Laboratory Tests Post Transplant and for Heart Failure
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Defines medical necessity, prior authorization, and coverage stance for circulating biomarker and molecular laboratory tests used to assess allograft rejection and to evaluate/manage heart failure for Medicare Advantage and Commercial products.
Effective 8/1/2025, specific tests (AlloSure Kidney, AlloMap, TRAC dd-cfDNA, VitaGraft kidney tests) are considered medically necessary when online authorization criteria are met.
Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products for a defined list of tests.
Tests considered not covered or not medically necessary include Heartsbreath, MMDx-Heart, MMDx-Kidney, myTAIHEART, Pleximark, and Presage ST2 Assay.
Coverage Criteria and Medical Necessity
Allograft molecular test medical necessity criteria
Tests considered medically necessary when the medical criteria in the online authorization tool for participating providers are met; additionally specific clinical criteria apply for allograft assessment:
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Coverage for dd-cfDNA and GEP-based tests
Covered when ALL of the following are met for dd-cfDNA and GEP as graft assessment tools:
References: AlloSure/HeartCare incremental information; QSant and general rationale
Prospera surveillance schedule: 1,2,3,4,6,9,12 months then quarterly; AlloSure described for surveillance and combination use
sST2 (Presage) coverage stance
Covered/considered medically necessary status for sST2:
Presage ST2 assay performance metrics (LOD/LOQ and CV) and nonspecific limitations
Insufficient evidence / investigational tests
Investigational/insufficient evidence group:
Single diagnostic accuracy and observational studies cited; evidence insufficient for net health outcome improvement
Medically necessary tests with authorization
Covered when the medical criteria in the online authorization tool for participating providers are met
Specific clinical decision rules and detailed criteria are maintained in the online authorization tool; see prior authorization requirements.
For Commercial Products, some genetic testing services may be excluded for self-funded groups under contract if the group has excluded the expanded coverage of biomarker testing related to the state mandate (R.I.G.L. §27-19-81). Coverage for these groups varies by Benefit Booklet and group contract; refer to the Genetic Testing Services or Proprietary Laboratory Analyses policies and the member’s Benefit Booklet for which tests are covered with prior authorization, are not medically necessary, or are contract exclusions.
The ST2 biomarker (sST2, measured by the Presage ST2 Assay) is a prognostic marker correlated with adverse cardiac remodeling and heart‑failure severity but is not intended to diagnose heart failure. sST2 concentrations are relatively nonspecific and can be elevated in many disparate conditions; natriuretic peptides (BNP, NT‑proBNP) remain the reference biomarkers when used with clinical findings to diagnose and manage heart failure.
The policy identifies specific CPT/PLA codes that are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. Examples called out include CPT 83006 (Presage ST2 Assay) and proprietary/unlisted codes used for assays listed in the not‑covered list.
Tests explicitly listed as not covered for Medicare Advantage Plans and considered not medically necessary for Commercial Products include: Heartsbreath; Molecular Microscope® MMDx–Heart; Molecular Microscope® MMDx–Kidney; myTAIHEART; Pleximark™; and the Presage ST2 Assay.
Several tests are designated as having insufficient evidence to demonstrate improvement in net health outcome. Examples called out in the policy include the Heartsbreath volatile organic compound breath test, myTAIHEART cfDNA assays, and current evidence for AlloSure Lung; the document cites limited diagnostic‑accuracy studies or small observational series and concludes evidence is inadequate to establish clinical utility.
Coding and Billing (CPT / PLA / Unlisted Codes)
| 81479 | Unlisted molecular pathology procedure (used in overview for multiple tests) |
| 0087U | Molecular Microscope MMDx - Heart |
| 0088U | Molecular Microscope MMDx - Kidney |
| 0055U | myTAIHEART |
| 0018M | Pleximark |
| 83006 | Presage ST2 Assay (immune assay) |
| 0493U | Prospera (Natera) |
| 81599 | QSant (NephroSant) or other unlisted molecular test code as listed |
| 0087U | Molecular Microscope MMDx -Heart (listed as not covered) |
| 0088U | Molecular Microscope MMDx -Kidney (listed as not covered) |
| 83006 | Presage ST2 Assay (listed as not covered / not medically necessary) |
| 81479 | Heartsbreath, myTAIHEART, Pleximark referenced as not covered (document lists tests; some use 81479) |
| 0540U | Allosure Kidney (new code effective 4/1/2025) |
| 81479 | Unlisted molecular pathology procedure (prior to 4/1/2025 used for Allosure Kidney) |
| 81595 | AlloMap (CareDx) |
| 0118U | TRAC dd-cfDNA (formerly Viracor TRAC dd-cfDNA) |
| 0508U | VitaGraft Kidney Baseline + 1st Plasma Test (Code deleted 12/31/2025) |
| 0509U | VitaGraft Kidney Subsequent (Code deleted 12/31/2025) |
| 0493U | Prospera — quantification of dd-cfDNA using NGS, plasma, reported as % dd-cfDNA |
| 83006 | Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1) — Presage ST2 Assay |
| 0018M | Pleximark — measurement of donor and third-party-induced CD154+ T-cytotoxic memory cells, algorithm reported as a rejection risk score |
| 0055U | myTAIHEART — cardiology (heart transplant), cell-free DNA, PCR assay of 96 DNA target sequences |
| 0493U | Prospera: quantification of donor-derived cell-free DNA using NGS, plasma, reported as percentage of donor-derived cfDNA |
| 83006 | Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1) — Presage ST2 Assay |
| 0018M | Pleximark: measurement of donor and third-party-induced CD154+ T-cytotoxic memory cells, algorithm reported as a rejection risk score |
| 0055U | myTAIHEART: cardiology (heart transplant), cell-free DNA, PCR assay of 96 DNA target sequences |
Provider Actions, Authorization, and Denial Risks
Prior authorization required or recommended
Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online authorization tool for participating providers for the listed tests (Allosure Kidney, AlloMap, TRAC dd-cfDNA, VitaGraft Kidney Baseline and Subsequent, AlloSure Heart/Lung, HeartCare, QSant, Prospera).
