| Medical Policy |
| Subject: Non-invasive Heart Failure and Arrhythmia Management and Monitoring Systems | |
| Document #: MED.00134 | Publish Date: 10/01/2025 |
| Status: Reviewed | Last Review Date: 08/07/2025 |
| Description/Scope |
This document addresses the use of non-invasive heart failure (HF) and arrhythmia management and monitoring systems as an early indicator for HF decompensation and arrhythmia detection. Examples of non-invasive HF and arrhythmia management and monitoring systems include the following:
Note: Please see the following related document for additional information:
| Position Statement |
Investigational and Not Medically Necessary:
The use of non-invasive heart failure and arrhythmia management and monitoring systems are considered investigational and not medically necessary for all indications.
| Rationale |
Summary:
A range of noninvasive, wearable, and remote monitoring technologies have received FDA 510(k) clearance for the management of individuals with HF and related fluid management disorders, including the AVIVO® Mobile Patient Management System, ZOE® Fluid Status Monitor, µ-Cor™ Heart Failure and Arrhythmia Management System (HFAMS), VitalConnect Platform with VitalPatch®, and the Bodyport™ Cardiac Scale. These systems utilize various biosensors and transmission methods to monitor physiological parameters such as electrocardiogram (ECG), heart rate (HR), respiratory rate (RR), posture, activity, thoracic fluid levels, body weight, impedance, and derived composite indices of cardiac function. While early validation studies, some unpublished or limited in scope, support technical feasibility and signal correlation with established reference standards (for example, Fick method), there remains insufficient evidence to determine the clinical utility or impact of these devices on management or net health outcomes in HF populations. Most studies to date are constrained by small sample sizes, lack of randomization, short follow-up durations, and absence of clinically meaningful endpoints. No current major cardiology guidelines endorse the routine use of these technologies. Robust, adequately powered trials are needed to evaluate whether these digital tools can improve outcomes compared to standard heart failure care.
Discussion:
AVIVO® Mobile Patient Management System
On January 4, 2012, the U.S. Food and Drug Administration (FDA) granted Medtronic Inc. (Mounds View, MN) FDA clearance through the 510(K) approval process for the AVIVO® Mobile Patient Management System. The AVIVO System is a wearable, wireless, arrhythmia detection system that is used to identify suspected cardiac arrhythmias and monitor physiologic signals. AVIVO is used in combination with interpretation services provided by the Corventis Monitoring Center, as well as online review of data by prescribing physicians. AVIVO purportedly enables arrhythmia detection and physiological data monitoring for up to 7 days. AVIVO monitors, derives, and displays, ECG, HR (including HR variability), activity, posture, RR (including RR variability), and body fluid status.
The AVIVO system components include:
The AVIVO system is indicated for individuals:
At this time, there is insufficient evidence available to assess how the AVIVO device impacts management or affects net health outcomes in individuals with HF. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.
ZOE Fluid Status Monitor
On November 13, 2012, the FDA granted Noninvasive Medical Technologies, Inc. (NMT) (Las Vegas, NV), FDA clearance through the 510(K) approval process for the ZOE Fluid Status Monitor. Subsequently on January 22, 2014, the FDA approved the ZOE3 model as substantially equivalent to the predicate device. The ZOE3 is a non-invasive, battery powered impedance monitor designed as an early warning monitor for detecting changes in the fluid status of individuals with fluid management problems. The ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance.
The ZOE3 is intended for use under the direction of a physician, for the non-invasive monitoring and management of individuals with fluid management problems including:
At this time, there is insufficient evidence available to assess how the ZOE3 device impacts management or affects net health outcomes in individuals with HF. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.
µ-Cor™ Heart Failure and Arrhythmia Management System (HFAMS)
On June 10, 2019, the FDA granted ZOLL® Medical Corporation (Pittsburg, PA), FDA clearance through the 510(K) approval process for the µ-Cor™ HFAMS. µ-Cor HFAMS is a patch-based sensor that can be worn continuously up to 30 days; the wireless system uses radiofrequency technology to monitor pulmonary fluid levels which is an early indicator for HF decompensation.
