ModifiedBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Laboratory Tests Post Transplant and for Heart Failure

Defines medical necessity, prior authorization, coverage stance, and CPT coding guidance for multiple laboratory tests used to assess allograft rejection (heart, kidney, lung) and biomarkers for heart failure for Medicare Advantage and commercial products; includes authorized tests effective 2025-08-01 and lists tests deemed not covered.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Laboratory Tests Post Transplant and for Heart Failure

Policy CodePolicy N/A

Change TypeCoverage and coding updates (tests designated medically necessary; CPT code transitions)

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization via the online authorization tool (required for Medicare Advantage; recommended for Commercial) — only the ordering physician may obtain authorization.

SourceLink

POLICY UPDATE CHANGES

Effective 8/1/2025, AlloMap, VitaGraft Kidney Baseline + 1st Plasma Test, TRACT dd-cfDNA, VitaGraft Kidney Subsequent, AlloSure Heart, and Allosure Kidney are considered medically necessary when online authorization criteria are met.

Allosure Kidney CPT code updated to 0540U with effective date 4/1/2025 (prior to that use 81479).

Prospera CPT code 0493U specified as new code effective 10/1/2024 (use 81479 for earlier dates of service).

6Medically necessary / may be necessary tests (primary)

4Not covered / not medically necessary

Unlisted CPT codes requiring authorization

≈95References cited (approx.)

Coverage Summary

Scope: This policy defines medical necessity, prior authorization expectations, coverage stance, and CPT coding guidance for multiple molecular and biomarker laboratory tests used to assess allograft rejection (heart, kidney, lung) and heart failure biomarkers for Medicare Advantage and commercial products. Effective date: 2025-08-01. Policy last reviewed: 2025-06-04. Authorizations: authorization criteria and the online prior authorization tool are available online and must be used for listed tests when indicated.

Coverage stance (high level): the policy is mixed — several tests are explicitly designated as medically necessary or may be considered medically necessary when medical criteria in the online authorization tool are met (examples: AlloMap, TRACT dd-cfDNA, VitaGraft Kidney Baseline/Subsequent, AlloSure Heart, Allosure Kidney); a subset of tests may be medically necessary when specific medical criteria are met (examples: AlloSure Lung, HeartCare, QSant, Prospera); and some tests are listed as not covered / not medically necessary (examples: Molecular Microscope MMDx-Heart, myTAIHEART, Pleximark, Presage ST2).

Primary covered vs not covered (concise): Primary covered or conditionally covered tests when criteria met include AlloMap (CPT 81595), TRACT dd-cfDNA (CPT 0118U), VitaGraft Kidney Baseline/Subsequent (CPTs 0508U/0509U), AlloSure Heart (CPT 81479), and Allosure Kidney (CPT 0540U when effective). Tests listed as not covered / not medically necessary due to insufficient evidence include Molecular Microscope MMDx-Heart (0087U), myTAIHEART (0055U), Pleximark (OO18M), and Presage ST2 Assay (83006). Prior authorization is required for Medicare Advantage and recommended for Commercial products for the listed tests.

Policy dates and quick facts

Effective date08/01/2025

Policy last reviewed06/04/2025

Next review

Policy statusMODIFIED

SubjectLaboratory tests for post-transplant rejection and heart failure biomarkers

Prior authorization requiredPrior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online authorization tool for listed tests

Medical Necessity Criteria

Not Covered / Not Medically Necessary

Rationale for not covered determinations: the policy designates certain tests as not covered or not medically necessary when evidence is insufficient to demonstrate improved net health outcomes. For example, Heartsbreath (breath VOC analysis) has only a single diagnostic accuracy study with limited specificity and low positive predictive value and no clinical utility studies; myTAIHEART reports validation/observational studies but lacks evidence that use improves outcomes; Presage ST2 evidence is predominately correlational and meta-analytic, often reanalyzing existing trials, and does not consistently show additive prognostic utility beyond established natriuretic peptides or evidence that testing changes management to improve outcomes; AlloSure Lung and other dd-cfDNA lung studies show variable PPV/NPV and concern about discrimination from infection or injury. Overall, the determinations reflect that available data are largely diagnostic accuracy or correlation studies without prospective evidence of improved clinical management or patient outcomes.

Coding Guidance

Medically necessary / may be considered medically necessary CPT codes (when criteria met and authorization obtained)CPTCovered

81595	AlloMap (CareDx)
0508U	VitaGraft Kidney Baseline + 1st Plasma Test
0118U	TRACT dd-cfDNA (formerly Viracor TRAC dd-cfDNA)
0509U	VitaGraft Kidney Subsequent
81479	Unlisted molecular pathology procedure (used for some tests prior to specific codes or when no specific CPT exists)
0540U	Allosure Kidney (new code effective 2025-04-01)
81479	AlloSure Heart (listed under 81479 for tests without specific code)

