CurrentCentenePolicy N/A

Concert Genetics Genetic Testing: Cardiac Disorders

Defines medical necessity criteria for genetic and gene-expression testing related to cardiomyopathy, arrhythmia, congenital heart defects, cholesterol disorders, and post-heart-transplant rejection assessment, with CPT/other code examples and investigational exclusions.

Policy Summary

PayerCentene

PolicyConcert Genetics Genetic Testing: Cardiac Disorders

Policy CodePolicy N/A

Change TypeRevisions to panel criteria, coding, and post-transplant testing

Effective Date

Next Review Date

Key ActionDocument diagnostic findings, family history, imaging/ECG/autopsy results and rule-outs as specified by each panel's criteria to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Policy developed/updated with revision dates 03/23 and 10/23; multiple wording and criteria changes across panels described in revision notes.

Multiple panel titles, coverage criteria language, and specific criterion thresholds were revised across arrhythmia and cardiomyopathy genetic testing panels and post-transplant testing policies.

Left Ventricular Non-Compaction Cardiomyopathy Panels criteria set retired.

Post Heart Transplant Gene Expression Panels renamed and split into 'via Peripheral Blood' and added tissue-based criteria.

Brugada syndrome criteria wording refined and numeric thresholds standardized to 'greater than or equal to 2 mm'.

Comprehensive Arrhythmia panel family-history and SCD age criteria changed (age cutoff moved to <50 years) and added requirement that clinical tests are non-diagnostic for reversible/ischemic/structural causes.

Coding, background, references, and tables updated; version titled V2.2024 and Approval Date(s) indicated (some dates blank in this part).

MultiplePanels and codes referenced

SeveralCardiac conditions covered

SomeInvestigational tests (examples)

3Explicit medically necessary tests called out

1Retired panel

1Code removed (81404)

Coverage Summary & Scope

This policy addresses genetic and gene-expression testing for cardiac disorders, including multigene sequencing for cardiomyopathy and arrhythmia, testing for congenital heart malformations, familial hypercholesterolemia panels, and post–heart transplant assessment using peripheral blood gene expression profiling and donor-derived cell-free DNA (dd-cfDNA). The coverage stance is mixed: many targeted genetic panels and peripheral blood transplant tests have explicit medically necessary criteria, while certain tests (for example, tissue‑based gene expression panels and other indications not meeting specified criteria) are considered investigational. The policy notes the retirement of the left ventricular non‑compaction cardiomyopathy panel and consolidates known familial variant testing criteria into a general genetic testing policy rather than maintaining separate cardiac‑specific familial variant criteria.

Medical Necessity Criteria (by panel)

Post Heart Transplant Gene Expression Panels for Rejection Risk via Peripheral Blood (81595) - Medically Necessary

Post heart transplant gene expression panels performed on peripheral blood (CPT 81595) may be used to assess risk of rejection following orthotopic heart transplant. Tissue-based expression testing (e.g., 0087U) and other investigational uses are addressed below.

ALL of the following

The patient has previously undergone orthotopic heart transplant (cardiac allograft).
The test is being ordered for surveillance of rejection risk (not for initial transplant evaluation).
The patient is classified as low immunologic risk per treating transplant program (e.g., no recent acute rejection, clinically stable).
Operational: classification should be documented in the medical record.
Timing: testing is being requested between 2 months and less than 5 years after transplant.2 months to <5 years post-transplant
There is documentation that the test has not been performed within the past 3 months (i.e., serial testing allowed per program protocols but not duplicate within 3 months).
Clinical programs may have different surveillance intervals; document rationale.

Medical Necessity Criteria (by panel)

The following uses are considered investigational and not covered.

