CurrentIndependent HealthPolicy M20200917101

Heart Failure Monitoring (Formerly Implantable Pulmonary Artery Monitoring Device for Heart Failure Monitoring - CardioMEMS)

Defines medical necessity and coverage stance for implantable pulmonary artery monitoring devices (e.g., CardioMEMS HF System) and the uCor wearable Heart Failure and Arrhythmia Management System across Independent Health lines of business.

Policy Summary

PayerIndependent Health

PolicyHeart Failure Monitoring (Formerly Implantable Pulmonary Artery Monitoring Device for Heart Failure Monitoring - CardioMEMS)

Policy CodePolicy M20200917101

Change TypeNo material clinical or coverage changes

Effective DateNov 1, 2020

Next Review Date

Key ActionObtain preauthorization for the uCor Heart Failure and Arrhythmia Management System when requested for Commercial, Self-Funded, or Medicare Advantage members.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

investigationalCardioMEMS investigational (Comm/Self-Funded)

not coveredState products do not cover devices

preauth requireduCor preauthorization

FDA-approved device notedCardioMEMS FDA-approved (background)

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Guideline uncertainty

Coverage Determinations

Coverage stance for implantable pulmonary artery monitoring and uCor

Coverage and medical necessity determinations by product line:

Commercial and Self-Funded - CardioMEMS: Implantable pulmonary artery monitoring (e.g., CardioMEMS HF system) for outpatient management of heart failure is considered investigational and has not been proven to be medically necessary.

Supports denial for medical necessity in these lines.

Commercial and Self-Funded - uCor: The uCor Heart Failure and Arrhythmia Management System has not been proven to be medically necessary and is considered investigational for Commercial and Self-Funded products.

Based upon lack of peer-reviewed literature.

Commercial and Medicare - uCor: The uCor Heart Failure and Arrhythmia Management System is considered investigational for Commercial and Medicare products.

May be denied as investigational in these lines.

State Products (MediSource, MediSource Connect, Essential Plan, Child Health Plus): MediSource, MediSource Connect, Essential Plan, and Child Health Plus do not cover implantable pulmonary artery monitoring (CardioMEMS) or the uCor Heart Failure and Arrhythmia Management System.

Explicit exclusion for State products; uCor is not a covered benefit for State products.

Coverage determinations vary by product line. For State products (MediSource, MediSource Connect, Essential Plan, Child Health Plus), uCor Heart Failure and Arrhythmia Management System is not a covered benefit and implantable pulmonary artery monitoring (e.g., CardioMEMS) is not covered. For Commercial and Self‑Funded lines the policy treats implantable pulmonary artery monitoring as investigational (see other blocks).

The policy finds that implantable pulmonary artery monitoring (e.g., CardioMEMS HF system) for outpatient heart failure management has not been proven to be medically necessary. Based on assessment of the peer‑reviewed literature, the technology is considered investigational for Commercial and Self‑Funded members and therefore may be denied as not medically necessary.

The uCor Heart Failure and Arrhythmia Management System is considered investigational for Commercial and Medicare products due to lack of peer‑reviewed evidence, and it is explicitly not a covered benefit for State products (MediSource, MediSource Connect, Essential Plan, Child Health Plus).

Coding and Billing References

Medicare HCPCS referenceHCPCS

HCPCS C-code (unspecified in document)

CMS provides coverage for an assigned HCPCS C code for this device (CardioMEMS) per Medicare guidance referenced.

Actions Required by Providers

Prior Authorization

Prior Authorization Required

Preauthorization is required for the uCor Heart Failure and Arrhythmia Management System for Commercial, Self‑Funded, and Medicare Advantage members. Obtain prior authorization before device placement or initiation of services for these member types to avoid claim denials.

Applies to Commercial, Self‑Funded, and Medicare Advantage

Note

Optimize Guideline‑Directed Medical Therapy First

The policy expects optimization of guideline‑directed medical therapy and standard heart failure management before considering device‑based monitoring such as implantable pulmonary artery monitors or wearable systems. Standard management includes appropriate use of diuretics, ACE inhibitors or ARBs, beta‑blockers, aldosterone antagonists, neprilysin inhibitors, device therapies (when indicated), and correction of reversible causes per heart failure guidelines.

