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ModifiedCommunity Health Plan WashingtonPolicy N/A

Concert Genetic Testing: Cardiac Disorders — Coverage Criteria

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Policy governing genetic and gene-expression testing related to cardiomyopathies, arrhythmias, congenital heart defects, cholesterol disorders, and post-heart-transplant rejection assessment for Community Health Plan Washington members and their providers.

Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert Genetic Testing: Cardiac Disorders — Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to post‑transplant testing, dd‑cfDNA addition, and multiple panel criteria

Effective DateN/A

Next Review DateN/A

Key ActionVerify coverage and prior-authorization requirements and submit prior authorization referencing the policy's medical necessity criteria for the indicated cardiac phenotype or transplant timing.

SourceLink

POLICY UPDATE CHANGES

Updated post-heart transplant gene expression panels to add tissue-based testing and to modify peripheral blood language per ISHLT 2022 guidance.

Added donor-derived cell-free DNA (dd-cfDNA) recommendation language referencing the American Society of Transplant Surgeons.

Numerous clinical-panel criteria and wording changes across cardiomyopathy, arrhythmia, and channelopathy panels (e.g., changes to sudden cardiac death language, panel names, CPT code removals).

Moved known familial variant analysis criteria to a consolidated policy and retired left ventricular non-compaction criteria.

Added ACC/AHA HCM imaging threshold language and clarification in Background and Rationale.

>8condition-specific criteria

includedpost-transplant testing

annualdefault monitoring frequency

0493UProspera code added

81401–81439CPT range referenced

Coverage Criteria for Cardiac Genetic and Transplant Tests

Comprehensive cardiomyopathy panels (81439) — medically necessary

Covered when ANY of the following are met:

Comprehensive cardiomyopathy panel criteria: A. Member has a diagnosis of cardiomyopathy; OR B. Member has a first-degree relative with sudden cardiac death (SCD) or sudden unexplained death (SUD) AND either (1) the relative's autopsy revealed unspecified cardiomyopathy (e.g., cardiomegaly or cardiomyopathy) OR (2) the relative's autopsy revealed an anatomically normal heart and the autopsy did not reveal a cause of death.uses family/autopsy findings

Panel code 81439

Comprehensive arrhythmia panels (0237U, 81413, 81414) — medically necessary

Covered when ANY of the following are met:

Comprehensive arrhythmia panel criteria: A. Member meets one of: (1) first-degree relative with SCD or SUD before age 50; OR (2) first-degree relative with SCD at age ≥50 AND the deceased had family history of premature SCD or death suspicious for genetic heart disease; OR B. Member has unexplained sudden cardiac arrest AND clinical tests were non-diagnostic for reversible, ischemic, or structural causes (e.g., ECG, stress test, echocardiogram, intravenous pharmacologic provocation).

Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert Genetic Testing: Cardiac Disorders — Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to post‑transplant testing, dd‑cfDNA addition, and multiple panel criteria

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

family history or unexplained arrest after non-diagnostic testing

Panel codes 0237U, 81413, 81414

Comprehensive arrhythmia and cardiomyopathy panels — medically necessary

Covered when ALL of the following are met:

Combined cardiomyopathy and arrhythmia panel criteria: Member meets clinical criteria for Comprehensive Cardiomyopathy Panels AND meets clinical criteria for Comprehensive Arrhythmia Panels.both sets required

Panel codes 81413, 81414, 81439

Hypertrophic cardiomyopathy panels (81439, S3865) — medically necessary

Covered when ANY of the following are met:

HCM panel criteria: A. Unexplained left ventricular hypertrophy (LVH) defined as myocardial wall thickness ≥15 mm in adults or a z-score ≥2 in children on echocardiogram or cardiac MRI; OR B. First-degree relative with sudden cardiac death and autopsy revealed an HCM phenotype.LV wall thickness / z-score or autopsy HCM

Codes 81439, S3865

Dilated cardiomyopathy panels (81439) — medically necessary

Covered when ALL of the following are met:

DCM panel criteria: A. Findings characteristic of dilated cardiomyopathy including: (1) left ventricular enlargement on echocardiogram or cardiac MRI; AND (2) systolic dysfunction (e.g., ejection fraction <50%) on echocardiogram, cardiac MRI, or left ventricular angiogram; AND (3) non-genetic causes of DCM have been ruled out (for example prior myocardial infarction, valvular/congenital disease, toxins, thyroid disease, inflammatory/infectious conditions, severe long-standing hypertension, radiation); OR B. First-degree relative with sudden cardiac death and autopsy revealed a DCM phenotype.LV enlargement + EF <50% + exclusion of non-genetic causes

Panel code 81439

Arrhythmogenic cardiomyopathy panels (81439) — medically necessary

Covered when member has ONE major OR TWO minor criteria from the specified categories:

ARVC major criterion (one required): Member has any one major criterion such as: echo showing regional RV akinesia/dyskinesia or aneurysm with PLAX RVOT >32 mm or PSAX RVOT >36 mm or fractional area change <33%; MRI with regional RV akinesia/dyskinesia or dyssynchronous contraction plus Rao RVEDV/BSA >110 mL/m2 (male) or >100 mL/m2 (female) or RVEF <40%; RV angiography regional findings; endomyocardial biopsy with fibrous replacement and residual myocytes <60%; specified ECG major abnormalities; or major family-history findings (ARVC confirmed in first-degree relative, pathologic confirmation, or pathogenic mutation identified).major criteria as listed

Panel code 81439

ARVC minor criteria (two required): Member has any two listed minor criteria such as: echo with PLAX RVOT 29–32 mm or PSAX RVOT 32–36 mm or fractional area change 33–40%; MRI Rao RVEDV/BSA borderline ranges or RVEF 40–45%; biopsy with residual myocytes 60–75%; ECG minor repolarization/late potential/VT findings; Holter >500 ventricular extrasystoles/24 h; or qualifying family-history items.two minor criteria as listed