ANY of the following

Post heart transplant gene expression testing performed on myocardial tissue samples (e.g., CPT 0087U).
Any use of peripheral blood gene expression testing (CPT 81595) outside the specified medically necessary criteria above, including: testing before 2 months post-transplant, testing 5 years or more post-transplant for routine surveillance, or testing in patients not recognized as low immunologic risk.
Use of gene expression panels (81595 or 0087U) for indications other than surveillance for rejection risk following orthotopic heart transplant, such as initial donor evaluation, pre-transplant risk stratification, or diagnosis of non-rejection conditions.

title":"Post Heart Transplant Gene Expression Panels - Investigational (Peripheral Blood 81595 and Tissue 0087U)","type":"criteria_group"},{

Coding — CPT/HCPCS/ICD-10 groups

Comprehensive cardiomyopathy panel (example)CPTCovered

81439

Comprehensive cardiomyopathy multigene panel (example; used throughout policy as panel code)

Comprehensive arrhythmia panelsCPTCovered

81413	Comprehensive arrhythmia panel (example)
81414	Comprehensive arrhythmia panel (example)
0237U	Proprietary arrhythmia panel example (0237U)

Hypertrophic cardiomyopathy panelsCPT|HCPCSCovered

81439	Multigene hypertrophic cardiomyopathy panel (example)
S3865	HCPCS example code listed for HCM panels

Long QT syndrome (LQTS) panelsCPTCovered

81403	LQTS-related panel component
81406	LQTS-related panel component
81407	LQTS-related panel component
81413	Panel code (used for larger panels)
81414	Panel code (used for larger panels)
81479	Unlisted molecular pathology procedure (used in some LQTS panels)

Short QT syndrome (SQTS) panelsCPTCovered

81403	SQTS-related panel component
81406	SQTS-related panel component
81413	Panel code
81414	Panel code
81479	Unlisted molecular pathology procedure

Brugada SCN5A testingCPT|HCPCSCovered

81407	SCN5A variant analysis (example)
S3861	HCPCS example code for SCN5A testing

CPVT panelsCPTCovered

81403	CPVT-related panel component
81405	CPVT-related panel component
81408	CPVT-related panel component
81413	Panel code
81414	Panel code
81479	Unlisted molecular pathology procedure

Familial hypercholesterolemia (FH) panelsCPTCovered

81401	FH-related panel component
81405	FH-related panel component
81406	FH-related panel component
81407	FH-related panel component
81479	Unlisted molecular pathology procedure

Congenital heart malformation panelsCPTCovered

81405	Congenital heart malformation panel component
81406	Congenital heart malformation panel component
81407	Congenital heart malformation panel component
81408	Congenital heart malformation panel component
81479	Unlisted molecular pathology procedure

Post-heart transplant peripheral blood gene expression panel (AlloMap)CPTCovered

81595

Post heart transplant gene expression panel for rejection risk via peripheral blood (AlloMap)

Post-heart transplant tissue gene expression panelCPTNot Covered

0087U

Post heart transplant gene expression panel (tissue) - considered investigational

Donor-derived cell-free DNA (dd-cfDNA) for heart transplant rejectionCPT|HCPCSCovered

81479	Donor-derived cell-free DNA (unlisted molecular pathology)
0118U	dd-cfDNA proprietary code example

ICD-10 codes referenced (neutral)ICD-10

I42.0	Dilated cardiomyopathy
I42.1	Obstructive hypertrophic cardiomyopathy
I42.2	Other hypertrophic cardiomyopathy
I42.5	Other cardiomyopathy
I42.8	Other cardiomyopathies
I42.9	Cardiomyopathy, unspecified
I45.81	Long QT syndrome (ECG code referenced)
I49.8	Other specified cardiac arrhythmias
Z13.71	Encounter for screening for genetic disease carrier
Z82.41	Family history of sudden cardiac death

1–10 of 21

1/3

CPT codes removed (mentioned in edits)CPT

81404

Multigene sequencing panel (code removed from multiple panel sections)

Provider Actions & Billing Rules

Documentation Required

Clinical documentation to support panels

Providers must document diagnostic findings, family history, autopsy findings, ECG/MRI/echocardiogram measurements, and confirmation that non-genetic causes have been considered/rule‑out as specified by each panel's criteria.