Medically necessary specific CPT codes for Prospera and other testsCPTCovered

0493U	Prospera - quantification of donor-derived cfDNA, NGS, plasma, reported as % dd-cfDNA (new code effective 2024-10-01; for dates of service to 2024-10-01 use 81479)
81599	Unlisted multianalyte assay with algorithmic analysis (QSant may use this)

Codes listed as not covered / not medically necessaryCPTNot Covered

83006	Presage ST2 Assay (Growth stimulation expressed gene 2 (ST2))
OO18M	Pleximark - measurement of donor and third-party-induced CD154+ T-cytotoxic memory cells (transplantation medicine, renal)
0055U	myTAIHEART - cell-free DNA PCR assay of 96 DNA target sequences (cardiology, heart transplant)
0087U	Molecular Microscope MMDx-Heart - mRNA gene expression profiling by microarray (cardiology, transplant tissue)
0088U	Molecular Microscope MMDx-Kidney - microarray gene expression profiling (kidney transplant tissue)

Unlisted CPT codes requiring authorizationCPT

81479	Unlisted molecular pathology procedure (requires authorization to determine service and coverage)
81599	Unlisted multianalyte assay with algorithmic analysis (requires authorization)

Coding transitions and timing: Allosure Kidney CPT code is updated to 0540U effective 2025-04-01 (use 81479 for dates of service prior to 2025-04-01). Prospera CPT code 0493U is effective 2024-10-01 (use 81479 for earlier dates of service). These code changes mirror the policy's billing notes and prior authorization code lists.

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products via the online authorization tool for participating providers. The ordering physician is responsible for obtaining prior authorization; laboratories and third parties may NOT obtain authorization on behalf of the ordering physician. All Unlisted genetic CPT codes and certain proprietary tests require authorization to determine the service rendered and whether it is covered or not medically necessary.

Affected tests include (but are not limited to): AlloSure Kidney; TRACTM dd-cfDNA; AlloMap (CareDx); VitaGraft Kidney Baseline + 1st Plasma Test; VitaGraft Kidney Subsequent; AlloSure Heart; AlloSure Lung; HeartCare; QSantTM; ProsperaTM
Note: Some services lack a specific CPT code and an Unlisted CPT code should be used (see billing rules).

Documentation Required

Ordering physician responsibility for authorization

Background & Evidence

Background (biomarkers vs biopsy): Biomarkers and molecular tests (eg, donor-derived cell-free DNA, gene expression profiling, breath volatile organic compound analysis, and sST2) have been developed to provide noninvasive assessment of allograft rejection and heart failure prognosis. Endomyocardial or tissue biopsy remains the criterion standard for diagnosing rejection but has limitations (interobserver variability, procedural risks, and imperfect alignment with clinical risk), and molecular approaches aim to reduce invasive testing or provide adjunctive information to guide immunosuppression and surveillance strategies.

Study / Topic	Key findings
Heartsbreath diagnostic accuracy study
NPV 97.2% for identifying grade 3 (now 2R) rejection; sensitivity 78.6%; specificity 62.4%; PPV 5.6%.
myTAIHEART validation
Validation study (n=158 matched samples) reported donor-specific fraction cutoff with 100% NPV for Grade 2+ rejection; prospective study (n=174) found donor fraction threshold 0.3% ruled out acute cellular or antibody-mediated rejection.
AlloSure Lung diagnostic performance
Studies reported PPV 34.1% and NPV 85.5% at threshold 0.87% and PPV 43.3% / NPV 83.6% in aggregate rejection cohorts; evidence insufficient for net health outcome improvement.
Presage ST2 evidence
Correlational studies and meta-analyses show sST2 associated with mortality risk, but evidence insufficient to show additive prognostic utility over natriuretic peptides or to change outcomes.
Key topics covered in references
ESC and ACC/AHA/HFSA heart failure guidelines; ST2 biomarker studies; NT-proBNP-guided therapy studies; gene-expression profiling (AlloMap); donor-derived cell-free DNA (Prospera, Allosure, AlloSure) validation and clinical utility studies; transplant society statements.

Thresholds

Prospera dd-cfDNA surveillance threshold>= 1% dd-cfDNA indicates increased risk for active rejection

AlloSure Lung suggested thresholdsSevere injury: 1%; Injury: 0.85%; Quiescence: <0.5%

Medicare Determinations

Name	Number	Type
HEARTSBREATH Test for Heart Transplant Rejection
260.10
NCD
MolDX: Molecular Testing for Solid Organ Allograft Rejection
L38629
LCD
MolDX: Molecular Diagnostic Tests (MDT)
L35160
LCD
MolDX: Molecular Testing for Solid Organ Allograft Rejection
L38680
LCD

Definitions

Definitions (brief)

dd-cfDNADonor-derived cell-free DNA — fraction of donor DNA in recipient plasma used as marker of allograft injury.

ARActive Rejection.

ACRAcute Cellular Rejection.

AMRAntibody-Mediated Rejection.

Revision History

2025-08-01policy_change_addedLatest

is_material: true; Effective 8/1/2025, AlloMap (CPT 81595), VitaGraft Kidney Baseline + 1st Plasma Test (CPT 0508U), TRACT dd-cfDNA (CPT 0118U), VitaGraft Kidney Subsequent (CPT 0509U), AlloSure Heart (CPT 81479), and Allosure Kidney (CPT 0540U) are considered medically necessary when online authorization criteria are met.