Panel code 81439

Restrictive cardiomyopathy panels (81439) — investigational

RCM panels: Genetic testing for restrictive cardiomyopathy (RCM) via multigene panel (81439) is considered investigational.investigational

no covered indications

Long QT syndrome panels — medically necessary

Covered when ANY of the following are met:

LQTS panel criteria: A. Asymptomatic member with confirmed prolonged QTc (greater than 460 ms prepuberty or greater than 480 ms for adults) on resting ECG and/or provocative testing; OR close relative with clinical LQTS and unknown genetic status; OR B. Symptomatic member (syncope, cardiac arrest, aborted sudden death) with either (a) cardiologist-established strong clinical suspicion based on history/family/ECG phenotype OR (b) Schwartz score ≥3.0, AND non-genetic causes of QT prolongation have been ruled out (e.g., QT-prolonging drugs, hypokalemia, structural heart disease, certain neurologic conditions).QTc thresholds and Schwartz score

Panel codes 81403, 81406, 81407, 81413, 81414, 81479

Short QT syndrome panels — medically necessary

Covered when ANY of the following are met:

SQTS panel criteria: A. Member has QTc ≤330 ms; OR B. Member has SQTS diagnostic score ≥4; OR C. Asymptomatic member with a first-degree relative with clinical SQTS and unknown genetic status. (Electrocardiographic and scoring details, including J-point–Tpeak measurements and required ECG points, apply as specified.)QTc ≤330 ms or SQTS score ≥4

Panel codes 81403, 81406, 81413, 81414, 81479

Brugada syndrome (SCN5A) — medically necessary

Covered when ALL of the following are met:

Brugada SCN5A testing criteria: A. Member has Type 1, Type 2 (with conversion to Type 1 after sodium channel blocker), or Type 3 (with conversion to Type 1 after sodium channel blocker) ECG pattern as defined; AND B. Phenocopies causing Brugada pattern (e.g., myocardial ischemia, electrolyte disturbances, drug intoxications) have been ruled out; AND C. Member has recurrent syncope, ventricular fibrillation, self‑terminating polymorphic VT, cardiac arrest, or a family history of sudden cardiac death.ECG pattern + exclusion of phenocopies + clinical events/family history

SCN5A testing codes 81407, S3861

Brugada syndrome — investigational for genes other than SCN5A

Other Brugada gene panels: Genetic testing for Brugada via genes other than SCN5A, including multigene panels (81404, 81406, 81407, 81413, 81414, 81479), is considered investigational.investigational

no covered indications for non-SCN5A testing

Brugada syndrome — SCN5A variant analysis (medically necessary)

Genetic testing via SCN5A is considered medically necessary when ALL of the following are met:

Brugada SCN5A testing criteria (variant analysis): A. Member meets one of ECG Type 1, Type 2 (with conversion to Type 1 after sodium channel blocker), or Type 3 (with conversion to Type 1 after sodium channel blocker); B. Phenocopies causing Brugada pattern have been ruled out; AND C. Member has recurrent syncope OR ventricular fibrillation OR self‑terminating polymorphic VT OR cardiac arrest OR a family history of sudden cardiac death.

Codes 81407, S3861 referenced for this covered indication

Brugada syndrome — investigational indications

Investigational Brugada testing: I. SCN5A testing is investigational for indications not meeting the above criteria; II. Genetic testing via genes other than SCN5A (including multigene panels 81404, 81406, 81407, 81413, 81414, 81479) is investigational for Brugada syndrome.

Catecholaminergic polymorphic ventricular tachycardia (CPVT) — multigene panel (medically necessary)

Genetic testing via multigene panel is medically necessary when ALL of the following are met:

CPVT panel criteria: A. No known structural cardiac abnormalities; AND B. Presence of at least one of: syncope during physical activity or acute emotion; history of exercise- or emotion-related palpitations and dizziness; sudden unexpected cardiac death triggered by acute emotional stress or exercise; family history of juvenile sudden cardiac death triggered by exercise or acute emotion; exercise-induced bidirectional or polymorphic ventricular arrhythmias; or ventricular fibrillation occurring in the setting of acute stress.

Codes 81403, 81405, 81408, 81413, 81414, 81479 referenced

CPVT — investigational indications

CPVT investigational: Genetic testing via multigene panel for CPVT is investigational for all other indications not listed above.

Familial hypercholesterolemia (FH) — multigene panel (medically necessary)

Genetic testing via multigene panel is medically necessary when ALL of the following are met:

FH panel criteria: A. Member has two or more elevated LDL-C measurements including assessment after intensive lifestyle modification; AND B. No apparent secondary cause of hypercholesterolemia; AND C. Age-specific LDL-C thresholds and family/personal history criteria are met (for example: children with LDL-C ≥190 mg/dL, children with LDL-C ≥160 mg/dL plus family criteria, adults with LDL-C ≥250 mg/dL, adults with LDL-C ≥190 mg/dL plus family criteria, or adults with LDL-C ≥160 mg/dL with family history as detailed in policy).See LDL-C thresholds in coding.thresholds

Codes 81401, 81405, 81406, 81407, 81479 referenced

FH — investigational indications

FH investigational: Genetic testing via multigene panel for FH is investigational for all other indications not meeting the criteria above.

Congenital heart malformation panels — medically necessary

Multigene panel analysis may be considered medically necessary when ALL of the following are met:

Congenital heart malformation criteria: A. Member has a complex congenital heart malformation (for example hypoplastic left heart, transposition of the great vessels, tetralogy of Fallot); AND B. Clinical features do not fit a known genetic disorder for which targeted testing could be performed (for example 22q11.2 deletion, Trisomy 21, Williams syndrome); AND C. Prenatal teratogen exposure has been considered and ruled out when possible.