The µ-Cor HFAMS is intended to periodically record, store, and transmit a “Thoracic Fluid Index.” It also continuously records, stores, and periodically transmits ECG, HR, RR, activity, and posture, The data provided can aid medical professionals in diagnosing and identifying various clinical conditions, events, and/or trends.
The µ-Cor HFAMS is intended for use in clinical and home settings and is indicated for individuals who are 21 years of age or older:
The FDA clearance was based on an evaluation of data collected from the unpublished Measuring Thoracic Impedance in Hemodialysis Patients with the µ-Cor Monitoring System (MaTcH; NCT03072732) study, a prospective, non-significant risk, randomized, 2-arm premarket validation trial. The study enrolled 20 hemodialysis participants wearing the µCor 3.0 HFAMS; all participants also had the ZOE Fluid Status Monitor applied. During dialysis sessions, readings from both devices were recorded simultaneously. The results were summarized as follows: “the µ-Cor 3.0 mean correlation 0.95; ZOE mean correlation 0.211; µ-Cor 3.0 95% confidence interval (CI), [0.92, 0.99].”
The Vital Signs Validation Study of the µ-Cor System (ViVUS, NCT02975050) was another prospective, non-significant risk, non-randomized, premarket study used to validate the capability of the µ-Cor 3.0 HFAMS to monitor ECG, HR, RR, posture, and activity. This study enrolled 15 healthy volunteers performing activities of breathing, walking and resting. During these activities, the participants RR, ECG, HR, activity, and posture were collected for comparison. The study found that:
Test results confirm that the µ-Cor Heart Failure and Arrhythmia Management System is at least as safe and effective as the predicate devices; therefore, the µ-Cor Heart Failure and Arrhythmia Management System is substantially equivalent to its predicate devices. (Product Label Information, 2019).
Boehmer (2024) conducted a multicenter, multinational, prospective, concurrent-control clinical trial evaluating the impact of using a wearable heart failure monitoring system (µ-Cor HFAMS) on post-discharge outcomes in individuals recently hospitalized for HF. The trial included two parallel arms: BMAD-HF (control; NCT03476187), where device data were blinded to both investigators and participants, and BMAD-TX (intervention; NCT04096040), where device data were accessible to investigators via a secure portal and could be used to guide HF management decisions. A total of 522 participants were enrolled across 93 sites, with 245 in the control arm and 249 in the intervention arm included in the intention-to-treat analysis. Over the 90-day follow-up period, 276 hospitalizations occurred among 189 participants, with 108 HF-related events in 82 individuals. Participants who managed using µ-Cor HFAMS data in the BMAD-TX arm experienced a 38% reduction in HF-related hospitalizations compared to the control group (hazard ratio [HR], 0.62; p=0.03). While the results suggest a potential clinical benefit of the µ-Cor HFAMS in reducing HF rehospitalizations, the lack of randomization may have increased the likelihood of bias by allowing unbalanced populations in the two arms based on differences in baseline characteristics. Additionally, because the study arms were created by site, variations in site practice may influence the outcome of the trial. These methodological limitations necessitate cautious interpretation of results and underscore the need for randomized controlled trials to confirm the utility of µ-Cor HFAMS in routine HF management.
An additional clinical trial for the µ-Cor™ HFAMS is ongoing (NCT04512703).
The current evidence base is insufficient to support µ-Cor™ HFAMS as an early indicator for HF decompensation and arrhythmia detection. Current completed studies are based on data intended to validate the capabilities of the system. However, no published evidence is available to assess how the device changes management or affects net health outcomes in the individuals with cardiac disease, as intended by FDA 510(k) clearance indications. Adequately designed studies of sufficient duration, enrolling participants with established cardiac diseases are needed to confirm longer-term effects of HFAMS on whether health outcomes are significantly improved relative to standard of care for HF management.
VitalConnect Platform/VitalPatch®
On February 6, 2020, the FDA granted 510K clearance to the VitalConnect Platform (Vital Connect Inc., San Jose, CA), a wireless remote monitoring system used by healthcare professionals for continuous collection of physiological data in home and healthcare settings. The device is indicated for use on individuals who are 18 years of age or older as an aid to diagnose and plan treatment. Data is measured via the VitalPatch® RTM biosensor, a battery-operated adhesive patch with integrated sensors and a wireless transceiver that measures vital signs, including HR, ECG, HR variability, RR, RR interval, body temperature, skin temperature, step count, and posture. The VitalPatch provides arrhythmia detection and event notification. Using a cloud-based algorithm it continuously analyzes ECG stream; a technicians confirms the results and provides notifications as needed. The patch was cleared by the FDA in 2019 (K190916).
