Cardiac Monitoring Devices in the Outpatient Setting
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Governs coverage of outpatient cardiac monitoring devices (hemodynamic monitors, implantable PA pressure sensors, intracardiac ischemia monitors, and related technologies) for Blue Cross Blue Shield North Carolina members and the providers who deliver them.
No material clinical or coverage changes in this revision.
Coverage Criteria and Policy Stance
General policy
Overall coverage stance and considerations
Policy statement
Implantable PA pressure sensor evidence
Evidence summary and uncertainty for implantable PA pressure sensors
Clinical evidence context
Pulmonary artery pressure monitoring — evidence summary
Summary of evidence-based coverage considerations and outcomes
Evidence insufficient to determine improvement in net health outcome (CardioMEMS and Cordella).
Thoracic bioimpedance monitoring
Inert gas rebreathing monitoring
Valsalva maneuver / LVEDP monitoring
Intracardiac ischemia monitoring
In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring using thoracic bioimpedance, inert gas rebreathing, arterial pressure/Valsalva-derived methods, implantable direct pulmonary artery pressure monitoring, and left atrial hemodynamic monitoring is considered investigational and therefore not covered.
Intracardiac ischemia monitoring systems, including the AngelMed® Guardian System, are considered investigational for all indications and are not covered. This includes use for detection of acute myocardial ischemic events or other applications.
Policy language was updated to explicitly state that the AngelMed® Guardian System is not covered: “Intracardiac ischemia monitoring (i.e., AngelMed® Guardian System) is considered investigational for all indications including, but not limited to, detection of acute myocardial ischemic events.” The entry documents the effective incorporation of this exclusion when the device received FDA approval.
Overall, cardiac monitoring devices in the outpatient setting are considered investigational for all applications. As investigational services, these technologies are not covered by BCBSNC.
Evidence is insufficient to support use of noninvasive modalities such as thoracic bioimpedance, inert gas rebreathing, and Valsalva-derived arterial pressure monitoring to improve net health outcomes. Studies are limited to uncontrolled series or are lacking entirely (inert gas rebreathing), and diagnostic performance data (e.g., Valsalva-derived LVEDP detection) do not establish clinical benefit; therefore these approaches remain investigational.
Coding and Device Listings
| BioZ | BioZ® Thoracic Impedance Plethysmograph, FDA Clearance = 2009 |
| Zoe | Zoe® Fluid Status Monitor, FDA Clearance = 2004 |
| Cheetah Starling SV | Cheetah Starling SV, FDA Clearance = 2008 |
| PhysioFlow SM-ICG | PhysioFlow® Signal Morphology-based Impedance Cardiography (SM-ICG™), FDA Clearance = 2008 |
| ReDS | ReDSTM Wearable System, FDA Clearance = 2015 |
| Bodyport Cardiac Scale | Bodyport Cardiac Scale, FDA Clearance = 2022 |
| Hemosphere Alta | Hemosphere Alta™ Advanced Monitoring Platform, FDA Clearance = 2023 |
| Sensinel CPM System | Sensinel Cardiopulmonary Management (CPM) System, FDA Clearance = 2024 |
| CardioMEMS | CardioMEMS™ Heart Failure Monitoring System — FDA PMA approved 2014; expanded approval 2022 |
| Cordella | Cordella™ PA Sensor System — FDA PMA approved 2024 |
| AngelMed Guardian | AngelMed Guardian® System — FDA PMA approved April 2018 |
Provider Actions, Verification, and Documentation
Verify benefits and prior authorization
Review the member's Benefit Booklet to confirm coverage and any prior authorization requirements before ordering or scheduling outpatient cardiac monitoring devices.
Applicable codes and medical necessity review
Inclusion of codes in the Billing/Coding section does not guarantee reimbursement; BCBSNC may require medical records to determine medical necessity for services billed with the listed codes.
Investigational status — coverage alert
Alert: Cardiac monitoring devices in the outpatient setting are considered investigational for all applications and are not covered by BCBSNC; submit requests with caution because claims may be denied on this basis.
Intracardiac ischemia monitoring — investigational
Alert: Intracardiac ischemia monitoring (e.g., AngelMed® Guardian System) is considered investigational for all indications, including detection of acute myocardial ischemic events; do not assume coverage.
Benefit verification — check member's Benefit Booklet
Review the member's specific benefit language in the Member's Benefit Booklet before applying this policy; benefits may vary by plan and determine whether services described are available to the member.
Documentation for medical necessity — include full clinical details
When BCBSNC requests medical records to determine medical necessity, include all specific clinical information required; letters of support alone are often useful but are not sufficient unless they contain all required details.
- Provide complete clinical records and documentation addressing the medical necessity criteria.
- Do not rely on letters of support alone unless they include all specific information needed for the determination.
Denial risk — investigational services
BCBSNC does not provide coverage for investigational services; claims for outpatient cardiac monitoring devices may be denied because the policy designates these services investigational for all applications.
Medical records may be requested — include required documentation
BCBSNC may request medical records to determine medical necessity; absence of required documentation may lead to denial of the claim or request.
Background and Rationale
Outpatient cardiac monitoring devices are intended to detect physiologic changes—hemodynamic or ischemic—that may allow earlier intervention to reduce hospitalizations and morbidity for conditions such as heart failure or acute coronary ischemia. Hemodynamic approaches covered by this policy include implantable pulmonary artery pressure sensors and noninvasive techniques (thoracic bioimpedance, inert gas rebreathing, Valsalva-derived measures); alternative diagnostic tools such as echocardiography and biomarkers are outside the scope of this policy.
Definitions and Device Descriptions
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