Codes 81405, 81406, 81407, 81408, 81479 referenced

Congenital heart malformation — investigational

Congenital CHD investigational: Multigene panel testing is investigational for all other indications, including simple congenital heart defects (e.g., VSD, ASD, PDA).

Post heart transplant gene expression panels (peripheral blood) — medically necessary

Peripheral blood gene expression panels to determine management after heart transplant are medically necessary when ALL are met:

Peripheral blood transplant panel criteria: A. Member has undergone heart transplant; AND B. Member is low-risk for organ rejection; AND C. Transplant was performed ≥2 months and <5 years ago.Time since transplant: >=2 months and <5 years

Code 81595 referenced

Post heart transplant peripheral blood panel — investigational

Peripheral blood transplant investigational: Use is investigational for all other indications not meeting the above criteria.

Post heart transplant gene expression panels (tissue)

Tissue transplant panel investigational: Use of post heart transplant gene expression panels for rejection risk via tissue (0087U) is considered investigational.

Donor‑derived cell‑free DNA for heart transplant rejection — medically necessary

Peripheral blood measurement of donor‑derived cell‑free DNA is medically necessary when ALL are met:

cfDNA transplant criteria: A. Member has undergone heart transplant; AND B. Peripheral blood donor‑derived cfDNA testing has not been performed in the prior 12 months.Testing interval: not performed in prior 12 months

Codes 0118U, 0493U, 81479 referenced

Comprehensive cardiomyopathy/arrhythmia panels — guideline context

Professional society guidance summarized supports phenotype‑focused testing and family cascade testing:

Guideline recommendations: HFSA/ACMG recommend genetic testing for patients with cardiomyopathy and testing the most clearly affected family member with cascade testing for pathogenic variants; APHRS/HRS and EHRA/HRS consensus statements emphasize multidisciplinary workup for SCA/SUD cases and recommend targeted testing to the index phenotype rather than hypothesis‑free large panels.

References: Hershberger et al 2018; Stiles et al 2020; EHRA/HRS/APHRS/LAHRS 2022

Arrhythmogenic cardiomyopathy (ARVC) diagnostic criteria

Diagnosis based on Task Force criteria: possible ARVC defined as one major criterion OR two minor criteria from different categories.

Possible ARVC

Major criteria examples: Echo: regional RV akinesia/dyskinesia/aneurysm with PLAX RVOT >32 mm or PSAX RVOT >36 mm or fractional area change <33%; MRI: regional RV akinesia/dyskinesia or dyssynchronous contraction with Rao RVEDV/BSA >110 mL/m2 male/>100 mL/m2 female or RVEF <40%; biopsy: fibrous replacement with residual myocytes <60%; ECG: inverted T waves in V1-V2 (>14 y) etc.
See chunks 55-56 for full major list
Minor criteria examples: Echo: PLAX RVOT 29–32 mm or PSAX RVOT 32–36 mm or fractional area change 33–40%; terminal activation duration >55 ms; >500 PVCs/24h; family history items.
See chunk 58 for full minor list

Long QT syndrome (LQTS) testing indications

Genetic testing for LQTS recommended based on clinical probability and QTc thresholds.

High probability LQTS: Offer molecular testing for definitive disease-associated genes (KCNQ1, KCNH2, SCN5A, CALM1-3) to index patients with high probability of LQTS (Schwartz score ≥3.5).Schwartz score ≥3.5

Also recommended for asymptomatic patients with QTc >480 ms (children) or >500 ms (adults).

Intermediate probability: For intermediate probability (Schwartz 1.5–3.0), testing of established genes may be considered; genes with limited/disputed evidence should not be tested routinely.Schwartz 1.5–3.0

Short QT syndrome (SQTS) testing indications

Genetic testing recommended for patients meeting diagnostic criteria or high diagnostic score.

SQTS diagnostic threshold: SQTS diagnosis uses ECG cutoff QTc ≤330 ms; genetic testing for disease genes (e.g., KCNH2, KCNQ1) is recommended when diagnostic criteria or SQTS score ≥4 are met. Cascade testing for at‑risk relatives is recommended when a pathogenic variant is identified.QTc ≤330 ms or SQTS score ≥4

Brugada syndrome testing indications

Testing should follow clinical diagnostic criteria including EKG patterns and exclusion of phenocopies.

Brugada suspicion: Suspect Brugada syndrome in individuals with syncope, ventricular arrhythmias, cardiac arrest, or family history of SCD AND diagnostic ECG patterns (Type 1–3) at baseline or after sodium channel blocker challenge; phenocopies such as ischemia, electrolyte disturbances, or drug intoxication must be excluded before diagnosis; report SCN5A primarily as the gene with strong evidence.EKG type 1 pattern or provoked type 1

Catecholaminergic polymorphic VT (CPVT) testing indications

Suspect CPVT in exercise/emotion-triggered syncope/arrhythmia with structurally normal heart and normal resting ECG.

CPVT diagnosis: Diagnosis established with structurally normal heart, normal resting ECG, and exercise- or emotion-induced bidirectional or polymorphic ventricular tachycardia; genetic testing appropriate in this context.

See chunk 67 for clinical features warranting testing.

Familial hypercholesterolemia (FH) genetic testing indications

Genetic testing recommended for individuals with a strong clinical index of suspicion for FH.

FH testing triggers: Offer genetic testing to children with persistent LDL‑C ≥160 mg/dL or adults with persistent LDL‑C ≥190 mg/dL without secondary causes and with supporting family history or premature CAD; higher LDL thresholds (≥190–250 mg/dL) warrant testing even without family history. If LDL unavailable, corresponding total cholesterol cutoffs may be used. Testing should include LDLR, APOB, PCSK9 at minimum; expanded panels can include phenocopy genes.LDL‑C ≥160 mg/dL (children); ≥190 mg/dL (adults)

Congenital heart malformation genetic testing rationale

Genetic testing can clarify recurrence risk, extracardiac involvement, neurodevelopmental risk, and prognosis.