The published literature demonstrating the efficacy of VitalPatch is limited. Clinical trial NCT03507439-REALIsM-HF Pilot Study (REALIsM-HF) was a non-randomized, multicenter, 12 week observational, prospective study in 3 countries from 2018-2021 with 29 participants. The study measured daily physical activity in participants aged ≥ 45 years with an established diagnosis of HF with NYHA class II-IV symptoms who were hospitalized due to worsening symptoms in the past 72 hours for the initiation of therapy. The AVIVO MPM patch or VitalPatch, and DynaPort MoveMonitor were used to collect data. HF with preserved ejection fraction was defined as EF ≥ 45% or reduced EF defined as EF ≤ 35%. However, due to non-compatibility of systems the data could not be derived from the VitalPatch biosensor at the time of report and no evaluation was possible. Additionally, activity data of the AVIVO patch as well as of the VitalPatch biosensor were not found to be scientifically evaluable.
At this time, there is insufficient evidence available to assess how the VitalPatch sensor impacts management or affects net health outcomes in individuals with HF. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.
Bodyport™ Cardiac Scale
On July 29, 2022, the FDA granted 510(k) clearance to the Bodyport™ Cardiac Scale (Bodyport Inc., San Francisco, CA), which is a battery powered non-invasive cardiovascular monitor and “smart” scale. This prescription device is intended for use in the home or clinic setting under the direction of a physician for the non-invasive monitoring and management of individuals with fluid management-related health conditions, including HF. The Bodyport is reported to measure and track body weight, peripheral impedance, pulse rate, and center of pressure in people over 21 years of age who are able to stand on the device platform and weigh less than 180 kg (397 lbs.). The device provides a ‘Bodyport Fluid Index’ a measure of biomarkers that is purported to augment weight and symptom tracking with longitudinal data regarding an individual’s heart function and fluid status. Lower body peripheral impedance, pulse rate, and center of pressure are measured through the feet of the user when standing on a platform with bare feet. The data is displayed on the device screen and then automatically transmitted to the Bodyport cloud app where it can be accessed through a supported web-based browser, dashboard, or application programming interface (API).
The published literature demonstrating the efficacy of Bodyport is limited. Yazdi (2021) assessed the accuracy of the scale’s ability to capture ballistocardiography, electrocardiography, and impedance plethysmography signals in individuals’ feet while standing on the scale platform; the data was used to measure stroke volume and cardiac output compared with the gold-standard direct Fick method. Thirty-two (n=32) individuals with unexplained dyspnea undergoing an invasive cardiopulmonary exercise test were analyzed. The results demonstrated that the Bodyport scale data obtained, and the direct Fick measurements of stroke volume and cardiac output before and immediately after invasive cardiopulmonary exercise tests, correlated with r=0.81 and r=0.85 respectively (p<0.001 each). The mean error of the scale-estimated stroke volume was −1.58 mL, the mean error for the scale-estimated cardiac output was −0.31 L/min, both had a 95% limit of agreement. The changes in stroke volume and cardiac output before and after exercise were 78.9% and 96.7% concordant, respectively. This study did not provide any data addressing the clinical utility of the device, including any potential health outcomes benefit for its use.
A randomized trial by Victoria-Castro (2022) assessed the impact of digital health technologies on the Kansas City Cardiology Questionnaire (KCCQ) quality of life rating in 200 individuals with HF. The trial compared usual care for HF to three digital technologies designed to promote self-management. Bodyport was one of the three digital interventions used to provide this data. However, the results provided by the authors were not stratified by intervention type. Thus, the individual contributions or impact of the Bodyport scale on the outcomes is unclear from this data. Additionally, the authors acknowledged that due to the exclusion of individuals over 80 years old, the study may be intrinsically biased towards individuals with more digital literacy.
