CurrentAetnaPolicy 0704

Indirect Measurement of Left Ventricular Filling Pressure (LVFP)

Defines Aetna's coverage stance for indirect, noninvasive measurement methods of LV filling pressure (e.g., VeriCor) and AI echocardiography tools (EchoGo) for evaluation/management of heart failure and related indications for Aetna members/providers.

Policy Summary

PayerAetna

PolicyIndirect Measurement of Left Ventricular Filling Pressure (LVFP)

Policy CodePolicy 0704

Change TypeNo material change

Effective DateMay 3, 2005

Next Review DateJul 25, 2024

Key ActionDo not bill or expect coverage for EchoGo Heart Failure post-processing (HCPCS C9786) for the listed indications; such claims may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2interventions listed as experimental/investigational

1FDA-cleared device example

84%VeriCor within 4 mm Hg (initial study)

50patients in small randomized trial

2005original effective date

Coverage Criteria

Experimental and Investigational

Aetna considers the following interventions experimental and investigational because effectiveness has not been established:

Experimental/Investigational - VeriCor: Indirect measurement of left ventricular filling pressure by computerized calibration of arterial waveform response to the Valsalva maneuver (e.g., the VeriCor System) is considered experimental and investigational due to insufficient evidence of clinical value in the diagnosis and management of congestive heart failure or other indications.

VeriCor has limited supporting data (accuracy study and small randomized trial) and overall clinical utility remains unproven per ACC/AHA guidance.

Experimental/Investigational - EchoGo Heart Failure: EchoGo Heart Failure for detection of heart failure with preserved ejection fraction (HFpEF), and all other indications, is considered experimental and investigational because effectiveness has not been established.

AI-based post-processing shows potential for detection of HFpEF but lacks sufficient outcome data to establish clinical benefit.

Aetna considers the use of the AI echocardiography post‑processing platform EchoGo Heart Failure (HCPCS C9786) to be experimental and investigational because effectiveness has not been established for detection of HFpEF or other indications. EchoGo Heart Failure is identified in the policy as a not‑covered post‑processing service for the indications listed.

Policy Summary

PayerAetna

PolicyIndirect Measurement of Left Ventricular Filling Pressure (LVFP)

Policy CodePolicy 0704

Change TypeNo material change

Effective DateMay 3, 2005

Next Review DateJul 25, 2024

Key ActionDo not bill or expect coverage for EchoGo Heart Failure post-processing (HCPCS C9786) for the listed indications; such claims may be denied.

SourceLink

On This Page

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Provider Actions and Requirements

Denial Risk

Billing and Coverage — Not Covered Codes

Claims for HCPCS C9786 (EchoGo Heart Failure — echocardiography image post processing for computer aided detection of heart failure with preserved ejection fraction, including interpretation and report) and related ICD-10 heart failure diagnosis codes (I50.1–I50.9) are identified as not covered for the indications listed in this Clinical Policy Bulletin. Providers should expect claim denials when these codes are submitted for the excluded indications.

HCPCS: C9786 — Echocardiography image post processing for computer aided detection of heart failure with preserved ejection fraction (EchoGo Heart Failure)
ICD-10: I50.1–I50.9 — Heart failure codes (not covered for indications listed in this CPB)

Note

Clinical Role — Uncertain Utility of Noninvasive Hemodynamic Measurements

Noninvasive hemodynamic measurements (including systems that estimate left ventricular filling pressure such as EchoGo or computerized calibration of arterial waveform response to the Valsalva maneuver) currently have an uncertain role compared with routine clinical assessment. The policy notes that available evidence does not establish clinical utility for these indirect measurements for the diagnosis or management of heart failure; published clinical outcome data and randomized studies demonstrating impact on management and outcomes are required before adoption.

Noninvasive estimates of LVFP have not been shown to be more valuable than routine clinical tests, including physical exam
Evidence is inadequate to support routine use for guiding therapy or predicting deterioration

Prior Authorization

Prior Authorization / Coverage Review

Prior authorization or coverage review may be required for novel post-processing services such as EchoGo (HCPCS C9786). Services billed with HCPCS C9786 have been identified as not covered for the indications listed in this bulletin; when review is available, prior authorization decisions will reference this Clinical Policy Bulletin.

Prior authorization/coverage review may be used to confirm indications and medical necessity
Aetna’s Clinical Policy Bulletin will be used to assist in administering plan benefits but does not guarantee coverage

Documentation Required

Provider Responsibility and Documentation

Providers are responsible for medical advice, treatment decisions, and documentation in the member’s medical record. The Clinical Policy Bulletin is provided to assist in administering plan benefits and is not a substitute for clinical judgment. Inclusion in this bulletin does not guarantee coverage; providers should follow plan provisions and submit complete documentation when requesting prior authorization or appealing denials.

Treating providers are solely responsible for medical advice and treatment
Clinical Policy Bulletins assist in administering benefits and do not constitute guarantees of coverage

Note

Evidence Requirements for Adoption

Aetna requires adequate clinical trial evidence and published outcome data (for example, randomized controlled trials and studies demonstrating correlation with catheter-measured LVEDP and impact on patient outcomes) before adopting noninvasive LVFP estimation technologies into covered practice. Until such evidence is available, these interventions are considered experimental and investigational.

Requirement for randomized studies or robust clinical outcome data demonstrating benefit
Correlation with invasive catheter LVEDP and demonstration of improved clinical outcomes required for adoption

Definitions

VeriCor System — key facts

Device nameVeriCor System (CVP Diagnostics)

FunctionEstimates left ventricular filling pressure (LVFP) by computerized analysis of arterial waveform response to the Valsalva maneuver using a proprietary algorithm.

Regulatory statusCleared by the U.S. Food and Drug Administration via 510(k) premarket notification.

Reported accuracyIn a study (Sharma et al., 2002), VeriCor measurements correlated with catheter-measured LVEDP (r = 0.86) and were within 4 mm Hg of direct LVEDP 84% of the time and within 6 mm Hg 93% of the time.

Intended clinical useNoninvasive estimation of LVEDP to aid assessment/management of patients with congestive heart failure, as an alternative to invasive catheter-based measurements for research/diagnostic consideration.

EchoGo Heart Failure — key facts

Product nameEchoGo Heart Failure

TechnologyAI-based echocardiography post-processing platform that detects heart failure with preserved ejection fraction (HFpEF) from echocardiogram images.

CapabilitiesAutomated quantification from echocardiogram images (examples noted include detection of HFpEF and automated measurements such as LVEF and GLS).

Coverage/Coding notePost-processing services using EchoGo Heart Failure are identified in policy coding as HCPCS C9786 and are listed as not covered for the indications in this bulletin.

OpenPayer

Indirect Measurement of Left Ventricular Filling Pressure (LVFP)

Coverage Criteria

Coding

Provider Actions and Requirements

Background

Definitions