for dates of service prior to 2021-01-01 |
Provider Actions & Billing Rules
Prior authorization required for AlloSure Heart and Kidney
Prior authorization is required for AlloSure Heart and AlloSure Kidney for Medicare Advantage members; report these services using Unlisted CPT when no specific CPT exists.
Use appropriate unlisted CPT codes when specific CPT is unavailable
When there is no specific CPT code for a service referenced in this policy, report the most appropriate unlisted CPT code. For AlloSure Heart and AlloSure Kidney use unlisted molecular pathology code 81479. For Heartsbreath use the most appropriate unlisted CPT for services dated on or after 2021-01-01; for dates of service prior to 2021-01-01 use 0085T.
- 81479
- 0085T
Ordering physician must handle authorization and appeals
Only the ordering physician may be involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity. Laboratories or laboratory representatives are prohibited from obtaining authorization or participating in the authorization process on behalf of the ordering physician; violations may result in termination from the BCBSRI provider network and financial liability for unauthorized services.
Member financial consent when services non-covered
If services are determined to be not medically necessary or are non-covered benefits, providers may not charge the member unless the member has been informed and has agreed in writing in advance to continue treatment at their own expense.
Policy informational use and member benefit determination; Policy revisions and inquiries
This policy is provided for informational purposes only. Benefits and eligibility are determined by the member's subscriber agreement or employer agreement, which supersede this policy. For member-specific benefit information, contact the provider call center. BCBSRI reserves the right to review and revise this policy at any time.
Background & Evidence Summary
Clinical assessment and noninvasive imaging for heart failure and transplant surveillance have important limitations: symptoms and signs may poorly correlate with objective measures of cardiac dysfunction and often present late, and endomyocardial biopsy—while the criterion standard for transplant rejection—has interobserver variability and procedural risks. These limitations have driven interest in circulating biomarkers and other noninvasive tests to improve detection, risk stratification, and to potentially reduce reliance on invasive biopsy.
For heart failure, circulating biomarkers (eg, BNP/NT-proBNP) are established reference tests for diagnosis and prognosis, and newer markers such as soluble ST2 (measured by the Presage® ST2 Assay) have been investigated because they reflect remodeling and myocardial stress but currently lack sufficient evidence to determine effects on health outcomes or to replace standard biomarkers in management.
For transplant rejection, noninvasive approaches evaluated include gene expression profiling (AlloMap) and donor-derived cell-free DNA assays (AlloSure, myTAIHEART), as well as breath volatile organic compound analysis (Heartsbreath). These tests aim to identify rejection or to inform the need for biopsy: AlloMap uses peripheral blood gene expression profiling, AlloSure and myTAIHEART quantify donor-derived cell-free DNA to estimate donor fraction, and Heartsbreath analyzes breath markers of oxidative stress. The policy addresses the following specific tests: AlloMap, AlloSure Heart, AlloSure Kidney, Heartsbreath, myTAIHEART, and Presage® ST2 Assay.
| Evidence item | Summary |
|---|---|
| AlloMap FDA status | |
| FDA-approved IVDMIA to aid identification of heart transplant recipients with low probability of moderate/severe acute cellular rejection when used with standard clinical assessment; characterized as a rule-out test and can complement dd-cfDNA testing | |
| sST2 evidence summary | |
| Observational studies and meta-analyses show sST2 associates with mortality and may predict rejection, but evidence is insufficient to determine effects on health outcomes or clinical utility for management or transplant prediction | |
| myTAIHEART validation | |
| Validation study (158 biopsy-plasma pairs) found donor fraction cutoff 0.32% with 100% NPV for Grade >=2 rejection; prospective study found ~0.3% cutoff; evidence insufficient for health outcomes | |
| Heartsbreath diagnostic study | |
| Single diagnostic accuracy study: NPV 97.2% for grade 3 (now 2R), sensitivity 78.6%, specificity 62.4%; single study inadequate to establish clinical validity or utility | |
| AlloSure renal evidence | |
| Small diagnostic studies in kidney transplant showed NPV ~84% for moderate-to-severe rejection; threshold not prespecified; evidence insufficient for health outcomes | |
| Reference count | |
| 31 citations referenced in policy (selected studies on ST2, AlloMap, dd-cfDNA, microRNAs, hs-troponin) |
Medicare Determinations
| Name | Number | Type | Effective Date |
|---|---|---|---|
| HEARTSBREATH Test for Heart Transplant Rejection | |||
| 260.10 | |||
| NCD | |||
| MolDX: Molecular Diagnostic Tests (MDT) | |||
| L35160 | |||
| LCD | |||
| MolDX: Allosure® or Equivalent Cell-Free DNA Testing for Kidney and Heart Allografts | |||
| L38355 | |||
| LCD | |||
Revision History
Policy effective date
Policy last updated
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