Fudim (2023) completed a prospective, multicenter study (n=300) that evaluated the accuracy of the Bodyport cardiac scale in predicting 50 worsening HF events through its composite heart function index score. The index is a composite measure including hemodynamic factors including weight, peripheral impedance, pulse rate and variability, and estimates of stroke volume, cardiac output, and blood pressure. The accuracy of the index in predicting worsening HF events was compared with simple weight-based algorithms (for example, weight increase of 3 lbs. in 1 day or 5 lbs. in 7 days). The authors concluded that the device is able to assess biomarkers related to cardiac congestion and perfusion, and showed a high correlation with the Fick method for measuring cardiac output (r=0.85, p<0.001), and stroke volume (r=0.81, p<0.001), and that future studies are needed to determine the ability of the index to improve clinical outcomes.
Victoria-Castro (2024) conducted an open-label, four-arm, parallel-group, randomized controlled trial (n=182) that evaluated the effectiveness of three digital health technologies (Bodyport Cardiac Scale, Conversa, and Noom), compared to usual care for improving health-related quality of life (QoL) in individuals with HF. Participants were randomized to receive one of the interventions or continue with standard care. The Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (OSS) was the primary outcome measured at 90 days. Among the 151 participants (83%) who completed the follow-up survey, none of the digital interventions demonstrated a statistically significant improvement in KCCQ OSS or self-efficacy compared to usual care. Median changes in KCCQ OSS were minimal across groups: Bodyport (+2.1), Conversa (+2.1), Noom (+3.4), and usual care (+0.3), with overlapping interquartile ranges that indicated no meaningful clinical effect. The study demonstrated potential improvements in KCCQ Total Symptom Score (TSS) and Clinical Summary Score (CSS) for the Noom group, however, the trial did not support a significant benefit of any individual technology in enhancing overall QoL or self-management. The authors concluded that digital tools hold promise as adjuncts to long-term HF care, however, larger adequately powered trials are needed to assess their clinical utility and define their role in HF management.
SCALE-HF1 was a multicenter, prospective, observational study designed to evaluate the predictive performance of a congestion index derived from the Bodyport device for identifying HF events (n=329). Participants conducted daily home monitoring by standing barefoot on the scale for approximately 20 seconds, the device collected hemodynamic data to determine a “congestion index”, that was applied retrospectively using a predefined threshold to trigger alerts. HF events were defined as unplanned IV diuretic administration or HF related hospitalizations. The study showed that over 238 participant-years of follow-up, 69 usable HF events were recorded. The congestion index correctly predicted 48 of 69 HF events (70%), yielding a sensitivity of 70% at an alert rate of 2.58 alerts per participant-year. In comparison, the traditional weight-based rule (for example, > 3 lb. gain in 1 day or > 5 lb. in 7 days) identified only 24 of 69 events (35%) with a higher alert rate of 4.18 alerts per participant-year. The congestion index demonstrated significantly greater sensitivity (p<0.01) and a lower alert burden than weight-based monitoring. The authors concluded that this demonstrates superior sensitivity for early detection of decompensation in individuals with HF, however, further validation in prospective, interventional trials are needed to establish Bodyport’s role in guiding clinical decision-making (Fudim, 2025).
An additional clinical trial (NCT04975633) for the Bodyport device is ongoing.
At this time, there is insufficient evidence available to assess how the Bodyport device impacts management or affects net health outcomes in individuals with HF, as intended by FDA 510(k) clearance indications. Future studies are needed to determine the ability of the device to improve clinical outcomes in individuals with fluid management-related health conditions, including HF.
Recommendations and Guidelines
The 2022 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) guideline for the management of heart failure does not address the use of non-invasive wireless technology to monitor pulmonary fluid levels as an early indicator for HF decompensation or arrhythmia detection (Heidenreich, 2022).
| Background/Overview |
According to the U.S. Centers for Disease Control and Prevention (CDC), nearly 6.7 million Americans are currently diagnosed with HF. In 2022, HF was mentioned on 457,212 death certificates (and responsible for 13.9% of all causes of death) (CDC, 2024). Approximately 50% of individuals with HF die within 5 years of diagnosis. As a result of HF, the weakened heart muscle causes inadequate filling of the left ventricle, as well as a backflow of blood into the left atrium, both resulting in decreased cardiac output and increased symptoms for the afflicted individual. Symptoms can include shortness of breath during daily activities, fatigue, weight gain and swelling in the ankles, feet, legs, abdomen and veins in the neck, and trouble breathing when laying down. Currently there is no cure for HF; medical therapy includes a combination of diuretics, digoxin, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), beta-blockers, and aldosterone antagonists. Some individuals may remain symptomatic despite medical therapy. Ongoing studies evaluate other treatment options to assist physicians in the management of individuals with severe HF.