2025-04-01coding_transition

is_material: true; Allosure Kidney CPT code updated to 0540U effective 4/1/2025 (for dates of service prior to 4/1/2025 use 81479).

2024-10-01coding_added

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Laboratory Tests Post Transplant and for Heart Failure

Policy CodePolicy N/A

Change TypeCoverage and coding updates (tests designated medically necessary; CPT code transitions)

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization via the online authorization tool (required for Medicare Advantage; recommended for Commercial) — only the ordering physician may obtain authorization.

SourceLink

On This Page

The ordering physician is solely responsible for initiating and managing the authorization, appeals, and any documentation related to medical necessity. Laboratories, their representatives, or any third party are not permitted to obtain authorization or participate in the authorization/appeal process on behalf of the ordering physician. If a laboratory or third party is found to have supported any portion of the authorization process improperly, BCBSRI may take severe actions up to termination from the provider network.

Laboratories may provide clinical information to the ordering physician but may not submit authorizations or appeals for the provider.
If a laboratory provides a service that has not been authorized, the service will be denied and the participating laboratory — not the member — may be financially liable.

Billing Rule

Use of unlisted CPT codes

Use of unlisted CPT codes is required when there is no specific CPT code for the service. Unlisted genetic CPT codes require prior authorization to determine the service rendered and coverage status. Billing must follow the authorization outcome.

Common unlisted/placeholder codes referenced in this policy: CPT 81479, CPT 81599
When a new, specific CPT code becomes effective, use the new code as instructed (see code transition notes).

Billing Rule

Code transition note for AlloSure Kidney

Code transition for AlloSure Kidney: effective 04/01/2025, CPT code 0540U is the new specific code for AlloSure Kidney. Prior to 04/01/2025, CPT code 81479 (unlisted molecular pathology procedure) must be used.

AlloSure Kidney: CPT 0540U (effective 2025-04-01); prior to this date use CPT 81479.

Billing Rule

Prospera CPT code effective date

Prospera (Natera) CPT coding: the Prospera CPT code 0493U is listed in this policy; providers should bill the specific CPT code when applicable and on or after the code effective date. Confirm code applicability with the online authorization tool and payer billing guidance.

Prospera (Natera): CPT 0493U

Denial Risk

Denial if laboratory obtains authorization

Authorization obtained by a laboratory, laboratory representative, or third party on behalf of the ordering physician will result in denial of the service. Only authorizations initiated and completed by the ordering physician will be considered valid.

Denial will be applied if evidence shows a lab or third party obtained the authorization instead of the ordering physician.

Denial Risk

Charge to member if service not medically necessary or non-covered

If a service is not medically necessary or is not a covered benefit under the member's plan (including services provided without required authorization), the member may be held financially responsible for the charge. Participating laboratories that render unauthorized services may be financially liable and may not bill the member.

Members should be referred to their Benefit Booklet/Evidence of Coverage for plan-specific coverage details.
If a laboratory provides a service without required authorization, BCBSRI may deny the claim and hold the laboratory financially responsible rather than the member.

Documentation Required

Policy informational nature and member eligibility

This policy is informational and describes coverage criteria, prior authorization expectations, and billing practices. Benefits and coverage may vary by contract and group; providers must verify member eligibility and benefits prior to ordering tests. For self-funded groups with exclusions, some genetic services may be contract exclusions — refer to the member’s Benefit Booklet or Evidence of Coverage.

Verify member eligibility and specific plan benefits before ordering tests.
Self-funded groups may have customized coverage — check the appropriate Benefit Booklet for exclusions.

Documentation Required

Provider inquiries

Provider inquiries regarding authorization decisions, billing, or coverage determination should be directed to BCBSRI Provider Services or via the online authorization tool for participating providers. Include clinical documentation necessary to support medical necessity when submitting authorizations or appeals.

Contact BCBSRI Provider Services or use the online authorization tool for participating providers.
Include relevant clinical documentation when requesting authorization or filing an appeal.

Documentation Required

Policy updates and review

This policy will be reviewed and updated as needed. Providers should consult the online authorization tool and payer resources for the most current requirements and code guidance.

Policy updates and review occur periodically; providers are encouraged to check for the latest policy version and coding/billing guidance.

is_material: true; Prospera CPT code 0493U specified as new code effective 10/1/2024 (for dates of service to 10/1/2024 use 81479).

prior authorization (ongoing)administrative_requirement

is_material: true; Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products for listed tests (including Allosure Kidney, TRACT dd-cfDNA, AlloMap, VitaGraft Baseline/Subsequent, AlloSure Heart; and AlloSure Lung, HeartCare, QSant, Prospera).

ongoingbilling_guidance

is_material: false; When no specific CPT code exists, unlisted CPT codes (eg, 81479 or 81599) require authorization to determine service rendered and coverage.