Congenital heart disease testing rationale: Genetic evaluation is clinically relevant to assess recurrence risk, extracardiac findings, neurodevelopmental delay risk, and prognosis in congenital heart disease survivors.

Post‑heart transplant gene expression testing

Noninvasive and tissue gene expression assays have specific recommended uses and availability considerations.

Peripheral blood GEP (AlloMap): AlloMap peripheral blood gene expression profiling can be used in low‑risk adult heart transplant recipients between 2 months and 5 years post‑transplant to identify low risk of current acute cellular rejection and reduce endomyocardial biopsy frequency.2 months to 5 years post‑HT

Class IIa recommendation per ISHLT 2022

Tissue-based molecular diagnostics (MMDx): Assessment of rejection-associated gene transcripts in allograft tissue (e.g., Molecular Microscope/MMDx) can help discriminate T-cell vs antibody-mediated rejection but may have limited availability outside North America.availability dependent

Post-heart transplant testing

Coverage guidance and criteria excerpts for post-heart transplant testing and transplant-related molecular tests:

Peripheral blood GEP (AlloMap): ISHLT 2022 states peripheral blood GEP can be used in low‑risk adult heart transplant recipients between 2 months and 5 years post-transplant to identify those at low risk of acute cellular rejection and reduce endomyocardial biopsy frequency.2 months to 5 years post-HT

Class IIa, Level of Evidence: B

Tissue-based GEP (MMDx): Assessment of gene expression within allograft tissue (e.g., Molecular Microscope, MMDx) permits improved discrimination between T-cell mediated or antibody-mediated rejection but may not be widely available outside North America.availability dependent

limited clinical availability

Donor-derived cell-free DNA (dd-cfDNA): American Society of Transplant Surgeons recommends dd-cfDNA may be utilized to rule out subclinical rejection for heart transplant recipients; policy reference table updated to include Prospera (0493U).not specified

Routine post-transplant monitoring frequency: Absent clear guideline-specified regimens, a default coverage frequency of once every 12 months will be adopted for routine monitoring.once every 12 months

utilization default for routine surveillance

Referenced Clinical Criteria and Testing Priorities

Clinical testing and interpretation guidance cited from professional societies and guidelines:

HCM diagnostic imaging and genetic testing guidance: In adults, HCM diagnosis can be established when imaging shows maximal end-diastolic wall thickness ≥15 mm in the absence of another cause; thickness 13–14 mm may be diagnostic in family members or with a positive genetic test; for children criteria adjust for body size (z-score ≥2). Postmortem testing may identify pathogenic variants enabling cascade testing.see thresholds

sourced to ACC/AHA and ESC guideline excerpt

LQTS genetic testing guidance: In patients with intermediate probability of LQTS (Schwartz score 1.5–3.0), testing should focus on established genes and avoid genes with limited, disputed or refuted evidence; established genes may be considered to help rule out diagnosis after phenotypic evaluation.Schwartz score 1.5-3.0

guideline-based testing prioritization

The tests, laboratories, CPT codes, and ICD codes shown in this policy are provided as examples to assist with coding and claims submission and are not exhaustive. Inclusion or exclusion of any code does not guarantee coverage; providers must reference up-to-date coding guidance and the payer's coding resources (e.g., Concert Platform) when submitting claims.

Unless an indication and documentation meet the specific, condition‑focused criteria shown elsewhere in this policy, use of the multigene panels listed (including comprehensive cardiomyopathy panels, comprehensive arrhythmia panels, combined cardiomyopathy/arrhythmia panels, and condition‑specific panels) is considered investigational for all other indications. Requests for panels outside the enumerated covered scenarios are expected to be denied as not medically necessary.

Hypothesis‑free testing (for example, very large unfocused gene panels, whole‑exome sequencing, or whole‑genome sequencing) is discouraged when a clinical phenotype is unknown. Professional consensus statements emphasize phenotype‑focused testing and recommend that hypothesis‑free approaches be considered mainly in research settings rather than routine clinical care.

Post‑heart‑transplant gene expression assays performed on allograft tissue (proprietary code 0087U, e.g., Molecular Microscope/MMDx) are considered investigational and excluded from coverage under this policy. Peripheral blood gene expression testing and donor‑derived cell‑free DNA have separate criteria and timing requirements described in the post‑transplant sections.

Before diagnosing Brugada syndrome and pursuing genetic testing, clinicians must exclude known Brugada phenocopies (for example, myocardial ischemia, electrolyte disturbances, or drug intoxication). Documentation showing phenocopies have been ruled out is required to support testing under the Brugada criteria.

Requests for analysis of a known familial variant (targeted single‑variant testing) are now routed to the payer's consolidated policy "Genetic Testing: General Approach to Genetic and Molecular Testing". Such requests submitted under this cardiac panels policy may be redirected or denied and should follow the referenced general approach policy.

Coverage under this policy is subject to the specific terms, exclusions, and limitations of the member's benefit documents. Where applicable, state Medicaid provisions override this policy. Inclusion of codes or tests in this document does not itself establish coverage—providers must verify member benefit coverage and any prior authorization requirements.

Genetic testing for restrictive cardiomyopathy using a multigene panel (e.g., 81439) is considered investigational (not medically necessary) and will not be covered under this policy.

Use of the genetic tests and multigene panels listed in this policy is considered investigational and therefore not medically necessary for indications that do not meet the specific clinical criteria provided for each condition (for example, Brugada testing outside SCN5A criteria, CPVT panels for non‑listed presentations, FH panels not meeting LDL‑C/family history thresholds, and congenital heart malformation panels for simple defects).

Testing genes with limited, disputed, or refuted evidence in the diagnostic evaluation of LQTS or Brugada syndrome is not recommended for routine clinical use. For LQTS, patients with intermediate probability (e.g., Schwartz score 1.5–3.0) should have testing focused on established genes rather than genes with limited or disputed validity; likewise, Brugada testing should prioritize SCN5A and avoid reporting/discouraging other genes with disputed gene‑disease validity in the diagnostic setting.

When evaluating patients with intermediate probability of LQTS, the policy discourages inclusion of genes with limited or disputed evidence on diagnostic panels. Laboratories and clinicians are advised to prioritize established LQTS genes (for example, KCNQ1, KCNH2, SCN5A) to avoid uncertain results that do not meaningfully inform diagnosis or management.

Coding, CPT / HCPCS / ICD References

Comprehensive Cardiomyopathy Panels - example CPT and ICD codesmixed

81439	Comprehensive cardiomyopathy panels (example)
I42.0	Cardiomyopathy ICD example
I42.1	Cardiomyopathy ICD example
I42.2	Cardiomyopathy ICD example
I42.5	Cardiomyopathy ICD example
I42.8	Cardiomyopathy ICD example
I42.9	Cardiomyopathy ICD example
Z13.71	Encounter for genetic carrier and counseling testing ICD example
Z82.41	Family history of cardiomyopathy ICD example
Z82.49	Family history of other cardiovascular disease ICD example

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Comprehensive Arrhythmia Panels - example CPT codesCPT

81413	Comprehensive arrhythmia panels / sequencing CPT example
81414	Comprehensive arrhythmia panels / sequencing CPT example
0237U	Genomic Unity Cardiac Ion Channelopathies Analysis (example)

Various syndrome-specific panels - example CPT/S codesmixed

81403	Panel CPT example (LQTS, SQTS, CPVT references)
81404	SCN5A/Brugada related CPT example
81405	Congenital heart malformation / panel CPT example
81406	Panel CPT example
81407	Panel CPT example
81408	Panel CPT example
81479	Unlisted molecular pathology procedure (example)
S3861	SCN5A variant analysis (example)
S3865	HCM panel related (example)

FH and Congenital Heart Disease Panels - example CPT and ICD codesmixed

81401	Familial hypercholesterolemia panel CPT example
E78	Disorders of lipoprotein metabolism and other lipidemias (ICD chapter)
E78.01	Familial hypercholesterolemia ICD example
Q20	Congenital malformations of cardiac chambers and connections ICD example
Q21	Congenital malformations of cardiac septa ICD example
Q22	Congenital malformations of pulmonary and tricuspid valves ICD example
Q23	Congenital malformations of aortic and mitral valves ICD example
Q24	Other congenital malformations of heart ICD example

Post-transplant testingneutral

81595

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

Post-transplant testing - cfDNA examplesneutral

0118U	Viracor TRAC Heart dd-cfDNA (example)
0493U	Prospera (Natera) — donor-derived cell-free DNA (example)
81479	Unlisted molecular pathology (example for dd-cfDNA)

Covered CPT/HCPCS and Proprietary Panel Codes (referenced throughout)mixed

81403	Tiered sequence analysis (as listed)
81405	Targeted sequencing panels (as listed)
81408	Comprehensive genomic sequencing panel (as listed)
81413	Multigene panel, cardiogenetic/arrhythmia panels
81414	Multigene panel, cardiogenetic/arrhythmia panels
81479	Unlisted molecular pathology procedure
81595	Gene expression profiling for transplant rejection (AlloMap)
0087U	Molecular Microscope (MMDx) Heart (tissue GEP)
0493U	Prospera dd-cfDNA (Natera)
0118U	Viracor TRAC Heart dd-cfDNA

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ICD-10 Codes referencedICD-10

Z13.71	Genetic susceptibility to cardiovascular disease
Z82.41	Family history of sudden cardiac death
Z82.49	Family history of other cardiovascular disorders
Z94.1	Heart transplant status
Z48.21	Encounter for aftercare following heart transplant
E78	Disorders of lipoprotein metabolism and other lipidemias
E78.01	Familial hypercholesterolemia

Brugada testing codesCPT | Modifier

81407	SCN5A variant analysis (listed in Brugada section)
S3861	Molecular pathology/proprietary code referenced with SCN5A

Multigene panel codes (various sections)CPT

81404	Multigene panel code (listed as investigational for Brugada other genes)
81406	Multigene panel code
81413	Multigene panel code
81414	Multigene panel code
81479	Unlisted molecular pathology/genetic testing code
81403	CPVT panel code (listed among CPVT panel codes)
81405	Panel/multigene code (used in multiple cardiology sections)
81401	Familial hypercholesterolemia panel code
81408	Panel code (listed in CPVT)

Post‑transplant monitoring codesCPT | HCPCS | Proprietary

81595	Post heart transplant gene expression panels for rejection risk via peripheral blood
0087U	Post heart transplant gene expression panels for rejection risk via tissue (MMDx)
0118U	Donor-derived cell-free DNA (Viracor TRAC Heart dd-cfDNA)
0493U	Donor-derived cell-free DNA proprietary code (Prospera, Natera)

Policy reference codes addedHCPCS

0493U

Prospera (Natera) — donor-derived cell-free DNA

Policy reference table additionsHCPCS

0493U

Prospera (Natera) — donor-derived cell-free DNA

Prevalence of CHD

Prevalence of congenital heart defects (CHD)Affects 1–1.2% of live births

DefinitionStructural heart defects present at birth; genetic and environmental etiologies

Clinical relevanceIdentifying genetic causes can inform recurrence risk, extracardiac evaluation, neurodevelopmental risk, and prognosis

QTc and wall thickness thresholds

Prolonged QTc thresholds>460 ms (prepuberty); >480 ms (adults) for confirmed prolonged QTc on resting ECG or provocative testing

Short QT diagnostic cutoffQTc ≤330 ms diagnostic for SQTS; SQTS score ≥4 indicates high probability

HCM wall thickness thresholdMyocardial wall thickness ≥15 mm in adults (z-score ≥2 in children)

ARVC imaging thresholds

Rao RVEDV/BSA definite threshold (MRI)>110 mL/m2 (male), >100 mL/m2 (female) for definite ARVC

RVEF definite thresholdRVEF <40% supports a definite MRI criterion

Biopsy residual myocytes (major)Residual myocytes 60–75% by morphometric analysis (major biopsy criterion)

LDL-C thresholds for FH testing

Children LDL‑C triggerChildren: persistent LDL‑C ≥190 mg/dL, OR ≥160 mg/dL with family criteria (first‑degree relative with elevated LDL‑C or premature CAD)

Adults LDL‑C triggerAdults: persistent LDL‑C ≥250 mg/dL, OR ≥190 mg/dL with family criteria, OR ≥160 mg/dL with supportive family history in select scenarios

Measurement requirementTwo or more LDL‑C measurements including assessment after intensive lifestyle modification (or total cholesterol equivalents if LDL unavailable)

Post‑transplant timing window for peripheral blood gene expression panel

Peripheral blood GEP timing window>= 2 months and < 5 years after heart transplant

Patient riskIntended for low‑risk adult heart transplant recipients to reduce biopsy frequency (per ISHLT 2022)

Code exampleAlloMap (81595) referenced for peripheral blood GEP

Donor‑derived cfDNA testing interval

Minimum interval since prior dd‑cfDNA testPeripheral blood dd‑cfDNA testing is covered when it has not been performed in the prior 12 months

Clinical contextUsed in management after heart transplant to detect or rule out rejection (ASCTS supports use to rule out subclinical rejection)

Example codesExamples include 0118U and 0493U (Prospera) as referenced

PLAX RVOT diameter (ARVC major/minor)

PLAX RVOT major criterion>32 mm (end diastole) (PLAX/BSA >19 mm/m2)

PLAX RVOT minor range29–32 mm (PLAX/BSA >16 to <19 mm/m2)

ContextMeasured at end diastole as part of Task Force imaging criteria for ARVC

PSAX RVOT diameter (ARVC major/minor)

PSAX RVOT major criterion>36 mm (end diastole) (PSAX/BSA >21 mm/m2)

PSAX RVOT minor range32–36 mm (PSAX/BSA >18 to <21 mm/m2)

Measurement noteMeasured at end diastole per echocardiographic Task Force criteria

Fractional area change (ARVC major/minor)

Fractional area change (FAC) major criterionFAC <33% (major)

FAC minor rangeFAC 33–40% (minor)

Use in diagnosisFAC calculated on echocardiography is a quantitative imaging component of ARVC Task Force criteria

LQTS QTc thresholds for asymptomatic testing

Asymptomatic LQTS testing trigger (children)Prepuberty QTc >480 ms (Class I recommendation for targeted genetic testing)

Asymptomatic LQTS testing trigger (adults)Adults QTc >500 ms (Class I recommendation)

Schwartz scoreUse Schwartz scoring to determine testing probability; high probability ≥3.5 points

SQTS QTc diagnostic cutoff

SQTS diagnostic QTc cutoffQTc ≤330 ms is the diagnostic cutoff for SQTS (Class I consensus)

SQTS diagnostic scoreSQTS score ≥4 indicates high probability and supports genetic testing

Testing genesTarget disease‑associated genes include KCNH2 and KCNQ1 per guideline recommendations

FH LDL‑C thresholds (condensed)

Condensed child/adult FH LDL‑C thresholdsChildren: persistent LDL‑C ≥160 mg/dL; Adults: persistent LDL‑C ≥190 mg/dL (two or more measurements) — triggers for genetic testing when coupled with family/premature CAD criteria

Higher LDL thresholdsChildren ≥190 mg/dL or adults ≥250 mg/dL warrant testing even without family history

Measurement requirementAt least two LDL‑C measurements including assessment after intensive lifestyle modification (or total cholesterol equivalents if LDL unavailable)

Post‑transplant surveillance frequency (default)

Default post‑transplant surveillance frequencyOnce every 12 months (default coverage frequency for routine monitoring absent specific guideline regimen)

RationaleAdopted as a utilization default when guideline‑specified schedules are not provided

Applies toRoutine post‑transplant molecular surveillance (e.g., dd‑cfDNA/other assays) unless guideline recommends otherwise

HCM imaging wall thickness (diagnostic thresholds)

Adult HCM diagnostic wall thicknessMaximal end‑diastolic wall thickness ≥15 mm in the left ventricle (in absence of another cause) — diagnostic in adults

Borderline thickness significanceMaximal thickness 13–14 mm may be diagnostic when present in family members of a patient with HCM or with a positive genetic test

Pediatric thresholdUse body surface area‑adjusted z‑score ≥2 for children

dd-cfDNA monitoring frequency (default)

Default dd‑cfDNA monitoring frequencyOnce every 12 months (default periodicity for routine post‑transplant monitoring)

Documentation requirementCoverage requires documentation that dd‑cfDNA testing has not been performed in the prior 12 months

Example proprietary code addedProspera (0493U) added to policy reference table as an example dd‑cfDNA test

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Providers should verify coverage and prior-authorization requirements and submit prior authorization requests for the genetic panel and transplant-related tests listed in this policy. Use the Concert Platform and current coding guidance when preparing requests; listed CPT/Codes are examples only and inclusion does not guarantee coverage.

Prior authorization expected for listed cardiac genetic panel codes (e.g., 81401, 81403, 81405, 81406, 81407, 81413, 81414, 81439, 81479, 0237U, S3861, S3865) when clinical criteria apply.
Prior authorization expected for transplant-related tests (e.g., 81595, 0087U, 0118U, 0493U, 0493U - Prospera) per policy criteria.

Prior Authorization

Post‑transplant Gene Expression Testing

Post‑transplant peripheral blood gene expression profiling (e.g., AlloMap, 81595) is supported for low‑risk adult heart transplant recipients between 2 months and 5 years post‑transplant when used to guide management per the policy criteria. Tissue‑based gene expression panels (e.g., 0087U) are investigational and will not be supported.

Peripheral blood GEP (81595) medically necessary when member is low‑risk and transplant occurred ≥2 months and <5 years ago.
Tissue-based GEP (0087U) considered investigational.

Prior Authorization

Post‑transplant dd‑cfDNA Monitoring

Donor‑derived cell‑free DNA (dd‑cfDNA) testing (e.g., 0118U, 0493U, 81479) is covered for monitoring heart transplant recipients when the member has had a transplant and dd‑cfDNA testing has not been performed in the past 12 months. For routine surveillance absent specific guideline timing, the policy adopts a default coverage frequency of once every 12 months.

Covered codes examples: 0118U, 0493U (Prospera), 81479.
Testing considered medically necessary when member has had heart transplant and no dd‑cfDNA in prior 12 months.
Default periodicity for routine post‑transplant monitoring: once every 12 months unless guideline-based schedule specifies otherwise.

Denial Risk

Brugada Gene Reporting Caution

When evaluating Brugada syndrome, report SCN5A testing when clinical ECG and exclusion criteria are met; testing of other Brugada-associated genes with disputed clinical validity is discouraged and may not be reported.

SCN5A variant analysis (81407, S3861) considered medically necessary only when ECG and clinical criteria in policy are satisfied.
Multigene panels or genes other than SCN5A are considered investigational for Brugada and reporting may be withheld for genes with disputed validity.

Note

Expert Consultation and Test Examples

Due to the complexity of cardiac genetic testing and potential for misinterpretation, the decision to test and interpretation of results should be performed by, or in consultation with, an expert in cardiac genetics.

Consider referral or consultation with a clinical geneticist, cardiologist with expertise in inherited cardiac conditions, or a certified genetic counselor for test selection and result interpretation.
Laboratory test examples in the policy are illustrative; selection should be phenotype‑directed and discussed with experts when unclear.

Documentation Required

Post‑transplant and FH Testing Documentation Requirements

Documentation submitted with prior authorization requests or claims must support transplant status and timing for post‑transplant testing, and must show clinical criteria for cardiac genetic testing indications. For FH testing, documentation must include persistent LDL‑C measurements (two or more) and assessment that secondary causes have been considered.

For dd‑cfDNA or GEP testing: documentation must show the member underwent heart transplant and provide transplant date to verify interval criteria (e.g., ≥2 months and <5 years for AlloMap; no dd‑cfDNA in prior 12 months for dd‑cfDNA).
For cardiac panel testing: include phenotype/clinical findings (ECG type, imaging results, exclusion of phenocopies), family history details (SCD/SUD, age), and prior non‑diagnostic testing where required.
For FH panel testing: provide at least two LDL‑C measurements (including after intensive lifestyle modification) and evaluation excluding secondary causes (e.g., hypothyroidism, nephrotic syndrome, medications).

Note

Preference for Phenotype‑Focused Testing

When phenotype supports testing, prefer phenotype‑focused panels (e.g., HCM, DCM, arrhythmia‑specific panels) rather than large unfocused panels. If a member meets criteria for both an arrhythmia and cardiomyopathy panel, the member is expected to meet criteria for the combined comprehensive panel to justify broader testing.

Phenotype‑focused panels are recommended by professional guidelines and are preferred for clinical and utilization reasons.
If clinical criteria are met for both individual panels, the member must meet combined-panel criteria for comprehensive panels (e.g., 81413, 81414, 81439).

Note

Sequential Gene Selection

Use a sequential, phenotype‑guided gene selection approach when appropriate: start with established, high‑evidence genes for the suspected condition and expand only if criteria remain unexplained. For restrictive cardiomyopathy consider HCM or DCM panels; for LQTS prioritize LQT1‑3 genes (KCNQ1, KCNH2, SCN5A) before broader genes with limited evidence.

For RCM: consider HCM or DCM panels first per ACMG recommendations; comprehensive RCM panels via 81439 are considered investigational.
For LQTS: prioritize testing KCNQ1, KCNH2, SCN5A (LQT1‑3) in patients with intermediate probability before testing genes with limited or disputed evidence.

Documentation Required

Provider Responsibility and Documentation

Providers are expected to exercise professional judgment, ensure documentation meets policy criteria, and recognize that coverage is subject to the member's benefit terms, exclusions, and limitations.

In some cases additional information may be requested to establish medical necessity.
Inclusion of codes in this policy does not guarantee coverage; verify member benefits and state Medicaid/Medicare rules as applicable.

Background and Rationale

Hereditary arrhythmias and cardiomyopathies encompass a range of genetic disorders that frequently present with variable expressivity and can be first recognized by clinical findings such as unexplained left ventricular hypertrophy, dilated cardiomyopathy, ventricular arrhythmias, or sudden cardiac arrest. Genetic testing can confirm a suspected diagnosis, enable targeted cascade testing of at‑risk relatives, and in some cases influence management or surveillance. Professional guidance favors phenotype‑directed genetic testing of the most clearly affected individual and multidisciplinary evaluation for survivors of unexplained sudden cardiac arrest or families with sudden unexplained death.

Definitions and Diagnostic Thresholds

Hereditary cardiac conditions definition

DefinitionHereditary cardiac conditions: cardiomyopathies and arrhythmias caused or influenced by germline genetic variants often involving multiple genes with variable expressivity

Clinical implicationsGenetic testing can identify pathogenic variants enabling cascade testing of asymptomatic relatives

Testing considerationsDecisions to test and result interpretation should involve an expert in cardiac genetics due to complexity and risk of misinterpretation

Congenital heart defects (CHD) — prevalence and definition

DefinitionCongenital heart defects (CHD): structural heart defects present at birth

PrevalenceAffect approximately 1–1.2% of live births

Genetic relevanceGenetic and environmental etiologies; genetic diagnosis can inform recurrence risk and extracardiac evaluation

Post-heart-transplant gene expression panels definition

DefinitionPost‑heart‑transplant gene expression panels: tests using gene expression (peripheral blood or allograft tissue) to assess rejection risk and guide management

Peripheral blood exampleAlloMap (peripheral blood GEP) used to identify low risk of acute cellular rejection between 2 months and 5 years post‑transplant

Tissue‑based exampleMolecular Microscope (MMDx) assesses rejection‑associated transcripts in allograft tissue though availability may be limited

Prolonged QTc definition

Prolonged QTc definitionQTc greater than 460 ms in prepubertal individuals or greater than 480 ms in adults (policy reference for prolonged QTc)

Clinical testing contextUsed to determine indications for LQTS genetic testing (asymptomatic and symptomatic patients)

Exclude secondary causesNon‑genetic causes of QT prolongation (drugs, electrolytes, structural disease) must be ruled out prior to testing

Unexplained LV hypertrophy (HCM threshold)

HCM threshold definitionUnexplained LV hypertrophy: myocardial wall thickness ≥15 mm in adults (z‑score ≥2 in children)

Clinical noteThickness 13–14 mm can be diagnostic in family members or with a positive genetic test per ACC/AHA guidance

Diagnostic methodsMeasured by echocardiogram or cardiac MRI (maximal end‑diastolic wall thickness)

Close relatives definition

DefinitionClose relatives include first‑, second‑, and third‑degree blood relatives (first‑degree: parents, siblings, children)

Second‑degree examplesGrandparents, aunts/uncles, nieces/nephews, grandchildren, half siblings

Third‑degree examplesGreat grandparents, great aunts/uncles, great grandchildren, first cousins

Phenocopy definition

DefinitionPhenocopy: a trait or disease resembling a genotype‑specific trait in an individual who is not a carrier of that genotype

Clinical implicationConsider phenocopies when interpreting genetic test results and when selecting gene panels (e.g., FH phenocopies)

Testing approachExpanded panels may evaluate for phenocopy conditions when clinically indicated

Sudden cardiac death (SCD) definition

DefinitionSudden cardiac death (SCD): death due to a cardiovascular cause occurring within one hour of symptom onset

Relation to policySCD in a relative can trigger genetic testing or autopsy‑based genetic evaluation in index cases or family members

DistinctionPolicy distinguishes SCD from reversible causes and emphasizes autopsy findings when available

Premature coronary artery disease (CAD) definition

DefinitionPremature coronary artery disease (CAD): male ≤55 years; female ≤65 years (adapted from AHA HeFH definition)

Use in FH criteriaPremature CAD in relatives is used as part of family history criteria to trigger FH genetic testing

Measurement contextApplies when correlating LDL‑C thresholds and family history for testing decisions

ARVC Task Force criteria (definition summary)

SummaryARVC Task Force criteria define 'possible ARVC' as one major OR two minor criteria from different categories (imaging, biopsy, ECG, arrhythmia, family history)

Major examplesImaging major examples: PLAX RVOT >32 mm, PSAX RVOT >36 mm, fractional area change <33%; MRI Rao RVEDV/BSA and RVEF thresholds also included

Minor examplesEcho minor ranges (PLAX 29–32 mm, PSAX 32–36 mm, FAC 33–40%), ECG and Holter minor findings, biopsy with higher residual myocytes

Schwartz score (LQTS) definition

PurposeSchwartz score: clinical point‑based system to stratify low, intermediate, and high probability of LQTS to guide molecular testing

Probability cutoffs≤1 point: low; 1.5–3.0: intermediate; ≥3.5: high probability (used to select patients for molecular screening)

Testing recommendationRecommend molecular testing for those with score ≥3.0–3.5 depending on referenced guidance

GEP (AlloMap / MMDx) definition

DefinitionGEP (AlloMap / MMDx): assessment of gene expression in peripheral blood (AlloMap) or allograft tissue (MMDx) to evaluate rejection risk after heart transplant

Peripheral blood vs tissueAlloMap used in peripheral blood (noninvasive); MMDx assesses tissue gene expression and may distinguish rejection subtypes but availability is limited

Guideline contextISHLT 2022 supports peripheral blood GEP in low‑risk adults between 2 months and 5 years post‑HT to reduce biopsy frequency

dd-cfDNA definition

DefinitionDonor‑derived cell‑free DNA (dd‑cfDNA): circulating donor DNA measured in recipient peripheral blood used to detect or rule out subclinical allograft rejection

Policy examplesProspera (0493U) and other proprietary assays (e.g., 0118U) referenced in policy as dd‑cfDNA tests

Society statementASCTS recommends dd‑cfDNA may be utilized to rule out subclinical rejection for heart transplant recipients

Sudden cardiac arrest / SUDS wording update

Wording updatePolicy language updated to use 'unexplained sudden cardiac arrest' and retitled SUDS definition to 'Sudden unexplained death (Sudden unexplained death syndrome, SUDS)'

Added definitionA definition for sudden cardiac arrest was added describing reversible event reversed by CPR/defibrillation/pacing

ContextUsed to clarify criteria for arrhythmia and sudden death-related testing indications