Diagnostic findings (clinical phenotype, imaging, ECG/MRI/echo measurements)
Family history including details of affected relatives and any autopsy findings
Autopsy findings (when available) including whether heart was anatomically normal or showed cardiomyopathy phenotype
Specific ECG, MRI, or echocardiogram measurements as required by panel criteria (e.g., wall thickness, RVOT, EF thresholds)
Documentation that non-genetic causes were considered and ruled out (e.g., ischemia, toxins, thyroid disease, drugs)

Background & Evidence

Hereditary and multifactorial factors contribute to arrhythmias and cardiomyopathies; while many cases are diagnosed clinically, identifying a pathogenic or likely pathogenic variant can enable cascade testing of at‑risk relatives. The policy recommends performing genetic testing first in an affected relative (the index case) when possible to guide testing of family members. It also explicitly includes congenital heart defects and familial hypercholesterolemia as genetic testing indications, and describes post‑transplant uses of peripheral blood gene expression profiling (e.g., AlloMap) and donor‑derived cell‑free DNA (dd‑cfDNA) for assessment of rejection risk or presence.

Reference	Summary/Level
ISHLT 2022 AlloMap recommendation	Class IIa, Level of Evidence: B for use in low-risk adult recipients between 2 months and 5 years post-HT (AlloMap peripheral blood gene expression)
AST position on dd-cfDNA	American Society of Transplant Surgeons (Mar 2023) position: dd-cfDNA may be used to rule out subclinical rejection for heart transplant recipients
Hershberger et al. 2018 (HFSA/ACMG)	Recommendation: Genetic testing recommended for patients with cardiomyopathy; multigene panels preferred over serial single-gene testing
Guideline updates referenced (EHRA/HRS/APHRS/LAHRS etc.)	Multiple consensus/guideline documents cited (e.g., EHRA/HRS/APHRS/LAHRS 2022 expert consensus; 2019 Towbin HRS statement; 2022 ISHLT guidelines; AHA genetic testing statement 2020) used as background to support panel indications and thresholds

Close relatives: defined as first-, second-, and third‑degree blood relatives with examples for each degree (first‑degree: parents, siblings, children; second‑degree: grandparents, aunts/uncles, nieces/nephews, grandchildren, half‑siblings; third‑degree: great grandparents, great aunts/uncles, great grandchildren, first cousins).

Phenocopy: a trait or disease that resembles the phenotype associated with a genotype but occurs in an individual who is not a carrier of that genotype.

Sudden cardiac death (SCD): death due to a cardiovascular cause that occurs within one hour of the onset of symptoms.

dd‑cfDNA: donor‑derived cell‑free DNA measured in peripheral blood for detection/assessment of heart transplant rejection; peripheral blood dd‑cfDNA testing is addressed with specific criteria (for example, not to be repeated if performed within the prior 12 months).

Revision History

03/23revised

Policy developed/updated with revision date 03/23; title updated to V1.2024, overview, coding table, background and references updated; multiple wording clarifications across panels documented.

10/23revised

Policy revised 10/23 with multiple wording and criteria changes across arrhythmia and cardiomyopathy panels; changes included removal/addition of specific CPT codes and edits to criteria phrasing.

04/24revisedLatest

Policy Summary

PayerCentene

PolicyConcert Genetics Genetic Testing: Cardiac Disorders

Policy CodePolicy N/A

Change TypeRevisions to panel criteria, coding, and post-transplant testing

Effective Date

Next Review Date

Key ActionDocument diagnostic findings, family history, imaging/ECG/autopsy results and rule-outs as specified by each panel's criteria to support medical necessity.

SourceLink

On This Page

citations":[],"intro":"Donor-derived cell-free DNA (dd-cfDNA) testing for heart transplant rejection is addressed separately (medically necessary when post-transplant and not performed in the prior 12 months; other uses investigational).","nodes":["{\"operator\":\"any\",\"children\":[{\"text\":\"When gene expression or dd-cfDNA testing is being considered, clinicians should document prior tests (type and date) and the clinical rationale for additional testing.\"},{\"text\":\"Results of genetic expression or dd-cfDNA tests should be integrated with clinical assessment, imaging, endomyocardial biopsy when indicated, and immunosuppression management decisions.\"}]}"],"title":"Operational Notes - Transplant Testing","type":"criteria_group"},{