- Prior authorization required for Medicare Advantage; recommended for Commercial Products.
- Applies to the specific tests named in the policy (see coding lists).
Prior authorization required for covered transplant/heart failure tests
Prior authorization via the payer's online authorization tool is required for the listed CPT/proprietary codes when the medical criteria in the online tool are met for participating providers.
Limit on multiple molecular tests
For a given patient encounter, only one molecular test to assess allograft status may be performed unless a second test that meets all policy criteria is reasonable and necessary as an adjunct.
- A follow-up molecular test is allowed only if it independently meets the same medical necessity criteria and is adjunctive.
Tests coded as not covered risk denial
Providers who order tests coded with CPTs listed as 'not covered' (eg, 83006, 0018M, 0055U) or that fail to meet the online authorization medical criteria risk denial of payment.
- Confirm test coverage status and meet online authorization criteria prior to testing to avoid denials.
- Services denied due to noncoverage are the responsibility of the provider/laboratory if authorization was not obtained.
Prior authorization submission and documentation
Prior authorization requests and supporting documentation must be submitted by the ordering physician through the payer's online authorization tool; laboratories may not submit on behalf of the ordering physician.
- Unlisted genetic testing CPT codes require prior authorization to identify the service and determine coverage.
- Only the ordering physician may be involved in authorization, appeals, or related administrative processes.
Medical criteria and online authorization
Medical criteria in the payer's online authorization tool must be met for the listed CPT codes to be considered medically necessary for Medicare Advantage and Commercial Products.
- Coverage is conditional on meeting the online authorization tool's medical criteria for participating providers.
- Specific clinical decision rules are maintained within the online authorization tool.
Required documentation and authorization
Providers must meet the medical criteria in the online authorization tool for participating providers; prior authorization is required for unlisted molecular/MAAA procedure codes.
Unauthorized lab services denied
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability rests with the participating laboratory; such services may not be billed to the member.
- Denial and financial responsibility apply where authorization was not obtained through the ordering physician via the online tool.
Prior authorization prerequisite for listed CPT codes
Tests not meeting the medical criteria in the online authorization tool for participating providers may be denied for Medicare Advantage (and Commercial Products if criteria not met).
- Prior authorization is a prerequisite for coverage determination of the listed CPT codes.
- Confirm online-tool criteria before ordering to reduce denial risk.
Unlisted CPT prior authorization
Use of unlisted molecular pathology (81479) or unlisted multianalyte assay (81599) procedure codes requires prior authorization for Medicare Advantage and Commercial Products to identify the service and determine coverage.
- Providers should request authorization via the online tool when using unlisted codes.
- Authorization is necessary to determine if the unlisted service is covered or not medically necessary.
Denial triggers
Tests that do not meet the medical criteria in the online authorization tool or that are coded with services listed as 'not covered' may be denied.
Acceptable Clinical Uses and Candidate Criteria
Acceptable allograft test uses
Clinical uses acceptable for tests assessing allograft status:
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Evaluation, Diagnostic Standards, and Test Role
Document physician pretest probability to justify testing
A physician‑assessed pretest probability of rejection must be documented to justify using a test to further evaluate allograft status.
Biopsy remains the diagnostic gold standard; noninvasive tests are adjuncts
Endomyocardial biopsy remains the diagnostic gold standard for rejection in heart transplants and renal biopsy is the standard for kidney transplants; noninvasive tests are intended to supplement evaluation, not replace biopsy as the diagnostic standard.
- Noninvasive tests may be used to optimize immunosuppression or reduce biopsies in appropriate contexts, but biopsy is the criterion standard.
Center and Ordering Requirements
Ordering physician must request authorization; labs may not act for physicians
Authorization must be requested by the ordering physician via the online authorization tool; laboratories may not act on behalf of ordering physicians in the authorization process.
Biopsy surveillance practices vary; some centers stop routine biopsies after 1 year
Endomyocardial biopsy schedules and practices vary among centers; some centers stop routine surveillance biopsies after 1 year in clinically stable patients.
Post-Transplant Molecular and Biomarker Test Coverage
Contraindications and Limitations
The myTAIHEART test has specified contraindications. It is contraindicated in patients who are pregnant; who currently have or previously had another transplanted organ (solid organ or allogeneic bone marrow); who have post‑transplant lymphoproliferative disease; who have active cancer or cancer within the previous 2 years; who are on mechanical circulatory support; or who are closely related to the transplant donor.
Definitions and Test Descriptions
Background and Rationale
Clinical assessment of heart failure is limited by nonspecific signs and symptoms and by imaging constraints. Circulating biomarkers (for example, BNP and NT‑proBNP) are commonly used to aid diagnosis, prognosis, and management. The soluble ST2 protein (sST2) is a circulating biomarker correlated with adverse cardiac remodeling and prognosis, but because sST2 elevations are relatively nonspecific it should not be used as a standalone diagnostic for heart failure; its role is primarily prognostic and adjunctive to established biomarkers and clinical evaluation.
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