Clinical Background and Evidence Summary

Heart failure diagnosis relies on clinical assessment supported by chest x‑ray, echocardiography, and plasma natriuretic peptide measurements, and management includes guideline‑directed medical therapy, diuretics, and device therapies. Implantable pulmonary artery monitors such as CardioMEMS are designed to measure pulmonary artery pressures remotely to guide medication adjustments and have shown reductions in heart failure hospitalizations in some trials; however, guideline authors and the policy note uncertainty about overall usefulness and definitive selection criteria. Wearable systems (for example, the uCor system) are intended to continuously record physiologic signals (ECG, thoracic fluid index, heart rate, respiration, activity) and transmit data for analysis, but peer‑reviewed evidence supporting clinical benefit for outpatient HF management is insufficient, which informs the investigational or non‑covered stances in this policy.

Device Definitions

CardioMEMS — device definition and key attributes

Regulatory statusFDA-approved implantable pulmonary artery monitoring device

Indicated patient population (documented)Patients with NYHA class III heart failure who have been hospitalized during the previous year

Physiologic measurementsSystolic, diastolic, and mean pulmonary artery pressures and heart rate

Intended clinical useGuide adjustment of heart failure medications via remote pressure monitoring to potentially reduce HF-related hospitalizations

Device components / operationImplanted PA sensor; external pillow antenna, bedside monitor connected by cable, and remote button; readings (~18 seconds) transmitted wirelessly to a secure database

Evidence / guideline noteGuidelines (ESC 2016; AHA/ACC/HFSA 2022) state usefulness/efficacy is less well established and patient selection criteria are not definitive

Policy Revision History

2025-08-01formatting updateLatest

Policy formatting revised (signature/approval on file noted); owner: Health Care Services.

2025-03-01review

Policy reviewed by Health Care Services.

2024-03-01revision

Policy Summary

PayerIndependent Health

PolicyHeart Failure Monitoring (Formerly Implantable Pulmonary Artery Monitoring Device for Heart Failure Monitoring - CardioMEMS)

Policy CodePolicy M20200917101

Change TypeNo material clinical or coverage changes

Effective DateNov 1, 2020

Next Review Date

Key ActionObtain preauthorization for the uCor Heart Failure and Arrhythmia Management System when requested for Commercial, Self-Funded, or Medicare Advantage members.

SourceLink

On This Page

Documentation Required

Device Definitions and Documentation

CardioMEMS (implantable pulmonary artery monitoring device) and uCor are defined as follows. Reference these definitions when submitting documentation and identify the specific device used.

CardioMEMS: An FDA‑approved implantable pulmonary artery monitoring device to measure systolic, diastolic, and mean pulmonary artery pressure and heart rate in patients with NYHA class III heart failure who were hospitalized in the previous year. Readings are transmitted wirelessly for clinician review to guide medication adjustments.
uCor Heart Failure and Arrhythmia Management System: A wearable sensor system that continuously records and transmits ECG, Thoracic Fluid Index, heart rate, respiration rate, activity, and posture. Data are sent to a gateway and analyzed; reports are provided to the prescribing physician.
When submitting requests or claims, specify whether the device is CardioMEMS (implantable PAP monitor) or uCor (wearable monitoring system).

Denial Risk

Investigational / Not Medically Necessary

Use of implantable pulmonary artery monitoring devices (e.g., CardioMEMS HF system) is considered investigational and not proven medically necessary for Commercial and Self‑Funded members. The uCor Heart Failure and Arrhythmia Management System is also considered investigational due to insufficient peer‑reviewed evidence.

Commercial and Self‑Funded: Implantable pulmonary artery monitoring (e.g., CardioMEMS) — investigational
Commercial and Self‑Funded: uCor Heart Failure and Arrhythmia Management System — investigational
State products: uCor is not a covered benefit
Commercial and Medicare products: uCor considered investigational

uCor Heart Failure and Arrhythmia Management System — device definition and key attributes

Device typeWearable sensor system (ZOLL µCor / uCor Heart Failure and Arrhythmia Management System)

Measured signalsContinuous acquisition of ECG (heart rhythm), Thoracic Fluid Index, heart rate, respiration rate, activity, and posture

Data transmission and reportingSensor transmits data to a Gateway, then to ZOLL for analysis by certified technicians who prepare reports for the prescribing physician

Patient interactionPatient-activated symptom trigger by double tapping the sensor when on the body

Coverage / authorization notePreauthorization required for uCor for Commercial, Self-Funded, and Medicare Advantage; uCor considered investigational for Commercial and Medicare and not covered for State products

Policy revised by Health Care Services.

2023-12-01revision

Policy revised by Health Care Services.

2023-04-01review

Policy reviewed by Health Care Services.

2022-05-01review

Policy reviewed by Health Care Services.

2021-05-01revision

Policy revised by Health Care Services.

2020-11-01effective date

Policy became effective: Heart Failure Monitoring (CardioMEMS/uCor).