citations":[],"intro":"Tissue-based gene expression testing (e.g., CPT 0087U) for assessment of rejection risk following heart transplant is considered investigational for all indications.","nodes":["{\"operator\":\"all\",\"children\":[{\"text\":\"Any ordering of myocardial tissue gene expression panels (CPT 0087U) to assess rejection risk following heart transplant.\"},{\"text\":\"Any use of 0087U for diagnosis, surveillance, or management decisions outside a research protocol.\"}]}"],"title":"Post Heart Transplant Gene Expression Panels (Tissue) (0087U) - Investigational","type":"criteria_group"},{

citations":[],"intro":"Summary of guideline-based recommendations and policy-linked guidance relevant to comprehensive cardiomyopathy/arrhythmia panels and other genetic panels:","nodes":["{\"operator\":\"all\",\"children\":[{\"text\":\"Hershberger et al. (2018): Genetic testing is recommended for patients with a clinical diagnosis of cardiomyopathy to facilitate family cascade testing; testing should include genes with established association to the phenotype.\"},{\"text\":\"ISHLT (2022): Post-transplant surveillance should use validated modalities; peripheral blood gene expression testing (81595) may be considered in specified low-risk populations during defined time windows, but tissue-based assays remain investigational.\"},{\"text\":\"Stiles et al. (2020): For sudden cardiac death (SCD) and unexplained cardiac arrest, combined arrhythmia and cardiomyopathy panels can be appropriate when clinical testing is non-diagnostic and family history suggests a genetic cause.\"},{\"text\":\"Guideline-based testing should prioritize targeted testing of an affected relative (index case) when available; multigene panels are preferred when phenotype is heterogeneous or multiple genes are implicated.\"},{\"text\":\"Laboratory selection: choose accredited laboratories with demonstrated analytical and clinical validity for the genes on the panel; variant interpretation should follow ACMG/AMP standards.\"}]}"],"title":"Guideline-based Recommendations and Policy-linked Guidance","type":"criteria_group"},{

citations":[],"intro":"Summary of general revisions and panel-specific criteria changes made in this policy update:","nodes":["{\"operator\":\"any\",\"children\":[{\"text\":\"Clarified medically necessary window for peripheral blood post-transplant gene expression testing: 2 months to <5 years post-transplant (previous version unspecified).\"},{\"text\":\"Explicitly designated tissue-based gene expression testing (0087U) as investigational for all indications; previously not clearly specified.\"},{\"text\":\"Consolidated investigational uses of 81595 to include testing outside the defined post-transplant window and uses for non-surveillance indications.\"},{\"text\":\"Added operational notes requiring documentation of immunologic risk, prior testing, and integration of results with clinical/bio-pathologic data.\"},{\"text\":\"Aligned policy language with recent guideline recommendations (Hershberger 2018, ISHLT 2022, Stiles 2020) regarding index-case testing and laboratory standards.\"}]}"],"title":"Policy Revisions and Panel-specific Changes - Summary","type":"criteria_group"}],

id":"medical-necessity-criteria","label":"MEDICAL-NECESSITY CRITERIA","title":"Medical Necessity Criteria (by panel)"}EOF.json (truncated)

Prior Authorization

Appropriate panel code use

If a panel is performed, use the appropriate panel CPT/HCPCS code listed for that panel type (see policy coding table and examples).

Denial Risk

Investigational indications denied

Tests ordered for indications labeled investigational (i.e., “all other indications not meeting the medically necessary criteria”) are considered investigational and are subject to denial/non‑coverage.

Documentation Required

Rule out phenocopies/secondary causes

For Brugada and other relevant panels, providers must document that phenocopies and secondary/non‑genetic causes (for example myocardial ischemia, electrolyte disturbances, drug intoxication, structural causes) have been considered and ruled out as required by the panel criteria.

Explicit documentation that conditions causing phenocopy were evaluated and excluded (e.g., ischemia, electrolyte abnormalities, drug/toxin exposure)
Relevant clinical testing results used to exclude secondary causes

Documentation Required

Family testing recommendations

Genetic testing is recommended to begin with an affected relative (the index case) when possible; cascade testing of at‑risk family members should follow identification of a pathogenic/likely pathogenic variant and testing decisions/interpretation should involve genetics experts.