Arrhythmias are deviations from the normal cadence of the heartbeat, which cause the heart to pump improperly. More than four million Americans have arrhythmias, most of which pose no significant health threat. As people age, the probability of experiencing an arrhythmia increases. In the United States, arrhythmias are the primary cause of sudden cardiac death, accounting for more than 350,000 deaths each year. The standard initial measure for a diagnosis of arrhythmias involves the use of electrocardiogram (EKG) testing, which allows evaluation of the electrical function of the heart.
| Definitions |
510k Clearance: The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976). The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. The FDA does not “approve” 510(k) submissions. It “clears” them.
Arrhythmia: Abnormal heart rhythms which may be classified as either atrial or ventricular, depending on the origin in the heart. Individuals with arrhythmias may experience a wide variety of symptoms ranging from palpitations to fainting.
Guideline-directed medical therapy (GDMT): The term replaces and is synonymous with “Optimal medical therapy.”
Heart failure: A condition in which the heart no longer adequately functions as a pump. As blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the lungs and other organs.
New York Heart Association (NYHA) Definitions: The NYHA classification of HF is a 4-tier system that categorizes subjects based on subjective impression of the degree of functional compromise; the four NYHA functional classes are as follows:
| Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Investigational and Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
| CPT |
|
| 93701 |
Bioimpedance-derived physiologic cardiovascular analysis [when specified as a fluid monitoring system] |
| 0607T |
Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (eg, ECG data), transmitted to a remote 24-hour attended surveillance center; set-up and patient education on use of equipment |
| 0608T |
Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (eg, ECG data), transmitted to a remote 24-hour attended surveillance center; analysis of data received and transmission of reports to the physician or other qualified health care professional |
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| HCPCS |
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| E1399 |
Durable medical equipment, miscellaneous [when specified as a fluid monitoring system] |
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| ICD-10 Diagnosis |
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All diagnoses |
| References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
| Websites for Additional Information |
| Index |
Arrhythmia Detection
AVIVO® Mobile Patient Management System
Bodyport™ Cardiac Scale
Heart Failure Decompensation
Non-invasive Heart Failure and Arrhythmia Management and Monitoring System
µ-Cor™ Heart Failure and Arrhythmia Management System (HFAMS)
VitalConnect Platform/VitalPatch® biosensor
ZOE Fluid Status Monitor
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
| Document History |
| Status |
Date |
Action |
| Reviewed |
08/07/2025 |
Medical Policy & Technology Assessment Committee review (MPTAC). Revised Description, Rationale, Background/Overview, References, and Websites sections. |
| Revised |
08/08/2024 |
MPTAC. Revised Title, revised Position Statement to remove device name and change from singular to plural devices. Revised, Description/Scope, Rationale, References, Websites, and Index sections. Updated Coding section to add CPT 93701 and E1399 NOC code. |
| Reviewed |
08/10/2023 |
MPTAC review. Updated Definitions, References and Websites sections. |
| Reviewed |
08/11/2022 |
MPTAC review. Updated Rationale, References and Websites sections. |
| Reviewed |
08/12/2021 |
MPTAC review. Updated Rationale, Background, References and Websites sections. |
| New |
08/13/2020 |
MPTAC review. Initial document development. |
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The requirements below are specific to the Florida Medicaid Managed Care Plan and are not a part of the Medical Policy or Clinical UM guideline approved by Elevance Health's Medical Policy and Technology Assessment Committee.
If the Florida Medicaid Managed Care Plan intends to deny coverage on the basis that a diagnostic test, therapeutic procedure, or medical device or technology is experimental or investigational, the Managed Care Plan shall submit a request for coverage determination to the Agency in accordance with rule 59G-1.035, F.A.C and Core SMMC Contract, Attachment II, Section VI.G.4.d.
Below is a list of the materials the plans are required to submit when they deny coverage as experimental/investigational: