Signal-Averaged Electrocardiography (SAECG) and Artificial Intelligence Algorithmic Electrocardiogram for Cardiovascular-Related Diseases
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Defines Aetna's coverage stance for SAECG and assistive/artificial intelligence algorithmic electrocardiogram analyses for detection and risk stratification of cardiovascular-related diseases; affects providers submitting claims to Aetna for these tests.
No material clinical or coverage changes in this revision.
Coverage Determinations
Experimental and Investigational — Not Covered
Aetna considers the following procedures experimental and investigational because effectiveness has not been established:
Exact wording from policy.
Evidence-based coverage considerations
Evidence-based stance and applicability summary from document excerpts
Suggests not supported as a replacement for angiography or standard diagnostic pathways.
Findings are hypothesis-generating; prospective validation required.
Dataset quality and external validation are concerns; insufficient evidence to support routine clinical use for detection of cardiac dysfunction.
CPT codes 0764T, 0765T, and 93278 are listed in this Clinical Policy Bulletin as not covered for the indications addressed. These codes correspond to assistive algorithmic electrocardiogram risk-based assessments (0764T, 0765T) and signal-averaged electrocardiography (SAECG) (93278). Providers should bill using standard ECG CPT codes (for example, 93000–93010) when appropriate and verify coverage before submitting claims that include the not-covered codes to avoid denial.
Computer-enhanced analyses marketed as Multifunction Cardiogram (MCG / 3DMP) are not supported as replacements for angiography or as primary diagnostic tests for coronary artery disease. Published evaluations found missed significant lesions and false positives, and prospective studies to validate clinical utility are lacking. In particular, analyses from MED-FIT reported poor diagnostic performance with low area under the curve (AUC 0.51–0.58) and low sensitivity/specificity using the reported severity cut-off, indicating the test is insufficiently accurate to select patients for definitive testing such as angiography.
Systematic reviews of AI-enabled ECG approaches to detect left ventricular systolic dysfunction (LVSD) report promising diagnostic accuracy (for example, median AUC ~0.90), but importantly no studies have examined the effect of these tests on treatment decisions or patient outcomes. Prospective, randomized trials are needed to demonstrate clinical impact, cost-effectiveness, and whether use of these algorithms improves management or outcomes before routine coverage can be recommended.
Signal-averaged electrocardiography (SAECG) is considered experimental and investigational in this bulletin because no prospective clinical studies have demonstrated that SAECG improves clinical outcomes. As a result, SAECG is not supported as medically necessary for the indications addressed in this policy.
Routine use of Multifunction Cardiogram (MCG/3DMP) or assistive AI-algorithmic ECG for detection of coronary artery disease or cardiac dysfunction is not supported by sufficient evidence of clinical utility. Existing studies have methodological limitations, variable performance, and lack prospective outcome data; therefore these technologies should not replace established diagnostic pathways outside of research or validated clinical programs.
Coding and Billing References
| 0764T | Assistive algorithmic electrocardiogram risk-based assessment for cardiac dysfunction (eg, low-ejection fraction, pulmonary hypertension, hypertrophic cardiomyopathy); related to concurrently performed electrocardiogram (List separately in addition to code for primary procedure). |
| 0765T | Assistive algorithmic electrocardiogram risk-based assessment related to previously performed electrocardiogram. |
| 93278 | Signal-averaged electrocardiography (SAECG) with or without ECG. |
| I05.0-I52 | Chronic rheumatic heart disease, hypertensive disease, ischemic heart disease, diseases of pulmonary circulation, and other forms of heart disease (ICD-10 range referenced). |
| Category III CPT codes | New Category III CPT codes for novel assistive AI algorithmic ECG risk assessment (AMA announcement) |
Provider Billing, Documentation, and Authorization Actions
Coverage / prior-authorization coding guidance: not-covered codes vs standard ECG codes
CPT codes 0764T, 0765T, and 93278 are identified in this Clinical Policy Bulletin as not covered for the indications listed; when appropriate, use standard ECG CPT codes 93000–93010 and verify coverage/prior authorization requirements with Aetna before submitting claims.
Prior authorization may apply to Category III AI-algorithmic ECG codes
The policy notes that novel assistive AI algorithmic ECG procedures have recently been assigned Category III CPT codes by the AMA; prior authorization or payer review may be required for these investigational/limited-use technologies.
- AMA issued new Category III CPT codes for assistive AI algorithmic ECG risk assessment (announcement dated July 7, 2022).
- Insufficient evidence of clinical utility is stated in the policy, and payer prior authorization may apply.
Policy dates and administrative links — verify operational requirements with Aetna
Policy effective and review dates and links to Aetna resources are provided in the policy history; the document does not enumerate specific procedural prior authorization rules in these sections—providers should consult Aetna resources for administrative requirements.
- Effective: 05/02/2003; Last review: 03/16/2023; Next review: 07/12/2024.
- Links provided for Review History and Definitions for additional operational details.
Provider action: confirm coverage before ordering or billing investigational ECG tests
Highlight: Follow the policy's not-covered determinations and verification steps before ordering or billing experimental ECG-based tests to avoid denials.
- Signal-averaged ECG and certain assistive AI/MCG procedures are considered experimental/investigational.
- Confirm coverage and prior authorization requirements with Aetna before testing or billing.
Use standard diagnostic pathways for suspected CAD before relying on ECG-based signal analysis
When evaluating suspected coronary artery disease (CAD), follow standard diagnostic pathways—clinical assessment, conventional ECG, stress testing, and angiography as indicated—before relying on ECG-based signal analysis devices as substitutes.
- 3DMP/MCG performance is variable and prospective studies are needed; it should not replace angiography.
- Follow established diagnostic evaluation (history/physical, standard 12‑lead ECG, appropriate stress testing, and invasive angiography when indicated).
Administrative action: verify payer-specific prior authorization and documentation rules
Administrative note placeholder: verify any payer-specific prior authorization, coverage, or documentation procedures with Aetna prior to ordering investigational ECG-based services.
- Policy history and links are provided; do not assume absence of other administrative requirements.
- Contact Aetna for operational/prior authorization specifics.
Documentation and coding: use standard ECG CPT codes 93000–93010; avoid experimental codes for covered indications
When billing ECG-related services, use standard ECG CPT codes 93000–93010 where appropriate; claims billed with the listed experimental/investigational codes may be processed as not covered under this bulletin.
Documentation: record SAECG-derived metrics and comparator clinical variables
If SAECG metrics are used for risk stratification, document the specific SAECG-derived values (for example, LSDf percentage) and comparator clinical variables such as LVEF, QRS duration, presenting symptoms, and any device therapy.
- Record the exact LSDf value and the 13.25% threshold if used in analysis.
- Include comparator data: LVEF, 12‑lead QRS duration, symptoms, and device therapy status.
Documentation: record P wave SAECG measures and rhythm monitoring strategy for ESUS evaluations
For stroke/ESUS evaluations using P wave SAECG, document measured P wave SAECG values (including P wave duration) and the rhythm monitoring strategy employed (Holter/ECG schedule) used to detect subclinical atrial fibrillation.
- Document P wave duration and note if PWD ≥ 135 ms was observed.
- Document rhythm monitoring plan and follow-up interval (Holter/ECG schedule or other monitoring).
Policy review and effective dates — consult linked resources for definitions and history
Policy history and review dates are listed in the Policy History section; consult the linked Definitions and Review History for additional operational and definitional details.
- Effective date: 05/02/2003; Last review: 03/16/2023; Next review: 07/12/2024.
- Links available for Review History and Definitions for further reference.
Denial risk: claims with CPT 0764T, 0765T, or 93278 for listed indications may be denied
Claims submitted with CPT codes 0764T, 0765T, or 93278 for indications listed in this Clinical Policy Bulletin are identified as not covered and may be denied.
- Do not submit these CPT codes for the listed indications without prior verification of coverage.
- Denials may occur if investigational/not-covered CPT codes are billed for these indications.
Risk: devices/tests with poor or unproven accuracy (eg, 3DMP/MCG) may cause missed diagnoses or false positives
Devices or tests with poor or unproven diagnostic accuracy (for example, 3DMP/MCG with missed significant lesions and false positives) may lead to missed diagnoses or false positives and could result in denial when used to replace definitive testing such as angiography.
- 3DMP missed some significant angiographic lesions and produced false positives in studies.
- Do not use such devices as a substitute for angiography or established diagnostic pathways without validated evidence.
Risk: MCG or assistive AI‑algorithmic ECG lacks sufficient evidence and may lead to noncoverage
Use of multifunction cardiogram (MCG) or assistive AI-algorithmic ECG for detection of cardiac dysfunction lacks sufficient evidence of clinical utility according to the policy; reliance on these modalities for diagnostic decision-making may lead to noncoverage or denial.
- Policy considers MCG/3DMP and assistive AI algorithmic ECG investigational due to insufficient evidence of clinical value.
- Claims relying on these technologies for diagnosis or management decisions may be denied.
Administrative note: confirm other payer-specific prior-authorization requirements despite policy silence
Policy history and review dates are provided; absence of an explicit prior-authorization requirement within this policy document does not eliminate other administrative or payer-specific prior authorization obligations—confirm with Aetna.
- The policy lists effective and review dates and provides links for definitions and review history.
- Providers should verify whether separate Aetna prior authorization requirements apply.
Background and Scope
Signal-averaged electrocardiography (SAECG) is a computerized analysis of ECG segments designed to detect ventricular late potentials, which have been associated with an increased risk of ventricular tachyarrhythmias and sudden cardiac death. The technique evaluates low-amplitude, high-frequency components of the QRS to identify late potentials, but evidence shows limited prospective validation and uncertain impact on clinical management, supporting the policy’s investigational stance.
Definitions and Key Terms
Policy Revision History
Scheduled next clinical policy review date.
Policy last reviewed on this date; content and evidence were evaluated.
Policy originally became effective.
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