Perform testing in at least one close relative with definite cardiomyopathy (index case) when feasible
Involve medical genetics or cardiomyopathy genetics experts for testing decisions and interpretation
Offer cascade testing to at‑risk relatives when a pathogenic/likely pathogenic variant is identified

Prior Authorization

Criteria-based coverage for AlloMap (81595)

AlloMap (CPT 81595) is covered only when the patient has undergone heart transplant, is low‑risk for rejection, and the transplant occurred at least 2 months and less than 5 years prior to testing; otherwise the test is investigational/not covered.

Code: 81595
Timing: ≥2 months and <5 years post‑transplant
Risk status: patient documented as low‑risk for organ rejection
Patient has undergone heart transplant

Prior Authorization

Donor-derived cfDNA testing frequency constraint

Donor‑derived cfDNA testing (examples: CPT 81479, HCPCS 0118U) is considered medically necessary only when the member has undergone heart transplant and peripheral blood dd‑cfDNA testing has not been performed in the past 12 months; repeat testing within 12 months is not indicated per policy.

Codes: 81479, 0118U
Requirement: peripheral blood dd‑cfDNA not performed within prior 12 months
Patient has undergone heart transplant

Denial Risk

Tissue-based gene expression panels investigational

Claims for tissue‑based post‑heart transplant gene expression panels (code 0087U) are considered investigational and are subject to denial for all indications.

Code: 0087U

Documentation Required

Use cardiology assessment for Brugada suspicion

For Brugada‑related genetic testing indications that require a strong clinical suspicion, the record must document that a cardiologist has established a strong clinical suspicion for Brugada syndrome based on history, family history, and ECG phenotype.

Documenting cardiologist assessment stating strong clinical suspicion
Include supportive clinical history and electrocardiographic findings per Brugada criteria

Documentation Required

Post-transplant testing specimen/source specification

For post‑transplant testing, providers must specify the specimen/source (peripheral blood vs tissue) and document the member's transplant status (confirmation that the member has undergone heart transplant) to meet the separate criteria for peripheral blood versus tissue testing.

Specify specimen source on the order/claim (peripheral blood or tissue)
Document that the member has undergone heart transplant (Z94.1 or aftercare Z48.21 may be applicable)
Follow the distinct criteria for peripheral blood (81595) versus tissue (0087U)

Billing Rule

CPT 81404 removal impact

CPT 81404 was removed from multiple panel sections; billing teams should not use 81404 for panels where it was removed and must follow the updated coding table in the policy.

81404

Documentation Required

Familial variant testing policy consolidation

Known familial variant (mutation‑specific) testing criteria have been consolidated into the policy 'Genetic Testing: General Approach to Genetic and Molecular Testing'; providers ordering familial variant analysis must follow that consolidated policy's criteria and documentation requirements.

Version updates V2.2024/V1.2024 noted with semi-annual review; coding, background, references, and tables updated; specific edits included removal of CPT 81404 from sections, renaming and splitting of post-transplant gene expression panels to 'via Peripheral Blood' with added tissue-based criteria, and movement of Known Familial Variant Analysis criteria to a consolidated genetic testing policy.

revised

Multiple panel titles, coverage criteria language, and specific criterion thresholds were revised across arrhythmia and cardiomyopathy genetic testing panels and post-transplant testing policies (examples: removal of ECG pattern text, standardization of Brugada threshold to 'greater than or equal to 2 mm', age cutoff changes for sudden cardiac death family criteria to 'before age 50 years', and added requirement that clinical tests be non-diagnostic for reversible/ischemic/structural causes).

removed

Left Ventricular Non-Compaction Cardiomyopathy Panels criteria set retired due to rarity of testing.

clarified

Brugada syndrome criteria wording refined (removed multigene panel language, replaced 'has' with 'meets', removed ECG patterns heading) and numeric thresholds standardized to 'greater than or equal to 2 mm'; added requirement to rule out phenocopies.

clarified

Comprehensive Arrhythmia panel family-history and sudden cardiac death age criteria clarified: 'before age 50 years' used and added requirement that deceased had family history of premature SCD or death suspicious for genetic heart disease; clinical tests must be non-diagnostic for reversible/ischemic/structural causes.